Qual Life Res (2014) 23:1–184 DOI 10.1007/s11136-014-0769-6

ABSTRACTS

21st Annual Conference of the International Society for Quality of Life Research

 Springer International Publishing Switzerland 2014

Cutting Edge Research Plenary (1) What’s ‘‘Up’’: Patients’ and clinicians’ intuitive interpretation of PRO scores Claire Snyder, PhD, Johns Hopkins, Baltimore, MD, United States; Katherine C. Smith, PhD, Johns Hopkins Bloomberg School of Public Health; Elissa Bantug, MHS, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Emily Little, MPH, Johns Hopkins School of Medicine; Michael Brundage, MD, Queen’s University, Kingston, ON, Canada; PRO Data Presentation Stakeholder Advisory Board, Various Institutions AIMS: Whether higher scores represent better or worse outcomes varies across patient-reported outcome (PRO) measures and, in some cases, depends on the domain within a measure. Preliminary research suggests that this lack of consistency is confusing to patients and clinicians, creating a barrier to their use of PROs in practice. This study explored how patients and clinicians intuitively interpret increasing and decreasing PRO scores, with the goal of improving approaches for presenting PROs to promote understanding and use. METHODS: This mixed-methods study recruited cancer patients who had completed acute treatment and cancer clinicians from a network of academic and community practices. Patients were purposively sampled by cancer type, care setting, and education; clinicians were purposively sampled by specialty and practice setting. Participants first self-completed a sample PRO questionnaire and were then shown two line graphs: one labeled ‘general well-being’ with the line trending up and one labeled ‘shortness of breath’ with the line trending down. No instructions regarding the meaning of direction were provided. For each graph, participants reported whether they thought the line represented a score that was getting ‘better,’ ‘worse,’ or ‘not sure.’ They were then shown various formats for presenting PRO data (e.g., line graphs, bar charts, heat maps). Following the selfdirected portion, qualitative interviews explored participants’ intuitive understanding of scoring direction. Interviews were transcribed and coded in Atlas.ti. The frequency distributions for the quantitative measures were calculated, and the qualitative results informed interpretation of the quantitative findings. RESULTS: The sample (n = 70) included 50 patients (median age 65, 54 % female, 78 % white, 44 % non-college graduate) and 20 clinicians (median age 42, 60 % male, 85 % white). The vast majority interpreted the increasing ‘general well-being’ line as getting better (patients: 96 % better, 2 % worse, 2 % not sure; clinicians: 80 % better, 15 % not sure, 5 %

worse). Interpretation of the decreasing ‘shortness of breath’ line varied (patients: 60 % worse, 34 % better, 6 % not sure; clinicians: 70 % better, 20 % not sure, 10 % worse). In the qualitative interviews, patients and clinicians both reported that presentation formats with variation across domains in whether higher/lower is better/worse were confusing and recommended consistent presentation. CONCLUSIONS: PRO scoring and/or presentation approaches are needed to address patients’ and clinicians’ intuitive interpretation and call for consistency.

(2) Do different health attributions make a difference in questions about work and other role activities? Jakob B. Bjorner, MD PhD, QualityMetric; Janine Devine, Charite´— Universita¨tsmedizin Berlin, Berlin, Germany; Barbara Gandek, MS, University of Massachusetts Medical School, Arlington, MA, United States; Mark Kosinski, MA, Quality Metric Incorporated, Lincoln, RI, United States; Matthias Rose, MD PhD, Charite´ Universita¨tsmedizin Berlin, Worcester, MA, United States; John E. Ware, Jr., PhD, University of Massachusetts Medical School, Worcester, MA, United States AIMS: Literature on the effect of health attribution on item response is scarce, though measurement implications can be large. Some standard tools, such as the SF-36 Role Physical and Role Emotional subscales, use items with health attribution (e.g., ‘‘… have you had any of the following problems with your work or other regular daily activities as a result of your physical health?’’). Other tools, such as the PROMIS Ability to Participate in Social Roles and Activities items, do not use health attribution (e.g., ‘I have trouble doing all of my usual work (include work at home)’’). This study compared items with and without health attribution and analyzed the prevalence of role limitations; agreement between items with different types of attribution; differences in validity in discriminating between clinical groups; and latent domain structure. METHODS: A representative sample of 900 U.S. adults completed 15 sets of role functioning items (33 items in total) which differed in attribution (no attribution or attribution to health, physical health, or emotional health) but were otherwise identical in content. Prevalence rates of role limitations and item response agreement statistics including Weighted Kappa were calculated. Logistic regression was used to examine known groups validity, and confirmatory factor analysis was used to examine the latent structure. RESULTS: Items without attribution detected

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2 significantly more role limitations than items with health attributions. We found high similarity between responses to items with attribution to health and items with attribution to physical health (kappa = 0.41–0.73). Items without attribution had lower validity in discriminating between clinical groups. Items with attribution to health or physical health were the most valid in discriminating between groups with and without physical conditions (OR = 2.3–4.9), while items with attribution to emotional health were the most valid in discriminating between groups with and without mental conditions (OR 6.2–9.5). Less than 50 % of the variance in responses to items without health attribution could be explained by health factors. CONCLUSIONS: Items without attribution seem to capture role limiting factors other than health. We recommend using items with health attribution when role functioning is being measured in health outcomes research.

(3) Group concept mapping: A novel, patient-centered, mixed methods approach to identifying relevant concepts for patient-reported outcome measures and facilitating participant engagement Tom Willgoss, PhD, Abacus International, Manchester, United Kingdom; Mary Kane, Concept Systems Inc.; Louise Humphrey, Abacus International, Bicester, United Kingdom; Michael Huffman, Concept Systems Inc.; Tara Symonds, PhD, Pfizer Ltd., Tadworth, United Kingdom; Joseph C. Cappelleri, PhD MPH, Pfizer Inc, Groton, CT, United States AIMS: Patient-reported outcome (PRO) researchers seek methods to capture and include the perspectives of patients, with the intention of aligning patient’s own experiences with meaningful and suitable or ‘fit for purpose’ clinical outcomes. The aim of this paper is to demonstrate the value of Group Concept Mapping (GCM) in developing patientcentered outcomes and encouraging participant engagement by piloting the approach with experts involved in PRO research. METHODS: GCM is an innovative, mixed methods approach that can generate a comprehensive participant-authored understanding of a construct. Using GCM to develop PRO measures for clinical programme research offers high potential to accelerate the development of PRO measures. To test the concept, we conducted a pilot study with researchers to demonstrate GCM’s use for developing a comprehensive conceptual map. The process used online Concept Systems tools to: (1) Generate concept content: N = 15 PRO researchers provided responses via email to this cue: ‘A specific characteristic of a ‘fit for purpose’ patientreported outcome is…’ This produced a list of statements from all participants on the concept of ‘fit for purpose.’ (2) Sort statements into conceptual groups: Participants sorted individually all responses into conceptual groups (self-identified categories). (3) Rate on importance: Participants rated each response on importance using a 5-point Likerttype scale. (4) Develop the group concept map: Participants’ sorting and rating responses were analyzed to produce a concept map through multidimensional scaling and hierarchical cluster analysis. RESULTS: We present the findings of the GCM methodology via interpretable concept maps. The analyses allow an understanding of how the group thinks the concepts are related to one another, the emergent domains, and which concepts are considered most important to the group. We compare ratings by predefined subgroups to assess consensus. CONCLUSIONS: GCM supports the development of a rich and lucid understanding of a construct. The approach can support developing patient-centered outcomes by engaging patients in the development of a conceptual model. This ensures that patients are active in the research process and limits researcher bias. GCM can generate comprehensive patient-centered conceptual models in small samples (typically N \ 20) to develop in-depth understanding of a construct where both time and budgets are limited.

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Symposium Sessions Symposium #1: Patient and public engagement (PPI) cafe´ II: towards a model of patient engagement (PE) for ISOQOL Kirstie Haywood, DPHiL BSc, Royal College of Nursing Research Institute, Warwick Medical School, Coventry, United Kingdom; Sam Salek, BSc RPh PhD FFPM, Cardiff University, Cardiff, United Kingdom; John Kirwan, BSc MD FRCP, University of Bristol, Bristol, United Kingdom; Maarten de Wit, PhD, VU University, Amsterdam, Netherlands Over the last decade, several organizations have led the way towards including patients as partners in research. Involving patients as active partners in the research process can widen focus, adjust ways of working, result in new developments in the research agenda, and inform the use of more patient-centered outcomes in clinical trials. Although often challenging, the cumulative effect of including the perceptions and beliefs of patients, health professionals and researchers, as well as a growing body of evidence regarding the benefit of active patient and public engagement, has resulted in a steady increase in patients as partners in PRO-related research. During this symposium, we will explore with patient partners and other stakeholders, including health professionals, researchers, and members of ISOQOL, the ‘best’ solution for Patient Engagement in health-related quality of life, patient-centered outcomes, and PROrelated research and the involvement of patient partners within the ISOQOL community. Following the success of the first ‘Patient Engagement Cafe´’ held at the 2013 ISOQOL conference, we will again adopt a ‘World Cafe´’ format for the symposium. Patient Partners, health professionals, researchers, and members of the ISOQOL community will be invited to participate.

Symposium #2: Doc, how bad is it? Setting standards for severity of patient-reported outcomes data using item banks from PROMISÒ and Neuro-QOL Moderator: David Cella, PhD, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States Panelists: Karon Cook, PhD, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States; David Victorson, PhD, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States; Deborah M. Miller, PhD, The Cleveland Clinic Foundation, Cleveland, OH, United States Health outcomes researchers are developing more precise measures of patient-reported outcomes (PROs) with increasing use of Modern Test Theory such as Item Response Theory (IRT). This approach allows for increased flexibility of assessment, score precision, and greater understanding of an individual item’s performance, including information and discriminability estimates. IRT-derived t-scores for a given PRO domain do not however provide a means of clinical classification for a given individual who receives a specific score. The field of educational testing has long used a mixed-methods, modified-Delphi consensus approach, the Bookmarking Method (BMM), to establish cut scores for academic tests. In this symposium, we draw from our collective experiences conducing three separate standing setting studies, two in cancer and one in multiple sclerosis (MS), and present an emerging methodology and results for the field of PRO Measurement Science to develop interpretive guideline for PROs. Applying this methodology to PROs can help patients and clinicians understand the severity of the symptom that patients experience and recognize when a threshold of change has occurred that may signal a need to reassess the current treatment approach. Before these interpretation guidelines can be applied in a clinical setting

Qual Life Res (2014) 23:1–184 however, it is also recommended that they are validated and confirmed in a larger clinical sample. The means for conducting this validation is also an emerging methodology we will discuss. The members of this panel will provide a general introduction to the BMM methodology and share how they have adapted and applied BMM and cut score validation methodologies for setting clinically meaningful interpretation guidelines for IRT-developed PROs for persons with a range of cancers and MS. Specifically, moderator Dr. Cella will offer an introduction and framing observations to the standard setting pedagogy and method that we have applied to PRO interpretation. This will be followed by key discussion questions to panelist Drs. Cook, Miller and Victorson, such as disease specific considerations when selecting standard setting participants, the pros and cons of using expert and/or patient panels, different score validation approaches (e.g., in-clinic vs. panel-testing organization) and differences in actual cut scores of the same measure across patient groups.

Symposium #3: Applying computer adaptive testing in child reported outcome measurement—a New Era of assessment? Moderators/Discussants: Ulrike Ravens-Sieberer, MPH, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Monika Bullinger, PhD, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Christopher B. Forrest MD PhD, Children’s Hospital of Philadelphia, Philadelphia, PA, United States Assessing Health-Related Quality of Life (HRQOL) via Computerized Adaptive Testing (CAT) promises to provide greater measurement precision while increasing efficiency and reducing respondent burden. Currently, CAT tools are rarely used in pediatric medical care or clinical research to assess child reported outcomes. AIMS: This symposium will provide an overview about CAT-applications and identify solutions for the barriers to adoption of pediatric CATs by evaluating several international case studies of CAT administration in a variety of clinical and research settings. METHODS: This symposium is presented as part of the ISOQOL Child Health Special Interest Group in recognition of the need to develop and disseminate new methods that address the challenges associated using new technologies when assessing Quality of Life (QOL) in pediatric populations. The symposium is comprised of six (6) presentations, each describing an innovative CAT application that improves pediatric PRO assessment for children and youth with a variety of physical and/or behavioral conditions. Presenters will describe the use of: (1) The KIDS-CAT: development and application of a CAT based on the European KIDSCREEN measurement model to assess generic QOL in European children in routine pediatric care; and (2) assessing disease-related QOL in children with a chronicgeneric CAT based on the European DISABKIDS measurement model; (3) CATs to improve the precision of QOL measurement and reduce test burden among children with Cerebral Palsy in rehabilitation medicine; (4) experiences from using child CATs in the Netherlands to assess psychosocial burden in preventive medicine; (5) integrating adaptive testing of PROs in medical records/healthcare in the US; and (6) CATs in young adults—experiences from a large scale application in psychosomatic medicine using a depression and anxiety CATs. CONCLUSIONS: By applying different innovative CAT approaches for children and adolescents as described in this symposium, researchers can ensure that relevant PROs meaningful to young people are measured in health care services. CATs are advancing pediatric PRO measurement by reducing burden for respondents and enhancing the patient-physician communication via instant score reports. Discussion will focus on these learnings and how they can be applied to accelerate CAT adoption.

3 Individual presentations The kids-CAT: Development and application of a computerizedadaptive test to assess generic quality of life in children and adolescents in routine pediatric care Dana Barthel, Dipl.-Psych., University Medical Center HamburgEppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Christiane Otto, Dr. rer. hum.biol., University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Janine Devine, PhD, University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Kirsten Gulau, Dipl.-Biol., University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Marcus Klein, MD, Christian-Albrechts-University of Kiel, Department of General Pediatrics, Kiel, Germany; Ute Thyen, PhD, University Medical Center Lu¨beck, Clinic of Paediatrics, Lu¨beck, Germany; Silke Schmidt, PhD, Ernst-Moritz-Arndt-University, Department Health and Prevention, Greifswald, Germany; Holger Mu¨hlan, Ernst-Moritz-Arndt-University, Department Health and Prevention, Greifswald, Germany; Sandra Nolte, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Annett Mierke, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Felix Fischer, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Otto Walter, MD, Head of Research and Development, Point of Mind, Munich, Germany; Matthias Rose, MD, PD, Head of Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Ulrike Ravens-Sieberer, MPH, Head of Research— Professor for Child Public Health, University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany AIMS: Item banks to measure child patient-reported-outcomes (PRO) have recently been developed; however, the implementation of Computerized-Adaptive Tests (CAT) in clinical practice is still rare. Only few CAT tools are available to assess pediatric HRQOL in an efficient and precise way. This paper aims at describing the development and application of a CAT to assess generic HRQOL of children: the KidsCAT. METHODS: The Kids-CAT was developed and validated along the European HRQOL KIDSCREEN-27 domain structure, allowing for a shorter, yet equally valid and precise assessment via CAT technology, and providing an instant feedback of HRQOL scores to the pediatrician. The development combined qualitative (Delphi) and quantitative methods, such as classical test theory and item response theory methods in line with the US pediatric PROMIS approach. Using large archival data of European HRQOL norm studies (n = 10,577 to 19,580), five Kids-CAT item banks were built (26 to 46 items per bank) measuring ‘physical well-being’, ‘psychological well-being’, ‘parent relations’, ‘social support & peers’, and ‘school well-being’. RESULTS: The five Kids-CAT item banks show good psychometric properties, i.e. high content validity, sufficient unidimensionality, local independence, low DIF, model conform IRCs. After programming, the CAT was applied in a longitudinally design to a clinical sample of 300 children (7–17 years) with chronic diseases (asthma, diabetes, rheumatoid arthritis) at two German pediatric medical centers and at schools to a norm sample of 1,200 German children. Reliability, validity, and responsiveness to change of the Kids-CAT were evaluated. The developed CAT-software allows for an easy administration, on average 4 to 6 items were displayed with a reliability of [ 0.9 (standard error of measurement below 0.32), easy scoring, and feedback of the scores. The median item response time varied according to age and reading

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4 abilities (2 to 3 min per item bank). In focus groups, conducted to evaluate feasibility, children reported high user-friendliness of Kids-Cat, while pediatricians emphasized the enhanced communication with the children. CONCLUSION: The Kids-CAT advances pediatric HRQOL measurement in routine pediatric care by allowing a precise and valid measurement, making it less burdensome for respondents, and enhancing the patient-doctor communication via instant score reports.

Assessing disease-related quality of life in children and adolescents with chronic conditions: development and application of a chronic-generic CAT derived from the DISABKIDS framework Holger Mu¨hlan, Ernst-Moritz-Arndt-University, Department Health and Prevention, Greifswald, Germany; Silke Schmidt, PhD, ErnstMoritz-Arndt-University, Department Health and Prevention, Greifswald, Germany; Janine Devine, PhD, University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Otto Walter, MD, Head of Research and Development, point of mind, Munich, Germany; Felix Fischer, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Sandra Nolte, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Matthias Rose, MD, PD, Head of Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Ulrike Ravens-Sieberer, MPH, Head of Research—Professor for Child Public Health, University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany BACKGROUND: Computer adaptive testing (CAT) had been successfully applied to quality of life measurement, also for assessing health status of children and adolescents. Nevertheless, by now no paediatric CAT was developed assessing disease-related quality of life based on a chronic-generic measurement approach. AIMS: It was aimed to develop a paediatric CAT by adopting a chronic-generic approach to quality of life assessment in children and adolescents with chronic health conditions. The item bank was derived from the modular DISABKIDS framework and implemented within the KIDSCAT approach. METHODS: The item bank was developed by applying a mixed-method approach, combing qualitative and quantitative strategies. The initial item set included items from the DISABKIDS chronic generic measure as well as the condition module of the KINDL-R. In a first step, several items were omitted by expert consensus. In a second step, the item set was analyzed with respect to unidimensionality, local independency, differential item functioning, and item response curves, using data of the European DISABKIDS and KIDSCREEN studies. In a further step of item bank development, CAT simulations had been conducted. The performance of the final item bank was tested in the field study, applying the paediatric CAT to assess disease-related quality of life in children and adolescents (n = 300) with several chronic conditions (e.g. diabetes and asthma). RESULTS: The paediatric CAT initially showed sufficient psychometric performance according to several psychometric properties. It has proven to be applicable for disease-related quality of life assessment in children and adolescents with different chronic health conditions. This final version of the CAT measure seems to be a meaningful tool to assess disease-related quality of life across different chronic conditions and to provide added value for clinicians by a realm-time score reporting system implemented in the CAT.

CATs in pediatric rehabilitation medicine Carole A Tucker PT, PhD, Temple University, Philadelphia PA, United States

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Qual Life Res (2014) 23:1–184 Child onset neuromusculoskeletal diseases present unique lifespan issues for the individual, their family and health care givers. Cerebral Palsy (CP) is the most common neuromusculoskeletal disease in children and causes alterations in sensory and muscle function resulting in impairments in mobility and possible restrictions in activity and participation. Assessment of physical functioning is critical for the management of the clinical outcome of children and adolescents with cerebral palsy (CP), and patient and parent/proxy reported outcomes (PROs) of health and health-related functioning are increasingly being used in pediatric rehabilitation settings. In recent years, efforts have focused on developing computer adaptive tests (CATs) to assess physical functioning, activity and participation in children with CP in a large clinical network of pediatric hospitals. CAT administration provides the best means to obtain precision in scores while minimizing administration burden—an important, even necessary for outcomes administered within clinic settings. Experiences with PROMIS pediatric and parent—proxy generic health patient reported outcomes. PROs and condition –specific (CP) CAT measures developed through Shriners Hospital for Children will be discussed. Both sets of instruments provides means to measure change after interventions, capture change longitudinally, and provide uniform assessment of individuals of different ages and skill levels in children with CP from both . The objectives of this session are to describe the development and application of these measures within the SCH clinic system, and plans for integration of these measures in both clinical and research settings within outpatient clinic settings across hospital networks.

Validation of a computerized adaptive test for the identification of children with psycho-social problems Symone B. Detmar PhD, TNO Child Health, Leiden, Netherlands; Meinou H.C. Theunissen, PhD, TNO Child Health, Leiden, Netherlands; Marianne S. de Wolff PhD, TNO Child Health, Leiden, Netherlands; Jacqueline Deurloo, MSc, TNO Child Health, Leiden, Netherlands Sijmen A. Reijneveld, MD PhD, TNO Child Health, Leiden, Netherlands, and University Medical Center Groningen, University of Groningen, Department of Health Sciences, Groningen, Netherlands; Paul H. Verkerk, PhD, TNO Child Health, Leiden, Netherlands; Anton. C.G. Vogels, PhD, TNO Child Health, Leiden, Netherlands BACKGROUND: Questionnaires used by health services to identify children with psychosocial problems are often rather short. The psychometric properties of such short questionnaires are often insufficient for an accurate distinction between children with and without problems. We aimed to assess whether PSYCAT, a short Computerized Adaptive Test (CAT) can overcome the weaknesses of short written questionnaires when identifying children with psychosocial problems. METHOD: We used a Dutch national data set obtained from parents of children aged 7–12 years old invited for a routine health examination by Preventive Child Healthcare (PCH) with 205 items on behavioral and emotional problems (n = 2,041, response 84 %). In a random subsample we determined which items met the requirements of an Item Response Theory (IRT) model to a sufficient degree. Using those items, item parameters necessary for a CAT were calculated and a cut-off point was defined. We determined the validity and efficiency of a Computerized Adaptive Test using simulation techniques. Next, it was investigated whether the validity as assessed in the simulation study can by replicated in the practice of routine health examinations by PCH. We invited 762 parents of children undergoing routine health examinations to complete the Child Behavior Checklist (CBCL) and the CAT. In both studies a clinical score on the CBCL was used as criterion. RESULTS: The simulation study showed that

Qual Life Res (2014) 23:1–184 for 90 % of the children a score above or below cut-off point of the clinical score could be determined with 95 % accuracy. The mean number of items needed to achieve this was 12. Sensitivity and specificity with CBCL as a criterion were 0.89 and 0.91, respectively. The second study showed that only 29 % of all parents invited to participate completed the PSYCAT. The CBCL classification clinical vs not clinical and PSYCAT elevated vs not elevated converged in 94 % of all cases (kappa = 0.41). CONCLUSION: An IRT-based CAT is a very promising option for the identification of psychosocial problems in children, as it can lead to an efficient, yet high-quality identification. Currently, a pilot study is conducted in using the CAT as a standard instrument in routine health examinations by PCH. Integrating computerized adaptive tests into electronic health records and clinical care Christopher B. Forrest, MD, PhD, Children’s Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, United States The clinical application of patient-reported outcomes (PROs) is perhaps the most rapidly expanding user community for these measures. The advent of patient portals and personal health records (EHRs) that are linked to and integrated with electronic health records creates new ways to obtain PRO data. The computerization of healthcare at the point-of-care via EHRs and patient portals greatly facilitates the use of computerized adaptive tests (CAT). In fact, our team has assisted the largest U.S. EHR vendor to integrate PROMIS fixed-length short forms into a new PRO application. The next phase of this work is the integration of CAT algorithms into this EHR system, which in the U.S. is used by 70 % of pediatric care centers. The talk will address the opportunities and challenges of the clinical integration of CATs into EHRs, focusing on issues of the data model, technical hurdles, work flows in routine practice settings, and analysis. In addition, our research team leads a newly funded national network of children’s hospitals called PEDSnet, which is part of the newly created clinical research network of networks, PCORnet, that PCORI has launched this year. One of the goals of both PEDSnet and PCORnet is to integrate PROs into routine care settings, so that these data can be used for comparative effectiveness research and quality improvement. This new research infrastructure will create a ‘‘big data’’ resource that will benefit from the precision and efficiency of PRO measurement that CAT offers. Sponsors: National Institutes of Health and Patient Centered Outcomes Research Institute

The application of CATs in young adults—10 years of experience with depression, anxiety and stress CATs in a psychosomatic setting Felix Fischer, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Sandra Nolte, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Matthias Rose, MD, PhD, Head of Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany BACKGROUND: Some of the first Computer-Adaptive Tests (CAT) in the field of Patient-Reported Outcomes have been developed in the beginning of the last decade at the Medical Clinic, Department of Psychosomatic Medicine, Charite´—University Medical Center Berlin, Germany. Since then, these tests have been applied in routine psychometric diagnostics in ambulatory care, at hospital admission and at discharge. We present our experiences with the application of CATs in clinical practice with a focus on young adults. METHODS: In a consecutive sample of patients we investigate differences in the

5 application of the Depression, Anxiety and Stress CAT with respective severity estimates between young adults and other patient groups. We present average item use, item response time, and test length. We also investigate whether the use of CATs imposes problems in young adults by collecting feedback from medical staff. RESULTS: Approximately 64,000 CATs were applied from 2006 until the beginning of 2014 at the Department of Psychosomatic Medicine. About 10 % of respondents were younger than 25 years, with 80 % being female. Median item response time was about 1–2 s shorter in young adults, while number of items presented was identical. Feedback from clinicians showed that interpretation of the theta scale can be unfamiliar for clinicians. CONCLUSION: Once a framework for the application of Computer-Adaptive Tests is established, CATs are a feasible alternative to static questionnaires in clinical practice. From our experience there is no indication that CAT application poses specific problems in young adults. On the contrary, barriers for successful CAT application such as difficulties to read from or to use an electronic device in general are more prevalent in other patient groups, such as the elderly or immigrants.

Symposium #4: Quality of life and cancer prevention Moderator: Carolyn Gotay, PhD, University of British Columbia, Vancouver, BC, Canada Cancer is one of the most prevalent chronic and fatal diseases worldwide, yet at least half of all cancer cases could be prevented. Preventive strategies include lifestyle changes such as tobacco cessation and increased physical activity, immunizations against infectious agents, chemoprevention including uses of hormonal and dietary agents, and surgical interventions. For cancer prevention treatments in healthy people who do not have a diagnosed disease, it is particularly important that interventions do not negatively impact health-related quality of life (HRQOL). Further, the impact of such interventions on HRQOL affect individuals’ acceptance of and adherence to the preventive strategy. This symposium presents information about the effects of a four different cancer prevention interventions on HRQOL and other outcomes. The interventions include a sleep intervention to reduce risks in shiftworkers at increased risk of breast cancer; immunizations for the human papilloma virus (HPV) in young women to prevent cervical cancer; randomized clinical trials of chemopreventive agents to prevent prostate cancer; and prophylactic mastectomy, to prevent breast cancer in women at increased genetic risk. The 90-min symposium will take the format of a brief introduction (5 min) to the goals of the session and cancer prevention, followed by four (15 min) paper presentations. An expert discussant will then provide (10 min) comments on HRQOL assessment in the context of prevention and similarities and differences compared to research in patients with health conditions. Ample time (15 min) will be allotted for audience questions and comments. This symposium will provide attendees with a novel perspective on the uses and contributions of HRQOL assessment, going beyond assessing wellbeing in patients with a diagnosed illness, toward contributing to health in the general population. Individual presentations A sleep intervention to improve quality of life (QOL) and sleep in shiftworkers at increased risk of breast cancer Carolyn Gotay, PhD; Hui Shen, PhD; Carola Munoz, BA, Cancer Prevention Centre, University of British Columbia, Vancouver, BC Canada BACKGROUND: Shiftwork that exposes women to light at night has been designated as a 2A carcinogen for breast cancer by the

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6 International Agency for Research in Cancer. While the specific biological mechanisms that confer increased risk are not yet established, sleep disruption is hypothesized to have both direct (e.g., effects on melatonin and cortisol) and indirect (e.g., effects on health behaviours and QOL) impacts on risk status. An intervention to improve sleep and QOL could reduce these risks. METHODS: Female night shiftworkers participated in a study examining the impact of a sleep intervention. The Quality of Life Enjoyment and Satisfaction (Q-LES-Q) assessed QOL; and the Pittsburgh Sleep Quality Index (PSQI) measured sleep quality. Data were assessed at baseline and 6 months later, during which women were provided with a 12-session, telephone-delivered cognitive behavior therapy (CBT) sleep intervention. RESULTS: This analysis is based on the first 48 women in this study. Mean age was 47, 68 % were partnered, and 62 % had diploma-level or higher education. Largest numbers were nurses (49 %) or paramedics (13 %) or in emergency communications (17 %). At baseline, 77 % had ‘‘poor’’ sleep quality on the PSQI, and 59 % at 6 months (p \ 0.008, based on McNemar’s test for the 29 women who completed baseline and follow-up questionnaires). Overall Q-LES-Q life satisfaction at baseline was 3.61 (SD = 0.71) on a 1–5 scale, and 3.88 (SD = 0.77) at 6 months (ns). These scores are significantly higher than norms for patients with psychiatric diagnoses and lower than community norms. The only QOL domains related to sleep quality were work satisfaction (p = 0.04) and ability to get around (p = 0.0009). DISCUSSION. Data indicate that female night shiftworkers report impaired sleep quality and QOL. The CBT intervention shows promising results to improve sleep quality. Preventive interventions need to consider and assess their effects on QOL; as well, QOL data provide indications that the intervention is having an impact well in advance of incidence-related outcomes.

Quality of life and HPV vaccine R. Hofman, Department of Public Health, Erasmus MC—University Medical Centre Rotterdam, Netherlands; E.W. de Bekker-Grob, Department of Public Health, Erasmus MC—University Medical Centre Rotterdam, Netherlands; J.H. Richardus, Department of Public Health, Erasmus MC—University Medical Centre Rotterdam, Netherlands, and Municipal Public Health Service Rotterdam-Rijnmond, Netherlands; H.J. de Koning, Department of Public Health, Erasmus MC—University Medical Centre Rotterdam, Netherlands; M. van Ballegooijen, Department of Public Health, Erasmus MC—University Medical Centre Rotterdam, Netherlands; I.J. Korfage, Department of Public Health, Erasmus MC—University Medical Centre Rotterdam, Netherlands BACKGROUND: Human Papillomavirus (HPV) vaccines have become available that provide protection against about 70 % of cervical cancers. As in many Western countries, the Netherlands included HPV vaccination in their immunization program, offering the vaccine to 12-year old girls. The introduction of the program coincided with an intensive societal debate involving politics, physicians, media, parents and girls. Almost 3 years after the introduction no serious side-effects were proven to be linked to the vaccine. Uptake rates increased from 52 % in 2009 to 59 % in 2011, but remain relatively low. We therefore assessed HPV vaccination preferences, reflecting Quality of Life domains and the concerns of target groups. METHODS: We conducted a Discrete Choice Experiment (DCE) among girls aged 11–15 years. In DCEs, participants trade off risks and benefits among competing programs. In DCEs it is assumed that a healthcare intervention can be described by its attributes and that levels of that attributes determine preferences for an intervention. By offering a series of choices between two or more intervention alternatives with different combinations of

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Qual Life Res (2014) 23:1–184 attribute levels, the relative importance of attributes can be assessed. A panel latent class model was used based on five attributes: degree of protection against cervical cancer; duration of protection; risk of mild side-effects; age of vaccination; and the number of required doses. RESULTS: The response rate was 85 % (500/592). Most girls preferred vaccination at the age of 14 years (instead of 9 years) and a 2-dose scheme (instead of the current 3-dose scheme). Girls were willing to trade-off 7 % (CI 3.2 % to 10.8 %) of the degree of protection to have 10 % less risk of mild side-effects, and 4 % (CI 1.2 % to 5.9 %) to receive 2 doses instead of 3. Latent class analyses showed that there was preference heterogeneity among girls: higher educated girls and HPV vaccinated girls had a higher probability to opt for HPV vaccination at a higher age than lower educated girls or non-vaccinated girls. CONCLUSIONS: We recommend not to lower the current target age of 12 years and to introduce a 2-dose scheme as its efficacy has been demonstrated.

Health-related quality of life outcomes in prostate cancer prevention clinical trials Carol M. Moinpour, PhD, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States; Amy K. Darke, MS, SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA, United States; Patricia Ganz, MD, Jonsson Comprehensive Cancer Center. University of California Los Angeles, Los Angeles, CA, United States; Eric Klein, MD, Cleveland Clinic Foundation, Cleveland, OH, United States; Ian Thompson, MD, University of Texas Health Science Center, Cancer Therapy & Research Center, San Antonio, TX, United States BACKGROUND: There is considerable public health interest in preventing prostate cancer because of the morbidity and mortality associated with the disease as well as the fact that both screening and treatment consume considerable resources. A broad definition of chemopreventive approaches for prostate cancer will include chemopreventive agents such as finasteride and dutasteride as well as antioxidant vitamins and minerals such as selenium and vitamin E. METHODS: The Prostate Cancer Prevention Trial (PCPT) and the Selenium (Se) and Vitamin E (E) Cancer Prevention Trial (SELECT) will be highlighted because each represented a different design challenge with respect to health-related quality of life (HRQOL) outcomes. In both cases, HRQOL was included as an outcome in order to document that a preventive intervention did no harm with respect to HRQOL. The PCPT randomized 18,882 men to finasteride or placebo; men were followed for 7 years and, if cancer free, had an end of study prostate biopsy. HRQOL was measured at study enrollment, 6 months, and annually for 7 years. SELECT randomized 35,533 men to Se ? placebo, E ? placebo, Se ? E, or placebo ? placebo. SELECT HRQOL monitoring occurred prior to randomization, and at years 1, 3, 5, and 7 of the follow-up period. HRQOL assessments in PCPT/SELECT included the following: SF-36 (SF-36 Veterans version for SELECT); sexual function with the MOS Sexual Problems Scale and a study-derived Sexual Activity Scale (PCPT); urinary function (PCPT); single item global measure (SELECT); baseline only physical activity, diet, and other health/ lifestyle behaviors (both trials). RESULTS: For the PCPT, although sexual function was statistically significantly associated with finasteride use, the difference was not clinically significant and the difference was smaller than interindividual variation after accounting for a number of covariates. Effects of finasteride on HRQOL although statistically significantly different from the placebo arm were smaller than those associated with the effect of comorbidities and smoking status. Analyses for the SELECT HRQOL data will occur in 2014 and be presented at the symposium. Challenges associated with the analysis and interpretation of HRQOL data in very large samples will also be addressed.

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Health-related quality of life (HRQOL) following prophylactic mastectomy and reconstruction

Individual presentations

Andrea Pusic MD, MHS, FRCSC, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Colleen McCarthy MD FRCS, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Anne Klassen, DPhil, McMaster University, Hamilton, ON, Canada; Stefan Cano, PhD, Plymouth University, Plymouth United Kingdom; Peter Cordeiro MD FACS., Memorial Sloan-Kettering Cancer Center, New York, NY, United States

Enhancing the sensitivity of quality of life measurement by taking the trait-state distinction and response shift into account

RESEARCH QUESTION: What are the HRQOL outcomes of women who undergo prophylactic mastectomies and reconstruction? BACKGROUND: As the availability of genetic screening expands, an increasing number of patients at high risk of breast cancer are electing to undergo prophylactic mastectomies with reconstruction. To optimize informed decision-making, these patients and their physicians require information on expected HRQOL outcomes such as body image, physical, psychological and sexual well-being. METHODS: The BREAST-Q PRO instrument was administered pre and postoperatively to 100 patients undergoing bilateral mastectomies and reconstruction. Patients were stratified based on whether or not mastectomies were performed for prophylaxis or treatment of invasive disease. To facilitate multivariate regression analysis, data was also collected on relevant covariables such as age, marital status, race/ethnicity, type of reconstruction, adjuvant therapy and complications. RESULTS AND DISCUSSION: The results of this study will be presented with a focus on how patient-centered data may used to improve preoperative education for patients undergoing prophylactic mastectomies. We will also consider differences in satisfaction and HRQOL comparing prophylactic surgery patients to patients undergoing surgery for invasive cancer.

Symposium# 5: Ambulatory monitoring and mobile assessment of quality of life Moderator: Silke Schmidt, PhD, Department Health and Prevention, Ernst-Moritz-Arndt-University, Greifswald, Germany Discussant: Mogens Gro¨nvold, MD PhD, Department of Public Health, Section of Health Services Research, Copenhagen, Denmark BACKGROUND: Ambulatory monitoring and mobile assessment of quality of life are emerging areas in clinical studies and scientific research. Due to technological developments, remote assessment of patient-reported outcomes has become more accessible and easy-to-use. AIMS: The symposium aims to provide an overview on several methodological challenges that are related to ambulatory monitoring and mobile assessment of quality of life, e.g. different assessment approaches, investigating temporal stability, adopting retrospective measures, implementing adaptive testing. METHOD: The symposium is comprised of 5 presentations, covering different methodological issues related to that emerging area: (1) improving assessment by taking the trait-state distinction and response shift into account, (2) describing challenges in ‘momentanizing’ the items of a standard (retrospective) instrument, (3) investigating the impact of ambulatory monitoring and changing health conditions on health-related cognitions, (4) analyzing the potential of computerized adaptive testing for ambulatory monitoring, and (5) evaluating the acceptance of a child/adolescent mobile CAT in children/adolescents. CONCLUSIONS: This symposium covers a range of methodological issues linked to ambulatory assessment of quality of life. Thereby, it puts emphasis on potentials for flexible assessment and improved measurement of quality of life in clinical settings and research studies.

Mirjam AG Sprangers, PhD, Department of Medical Psychology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; Pythia T. Nieuwkerk, Department of Medical Psychology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; Carolyn Schwartz, ScD, DeltaQuest Foundation, Inc., Concord, MA, United States AIMS: Despite apparent changes in health, patients may report surprisingly stable quality of life (QOL).Two key causes are addressed that are generally ignored in QOL research: (1) standard QOL questionnaires predominantly tap stable (trait) rather than changeable (state) components of QOL; and (2) they do not take changes in internal standards, values and conceptualisation of QOL (so called response shifts) into account. The overall objective is to improve the conceptualisation of QOL and to enhance the sensitivity of its measurement by taking the traitstate distinction and response shift into account. METHODS: This presentation synthesizes insights from the trait-state, response shift, and Ecological Momentary Assessment (EMA or ambulatory assessment) literature to propose a new strategy for QOL conceptualisation and assessment. RESULTS: We will present the argument that EMA (state measures) and retrospective self-reports (trait measures) provide unique and complementary information. We will discuss how one conceptualizes and distinguishes trait and state measures, and the challenges therein. We will discuss the current literature on EMA and response shift, and relevant questions relating the two. Finally, we will discuss the statistical implications of including both trait and state components and response shift effects on model fit, error terms, and power. CONCLUSIONS: With this study we hope to recommend best practices for integrating state and trait assessments and response shift effects in QOL research to enhance its measurement. We will also address the theoretical and ethical implications of the trait-state distinction of QOL and response shift for the delivery and allocation of care.

The impact of ambulatory health monitoring and changing health conditions on health-related cognitions Holger Muehlan, PhD, Department Health and Prevention, ErnstMoritz-Arndt-University, Greifswald, Germany; Tim Rostalski, Dipl.Psych., Department Health and Prevention, Ernst-Moritz-Arndt-University, Greifswald, Germany; Silke Schmidt, PhD, Department Health and Prevention, Ernst-Moritz-Arndt-University, Greifswald, Germany AIMS: Initially established as a methodological approach for research on daily life experiences, ambulatory monitoring of self-reported data has become an established method for remote and continuous assessment of patient-reported outcomes. Beyond studies on measurement bias, little is known about the impact of health monitoring on health-related attention and cognitions. We investigated the impact of ambulatory monitoring of health status/health-related quality of life as well as changing health conditions on health-related attention and cognitions (e.g. rumination). METHODS: Ambulatory monitoring was applied to 50 participants with minor or seasonal health conditions (A) allergic rhinitis, (B) in 2 consecutive studies each with 2-week time periods with 42 points of measurement. We tracked mood on three daily occasions as well as health status and healthrelated quality of life on one daily occasion. Participants were also asked to fill out a questionnaire battery at the onset of the monitoring trial, after finishing the trial and following a 2-week period after the treatment. All study participants completed a questionnaire containing

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8 dispositional self-assessments, health-related self-assessments and manipulation checks. Changes in health conditions were naturally initialized, implementing the field studies at times with higher incidence of seasonal changes in health conditions (common cold, seasonal rhinitis). RESULTS: Manipulation checks indicate that ambulatory health monitoring does match the purpose to increase attention to individual’s health within the 2-week time period of the field study. As a main result, both studies did not indicate any substantial impact of ambulatory monitoring of health status and healthrelated quality of life on self-reported measures of health-related cognitions (e.g. awareness, rumination). CONCLUSIONS: Healthrelated cognitions (e.g. health-related rumination) do not seem to be affected by daily health monitoring. To provide more evidence on this issue, future studies are directed to extend the time periods, to include further settings of naturalistic changes in health conditions and to implement assessments that allow for more sensitive distinction of state and trait components.

Computerized adaptive tests for ambulatory monitoring Sandra Nolte, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Matthias Rose MD PhD, Head of Department of Psychosomatic Medicine, Charite´— University Medicine Berlin, Berlin, Germany; Felix Fischer, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany AIMS: Computerized adaptive tests (CAT) have abundant theoretical advantages over established static instruments which could improve ambulatory monitoring of patient-reported outcomes (PROs). However, out of the few real CAT applications that are available today, only very few are specifically developed for mobile assessments. Within the presentation we aim to provide an overview of the status of available CAT applications, their different psychometric properties, and which technical solutions are available for ambulatory PRO assessments. METHODS: We reviewed the literature and evaluated existing data to discuss the potential of CATs for use in ambulatory monitoring outside of clinical facilities. In addition, we will introduce our own CAT developments for mobile devices that have been in use in clinical practice since 2004. Experiences with different operating systems (Symbian OS, Linux, Windows mobile, Apple iOS) as stand-alone versions as well as server-client applications in clinical practice or clinical studies will be reported. RESULTS: CATs are rarely used for ambulatory monitoring so far but cumulating evidence from their use in health care research allows for discussion of some issues relevant to ambulatory care. Studies show that CATs are as good as established static tools in capturing the most relevant health outcomes, with substantially decreased respondent burden. They can be more precise than static tools of similar length and can reduce floor and ceiling effects. CATs can reliably measure a construct over time with different items, yielding the potential of introducing item exposure control in ambulatory monitoring. Studies have shown that CATs can be at least as valid as welldesigned static tools in group comparisons but further investigation is needed to determine if psychometric advantages lead to increased responsiveness of CATs. CONCLUSIONS: Ambulatory monitoring of patient-reported outcomes demands short, yet very precise measurements that can be repeated up to many times a day. CATs may address several shortcomings of current ambulatory monitoring of PROs efficiently. However, most CAT developments have primarily focused on psychometric improvements. To utilize the full potential of CATs for ambulatory monitoring purposes, advanced technical solutions must be developed and content must also be considered carefully.

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Qual Life Res (2014) 23:1–184 Mobile assessment of quality of life in children via computerizedadaptive testing—application and acceptance of the kids-CAT tool Dana Barthel, Dipl.-Psych., University Medical Center HamburgEppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Sandra Nolte, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Christiane Otto, Dr. rer. hum.biol., University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Marcus Klein, MD, Christian-Albrechts-University of Kiel, Department of General Pediatrics, Kiel, Germany; Anja Bu¨nte, Christian-Albrechts-University of Kiel, Department of General Pediatrics, Kiel, Germany; Ute Thyen, University Medical Center Lu¨beck, Clinic of Paediatrics, Lu¨beck, Germany; Andrea Knaak, University Medical Center Lu¨beck, Clinic of Paediatrics, Lu¨beck, Germany; Janine Devine, PhD, University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Michaela Dabs, Dipl.-Soz., University Medical Center HamburgEppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Sigrid Reisinger, University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany; Matthias Rose, MD, PD, Head of Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Ulrike Ravens-Sieberer, MPH, Head of Research—Professor for Child Public Health, University Medical Center Hamburg-Eppendorf, Department of Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics, Hamburg, Germany AIMS: Computer-Adaptive Tests (CAT) have been applied in routine patient assessment to measure health-related quality-of-life (HRQOL) in adults. While CATs reduce respondent burden and increase measurement precision, there is still a lack of assessing QOL via CATs in chronically ill children and adolescents. Such CAT has now been developed as part of the Kids-CAT-project led by the University Medical Center Hamburg-Eppendorf, Germany. This abstract aims at presenting the application of the Kids-CAT to be administered on mobile computers as well as children’s and physicians’ perception of the tool and user interface feasibility. METHODS: The core KidsCAT comprises five domains:’physical well-being’,’psychological well-being’,’parent relation’,’social support & peers’, and’school well-being’ and was developed combining classical test theory and item response theory methods. For administration of the Kids-CAT items, a web-based facility was developed including a design of a graphical user interface oriented at the child and adolescent target population. To assess children’s and physicians’ acceptance of the respective design, focus groups with children and paediatricians were carried out. RESULTS: After programming, the Kids-CAT is applied to monitor HRQOL in chronically ill children and adolescents suffering from asthma, diabetes or rheumatoid arthritis (N = 300, 7–17 years, 47 % being female) at two German paediatric university medical centres. The developed CAT-software allows for an easy administration, on average 4 to 6 items are displayed with a reliability of 0.9, easy scoring, and feedback of the scores to the physicians. The Kids-CAT web interface was perceived positively by almost all children. In focus groups, conducted to evaluate feasibility, children reported a very high user-friendliness of Kids-CAT, while paediatricians emphasize the enhanced communication with the children and the benefit of instant short and easy-to-interpret Kids-CAT-scorereports for their daily clinical routine. CONCLUSIONS: The KidsCAT is on its way to advance the assessment of HRQOL in children in routine medical care. The results of the application and the focus groups suggest that for this particular target group the development of

Qual Life Res (2014) 23:1–184 comprehensive items, an attractive web interface to keep children’s attention as well as easy-to-interpret score-reports are necessary to enhance acceptance of ambulatory HRQOL monitoring.

Symposium #6: An international consensus process to identify priorities in child-reported outcomes research Organizer & Moderator: Anne Riley, PhD, Johns Hopkins University, Baltimore, MD, United States AIM: To achieve an international consensus on the top research priorities to advance the science of child reported outcomes (CROs) about their health related quality of life (HRQOL). METHODS: An international consensus process that included child health experts representing a variety of countries and stakeholders was conducted. All ratings were completed anonymously using Red Cap, an Internet survey interface. Round 1 participants (n = 33) included 21 of the 56 ISOQOL Child Health Interest Group (CHIG) members (38 %) and 12 pediatric PROMIS researchers who were asked ‘‘What are the most important research questions that the field of CRO’s should address over the next 10 years?’’ Resulting topics were reviewed by three investigators and consolidated to eliminate redundancies. Round 2 participants (n = 62) included ISOQOL CHIG members and authors of recent peer-reviewed child HRQOL publications who rated the importance of each topic on a 10-point Likert scale; rankings means, SD’s, and interquartile deviations (IQD) were calculated. Adequate consensus was defined as IQD \ 1.5, these were retained (45 of 52 topics). In Round 3, a subgroup of 9 experts rated these topics. RESULTS: The highest research priority areas were: meaning of differences in PRO scores (defining ‘true’ change); methods for linking age-specific PRO instruments in longitudinal research; establishing crosswalks across measures; understanding response shifts; developing assessments for young children; establishing optimal recall periods, response options and other approaches to improve CRO usefulness and acceptability. CONCLUSIONS: Topic areas reflect the current CRO field, with its increased focus on understanding HRQOL and adaptation to illness in the context of child development. No longer are instrument development and validation the primary drivers. Now advances are needed to support longitudinal research that employs triangulation of methods and reporters. Better understanding of the meaning of changes in scores is critical. Approaches from other fields and novel software applications offer opportunities for assessing a broader range of children, including those with cognitive limitations. The consensus process has helped to focus research, and will hopefully foster collaborations and visionary research programs to both improve methods for obtaining children’s perspectives on their HRQOL and enhance their health.

Individual presentations Advances and innovations in assessment methods for child reported outcome research and applications Jeanne M. Landgraf, MA, HealthAct CHQ Inc., Boston, MA, United States; Anne W. Riley, PhD, Johns Hopkins University, Baltimore, MD, United States AIMS: To address several highly rated priorities for child reported outcomes research (CROs) that focus on refinement and development of methods to enhance reliability and validity of reports from children with a particular focus on those with cognitive limitations due to age or disabling conditions, and the integration of reports from multiple sources. METHODS: An international consensus process involving over 75

9 clinical and academic researchers with expertise in children’s health related quality of life (HRQOL) generated and then rated the priority of 45 research topics. RESULTS: Respondents prioritized a number of topics to improve methods for eliciting information from and about children and the challenges of integrating information across reporters. This presentation will review the field and make recommendations for next steps in research in four areas: 1) novel approaches for assessing those with limited cognitive function, including triangulation of assessments and opportunities for cross-discipline methods from biometrics to play; 2) needed advances to integrate data from multiple sources; 3) opportunities for clarifying optimal recall periods for different aspects of HRQOL and to enhance response option formats; and 4) next steps in describing the effects of mental health and neurological conditions on HRQOL and CRO’s. CONCLUSIONS: Although CRO’s are increasingly used in clinical care and even required for clinical trial research, experts recognize the need for several methodological advances. Such work can help adapt CRO’s and other pediatric HRQOL assessments to specific contexts and for children with different conditions and cognitive capacities, across gender and the entire developmental spectrum, for a range of generic and disease specific measures. Methods must support longitudinal research that employs triangulation of methods and reporters. We need to explore opportunities to develop, adapt and validate innovative cross-discipline methods such as play, storytelling, narrative inquiry, and the integration of software applications for CRO’s in the very young and those with cognitive disabilities. Creativity and innovation using emerging technologies are increasingly possible and could prove advantageous to the field and the study and promotion of children’s health outcomes.

Recommendations for advancing child reported outcome (CRO) measurement across the lifecourse Ulrike Ravens-Sieberer, MPH, University Medical Center HamburgEppendorf, Hamburg, Germany; Monika Bullinger, PhD, Institute for Medical Psychology, Hamburg University, Hamburg, AIMS: A major challenge of assessing health-related quality of life from childhood to adulthood is the effect of developmental processes that drive changes in virtually all domains of health, functioning and well-being. This issue is highly relevant for the provision of care to people with chronic health conditions, where the transition from pediatric care to adult medicine affects the quality of life of young patients and their families. METHODS: An international consensus process involving over 75 clinical and academic researchers with expertise in health-related quality of life (HRQOL) and CRO’s generated and then rated the priority of 45 research topics. Three highly rated topics were related to the need for advances in HRQOL measurement across the life course: 1) Demonstrate the statistical tests needed to determine when it is acceptable to pool data generated by different age-specific versions of PRO instruments that are conceptually consistent but include items worded differently; 2) Develop practical methods for maintaining consistency in measurement in longitudinal studies over childhood and adolescence; 3) Develop practical methods for linking child-report health measures across ages. RESULTS: A review of the field suggests the following options to address these three topics: Reference group based scoring; Weighting along distributional scale characteristics within age groups; Identification of age insensitive items and domains; Linking items to a core item; Age related item banks; Computer Adaptive Testing. CONCLUSIONS: An elegant solution to solve the problem of transition is the application of computer adaptive testing. New measures should be conceptually comparable to and harmonized with existing age-related QOL measures with an overlap of core-items to permit scale linking, and use an item pool including child and adult measurement items without differential item functioning. This

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10 approach may be used in research to link existing age-specific measures as well as develop new ones. Conceptually equivalent child and adult QOL measures allow the possibility of linkage by placing the pediatric version on the adult scale to form comparable scores. These and other potential next steps will be discussed as ways to advance CRO science and provide the opportunity for true longitudinal research across the childhood-adolescence-adult transition.

State of the art and needed research to advance the science of clinically meaningful change in CRO scores I-Chan Huang, PhD, University of Florida, Gainesville, FL, United States; Katherine Bevans, PhD, The Children’s Hospital of Philadelphia, Philadelphia, PA, United States AIMS: To address the current status and needed next steps for identifying clinically meaningful change in child-reported outcomes (CROs). METHODS: Seventy-five CRO researchers and clinicians from various countries engaged in a 3-phase modified e-Delphi process to develop an international consensus regarding the most important priorities for advancing CRO research. RESULTS: The need to advance methods for detecting and interpreting change in CRO scores were emphasized in the most highly prioritized research foci. Specific priorities identified in this area were: 1) Defining what a clinically meaningful change in health is for children and adolescents and 2) Demonstrating which measures of key aspects of patient-reported outcomes (PROs) have shown sensitivity to change. These were ranked as the 1st and 3rd most important priorities, respectively, by consensus participants Potential Next Steps in Research: We will distinguish two concepts related to the meaning of change in CRO/PRO scores: sensitivity to change (a.k.a. responsiveness to change) and clinically meaningful change (a.k.a. minimal clinically important differences (MCIDs)). Sensitivity to change in a CRO/PRO measure has classically relied on statistical tests, which are influenced by sample size such that large samples can produce a significant result for small, not clinically meaningful, change scores. In contrast, defining a clinically meaningful change in a CRO/ PRO measure typically relies on an external anchor such as patients’ subjective judgment of change experienced through global rating of change approach or the use of other external anchors. However, the value of MCIDs might be offset if they contain measurement errors. To address this issue, information on the smallest detectable change should be incorporated to confirm that the MCIDs are larger than the potential size of the measurement errors. CONCLUSIONS: Children’s cognitive/developmental status changes rapidly, therefore we will address potential further studies using advanced qualitative and quantitative methods to investigate whether the responsiveness to change and MCIDs estimated by conventional methods are valid or the conditions under which they may be biased.

Advances needed for distinguishing true change in health from changes due to other causes Hein Raat, MD PhD MBA, Erasmus MC—University Medical Centre Rotterdam, Rotterdam, Netherlands AIMS: Response shift refers to changes in internal standards (recalibration), values (reprioritization), and the conceptualization of QOL (reconceptualization) that may attenuate or exaggerate estimates of changes in health states over time (e.g., in response to intervention). We will identify common factors that catalyze response shift in children. Methodological advances and remaining challenges that impact our understanding of response shift among children will be explored. METHODS: Seventy-five CRO researchers and clinicians from various countries engaged in a 3-phase modified e-Delphi

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Qual Life Res (2014) 23:1–184 process to develop consensus regarding the most important priorities for advancing CRO research. RESULTS: Participants rated the need to improve methods for distinguishing true changes in health from changes in internal standards, normal developmental processes, and self-reporting capacities as high priorities for research. Potential Next Steps in Research: Threats to the interpretation of changes in CRO scores can occur due to respondents’ recalibration, reprioritization, and reconceptualization of QOL. Particularly among children, response shift may also be impacted by normative changes in the perceived importance of specific health outcomes (e.g., increased importance of romantic relationships during adolescence), altered worldviews, or differences in self-reporting due to cognitive development that influences interpretation of health cues or language. The recent advances in the assessment of response shift generally require that participants complete tasks with relatively high cognitive demands (e.g., rating both the level and importance of multiple health outcomes). For children, statistical methods (e.g.., growth curve modeling) that infer response shift without requiring the direct assessment of internal standards, priorities, or QOL conceptualization may yield more reliable and valid estimates of response shift. CONCLUSIONS: There is a critical need for feasible, reliable, and valid methods of detecting response shift among children. This requires disease-specific attention to typical changes over time during growth and development that may be interrelated with response shift. Both quantitative research and qualitative research may provide insight in the mechanisms that underlie ‘recalibration’,‘re-prioritization’, or ‘re-conceptualization’ in child-focused studies.

Critique and considerations of the CRO research agenda identified through the ISOQOL CHIG consensus process Discussant: Katherine B. Bevans, PhD, The Children’s Hospital of Philadelphia, Philadelphia, PA, United States Dr. Bevans, a leading HRQOL methodologist, who is involved in the PROMIS initiative and is leading a major PCORI-funded research project focused on the values, preferences and outcomes of children with chronic conditions, will provide a critique of the four papers presented.

Symposium #7: 2014 PROMISÒ update: news, expanded pediatric item banks, international, and industry developments Organizer & Moderator: Joan E. Broderick, PhD, University of Southern California, Playa Vista, CA, United States The Patient-Reported Outcomes Measurement System (PROMIS), a National Institutes of Health (US) initiative, has developed a contemporary and innovative approach to the measurement of physical health, mental health, and social quality of life for children and adults. These tools were initially conceived to revamp patient reported outcomes (PROs) for clinical research. Over the 10 years since PROMIS began, that effort has expanded to include more than 50 item banks and their associated short form and computerized adaptive testing (CAT) options for measuring a host of important self-reported health domains. A key strategy has been generation of generic item banks, that is, not disease specific, in order to facilitate a common language and metric across clinical, research, and survey applications. With significant progress in achieving its initial goals, interest in PROMIS has rapidly broadened to the international level and pharmaceutical research and development industry. Those attending this symposium will hear an update on the development side of PROMIS initiatives and what is on the horizon. An overview of newly released pediatric and parent-proxy item banks, in total covering 21 domains, will be described. Two

Qual Life Res (2014) 23:1–184 presentations will focus on international testing and adoption of PROMIS. The first will outline important advantages and challenges for international users of PROMIS. The second will report on calibrations (IRT parameters) and examination of differential item functioning of German translations of PROMIS depression, anxiety, and physical functioning item banks in German community and clinical samples. The fifth presentation will report on recent interest in PROMIS by industry and the working groups that are exploring pathways for qualifying generic, universally relevant measures for product approval and labeling. Consideration of advantages of PROMIS for global research will be discussed.

Individual presentations PROMISÒ: Current status, recent developments and future plans David Cella, PhD, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States; Nan Rothrock, PhD, Northwestern University, Chicago, IL, United States; Susan Yount, PhD, Northwestern University, Chicago, IL, United States; Karon Cook, PhD, Dept of Medical Social Sciences, Northwestern University, Chicago, IL, United States; Helena Correia, PhD, Dept of Medical Social Sciences, Northwestern University, Chicago, IL, United States; Richard Gershon; PhD, Dept of Medical Social Sciences, Northwestern University, Chicago, IL, United States The Patient-Reported Outcomes Measurement Information System (PROMISÒ) is an expanding and evolving PRO measurement science initiative. It began as a mixed (qualitative and quantitative) methods approach to develop and validate item banks to measure several dozen common symptoms and functional concerns of people with chronic illnesses. Over the 10 years since PROMIS began, that effort has expanded to include more than 50 item banks and their associated short form and computerized adaptive testing (CAT) options for measuring a host of important self-reported health concepts. PROMISÒ has evolved from an effort focused primarily on supporting clinical research, to an array of other applications, ranging from population screening and health monitoring, to clinical practice improvement and health care quality reporting, and international collaborations in measurement, linguistic translations and cross-cultural research. The PROMISÒ approaches to measurement, and the standards proposed by its more than 150 collaborators across 15 institutions and the US National Institutes of Health, provide a framework for scientific discourse and collaboration worldwide. The PROMIS Framework and base of papers and products provide several unique opportunities for advancing the science and application of PRO measurement. This includes mixed qualitative and quantitative methodologies to develop relevant, patient-centered measures, clinical applications of item response theory (IRT) and computerized adaptive testing (CAT), measuring meaningful change over time, testing assumptions regarding disease-specific versus a more universal (generic) approach, creating a standardized, common metric upon which to compare and contrast health conditions and interventions, and a framework for classifying and valuing health states based on multiple dimensions of physical, mental and social health. Many of today’s PRO measurement challenges have been addressed by PROMISÒ over the past decade. Some of these challenges still stand between quality PRO data capture and meaningful use or application. The PROMISÒ approach is an open one that offers specific suggestions and direction for tackling those challenges. This presentation will summarize the current availability of PROMIS tools, and will present its measurement standards and challenges in such a fashion that frame a research and practice agenda for the next 10 years.

11 Advancing the PROMISÒ pediatric patient-reported outcome portfolio: new measures and methods Christopher B. Forrest, MD PhD, The Children’s Hospital of Philadelphia, Philadelphia, PA, United States The PROMISÒ measurement system uses a life course approach for instrument development and application. This means that each domain for which an instrument is developed is evaluated in terms of its meaning and developmental appropriateness for all age groups across the lifespan. Over the last 4 years, our research group has been using this developmental perspective to produce 22 new PROMISÒ pediatric item banks, which are now available for public release as fixed short forms or computerized adaptive tests. In this talk, I will present the methodological approach to qualitative development, psychometric evaluation, and national norming of these new measures, each of which includes child self-report (ages 8–17 years-old) and parent-proxy report (ages 5–17 years-old) versions. Within Physical Health, the measures are Physical Activity, Strength Impact, a Sedentary Behavior index, and Physical Stress Experiences; within Mental Health, the new measures are Psychological Stress Experiences, Positive Affect, Life Satisfaction, and Meaning and Purpose; and, within Social Health, the measures are Family Belonging and Family Involvement. We also developed a Pediatric Global Health (PGH-7) measure that is conceptually equivalent to the PROMISÒ adult Global Health measure. These new measures expand the PROMISÒ pediatric portfolio, which now includes item banks for 21 distinct domains of health across physical, mental, and social health dimensions. The item banks have been normed to the U.S. population, which enhances the interpretability of scores, and translated into Spanish and German. To account for the inability of some younger children to read the items, we have developed audio recordings that are an optional feature for the entire suite of PROMISÒ pediatric measures. Of the 21 measures, 9 have parallel and conceptually equivalent adult versions. The PROMISÒ pediatric portfolio can be used in studies that span pediatric and adult populations, to evaluate clinical response to healthcare treatments, in clinical and population health research, and for performance assessment. Additional research is needed to lower the age range of the measures and to identify and develop additional content for domains that are prioritized by patients, families, and clinicians but are not represented in the PROMIS portfolio.

Who is the norm? Hurdles on the way to an international standardization of PRO assessments Matthias Rose, MD, PD, Head of Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Felix Fischer, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Sandra Nolte, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany BACKGROUND: The generously funded NIH initiative for the development of a comprehensive Patient-Reported Outcome Measurement Information System (PROMISÒ) is the most consequent effort worldwide for the standardisation of PRO-assessments. IRT item banks provide a common metric on which different existing tools like the SF-36 can be compared easily. Today, all PROMISÒ item banks are normed such that a t-score of 50 represents the U.S. population mean with a standard deviation of 10. AIMS: However, the international adaptation of PROMISÒ measures imposes a number of important challenges. One of those is the definition of a common scale anchor for easier interpretability. One goal of the PROMISÒ International Group is to explore whether IRT item parameters derived from the U.S. sample are appropriate for other languages, and if scores can be interpreted in a

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12 similar way in every country adopting the PROMISÒ measures. METHODS: Using data from the U.S. calibration sample (n = 14,898), in a German representative population sample (n = 2,504) and a German clinical sample (n = 643), we investigated differential item functioning (DIF) in the PROMISÒ Depression and Anxiety item banks. Furthermore, we estimated item parameters in the German samples, and compared those to the U.S. item parameters. Data collection for the Physical Functioning Item bank is ongoing. RESULTS: Overall, little DIF was observed between the two language versions, and item parameters are very similar in both language versions, leading to analogous item response curves (IRC). However, if US item parameters are applied to the German representative sample, mean t-scores are around 45, i.e. ‘ a standard deviation below the U.S. mean. CONCLUSIONS: IRT methods allow for innovative analyses to compare the psychometric equivalence of different language versions. Available results so far justify the use of the same item parameters in different languages, including German or Spanish, as has been shown before. However, score interpretation may be different, if different norm-setting samples are used in different countries. It needs to be discussed what relevance national scale-setting samples have for a global harmonisation of PRO-measurement.

The case for an international PROMISÒ initiative* Presenter & authors: Jordi Alonso, MD PhD, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Matthias Rose, MD, PD, Head of Department of Psychosomatic Medicine, Charite´— University Medicine Berlin, Berlin, Germany; Caroline Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands; Sandra Nolte, PhD, Department of Psychosomatic Medicine, Charite´—University Medicine Berlin, Berlin, Germany; Dennis Revicki, PhD, Evidera, Bethesda, MD, United States; Christopher B. Forrest, MD PhD, The Children’s Hospital of Philadelphia, Philadelphia, PA, United States; Dave Cella, PhD, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States for the PROMISÒ International group PROMISÒ, a National Institutes of Health initiative, is a U.S.-based cooperative group of research sites whose purpose is to develop and standardize generic patient reported outcome (PRO) measures across studies and settings. If extended to a global collaboration, PROMISÒ has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings, international population monitoring and policy development, health services administrators and planners access to relevant information on the populations they serve, better assessment and monitoring of patients by providers, and improved shared decision making. The goal of the current PROMISÒ International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is important to demonstrate that all items possess expected strong measurement properties. Finally, validity, reliability and responsiveness to change of PROMISÒ measures when used in an

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Qual Life Res (2014) 23:1–184 international context should be established. An important emphasis will be on the assessment of differential item functioning (DIF). Item Response Theory (IRT) based item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. During the session, the PROMIS International initiative constituency and its immediate action plans will be described and discussed. * Based on Alonso et al. Health and Quality of Life Outcomes 2013; 11: 210.

Sharing the progress of the PROMISÒ industry interest committee Tara Symonds, PhD, Pfizer, Ltd, Canterbury, United Kingdom The PROMISÒ Industry Interest Committee (PIIC) is a subcommittee of the PROMISÒ Steering Committee’s Outreach Committee. The PICC was established to provide the PROMISÒ Steering Committee with advice and input to increase the utility of PROMISÒ (measures, administration platform, standards, science) to industry and increase the use of PROMISÒ in industry-sponsored research. One aim is to help create a pathway for PROMISÒ measures to be qualified for potential use as endpoints suitable to measure treatment benefit for product approval and labeling. Currently, due to the US Food and Drug Administration (FDA) emphasis on establishing content validity for a specific ‘concept of interest’ within a very specific ‘context of use’, qualification of measures by the FDA favor disease-attributed measures rather than more universally relevant concepts. Given the investment in developing PROMISÒ, the legacy of measures/items incorporated in PROMISÒ item banks, and similar experiences of patients across a broad range of diseases/conditions, industry believes there is a missed opportunity for using these measures in drug development. This presentation will discuss the actions being taken by the PIIC, including the establishment of several working groups (WG), to provide focused effort in achieving its stated objectives in helping to support and advance the use and development of PROMISÒ. For example, the Regulatory WG, provides input on regulatory issues regarding the qualification and/or use of PROMISÒ measures, and is working to explore potential qualification of the PROMISÒ Fatigue item bank. The issues related to this will be discussed such as qualifying the measure for use across populations and content validity concerns. Other activities are on-going via additional working groups, progress of these will also be discussed: Technical WG to provide input and recommendation on further development of Assessment Center to ensure PROMIS meets the needs of industry; Communication and Outreach WG to coordinate activities on the development of papers and outreach to the broader scientific community, especially industry researchers; Clinical Trial Implementation WG to provide input on issues pertaining to implementation of PROMISÒ in global development programs; and the Scientific WG to collect and analyze data to evaluate PROMISÒ and its use in industry-sponsored research.

Symposium 8: Monitoring patient-reported outcome alerts in clinical trials and routine practice: an expert panel discussion of current knowledge and priority areas for research Chair: Michael Brundage, MD, Queen’s University, Kingston, ON, Canada Discussant: Madeleine T. King, PhD, Psycho-oncology Cooperative Research Group (PoCoG), University of Sydney, Sydney, Australia The assessment of patient-reported outcomes (PROs) in clinical trials, presents researchers with a number of potential problems. What happens when a patient reports extreme pain, fatigue or depression on a

Qual Life Res (2014) 23:1–184 questionnaire and the data is not reviewed until the end of the trial? Do researchers face liability if they do not respond to ‘concerning levels of psychological distress or physical symptoms that may require an immediate response’; so called ‘PRO Alerts’? Commonly, alerts become apparent through extreme questionnaire scores, or in additional information provided by a patient on the form. PROs are increasingly collected in routine clinical care, for audit purposes or to inform clinical decision making, PRO alerts may also present in this context. Accordingly, care teams should be aware of the potential implications of PRO Alerts, consider and identify appropriate thresholds for response and have an appropriate management plan in place. In this symposium we will introduce the concept of ‘PRO Alerts’, identify ethical and logistical considerations for their management and share the latest evidence on current management practices based on survey findings from [ 600 trialists. The panellists will consider PRO Alerts in the context of the National Cancer Institute’s PRO-CTCAE initiative to develop a standardized patient-centered approach to adverse event reporting in clinical trials and will discuss how this approach has been applied to routine clinical care using the ‘real-world’ example of e-RAPID. The panel discussion will comprise of a series of brief presentations on each of the issues described above followed by interactive debate amongst panel members and with the audience. By the end of the symposium attendees will have a clear understanding of the issues facing researchers, clinicians and Institutional Review Boards in relation to PRO Alerts, the options currently available for use in different contexts and priority areas for future research. Individual presentations Current practices in patient-reported outcome (PRO) alert management in clinical trials Derek Kyte, MSc; Jonathan Ives, PhD; Heather Draper; and Melanie Calvert, PhD, PRO Research Group, University of Birmingham, Edgbaston, United Kingdom AIMS: 1) To explore reported instances of ‘PRO Alerts’ in trials and 2) outline current practices in ‘PRO Alert’ management. METHODS: Recent qualitative evidence suggests that trial personnel may encounter PRO data that cause them to become concerned for the wellbeing of the trial participant: so called ‘PRO Alerts’. Some researchers reported administering non–prespecified participant interventions in response to an alert. These interventions were not routinely recorded in trial documentation, risking co-intervention bias. In order to explore these findings we conducted a national survey of UK-based trialists with experience of involvement in trials including a primary or secondary PRO. Potentially eligible research nurses, trial coordinators, data managers and chief and principal investigators, across 19 Comprehensive Local Research Networks and all registered clinical trials units in the UK, were invited to participate in an electronic survey. RESULTS: 679 trialists completed the electronic survey (research nurses n = 560, trial coordinators n = 129, data managers n = 41, chief and principal investigators n = 37). Preliminary evaluation of the survey data suggest that, depending on their role within the trial, between one-third and half of all respondents had encountered a ‘PRO Alert’, over 75 % had intervened in response to the alert and over onethird of interventions went unreported. The survey data also highlight that guidance and training on ‘PRO Alert’ monitoring and management is lacking in trials. The final results of the survey and their implications for both internal and external validity of trial results will be discussed. CONCLUSIONS: Trial personnel are experiencing ‘PRO Alerts’ in trials, but are unsure how best to manage them as appropriate guidance is lacking. Some staff are intervening to aid the trial participant in distress, but not all interventions are being recorded which may lead to bias. Future research should aim to develop ‘PRO Alert’ management

13 recommendations, which are aimed at supporting trial personnel to conduct high quality data collection, whilst protecting the interests of individual trial participants. Mr Kyte, Dr Ives and Profs Draper and Calvert are funded by the National Institute for Health Research School for Primary Care Research. Prof Calvert is a member of the Medical Research Council Midland Hub for Trials Methodology Research (Medical Research Council grant G0800808). Development of an integrated online toxicity reporting and management system for oncology: eRAPID (Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) Galina Velikova, MD PhD FRCP; Patricia Holch, PhD; Leon Bamforth, Lorraine Warrington, Robert Carter, and Kate Absolom, PhD, University of Leeds, Psychosocial Oncology Clinical Practice Research Group, St James’s Institute of Oncology, Bexley Wing, Leeds, United Kingdom BACKGROUND/AIMS: eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is a research programme to develop and test a system for cancer patients to report and manage treatment-related adverse events (AE) online. The system has been designed to display patient AE reports within electronic patient records (EPR), provide clinician alerts for severe AE and patient self-management advice. Successful integration into clinical practice requires usability testing with patients and clinicians. METHODS: The patient AE reporting was built into a custom online questionnaire system (QTool) and linked to the Leeds-Cancer-Centre EPR system (PPM) alongside a web-service that allows non-identifiable questionnaire response data to be linked to patient records. Clinicians accessing EPR can view patients’ results in graphical and tabular format and receive severity-appropriate email alerts based on algorithmic questionnaire scoring. The system has undergone preliminary usability testing with patients and health professionals and is currently being assessed in a breast cancer service with chemotherapy patients. This is the first assessment of the system where clinician email alerts are being generated for severe AEs and patient reported data is available for use in clinical practice. RESULTS: From initial usability testing, the eRAPID QTool-EPR interface received positive feedback from patients (N = 13) and staff (N = 19, oncologists and nurses). The current usability testing in the breast service will provide preliminary data on clinicians’ views of the value and integration of the alerting system in clinical care. The preliminary findings of eRAPID feasibility testing will be presented and the implications for AE management in routine clinical care discussed. CONCLUSION: We expect eRAPID to improve and unify AE monitoring and enhance patient care. The clinician alerts for patient reported severe AEs are a unique and integral element of the intervention. Understanding how alerts are utilised and monitored in practice by clinicians is an essential aspect of both the current usability testing and the future planned randomised controlled trials to assess eRAPID. eRAPID presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG0611-2008)

Oral Sessions 101: Advancing Quality of Life Measurement in Neurology (101.1) Developing a Conceptual Model of Patients’ Experience of Migraine

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14 Anne Skalicky, MPH, Evidera, Bethesda, MD, United States; Sally Mannix, BA, Evidera, Bethesda, MD, United States; Hafiz Oko-Osi, Evidera; Katherine L. Widnell, MD, Amgen; Asha Hareendran, PhD, Evidera, London, United Kingdom; Patricia K. Corey-Lisle, PhD, Amgen AIMS: A conceptual model of migraine was developed to visually organize key features of patients’ experiences of the disease. The aim was to use this model to help identify and prioritize concepts of interest to aid in selecting endpoints for specific context of use—to evaluate treatment benefits of interventions for migraine from the patients’ perspective. METHODS: Concept identification work was conducted to understand the impact of migraine on patient functioning in adults with migraines. A focused literature review of relevant articles from key literature databases (EMBASE/MEDLINE; years: 1998–2013) was completed. Relevant articles included qualitative studies on functional and social experience and perception of migraine/headache, methodology papers on gathering information on headache/migraine-related impairment, and migraine impact studies. Following the review, structured interviews were conducted with 3 migraine experts and a patient-reported outcomes (PRO) tool developer. Results of concept elicitation interviews with adults with migraine also informed the model. RESULTS: A total of 563 abstracts were screened in the literature review; nine articles were identified for full review. The domains and concepts drawn from these articles informed the conceptual model and included patients’ experiences of cardinal migraine symptoms, the proximal impact of migraine on functioning (performing day-to-day activities) as well as more distal concepts such as participation in social and leisure activities and emotional responses to migraine (frustration, depression, anxiety). The interviews with experts helped to refine and finalize preliminary versions of the model. Concept elicitation interviews with 32 migraine patients identified that migraine symptoms have an immediate impact on the ability to move, in addition to impacts on daily activities, social and leisure function, and impacts on emotions. CONCLUSIONS: Movement was identified as an impact of migraine, not previously identified in the literature. A conceptual model of the patient experience of migraine was developed based on data from published literature, and interviews with migraine experts and adults with migraine. This model can be used not only to select endpoints for evaluating interventions for migraine but also to guide the development of interview guides for concept elicitation studies to inform the development of PRO instruments for adults with migraine.

(101.2) Quality of life and patient preferences: identification of sub-groups of multiple sclerosis patients Rosalba Rosato, PhD, University of Turin, Turin, Italy; Silvia Testa, University of Turin; Giorgia Molinengo, University of Turin, Turin, Italy AIMS: Multiple sclerosis is a chronic disease with a modest impact on life expectancy, but a broad spectrum of physical, social and psychological effects, as well as a significant impact on quality of life, mainly due to functional and neurological impairment. Discrete Choice Experiments have been extensively used in health economics to value health-care intervention and policies and have recently been applied to understand preferences for quality of life (QOL) attributes. The relative priority about QOL attributes have been estimated in a sample of person with multiple sclerosis. The main aim of the study is to estimate preferences related to QOL attributes in patients affected by multiple sclerosis, by keeping heterogeneity of patient preference in mind, using the Latent Class approach. The secondary aim is to explore the relationship between QOL preferences, demographic and

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Qual Life Res (2014) 23:1–184 Table 1

Utility parameters and average class probability in 3-latent class logit model. Number of respondent: 152; number of observations: 2.128 Attributes

First class b

Second class

se

p

b

Third class

se

p

b

se

p

ADL No limitation

(Ref)

One limitation

0.65

0.12

\0.001

0.31

(Ref) 0.47

0.517

0.18

(Ref) 0.24

0.439

Several limitations

2.26

0.16

\0.001

1.34

0.97

0.167

0.01

0.31

0.979

IADL No limitation

(Ref)

One limitation

0.94

0.15

\0.001

2.25

(Ref) 1.22

0.065

1.96

(Ref) 0.68

0.043

Several limitations

2.24

0.20

\0.001

3.60

2.01

0.073

2.03

0.57

0.001

PAIN and/or FATIGUE No difficulties

(Ref)

(Ref)

(Ref)

Some difficulties

0.22

0.15

0.15

3.15

1.17

0.007

-0.86

0.53

0.105

A lot of difficulty

1.23

0.13

\0.001

6.98

2.45

0.004

0.90

0.28

\0.001

ANXIETY and/or DEPRESSION No difficulties

(Ref)

(Ref)

(Ref)

Some difficulties

0.68

0.18

0.001

-0.77

0.67

0.250

2.46

0.63

0.001

A lot of difficulty

1.17

0.14

\0.001

3.78

1.58

0.017

3.61

0.39

\0.001

0.006

ATTENTION and/or CONCENTRATION No difficulties

(Ref)

(Ref)

(Ref)

Some difficulties

0.59

0.13

0.001

1.01

0.96

0.295

0.96

0.35

A lot of difficulty

1.18

0.18

\0.001

2.47

1.41

0.079

2.01

0.54

0.001

Average class probability

0.62

0.05

\0.001

0.16

0.04

0.001

0.22

0.03

\0.001

clinical information. METHODS: A discrete choice experiment survey was developed using the following attributes: ADL, IADL, pain/ fatigue, anxiety/depression and attention/concentration. Choice sets were presented as pairs of hypothetical health status, based upon a fractional factorial design. RESULTS: The Latent Class Logit model estimated on 155 patients identified three subpopulations, which, according to attribute, attached more importance respectively to: 1) physical dimensions (ADL and IADL); 2) pain/fatigue and anxiety/ depression; and 3) functional physical impairments (IADL), anxiety/ depression and attention/concentration. A posterior analysis suggests that the latent class membership may be related to an individual’s age to some extent, or to diagnosis and treatment, while apart from energy dimension, no significant difference exists between latent groups, with regards to MSQOL-54 scales. CONCLUSIONS: A QOL preference-based utility measure for person with multiple sclerosis was developed. The main finding of the study was the absence of homogeneity in the mean preference attached to quality of life attributes among mildly impaired multiple sclerosis patients. These utility values allow identification of a hierarchic priority among different aspects of QOL and may allow physicians to use a broader measurement of disease impact or to develop a care program tailored to patient needs (Table 1).

(101.3) Development of a new measurement system to assess HRQOL in individuals with Spinal Cord Injury David Tulsky, PhD, Kessler Foundation, New York, NY, United States; Pamela A. Kisala, University of Michigan; Denise G. Tate, PhD, University of Michigan, Ann Arbor, MI, United States; Allen W. Heinemann, Northwestern University, Chicago, IL, United States; David Victorson, PhD, Northwestern University Feinberg School of

Qual Life Res (2014) 23:1–184 Medicine, Evanston, IL, United States; Susan Charlifue, PhD, Englewood, CO, United States; Seung W. Choi, PhD, Northwestern University, Evanston, IL, United States; David Cella, PhD, Northwestern University, Chicago, IL, United States AIMS: To develop a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with spinal cord injury (SCI). This measurement system, the SCI-QOL, builds on the work of other large PRO measurement initiatives, (e.g., the PROMIS). METHODS: Five phases of research have been conducted to develop the SCI-QOL measurement scale. In Phases 1 and 2, qualitative techniques including individual interviews (n = 44) and focus groups (n = 65 individuals with SCI and n = 42 SCI clinicians) were utilized to select key HRQOL domains and to inform the development of item banks in each selected domain. In Phase 3, items were field tested in a large sample of individuals with traumatic SCI (n = 877). Phase IV consisted of advanced psychometric analyses using confirmatory factor analyses, Item response theory (2-parameter graded response model), differential item functioning and the development of computer adaptive tests and static short forms. Phase V consisted of administration of CATs and Short forms in multiple assessments at different points post injury in a new sample (n = 240) and testing assessing the test retest reliability, stability, and change over time of the calibrated item banks. RESULTS: Nineteen unidimensional calibrated item banks and three calibrated scales across physical, emotional, and social health domains were developed. Item banks may be administered as computerized adaptive tests (CATs) or short forms. Scales may be administered in a fixed-length format only. The item banks show high test–retest reliability and high internal consistency. Moreover, measures of physical functioning show significant change over time at 3, 6, and 12 month time periods post injury while the psychosocial item banks show a different pattern of change. CONCLUSIONS: The SCI-QOL measurement system uses advanced test development methodology to develop targeted banks of items for assessment of HRQOL in SCI research and practice while linking the work to larger initiatives designed for the general medical population.

(101.4) Improving the measurement of QALYs in multiple sclerosis: Estimating a preference-based index for use in deriving quality-adjusted life-years (QALYs) for multiple sclerosis Elizabeth Goodwin, University of Exeter Medical School, Exeter, United Kingdom; Colin Green, PhD, University of Exeter, Exeter, United Kingdom AIMS: Although many studies employ generic preference-based measures to quantify health outcomes and to estimate quality-adjusted life-years (QALYs), research indicates that these measures may lack relevance, sensitivity and responsiveness when applied to multiple sclerosis (MS). Here we describe the second stage in developing a condition-specific preference-based measure (CSPBM) for MS: undertaking a valuation study to estimate a preference-based index for the Multiple Sclerosis Impact Scale 8D (MSIS-8D), a previously developed descriptive system suitable for a CSPBM, derived from the commonly used MSIS-29. METHODS: A health state valuation survey was undertaken with a representative sample of the UK general public. Internet survey methods were used to collect preferences for 169 health states, selected from the eight dimensional MSIS-8D descriptive system. The time trade-off (TTO) technique was used to elicit preferences. Each respondent provided preferences for 6 health states, using a TTO valuation schedule adapted from the MVH protocol that was used to estimate the UK EQ-5D-3L index. Multivariate regression models were applied to estimate health state values across

15 the MSIS-8D descriptive system. A range of models were compared using statistical criteria, including the size and significance of individual parameter estimates, mean absolute error (MAE) and number of errors. Analyses were undertaken to validate the selected model. RESULTS: Preferences were elicited from 1702 respondents. The internet valuation survey proved practical and feasible; over 90 % of respondents reported that they found the questions easy to understand. A random effects model had the optimum performance across all applied criteria (MAE of 0.04), and was selected to provide a preference-based index for the MSIS-8D descriptive system, with health state values ranging from 0.882 to 0.079. Validation analyses support the performance of the MSIS-8D index compared to MS health status measures and generic PBMs (EQ-5D & SF-6D). CONCLUSIONS: The preference-based single index for the MSIS-8D, presented as a CSPBM for MS, provides a valuable contribution to the methods available to assess HRQOL and to estimate QALYs for MS for use in a HTA/decision-making context. The measure allows assessment of QALYs using the MSIS-8D, including retrospective analyses in existing MSIS-29 data sets, and future prospective settings.

(101.5) Patients and health economists: working together to build a better research base for making decisions about the funding of treatments for MS Annie Hawton, University of Exeter Medical School, Exeter, United Kingdom; Elizabeth Goodwin, University of Exeter Medical School, Exeter, United Kingdom AIMS: The terms ‘public and patient involvement (PPI)’ and ‘health economics’ are rarely heard together, yet health economic approaches inform decisions about the funding of healthcare services. The broad aim of this work was to explore involving patients in health economics research. The specific aim was to improve the quality of a Multiple Sclerosis (MS) preference-based measure of health-related quality of life (HRQOL), by involving people with MS in the development process. METHODS: A descriptive system of the HRQOL of people with MS was devised for use in a health state valuation survey. Such descriptive systems can include combinations of health domains and levels of severity that are implausible, meaning they are unlikely to be experienced. Inclusion of implausible health states in valuation surveys can reduce the validity of responses. The usual manner of addressing implausibility is to remove health states based on assumptions made by clinicians and/or researchers. In this study, people with MS assessed health state descriptions and determined implausible health states. Three people with MS took part in an interactive task. They imagined a series of scenarios where they had some ‘extreme’ health issues whilst simultaneously experiencing ‘no problems’ with other health dimensions. They were asked whether such health states might ever be experienced by someone with MS. RESULTS: Thirty-three combinations of health state descriptions were judged implausible. This led to 12 of the 169 health states initially selected for the survey being excluded. Patients gave feedback on what worked well and not so well regarding their involvement, and ways of discussing the often complex and emotive field of health economics with non-health economists. The research also captured what people with MS and health economists felt they had gained from the process. CONCLUSIONS: Involving people with MS in the development of a preference-based measure should result in an instrument that is more relevant and better able to detect changes in HRQOL. This work has demonstrated the potential and value of working with patients in health economics research. As in other areas of health services research, PPI should be integral in the discipline of health economics.

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16 102: The Importance of Context: Response Shift and Differential Item Functioning (102.1) Latent Variable Mixture Models for Differential Item Functioning: Application to the SF-36 Physical Functioning and Mental Health Sub-Scales Xiuyun Wu, University of Manitoba, Winnipeg, MB, Canada; Richard Sawatzky, PhD RN, Trinity Western University, Langley, BC, Canada; Wilma Hopman, Clinical Rsrch Ctr, Kingston General Hospital, Kingston, ON, Canada; Nancy E. Mayo, PhD, McGill University Health Centre, Montreal, QC, Canada; Tolulope T. Sajobi, PhD, University of Calgary, Calgary, AB, Canada; Juxin Liu, University of Saskatchewan; Lisa M. Lix, University of Manitoba, Winnipeg, MB, Canada AIMS: Differential item functioning (DIF) occurs when individuals with the same underlying level of health respond differently to items that comprise a health measure. Latent variable mixture models (LVMMs), which identify latent (i.e., unobserved) groups of respondents with a similar pattern of responses, have been recommended to test for DIF in patient-reported outcomes from heterogeneous populations. This research applied LVMMs to test for DIF in the SF-36 physical functioning (PF) and mental health (MH) sub-scales in a population-based cohort. METHODS: Data were from the Canadian Multicentre Osteoporosis Study (CaMos), a prospective cohort study that provides national estimates of the prevalence and incidence of osteoporosis. LVMMs were applied separately to the ten PF and five MH items. A one-class standard graded response model was compared to multi-class models. Fit was assess using penalized information criteria and the Vuong-Lo-Mendell-Rubin likelihood ratio test. Multinomial logistic regression with pseudo-class random draws was used to characterize the latent classes on demographic and health variables. RESULTS: The CaMos cohort (N = 9423) was primarily female (68.7 %) and almost equally split between 25–64 years (51.9 %) and 65 ? years (48.1 %) age groups. For PF, a three-class model had the best fit, with class proportions of 0.59, 0.24, and 0.17. For MH, a two-class model had the best fit, with class proportions of 0.84 and 0.16. The estimated probability of reporting greater limitations was consistently higher in class 3 for PF items (highest probabilities for vigorous activities) and class 2 for MH items. For PF, large differences in factor scores were observed between one- and three-class models, with a standardized mean difference = 0.3 for 26 % of respondents; this suggests substantial bias in sub-scale scores from ignoring heterogeneity in item responses. For MH, differences in standardized factor scores for one- and two-class models were small. Age, sex and general health were associated with class membership. CONCLUSIONS: We identified latent groups of respondents for which the SF-36 PF and MH items functioned differently in a diverse national sample. Heterogeneity in item responses affects the comparability of SF-36 sub-scale scores, which can bias the interpretation of clinical and epidemiologic studies.

(102.2) Structural equation modeling to characterize the occurrence of Response Shift effect in a longitudinal quality of life study using EORTC questionnaires Ame´lie Anota, Quality of Life in Oncology Platform, France, Besanc¸on, France; Caroline Bascoul-Mollevi, ICM | Val d’Aurelle, Montpellier, France, Montpellier, France; Thierry Conroy, Centre Alexis Vautrin, Les-Nancy, France; Francis Guillemin, MD, PhD, Ecole de Sante Publique—Lorraine University, Vandoeuvre Les Nancy, France; Michel Velten, Epidemiology and public health laboratory, College of Medicine, Strasbourg, Strasbourg, France;

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Qual Life Res (2014) 23:1–184 Damien Jolly, University Hospital of Reims; Zeinab Hamidou, AixMarseille University, Marseille, France; Franck Bonnetain, PhD, University Hospital of Besanc¸on, Besanc¸on, France AIMS: Health-related quality of life (HRQOL) is a dynamic concept dependent on the patient adaptation to the disease and reflected by a response shift (RS) effect. RS results in recalibration, reprioritization and reconceptualization of key HRQOL domains. The longitudinal analysis of HRQOL should take into account the possible occurrence of RS effect. Structural Equation Modeling (SEM) is a statistical approach often used to characterize occurrence of RS. At this time, SEM is generally applied on SF-36 generic questionnaire respecting a particular structure in two domains (mental health and physical health). The objective was to investigate SEM to characterize RS effect on two EORTC HRQOL cancer specific questionnaires among women with breast cancer. METHODS: This work builds on data of a prospective multicenter study including all primary breast cancer patients or suspicion. HRQOL was evaluated using the EORTC QLQC30 and QLQ-BR23 breast cancer module at baseline, after surgery, at 3 and 6 months. The measurement model integrates both functional and symptomatic scales of both questionnaires and considers patient’s symptomatic status impacts her functional status. Oort procedure (Quality of Life Research, 2005) was used. Reconceptualization was not explored considering the construction of the measurement model. The procedure was applied integrating 1) baseline and after surgery measures, 2) baseline and 3 months measures and 3) 3 and 6 months measures. RESULTS: Between 2006 and 2008, 381 patients were included, 90 % had a confirmed breast cancer. At each measurement time, analyses highlight non uniform recalibration of fatigue, body image, financial difficulties, role and emotional functioning and uniform recalibration of emotional and cognitive functioning, fatigue and insomnia. After surgery and at 3 months, a downward reprioritization of fatigue (factors loadings decrease of -2.69 points after surgery and -2.33 at 3 months) and of global health status (-0.65 and -0.31 respectively) is highlighted (p \ 0.001). CONCLUSIONS: SEM allows to highlight recalibration and reprioritization components of RS on EORTC questionnaires without the necessity of a retrospective measure such a then-test. However, these models seem difficult to use longitudinally. Further investigations will be carried out in order to ensure their ability to capture the entire RS on these questionnaires.

(102.3) Comparison of Item Response Theory and Structural Equation Models for response shift detection at the item level Myriam Blanchin, University of Nantes, Nantes, France; Alice Guilleux, University of Nantes, Nantes, France; Antoine Vanier, MD, University Pierre Et Marie Curie Paris 6, Paris Cedex 13, France; Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France; Veronique Sebille, ScD, University of Nantes, Nantes, France AIMS: Issues regarding the identification of the most appropriate methodological approach for the identification of response shift (RS) occurrence and for its appropriate adjustment in the analyses of longitudinal Patient-reported Outcomes (PRO) data remains debated. Analyses are usually performed at the dimension level. Performing analyses at the item level could provide new insight to RS investigation. Relative performances of Item Response Theory (IRT) models and Structural Equation Modeling (SEM) both implemented at the item level for RS detection and adjustment are assessed and compared in a simulation study. METHODS: Simulation studies are performed to compare IRT and SEM for detection and adjustment of RS effects at the item level in several simulated settings according to: a) absence or presence of RS, b) absence or presence of true change, c) number of

Qual Life Res (2014) 23:1–184 items affected by RS, d) different types of RS (uniform or non-uniform recalibration, reprioritization), e) different sample sizes. Generalized Partial Credit Models are used for simulating 500 complete datasets for all previous parameters combinations. The performance of IRT and SEM is assessed regarding the type I error (when no RS is simulated), the power (when RS is simulated), RS assessment (regarding the items and the types of RS that were detected). Model fit and convergence are also evaluated for both methods. RESULTS: Model fit and convergence should be good for IRT and SEM in most cases but it might be altered when many items are affected by RS. The type I error is expected to be controlled for both methods. The power is expected to increase with the number of items affected by RS for all types of RS for both methods, especially for IRT whose power is expected to be higher than the power of SEM. CONCLUSIONS: This extensive simulation study provides the possibility to formally compare IRT and SEM response shift analyses performed at the item level. The pros and cons of using one method or another as well as the potential of using both of them as complementary analyses for RS and true change assessment will be underlined.

(102.4) Estimating quality of life when differential item functioning is present Jean-Francois Hamel, University Hospital of Angers, Angers, France; Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France; Yves Roquelaure, Lab. of Ergonomics and Epidemiology in Health at Work, University of Angers; Veronique Sebille, ScD, University of Nantes, Nantes, France AIMS: Chronic low back pain (CLBP) is a very common health problem worldwide and a major cause of disability, responsible for degradation of general well-being and quality of life (QOL). Such a QOL degradation—measured using patient-reported outcomes (PRO)—can be truly gender-related, because of physical and psychosocial gender differences. Such differences could also be related to differences of interpretation and perceived meaning of the PRO questions (constituting a differential item functioning (DIF) phenomenon due to cultural and social gender differences), but not to real QOL differences. METHODS: We used the SF36 questionnaire for searching QOL differences depending on gender using data from the Pays-de-la-Loire Workers Surveillance Program (France). The SF-36 consists of eight sub-scales, combined in two psychometrically-based components : the physical-component summary (PCS, comprising the physical functioning (PF), bodily pain (BP), role-physical (RP) and general health (GH) sub-scales) and the mental component summary (MCS, comprising the role-emotional (RE), social functioning (SF), vitality (VT) and mental health (MH) sub-scales). These sub-scales were analysed using Item Response Theory based models for jointly studying DIF and gender QOL differences. DIF was studied including interactions between item parameters and gender covariate. RESULTS: 768 men and 574 women suffering from CLBP completed the questionnaire. When DIF was not taken into account, females had a significantly lower quality of life than males for all the subdimensions considered, except the RP sub-dimension. When DIF was taken into account, a difference between males and females was still highlighted using the mental sub-dimensions, but there was no longer significant differences regarding the physical sub-dimensions. CONCLUSIONS: Taking into account differential item functioning, i.e. cultural and social differences is one of the most important issues of the subjective health measurements. A naive approach, consisting in considering the items characteristics as being equal for all the individuals could provide possibly biased results. We propose a Stata macro-program allowing estimating partial credit based models for

17 studying DIF by minimizing AIC or BIC criteria using forward or backward procedures. We believe that such a program could facilitate the use of such models.

(102.5) Can appraisal as a person factor be used for detecting response shift? Karl Bang Christensen, Department of Public Health, University of Copenhagen, Copenhagen, Denmark; Armon Ayandeh, DeltaQuest Foundation; Bruce D. Rapkin, PhD, Yeshiva University, Bronx, NY, United States; Carolyn E. Schwartz, ScD, DeltaQuest Foundation, Inc., Concord, MA, United States AIMS: To use multiple sclerosis (MS) patient responses to ‘sampling of experiences’ items from the Quality of Life (QOL) Appraisal Profile as a person factor and thereby to investigate whether: (i) items from the Symptom Inventory fatigue subscale (n = 859) function differentially across groups; (ii) the person-factor classification can be used to identify response shift. METHODS: Observational study of MS patients at two time points: baseline and 6-month follow-up. Patient-reported appraisal measured by the QOL Appraisal Profile, and fatigue measured by the Fatigue subscale of the Symptom Inventory Disability-Specific Short-Forms. Tests for differential item function (DIF) with respect to appraisal using likelihood ratio tests in generalized Partial Credit Models. Recalibration response shift was tested using Oort’s approach of evaluating if item parameters differ over time. Significant DIF evidence was supplemented with plots of item score against the total score and in each of the groups in order to study the magnitude of DIF. We considered the impact of the level of appraisal at each time point, and also the impact of changes in appraisal. Change in appraisal was operationalized as a change of 1 point over time in endorsement of a specific appraisal strategy. RESULTS: Out of the 9 Fatigue items, DIF was detected in 5 items and being affected by 1–3 Experience-Sampling items. The items most prone to DIF were ‘My fatigue is worse when I am hot’ (SI96) and ‘I can only do things for a short period of time because I fatigue easily’ (SI98), each showing DIF with respect to three QOL Appraisal items. SI96 showed DIF with regard to balancing positives with negatives, recall recent events, and considering the survey context when answering. SI98 showed DIF with regard to thinking about the worse moments, trying to remember everything relevant, and considering the survey context when answering. Other items showed DIF with other Experience-Sampling items. Plots of impact of the relationship between total score and item score in each of the groups indicated that the impact of DIF is not large, but of a magnitude that should be accounted for. There was no evidence of changes in item parameters across time and thus no evidence of recalibration. CONCLUSIONS: Appraisal impacts the way respondents use the response categories of Symptom Inventory Fatigue subscale items, and each item is affected by different appraisal processes. Although the DIF impact does not appear to be large, it likely results in clinically meaningful differences. No strong evidence of response shift was disclosed, but response shift may occur in sub populations defined by the person factor appraisal.

103: Transforming Care: Quality of Life, Policy & Decision Making (103.1) Quality of life in the early assessment of benefit in Germany: a qualitative study Christine Blome, PhD, University Medical Center HamburgEppendorf, Hamburg, Germany; David Lohrberg, University Medical

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18 Center Hamburg, Hamburg, Germany; Matthias Augustin, MD, University Medical Center Hamburg, Hamburg, Germany AIMS: Since January 2011, an early assessment of benefit (EAB) is required for all new medicines in Germany. The pharmaceutical manufacturer submits a dossier presenting benefits over comparative treatment, which is scientifically evaluated by the Institute for Quality and Efficiency in Health Care (IQWiG). Subsequently, the Federal Joint Committee (G-BA) decides on the additional benefit, triggering price negotiations between manufacturers and health insurance funds. Evaluation criteria are defined as mortality, morbidity, quality of life (QOL), and side effects. Aim of this qualitative study was to analyse the role of QOL in EAB in Germany. METHODS: A qualitative content analysis according to Philipp Mayring was conducted. Documents of all EABs completed until December 2013, including benefit dossier, IQWiG evaluation, protocol of the oral hearing, and G-BA decision, were searched for the term ‘‘QOL’’ or synonyms. Relevant passages were extracted and reduced to key content independently by two researchers. Subsequent consensus building regarding quintessential phrases led to recurring themes of the term’s usage in the EAB process. Additionally, quantitative data were collected (e.g., medical indication, QOL instruments used, outcome of benefit assessment). RESULTS: 66 EAB were included. Recurring topics related to the definition of QOL, the relevance of QOL assessment, and QOL methodology. Although QOL data wasn’t often reported, all parties involved highlight the concept’s importance. In some cases, postulated benefits in morbidity or side effects were questioned by the IQWiG because they did not reflect in QOL benefits. IQWiG and G-BA expressed a narrower understanding of QOL, whereas pharmaceutical manufacturers also subsumed, for example, patient satisfaction or symptoms under this construct. IQWiG and G-BA emphasized the need to use validated QOL questionnaires and minimal clinically important differences. CONCLUSIONS: QOL is of pivotal importance in German EAB and can have high impact on the additional benefit determined by the G-BA. QOL assessment and analysis in clinical studies that shall enter benefit dossiers should confirm with methodological requirements regarding QOL measurement.

(103.3) Understanding Safe Surgery Checklist Experiences in Alberta Sandra Zelinsky, University of Calgary, Calgary, AB, Canada; Mary Sheridan, University of Calgary, Calgary, AB, Canada; Nancy Marlett, University of Calgary, Calgary, AB, Canada; Svetlana Shklarov, University of Calgary, Calgary, AB, Canada; Tracy Wasylak, Alberta Health Services AIMS: This presentation looks at the impact of Patient Engagement Research within the context of Quality Improvement in healthcare. The Surgery Strategic Clinical Network, Alberta Health Services, wanted to assess the roll out of the Safe Surgery Checklist from a patient’s perspective. This led to contracting an innovative program, Patient and Community Engagement Research, at the University of Calgary. Patients trained as researchers engaged with other patients to gather their presurgical experiences to help improve the delivery of the Safe Surgery Checklist. METHODS: Patient Researchers used a methodology called Set, Collect and Reflect. The research priorities were: provincial representation and training surgery patients as research assistants. In the Set Focus Group, patients advised on the research protocols and questions. For this study, participants were also trained as research assistants to engage other surgical patients in a semi-structured interview. The Collect Phase was a series of 32 patient to patient interviews. The Reflect Phase

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Qual Life Res (2014) 23:1–184 confirmed the analysis resulting in the re-interviewing of a handful of patients to explore how the application of the Safe Surgery Checklist might include more patient engagement and inclusion. RESULTS: In this Patient and Community Engagement Research project we uncovered four themes as described by patients: 1. Knowing is a good thing; 2. Not just a number; 3. Like going through airport security; 4. Knowing there is a checklist would be a good thing. Some major recommendations resulting from the analysis of the themes included the need to inform patients explicitly about the checklist and its purpose prior to the application of the checklist, and making the checklist available to patients prior to their surgery, to engage patients as partners in their surgery journey. CONCLUSIONS: The results were presented to the Surgery Network advisory committee, the recommendations were discussed and changes made. We will track the implementation of the Safe Surgery Checklist based on what the patient-conducted research suggested. These results demonstrate the impact and value of basic patient engagement research and its implementation on improving the quality of patient experience in surgery (Fig. 1).

Fig. 1 Patient and community engagement research (PACER) research methodology

(103.4) Integration of patient-reported outcomes (PRO) in drug development strategy decisions Anders P. Ingelga˚rd, PhD Docent, Covance, Go¨teborg, Sweden; Mika Nokela, Covance Market Access; Anna-Karin Berger, PhD, Covance Market Access; Jason C. Cole, PhD, Covance Market Access Services, San Diego, CA, United States AIMS: The aim of this study is to suggest activities to integrate PRO science and knowhow in drug development strategy decision making in order to facilitate successful regulatory approval, market access, and reimbursement of a new drug. The need for new, innovative, and smarter knowledge management in planning clinical development is high, particularly since the pharmaceutical industry is facing growing demands to bring marketable products out in ever shorter timelines. Despite extensive examples of the impact successful PRO results have on improving market access and profitability, PROs are typically not part of drug development decision making. The lack of clear guidance on how to integrate PROs into the drug development process may be one impediment to their successful inclusion. METHODS: A literature review was carried out on patient-reported outcome and strategy decisions in drug development in phase I to phase IV. The authors also included an additional search on knowledge management, strategy decisions in drug development, and patient-reported outcomes. RESULTS: Few references were found where strategy decisions in drug development included patient-reported outcomes and even less concerning knowledge management and PROs. However, there were many references to strategy decisions in drug development. Based on literature findings a generic model was

Qual Life Res (2014) 23:1–184 developed where drug development strategy decisions include patient-reported outcomes. Each strategy decision in the drug development process can associated with an action related to PROs in the following rough steps: 1) Disease area decision—PRO opportunity assessment; 2) Preliminary TPP and TPC decision—PRO opportunity assessment; 3) Phase II- Developing Conceptual Model; 4) Measurement Strategy; 5) Phase III- Conceptual Framework; 6) Endpoint Model; 7) Final TPC; and 8) PRO Dossier. CONCLUSIONS: These suggested actions could be used as an attempt to structure the PRO activities into a set of actions and work tasks support decision making. If an opportunity is found, then the responsible project development team is in better position to plan and prepare for inclusion of PROs in the upcoming clinical development phases. This would save costs and resources, but more importantly, ensure that the PRO strategy and drug development strategy are aligned.

(103.5) Patients’ Health-Related Quality of Life While Transitioning from Acute-Based to Community-Based Care Maria-Jose Santana, MPharm PhD, Department of Community Health Sciences, W21C Research and Innovation Centre, Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; Barbara Okoniewska, BSc, Department of Community Health Sciences, W21C Research and Innovation Centre, Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; Katy Eso, MS CGC, Department of Community Health Sciences, W21C Research and Innovation Centre, Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; Wrechelle Ocampo, RN MBT, Department of Community Health Sciences, W21C Research and Innovation Centre, Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; Nancy Clayden, EMT-P, Department of Community Health Sciences, W21C Research and Innovation Centre, Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; Jayna Holroyd-Leduc, MD FRCPC, Department of Community Health Sciences, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada; Maeve O’Beirne, MD FCFP PhD, Department of Family Medicine, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada; W. Flemons, MD FRCPC, Department of Medicine, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada; Deborah White, RN PhD, Faculty of Nursing, University of Calgary, Calgary, Alberta, Canada; AJ Forster, MD FRCPC MSc, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; William Ghali, MD FRCPC MPH, Department of Community Health Sciences, W21C Research and Innovation Centre, Institute of Public Health, University of Calgary, Calgary, Alberta, Canada AIMS: The transition between acute care and community care represents a vulnerable period in healthcare delivery. This study examines patients’ health-related quality of life (HRQOL) while transitioning from acute-based to community-based care. METHODS: Consecutives patients admitted to a Medical Teaching Unit of a Canadian tertiary care centre were invited to complete the Health Utilities Index (HUI3) at admission to hospital and at 1- and 3-months after discharge from hospital. After discharge patients were interviewed via telephone for the follow up measurements. HUI3 is a generic preference-based patient-reported outcome measure (PROM). HUI3 includes eight attributes (vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain and discomfort), with 5–6 levels for each attribute. Single-attribute (SAUS) and overall utility scores (OUS) were calculated using the HUI3 utility function derived from community health-state preferences. SAUS level 1 (not impaired) = 1.00, and the lowest level (most impaired) = 0.00. OUS

19 are on a scale in which perfect health = 1.00 and dead = 0.00. The minimum OUS is –0.36. Negative scores represent health states considered worse than dead. Disability categories range from no disability = 1 to severe disability \ 0.70. Changes in SAUS of 0.05 and changes of 0.03 in OUS are clinically important. These changes were used to describe patient’s HRQOL while transitioning between acute and community-based care, as well as to compare patients’ HRQOL between groups. The sample size was calculated based on hypothesized changes in HUI overall score. RESULTS: A total of 1103 patients completed the HUI3 at admission, 1-month and 3-month after discharge from hospital. OUS ranges from -0.33 to 1; -0.32 to 1; -0.27 to 1 respectively at admission, 1-month and 3-month. Mean (SD) OUS was 0.304 (0.317); 0.591 (0.354); 0.593 (0.355) respectively at admission, 1-month and 3-month. We detected clinically important and statistically significant changes in mean OUS and mean SAUS for pain, cognition, emotion, ambulation and hearing. CONCLUSIONS: We used HUI3 to describe HRQOL of patients while transitioning from acute to community-based care. The results of this study provide evidence of the value of PROMs in explaining patients’ illness burdens. PROMs could be used to assess the effectiveness of healthcare interventions while patients transition across the continuum of care.

104: Advancing Quality of Life Measurement in Older Adults (104.1) Bibliometric Analysis of PROMs and PREMs for Elderly Patients in Acute Care Eric K. H. Chan, PhD, Trinity Western University, Langley, BC, Canada; Richard Sawatzky, PhD RN, Trinity Western University, Langley, BC, Canada; Duncan Dixon, Trinity Western University; Dorolen M. Wolfs, Trinity Western University; Anne M. Gadermann, PhD, University of British Columbia, Vancouver, BC, Canada; PROM-PREM Knowledge Synthesis Team, Trinity Western University AIMS: There is widespread interest in the use of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) for seriously ill elderly patients in acute care and their families. In this bibliometric study we set out to identify a) existing PROMs and PREMs and b) the number of scholarly publications on the identified instruments relevant to elderly patients in acute care and their families. This study is part of an overarching knowledge synthesis initiative on the measurement properties and development of evidence-based recommendations for the selection and utilization of PROMs and PREMs for this patient population and their families. METHODS: Potentially relevant PROMs and PREMs were identified using the following sources: 1) database searches (using nine databases), 2) PROQOLID, 3) Handbook of Disease Burdens and Quality of Life Measures, 4) relevant review articles, 5) subject matter experts, and 6) internet browsing. Subsequently, we conducted systematic searches of the identified instruments using MedLine, CINAHL, and EMBASE to determine the number of scholarly publications on each of the identified PROMs and PREMs. Specific search strings were developed for each instrument. Inclusion/exclusion criteria, screening criteria, and coding forms were developed and applied following standard knowledge synthesis procedures. RESULTS: Thus far, 203 PROMs and 27 PREMs have been identified, and three instruments were both PROMs and PREMs. Per instrument, the median number of publications relevant to elderly patients in acute care was 12 (lower quartile = 1; upper quartile = 60). Several instruments were specifically developed for use in older adults, whereas others, such as the SF-36, were developed for general populations but are widely-used in older adults. The majority of the instruments were

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20 multidimensional. Forty-five percent of the instruments were generic and six percent were new instruments (developed within past five years). CONCLUSIONS: There is a large number of PROMs and PREMs that have been used in acute care settings for elderly patients. Our next steps are to evaluate the psychometric properties of the most widely applicable instruments and to develop guidelines and recommendations regarding the selection and utilization of PROMs and PREMs for seriously ill elderly patients and their families.

(104.2) Response shift in quality of life in older men: the Manitoba Follow-up Study Maryam A. Alshammari, University of Manitoba, Winnipeg, MB, Canada; Robert B. Tate, University of Manitoba; Donna Collins, University of Manitoba; Ruth Barclay, PhD MHSc BMR (PT), University of Manitoba, Winnipeg, MB, Canada AIMS: As people age, they may alter their values (reprioritization) and concepts (reconceptualization) regarding what is important to their quality of life (QOL). Reprioritization and reconceptualization are known as types of response shift (RS). Currently, RS in aging has not been often studied. The objective is to estimate the timing, magnitude, and direction of reprioritization and reconceptualization RS in older men. METHODS: Since 1948, 3,983 male World War II Royal Canadian Air Force aircrew have been followed by the Manitoba Follow-up Study (MFUS) to identify incidence of cardiovascular diseases, and recently, predictors of successful aging. Data from the MFUS, Successful Aging Questionnaire was used. In each of 5 years of data (2007–2011), participants identified the importance of 15 items which reflect the QOL domains of physical, mental, and social function. Items were scored as ‘not important, moderately important or very important’ to the participant’s present QOL. Data were analyzed using frequency crosstab tables in 2, 3, and 4 year periods (4 years period presented here). Reprioritization and reconceptualization were identified by change in priority of individual items over time. RESULTS: 360 men had a mean age of 89.7 (2.9) years in 2007. RS was identified in all of the items at each time period. Across all items, an average of 24.9 % of men demonstrated RS. Reprioritization presents as increased or decreased importance of items over time; e.g., of those respondents who demonstrated reprioritization in the ‘keeping physically active’ item, 26 % showed an increase in importance and 74 % showed a decrease in importance. RS type varied among items and domains; e.g., of all -RS identified-in the item, ‘keeping mentally active’, 93 % was reprioritization and 7 % was reconceptualization, whereas in the ‘volunteering’ item, 24 % was reprioritization and 76 % was reconceptualization. CONCLUSIONS: This is a novel study which identified that older men reprioritize and reconceptualize aspects of QOL over time. Whether RS is a result of other changes to their life or adaptation to deteriorating health remains to be untangled. RS is a potentially important part of aging and needs to be considered when planning resources and interventions for this population.

Qual Life Res (2014) 23:1–184 reaching, grasping and carrying). The aim of this study was to develop and test a tool to assess meaningful physical activities that could be integrated in the daily routines of residents? METHODS: In a first phase an interdisciplinary team of researchers and care professionals developed in an iterative process a method (called ‘‘MIBBO’’) to identify the preferred physical activities of nursing home residents. Several requirements for the use of the method were defined beforehand. The first version of the MIBBO was used in a small sample (n = 10). In a second phase, the adapted MIBBO version was used in a larger sample of elderly with different pathologies (n = 123). Data was collect on most often chosen activities and to investigate whether preferences stayed stable over time (test- retest). RESULTS: A tool in seven steps to identify preferred physical activities in elderly residents in health care facilities was developed. The main part of the MIBBO is a photo interview; residents assess and sort photos of 30 physical activities into two piles (‘yes, I like to do’ versus ‘no, I’m not interested’). In the next steps the resident selects her/his top five activities. The method takes on average 30 min to conduct and was assessed feasible within a small sample. The overall top 5 of frequently chosen activities were: gymnastics and orchestra (each 28 %), preparing a meal (31 %), walking (outside, 33 %), watering plants (38 %) and feeding pets (40 %). During the retest, 69.4 % of the initially selected activities were selected again. CONCLUSIONS: The tool MIBBO can help health care professionals in tailoring physical activities to the preferences of their residents. A logical next step would be to focus on the implementation of the tailored activity plan into daily routine in nursing home care and to assess the effects of this implementation on the residents’ level of physical activity (Fig. 1).

(104.3) MIBBO: a tool to assess meaningful physical activities for nursing home residents Melanie Kleynen, Zuyd University of Applied Sciences, Heerlen, Netherlands; Susy Braun, Zuyd University of Applied Sciences, Heerlen, Netherlands; Kim Van Vijven, Zuyd University of Applied Sciences, Heerlen, Netherlands; Erik Van Rossum, Zuyd University of Applied Sciences, Heerlen, Netherlands; Anna Beurskens, PhD, Zuyd University of Applied Sciences, Heerlen, Netherlands AIMS: Elderly nursing home residents are on average less active and often difficult to stimulate to become more active. However, all sorts of routine activities in daily life have a ‘natural’ activity component (e.g. setting the table for a meal and watering plants involve walking,

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Fig. 1 Steps of the MIBBO

(104.4) How Do Local Care Amenities Shape Late-life Development in Well-being? Nina Vogel, Humboldt University, Berlin, Berlin,; Denis Gerstorf, Humboldt University, Berlin, Germany; Nilam Ram, Pennsylvania State University; Jan Goebel, German Institute for Economic

Qual Life Res (2014) 23:1–184 Research (DIW); Gert G. Wagner, German Institute for Economic Research (DIW) AIMS: Both psychologists and sociologists highlight the role context plays in shaping individual development across the life span. Operationalizing regional context as the characteristics of care services in one’s county, we aim to examine associations between local care amenities and late-life development, operationalized as terminal decline in life satisfaction. METHODS: We combine 22 waves of yearly, longitudinal reports of life satisfaction obtained from now deceased participants (n = 4,159) in the Socio-Economic Panel Study (SOEP) with German Statistics of Care (German Federal Bureau of Statistics) and run three-level growth curve models. RESULTS: We find that between-county differences contribute 7 % of variance to between-person differences in both level and rates of change in life satisfaction. Specifically, availability of beneficial care services (e.g., lower working load in inpatient facilities) contributes to more positive life satisfaction trajectories. CONCLUSIONS: Our results support long-standing notions that local amenities play a role for individual late-life development, and we discuss possible routes through which local care services can shape well-being trajectories. In follow-up analyses we will check whether availability of care characteristics contributes differently to wellbeing trajectories of individuals who receive care and those who don’t.

(104.5) Community Aged Care Assessment: Results from a National Field Trial Janet E. Sansoni, MSc, University of Wollongong, Fadden, Australia; Peter Samsa, University of Wollongong; Cathy Duncan, Centre for Health Service Development, University of Wollongong, Wollongong, Australia; Kathy Eagar, University of Wollongong; Bruce Shadbolt, Faculty of Medicine, Australian National University AIMS: An aged care assessment suite to enable elderly people to access community aged care services was redesigned for national application and field tested across Australia (N = 1,011). A 3-tiered model for assessment related to the need for services underpinned the assessment battery: * Level 1—for those requiring basic services such as domestic assistance or transport etc.; * Level 2—for those requiring more substantial use of services including elements of personal care; * Level 3—for those requiring a comprehensive clinical assessment to obtain higher levels of care. The field trial was concerned with the first two levels of assessment and referral to a Level 3 agency. METHODS: The Level 1 assessment included background information, a Functional Profile (FP) containing validated items concerning ADL and IADL function and seven trigger items to determine whether a Level 2 assessment was required. The Level 2 assessment contained supplementary profiles (dementia, health, psychosocial, carer need, caring role and financial/legal issues profiles) which were only completed if triggered. Most assessments were undertaken by telephone. Assessors used a customized, knowledge-management, web-based platform to provide decision support and to record the assessment. Consecutive applicants at seven assessment locations throughout Australia were assessed over the two month trial period. RESULTS: Overall 49 % of applicants received a Level 1 Assessment, 51 % a Level 2 Assessment and 10 % of applicants were referred to a Level 3 agency. There was a significant difference in the FP scores between Level 1, Level 2 and applicants referred to Level 3. Most Level 1 applicants (89 %) required only 1 basic service whereas most Level 2 applicants (65 %) required multiple services.

21 The FP score was significantly associated with the number of case complexity profiles triggered and with referral to Level 3. Although the internal consistency of the FP was alpha = 0.82 item analysis indicated the scale could be streamlined by the removal of one item which slightly increased the alpha. CONCLUSIONS: A tiered webbased assessment system with various exit points for referral was useful in assigning people to services and in tailoring the level of assessment to client need.

105: New Approaches to Evaluating Cancer Treatments (105.1) Effect of low versus high intensity physical exercise during chemotherapy on physical fitness, fatigue and chemotherapy completion rates: Results of a randomized, controlled trial Hanna Van Waart, The Netherlands Cancer Institute, Amsterdam, Netherlands; Martijn M. Stuiver, The Netherlands Cancer Institute; Gabe S. Sonke, The Netherlands Cancer Institute; Wim H. Van Harten, The Netherlands Cancer Institute; Neil K. Aaronson, PhD, The Netherlands Cancer Institute, Amsterdam, Netherlands AIMS: Cancer chemotherapy is frequently associated with a decline in physical condition and muscle strength, and an increase in fatigue. Exercise programs have been shown to have a beneficial effect on patients undergoing chemotherapy. The optimal intensity of such programs is as yet unknown. This study evaluated the efficacy of a low intensity, home-based, self-management physical activity program (Onco-Move), and a high intensity, structured, supervised exercise program (OnTrack) in terms of maintaining or enhancing cardiorespiratory fitness and muscle strength, minimizing fatigue, enhancing health-related quality of life (HRQOL), and maximizing chemotherapy completion rates of patients undergoing adjuvant chemotherapy for breast and colon cancer. METHODS: In this multicenter, prospective, 253 patients were randomized to: Onco-Move (n = 85), OnTrack (n = 83) or a Usual Care (n = 85). Outcomes included both performance and self-report measures of cardiorespiratory fitness and muscle strength, self-reported fatigue, HRQOL and chemotherapy completion rates as determined by medical record review. Outcome measures were assessed prior to chemotherapy, at the end of chemotherapy, and 6 months later. RESULTS: Participants in OnTrack had significantly less decline in cardiorespiratory fitness (ES = 0.52 and ES = 1.17), enhanced muscle strength (ES = 0.59) and experienced less physical fatigue (ES = 0.64) as compared to the control group. Both exercise groups reported better physical functioning (ES = 0.62), less nausea (ES = 0.43) and pain (ES = 0.33). Only participants in OnTrack reported less constipation (ES = 0.78) at follow-up than the control group. Significantly more participants in OnTrack completed their prescribed chemotherapy regimen without dose adjustments than those in the control group (84 % versus 62 %) (OR 3.3). CONCLUSIONS: High intensity physical exercise during chemotherapy enhances muscle strength, reduces the decline in cardiorespiratory fitness and fatigue, and leads to less dose reductions in chemotherapy regimens. Low intensity exercise also has a salutary effect on physical fatigue and other symptoms, but less so than high intensity exercise.

(105.2) Quality of life among patients after bilateral prophylactic mastectomy: A systematic review of patient-reported outcomes Shantanu N. Razdan, MD MSPH, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Vishal Patel, BS, Weill Cornell Medical College; Colleen McCarthy, MD MS, Memorial Sloan Kettering Cancer Center, New York, NY, United States

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22

Fig. 1 Flow diagram for systematic review methodology in line with PRISMA guidelines AIMS: Bilateral prophylactic mastectomy (BPM) is effective in reducing the risk of breast cancer in women with a well-defined family history of breast cancer or in women with BRCA 1 or 2 mutations. BPM involves the removal of healthy breasts and as such, women undergoing BPM have a unique psychosocial state and expectations prior to surgery. Evaluating patient-reported outcomes following BPM are thus essential for evaluating success of BPM from patient’s perspective. Our systematic review aimed to: (1) identify studies describing health-related quality of life (HRQOL) outcomes in patients following BPM with or without reconstruction; (2) assess the effect of BPM with or without reconstruction on HRQOL; and, (3) identify predictors of HRQOL post BPM. METHODS: We performed a systematic review of literature using the PRISMA statement. PubMed, Embase, PsycINFO, Web of Science, Scopus and Cochrane databases were searched. RESULTS: The initial search resulted in 1,082 studies (Fig. 1); 23 of these studies fulfilled our inclusion criteria. Four studies were prospective and 19 were retrospective. Of these studies, 12 used ad hoc questionnaires alone; 11 used 13 HRQOL instruments either alone or in combination with an ad hoc questionnaire. In only 1 study was a breast-specific instrument used. Different studies evaluated different HRQOL domains. Only 5 studies compared HRQOL between patients who had reconstruction post BPM with those that did not. Vulnerability and psychological distress were found to be significant negative predictors of quality of life post BPM. Preoperative cancer distress predicted a negative body image post BPM and reconstruction. CONCLUSIONS: There is a paucity of high quality data on HRQOL outcomes post BPM. The reporting of HRQOL domains is also inconsistent. This is most likely due to the use of multiple, ad hoc instruments used in these studies. Future studies should strive to use validated and breast-specific PRO instruments for measuring HRQOL. This will facilitate shared decision-making by enabling surgeons to provide evidence-based answers to women contemplating BPM.

(105.3) Quality of life in patients with localized prostate cancer according to treatment and biochemical relapse Monica Avila, PharmD, MPH, IMIMI (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Angels Pont Acunda, Hlth Svcs Research Unit, Barcelona, Catalunya, Spain; Olatz Garin, MPH, PhD, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Montserrat Ferrer, MD PhD MPU, Hospital Del Mar Research Institute (IMIM), Barcelona, Spain

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Qual Life Res (2014) 23:1–184 AIMS: Localized prostate cancer has low biochemical relapse and disease progression rates, regardless of the curative treatment applied. Our objective is to evaluate Health-Related Quality of Life (HRQOL) at five years after treatment in patients with localized prostate cancer according to biochemical relapse and primary curative treatment. METHODS: The cohort of ‘‘Multicentric Spanish Study of Clinically Localized Prostate Cancer’’ was composed of 762 patients treated with radical prostatectomy, external radiotherapy or brachytherapy in 10 Spanish hospitals (2003–2005). The treatment decision was taken jointly by doctor and patient. HRQOL was assessed annually after treatment, using the Expanded Prostate Cancer Index (EPIC) questionnaire, which measures five scales: urinary incontinence, urinary irritative-obstructive, bowel, sexual, and hormonal (scores ranging 0–100). A higher score represents better HRQOL. Biochemical relapse was defined from the levels of PSA according to the criteria of the American Urological Association and the American Society for Radiation Oncology. To compare HRQOL of patients with and without relapse, Student’s t test was applied after stratifying by treatment. RESULTS: Of the 719 patients who completed HRQOL assessments, 188 were treated with radical prostatectomy, 306 with brachytherapy and 225 with external radiotherapy. Of the 113 patients (15.7 %) who had relapse within five years after treatment: 32 were treated with radical prostatectomy, 43 with brachytherapy, and 38 with external radiotherapy. No statistically significant differences were found in HRQOL according to relapse among patients treated with radical prostatectomy. Brachytherapy patients with relapse obtained lower EPIC scores than patients without relapse in urinary irritative-obstructive (80.7 vs 90.3, p = 0.02) and hormonal (84.2 vs 91.7, p = 0.02) domains. For external radiotherapy, a lower score was observed only for the hormonal domain when comparing patients with and without relapse (79.8 vs 89.8, p = 0.01). Regardless of the relapse, each treatment maintained its distinctive side-effects pattern: urinary incontinence and sexual dysfunction for radical prostatectomy, irritative-obstructive urinary problems for brachytherapy, and bowel problems for external radiotherapy. CONCLUSIONS: HRQOL of patients with localized prostate cancer depends mainly on the primary treatment applied, except for hormonal side effects appearing among relapsing patients, which were associated with the biochemical relapse hormonal therapy.

(105.4) Health-Related Quality of Life in Patients with Unresectable or Metastatic Melanoma: Preliminary Results from IMAGE Study Susan D. Mathias, MPH, Health Outcomes Solutions, Winter Park, FL, United States; Srividya Kotapati, Bristol-Myers Squibb; T Kim Le, Bristol-Myers Squibb; Amy P. Abernethy, Duke Comprehensive Cancer Center AIMS: To present preliminary health-related quality of life (HRQOL) data from IMAGE, a Phase IV, global, prospective, observational study of individuals with unresectable or metastatic melanoma who either received ipilimumab or another approved treatment as second line or subsequent line of treatment. METHODS: Patients completed the EORTC-QLQ-C30 and EQ-5D upon entry into the study (baseline) and every 3 months for the first year of the study. Adjusted mean change scores from baseline to month 3 were compared by treatment groups. ANCOVA regression was used to adjust mean scores for baseline score, demographics (e.g., age, gender, race), and clinical characteristics (e.g., time since diagnosis, disease stage) and ECOG status. Data collection is still ongoing; results are presented for those participants with baseline and month 3 data. RESULTS: Compared to other treatments (n = 31), the ipilimumab group (n = 125) had more males (60 % vs. 52 %), were older (62 vs. 60 years), less with Stage IV cancer (95 % vs. 97 %), longer mean time since diagnosis (51 vs. 45 months), and higher percentage with ECOG performance status of 0 or 1 (94 % vs. 68 %). In general, ANCOVA adjusted EORTCQLQ-C30 and EQ-5D mean change scores worsened for both

Qual Life Res (2014) 23:1–184 Table 1

23

EORTC and EQ-5D—analysis of covariance

Measure

Patients receiving Ipilimumab (n = 367) Mean ± SE (n)

Patients receiving other approved treatments (n = 89) Mean ± SE (n)

EORTC* Global health status

-13 ± 12 (n = 125)

-18 ± 13 (n = 31)

Physical functioning

-20 ± 12 (n = 125)

-23 ± 12 (n = 29)

Role functioning

-28 ± 17 (n = 125)

-24 ± 18 (n = 29)

Emotional functioning

3 ± 12 (n = 125)

5 ± 12 (n = 31)

Cognitive functioning

-15 ± 11 (n = 125)

-11 ± 11 (n = 31)

Social functioning 

-12 ± 16 (n = 125)

-25 ± 16 (n = 31)

Fatigue Nausea and vomiting

17 ± 14 (n = 125)

15 ± 14 (n = 28)

-0.18 ± 12 (n = 124)

-1 ± 12 (n = 29)

Pain 

15 ± 15 (n = 123)

28 ± 15 (n = 31)

Dyspnea

-6 ± 15 (n = 124)

-5 ± 16 (n = 28)

Insomnia

24 ± 15 (n = 124)

24 ± 15 (n = 29)

Appetite loss

2 ± 17 (n = 124)

3 ± 17 (n = 27)

Constipation

3 ± 11 (n = 125)

6 ± 11 (n = 29)

-8 ± 15 (n = 124)

-6 ± 15 (n = 30)

-0.20 ± 0.17 (n = 114)

-0.28 ± 0.17 (n = 27)

Diarrhea EQ-5D** EQ-5D index

* Positive mean change scores for functioning represent improvement and negative change scores represent worsening. Positive mean change scores for symptoms represent worsening and negative change scores represent improvement ** Negative mean change scores represent worsening

impact their health-related quality of life (HRQOL). The Trial Outcome Index (TOI) may be used to evaluate these effects and is reported to be an efficient and precise summary index of physical and functional outcomes (Webster et al. 2003). The objective of this study is to examine TOI scores over the course of treatment of patients with esophageal cancer. METHODS: A longitudinal study of 30 patients with esophageal cancer treated with neoadjuvant chemoradiation followed by surgery completed FACT-E questionnaires at: 1) baseline (prior to chemoradiation); 2) 6–8 weeks (post-chemoradiation); 3) 12–14 weeks (prior to surgery); 4) post-esophagectomy at 1, 3, 6, 9, 12, 18, 24, and 36 months. The Trial Outcome Index (TOI) includes three scales of the FACT-E: Functional well-being, Physical wellbeing and the Esophageal-specific concerns. Higher scores indicate better physical/functional well-being. A linear mixed-effects model analysis with GEE (Generalized Estimating Equations) was used to address the longitudinal pattern of the scores of the TOI by time and age. Tukey–Kramer pairwise comparisons were also done between the different time periods. RESULTS: TOI scores differed over time (p \ 0.001) with a significant decrease in TOI from baseline to 6–8 weeks (after chemoradiation) (p \ 0.0001; Median: 93.00 vs 73.00). However, TOI improved prior to surgery. At 1 month post-op, TOI was significantly worse than at baseline (p \ 0.0001; Median: 93.00 vs 78.00). TOI at 3 months post-op (Median: 89.50) was not significantly different from baseline, or preoperative values. Beyond 3 months, post-op TOI scores either stabilized or increased. Interestingly, there was a significant relationship between age and TOI scores (p = 0.0054) with younger patients having lower TOI scores. For each year increase in age, TOI scores increased by 1.119. CONCLUSIONS: The observed changes in TOI scores reflect clinical observations. TOI scores suggest that patients recover faster from surgery than previously thought as the majority of patients recover to baseline levels by three month post-op. Also, older patients report better physical functioning and fewer symptoms. This finding warrants further exploration.

  p \ 0.05

treatment groups between baseline and month 3 (Table 1). However, the ipilimumab group reported statistically and clinically significant less worsening than the non-ipilimumab group on Social Functioning (-12 vs. -25) and Pain (15 vs. 28), p \ 0.05. Although change scores did not achieve statistical significance, for the majority of EORTC-QLQ-C30 scales and the EQ-5D Index score, patients receiving ipilimumab reported numerically less worsening than those receiving other approved treatments. Both groups reported improvements in Emotional Functioning, Dyspnea, and Diarrhea. CONCLUSIONS: Patients with advanced melanoma experience deteriorations in HRQOL during the first 3 months of treatment. Preliminary data suggest the extent of worsening may be less pronounced, particularly in Social Functioning and Pain, in the ipilimumab group compared to those receiving other approved treatments. Longer-term follow up data with a larger sample size will demonstrate if these results persist.

(105.5) Evolution of Trial Outcome Index (TOI) scores at different time periods for esophageal cancer patients treated with neoadjuvant chemoradiation and surgery Julie G. Trudel, PhD, University Health Network, Toronto, ON, Canada; Joanne Sulman, Qualitative Research and Group Wok Consultant; Eschetu Atenafu, Princess Margaret Cancer Center; Jennifer Lister, Thoracic Surgery Department, Toronto General Hospital, Toronto, ON, Canada; Gail Darling, Thoracic Surgery Department, Toronto General Hospital, Toronto, ON, Canada AIMS: Esophageal cancer patients treated with chemoradiation followed by surgery experience significant physical side effects that

106: New Measures and Methods I: Development & Evaluation (106.1) Preliminary Validity Evidence for the PROMISÒ Smoking Assessment System Maria O. Edelen, PhD, RAND Corporation, Boston, MA, United States; Brian D. Stucky, PhD, RAND Corporation, Santa Monica, CA, United States; Joan S. Tucker, RAND Corporation; Mark Hansen, UCLA-CRESST; William Shadel, RAND Corporation AIMS: The PROMIS Smoking Initiative has developed six items banks for assessment related to cigarette smoking among daily and nondaily adult smokers. Descriptive information and validity evidence for the item banks (Nicotine Dependence, Coping Expectancies, Emotional and Sensory Expectancies, Health Expectancies, Psychosocial Expectancies, and Social Motivations) are presented. METHODS: Using data from a large calibration sample of daily (N = 4,201) and nondaily (N = 1,183) smokers, we generated mean daily and nondaily smoking bank scores according to select demographic groups, examined correlations among the six banks, and examined associations of bank scores with smoking behavior items (e.g., quantity of smoking, interest in quitting) and select PROMIS health-related quality of life measures (i.e., physical functioning, anxiety, alcohol consumption). These associations were re-evaluated using data from daily and nondaily smokers in a follow-up subset of the calibration sample (N = 491) and an independent community sample (N * 400). RESULTS: In the calibration sample, correlations among the six banks are moderate (Daily mean r = 0.48, range = 0.04–0.80; Nondaily mean r = 0.46, range = 0.11–0.74). The pattern of associations between bank scores and other measures provides validity evidence for the bank domains. For example,

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24 nicotine dependence is most strongly associated with smoking quantity and time to first cigarette of the day, and health and psychosocial expectancies are most related to quitting recency and interest. Associations with physical functioning were strongest for nicotine dependence and health and psychosocial expectancies; nicotine dependence and coping expectancies scores were most strongly associated with anxiety, and no bank scores were significantly associated with alcohol consumption. Analyses of the follow-up and independent community samples are ongoing. Early results indicate that these associations are largely replicated with the new data. CONCLUSIONS: These analyses provide useful descriptive information about the six smoking item banks, as well as preliminary evidence for their validity. Additional analyses with the new data will examine whether baseline bank scores are related to changes in smoking behaviors and readiness to quit (follow-up), establish the correspondence between bank scores and ‘legacy measures’ (followup), and explore associations of bank scores with other key variables (e.g., use of other tobacco products, health service utilization; followup and community).

(106.2) Replication and relative validity of the mental and physical higher order model of the EORTC QLQ-C30 Jacobien M. Kieffer, PhD, The Netherlands Cancer Institute, Amsterdam, Netherlands; Johannes M. Giesinger, PhD, Innsbruck Medical University, Innsbruck, Tyrol, Austria; Peter Fayers, PhD, University of Aberdeen, Aberdeen, United Kingdom; Mogens Groenvold, MD, PhD, University of Copenhagen, Copenhagen, Denmark; Morten Aa Petersen, MSCi, Bispedjerg Hospital, Copenhagen, Denmark; Neil W. Scott, MA MSc PhD, University of Aberdeen, Aberdeen, United Kingdom; Mirjam AG Sprangers, PhD, Academic Medical Center, Amsterdam, Netherlands; Galina Velikova, MD PhD FRCP, University of Leeds, Leeds, United Kingdom; Neil K. Aaronson, PhD, The Netherlands Cancer Institute, Amsterdam, Netherlands AIMS: To extend the study of Gundy et al. 2012 comparing 7 higher order models for the QLQ-C30, by replicating and validating their best fitting model with physical (PHC) and mental (MHC) health components. METHODS: We used pre- and on-treatment QLQC30v3.0 data from the remaining 50 % sample of 9,044 cases in the dataset used in the Gundy study. We applied confirmatory factor analysis to the pre-treatment data to replicate the physical/mental health model. We calculated weighted (unstandardized factor loadings) and unweighted component scores and used these and the original QLQ-C30 scales in known-groups comparisons of pre-treatment data, with tumor stage and performance status as grouping variables. We evaluated responsiveness, comparing pre- versus –ontreatment data and calculated effect sizes (ES) and relative validity (RV) (if F-statistic ratio (FA:FB) [ 1, then measure A performs better than B). RESULTS: The physical/mental health model fit the data well (CFI = 0.943; TLI = 0.971; RMSEA = 0.056). We first compared the weighted and unweighted component scores. The weighted and unweighted PHC scores performed similarly in discriminating between groups based on tumor stage and performance status. (?ES \ 0.06;?RV \ 0.12). The unweighted MHC was superior to the weighted score (tumour stage: ES = 0.61 vs. 0.44, RV = 0.49; performance status: ES = 0.85 vs. 0.61, RV = 0.45). Responsiveness was comparable between the weighted and unweighted components (PHC: ES = -0.25 vs. -0.23, RV = 1.19; MHC: ES = -0.10 vs. -0.13, RV = 0.44). Based on these results, we conducted additional known-groups comparisons with the unweighted component scores only, in comparison to their underlying QLQ-C30 scales. The component scores outperformed the subscales for tumor stage and performance status. The observed change scores from pre- to on-

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Qual Life Res (2014) 23:1–184 treatment were small, resulting in limited responsiveness of both the components and subscales (ES range 0.01–0.34). However, the PHC outperformed 8 of 11 subscales (exceptions Physical Functioning, Fatigue, and Nausea/Vomiting). The MHC outperformed 4 of 7 subscales (exceptions Role Functioning, Cognitive Functioning and Fatigue). CONCLUSIONS: Unweighted PHC and MHC scores can be used instead of or as a first step in analyzing QLQ-C30 data. This can help minimize Type I errors introduced by analyzing all 15 QLQC30 subscales separately. Further research is required into the responsiveness of the PHC and MHC scores.

(106.3) The minimally important difference for better interpretation of patient-reported outcome measures in patients with intermittent claudication Anne P. Conijn, MD, Academic Medical Center Amsterdam, Amsterdam, Netherlands; Wilma Jonkers, Achmea Insurances, Zeist, Netherlands; Ellen V. Rouwet, Erasmus Medical Center Rotterdam; Anco Vahl, OLVG Amsterdam; Mark JW Koelemay, Academic Medical Center Amsterdam, Amsterdam, Netherlands AIMS: The aim of this study was to determine the MID for two frequently used PROMs, the Vascular quality of life questionnaire (VascuQOL) and the Walking impairment questionnaire (WIQ) in patients with intermittent claudication (IC). METHODS: In this prospective multicenter study we recruited 294 patients with IC. All patients completed the VascuQOL and the WIQ at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status as improved, unchanged or deteriorated at follow-up. We used two different methods to calculate the MID. In the anchor-based approach, the MID was calculated as the 95 % confidence interval of the mean change of the group who considered their health status as unchanged. In the distribution-based approach, the MID was calculated as half the standard deviation of the baseline score of the sample. RESULTS: The VascuQOL was sufficiently completed by 224 patients at both baseline and follow-up, the WIQ by 184. The mean VascuQOL score changed from 4.25 (±1.16) to 5.11 (±1.24). The MID for the VascuQOL was 0.28 and 0.79 for deterioration and improvement respectively, using the anchor-based approach, and -0.58 and 0.58 using the distribution-based approach. The mean WIQ score changed from 0.40 (±0.24) to 0.55 (±0.29). The MID for the WIQ was -0.01 and 0.12 for deterioration and improvement, respectively, by the anchor-based approach, and -0.12 and 0.12 by the distribution-based approach. Applying the MID values to our patient sample indicates that 45 % of patients experienced a clinically relevant improvement on the VascuQOL by the anchor-based approach, whereas 32 % experienced a relevant deterioration. By the distribution-based approach, 54 and 10 % showed a relevant improvement and deterioration, respectively. On the WIQ, 53 % of patients reached a clinically relevant improvement, and 27 % showed a relevant deterioration, by the anchor-based approach. With the distribution-based approach 53 % showed relevant improvement and 13 % relevant deterioration. CONCLUSIONS: In this study we calculated the MID for two frequently used PROMs in patients with IC. Applying the MID values found in this study facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care.

(106.4) Minimal Clinically Important Difference (MCID) Calculated Using the Standard Error of the Measurement (SEM) May Vary as a Function of the Patient Population Arlene S. Swern, PhD, Celgene Corporation, Berkeley Heights, NJ, United States; Mikkael A. Sekeres, Cleveland Clinic Taussig Cancer Institute, Leukemia Program, Cleveland, OH, United States;

Qual Life Res (2014) 23:1–184

25

Chengqing Wu, Celgene Corporation, Summit, NJ, United States; Mary M. Sugrue, Celgene Corporation, Summit, NJ, United States AIMS: Patient-reported outcomes (PROs) have become increasingly important in discriminating between therapies and assessing change from baseline. Statistical significance is insufficient when evaluating PROs; it is important to assess the MCID, i.e. the smallest difference that could be detected by a patient that might result in a change in the patient’s management. Methods to evaluate MCID fall into 2 main categories: anchor-based, using an external standard; and distributionbased, reflecting a minimal statistically quantifiable difference in scores. SEM, a distribution-based method, is assumed to be constant and a property of the scale rather than patient characteristics. However, standard statistical theory dictates that more diverse patient populations will have greater variability of measurements and SEM. Myelodysplastic syndromes (MDS) are a heterogeneous group of hematopoietic clonal disorders characterized by peripheral blood cytopenias and increased requirement for red blood cell (RBC) transfusions (Garcia-Manero G. Am J Hematol. 2014;89:97–108). The present analysis aimed to assess the impact of various distributions of patient characteristics, including baseline RBC transfusion burden on MCID for health-related quality of life (HRQOL) domains as measured by SEM. METHODS: AVIDA is a prospective, US, community-based registry of patients treated with azacitidine (www.ClinicalTrials.gov, NCT00481273). This analysis includes 421 MDS patients enrolled from 105 sites. Patients reported HRQOL using the EORTC QLQ-C30 questionnaire. SEM measurements for selected EORTC QLQ-C30 domains, i.e. Global, Role Functioning, Social Functioning, and Fatigue, were calculated for AVIDA and hypothetical patient populations with varying distributions at baseline of Eastern Cooperative Oncology Group (ECOG) performance status scores and RBC transfusion burden. RESULTS: SEM measurements changed with varying distributions at baseline of ECOG performance status scores (Table 1) and RBC transfusion burden (Table 2; Fig. 1) across AVIDA and hypothetical patient populations. SEM calculations for the Global domain ranged from 6.7–7.3 to 7.1–7.9 for the varying distributions of ECOG performance status and RBC transfusion burden, respectively; a greater variability in SEM calculations was observed within the individual domains. CONCLUSIONS: This analysis demonstrates the extent to which the MCID calculated by SEM can vary dependent on patient characteristics within a study. Therefore, this method could be less meaningful when extrapolating these data to patients with differing disease severity.

Table 1 Varying distributions of patients stratified by baseline ECOG performance status score and associated SEM measurements ECOG performance status score, % patients

AVIDA registry

Hypothetical distributions A

B

C

0

28

50

10

10

1

53

30

10

80

2–3

19

20

80

10

EORTC QLQ-C30 domain Global Role functioning

SEM for AVIDA registry

SEM for hypothetical distributions

7.1

6.7

6.8

7.3

11.6

11.4

13.2

11.12

Social functioning

12.9

12.6

14.1

13.0

Fatigue

10.2

10.0

10.8

10.3

EORTC European organisation for research and treatment of cancer

Table 2 Varying distributions of patients stratified by baseline RBC transfusion burden and associated SEM measurements RBC transfusion AVIDA Hypothetical burden registry distributions (median units/8 weeks), % patients A B

C

0

48

50

10

10

[0 to \ 5

47

30

10

80

5

20

80

10

C5

EORTC QLQ-C30 domain Global Role functioning

SEM for AVIDA registry

SEM for hypothetical distributions

7.1

7.2

7.9

7.3

11.6

10.7

7.2

10.7

Social functioning

12.9

12.4

11.1

13.0

Fatigue

10.2

10.5

11.0

9.7

Fig. 1 SEM measurements calculated by varying distributions of patients stratified by RBC transfusion burden

(106.5) Normative data and clinically significant effect sizes for single-item numerical linear analogue self-assessment (LASA) scales Jasvinder A. Singh, MD MPH, University of Alabama at Birmingham, Birmingham, AL, United States; Dona EC Locke, Mayo Clinic; Daniel Satele, Mayo Clinic; Suneetha Puttabasavaiah, Mayo Clinic; Jan Buckner, Mayo Clinic; Jeff Sloan, PhD, Mayo Clinic, Rochester, MN, United States AIMS: To provide normative data for the single-item numerical linear analogue self-assessment (LASA) scale for overall quality of life (QOL). METHODS: We analyzed baseline data from 36 clinical trials and 6 observational studies from various populations, including healthy volunteers, cancer trial patients (patients with advanced incurable cancer and patients receiving treatment with curative intent), and hospice patients. The QOL LASA was rated 0 (as bad as it can be) to 10 (as good as it can be). We calculated the summary statistics and the proportion of patients reporting a clinically meaningful deficit (CSD) of a score equal to 5 or less on the 0–10 scale. RESULTS: For the collective sample of 9,295 individuals, the average overall QOL reported was 7.39 (SD = 2.11) with a markedly skewed distribution. Roughly 17 % reported a score of 5 or below indicating a clinically significant deficit in overall QOL. Hospice patients report a much lower average score of 5.7 upon entry to hospice; hospice caregivers average 7.4. Cancer patients vary within

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26 these two extremes with most patient scores averaging in the 7 s on the 0–10 scale (range, 0–10). Men and women’s QOL distributions were virtually identical (average of 7.6 and 7.5, respectively). Overall baseline QOL was weakly related to performance status with a Spearman correlation coefficient of -0.29. Overall QOL varied across tumor type and was not related to tumor response, i.e. patients with a full or partial response reported a CSD in 11.4 % of cases compared to 14.4 % among those with stable disease and 18.5 % among those with disease progression. CONCLUSIONS: This study provides normative data for cancer patients and healthy volunteers for overall QOL using the LASA, indicating that overall QOL is independent of performance status and tumor response. These data can serve as benchmarks for future studies.

(106.6) Multiple imputation of missing values in studies with many multi-questionnaire outcomes Iris Eekhout, VU University Medical Center, Amsterdam, Amsterdam, Netherlands; Henrica C.W. de Vet, Sr., PhD, EMGO Institute VU Medical Center, Amsterdam, Netherlands; Michiel R. De Boer, VU University, Amsterdam, Netherlands; Jos WR Twisk, VU University Medical Center, Amsterdam, Netherlands; Martijn W. Heymans, VU University Medical Center, Amsterdam, Netherlands AIMS: Many epidemiological studies use a battery of multi-item questionnaires to measure several patient-reported outcomes. From previous studies we know that missing data on multi-item questionnaires need to be handled by multiple imputation at the item level. However, when many questionnaires are used the number of items in an imputation model will become too large to reliably estimate the imputations. Alternative methods are needed to circumvent this problem. METHODS: In a simulation study we tested the performance of two new methods in a RCT with five questionnaire outcomes. Method 1: using only item scores of one questionnaire and total scores of other questionnaires in the imputation model. The total scores of the other questionnaires are updated from imputed items of those questionnaires between each imputation iteration to include most current information from other questionnaires. Method 2: as method 1 but using the average of the available item scores of other questionnaires as predictors instead of the updated total scores. These methods were compared to applying multiple imputation to the total scores directly. Descriptive statistics of the questionnaire total scores and treatment coefficient estimates from linear regression were compared to the ‘true’ parameters on bias, mean square error and coverage. RESULTS: The methods we propose, multiple imputation of item scores by using the total scores or the average of the items from the other questionnaires as predictors, have an average standardized bias of less than 10 %, while imputing the total score directly results in over 60 % standardized bias for the questionnaire total scores. The sample size for imputing the total scores directly needs to be increased by at least 25 % to reach same mean square error in the regression coefficients as method 1 and 2. CONCLUSIONS: We showed that in case of missing data in questionnaire item scores, item imputations are valid when total scores or average item scores of other questionnaires are used in the imputation model. Method 1 performs best but is slightly more complicated to perform. Method 2 is available in all multiple imputation software. The proposed methods circumvent the problem of too large imputation models without losing imputation accuracy.

Qual Life Res (2014) 23:1–184 WestChronic; Anne Jessen, WestChronic; Niels Henrik Hjollund, Aarhus University Hospital, Herning, Denmark AIMS: Patient-reported outcomes (PRO) are increasingly being used in clinical practice. Using PRO in clinical practice has several advantages such as better communication between patient and clinician, patient involvement, identifying symptoms and efficient utilization of resources. The aim is to describe development, implementation and initial results of AmbuFlex that use PRO in clinical decision making. METHODS: The AmbuFlex system is used to evaluate whether the patient needs a visit or not. Questionnaires provide information specific to symptoms, aspects of daily life with epilepsy and if the patient wants a visit under any circumstances. A questionnaire is sent every 3, 6 or 12 month. The results of the questionnaire are presented graphically to the clinician within the regional electronic health record system. Decision for each questionnaire consists of two steps: first an automated algorithm based decision in PROs with definite need of contact (red response) or definitely no need of contact (green response). In a second step for the remaining cases (yellow response), a clinician decide with PRO-based decision support. Data analyzed here is based on questionnaires sent to epilepsy outpatients at 3 clinics in one Danish Health Region between 14th of February 2012 and 9th of April 2014, n = 4147. RESULTS: A total of 3250 patients are referred to AmbuFlex. In the largest department about 70 % of all epilepsy out-patients are referred. An overview of the flow of PRO-questionnaires and decisions is shown in Fig. 1. The response rate is 92 % in the initial PRO and 95 % in subsequent PROs. In 39 % the algorithm decides automatically if the patient should be seen or not. In the remaining 61 % the clinician most often (37 %) decides that no further contact is needed. Overall, 48 % had no further contact than the PRO, while 52 % had a subsequent follow-up visit in the outpatient clinic or a telephone consultation. CONCLUSIONS: AmbuFlex is a flexible tool that may improve quality of care, patient involvement and a way of optimizing the use of resources in the health care system. At the moment AmbuFlex is being implemented in Region Central Denmark in a number of other diagnostic groups including neuromuscular diseases, renal failure, sleep disorders and rheumatoid arthritis.

Patient referral N=3250 Questionnaires posted N=4147 Patient responded 92% N=3677

Green response N=394 (11%) Automatic decision making

No contact 37%

Yellow response N=2259 (61%) Clinical decision making using AmbuFlex

Red response N=1040 (28%) Contacted

Contacted 24%

107: Transforming Clinical Practice (107.1) AmbuFlex—experiences of PRO based decisions in clinical practice Liv Marit Valen Schougaard, VestKronik, Regional Hospital West Jutland, Herning, Denmark, Herning, Denmark; Louise Pape Larsen,

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No further contact 48%

Fig. 1 .

Contact 52%

Qual Life Res (2014) 23:1–184 (107.2) Using Patient-reported Outcomes (PROs) to inform interdisciplinary team clinical decision-making: Clinicians’ perceived benefits and challenges Sara Ahmed, PhD, McGill University, Montreal, QC, Canada; Owis J. Eilayyan, McGill University, Montreal, QC, Canada; Patrick Ware, McGill University, Montreal, QC, Canada; Amede Gogovor, McGill University, Montreal, QC, Canada; Roderick Finlayson, McGill University Health Center, Montreal, QC, Canada; Regina Visca, McGill University Health Center, Montreal, QC, Canada AIMS: In interdisciplinary pain management programs, PROs can play a central role in intervention planning and for evaluating response to treatment. However, achieving routine use of PROs in clinical practice is challenging. The objective of this study was to evaluate the feasibility and clinicians’ perceived benefits and challenges of using PROs within an interdisciplinary care program for low back pain (LBP). METHODS: This study was integrated into a larger study evaluating the impact of a 6-month interdisciplinary team and selfmanagement program on patient and health system outcomes. PROs that evaluate pain intensity and interference, physical function, and depression were administered at baseline, 3, and 6 months. As part of the clinical process, teams reviewed PRO scores at baseline to guide individual treatment planning, and were provided with patient group scores on a quarterly basis to inform program changes. The proportion of patients completing PROs was evaluated. Semi-structured interviews were conducted with 16 clinicians to evaluate their perceptions about the benefits and challenges of administering and interpreting PRO scores for individual patient clinical decision-making and program evaluation. Thematic analyses of interview transcripts were conducted. RESULTS: To date, 129 patients have been enrolled. The percent of patients missing questionnaires at baseline, 3 and 6 months was 28, 36, and 30 % respectively. Preliminary results showed that clinicians identified the following benefits of using PROs: clinical visit optimized when scores are received prior to the visit, helps to understand what patients are experiencing and how they perceive their pain, helps plan the frequency of follow-up visits, the teams look forward to receiving results to gauge the impact of the program. Challenges included: time to administer measures, difficulty interpreting scores, sometimes difficult to reconcile scores from many measures providing different information, changes in patient function sometimes not reflected in change scores on the measures. CONCLUSIONS: Addressing the challenges of integrating PROs into routine interdisciplinary and self-management clinical care (e.g. providing clinician training on the use of PROs) will maximize the potential benefits of using PROs for clinical decision-making. Future work will develop recommendations on how to address issues identified by patients using PROs for pain management.

(107.3) Using a patient-reported outcome measure in chemotherapy review consultations: The impact of an interactive doctor training session Kate Absolom, PhD, University of Leeds, Leeds, United Kingdom; Elena Takeuchi, University of Leeds; Lorraine Warrington, University of Leeds; Patricia Holch, PhD, University Of Leeds, Leeds, United Kingdom; Ceri Hector, University of Leeds; Emma Ingleson, University of Leeds; Lucy Kenyon, Leeds Teaching Hospitals NHS Trust; Galina Velikova, MD PhD FRCP, University of Leeds, Leeds, United Kingdom AIMS: There is a growing demand for oncologists to assess and monitor the adverse effect of cancer and treatment on patients’ physical and psychosocial wellbeing. Patient-reported outcome measures (PROMs) can be used to monitor patients’ health status, and these data can be useful in clinical practice to facilitate doctor-patient communication and

27 identify problems. Clinicians have however expressed a need for training in how to interpret and utilize PROMs effectively. We designed an interactive PROMs training session for oncologists and assessed this in a pilot study with patients receiving chemotherapy. METHODS: A small group interactive training session was developed with DVD excerpts of doctors and patient-actors using PROMs in simulated oncology consultations. These were used to encourage discussions during training and highlight key learning points. A before-after design study with 3 oncologists (from breast/colorectal/gynaecology services) was conducted. Patients completed a chemotherapy specific PROM on touch screens before consultations. This included general functioning scales (e.g. physical/everyday tasks/emotional distress) and common treatment related symptoms (e.g. nausea/appetite/diarrhoea/pain). Oncologists received the results graphically; scores were coded red/amber/green to denote severity. A minimum of 10 patients per doctor were recruited before, then after delivery of the interactive training. Consultations were audio-recorded and analysed using content-analysis to assess discussed topics and actions/advice provided. RESULTS: 61 patient-consultations (31 pre-training/30 post-training) were analysed. Overall the PROM was explicitly referred to in significantly more consultations in the posttraining phase (48.4 % vs 76.7 %, p \ 0.05). Although the mean number of common cancer symptoms discussed did not significantly differ between study phase (3.81 vs 4.27, p = 0.24) the mean number of functions discussed did (2.23 vs 2.90, p \ 0.05). Specifically, physical functioning was raised more frequently in the post-training consultations (61.3 % vs 86.7 %, p \ 0.05) as was pain (51.6 % vs 86.7 %, p \ 0.05). CONCLUSIONS: There is an ongoing need to ensure clinicians are equipped to use PROMs data in clinical practice. Although limited by the small sample size this preliminary pilot data is encouraging and suggests there is value in providing more in depth training given the associated increase in use of the PROM data in consultations.

(107.4) What can content analysis of the medical record tell us about physician-patient communication? Joel Finkelstein, MD, Sunnybrook Health Sciences Ctr, Toronto, ON, Canada; Armon Ayandeh, DeltaQuest Foundation; Carolyn E. Schwartz, ScD, DeltaQuest Foundation, Inc., Concord, MA, United States AIMS: Medicine remains both an art and a science, and has been forced to evolve with improvements in technology, changing patient expectations, and an increasingly litigious world. The training of future physicians has likewise evolved and curricula sanctioned by governing bodies have helped maintain a high standard of care. All agree that effective communication is critical for optimal patient outcomes. Central to effective communication is being able to convey effectively oral and written information about a medical encounter. We investigated the indirect effects of physician-patient communication by examining the content in the clinical note for patient encounters after spine surgery. We compared the patient records where the perceived subjective assessment of surgery outcomes agreed or disagreed with the surgeon’s perception of that outcome (Subjective Disagreement). METHODS: This study included 172 spine surgery patients of three spine surgeons at a Canadian teaching hospital. We compared pre-surgical and 8-week follow-up data from patient-reported outcomes (Oswestry Disability Index, SF-36, Visual Analogue Scale (VAS) item for leg pain) and performed medical record abstraction assessing both subjective and objective parameters in the record. We content-analyzed the clinical note using NVIVO10. We compared quantitative and qualitative predictors of Subjective Disagreement (disagreed n = 41 vs. 131) using Stata 13 for logistic regression modeling. RESULTS: Patients whose subjective assessment of outcome was worse than their surgeon’s tended to report post-operative leg complaints (OR 48.6, 95 % CI 9.2–257.2,

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28 p \ 0.0001). Content analysis revealed no impact of re-engaging in activities of daily living or complications/symptoms, but that communication patterns in the chart note were predictive of group membership. Specifically, when there was disagreement between the perceived outcomes, surgeons were less likely to use language that emphasized the findings (OR 0.10, 95 % CI 0.02–0.56, p = 0.008), after adjusting for education and smoking (Pseudo R2 = 0.59; 90 % correctly classified). CONCLUSIONS: Our results suggest that mismatches in the surgeon-patient perspective are associated with having post-operative leg complaints and the surgeon’s clinical note underemphasizing clinical findings. The ability to represent the clinical encounter effectively may be compromised in cases where there may be fear of affecting the doctor–patient rapport or when the two parties disagree about the outcome.

(107.5) Development and Pre-testing of a Communication-specific EORTC Questionnaire Juan Ignacio Arraras, PhD, Servicio Navarro de Salud, Pamplona, Navarra, Spain; Anne Bredart, PhD, Institut Curie, Paris, France; Anna Costantini, Sant’Andrea Hospital. Sapienza University of Rome, Italy; Dirk Hofmeister, University of Leipzig, Leipzig, Germany; Meropi Kontogianni, Harokopio University, Athens, Greece; Monika J. Sztankay, Innsbruck Medical University, Innsbruck, Austria; Krzsystof Tomaszewski, Jagiellonian University Medical College, Krakow, Poland; Iwona M Tomaszewska, Jagiellonian University Medical College, Krakow, Poland; Lisa M. Wintner, Department of Psychiatry and Psychotherapy, Innsbruck Medical University, Innsbruck, Austria; Wei-Chu Chie, PhD, Inst of Epdeimiology and Preventive Medicine, Nat’l Taiwan Univ, Taipei, Taiwan, Taiwan; Eva Greimel, PhD, Medical University Graz, Austria; Michael Koller, PhD, University Hospital Regensburg. Germany; Karin Kuljanic. University Hospital Center Rijeka, Croatia; Dagmara Kullis. EORTC QL Unit. Brussels, Belgium; Astrid Helene Liavaag, Sørlandets Sykehus, Arendal, Norway; Andrea Talacchi, University of Verona, Italy; Teresa Young, BSc, Mount Vernon Hospital, London, United Kingdom AIMS: Communication between patients and professionals is a key element in the support offered to cancer patients. We present the development and pretesting of a cancer-specific instrument to measure different aspects of patients’ communication with health care professionals. It is based on the Patient-Centered Communication Model, takes cross-cultural aspects into account and is suitable for any tumour site as well as different disease and treatment stages, including palliative care. METHODS: Questionnaire development follows the four phase process as described in the EORTC Quality of Life Group Module Development Guidelines. Phase I (literature review) and II (patient and professional interviews) are already completed, phase III (pretesting of questionnaire and structured interviews of patients) is currently ongoing. RESULTS: Within a comprehensive literature review, 204 papers and 79 questionnaires for communication assessment were evaluated. We conducted two rounds of patient interviews (23 and 18 patients, respectively) and interviewed 23 health care professionals (phase I). A list of issues was created, converted into questions and organized in scales. Based on these results, a provisional questionnaire comprising 34 items was constructed and translated into eight languages (phase II).The provisional questionnaire is currently pre-tested (phase III) within 10 centres (Northern and South Europe, UK, Poland and Taiwan) recruiting patients fitting into seven subgroups (localized and advanced disease before, during and after treatment, respectively; palliative patients). Structured interviews with each patient are being conducted after completion of the questionnaire. So far, data from 90 patients has been collected and patients’ interviews are expected to be finished in June 2014. Analyses will be conducted both qualitatively

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Qual Life Res (2014) 23:1–184 and quantitatively. The results: the structure and content of the questionnaire will be presented in the meeting. CONCLUSIONS: Following the EORTC Quality of Life Group Module Development Guidelines, key areas of the communication between cancer patients and health care professionals have been detected and incorporated into a stand-alone questionnaire. Multi-centred pre-testing covers different cultural areas for improved intercultural instrument validity. After finishing phase III, the questionnaire will be internationally field-tested within a large group of cancer patients.

(107.6) An educational program to improve self-care in Brazilian patients who underwent percutaneous coronary intervention: a randomized controlled trial Rejane K. Furuya, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing, Ribeira˜o Preto, Brazil; Eliana C. Arantes, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Carina A.M. Dessotte, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Ma´rcia A. Ciol, School of Medicine, University of Washington, Seattle, WA, United States; Jeanne M. Hoffman, School of Medicine, University of Washington, Seattle, WA, United States; Andre´ Schmidt, School of Medicine of Ribeira˜o Preto, University of Sa˜o Paulo; Rosana Spadoti Dantas, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil; Lidia A. Rossi, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil AIMS: To test an educational program with telephone follow-up to improve self-care in Brazilian patients who underwent percutaneous coronary intervention (PCI). METHODS: We conducted a randomized controlled clinical trial with patients who were preparing for their first PCI between August 2011 and June 2012. Patients were randomly allocated to an educational program with telephone follow-up (N = 30) or a control group receiving usual care (N = 30). The primary outcome measure was perceived heath status, and it was assessed with the Medical Outcomes Study 36-Item Short Form (SF-36). Secondary outcomes were symptoms of anxiety and depression and self-efficacy. Outcome measures were assessed before the PCI procedure (baseline) and at six months after hospital discharge (six-month follow-up). We used repeated measures analysis of variance to assess changes in the outcomes, using time (baseline vs. six-month follow-up), group (intervention vs. control), and an interaction of time by group. Significance level was set at 0.05. RESULTS: For the Mental Component Summary of the SF-36, there was no statistically significant effect of time, group or interaction. For the Physical Component Summary of the SF-36, there was only an effect of time (p = 0.009), with an improvement from baseline to six-month follow-up for both groups. For the SF-36 domains, there was a statistically significant time effect for ‘Physical Functioning’ (p = 0.02), ‘Role–Emotional’ (p = 0.007), and ‘Role–Physical’ (p \ 0.001) domains. Regarding anxiety, there was a statistically significant group by time interaction effect (p = 0.04), with anxiety symptoms decreasing over time in the intervention group, but increasing in the control group. For the depression symptoms, and selfefficacy, there was no statistically significant effect of time, group or interaction. CONCLUSIONS: The educational program with telephone follow-up is a promising intervention to reduce anxiety symptoms following PCI. Improvement in the intervention may be needed to achieve additional positive effects on perceived heath status and self-efficacy. Sa˜o Paulo Research Foundation (FAPESP), Grants 2010/19761-3 and 2010/10006-8, sponsored this study.

108: Advancing Utility Assessments (108.1) The development of cancer-specific multi-attribute utility instruments from the EORTC QLQ-C30 and FACT-G Daniel S. J. Costa, PhD, Psycho-oncology Co-operative Research Group (PoCoG), Sydney, Australia; Madeleine T. King, PhD, Psycho-

Qual Life Res (2014) 23:1–184 oncology Cooperative Research Group (PoCoG), Sydney, Australia; Neil K. Aaronson, PhD, The Netherlands Cancer Institute, Amsterdam, Netherlands; John E. Brazier, PhD, Univ of Sheffield, Sheffield, United Kingdom; David Cella, PhD, Northwestern University, Chicago, IL, United States; Peter Grimison, Chris O’Brien Lifehouse and University of Sydney, Sydney, Australia; Monika Janda, PhD, Brisbane, Australia; Helen McTaggart-Cowan, Ph.D., Canadian Centre for Applied Research in Cancer Control, Vancouver, BC, Canada; A Simon Pickard, University of Illinois at Chicago, Chicago, IL, United States; Rob Arbuckle, Adelphi Values, Cheshire, United Kingdom AIMS: Our aim was to use traditional and modern psychometrics methods to identify key attributes from the EORTC QLQ-C30 and FACT-G for subsequent inclusion in health state classification systems for two cancer-specific multi-attribute utility instruments (MAUIs). METHODS: We conducted secondary analyses on pooled data from international sources (QLQ-C30, N = 2616; FACT-G, N = 6912). Guided by conceptual models (separately for the QLQ-C30 and FACTG) we assessed the established dimensionality of the instruments using confirmatory factor analysis (CFA) and then conducted Rasch analysis separately on each dimension to assess fit to the Rasch model, local dependence, item response threshold ordering and differential item functioning by cancer stage and sex. We also examined the responsiveness index for each item, comparing on-treatment to off-treatment observations. Finally, we collected data via surveys from 177 cancer patients to examine which items within each dimension were most important to patients. RESULTS: The established factor structure of each instrument was generally supported. For the QLQ-C30, most items performed well in the Rasch analysis, whereas for the FACT-G over half of the items exhibited item threshold disordering. Some items were more responsive than others but none clearly stood out from the others. For most domains there were one or two items that clearly had higher frequencies than the others in terms of patient ratings of importance. Based on these analyses and input from our multidisciplinary research team, a health state classification system was devised for the QLQ-C30 (10 attributes: long/short walk, work limitations, depression, family/ social, tiredness, nausea/vomiting, pain, sleep, appetite, constipation/ diarrhoea) and the FACT-G (8 attributes: nausea, pain, fatigue, sleep, work, worry condition will get worse, sad, family support). CONCLUSIONS: CFA, Rasch analysis and responsiveness analysis, guided by clinical expertise and patient input, provided a rigorous and structured method for developing a health state classification system from two existing cancer-specific instruments. The next stage in this research is to obtain population-based valuations for the health states included in these utility instruments. An advantage of adapting existing instruments is that they can be used retrospectively to conduct cost-utility analysis on any previously collected QLQ-C30 or FACT-G data.

(108.2) Valuing a utility instrument derived from the EORTC QLQ-C30 (QLU-C10D): feasibility and respondent preference for presentation of 10 domains in a discrete choice experiment (DCE) Richard Norman, PhD, Centre for Health Economics Research & Evaluation, University of Technology Sydney, Australia; Rosalie Viney, PhD, Centre for Health Economics Research & Evaluation, University of Technology Sydney, Australia; Daniel Costa, PhD, Psycho-oncology Co-operative Research Group, University of Sydney, Australia; Neil Aaronson, PhD, Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands; David Cella, PhD, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States; Peter Fayers, PhD, University of Aberdeen, and Norwegian University of Science and Technology, Trondheim, Norway Georg Kemmler, PhD, Department of Psychiatry

29 and Psychotherapy, Innsbruck Medical University, Innsbruck, Austria; A. Simon Pickard, PhD, Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago, Chicago, IL, United States; Deborah Street, Centre for Health Economics Research & Evaluation, University of Technology Sydney, Australia; Galina Velikova, MD PhD FRCP, Faculty of Medicine and Health, University of Leeds, United Kingdom; Tracey Young, PhD MSc BSc CStat, Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Sheffield, United Kingdon; Madeleine T King, PhD, Psycho-oncology Co-operative Research Group, University of Sydney, Australia on behalf of the MAUCa Consortium AIMS: To assess the feasibility of using a DCE to value health states of the EORTC QLU-C10D (which contains 10 domains: mobility, daily activities, social life, worry, pain, fatigue, sleep, appetite, nausea, bowel disturbance; each with 4 levels), to assess clarity and difficulty of response of two DCE presentation formats, and to determine which format was preferred by participants. METHODS: The DCE was run in an Australian online panel. Respondents answered 16 choice pairs. Two presentation formats were tested, each in half of the choice pairs, with order of format randomised. In the ‘‘highlight’’ format, all domains were presented, and domains which differed in level between a pair of choice options were highlighted in yellow. In the ‘‘text and table’’ format, domains with the same levels in the two choice options were described in text, and only domains that differed were presented. Difficulty and clarity of the choice task was explored for each format using Likert scales, and a direct preference question was asked (‘‘which format did you prefer?’’). Conditional logit analysis was performed on responses for the pooled dataset as well as stratified by format. Semi-structured telephone interviews explored respondents’ approaches to the choice task and their reasons for format preference. RESULTS: 449 individuals were recruited to the online DCE valuation task. 430 completed at least one choice set and 422/449 (94 %) completed all 16 choice sets. Interviews conducted with 8 respondents revealed that they found 10 domains difficult, and most adopted simplifying heuristics to make the task easier. Most stated that the 10 domains adequately described health, but three suggested greater emphasis on mental health. Results for the clarity and difficulty questions were identical between presentation formats, but the ‘‘highlight’’ format was preferred by 68 % of respondents. Conditional logit parameter estimates were monotonic within domains, supporting the structure of the health classifier and providing indirect evidence of the validity of a DCE approach. CONCLUSIONS: A DCE can be used to value health states for a utility instrument with 10 domains. The ‘‘highlighted’’ presentation format is recommended for definitive valuations of the EORTC QLUC10D which are planned throughout the world.

(108.3) Retrospective calculation of disease-specific utilities for cancer patients—a demonstration of its use based on the EORTC QLQ-C30 Georg Kemmler, PhD, Innsbruck Medical University, Innsbruck, Austria; Eva-Maria Gamper, Innsbruck Medical University, Innsbruck, Austria; Johannes Giesinger, Netherlands Cancer Institute; Madeleine T. King, PhD, Psycho-oncology Cooperative Research Group (PoCoG), Sydney, Australia; Bernhard Holzner, PhD BE, Univ. Hospital, Innsbruck, Innsbruck, Tyrol, Austria AIMS: A convenient method to obtain utilities within the framework of health technology assessment (HTA) is via multi-attribute utility instruments (MAUI). While generic MAUIs like the EQ-5D have been used for many years, disease-specific MAUIs have only recently emerged. Based on two examples of MAUIs for the EORTC QLQ-

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30 C30, this presentation aims to demonstrate how utilities can be obtained retrospectively from formerly collected quality of life (QOL) data. METHODS: From the large pool of QOL data collected by our research team, QLQ-C30 data of four groups of cancer patients (breast, ovarian, testicular and lung cancer) were selected for this analysis, providing a total sample size of 1112. Calculation of utilities was based on two studies in which utility weights for the QLQ-C30 had been determined by the time trade-off method (TTO): one based on cancer patients as informants (Pickard et al., Value Health 2009; 12: 977–988), the other based on general population ratings (Rowen et al., Value Health 2011; 14: 721–731). RESULTS: Retrospectively calculated utilities ranged from 0.17 to 1.0, i.e., all of them represented health states better than death. Across diagnostic groups, utilities based on the valuation algorithm derived from the general population were substantially lower than those based on the valuation algorithm derived from patient ratings. However, the rank order of the utilities by cancer site was the same for both utility measures and in good agreement with clinical experience. CONCLUSIONS: As a large study for the determination of utility weights for the QLQ-C30 is presently being conducted (King et al., Asia-Pac J Clin Oncol 2012; 8(Suppl. 3): 808) our results should be regarded as preliminary. A further limitation of the current analysis is that while TTO was the valuation method used by both Pickard et al. and Rowen et al., there were significant differences in how TTO was used to derive utility weights. However, our findings indicate that retrospective calculation of utilities using MAUIs obviously yields plausible results and thus has considerable potential for future HTA analyses in oncology.

(108.4) States selection on the valuation of EQ-5D-3L. Brazilian study Andre´a L. Monteiro, MSc, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil; Monica A C T Cintra, MD, PhD, National Institute of Cardiology Brazil, Rio de Janeiro, Brazil; Bernardo R. Tura, National Institute of Cardiology Brazil; Bra´ulio Santos, National Institute of Cardiology; Monica V. Andrade, Federal University of Minas Gerais; Kenya Noronha, Universidade Federal de Minas Gerais; Luciane N. Cruz, MD, PhD, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; Suzy A. Camey, Federal University of Rio Grande do Sul; Marisa Santos, MD, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil AIMS: Although most EQ-5D-3L valuation studies include the original set from the MVH study, the selection of additional health states varies greatly across subsequent studies and, in most cases, the selection criteria is based on theoretical assumptions. To assesses, based in empirical support, an alternative selection criteria to estimates that time trade-off (TTO) responses on EQ-5D-3L. METHODS: Following a saturated version of the UK MVH protocol, we conducted a valuation study at three Brazilian urban centers aiming to produce tariffs for EQ-5D-3L states on a QALY scale. A probabilistic sample of the population, aged from 18 to 64 years, were interviewed at their residences. Each respondent valued 7 of the 243 health states using the TTO.. For prior to the analysis of TTO responses, four different selection criteria were applied to the 243 states creating 4 subsets: Subset 1: 42 states from MVH study; Subset 2: 75 states with lower variance; Subset 3: 121 prevalent states; Subset 4: 121 non-prevalent states. With each subset, we estimated a robust linear regression and computed the mean absolute error between the predicted and mean results for the full set of states. The agreement was also estimated by Lin’s concordance correlation coefficient. RESULTS: Data were collected from 5,785 subjects (2,677 male, 3,108 female). The median age was 38 (Q1 27; Q3 49) years. The health states prevalence data showed that 13 of the original 42 MVH states weren’t among the 121 prevalent states. Likewise, 102 prevalent states were not in the original

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Qual Life Res (2014) 23:1–184 Table 1 States selection on the valuation of EQ-5D-3L (Brazilian study) Subset

MAE

LIN [Subset 9 full set (95 % CI)]

1

0.071

0.990 (0.988–0.992)

2

0.095

0.962 (0.953–0.969)

3

0.065

0.995 (0.994–0.996)

4

0.046

0984 (0.980–0.982)

MVH set. Nevertheless, all the models showed similar MAE and agreement results and the scatter plots did not illustrate improvement in the prediction with the use of non-MVH states. Overall, the tariffs obtained from the subset of more prevalent states showed better concordance with the full set data. CONCLUSIONS: The findings showed some evidence that among the selection criteria, the tariffs based on prevalent states showed better concordance with mean estimates for the full set. The changes are small and a future analysis intends to relax the model assumptions to explore whether the change is robust to alternative regression specifications (Table 1).

(108.6) Comparing and assessing the performance of the EQ-5D3L and the EQ-5D-5L in young adults Pedro L. Ferreira, PhD, University of Coimbra, Coimbra, Portugal; Lara N. Ferreira, PhD, CEISUC-Centre for Health Studies & Research, University of Coimbra, Faro, Algarve, Portugal; Luis N. Pereira, University of the Algarve-ESGHT; CIEO; Filipa Perdiga˜o, CSSL/ESGHT AIMS: Over the past 30 years, EQ-5D-3L has been used in cost-utility analysis. However, some studies have reported a ceiling effect, especially in healthy and/or young individuals. The purpose of this study was to assess the properties of this new EQ-5D-5L in comparison with the standard EQ-5D-3L in a sample of individuals aged 30 years or less and to compare the statistical results with data collected from in-depth interviews. METHODS: Two university students’ samples were used: 624 aged 30 or less and 292 aged over 30. They completed a single questionnaire with both 3L and 5L versions. They were compared in terms of feasibility, level of inconsistency, redistribution properties and ceiling effect. The analysis of the descriptive system was performed using Spearman’s correlation coefficient, a global consistency index and an identically classified index. The level of agreement was assessed using intraclass correlation coefficient and Bland–Altman plots. Knowngroups validity was also assessed. The discriminative properties of the indexes were compared using receiver operating characteristic curve. 30-min Interviews explored how respondents were interpreting and responding. RESULTS: Majority of the sample was female (60.4 %), 33 % were employed and 82.3 % did not have a medical condition. The proportion and weight of inconsistencies were 0.55 and 1.29 %. Ceiling effect was reduced by 21.9 %. Discriminatory power changed from 0.54 to 0.80 and relative discriminatory power from 0.34 to 0.35. The mean indexes were 0.92 and 0.90, similar to the comparison sample. Strong correlation and agreement between both indexes. Known-groups validity was confirmed for the 5L. Interviews revealed ambiguity in interpreting the questions and difficulty in conceptualizing the different degrees. CONCLUSIONS: The 5L version performed better than 3L and reduced ceiling effect. However, respondents showed ambiguous interpretations and difficulty in pinpointing the differences in degree of pain/anxiety/ mobility. Respondents also showed inconsistency in their answers in terms of how they felt ‘today’ (very well) and how they assessed their health. Although the ceiling effect is reduced, this study reflects on the methodological issues that arise when questionnaires are used, namely

Qual Life Res (2014) 23:1–184 about how questions are linguistically framed. These findings need to be replicated in other samples of healthy and sick individuals. 109: New Measures and Methods II: Interpretation & Implementation (109.1) Conducting Meaningful Cognitive Debriefing Interviews for Patient-Reported Outcome Assessment: Theory and Practice Bhumi Trivedi, Covance; Andrew Palsgrove, Covance, San Francisco, CA, United States; Rebecca Cheng, Covance Market Access Services, Inc.; Colleen A. McHorney, Covance Market Access, Inc., Gaithersburg, MD, United States; Jason C. Cole, PhD, Covance Market Access Services, San Diego, CA, United States AIMS: Cognitive debriefing interviews (CDIs) are conducted to test a patient-reported outcome (PRO) instrument with patients in the target study population and language. The intent of CDIs is to confirm that the drafted or modified PRO items are clearly expressed and understood by patients. CDIs are also used as part of the linguistic validation process to ensure conceptual equivalence of the PRO measure. The purpose of this research is to discuss state-of-the art methodologies associated with CDIs used for both establishing content validity and linguistic validations of PROs. METHODS: A literature search was completed to understand previously defined standards and best practices for conducting CDIs from field workers. Observations, challenges, and best practices from the authors’ combined first-hand experience with conducting and observing over 100 CDIs was used to create a set of best practices and ‘‘lessons learned’’ from the field. Specific case examples were identified to demonstrate key points and offer practical insights on improving interviewing techniques to gain the most insight out of each interview. RESULTS: Results from this analysis included identification and insight into the following common challenges: (1) how to engage with the interview participant in a successful manner; (2) how to guide the participant without leading them in order to answer prompts effectively; (3) how to adjust interview tactics based on the patient’s condition and project goals; and (4) what questions to ask to maximize productive responses. It is crucial that participants understand the intent of the interview prior to initiation. The interview layout should be clearly instructed to the participant. For certain disease states, the format or structure of the interview may have to be changed to gain the best insight. All potential changes to the instrument should be documented in an item change tracking matrix. Saturation and instrument modification should be measured on an ongoing basis. Also, a unique set of challenges and resolutions in conducting CDIs for linguistic validation were identified. CONCLUSIONS: Crucial to the instrument validation process, CDIs reveal a wealth of information if properly conducted. Following best practices can lead to maximizing the value of CDIs.

(109.2) From Conceptual Framework to Questionnaire: Cognitive Testing a New Measure of Patient Treatment Burden David T. Eton, PhD, Mayo Clinic, Rochester, MN, United States; Kathleen J. Yost, PhD, Mayo Clinic, Rochester, MN, United States; Jennifer L. Ridgeway, Mayo Clinic, Rochester, MN, United States; Jason S. Egginton, Mayo Clinic, Rochester, MN, United States; Mark Linzer, Hennepin County Medical Center, Minneapolis, MN USA; Deborah Boehm, Hennepin County Medical Center, Minneapolis, MN USA; Sara Poplau, Minneapolis Medical Research Foundation, Minneapolis, MN, United States; Laura Odell, Mayo Clinic, Rochester, MN, United States; Roger Anderson, PhD, Penn State Hershey, Hershey, PA, United States AIMS: Treatment burden, the workload of health care and its impact on patient functioning and well-being, can be substantial for patients coping with chronic illnesses. We previously developed a multi-

31 faceted conceptual framework of treatment burden and used it to draft a pilot questionnaire. Cognitive debriefing of the measure with patients is desirable. The objectives of this study are to lead patients in a review of the measure and revise it according to their feedback. METHODS: Two rounds of cognitive interviews were conducted with a diverse patient sample. Prior to being interviewed, patients completed the draft measure on their own. Patients were then led through a series of questions about items within each domain. This included a rating of the relevance/importance of each item as well as questions about the appropriateness of the recall time frame and comprehension of item content, embedded definitions, and questionnaire instructions. Additional narrative feedback was recorded and used to inform revision. RESULTS: Eleven patients with multiple chronic conditions (MCCs) were interviewed in round one (39–73 years of age, 55 % female, 55 % white, 27 % college educated). Responses supported the following revisions: (a) wording changes to clarify 11 items, (b) dropping 6 items due to low importance ratings and endorsement frequencies, and (c) inclusion of a ‘‘does not apply to me’’ option for certain domains. The revised measure was tested in a second round of interviews with 12 MCC patients (45–80 years of age, 92 % female, 58 % white, 42 % college educated). Responses supported wording changes to clarify 3 items and dropping 3 items due to low importance ratings, low endorsement, or differential interpretation. The result is a 78-item pilot measure organized into fourteen content domains that map onto the following three global themes of treatment burden: self-care workload (e.g., taking medications, keeping medical appointments), challenges that worsen burden (e.g., financial issues, confusion about medical information), and impacts of burden (activity limitations, exhaustion). CONCLUSIONS: The pilot measure (the ‘Patient Engagement in Treatment and Self-Care Questionnaire’) is set to undergo quantitative validation with the goal of establishing subscales and scoring, further reducing the number of items, and determining its psychometric characteristics.

(109.3) Measuring Physical Abilities by Self-Report: An Approach Based on the Activity Space Model Jacek Kopec, PhD, University of British Columbia, Richmond, BC, Canada; Lara Russell, Providence Health Care Research Institute; Eric C. Sayre, PhD, Arthritis Research Centre of Canada, Vancouver, BC, Canada; M. Mushfiqur Rahman, Arthritis Research Centre of Canada AIMS: Both conventional and item response theory based self-report measures of physical function tend to assess only selected levels of specific abilities and combine different abilities into an overall score. As a result, scores from such measures may be difficult to interpret in a clinical context. The purpose of this study was to develop and validate self-report measures of selected physical abilities based on the activity space model (ASM, Kopec, 1995). Such measures may provide responses that are conceptually and clinically meaningful and more easily interpretable. METHODS: In the ASM, abilities are defined and evaluated as functions (curves) depicting the relationship between an objective challenge (e.g., distance to walk) and a subjective response (e.g., difficulty). Accordingly, we developed scales for walking, running, and lifting. The scales were validated in an online survey among members of the Canadian Association of Retired Persons. Areas under the curves were used as summary measures. We plotted the relationships between distance or weight and difficulty, and assessed test–retest reliability, correlations with SF-36 scales, discrimination, and responsiveness of the summary scores. RESULTS: Baseline and follow-up data were obtained on 1089 and 851 persons, respectively, and 289 provided test–retest data. At baseline, 44.1 % were men, mean age was 66.3, and 53.7 % had

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32 college or university education. Individual difficulty curves varied in shape but were generally monotonic and easily interpretable. Test– retest reliability (intraclass correlation coefficient) was high (walking 0.89, running 0.88 and lifting 0.81). Correlations with the SF-36 were consistent with expectations and ranged from 0.81 (walking and physical function) to 0.09 (running and mental health). Discrimination with respect to health services use showed a dose–response relationship and compared favorably with that for the SF-36. In persons reporting any deterioration in health status (n = 199), scores for walking (p \ 0.001), running (p = 0.002), and lifting (p = 0.016) declined over 6 months, as expected. CONCLUSIONS: The approach to measuring walking, running and lifting ability based on the ASM is psychometrically valid and provides a detailed and clinically meaningful assessment of these abilities.

(109.4) A new perspective on proxy report: Implicit processes of understanding and neurological reserve Carolyn E. Schwartz, ScD, DeltaQuest Foundation, Inc., Concord, MA, United States; Armon Ayandeh, DeltaQuest Foundation; Jonathan D. Rodgers, University of Buffalo, Buffalo, NY, United States; Paul Duberstein, University of Rochester Medical Center; Bianca Weinstock-Guttman, University of Buffalo, Buffalo, NY, United States; Ralph HB Benedict, University of Buffalo, Buffalo, NY, United States AIMS: Utilizing proxy report is a common solution to gathering quality-of-life (QOL) information from people who are not capable of answering questionnaires, such as young children, people with dementia, severe mental illness, or end-stage disease. Research using proxy report generally focuses on its reliability and validity. Proxy report could also provide information about patients’ implicit processes of understanding. Implicit processes are attentional, interpretational, and memory biases that are schema-driven responses and trait-like. We investigated the relationship between active (current) and passive (premorbid) neurological reserve, implicit processes of understanding, and healthy lifestyle behaviors. METHODS: We conceptualize three aspects of these implicit processes of understanding: (a) those related to social understanding, which reflect more subtle aspects of character that require more intimate knowledge (e.g., neurocognitive disability, personality characteristics) and for which no ‘gold standard of truth’ exists; (b) those related to insight into physical disability, for which a ‘gold standard of truth’ exists (e.g., an objective neurological exam); and (c) those related to somatic awareness, reflecting a kinesthetic cognizance of internal bodily cues. This secondary analysis involved a cohort of 118 Multiple Sclerosis patients and their caregiver-informants (n = 118 pairs). Measures included a neurologist-administered Expanded Disability Status Scale; patientand informant-completed self-report measures, and a heartbeat-perception test (interoception). Patient-Other congruence assessed implicit processes of understanding: Social Understanding (neurocognitive and personality); Physical Disability Insight; and Somatic Awareness (interoception). RESULTS: The three aspects of implicit processes of understanding had small effect-size inter-correlations, suggesting that they are distinct constructs. Social understanding was associated with higher passive reserve, active reserve, and healthy lifestyle behaviors (small effect sizes). Physical disability insight was associated with lower passive reserve and social understanding (small effect sizes). Somatic awareness was associated with lower active reserve, and higher social understanding and physical disability insight (small effect sizes). Social Understanding and Active Reserve were independent predictors of Healthy Lifestyle Behaviors (R2Adjusted = 0.18; small effect sizes). CONCLUSIONS: Proxy versus patient report on different domains relevant to QOL can provide information about underlying attentional and interpretational processes. These

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Qual Life Res (2014) 23:1–184 processes are distinct from patient resources (e.g., neurological reserve), predict health outcomes, and can inform lifestyle-changing interventions.

(109.5) Update of the COSMIN checklist for evaluating the methodological quality of studies on measurement properties Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands; Cecilia AC Prinsen, VU University Medical Center, Amsterdam, Netherlands; Henrica C.W. de Vet, Sr., PhD, EMGO Institute VU Medical Center, Amsterdam, Netherlands; Lidwine B. Mokkink, VU University Medical Center, Amsterdam, Netherlands AIMS: The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed in 2010 for evaluating the methodological quality of studies on measurement properties. The COSMIN checklist has been used in over 50 systematic reviews of measurement instruments. Based on user experiences and current standards for instrument development and evaluation, our aim was to develop an updated version of the COSMIN checklist, with more emphasis on content validity and Item Response Theory (IRT) methods. METHODS: It was decided to develop three updated versions of the COSMIN checklist: COSMINS for use in systematic reviews; COSMIN-P for use in protocols of studies on measurement properties; and COSMIN-R for reporting studies on measurement properties. Here we discuss the development of COSMIN-S. Proposed changes were based on recent literature on content validity and IRT analyses, such as the PROMIS standards, and were discussed among the authors. A draft version of COSMIN-S was sent for feedback to experts on qualitative research and IRT, to users of the COSMIN checklist, and to panel members of the original COSMIN Delphi study. RESULTS: The COSMIN-S checklist is divided into two parts. Part 1 contains standards for content and internal structure of an instrument: face and content validity, structural validity and internal consistency. Part 2 contains standards for evaluation of the following measurement properties: reliability, measurement error, construct validity, criterion validity, cross-cultural validity, and responsiveness. Two major revisions were made: The standards for content validity have been extended with standards for qualitative research to identify relevant concepts, and standards for cognitive debriefing to assess comprehensibility and comprehensiveness of an instrument. The standards for structural validity have been extended with more specific standards for factor analysis and IRT methods. Other changes concerned the items on sample size and handling missing data. In a systematic review it is recommended to evaluate only those instrument in part 2 that satisfy the content and structure criteria in part 1. CONCLUSIONS: The COSMIN-S checklist is tailored for use in systematic reviews of measurement instruments. Improvements have been made with regard to content and internal structure to meet current standards for instrument development.

(109.6) An updated guideline for systematic reviews of measurement instruments Cecilia AC Prinsen, VU University Medical Center, Amsterdam, Netherlands; Lidwine B. Mokkink, VU University Medical Center, Amsterdam, Netherlands; Henrica C.W. de Vet, Sr., PhD, EMGO Institute VU Medical Center, Amsterdam, Netherlands; Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands AIMS: The importance of systematic reviews of measurement instruments is increasing. Not only to inform the selection of

Qual Life Res (2014) 23:1–184 instruments for research or clinical practice, but also to inform the development of agreed standardized sets of outcomes (‘core outcome sets’). However, guidance on how to perform such systematic reviews is limited. Our aim was to update and extend a comprehensive guideline for the methodology of systematic reviews of measurement instruments. METHODS: The present guideline was written on behalf of the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Initiative. Review authors will be guided through a systematic process of conducting a systematic review of measurement instruments. In general, Cochrane methodology for systematic reviews is followed. New developments were incorporated, such as information on the updated COSMIN checklist and on the GRADE methodology. RESULTS: A review of measurement instruments should start with a clear definition of the construct of interest, including a conceptual framework for the review, which informs the systematic search strategy. The updated COMSIN checklist is used to evaluate the methodological quality of the included studies. The quality of the measurement instruments is evaluated in two parts: 1) content validity and the internal structure of an instrument, and 2) further evaluation of the measurement properties of those instruments that meet the quality criteria of part 1. Herewith, content validity has a prominent role in the evaluation of outcome measurement instruments. Further, it is recommended to evaluate the quality of the evidence using the GRADE methodology. CONCLUSIONS: The present guideline is in accordance with new developments, such as the updated COSMIN checklist and the application of the GRADE methodology. With this updated and extended guideline we contribute to an international standardization of performing systematic reviews of measurement instruments.

33 100% 100% 99% 98% 97%

96%

96%

95%

95%

94%

94% 93% 92% 91% PREE

ASES-e

Measure to ICF linkage

PREE

ASES-e

Percentage agreement between raters

Fig. 1 ICF linkage indicator for measure to ICF linkage and percentage agreement between the raters

201: Transforming Practice: Rehabilitation (201.1) Linking of the Patient Rated Elbow Evaluation (PREE) and the American Shoulder and Elbow Surgeons—Elbow questionnaire (pASES-e) to the International Classification of Functioning Disability and Health (ICF) and Hand Core Sets Joshua I. Vincent, PT MPT, The University of Western Ontario, London, ON, Canada; Joy MacDermid, PhD, McMaster University, Hamilton, ON, Canada; Ruby Grewal, University of Westren Ontario; Graham King, University of Western Ontario AIMS: The purpose of this study was to analyse the conceptual basis of the Patient Rated Elbow Evaluation (PREE) and the selfreport section of the American Shoulder and Elbow Surgeons society—Elbow form (pASES-e) by linking the meaningful concepts in these PROs to the ICF using established linking rules; and to assess the extent to these measures reflect the ICF core set for hand conditions. METHODS: Two raters independently linked the items from the PREE and pASES-e using established linking rules. The raters met to determine consensus on discordant items. The percentage agreement was calculated between the raters. ICF and Core set linkage indicators namely 1) Measure to ICF linkage 2) Measure to core set absolute linkage 3) Measure to core set unique linkage 4) Core set representation 5) Core set unique disability representation were used to summarize the extent to which items could be linked to ICF and the extent to which the core sets were represented on the pASES-e and PREE. RESULTS: All the items of the PREE (Measure to ICF linkage-100 %) and all but one item of the pASES-e (Measure to ICF linkage-95 %) were linked to the ICF. The satisfaction item on the ASES-e was not-covered by the ICF. Percentage agreement on linking between the raters was 96 and 95 % for the PREE and the pASES-e respectively. The unique

Fig. 2 ICF linkage indicators to define the depth and breadth of linkage between items of the PREE and ASES-e and the ICF core sets

linkage of the PREE and the pASES-e to the unique codes on the brief and comprehensive core set lower than absolute linkage to the core set for hand conditions. The PROs represented less than 20 % of the comprehensive core set and more than 70 % of the brief core set. While for the unique core set disability representation the 2 measures represented 100 % brief core set unique disability codes and less than 35 % of the comprehensive core set unique disability codes. CONCLUSIONS: The results of the current study indicate that the PREE and the pASES-e confirm to the framework of the ICF and the linkage indicators obtained endorses the use of the core set for hand conditions in assessment of elbow disorders (Figs. 1, 2).

(201.2) Using the ICF’s Environmental Factors Framework to Develop an Item Bank Measuring Built and Natural Environmental Features Affecting Persons with Disabilities Allen W. Heinemann, Northwestern University, Chicago, IL, United States; Jin-Shei Lai, PhD, Northwestern University, Chicago, IL, United States; David Gray, Washington University; Susan Magasi, University of Illinois; Joy Hammel, University of Illinois; David Tulsky, PhD, Kessler Foundation, New York, NY, United States; Elizabeth Hahn, MA, Northwestern University, Chicago, IL, United

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34 States; Sofia Garcia, PhD, Northwestern University, Chicago, IL, United States; Sara Jerousek, Rehabilitation Institute of Chicago; Alex Wong, PhD, Rehabilitation Institute of Chicago, Chicago, IL, United States AIMS: Enhanced quality of life is a key rehabilitation goal. Environmental factors (EF) may affect quality of life, but the validity of existing measures is not well established. The aims of this study were to develop EF measures using contemporary measurement methods; this presentation focuses on Chapter 2 of the ICF Environmental Factors—Natural Environment and Human-Made Changes. METHODS: Methods included a literature review, item classification, item writing, and cognitive testing using the Patient-Reported Outcomes Measurement Information System methodology. Ten content and outcome measurement experts contributed to instrument development; 200 individuals participated in focus groups to clarify EF concepts, and 15 participated in cognitive testing. Pilot testing involved 305 adults with spinal cord injury, stroke, and traumatic brain injury; testing with revised items involved 604 people with the same impairments. The item pool consisted of 18 items covering functioning in home, outdoor, and community settings. Respondents used a 5-point rating scale (1 = Never; 5 = Always) to describe the influence of barriers to moving around, seeing objects, hearing sounds, hearing conversations, feeling safe, and temperature regulation. We used confirmatory factor analysis to evaluate dimensionality of the items (criteria: comparative fit index, CFI, [ 0.90; RMSEA \ 0.1; R-square [ 0.3; Residual correlation \ 0.20), and then used Rasch analysis to identify misfitting response patterns (criterion: Mean Square fit statistics \ 1.4) of items that met unidimensional criteria and how well they discriminate patients (criterion: separation index [ 2). We evaluated differential item functioning (DIF) across impairment groups. RESULTS: 13 items demonstrated satisfactory fit (CFI = 0.958, RMSEA = 0.091, all R-square [ 0.3, no residual correlation [ 0.2). The Rasch separation index of 1.59 indicates that the items discriminate EF perceptions into nearly 3 distinct levels. The 13 items had MnSq \ 1.4 except 1 item, ‘‘How much difficulty do you have moving around your home?’’ which had marginal fit (1.43). Because this was the only item tapping ‘‘moving around,’’ we retained it. 47 % of the respondents were reliably (r [ 0.7) measured using these items; those with r \ 0.7 were those who did not report any barriers. Impairment-related DIF was negligible. CONCLUSIONS: EF measurement is enhanced when instruments are developed using a structured and reproducible methodology. Investigators and clinicians can measure perceptions of the natural environment and human-made changes reliably with the items described here.

(201.3) Using the ICF’s Environmental Factors Framework to Develop an Item Bank Measuring Services, Systems, and Policy Affecting Persons with Disabilities Jin-Shei Lai, PhD, Northwestern University, Chicago, IL, United States; Joy Hammel, University of Illinois; Allen W. Heinemann, Northwestern University, Chicago, IL, United States; David Gray, Washington University; Susan Magasi, University of Illinois; David Tulsky, PhD, Kessler Foundation, New York, NY, United States; Elizabeth Hahn, MA, Northwestern University, Chicago, IL, United States; Sofia Garcia, PhD, Northwestern University, Chicago, IL, United States; Sara Jerousek, Rehabilitation Institute of Chicago; Alex Wong, PhD, Rehabilitation Institute of Chicago, Chicago, IL, United States AIMS: Enhanced quality of life is a key rehabilitation goal. Environmental factors (EF) may affect quality of life, but few measures of environmental factors have been validated using contemporary measurement models. The aims of this study were to develop measures of EF using contemporary measurement methods; this presentation focuses on Chapter 5 of the ICF—Services, Systems, and Policies

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Qual Life Res (2014) 23:1–184 (SSP). METHODS: Instrument development included literature review, focus group analyses, item classification, item writing, and cognitive testing using the Patient-Reported Outcomes Measurement Information System methodology. Ten content and outcome measurement experts contributed to instrument development; 201 individuals participated in focus groups and 15 participated in cognitive testing. Pilot testing involved 304 adults with spinal cord injury, stroke, and traumatic brain injury; testing with revised items involved 604 people with the same impairments. The SSP item pool consisted of 69 items covering 5 SSP areas: healthcare access, community living, participation, work, and transportation. Respondents used a 5-point rating scale (1 = Never; 5 = Always) to evaluate SSP impact on participation. We used confirmatory factor analysis to evaluate dimensionality of the items (criteria: comparative fit index, CFI, [ 0.90; RMSEA \ 0.1; R-square [ 0.3; Residual correlation \ 0.20), and then used Rasch analysis to identify misfitting response patterns (criterion: Mean Square fit statistics \ 1.4) of items that met unidimensional criteria and how well they discriminate patients (criterion: separation index [ 2). We evaluated differential item functioning (DIF) across impairment groups. RESULTS: 41 items demonstrated satisfactory fit indices (CFI = 0.964, RMSEA = 0.058, all R-square [0.3, no residual correlation [0.2). The 41 items demonstrated acceptable fit to the Rasch model (MnSq range: 0.68–1.29). The separation index of 3.28 indicates that the items discriminate individuals’ SSP self-reports into four distinct levels. Impairment-related DIF was negligible. Test information function results demonstrate that 93 % of individuals were reliably (r [ 0.8) measured with 41 items. We created 2 shortforms; one contains 5 items representing primary content areas, and the second contains the 5 most informative items. CONCLUSIONS: Measuring environmental factors is enhanced when instruments are developed using a structured and reproducible methodology. Investigators and clinicians can measure self-reports of SSP barriers and facilitators reliably with the items described.

(201.4) Validity and utility of the Brandtsta¨dter Tenacious Goal Pursuit/Flexible Goal Adjustment measure in adults aging with long-term physical disabilities Alexandra L. Terrill, University of Washington, Seattle, WA, United States; Ivan Molton, PhD, University of Washington, Seattle, WA, United States; Amanda E. Smith, University of Washington, Seattle, WA, United States; Mark Jensen, University of Washington, Seattle, WA, United States AIMS: Much evidence suggests age-related changes in the use of assimilative and accommodative coping. However, this area has received little attention in disability research, and no studies have tested the validity of widely used measures of this coping construct in adults aging with long-term physical conditions. The aims of this study were to evaluate the psychometric properties of Brandtsta¨dter’s 30-item Tenacious Goal Pursuit and Flexible Goal Adjustment scale (TGP/FGA) in a large sample of middle-aged adults with physically disabling conditions. METHODS: 935 middle-aged individuals (aged 46–67) with physical disability secondary to either spinal cord injury, post-polio syndrome, neuromuscular disease or multiple sclerosis completed a return-by-mail survey that included the 30-item TGP/ FGA scale, as well as measures of depression and quality of life. Analyses included confirmatory factor analysis under the rubric of structural equation modeling. RESULTS: A model specifying the original 2-factor structure and using all 30 items was a poor fit to the data. Model trimming, including removing items with significant cross-loadings, resulted in a 2-factor structure containing 10 items each. Fit for this revised measure was acceptable [9 2/df = 3.48, CFI = 0.94, RMSEA = 0.05], and internal consistency was

Qual Life Res (2014) 23:1–184 established by Cronbach’s criteria ([ 0.70). Age was not significantly associated with the revised TGP subscale, but had a curvilinear relationship with the FGA subscale. Lower scores on TGP (ß = 0.32) and higher scores on FGA (ß = -0.32) subscales were associated with increased depressive symptoms (ps \ 0.001). CONCLUSIONS: A 20-item version of the TGP/FGA measure demonstrates acceptable psychometric qualities in a sample of persons with physical disability. These results also emphasize that a shift toward more accommodative coping may be essential in promoting quality of life for those aging with long-term physical disabilities.

(201.5) Predictors of self-efficacy in individuals aging with a disability Dagmar Amtmann, PhD, University of Washington, Seattle, WA, United States; Alyssa M. Bamer, MPH, University of Washington, Seattle, WA, United States; Kathy Yorkston, University of Washington, Seattle, WA, United States AIMS: To examine the association of self-efficacy (SE) related to management of chronic disease with demographic and clinical indicators in individuals aging with physical disability. Self-efficacy is a critical mediator of human behavior and an important target for interventions to improve health outcomes. Changes in SE have been reported to be the best predictors of response to rehabilitation treatments. Understanding the role of SE in people’s ability to successfully self-manage and live effectively with physical limitations is important for designing treatments that can lead to better quality of life (QOL). METHODS: The University of Washington Self-Efficacy Scale (UWSES) that conceptualizes SE as perceived confidence in managing challenges related to living with a physical disability was used to measure SE. PROMIS short forms (version 1) were used to measure pain interference, physical function, fatigue and social soles satisfaction. In addition to demographics we measured social support (the Multi-dimensional Scale of Perceived Social Support), depression (PHQ9), resilience (the Connor-Davidson Resiliency scale), interference with participation, and falls. A multivariate regression model was used to examine associations between SE and demographics, and symptoms or QOL indicators. RESULTS: 858 older people (aged 45 ?) with muscular dystrophy (MD: 18 %), multiple sclerosis (MS: 32 %), spinal cord injury (SCI: 26 %), or post-polio syndrome (PPS: 24 %) who participated in a study of aging with a disability responded to a mail survey. Of the 2,041 people invited 1,862 completed it (91 % return rate). About a half of the participants were asked to respond to UWSES. The final multivariate model explained 68 % of the variance in self-efficacy and included the following statistically significant independent variables: satisfaction with social roles, resilience, pain interference, interference with participation, social support, fatigue, and employment. Age, gender, marital status, education, income, physical function, depression, falls, and overall mobility were not found to be statistically significantly related to SE. CONCLUSIONS: There is a strong link between SE, social variables and other clinical indicators including resilience, and symptoms of fatigue and pain. Interventions aimed at increasing SE in older adults living with physical disability should include strategies for improving social participation, increasing resiliency, and management of fatigue and pain.

202: Advancing Quality of Life Measurement in eHealth (202.1) Development of the Spanish and Catalan digital versions of the KIDSCREEN-52 and comparison with the paper version Luis Rajmil, PhD, Catalan Agency for Health Quality and Assessment (AQuAS), Barcelona, Spain; Noemı´ Robles-Mun˜oz, Age`ncia de

35 Qualitat i Avaluacio´ Sanita`ries de Catalunya; Dolors Rodrı´guezArjona, Age`ncia de Qualitat i Avaluacio´ Sanita`ries de Catalunya; Francisco Codina, Corporacio´ de Salut del Maresme i la Selva; Marta Azuara, Corporacio´ de Salut del Maresme i la Selva; Hein Raat, MD, PhD, MBA, Erasmus MC—Univ Medical Ctr Rotterdam, Rotterdam, Netherlands; Ulrike Ravens-Sieberer, MPH, University Medical Center Hamburg-Eppendorf, Hamburg, Germany AIMS: To develop the web-based Spanish and Catalan versions of the KIDSCREEN (eKIDSCREEN), and to compare scores and psychometric properties with the paper version METHODS: Internet and paper Spanish and Catalan versions of the KIDSCREEN-52 were administered to all students 8 to 18 years old from the Primary and Secondary schools in Palafolls (Barcelona, Spain, n = 923) during October and November 2013. The order of administration was randomized during the same day with at least 2 h apart. The KIDSCREEN-52, mental health (Strengths and Difficulties Questionnaire, SDQ) and sociodemographic variables were collected. Missing values, floor and ceiling effects, and internal consistency were computed and compared between both versions. Mean score differences and level of agreement was analyzed using Bland and Altman plots, intraclass correlation coefficient (ICC), and standardized mean differences (effect size, ES). Validity was assessed using known group approach and also analyzing the ability to discriminate according to mental health status RESULTS: Participation rate was 77 % (n = 715). Both versions showed similar high ceiling effect (range 0 to 44 %). The web version showed less missing values than the paper version. ES were lower than 0.2 in all dimensions. Internal consistency ranged from 0.7 to 0.88, and the degree of agreement was excellent (ICC range = 0.75 to 0.87). The expected differences by sex, age socioeconomic status and mental health status were found. The higher ES for probable cases were seen in the dimensions of Moods and Emotions (ES = 0.98 in both versions) and Psychological well-being (ES = 0.78 and 0.86 for the web and paper versions, respectively) CONCLUSIONS: Internet version of KIDSCREEN-52 showed similar scale score and reliability and validity than the paper version. It will incorporate the child population in the assessment of HRQOL providing a more attractive format, and easier to manage and analyze than the paper version Funding: Spanish Ministry of health (FIS, contract PI12/01296)

(202.2) Long-term findings from three Scandinavian RCT studies in the European telemedicine project Renewing Health: Selfmanagement telehealth interventions with health counseling Astrid CV Torbjørnsen, Oslo and Akershus University College of Applied Sciences, OSLO, Norway; Anne Karen Jenum, University of Oslo, Oslo, Norway; Eirik Arsand, Norwegian Centre for Integrated Care and Telemedicine; Milada C. Smaastuen, Department of Nursing, Oslo and Akershus University; Inger Lindberg, Lulea˚ University of Technology, Sweden; Tuula Karhula, University of Helsinki, Helsinki, Finland; Lis Ribu, PhD, Oslo and Akershus University College, Oslo, Norway AIMS: To investigate whether the introduction of technology supported self-management, with and without health counselling, produces benefits in terms of desired outcomes, as reflected in the haemoglobin HbA1c level, health-related quality of life, self-management. METHODS: Patients with type 2 diabetes were recruited by their general practitioners in primary healthcare in Finland, Norway and Sweden. Inclusion criteria: age [ 18, diagnosed with type 2 diabetes [ 3 months prior to inclusion, high HbA1c according to national protocols, capability of filling in questionnaires in native language, able to use the system. All countries have conducted nonblinded randomised controlled trials (RCT) with one control and one or two (in Norway) intervention group(s). Usual care according to

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36 national guidelines was provided for all groups. Intervention groups in all three countries were given self-management applications installed on smartphones, tablets or computers. All intervention groups (except one in Norway) were given health counseling to support self-management. Data was collected at two points (baseline and after one year). The methodology used was MAST (1), which ensured a broad evaluation, and with outcomes such as clinical impact, health-related quality-of-life (HRQOL), safety, and patients perception. Meta-analysis for all countries was performed to synthesize the results. The CONSORT statements for pragmatic designs are used in the reporting. RESULTS: In total, 485 participants were recruited in the three regions, and 397 (82 %) were analysed after one year. The participants were successfully randomized in all countries with few statistically significant differences between the groups in baseline variables. There were small differences between the countries regarding age and gender. Preliminary findings indicate no statistically significant effects of the interventions after long-term follow-up neither in HbA1c nor in HRQOL. Of interest, concerning the participants’ perception of their satisfaction with the kit when analysed with the Service User Technology Acceptability Questionnaire (SUTAQ), the data revealed that participants from all countries are in general satisfied with the kit, and that it may be a support in the patients’ self-management. More detailed analysis will be presented at the ISOQOL Annual Conference. CONCLUSIONS: Our findings indicate a general acceptability with telehealth solutions provided, but no effect on other predetermined outcomes.

(202.3) Lessons Learned from the Open Research Exchange Paul Wicks, PhD, PatientsLikeMe, Lichfield, United Kingdom; Magdalena Harrington, PatientsLikeMe Inc., Cambridge, MA, United States; Shimon Rura, PatientsLikeMe, Cambridge, MA, United States; Benjamin Heywood, PatientsLikeMe; James A. Heywood, PatientsLikeMe AIMS: To dramatically accelerate patient feedback into the design of patient-reported outcomes (PROs) and build an open measurement database to allow for rapid evaluation, adaptation, and validation. METHODS: The Open Research Exchange (ORE), funded by the Robert Wood Johnson Foundation, applies methods of open source software development and user-centered design to PRO development. A digital platform allows researchers to perform concept elicitation, cognitive debriefing, psychometric validation against legacy instruments, and test–retest validation all in a matter of days or weeks rather than the months or years such work would normally take. All instruments developed on the platform are available under Creative Commons license, making them free to use and adapt. In year 1 of the project four research collaborators developed measures including treatment burden, diabetes satiety, hypertension self-management, palliative care, and suicidal ideation. RESULTS: Collaborators selected to take part reported high overall satisfaction with the process, particularly with the speed and volume of feedback submitted. Patient participants have been responsive, with one-week response rates around 20 %. However challenges have been identified which must be addressed to further advance the field. For example, 80 % of patients in one study agreed to share their medical notes to confirm their diagnosis, although this may offset other advantages of the platform such as anonymity. Comparisons of concept elicitation rates of saturation using online methods compared to telephone interview found online data density to be sufficient. To address the implications of Creative Commons licensing for instruments we have invited collaborations and partnerships with such groups and encouraged debate as to where changes in practice might maintain viable business models through reducing logistical costs and charging for labor rather than licensing. CONCLUSIONS: Online

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Qual Life Res (2014) 23:1–184

Fig. 1 .

methods supported by open data philosophies have the potential to revolutionize PRO development but require thoughtful consideration of the impact on other stakeholders within the PRO ecosystem (Fig. 1).

(202.4) Equivalence of Electronic and Paper Administration of Patient-Reported Outcome Measures: A Systematic Review and Meta-Analysis Diane J. Wild, MSc, Icon plc, Oxford, United Kingdom; Helen Doll, DSc, MSc, Oxford Outcomes, Carrington, United Kingdom; Paul O’Donohoe, CRF Health, London, United Kingdom; Willie Muehlhausen, Oxford Outcomes AIMS: To conduct a systematic review and meta-analysis of the equivalence between electronic and paper administration of patientreported outcome measures (PROs). METHODS: A systematic literature review identified 1,997 records from which 72 studies met pre-defined inclusion/exclusion criteria. PRO data from each study were extracted, in terms of both correlation coefficients (ICCs, Spearman and Pearson correlations, Kappa statistics) and mean differences. Pooled estimates of correlation and mean difference were estimated. The modifying effects of mode of administration, year of publication, study design, and time interval between administrations were examined. RESULTS: 435 individual correlations were extracted, these correlations being highly variable (I2 = 93.8) but showing generally good equivalence, with ICCs ranging from 0.65 to 0.99 and the pooled correlation coefficient being 0.88 (95 % CI 0.87 to 0.88). Standardised mean differences for 307 studies were small and less variable (I2 = 33.5) with a pooled standardized mean difference of 0.037 (95 % CI 0.031 to 0.042). Average platform-specific correlations from 56 studies (61 estimates) had a pooled estimate of 0.88 (95 % CI 0.86 to 0.90) and were still highly variable (I2 = 92.1). Similarly, average platform-specific ICCs from 39 studies (42 estimates) had a pooled estimate of 0.900 (95 % CI 0.878 to 0.918) with an I2 of 91.5. After excluding 20 studies with outlying correlation coefficients (= 3SD from the mean), the I2 was 54.4, with the equivalence still high, the overall pooled correlation coefficient being 0.875 (95 % CI 0.87 to 0.88). Agreement was found to be greater in more recent studies (p \ 0.001), in randomized studies compared with non-randomised studies (p \ 0.001), in studies with a shorter interval (\ 1 day), and in respondents of mean age 28 to 55 compared with those either younger or older. In terms of platform, paper vs IVRS comparisons had the lowest pooled agreement and paper vs tablet/touch screen the highest (p \ 0.001). CONCLUSIONS: The present study supports the conclusion of a previous meta-analysis showing that PRO assessments administered on paper are quantitatively comparable with assessments administered on an electronic

Qual Life Res (2014) 23:1–184 device. This finding should be reassuring to investigators, regulators and sponsors using electronic devices, raising questions about the necessity of conducting equivalence testing moving forward.

(202.5) An interactive web-based application for displaying population-specific comparisons using PROMISÒ scores Sandra D. Griffith, PhD, Cleveland Clinic, Cleveland, OH, United States; Irene Katzan, Cleveland Clinic, Cleveland, OH, United States AIMS: The ability to compare a patient’s health status to other patients represents a major draw for using PROMIS measures; however, PROMIS is normed to general population samples, providing comparisons that may not be as meaningful to all patients, for example those with chronic conditions or disability. Our objective was to develop a web-based application that allows users to enter PROMIS scores and make comparisons to other patients in selected reference groups. METHODS: PROMIS Fatigue and Physical Function scales were collected using Computerized Adaptive Testing (CAT) on 3,446 patients seen at the Cleveland Clinic Cerebrovascular Center as part of routine outpatient care through the Knowledge Program. PROMIS Depression was collected using short forms on 1,329 patients seen in the ambulatory neurological setting across a variety of sub-specialty visits. For the fatigue and physical function scales, we estimated distributional parameters within clinically-relevant sub-populations based on gender, age, stroke type, and time since stroke. For the PROMIS Depression scale, we computed the same distributional estimates and also utilized item response theory (IRT) to obtain estimates of the latent parameters specific to our neurological population. We developed an interactive web application using the Shiny package in the R statistical software platform to provide graphical and numeric feedback based on user-entered PROMIS data and selected reference populations, e.g. females over 70 years experiencing an ischemic stroke in the last 1–3 months. RESULTS: The Shiny and R development platform permitted rapid deployment of interactive web applications for researchers with knowledge of statistical software but without specialized web development experience. The application is scalable and capable of performing sophisticated statistical calculations, such as on-the-fly factor scoring, without additional input from the end user. We found similar results for comparisons using IRT-based methods vs. those using distributional estimates. Additional data continue to accrue, allowing increased sample sizes and finer comparisons on an ongoing basis. CONCLUSIONS: Deployment of interactive applications for population-specific comparisons of PROMIS scores is feasible and holds potential for wide application. The similar results between the IRT and distributional methods support the adequacy of a straightforward approach that is possible with data collected through either CAT or short forms.

37 Ctr., New York, NY, United States; Bryce B. Reeve, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Ethan Basch, MD MSc, University of North Carolina—Chapel Hill, Chapel Hill, NC, United States, on behalf of the National Cancer Institute PRO-CTCAE Research Group AIMS: This analysis examines the responsiveness of items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), an item library for patient self-reporting of symptomatic toxicities containing 124 items reflecting 78 adverse events. METHODS: English-speaking patients (n = 940; 43 % male; median age 59; 17 % ECOG Performance Status 2–4) receiving cancer treatment at nine sites completed PROCTCAE items (item scoring range 0–4; 7-day recall) and EORTC QLQ-C30 at two clinic visits one to six weeks apart. At the second visit, patients also completed three Global Impression of Change (GIC) items measuring change since first visit in overall quality-oflife, physical and emotional condition (seven possible responses ranging from ‘‘very much better’’ to ‘‘very much worse’’). Data were derived from a previously reported validation study (J Clin Oncol 30, 2012 [suppl; abstr 9047]). Change in 27 PRO-CTCAE items representing 13 core symptomatic AEs was examined using a Jonckheere-Terpstra test across patients who reported worsening (‘‘a little worse’’ to ‘‘very much worse’’), no change (‘‘about the same’’), or improvement (‘‘a little better’’ to ‘‘very much better’’). Standardized response means (SRM) were computed as the mean change score divided by the standard deviation of the change scores within each change category (worsening vs. no change vs. improvement). Pearson correlations were computed between PRO-CTCAE item changes and EORTC QLQ-C30 scale changes. One GIC item and EORTC QLQ-C30 scale were specified a priori for each PROCTCAE item. RESULTS: The median SRM in patients reporting worsening was 0.19 (range 0.03–0.40), whereas median SRM in patients reporting improvement was -0.14 (range -0.30 to 0.09). Across the three ordered GIC categories (worsening to no change to improvement), statistically significant (p \ 0.05) monotonically decreasing mean PRO-CTCAE change scores were observed for 23 of 27 items (p \ 0.001 for 13 items). Statistically significant correlations were observed between PRO-CTCAE item changes and corresponding EORTC QLQ-C30 scale changes for all 27 items (median r = 0.43, range 0.10–0.56; all p \= 0.006). CONCLUSIONS: Core PRO-CTCAE items are responsive to conceptually relevant anchors and retrospective reports of change in physical condition, emotional state, and quality-of-life. Prospective studies

203: Transforming the Quality of Care (203.1) Responsiveness of Items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Amylou C. Dueck, PhD, Mayo Clinic, Scottsdale, AZ, United States; Sandra A. Mitchell, PhD CRNP AOCN, National Cancer Institute, Bethesda, MD, United States; Tito R. Mendoza, PhD, Univ. of Texas M.D. Anderson Cancer Ctr., Houston, TX, United States; Antonia V. Bennett, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Lauren Rogak, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Thomas M. Atkinson, PhD, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Yuelin Li, PhD, Memorial Sloan-Kettering Cancer

Fig. 1 Standardized response means across 27 PRO-CTCAE items by global impression of change category

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38 examining responsiveness and minimally important differences are ongoing in cancer treatment trials. (Funding Acknowledgement: NCI contracts HHSN261200800043C, HHSN261201000063C, and HHSN261200800001E) (Fig. 1).

(203.2) The Outcomes and Experience Questionnaire: Development and Evaluation Elizabeth J. Gibbons, MSc, University of Oxford, Oxford, Oxon, United Kingdom; Paul Hewitson, Nuffield Department of Population Health, University of Oxford; David Morley, University of Oxford, Oxford, United Kingdom; Crispin Jenkinson, Health Services Research Unit, Oxford, United Kingdom; Raymond Fitzpatrick, PhD, Univ of Oxford, Dept of Public Hlth, Oxford, United Kingdom AIMS: In England the National Health Service (NHS) has made patient experience a key performance indicator both nationally and locally. In addition to views about how patients experience services, they also have distinctive and important views about the outcomes of their healthcare, and consequently separate measures of these two distinct aspects of patients’ responses have emerged. Questionnaires addressing how patients experience the care they receive (patientreported experience measures, PREMs) have largely non-overlapping content with questionnaires to capture their views of the outcomes of that care (PROMs). This report presents evidence regarding the development and validation of a new questionnaire, the Outcomes and Experiences Questionnaire (OEQ). The rationale was to bring together into one short instrument questions about two distinct domains—patients’ reports of the outcomes of their care and how they experience care. METHODS: The OEQ was developed from literature reviews, iterative drafting of items and cognitive testing with a sample of patients who had hospital experience in the previous year. Two validation studies were carried out with an eleven item OEQ. The goals of the studies were to examine response rates for OEQ but also to test specific hypotheses of how OEQ should relate to other variables normally collected in the two studies. RESULTS: In the first study, the OEQ was added to the follow-up questionnaires for patients receiving surgery for hip or knee replacement or varicose vein procedures and participating in the national PROMs programme in England. The results provided consistent and substantial evidence of construct validity of OEQ. In particular OEQ sub-scales covering outcomes and experiences behaved differently and as predicted against other PROMs variables. In the second study, patients from three contrasting NHS hospital trusts in England who completed a standard inpatient survey of experiences also completed the OEQ. Again hypotheses of how the two sub-scales regarding outcomes and experiences would relate to the existing domains of patient experience in the inpatient survey were broadly confirmed. CONCLUSIONS: The studies provides encouraging evidence of the OEQ’s capacity to assess distinct reports from patients about outcomes and experiences of care within a single short questionnaire. Reference: Department of Health (2012) NHS Outcomes Framework 2013–2014

(203.3) Development of a measure of Patient-reported Experiences and Outcomes of Patient Safety in Primary Care: the PREOS-PC instrument Jose M. Valderas, MD MPH PhD, University of Exeter, Exeter, United Kingdom; Anthony Avery, University of Nottingham; Ignacio Ricci-Cabello, University of Oxford, Oxford, United Kingdom

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Qual Life Res (2014) 23:1–184 AIMS: Despite the huge potential for adverse events in primary care, the knowledge base for patient safety in this context is still sparse, particularly in relation to appropriate measurement methods. The aim of this study is to develop a patient-reported instrument to measure patient safety experiences and outcomes in primary care in England. METHODS: The instrument was developed in three stages. First, we developed a conceptual framework and compiled the information for item generation through a process that included a systematic literature review of instruments, a meta-synthesis of qualitative studies and four focus groups with patients. Second, we developed the first version of the instrument by selecting and modifying pre-existent items and creating new items when necessary. Third, we developed a pre-final version of the instrument through an iterative process that involved an Expert Panel and cognitive interviews with patients. That version was piloted with 1,950 patients from 26 practices. RESULTS: The ‘‘Patient-reported Experiences and Outcomes of Safety in Primary Care’’ (PREOS-PC) contains 70 items distributed in 10 domains capturing the following aspects: general perceptions of safety (safe environment, safety perception, trustworthiness); patient proactivity; experiences of safety events (frequency of events, preventability, responsibility, and patients’ and practices’ response to the event); and harm. Completed questionnaires were returned by 449 patients (23 %). Respondents were predominantly female (60 %) and of ‘‘white’’ ethnicity (93 %). Item level response rate was high ([90 %) for most of the items. Additionally, the three main scales (safe environment, frequency of event and practices’ response to safety problems) showed adequate internal consistency (Cronbach’s a = 0.92, 0.85 and 0.82 respectively), and structural validity. Results obtained allowed us to identify some aspects of the questionnaire that could be improved (e.g. minimize the number of branching questions/ improve cognitive properties of the visual analogue scales). CONCLUSIONS: PREOS-PC is the first patient-reported instrument to measure patient safety experiences and outcomes in primary care in England. A final version of the instrument will be produced based on the preliminary results obtained, and its psychometric properties will be examined in a pilot-test involving 7,500 patients from 50 practices across England.

(203.4) Item Analysis of a Measure to Understand Over-theCounter Medicine Safety Among 6th Grade Students Kristin Recchiuti, McNeil Consumer Healthcare; Stacie Hudgens, MA (AbD), Clinical Outcomes Solutions, Tucson, AZ, United States; Mary Kathryn Malone, Apple Seed; Brenda Zimmerman, McNeil Consumer Healthcare; Ed Kuffner, McNeil Consumer Healthcare AIMS: The goal of the Over-the-Counter (OTC) Medicine Safety Assessment is to ascertain understanding and knowledge of prescription and OTC medicines including the Drug Facts Label on OTC medicines. This phase of the study was to evaluate the psychometric properties of the OTC Medicine Safety Assessment at baseline. METHODS: The OTC medicine literacy program was piloted by 50 sixth grade classrooms in 17 schools (N = 1,117). The OTC Medicine Safety Assessment is a 46-item instrument utilizing mixed rating scales measuring the following domains: 1) understanding similarities/dissimilarities between prescription and OTC medicines, 2) how to read and use Drug Facts Label information, 3) knowledge of responsible use of medicines and the dangers of taking medicines not as labeled, 4) knowledge of good storage behaviors for prescription and OTC medicines, and 5) using OTC medicines with adult permission and supervision. Andrich’s Partial Credit Model, a Rasch model for mixed scales, was used to evaluate reliability (threshold [0.70), separation (threshold [2.0), dimensionality (threshold for unidimensionality [0.60), and item fit (infit threshold between 0.70 and 1.5). RESULTS: In total, 1,117 sixth grade students completed

Qual Life Res (2014) 23:1–184 the pretest OTC Medicine Safety Assessment. A principal component factor analysis revealed that the Rasch dimension explained 25.9 % of the variance which supports the multidimensionality of the measure. Items were well targeted to the population and able to separate students along the performance continuum (reliability = 0.81, separation = 2.04) with higher scores indicative of higher knowledge at pretest. There were no items above the infit criteria of 1.5 indicating that students responded consistently to items of similar difficulty. CONCLUSIONS: The OTC Medicine Safety Assessment demonstrates strong psychometric characteristics while successfully discriminating between levels of student knowledge and understanding. These characteristics make it an appropriate tool for assessing knowledge and behavior with respect to OTC medicines.

(203.5) Burnout among surgeons—the problem and evolving solutions Juliane Bingener, Mayo Clinic, Rochester, MN, United States; Tait Shanafelt, Mayo Clinic; Susan Hallbeck, Mayo Clinic; Jeff Sloan, PhD, Mayo Clinic, Rochester, MN, United States AIMS: Burnout is common among American surgeons with national incidence rates as high as 40 % and even higher rates reported by single institutions or specialties. Burnout has a number of personal consequences including depression, anxiety, substance abuse, and an adverse impact on personal relationships. Burnout also has important professional consequences including cynicism in dealing with patients and colleagues, loss of meaning in work, and increased risk of major medical errors. This presentation reports on evolving assessment and intervention efforts. METHODS: Burnout assessments were included in routine staff satisfaction surveys. A brief qualitative survey was developed to assess burnout causes and to facilitate intervention creation. Research projects were initiated to deal with burnout related to surgical practices. One project involved using the Surgical Task Load Index (Surg-TLX) was used to evaluate 6 sub-scales evaluating mental, physical and temporal demands, situational awareness, task complexity and operating room distractions. The Surg-TLX was used to evaluate the impact of short pauses and stretches during long surgical procedures. Another project assessed alleviation of physical pain of surgeons. RESULTS: The overall burnout rate among surgeons was 42 %, with variation across units. Factors contributing to burnout included difficulties with work/life balance, excess administrative work, and overscheduling. Over 75 % of 33 surgeons participating in 90-s stretching breaks during 118 cases wanted to continue incorporating this approach into their operations. 50 % reported stretching breaks improved their physical performance and 30 % reported improved mental focus during surgery. 57 % of surgeons reported physical pain at the end of the operating day (back (87 %), neck (60 %), and feet (63 %)). 55 % reported pain affected their work and 57 % stated it affected their life outside of work. Over 90 % of surgeons invited to try a fatigue reducing mat tried and endorsed use of the mat. CONCLUSIONS: Evidence-based interventions are needed to reduce burnout, improve professional satisfaction, and reduce occupation-related pain among surgeons. The preliminary results reported here identify several practical strategies to assist surgeons. Additional studies are needed to identify individual and institutional approaches to reduce burnout and enhance surgeon well-being and function.

204: PRO Development: From Conception through Revision (204.1) Development and validation of the Myeloma Patient Outcome Scale (MyPOS): A quality of life questionnaire for use in the clinical care of people with multiple myeloma

39 Thomas Osborne, MA MBBS MRCP, King’s College London, London, United Kingdom; Christina Ramsenthaler, Cicely Saunders Institute, King’s College London, London, United Kingdom; Susanne De Wolf-Linder, Cicely Saunders Institute, King’s College London, London, United Kingdom; Caty Pannell, Cicely Saunders Institute, King’s College London, London, United Kingdom; Richard J. Siegert, Auckland University of Technology, Auckland, New Zealand; Polly Edmonds, Department of Palliative Care, King’s College Hospital; Steve Schey, Department of Haematological Medicine, King’s College Hospital; Irene J. Higginson, Cicely Saunders Institute, King’s College London, London, United Kingdom AIMS: A systematic literature review showed that existing quality of life (QOL) questionnaires developed or validated for use in multiple myeloma do not capture all the issues important to patients, and may not be well suited to clinical use. The aim was therefore to develop and validate a disease-specific questionnaire for use in the clinical setting to aid the assessment of QOL in people with multiple myeloma. METHODS: Phase 1: Qualitative interviews with myeloma patients (n = 40), two patient focus groups (n = 7, n = 4) and one healthcare professional focus group (n = 6) to identify the issues important to QOL, develop a theoretical model and identify problems with existing questionnaires. Phase 2: Development of the MyPOS questionnaire and pre-testing using cognitive interviews (n = 12). Phase 3: National, multi-centre, cross-sectional survey in a clinically representative sample of myeloma patients recruited from 14 hospital trusts across England (n = 380). Psychometric evaluation including assessment of acceptability (time to complete), internal consistency (Cronbach’s alpha), structural validity (exploratory and confirmatory factor analysis and item response theory modeling), construct validity (known-group comparisons) and criterion validity (comparison to the EORTC QLQ-C30 and MY20 and the EuroQOL EQ-5D-3L). RESULTS: A conceptual model of QOL in myeloma is presented to form the basis for item development. Patients highlighted the importance of questions about sexual function, health service factors and the impact of symptoms on function. The MyPOS was developed with a combination of structured (27) and open (6) questions. Items were further refined and acceptability confirmed using cognitive interviews. Psychometric evaluation showed good internal consistency (a = 0.89). Factor analysis confirmed three subscales for Symptoms & Function; Emotional Wellbeing and Support factors. The MyPOS and its subscales showed a strong ability to distinguish between clinically different groups (performance status (F = 26.33, p \ 0.001), disease stages (F = 11.89, p \ 0.001), on/off treatment (t = 3.415, p \ 0.001), and good convergent and discriminant validity to hypothesized subscales of EORTC and EQ-5D. CONCLUSIONS: The MyPOS is a reliable and valid instrument for use in myeloma patients at all stages of disease. Further longitudinal work is needed to assess responsiveness to change and test–retest reliability.

(204.2) The Plus-M: Item Bank Of Mobility For Prosthetic Limb Users Dagmar Amtmann, PhD, University of Washington, Seattle, WA, United States; Daniel C. Abrahamson, University of Washington, Seattle, WA, United States; Sara Morgan, University of Washington, Seattle, WA, United States; Rana Salem, University of Washington, Seattle, WA, United States; Robert L. Askew, University of Washington, Seattle, WA, United States; Robert Gailey, University of Miami, Miami, FL, United States; Ignacio Gaunaurd, VA Miami, Miami, FL, United States; Andre Kajlich, University of Washington, Seattle, WA, United States; Brian Hafner, University of Washington, Seattle, WA, United States

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40 AIMS: Measurement of mobility in people who use lower limb prostheses for ambulation is challenging because general measures of mobility often are not appropriate for prosthetic limb users. The aim of this study was to develop the Prosthetic Limb Users Survey of Mobility (PLUS-M)- a standardized outcome measure suitable for measuring mobility in prosthetic limb users. PLUS-M is intended to be used for research and clinical purposes, including comparative effectiveness studies, documentation of health outcomes, and facilitation of evidence-based treatment decisions. METHODS: Modern psychometric methodology was used to develop PLUS-M. A candidate item bank was developed with input from literature review, clinicians, researchers, end-users, and other stakeholders. Five possible responses range from ‘‘without any difficulty’’ to ‘‘unable to do.’’ Items were tested in cognitive interviews with prosthetic limb users and administered to a large sample of people with unilateral amputation. IRTPRO was used to fit a 2 parameter Item Response Theory (IRT) model. RESULTS: One hundred five candidate items were administered to 1091 prosthetic limb users with lower limb amputation due to trauma or dysvascular reasons. Confirmatory factor analysis results supported unidimensionality. Items with poor discrimination or less-than-optimal fit were removed from the bank, resulting in a final item bank of 44 calibrated items. PLUS-M score is a T-score (M = 50, SD = 10), centered on the development sample mean. The PLUS-M score is reliable at 0.9 or higher from 3SD below and 2SD above the mean. Both 7- and 12-item short forms (SFs) are available and their scores are highly correlated (r [ 0.96) with the full bank score. The PLUS-M computerized adaptive test (CAT) administered on average 5 items to reach standard error of 3.0. The correlations of PLUS-M scores with scores from similar and dissimilar domains were in the expected directions and magnitudes. CONCLUSIONS: PLUS-M is a clinically meaningful and psychometrically sound measure of mobility for prosthetic limb users. IRT calibrations allow for flexible modes of administration by paper or CAT on phones, tablets, or computers. Full item bank calibrations and short forms are freely available and ready for use in clinical care and research (www.plus-m.org).

(204.3) Development of the EORTC emotional functioning item bank for computer adaptive testing (CAT) Morten Aa Petersen, MSCi, Bispedjerg Hospital, Copenhagen, Denmark; Eva-Maria Gamper, Innsbruck Medical University, Innsbruck, Austria; Anna Costantini, Sant’Andrea Hospital. Sapienza University of Rome. Italy; Johannes M. Giesinger, PhD, Innsbruck Medical University, Innsbruck, Tyrol, Austria; Bernhard Holzner, PhD BE, Univ. Hospital, Innsbruck, Innsbruck, Tyrol, Austria; Colin Johnson, Mchir, Dept of Surgery, Southampton, Hants, United Kingdom; Monika J. Sztankay, Innsbruck Medical University, Innsbruck, Austria; Teresa E. Young, BSc, Mount Vernon Hospital, Northwood, United Kingdom; Mogens Groenvold, MD, PhD, University of Copenhagen, Copenhagen, Denmark AIMS: Emotional functioning (EF) is a key aspect of health-related quality of life (HRQOL). Hence, precise measurement of EF is essential for a comprehensive description of a patient’s HRQOL. Using computerized adaptive testing (CAT) based on item response theory (IRT) an instrument can be adapted to the individual while maintaining comparability of scores across patients. This allows for more precise and appropriate measurement. To utilize these advantages, the EORTC Quality of Life Group is developing an EF item bank for CAT measurement which will be within the HRQOL framework of the EORTC QLQ-C30 questionnaire. METHODS: Based on literature search and evaluations by international samples of experts and cancer patients 38 candidate items were developed. The psychometric properties of the items were evaluated in a large international sample of cancer patients. This included evaluations of dimensionality using factor analysis

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Qual Life Res (2014) 23:1–184 methods for categorical data, calibration of IRT model and evaluation of item fit, investigation of differential item functioning (DIF) using logistic regression methods and evaluation of the practical impact of DIF findings, and evaluation of the measurement precision/statistical power of the CAT measure particularly in comparison with the QLQC30 EF scale. RESULTS: Responses were obtained from 1,023 cancer patients from four countries (Austria, Denmark, Italy, and the UK). Factor analysis showed that 24 items could be included in a unidimensional model with acceptable fit (RMSEA = 0.089, CFI = 0.91 and TLI = 0.99). Tests of item fit indicated good fit to a generalized partial credit model for all 24 items. Twelve of 216 tests for DIF were significant. However, none of the significant findings seemed to have more than negligible impact on the estimation of EF. Evaluations indicated that the CAT measure may reduce sample size requirements by up to 25 % compared to the QLQ-C30 EF scale. CONCLUSIONS: Based on thorough psychometric evaluations we have established an EF item bank of 24 items. This will allow for more precise and flexible measurement of EF, while maintaining backward compatibility with the QLQ-C30 EF scale.

(204.4) The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects Torquil Watt, MD PhD, Copenhagen University Hospital, Copenhagen, Denmark; Per Cramon, MD, Copenhagen University Hospital, Copenhagen, Denmark; Laszlo Hegedu¨s, Odense University Hospital, Odense, Denmark; Jakob B. Bjorner, MD PhD, QualityMetric; Steen ˚ se K. J. Bonnema, Odense University Hospital, Odense, Denmark; A Rasmussen, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Ulla Feldt-Rasmussen, Copenhagen University Hospital, Copenhagen, Denmark; Mogens Groenvold, MD, PhD, University of Copenhagen, Copenhagen, Denmark AIMS: The purpose of this study was to evaluate responsiveness of the thyroid-related quality of life (QOL) instrument ThyPRO in patients undergoing relevant clinical treatments for benign thyroid diseases, and to compare it with responsiveness of the generic SF-36 Health Survey V2 METHODS: A sample of 435 patients undergoing treatment completed ThyPRO and SF-36 Health Survey at baseline and 6 months after treatment initiation. Responsiveness was evaluated in three thyroid patientgroups: Patients with hyper- (n = 66) and hypothyroidism (n = 84) rendered euthyroid, and patients with a clinically detectable non-toxic goiter treated with surgery or radioactive iodine and remaining euthyroid (n = 62). Changes in QOL were evaluated in terms of effect size and compared to the changes predicted by clinical experts. The responsiveness of equivalent scales from ThyPRO and SF-36 Health Survey V2 were compared with the relative validity index. RESULTS: The ThyPRO demonstrated good responsiveness across the whole range of QOL aspects in patients with hyper- and hypothyroidism. Responsiveness to treatment of non-toxic goiter was also demonstrated for physical and mental symptoms and overall QOL, but not for impact on social life or cosmetic complaints, in contrast to clinicians’ predictions. For all comparable scales except one, the ThyPRO was more responsive to treatment than the SF-36 Health Survey. CONCLUSIONS: The ThyPRO was responsive to treatment across the range of benign thyroid diseases. We suggest implementing this measurement instrument as a patient-reported outcome in clinical studies and in clinical management.

(204.5) Psychometric properties of the Functional Assessment of Chronic Illness Therapy—Spiritual Well-Being, Expanded Hayley S. Whitford, PhD, Cancer Council Australia, Sydney, Australia; Simeon B. W. Jones, BA (Hons), University of South Australia,

Qual Life Res (2014) 23:1–184 Adelaide, Australia; Ian N. Olver, MD PhD FRACP, Cancer Council Australia, Sydney, Australia AIMS: To investigate underlying components of the expanded version of the Functional Assessment of Chronic Illness Therapy—Spiritual WellBeing (FACIT-Sp-Ex) in a sample of cancer survivors. METHODS: As part of an Australian, longitudinal, online community-wide survey about existential wellbeing, 1,045 cancer survivors (49.4 % of the larger sample) completed the 23-item FACIT-Sp-Ex at baseline. RESULTS: A principal components analysis using oblique (Oblimin) rotation revealed four interpretable domains (eigenvalues [ 1) explaining 65.9 % of the variance with all 23-items accounted for (coefficients [ 0.3). The first three components supported previous factor interpretations (Peace, Meaning, Faith) of the more commonly used 12-item scale with minor additions from the new 11-item expanded section. ‘Meaning’ retained its original 4 items and gained 3 new loadings, explaining 42.0 % of the variance (a = 0.88). The new items about connectedness to others and giving/receiving love further highlight Meaning’s reported strong associations with social wellbeing. ‘Faith’ explained 12.1 % of the variance (a = 0.92), and ‘Peace’ 7.2 % (a = 0.84). ‘Faith’ retained its original 4-item structure and gained 1 item from the expanded scale, despite item 12 loading slightly more strongly on ‘Peace’. This retention was for improved interpretability and reliability. ‘Peace’ thus maintained its original 4-item structure. The fourth component explained 4.6 % of the variance, consisting of the remaining 7 items of the expanded scale (a = 0.87). Given the mix of item themes (forgiveness, gratitude, appreciation, hope, compassion/empathy), we termed this component ‘Positive Interaction’ based on references to others, self, past, future, present, and the external world. The total FACIT-Sp-Ex evidenced improved reliability (a = 0.93) compared to the 12-item version (a = 0.89). CONCLUSIONS: Adding 11 items of mixed, complex themes to the 12-item Spiritual Wellbeing scale appears to be a psychometrically superior expansion, more reliably assessing the over-arching construct and accounting for an additional subscale. The FACIT-Sp-Ex appears to equally provide clear, multiple dimensions, supportive of factors derived from the shorter version, with reliable extension. Given the replicated clinical utility of assessing the original Peace and Meaning subscales, investigation into whether the expanded components provide additional clinical significance will be of high priority.

205: Expanding Cancer Assessments: New Measures & Methods (205.1) Evaluation of pedometry as a patient-centered outcome in patients undergoing hematopoietic stem cell transplant (HSCT): A comparison of pedometry and patient-reports of symptoms, physical activity, health, and quality of life Antonia V. Bennett, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Bryce B. Reeve, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Ethan Basch, MD MSc, University of North Carolina—Chapel Hill, Chapel Hill, NC, United States; Sandra A. Mitchell, PhD CRNP AOCN, National Cancer Institute, Bethesda, MD, United States; Mathew Meeneghan, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Claudio Battaglini, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Abbie Smith-Ryan, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Charlotte Shatten, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Thomas C. Shea, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; William A. Wood, MD, MPH, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States AIMS: Patient-reported outcomes (PRO) capture the patient perspective on symptoms and functional outcomes of disease and treatment. However, data missing not at random (MNAR) occurs when patients are too

41 sick to complete surveys, and PRO assessments may be infeasible in patients with impaired cognitive function, limited literacy, and those who are unwilling or too burdened to complete surveys. We evaluated pedometry as a novel patient-centered outcome (PCO) because it enables passive continuous assessment of activity and the consequences of symptomatic toxicity, and it provides information that complements selfreport. We report interim analyses describing observed relationships between pedometry data and PROs. METHODS: Adult patients undergoing HSCT wore pedometers and completed PRO assessments during post-transplant hospitalization (4 weeks) and up to 4 weeks post-discharge. Patient-reports of symptomatic treatment toxicities (single items from PRO-CTCAE, http://appliedresearch.cancer.gov/pro-ctcae) and symptoms, physical activity, health, and quality of life (single items from PROMIS-29, http://nih.promis.org) assessed weekly with 7-day recall on Likert scales via paper survey, were compared individually with pedometry data, summarized as total steps in a week divided by 7 days, using linear mixed models. RESULTS: 15 patients [median age 58 (range 27–76), 33 % female, 80 % white, 40 % allogeneic, 60 % autologous] completed a median 6 (range 2–8) weeks of assessments. Mean average daily steps was 3253 (SD = 2282). Model coefficients indicating the decrease in average daily steps per unit worsening in PRO item scores were largest for PRO-CTCAE items measuring pain (beta = 896, p \ 0.001), shortness of breath (beta = 731, p \ 0.015), dizziness (beta = 1081, p \ 0.003), and vomiting (beta = 801, p \ 0.002), and were large for PROMIS items measuring physical activity (beta: 657, p \ 0.003), and physical health (beta = 720, p \ 0.056). There was no association with fatigue, health, mental or emotional health, or quality of life. CONCLUSIONS: In this small sample of HSCT recipients, more severe symptoms, impaired physical health, and restrictions in the performance of usual daily activities were associated with statistically significant decrements in objectively measured daily steps. Findings will be updated for ISOQOL based on accrual of 30 participants. Further examination of pedometry as a PCO will explore its association with fatigue, and its responsiveness, predictive power, and utility for clinical decision-making.

(205.2) Mixed-effects regression Models for longitudinal Analysis of Quality of Life in Oncology Antoine Barbieri, Biometrics Unit, ICM—Val d’Aurelle, Montpellier, France, Montpellier, France; Christian Lavergne, Institut de Mathe´matiques et de Mode´lisation de Montpellier, Montpellier, France; Thierry Conroy, Centre Alexis Vautrin, Les-Nancy, France; Sophie Gourgou-Bourgade, CRLC Val d’Aurelle, Montpellier, France; Beata Juzyna, Unicancer R&D, Paris, France; Caroline Bascoul-Mollevi, ICM | Val d’Aurelle, Montpellier, France, Montpellier, France AIMS: In oncology, the Health-related Quality of Life (HRQOL) has become an essential endpoint in clinical trials. However, HRQOL longitudinal analysis remains complex and non-standardized. The development of longitudinal analysis tools adapted to this HRQOL clinical data is currently an important challenge. The aim of this work is to propose an inventory of mixed-effects regression models to process HRQOL longitudinal analysis giving advantages and drawbacks. METHODS: The observations were obtained from questionnaires filled by the patients themselves. The questionnaires are collected at different times predefined in the study protocol in order to assess the HRQOL change over time. The HRQOL data have three important characteristics: ordinal categorical, multiple responses and repeated measures. Given the characteristic of data and the aim to assess the factor influence (e.g. the treatment), the mixed-effects regression models are particularly adapted. The random effects allow taking into account the dependence from data of same patient. The first model (LMM, linear mixed model) from classical test theory is based on the HRQOL score study which is the average of the items.

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42 The two others presented models for ordinal categorical data were mixed-effects regression models and correspond precisely to adjacent-categories logit model and Cumulative logit Model (CM) (De Boeck and Wilson 2004). From IRT view, they are respectively an extension of Partial Credit Model (LCPM) (Masters 1982) and Graded Response Model (Samejima 1969). RESULTS: The LMM which is the most used model to analyze HRQOL data in cancer clinical trial is not adapted: the score is not a really continuous variable and the model doesn’t take into account the ceiling and floor effect of score. Bias estimations occurred in this case. CM is particularly known to be adapted to ordinal categorical data and have an easier interpretation. These methods were illustrated on HRQOL data from the ACCORD11 clinical trial, which recruited 342 patients treated for metastatic pancreatic cancer. CONCLUSIONS: The inventory of mixed-effects regression models lead to a better understanding of these statistical tools for the HRQOL longitudinal analysis. The HRQOL concept is very complex, it is necessary to use the best statistical tool from methodological view.

(205.3) Sleeping Like a Baby? Exploring PROMISÒ Sleep Disturbance DIF by Race/Ethnicity and Age Roxanne E. Jensen, PhD, Georgetown University, Washington, DC, United States; Bellinda L. King-Kallimanis, PhD, TILDA, Trinity College Dublin, Dublin, Ireland; Jeanne A. Teresi, Columbia University Stroud Center; Eithne Sexton, Royal College of Surgeons in Ireland, Dublin, Ireland; Arnold L. Potosky, PhD, Georgetown University, Washington, DC, United States AIMS: To evaluate model fit and differential item function (DIF) in the PROMIS sleep disturbance item bank. METHODS: Cancer survivors (n = 5,050) recruited by the Measuring Your Health (MYHealth) study through 4 SEER cancer registries in three states and diagnosed with colorectal, lung, NHL, breast, gynecologic or prostate cancer. Sleep Disturbance was measured by the three established (4a, 6a, and 8b), and one custom 10-item short form that also included frequently selected items using computer adaptive testing (CAT) administration. Patients were surveyed 6–13 months after cancer diagnosis. The measurement model was tested for fit using confirmatory factor analysis (CFA). DIF was examined with respect to race/ethnicity (White, Black, Hispanic and Asian), age, and sex. DIF was assessed using both multi-group CFA and multiple indicators, multiple methods (MIMIC) analyses. RESULTS: A satisfactory single sleep disturbance construct was found (x2(6) 37.6, p \ 0.001). However, to achieve appropriate fit 4 items from the hypothesized model were removed due to item content overlap. A method effect was also identified due to the use of both positively and negatively worded items, and residual covariances were added to positively worded items. The resulting 6-item model was tested for DIF with respect to race/ethnicity. One case of DIF was identified. White survivors were less likely to agree with the statement ‘‘I had difficulty falling asleep’’ compared to other Race/Ethnic groups at the same level of sleep disturbance. This model was then extended into a MIMIC model to assess the effect of age and sex. No additional DIF was identified and the overall fit was good (x2(128) 192.7, p = 0.0006). Across all race/ethnicity groups, the adjusted overall means suggest that older adults reported significantly lower sleep disturbance, and white, black, and Hispanic women reported significantly higher sleep disturbance than male survivors of the same race. CONCLUSIONS: After the removal of overlapping item content, this 6-item measurement model fit the data well. There was very little evidence of substantial DIF, suggesting that this sleep disturbance scale can be used in different groups, across the adult lifespan and in males and females in a heterogeneous cancer population.

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Qual Life Res (2014) 23:1–184 (205.4) Is the CTCAE system suitable to use in trials in surgery and radiotherapy? A content analysis of the NCI-PRO-CTCAE and EORTC systems Elaine E. O’Connell Francischetto, BSc, MSc, University of Bristol, Bristol, United Kingdom; Alexandra Gilbert, University of Leeds; Galina Velikova, MD PhD FRCP, University of Leeds, Leeds, United Kingdom; Jane Blazeby, MD, University of Bristol, Bristol, United Kingdom AIMS: Adverse events (AEs) in clinical trials in oncology are traditionally reported by clinicians using the Common Toxicity Criteria and Adverse Events (CTCAE), which is based on clinicians’ observations and has evolved originally to document AEs in cancer drugs trials. Recently, a patient-reported version has been developed by the National Cancer Institute (NCI-PRO-CTCAE). Whether this CTCAE system is comprehensive and applicable to trials of surgery and radiotherapy is unknown. This study investigated the content of the NCI-PRO-CTCAE for radiotherapy and surgical trials, the patient focused EORTC Quality of Life questionnaires (QLQ) were used as a comparative case study. METHODS: The NCI-PRO-CTCAE (01/ 2011 Version), the EORTC QLQ-C30 and 17 available validated disease specific modules were evaluated using an inductive content analysis. All questionnaire items were included and openly coded by one researcher. To check for reliability a second researcher independently coded the NCI-PRO-CTCAE, EORTC QLQ-C30 and 4 EORTC modules. Codes were grouped into broader health domains, discrepancies discussed and final code and domain names agreed. Scrutiny of the CTCAE version 4 was undertaken to look for clinician observed symptoms not included in the NCI-PRO-CTCAE or EORTC QLQ-C30 and modules. RESULTS: There were 37 domains and 77 codes in the NCI-PRO-CTCAE and 42 domains and 164 codes in the EORTC questionnaires. Content analysis identified 12 domains and 114 codes in the EORTC questionnaires that were not in the NCIPRO-CTCAE system but relevant to surgical oncology and radiation treatment. There were 7 domains and 25 codes in the NCI-PROCTCAE not covered by the EORTC systems. Gaps in the NCI-PROCTCAE included problems with weight, haemoptysis, blood in stools and stoma issues, which are included in the CTCAE within item descriptions, some psychosocial domains were also missing. Gaps in the EORTC modules included dizziness, heart palpitations and nosebleeds, and codes related to specific skin issues (such as acneform rashes). CONCLUSIONS: This study has compared the content of the EORTC system for PRO assessment in trials with the NCIPRO-CTCAE in the context of surgery and radiotherapy. It shows areas where both systems have gaps and recommends modifications to optimise the use of these systems in surgical oncology and radiation treatment. Acknowledgements: We would like to thank Ethan Basch, Sandra Mitchell and the NCI PRO-CTCAE research group for allowing us to use the NCI-PRO-CTCAE items in this research project. This abstract presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Reference Number RP-PG-061120008). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health

(205.5) Institutional Quality of Life Compliance in an Advanced Ovarian Cancer Surgery Phase III Study Corneel Coens, MSc, EORTC HQ, Brussels, Belgium; E. Greimel, Medical University Graz, Graz, Austria; A. Casado, Department of Medical Oncology, Hospital Universitario San Carlos, Madrid, Spain;

Qual Life Res (2014) 23:1–184 G. B. Kristensen, The Norwegian Radium Hospital, Oslo, Norway; N. S. Reed, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; G. Rustin, Mount Vernon Hospital, Northwood, United Kingdom; Andrew Bottomley, PhD, EORTC Headquarters, Brussels, Belgium; I. Vergote, Gasthuisberg University Hospital, Leuven, Belgium AIMS: Health-related quality of life (HRQOL) has become an important outcome measure in cancer clinical trials. However assessment via self-reported validated questionnaires is often hampered by missing data. In this study, we investigated indicators of HRQOL compliance in an advanced ovarian cancer trial. METHODS: A total of 586 patients from 46 institutions with ovarian cancer stages IIIc-IV were enrolled by the EORTC GCG into the EORTC 55971 trial. These patients were randomized to either upfront debulking surgery (UDS) versus neo-adjuvant chemotherapy (NACT) with interval debulking surgery. The primary endpoint was overall survival (OS) and secondary endpoints were progression free survival (PFS), adverse effects, and HRQOL. Patients completed the EORTC QLQ-C30 before treatment (baseline assessment), on the day of the third and sixth cycle of chemotherapy, and at six and twelve months follow-up. RESULTS: Compliance rate was 73 % at baseline and ranged from 51 % to 35 % during follow-up. The institutions were categorized into good compliance (GC) (17 institutions, N = 325) with at least 50 % compliance at baseline and more than 35 % during follow-up or low compliance (LC) (29 institutions, N = 261) otherwise. Patient characteristics such as age, performance status and tumour size were well balanced except for FIGO stage with more stage IV patients in the GC group (28 % vs 20 %). Overall debulking rates were higher in the GC group with 44 % of the patients achieving optimal (0 mm) debulking compared to 20 % in the LC group. Protocol deviations occured less in the GC group (5 % vs 15 % in the LC group). Both OS and PFS were significantly better in the GC group than in the LC group (OS: 32 vs 23 months; p \ 0.001—PFS: 10 vs 12 months; p \ 0.001). CONCLUSIONS: In this surgery RCT, institutions with better HRQOL compliance rates achieved better surgical outcomes, lower protocol deviations and improved survival. Therefore, HRQOL compliance in RCTs is an indicator of institutional quality assurance and overall adherence to the study protocol and not only dependent on individual patient preference.

206: PROMISÒ: New Measures, New Populations (206.1) Exploratory and Confirmatory Factor Analysis of PROMISÒ Pain Quality Version-2 Items Dennis Revicki, PhD, Evidera, Bethesda, MD, United States; WenHung Chen, RTI; Esi Morgan DeWitt, MD, MSCE, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States; Cindy Nowinski, MD PhD, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Kaleb Michaud, PhD, National Data Bank for Rheumatic Diseases; Fred Wolfe, National Data Bank for Rheumatic Diseases; David Cella, PhD, Northwestern University, Chicago, IL, United States AIMS: Pain quality descriptive measures are important as outcome measures and may have a role in pain diagnosis and phenotyping. The pain quality items have been recently revised and updated in the PROMIS project. The objective of this study was to examine the factor structure of the dichotomous items in the revised PROMIS pain quality bank. METHODS: Pain quality item bank data were collected on samples of patients with rheumatoid arthritis (n = 314), osteoarthritis (n = 106), fibromyalgia (n = 228), cancer neuropathy (n = 134), and diabetic neuropathy (n = 181). The revised pain

43 quality bank includes 26 dichotomous (yes/no) items covering affective descriptors (e.g., miserable, vicious, awful, sickening, etc.). The sample was randomly split into two halves. Exploratory factor analysis (EFA) was performed on one mixed diagnosis subsample (N = 483), followed by confirmatory factor analysis (CFA) on the second mixed diagnosis subsample (N = 480). RESULTS: The EFA resulted in four extracted factors [eigenvalues: 16.236, 1.870, 1.574, 1.236; comparative fit index (CFI) = 0.995; root mean square error of approximation (RMSEA) = 0.033]. The factors were interpreted as intolerable/unbearable (7 items), worrying/horrible (9 items), annoying/uncomfortable (seven items), and nauseating (three items). The CFA confirmed the same four pain quality factors identified in the EFA (CFI = 0.973; RMSEA = 0.07). CONCLUSIONS: The factor analyses supported meaningful pain quality factors based on the revised PROMIS pain quality items. Future research can evaluate the extent to which factor scores can help diagnose or differentiate chronic pain conditions, or be useful outcomes in clinical trials.

(206.2) Validation of the PROMISÒ Mobility Computer Adaptive Test in Patients with Orthopaedic Trauma to a Lower Extremity Nan Rothrock, PhD, Northwestern University, Chicago, IL, United States; Mark Vrahas, Harvard Orthopedic Trauma Service, Boston, MA, United States; Robert V. O’Toole, University of Maryland School of Medicine; Sarah Buono, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; Amanda Holmes, University of Maryland School of Medicine; Jordan Morgan, Harvard Orthopedic Trauma Service, Boston, MA, United States; Suzanne Morrison, Harvard Orthopedic Trauma Service, Boston, MA, United States; Richard Gershon, PhD, Northwestern University, Chicago, IL, United States AIMS: The PROMIS Physical Function (PF) item bank was developed and validated as a universal instrument for assessing functional capacity. Because some populations may have areas of the body differentially affected by a medical condition, the PROMIS Mobility subdomain was created by extracting 16 items focusing exclusively on lower extremity function. This study evaluated the validity of the PROMIS Mobility computer adaptive test (CAT) in a sample of 405 patients with orthopedic trauma isolated to the lower body. METHODS: Participants were ambulatory prior to injury and received treatment in the past 1–12 months. During a scheduled clinic visit, participants completed the PROMIS Mobility CAT, PROMIS 8-item PF short form, RAND 36-item PF scale, Foot and Ankle Ability Measure ADL Index (FAAM) and Sports Subscale (FAAM Sport), Short Musculoskeletal Function Assessment (SMFA), and UCLA Activity Scale on a tablet computer. RESULTS: The mean T-score for the PROMIS Mobility CAT was 35.6 (SE = 2.4), about 1‘ standard deviations below the US General Population mean. The PROMIS Mobility CAT was correlated (p \ 0.01) with other measures of PF including the PROMIS 8-item short form (r = 0.902), Rand-36 PF (r = 0.807), FAAM (r = 0.840), FAAM Sport (r = 0.765), SMFA (r = -0.769), and UCLA Activity Score (r = 0.615). Mobility was also correlated with days since surgery (r = 0.317, p \ 0.01). A measurement floor or ceiling was defined as the lowest/highest 3 scores with a goal of under 5 % of the sample in that range. The PROMIS Mobility CAT demonstrated neither a floor nor ceiling whereas floors were present for other measures (e.g., RAND-36 PF had 31.4 % sample in 3 worst score categories). The Mobility CAT was completed in 1.4 min with 4–12 items similar to instruments of similar length (RAND-36 PF, PROMIS PF 8-item short form). Longer instruments required substantially more time (SMFA = 5.4 min, FAAM = 2.7 min, p \ 0.001). CONCLUSIONS: Scores on

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44 the Mobility CAT were consistent with expectations for poor functioning. It demonstrated convergent construct validity. Measurement in the lowest range of functioning should be enhanced through creation and calibration of supplemental items for the Mobility item bank. Completion time was brief, supporting the feasibility of integrating CAT data collection into routine clinical care.

(206.3) Differential Item Functioning between English source version and a German translation of the PROMISÒ Item Bank for Depression Felix Fischer, PhD, Charite´—Universita¨tsmedizin Berlin, Berlin, Germany; Inka Wahl, PhD, University Medical Center HamburgEppendorf, Hamburg, Germany; Sandra Nolte, PhD, Charite´— Universita¨tsmedizin Berlin, Berlin, Germany; Elmar Bra¨hler, Leipzig University; Bernd Lo¨we, University Medical Center HamburgEppendorf & Scho¨n Klinik Hamburg Eilbek; Matthias Rose, MD PhD, Charite´ Universita¨tsmedizin Berlin, Germany AIMS: Over the past years, the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative has developed a large number of item banks assessing different dimensions of the patient’s subjective health status. Recently, the PROMIS depression item bank was translated into German. This study investigates psychometric differences between the source version of the instrument and its German translation in terms of measurement properties. METHODS: Using data from the US calibration sample (n = 14,898), a German representative population sample (n = 2,504) and a German clinical sample (n = 643) we investigated differential item functioning (DIF) in the 28-item PROMIS Depression item bank. An iterative ordinal logistic regression modeling strategy with different DIF criteria was used to estimate the impact of language on differences in item responses. Furthermore, we assessed differences in depression severity estimates when accounting for DIF in the German sample. RESULTS: Dependent on criteria, number of items exceeding cutoff values ranged from 0 to 20. As more items were reestimated to control for DIF we observed stronger impact on depression severity estimates. Reestimated item characteristic curves are similar over DIF models. A set of 8 anchor items could be identified which showed no DIF in all analyses. CONCLUSIONS: Correcting for DIF lead to considerable changes in theta distribution, precision and concordance of estimates only in case of a rather strict criterion. Future cross-language studies can use the anchor items or a corrected IRT model to obtain comparable estimates of depression severity. Our analysis shows that the PROMIS Depression item bank fulfills high standards with respect to language invariance.

(206.4) Psychometric properties of the Spanish version of the Patient-reported Outcomes Measurement Information System (PROMISÒ) depression item bank in a clinical sample Gemma Vilagut, MSc, IMIM (Hospital del Mar Medical Research Institute); UPF, Barcelona, Spain; Carlos Garcia Forero, PhD, IMIM, Barcelona, Spain; Elena Olariu, Hospital Del Mar Medical Research Institute; UPF, Barcelona, Spain; Jordi Alonso, MD PhD, IMIMHospital del Mar Medical Research Institute, Barcelona, Spain; On Behalf of INSAyD Inv., Hospital Del Mar Medical Research Institute, Barcelona, Spain AIMS: Psychometric properties of the Spanish PROMIS depression item bank (PROMIS-D) have not yet been evaluated. Our aims were to study unidimensionality, reliability, construct validity and responsiveness of this item bank in a clinical sample. METHODS:

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Qual Life Res (2014) 23:1–184 Prospective follow-up study (baseline and 3 months) of patients seeking assistance for active mood/anxiety symptoms (n = 233). PROMIS-D was self-reported and z-scores were calculated, higher values representing higher depression levels. DSM-IV diagnoses of major depression episode (MDE), panic disorder (PD) and generalized anxiety disorder (GAD) were conducted with the MiniInternational Neuropsychiatric Interview (MINI); Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) assessed severity. Unidimensionality was assessed with a Confirmatory Item Factor Analysis (CIFA), using Comparative Fit Index (CFI [ 0.95), Tucker-Lewis index (TLI [ 0.95), Root Mean Square Error of Approximation (RMSEA \ 0.08) for examining goodness of fit. Reliability was assessed with Guttman’s Lambda 2, Cronbach’s alpha and composite model-based reliability, and IRT information curves were estimated. Construct validity was evaluated through correlations with other self-reported and clinical measures, and known-groups validity comparing PROMIS-D means across MINI diagnostics (No disorder, pure MDE, pure anxiety and comorbid MDE and anxiety). Responsiveness to change was evaluated with Cohen’s effect sizes (ES) for two groups (stable and recovered). RESULTS: One-factor CIFA showed adequate fit (CFI = TLI = 0.97, RMSEA = 0.08), with reliability indexes over 0.98. Information curves showed measurement precision comparable to reliability of 0.90 throughout most of the score continuum. As hypothesized, correlations with Patient Health Questionnaire measuring depression were high (r = 0.82), and moderate with self-reported anxiety (Beck Anxiety Inventory somatic component r = 0.55, subjective component r = 0.69), and with clinical HAM-D (r = 0.62) and HAM-A (r = 0.53). A gradient was observed in PROMIS-D scores from no disorder (mean = -0.2, SE = 0.06), pure anxiety (mean = 0.0, SE = 0.10), pure MDE (mean = 0.54, SE = 0.05) and comorbid MDE (mean = 0.58, SE = 0.04). High responsiveness was found, with large effect size values for patients who recovered (ES = 0.82) and small for stables (ES = 0.12). CONCLUSIONS: Results provide support for the reliability, construct validity and responsiveness of the Spanish PROMIS-D, suggesting it is adequate for monitoring depression levels of patients in clinical settings. Funding: ISCIII FEDER PI13/ 00506; ISCIII FEDER PI10/00530; JCI-2009-05486; AGAUR 2009 SGR 1095

(206.5) Validation of the Dutch-Flemish PROMISÒ Pain Behaviour and Pain Interference Item Banks in Patients presenting for Spinal Manipulative Treatment Wouter Schuller, EMGO ? Institute for Health and Care Research, Amsterdam, Netherlands; Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands; Francisca Galindo-Garre, EMGO Institute for Health and Care Research; Niels Smits, VU University Medical Center, Amsterdam, Netherlands; Raymond Ostelo, EMGO Institute for Health and Care Research, VU University Medical Centre; Henrica C.W. de Vet, Sr., PhD, EMGO Institute VU Medical Center, Amsterdam, Netherlands AIMS: The aim of our study was to validate the Dutch-Flemish translation of the PROMIS pain behaviour item bank (DF-PROMIS-PB) and the Dutch-Flemish pain interference item bank (DFPROMIS-PI) in patients presenting for spinal manipulative treatment. METHODS: The DF-PROMIS-PB consists of 39 items with a 6-point Likert scale (1 = had no pain and 6 = always) and the DFPROMIS-PI consists of 41 items with a 5-point Likert scale (1 = low interference and 5 = high interference). A web-based survey, including the full DF-PROMIS-PB and DF-PROMIS-PI, was completed by 1787 patients who presented at OrthoManual physicians for spinal manipulative treatment.To check unidimensionality a one-

Qual Life Res (2014) 23:1–184 factor confirmatory factor analysis (CFA) was performed. With the future strategy to develop computer assisted testing (CAT) item response theory (IRT) models were used to evaluate the item characteristics of the two item banks. A graded item response model (GRM) was fitted to scale the separate item banks on either the pain behaviour or pain interference construct. Differential Item Functioning (DIF) was evaluated for age, gender and language. RESULTS: These results are based on an interim analysis of 1603 of the currently 1787 included patients. The DF-PROMIS-PB demonstrated good fit to a one-dimensional model (CFI = 0.947, TLI = 0.944). The item means ranged from 0.124 to 1.972 (mean = 0.967; SD = 0.459). Cronbach’s alpha was 0.94. A GRM model was fitted. The theta covered by test information [ 0.3 SE ranged from -4 to ?5. One item presented DIF with respect to gender and 5 items presented DIF with respect to language. For the DFPROMIS-PI we included data from 1568 patient with complete response patterns. The DF-PROMIS-PI demonstrated good fit to a one-dimensional model (CFI = 0.976, TLI = 0.975). The item means ranged from 1.653 to 3.269 (mean = 2.355; SD = 0.392). Cronbach’s alpha was 0.98. A GRM model was fitted. The theta covered by test information [0.3 SE ranged from -4 to ?3.5. No item presented DIF with respect to age or gender and 3 items presented DIF with respect to language. CONCLUSIONS: The DFPROMIS-BP demonstrated a good coverage of the pain behavior construct and the DF-PROMIS-PI demonstrated a good coverage of the pain interference construct in patients presenting for spinal manipulative treatment.

(206.6) The impact of Dutch- versus English-language calibrations on theta estimates of the Dutch-Flemish PROMISÒ Pain Behavior and Pain Interference Item Banks Martine H.P. Crins, Reade | Amsterdam Rehabilitation Research Center, Amsterdam, Netherlands; Niels Smits, VU University Medical Center, Amsterdam, Netherlands; Leonard Roorda, MD PhD, Amsterdam, Netherlands; David Cella, PhD, Northwestern University, Chicago, IL, United States; Karon F. Cook, PhD, Northwestern University, Chicago, IL, United States; Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands AIMS: This study aimed to evaluate the impact of using Dutch-language calibrations versus English-language calibrations on theta estimates of the Dutch-Flemish PROMIS Pain Behavior Item Bank (DF-PROMIS-PB) and the Dutch-Flemish PROMIS pain interference item bank (DF-PROMIS-PI). METHODS: The study included post hoc Computer Adaptive Test (CAT) simulations based on the DFPROMIS-PB and DF-PROMIS-PI calibration samples including 1111 chronic pain patients. In this, both the Dutch-language item parameters (slopes and thresholds) and the English-language item parameters were applied in separated simulations. Furthermore, a simulation was done with Dutch-language item parameters for items with Differential Item Functioning (DIF) and English-language item parameters for non-DIF items. Several stopping rules, such as a minimum number of 5 items, a maximum number of 20 items, and a standard error of at least 0.30 were used. Criterion variables were variance and bias using the Dutch-language items parameters as a gold standard, and the correlation between the theta estimates of the Dutch- and Englishlanguage item parameters. In addition, the effect on clinical decisions was studied. RESULTS: The simulations gave mixed results: items with larger DIF had more impact on the criterion variables than items without DIF. In this, DIF for language was taken into account during the DIF analyses of the DF-PROMIS-PB and DF-PROMIS-PI chronic pain sample. Furthermore, the simulations showed that the impact of the

45 items with larger DIF varied depending on the test application goal. Items with larger DIF had more impact when the goal was to decide whether patients are below or above a certain cut-off score. And the impact was less when the goal was to decide about the relative ordering of patients. CONCLUSIONS: This simulation study demonstrated that the impact of using Dutch- versus English-language calibrations on the theta estimates of the item banks depends on the main testing goals. We recommend the choice for Dutch- or English-language calibrations to depend on the user’s testing goals (e.g. screening versus measuring purpose) of the DF-PROMIS-PB and DF-PROMIS-PI.

207: Advancing Mental Health Assessment (207.1) What can modern measurement methods tell clinicians about adaptive responses of depression? Skye P. Barbic, PhD, OT, University of Toronto, Toronto, ON, Canada; Zachary Durisko, Centre for Addiction and Mental Health, Toronto, ON, Canada; Paul W. Andrews, McMaster University, Hamilton, ON, Canada AIMS: Current diagnostic criteria for major depressive disorder are arbitrary, and there is debate that these criteria may pathologize normal, adaptive responses to stressors. Depressive rumination, distraction-resistant thoughts about the episode, is considered pathological. Evidence of an analytical subtype of rumination (AR) has led some to re-conceptualize rumination as potentially adaptive. Unfortunately, research has been hampered by the lack of a theoretically-derived and psychometrically sound instrument for measuring AR. The objective of this study is to develop a clinically meaningful patient-reported outcome measure to assess analytical rumination. METHODS: Expert panels and an extensive literature review were used to develop a conceptual framework for AR and a list of 22 questionnaire items. We developed a priori hypotheses about the hierarchical ordering of the items and how they covered the range of the construct. Items were field tested to 575 university students; 161 also completed the test at two points in time. Rasch measurement methods were used to construct scales, and traditional psychometric analyses were performed for comparison with existing measures. RESULTS: Analysis showed high data quality (low missing data \ 1 %, high reliability (Cronbach’s alpha = 0.92; test–retest intraclass correlations [ 0.81; and evidence for divergent validity. We observed misfit of three items and disordered thresholds (12/22). Upon rescoring the items to a 4 point scale and deleting three items, the revised 19-item Analytical Rumination Questionnaire (ARQ) showed overall fit to the Rasch model (?2 = 89.99, df = 72, p = 0.10), high reliability (r = 0.91), ordered response scale structure, and no item bias (gender, age, time). Items covered a range of 6.2 logits with a gap at the higher end of the measurement spectrum ([?2.3 logits). CONCLUSIONS: The sensitivity and potential utility of the ARQ as an outcome measure for trials and clinical practice could be improved by including more items at the upper extreme of the scale range, and reconsidering items that misfit and whose response categories have reversed thresholds. The analysis provided insight into solving the measurement problems of the ARQ, and further refining the concept for use in self-management and clinical treatment of depression.

(207.2) How to interpret multidimensional quality of life questionnaire in schizophrenia? Pierre Michel, Aix Marseille Universite´, Marseille, France; Karine Baumstarck, Faculte´ de Me´decine, AMU, Marseille, France; Pascal Auquier, Public Health Department, University Hospital of Marseille, France; Anderson Loundou, EA3279, Self-perceived Health

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Qual Life Res (2014) 23:1–184

Assessment Research Unit, Marseille, France; Julie Berbis, Department of Public Health, Medicine University, Marseille, France; Christophe Lanc¸on, Aix Marseille Universite´, Marseille, France; Badih Ghattas, Faculte´ Des Sciences de Luminy, Marseille, France; Laurent Boyer, PhD, Aix-Marseille University, Marseille, France AIMS: The classification of patients into distinct categories of quality of life (QOL) levels may be useful for clinicians to interpret QOL scores from multidimensional questionnaires. The aim of this study was to define clusters of QOL levels from a specific multidimensional questionnaire (SQOL18) for patients with schizophrenia and to test the validity regarding sociodemographic, clinical and QOL information. METHODS: In this multicentre and cross-sectional study, patients with schizophrenia were classified using a clustering analysis based on unsupervised binary trees. A three-group structure was considered, as follows: ‘‘high’’, ‘‘moderate’’, and ‘‘low’’ QOL levels. Sociodemographic, clinical and QOL data were compared between the 3 clusters to ensure their clinical relevance. RESULTS: A total of 514 patients were analysed: 78 were classified with ‘‘low’’, 265 with ‘‘moderate’’, and 171 with ‘‘high’’ QOL levels. The clustering showed satisfactory statistical properties, including repeatability (using bootstrap) and discriminancy (using factor analysis). The three clusters consistently differentiated patients based on clinical characteristics and QOL measures. Individuals of the ‘‘high’’ QOL level cluster reported the lowest scores on the Positive and Negative Syndrome Scale (p = 0.01) and the Calgary Depression Scale (p \ 0.01), the highest scores on the Global Assessment of Functioning (p \ 0.03), the Short Form Health Survey, the EuroQOL and the Quality of Life Inventory (all p values \0.01). CONCLUSIONS:

Easy to apply, this classification may be useful for facilitating interpretation of QOL scores of the SQOL18 in clinical practice (Figs. 1, 2; Table 1).

Table 1

. Cluster 1 Low QoL

Cluster 2 Moderate QoL

Cluster 3 High QoL

N = 41

N = 121

N = 84

33.4 ± 9.6

36.0 ± 9.9

Male

31 (79.5)

Female

8 (20.5)

Age, years M ± SD

p*

p1 versus 2

p1 versus 3

p2 versus 3

34.4 ± 10.6

0.33

0.56

1.00

0.86

91 (77.1)

61 (72.6)

0.65

27 (22.9)

23 (27.4)

Sex N (%)

Educational level N (%) \12 years

28 (70.0)

67 (57.3)

53 (63.9)

C12 years

12 (30.0)

50 (42.7)

30 (36.1)

0.32

Marital status N (%) Not single

27 (67.5)

62 (53.0)

54 (65.1)

Single

13 (32.5)

55 (47.0)

29 (34.9)

0.12

Worker or student

5 (12.5)

18 (15.7)

9 (10.8)

Not working

35 (87.5)

97 (84.3)

74 (89.2)

159.1 ± 200.4

157.7 ± 100.2

157.9 ± 168.4

1.00

1.00

1.00

1.00

0.46

Occupational status N (%)

Disease duration, years M ± SD

0.61

PANSS Positive score

17.0 ± 6.4

15.7 ± 6.5

14.4 ± 5.6

0.09

0.77

0.09

Negative score

22.0 ± 7.7

21.2 ± 7.4

20.7 ± 8.1

0.66

1.00

1.00

1.00

General psychopathology score

40.6 ± 10.0

36.5 ± 9.2

34.3 ± 10.0

\10-2

0.07

\10-2

0.34

Total score

79.6 ± 18.7

74.5 ± 16.3

68.2 ± 16.5

0.01

0.50

0.01

0.09

EGF

48.0 ± 15.4

53.3 ± 16.0

56.2 ± 16.2

0.03

0.22

0.03

0.63

4.1 ± 3.9

2.9 ± 3.7

1.4 ± 2.3

\10-2

0.15

\10-2

\10-2

30.6 ± 12.2

51.7 ± 13.4

73.9 ± 11.3

\10-2

\10-2

\10-2

\10-2

48.8 ± 22.9

57.5 ± 19.7

70.0 ± 16.4

\10-2

0.11

\10-2

\10-2

3.2 ± 1.7

4.2 ± 1.3

5.0 ± 1.0

\10-2

\10-2

\10-2

\10-2

Calgary score CDSS SQoL Index EuroQoL EVA QoLi SUBJ 1 SF-36 M ± SD

Fig. 1 .

1

4

1 = "low" 2 = "moderate" 3 = "high"

1

1 1

2

1

1

0

1

1

1

1 1 1

2

3

1 33 2

2

23

3

123

\10-2

\10-2

\10-2

0.11

\10-2

\10-2

\10-2

\10-2

RP

36.6 ± 37.3

40.4 ± 37.1

65.3 ± 33.9

\10-2

1.00

\10-2

\10-2

RE

24.4 ± 33.4

38.0 ± 41.3

59.8 ± 39.8

\10-2

0.18

\10-2

\10-2

MH

40.6 ± 19.1

54.3 ± 18.6

70.7 ± 15.8

\10-2

\10-2

\10-2

\10-2

Vi

34.6 ± 20.4

48.6 ± 18.6

59.7 ± 18.7

\10-2

\10-2

\10-2

\10-2

BP

58.8 ± 30.5

67.6 ± 24.3

74.2 ± 20.9

\10-2

0.15

\10-2

0.17

GH

38.7 ± 19.3

53.3 ± 21.4

67.9 ± 18.4

\10-2

\10-2

\10-2

\10-2

PCS

44.7 ± 11.0

47.8 ± 8.1

49.8 ± 6.4

0.01

0.12

\10-2

0.31

MCS

28.4 ± 10.7

35.9 ± 10.1

45.0 ± 9.8

\10-2

\10-2

\10-2

\10-2

3

3

3

3

1 2 1 1

12 1

1 2 2

2

2

1

2

2 12

0

First linear discriminant

Fig. 2 .

87.1 ± 17.2 67.9 ± 25.6

3

1

33 3 3 2 2 3 3 3 3 22 3 3 3 3 3 33 3 3 3 2 3 3 3 23 3 2 22 2 333 3 3 22 33 2 33333 3 3 3 2 22 3 3 3 3 3 2 3 3 3 3 3333 3 33 2 2 3 232 2 1 3 3 3333 33 333 2 2 2 1 1 3 3 3333 23 1 3 3 11 333 1 2 22 2 3 3 33333 3 2 2 32 3 1 3 3 2 3 33 3 2 3 2 1 12 2 2 3 222 2 2 1 11 1 1 2 2 2 2 2 22 2 222 3 3 3333 2 2 3 3 3 23 3 2 2 2 2 2 3 2 3 22 2 2 33 2222 33 33 2 22 3 3 2 1 3 2 2 11 3 33 2 22 2 2 22 3 1 2 22 22 2 3 2 2 22 2 2 2 2 22 2 2 2 2 2 22 2 22 33 2 2 2 2 22 2 2 2 22 2 2 2 2 22 2 22 222222 222 2 22 2 33 33 2 2 2 2 2 22222 22 2 322 3 2 22 2 3 2 33 3 2 2 2 2 2 2 2 2 2 2 22 2 2 2 2 2 2 2 2 2 22 2 2 2 2 2 2 22 2 2 2 2 2 22 2 22 2 2 2 2 2 22 2 222 2 2 2 2 22 2 2 2 22 2 22 2 22 2 22 2 2 2 2 2 2 11

1 1

1

1 11 1 1 1

−5

1 1

1 1 1 1 1 11 1 1 1 11 1 1

−2

Second linear discriminant

2 1 1

1

80.4 ± 22.9 52.9 ± 25.6

13

1 1

1

67.2 ± 30.0 32.6 ± 26.2

1

1 1

PF SF

(207.3) Low functional status as a predictor of incident emotional disorders: a population-based study

5

Gabriela Barbaglia Navarro, MD, MPH, IMIM (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Ron De Graaf, The Netherlands Institute of Mental Health and Addiction; Margeret Ten Have, The Netherlands Institute of Mental Health and Addiction; Saskia Van Dorsselaer, The Netherlands Institute of Mental Health and Addiction; Gemma Vilagut, MSc, IMIM (Hospital del Mar

Qual Life Res (2014) 23:1–184 Medical Research Institute); UPF, Barcelona, Spain; Jordi Alonso, MD PhD, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain AIMS: To examine the association between baseline functional status and the development of any emotional disorder at follow-up, after controlling for potential confounders. The effect modification of previous mental disorders and physical conditions on this relationship was assessed. METHODS: Data are from the Netherlands Mental Health Survey and Incidence Study (NEMESIS)-2, a representative population-based, 3-year longitudinal study completed in 2012. Individuals at risk for a new or a recurrent emotional disorder were selected at baseline (n = 4,574). 3-year incidence of any emotional disorder (depression, dysthymia, bipolar, panic, agoraphobia, social and simple phobia and generalized anxiety disorder), assessed with the Composite International Diagnostic Interview (CIDI) 3.0, was the outcome. Functional status at baseline was assessed with the Physical (PCS) and Mental Component Summary (MCS) of the SF-36 and with the number of disability days (WHO Disability Assessment Scale-II). An effect size = 0.8 was applied to define low PCS and MCS at baseline. Disability days were categorized (0, 1–7; 8–15:16–30 days). Multiple logistic regression models adjusting by socio-demographic characteristics were built. Interaction terms between previous mental disorders or physical conditions with the predictors were tested. RESULTS: At baseline, 12.1 % had low PCS score, 5.9 % had low MCS score and 30.3 % reported any disability days. 3-year incidence of emotional disorders was 9.1 %. Having low PCS score (aOR = 1.62) or reporting more than 15 disability days (aOR = 1.77) were significantly associated with an incident emotional disorders in the following three years. Having a previous mental disorder modified the relationship between MCS and incident emotional disorders. Among those with a low MCS score at baseline a previous mental disorder considerably increased the risk of developing an emotional disorder at follow-up (aOR = 2.67). CONCLUSIONS: Low functional status is an independent risk factor for developing emotional disorders in the general population. Appropriate identification followed by early intervention may contribute to reduce their associated burden. Rio Hortega-CM 10/00099; AGAUR 2009 SGR 1095

(207.4) Factors Associated with Quality of Life in Bipolar Disorder Sandro R P S Miguel, MD, Institute for Health Technology Assessment, Porto Alegre—Rio Grande Do Sul, Brazil; Luciane N. Cruz, MD, PhD, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; Mı´rian Cohen, Universidade Federal do Rio Grande do Sul; Jacques Zimmermann, MD MSc, Porto Alegre, Brazil; Marcelo P. Fleck, PhD, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil; Ana Fla´via B S Lima, Universidade Federal do Rio Grande do Sul AIMS: To assess relationship between bipolar symptoms and quality of life in a mood disorder (MD) Brazilian sample, after 8 weeks follow-up. METHODS: Subjects between 18 and 65 years old with current mood symptoms were selected. The patients were monitored every two weeks in an outpatient program. A standardized intervention to treat MD in the form of algorithms for mixed states and bipolar depression using drugs supplied by the Brazilian Unified Health System (SUS) was employed. Pearson’s Correlation and Multiple Linear Regression were performed to verify the relationship between the response to treatment and quality of life domains values and utility scores. Demographic, clinical characteristics, and response to treatment were assessed during this period, using the instruments: WHOQOL-BREF, SF-6D, Young Mania Rating Scale (YMRS), and Hamilton Depression Rating Scale (HMRS-D), along with non-standardized clinical and social-demographic questionnaire. RESULTS: Sample of 193 subjects, mean age of 42.98 (SD

47 11.57) years, female gender (79.3 %), married (50 %), mean age of 21.76 (SD 10.0) years at symptoms onset, mean time to start treatment of 11.98 (SD 8.84) years, and mean time to receive mood stabilizer of 16.64 (SD 11.0). Significant associations at baseline were found between HMRS-D and WHOOQOL-BREF physical domain (ß = -0,471, p \ 0.10); environmental domain values were associated with time to start treatment (ß = -0.621, p \ 0.10), time to start mood stabilizer (ß = 871, p \ 0.10), and HMRS-D (ß = -0.320, p \ 0.10). At 8 weeks of follow-up, significant association was observed between YMRS and overall (ß = -0.534, p \ 0.10), psychological (ß = -0.558, p \ 0.10), and environmental (ß = -0.718, p \ 0.10) WHOQOL-BREF domains. Moderate correlations were found between the overall domain (WHOQOL-BREF) and gender and marital status. CONCLUSIONS: Very few variables seem to be related to changes in quality of life scores for mood disorder patients sampled. The main finding is in this study is that time wasted prior to first adequate treatment is directly related to increased difficulties in obtaining positive changes in effectiveness and quality of life after treatment start. Analyzes of changes in quality of life related to social-demographics in mood disorder would be greatly benefited of larger scale studies.

(207.5) Patient Health Questionnaire 9 (PHQ-9) use in primary care clinical practice—Association with prescription of antidepressants and referral to behavioral health specialists Colleen M. Renier, BS, Essentia Institute of Rural Health, Duluth, MN, United States; Thomas E. Elliott, MD, HealthPartners Institute for Education and Research, Minneapolis, MN, United States; Jeanette A. Palcher, Essentia Institute of Rural Health AIMS: To evaluate the relationship between Patient Health Questionnaire9 (PHQ-9) assessment, demographic and diagnostic characteristics and initiated treatment, internal behavioral health referral (BHR) and prescription of antidepressant medications (ADRx), as documented in the electronic medical record (EMR) of a large health care system in the U.S. Upper Midwest. METHODS: This retrospective observational study used existing data in the health care system’s EMR from January 1, 2007 to December 31, 2011. All adult patients (age 18 or older) with at least one PHQ-9 assessment ordered by primary care, family practice or internal medicine, and at least two assessments overall were included. Study variables included all PHQ-9 data, patient demographics, depression diagnoses (ICD-9CM), and antidepressant medications. Generalized estimation equations (repeated measures) evaluated predictive models for BHR and ADRx. RESULTS: A total of 17,770 patients, 67.7 % female, mean age 48.0 years, were included in the analysis, with a maximum of 73 visits with PHQ-9 per patient. Rural patients (RUCA code 10) were significantly less likely to receive either BHR or ADRx [odds ratio (95 % C.I.)], 0.09 (0.05–0.18) and 0.52 (0.46–0.59), respectively (than metropolitan patients—RUCA code 1). Female patients were more likely to receive ADRx, 1.4 (1.3–1.6), but significantly less likely to receive BHR, 0.79 (0.68–0.93). Odds of ADRx decreased stepwise after 2008: 0.78 (0.69–0.87), 0.57 (0.50–0.64), and 0.43 (0.38–0.50) in 2009, 2010, and 2011, respectively, while, BHR increased steadily after 2007: 1.9 (1.4–2.4), 2.2 (1.7–29), 3.1 (2.4–4.0) and 3.7 (2.7–4.9) in 2008, 2009, 2010 and 2011, respectively. After adjusting for all of these covariates, as PHQ-9 depression level increased from mild = 5–9 to severe = 20?, odds of BHR demonstrated an increase from 1.7 (1.3–2.2) to 3.3 (2.363–4.504), with a similar increase in the odds of ADRx, from 1.4 (1.3–1.5) to 3.2 (2.8–3.7). Suicidal ideation, as identified by the PHQ-9, was also associated with increased odds of BHR and ADRx, 1.2 (1.02–1.5) and 1.2 (1.05–1.3), respectively. CONCLUSIONS: Many factors influence internal referral to behavioral health and prescription of antidepressant medications. Among patients with PHQ-9 assessments, the magnitude of PHQ-9 total score, as well as identification of suicidal ideation are strongly associated with these decision processes

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48 (207.6) Mindfulness and Health-Related Quality of Life Cynthia Gross, PhD, Univ of MN, Pharmacy & Nursing, Minneapolis, MN, United States; Maryanne Reilly-Spong, University of Minnesota; Olga Gurvich, University of Minnesota AIMS: Reviews suggest mindfulness training reduces symptoms and enhances QOL in persons with cancer, chronic medical conditions and psychological disorders, and clinical trials have shown efficacy for weight loss and smoking cessation. It is posited that mindfulness builds capacity to self-regulate behavior. Being open, aware and attentive, mindful people recognize unhealthy behaviors and more effectively gather and interpret factual information to attain positive health outcomes. However, little is known about how mindfulness is related to HRQOL. The aim of this analysis was to determine which aspects of HRQOL are related to mindfulness in a sample of patients with no training in mindfulness meditation. METHODS: Study subjects were kidney transplant candidates enrolled in a randomized trial to compare the impact of mindfulness training versus a support group on anxiety and other symptoms. The data for this paper were collected using paper and pencil questionnaires completed before randomization. Mindfulness was evaluated by the Mindful Attention Awareness Scale (MAAS). HRQOL measures were: physical and mental health (SF-12v2 PCS and MCS), ‘‘overall QOL’’ and ‘‘health in general’’ single-item ratings, kidney disease effects and burden (KDQOL subscales), anxiety (STAI), depression (CESD), sleep (PSQI), worry (PSWQ) and perceived stress (PSS14). RESULTS: 63 patients (27 men, 36 women; mean age 53, range 26 to 85 years) were entered into the trial and 59 completed the baseline questionnaires. Mindfulness was not associated with age, education, gender, race, employment, marital status, living arrangements, social support, body mass index, smoking or alcohol use. Mindfulness was not correlated with physical health, kidney disease effects or kidney disease burden (|r| \ 0.2, all), and correlations between mindfulness and overall QOL (r = 0.325, p = 0.012) and health in general items were weak (r = 0.236, p = 0.072). There were moderately strong (|r| [ 0.35), but not high (|r| [ 0.7) correlations between mindfulness and stress (r = -0.588), depression (r = -0.568), mental health (r = -0.530), worry (-0.464), anxiety (r = -0.416), and sleep problems (r = -0.387) (p \ 0.002, all). CONCLUSIONS: Findings suggest mindfulness is distinct from HRQOL, but related to mental health. Cross-sectional associations suggest that interventions to enhance mindfulness have potential to improve perceived stress and stressrelated symptoms including depression, worry, anxiety, poor sleep and overall mental health.(NIH/NIDDK P01DK013083)

208: Advancing Preference-Based Measurement Science (208.1) Construct validity of SF-6D health state utility values in an employed population Siyan Baxter, PhD Candidate, University of Tasmania, Hobart, Australia; Kristy Sanderson, University of Tasmania; Alison Venn, University of Tasmania; Petr Otahal, University of Tasmania; Andrew J. Palmer, University of Tasmania AIMS: A valid utility-based self-report measure is essential for evaluating health changes in employees. Health utility values permit cost utility analysis (CUA) to be performed, an analytical technique rarely utilized in economic evaluations of workplace health promotion (WHP). There is no validated health utility measure in working populations. Objective: To investigate the construct validity of SF-6D health utility instrument in a public service workforce. METHODS: The SF-12v2 Health Survey was administered to 3409 randomly selected public service employees in a state government in Australia in 2010. SF-12 scores were converted to SF-6D health utility values

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Qual Life Res (2014) 23:1–184 using Brazier’s algorithm. Utilities ranged from 0 to 1, with zero representing death and one representing perfect health. Associations with health, socio-demographic and work characteristics were explored using Spearman correlations. Linear regression was performed to identify correlates. Ceiling effects were analysed. For comparative purposes, normative SF-36v1 data from a general employed population and a subset of public servants were obtained from Release 11 of the Household, Income and Labour Dynamics in Australia (HILDA) survey (n = 11,234). All analyses were stratified by sex. RESULTS: Mean (SE) health utility was higher in males 0.794 (0.004, n = 927) than females 0.773 (0.003, n = 2,387). Health utility was negatively correlated with psychological distress (K10) (r = -0.69 females, r = -0.69 males), comorbidity count (r = -0.35 females, r = -0.28 males), and effort-reward imbalance (ERI) (r = -0.36 females, r = -0.33 males). SF-6D was independent of age, BMI and annual salary. Lower SF-6D was significantly associated (p \ 0.05) with higher comorbidities, K10, ERI, education (in females) and absenteeism, and lower physical activity (in females). The Australian normative mean (SE) SF-6D was 0.792 (0.002, n = 4,955) for males and 0.775 (0.003, n = 4,639) for females in the overall working population. Similar correlates and associations of SF-6D were seen in the normative sample and the subset of public servants. Health utility showed a significant inverse association with age and positive association with salary in the general employed. CONCLUSIONS: SF-6D health utilities differentiated between and associated as expected with key health, social and economic factors. These results validate the suitability of SF-6D health utility values to measure perceived health states in an employed population.

(208.2) Cross-Sectional Construct Validity of Five Generic Preference-Based Measures in Teens David Feeny, PhD, McMaster University, Hamilton, ON, Canada; Frances L. Lynch, The Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States; John Dickerson, The Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States; Gregory Clarke, The Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States; Alex MacMillan, The Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States AIMS: To examine the known-groups cross-sectional construct validity of five widely-used generic preference-based measures in teens with and without depression. METHODS: 392 teen members of Kaiser Permanente Northwest (KPNW) ages 13–17 were recruited. Professional mental health interviewers administered the following instruments at baseline (recruitment): the Child Depression Rating Scale-Revised (CDRS-R); the EuroQOL 3-level (EQ-5D); the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3); the Quality of Well Being Scale (QWB); the RAND-36 (used to generate ShortForm 6D (SF-6D) scores); and the Pediatric Quality of Life Inventory Version 4.0. Using CDRS-R scores as the criterion, 117 were classified as non-depressed; 106 as sub-threshold depressed; and 169 as full-threshold depressed (133 with mild to moderate depression; 36 with severe depression) [three main groups]. Mean scores were compared among the three main groups. Mean scores were also compared across the sub-threshold, mild to moderate depression, and severe depression groups [three clinical groups]. Relevant domain and single-attribute utility scores were also compared across the two sets of known groups. RESULTS: In general, differences in mean overall scores across the three main groups for the five preference-based measures were clinically important and statistically significant. HUI2 cognition, emotion, and pain scores, and HUI3 emotion, cognition, and pain scores also distinguished among the three main groups,

Qual Life Res (2014) 23:1–184 although the differences for pain for sub- versus full depression were not significant. RAND-36 mental health summary scores distinguished among the three main groups while RAND-36 pain scores discriminated between sub-threshold and full depression. Differences in overall mean scores for the five preference-based measures were clinically important and statistically significant for 8 of 10 comparisons among the three clinical groups. CONCLUSIONS: In general, the five preference-based measures performed well in non-depressed and depressed teens.

(208.3) Developing version 2 of the SF-6D: The health state classification system Brendan Mulhern, University of Sheffield, Sheffield, United Kingdom; John E. Brazier, PhD, Univ of Sheffield, Sheffield, United Kingdom AIMS: The SF-6D is a generic preference based measure developed from the SF-36/SF-12 (Brazier et al. 2002, 2004) for use in the economic evaluation of health interventions. Since then there have been concerns raised about the health state classification system relating to some of the items selected. Therefore the aim of this study is to develop a new version of the SF-6D classification system using items from the SF-36v2. METHODS: The dimensionality of the SF-36 was reassessed using both exploratory and confirmatory factor analysis on two large datasets (n = 48,777; 4,384) from four countries. Classical psychometric, Rasch and Item Response Theory techniques were applied to 14 different dimension combinations to select items for the classification system. To select items we used item fit, item severity coverage and position on the underlying latent scale as key criteria. All items included in the SF-36 (except the general health dimension) were available for selection, and were not restricted to those that also appear in the SF-12. RESULTS: A six dimension structure of physical functioning, role functioning, mental health, social functioning, pain and vitality dimensions was retained. Items were selected from the SF-36 to represent each domain, with ten used in total. The main changes with version one are the use of a negatively worded vitality item, the simplification of the role and pain dimensions, and a change in the wording of the items used for the mental health dimension. SF-36 v2 wording is used throughout. CONCLUSIONS: Revisiting the SF-6D classification system using large international datasets has led to improvements in the wording used for a number of the six dimensions whilst retaining the same dimension structure. The next stage of this project is to carry out a valuation study to produce the utility tariff for use in the economic evaluation of health interventions.

(208.4) Comparison of an online survey and face-to-face interviews for eliciting societal preferences Donna Rowen, PhD, University of Sheffield, Sheffield, United Kingdom; John E. Brazier, PhD, Univ of Sheffield, Sheffield, United Kingdom; Anju Keetharuth, University of Sheffield, Sheffield, United Kingdom; Aki Tsuchiya, School of Health and Related Research, University of Sheffield; Angela Robinson, University of East Anglia; Clara Mukuria, PhD, University of Sheffield, Sheffield, United Kingdom AIMS: This study explores the impact of mode of administration and framing on a survey for a new framework designed to elicit societal preferences for characteristics deemed as important for Value-Based Pricing: burden of illness (BOI), therapeutic improvement (TI) and end of life (EOL). METHODS: A 6-arm pairwise comparison survey was conducted involving three different framings of questions, and each were administered using both

49 face-to-face interviews and online. Respondents were asked which of two groups they thought the NHS (National Health Service) should treat, where the two groups varied in terms of four attributes: life expectancy without treatment, health-related quality of life (HRQOL) without treatment, survival gain from treatment and HRQOL gain from treatment. The framing differed by: the inclusion or exclusion of pictures to accompany the descriptions of the alternatives, stating the levels of the attributes with and without treatment or stating the change in the attributes, the labeling of the no treatment, treatment and expected health profiles, and the labeling of the groups. Respondents were also asked questions on their general attitudes for prioritizing patients for treatment. Responses across arms were compared using Fischer’s Exact test. Probit regression analysis was used to assess the impact of mode of administration and framing on the pairwise comparison responses whilst controlling for the underlying attitudes and socio-demographics of respondents. RESULTS: The sample contains 371 respondents, 69 were interviewed and 302 completed the questionnaire online. There was little difference in responses across the different modes of administration and questionnaire framing. Whilst there were a small number of statistically significant differences in responses, there was no clear pattern indicating any systematic differences. In the regression analyses mode of administration and framing variables were mainly insignificant after controlling for the socio-demographic characteristics of respondents and their underlying attitudes. CONCLUSIONS: The online and interviewer modes of administration were found to be feasible with similar self-reported difficulty of understanding the questions. Responses were generally similar across the different modes of administration and questionnaire framing. The results were used to inform a large follow-on study to elicit societal preferences and QALY weights for BOI, EOL and TI.

(208.5) Does Weighting matter? Comparing Unweighted vs. Weighted Values in Two Health State Utility Instruments (EQ-5D-5L and 15D) Admassu Nadew Lamu, University of Tromsø, Tromsø, Norway; Thor Gamst-Klaussen, University of Tromsø; Jeff Richardson, University of Monash; Jan Abel Olsen, PhD, University of Tromso, Tromso, Norway AIMS: Health state utility (HSU) instruments use weighted tariffs, subjective well-being (SWL) instruments do not. The objective of this paper is to investigate whether the use of weights make any real difference when computing scores byHSU instruments using EQ-5D5L and 15D tariff. METHODS: Descriptive statistics are derived using data collected from a representative healthy cohort and from patients in seven clinical areas from six countries (n = 7,933). We consider the most widely used and least fine-graded instrument (EQ5D-5L with 3,125 combinations), and the most fine-graded instrument (15D with 30 billion combinations). We test for differences between weighted and unweighted scores for each instrument across two disease groups: depression (mental health) vs. arthritis (physical health).For comparisons over the ranges of utility values where most respondents are found ([ 0.5 on EQ-5D and [ 0.7 on 15D), we explore the extents to which the variation in the slopes differ much when using unweighted values as compared to the weighted tariffs. RESULTS: The association between unweighted and weighted EQ5D-5L scores (Pearson’s r = 0.95) and the association between their ranks (? = 0.98) is very high. These values are extremely high in the case of 15D scores (? = r = 0.99), indicating almost perfect linearity between the two values. Close examination of variations in the slopes

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50 reveal similar results. The slopes of unweighted and weighted 15D scores are nearly the same for the total scores as well as for each disease group. The weighted and unweighted EQ-5D slopes are nearly parallel for most respondents except for few of the extreme health sates. Thus, weighting doesn’t improve the performance of HSU instruments. In instruments with many dimensions, such as 15D,there is negligible difference between unweighted values and the weighted tariffs. CONCLUSIONS: This paper demonstrates that HSU instruments with greater dimensions show no difference between unweighted and weighted tariffs. Therefore, major attention should be given to instrument descriptive system rather than the improvement of sophisticated algorithms for fine-graded instruments like 15D (Figs. 1, 2, 3; Tables 1, 2).

Qual Life Res (2014) 23:1–184 Scatter plot for EQ5D (weighted on unweighted) 1

.5

0

-.5 0

.2

.4

.6

.8

1

EQ5D_unweighted

EQ5D_score

Fitted values

Scatter plot: Prediction of 15D scores on 15D_unweighted 1

.8

.6

.4

.2 .2

.4

.6

.8

1

Unweighted_15D 15D Utility Score

Fig. 1 Slope of weighted vs. unweighted EQ-5D-5L scores. NB: Similar results obtained for depression and arthritis

Fitted values

Fig. 3 These scatter plot also shows the degree of association between weighted and unweighted scores: the extent to which the points fall along a line

Table 1 Association between weighted and unweighted scores (15D and EQ-5D) Pearson’s correlation EQ5D_W

EQ5D_W

EQ5D_U

0.9465

1.0000

0.8163

0.8598

1.0000

15D_U

0.8224

0.8579

0.9891

EQ5D_U

15D_W

15D_U

0.9787

1.0000

1.0000

0.8250

0.8484

1.0000

0.8179

0.8452

0.9861

1.0000

Summary statistics of 15D and EQ-5D EQ5D weighted score EQD weighted score Valid

7,933

Missing 0

123

EQ5D_W

1.0000

EQ5D_U

N

15D_U

1.0000

15D_W

Table 2

Fig. 2 Slope of weighted vs. unweighted overall 15D scores. Note that the weighted and unweighed line overlap in the case of depression and arthritis also, this demonstrates that weighting is not important for instruments with many dimensions like 15D

Spearman’s rank correlation 15D_W

EQ5D 15D unweighted weighted score

15D VAS unweighted

Self TTO_Score

7,933

7,932

7,932

7,760

7,932

0

1

1

173

1

0.6735 0.7898

Mean

0.73959

0.8433

0.8522

0.8536

Median

0.76800

0.9000

0.8839

0.8833

0.7500 0.9750

SD

0.2246

0.1598

0.12634

0.1224

0.2154 0.3195

Minimum

-0.5100

0.0500

0.2500

0.2500

0.000

0.000

Qual Life Res (2014) 23:1–184

51 assessment) and the establishment of patient-oriented guidelines. (157132011/14)

Table 2 continued EQD weighted score

EQ5D 15D unweighted weighted score

15D VAS unweighted

Self TTO_Score

Maximum

1.000

1.000

1.000

1.000

1.000

1.000

Percentiles 10

0.42600

0.6000

0.6675

0.6833

0.3500 0.1500

20

0.63400

0.7500

0.7523

0.7500

0.5000 0.6500

30

0.70600

0.8000

0.8070

0.8167

0.6000 0.7500

40

0.74000

0.8500

0.8489

0.8500

0.7000 0.9000

50

0.76800

0.9000

0.8839

0.8833

0.7500 0.9750

60

0.83700

0.9000

0.9133

0.9167

0.7500 0.9750

70

0.83700

0.9500

0.9402

0.9333

0.8000 0.9900

80

0.87900

0.9500

0.9631

0.9667

0.8500 0.9900

90

1.0000

1.000

0.9860

0.9833

0.9000 0.9900

There is no significant difference between the weighted and unweighted scores for 15D instrument, which might imply that weighting play negligible role for health state utility instruments with many dimensions

(208.6) HYE and ME as identical currencies in preference studies? A Discrete-Choice Experiment in Type-II-Diabetes Axel C. Muehlbacher, Hochschule Neubrandenburg, Neubrandenburg, Germany; Susanne Bethge, Hochschule Neubrandenburg, Neubrandenburg, Germany AIMS: Aim of the empirical study is the evaluation of patients’ preferences for different characteristics of treatment in Type-II-Diabetes, as well as the influence of those criteria on the patient benefit. As Type-II-Diabetes treatment asks for strict adherence, patient’s needs and preferences should be displayed. By separating the decision model and including a) healthy life years equivalents (HYE) or b) money equivalents (ME) it should be derived if both lead to similar preference patterns and allow answering the question: Can HYE or ME both serve as ‘‘currency’’ for patients? METHODS: Based on a qualitative and quantitative pre-study a discrete choice experiment (DCE) was applied to identify patient preferences. The DCE was separated into two versions. Apart from six identical (adjustment of HbA1c, prevention of hypoglycemia, risk of genital infection, risk of gastrointestinal problems, risk of urinary tract infection and weight change) a continuous variable either Healthy life years equivalents or money equivalents was included. The DCE was conducted using a fractional factorial design and the statistical data analysis used random effect logit models (Stata, xtlogit and gllamm). RESULTS: In total N = 626 type-II-Diabetes patients participated in the survey. The estimation revealed a clear dominance for ,,prevention of hypoglycemia‘‘(coef.year: 0.937; coef.€: 0.847) and ,,adjustment of HbA1c‘‘(coef.year: 0.541; coef.€: 0.649). The side effects ,,risk of genital infection‘‘(coef.year: 0.301; coef.€: 0.416), ,,risk of gastrointestinal problems‘‘(coef.year: 0.296; coef.€: 0.408) and ,,risk of urinary tract infection ‘‘(coef.year: 0.241; coef.€: 0.355) joined in. Possible ,,weight change‘‘(coef.year: 0.047; coef.€: 0.067) was of less importance to the patients in this evaluation. The attributes ,,additional healthy life years‘‘(coef.: 0.458) or ,,additional cost‘‘(coef.: 0.420) were in the middle and equally located. CONCLUSIONS: The results shed light on how much a decision criterion affects the treatment decision from the perspective of the patient. HEY and ME led to comparable preference patterns, both can be discussed as summary measures of health outcome, which incorporates the impact of the attributes on patients decision. The preference data can be used for approval (risk–benefit assessment), reimbursement (cost-benefit

209: Adapting Measures Across Languages and Cultures (209.1) Linguistic validation of the Spanish translation of the U.S. National Cancer Institute’s Patient- Reported Outcomes version of the Common Terminology Criteria for Adverse Events Benjamin J. Arnold, MA, FACITtrans, Elmhurst, IL, United States; Sandra A. Mitchell, PhD CRNP AOCN, National Cancer Institute, Bethesda, MD, United States; Lauren Lent, DHA, MS, FACIT.org and FACITtrans, Elmhurst, IL, United States; Tito R. Mendoza, PhD, Univ. of Texas M.D. Anderson Cancer Ctr., Houston, TX, United States; Lauren Rogak, MA, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Natalie Barragan, Memorial SloanKettering Cancer Center, New York, NY, United States; Gordon B. Willis, National Cancer Institute; Mauricio Medina, National Cancer Institute; Suzanne C. Lechner, University of Miami, Miami, FL, United States; Jay Harness, St. Joseph Hospital of Orange; Ethan Basch, MD MSc, University of North Carolina—Chapel Hill, Chapel Hill, NC, United States AIMS: The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system to elicit the presence, frequency, severity, and functional interference caused by 78 symptomatic treatment toxicities. Developed and validated in English, PRO-CTCAE items permit patients on cancer treatment trials to self-report symptomatic adverse events. A harmonized Spanish translation expands the access of PRO-CTCAE. The objectives of this study were to develop the Spanish version of the PRO-CTCAE, and to conduct a linguistic validation in a heterogeneous US sample of Spanish-speakers undergoing cancer treatment. METHODS: PRO-CTCAE was translated using double-back translation methods, and cognitive interviews were conducted in Spanish by trained bilingual interviewers. Spanish-speakers who were currently undergoing treatment were recruited from five cancer treatment facilities in the US (see Table 1). Maximum variation sampling was used to ensure balanced recruitment with respect to factors such as country of origin, educational attainment and gender. Participants completed PRO-CTCAE items and were debriefed about response options and terminologies that were difficult to understand; they were also asked to explain the meaning of symptom terms in their own words. Based on continuous content analysis, refinements to the translations were made after the first round of interviews (n = 77), and were retested in a second round (n = 24). RESULTS: During the first round, seven symptom terms were flagged as problematic. Alternatives for five symptom terms (hot flashes, skin cracking, sweating, loose stools, and unhappy feelings) were identified; the original translation of two symptom terms (control of bowel movements and anxiety) was retained. For these seven symptom terms, convergence around phrasing that was both culturally acceptable and semantically comprehensible was achieved in the second round of interviewing. Across the two rounds, statements from participants describing the meaning of the PRO-CTCAE terms support conceptual equivalency to the English version. CONCLUSIONS: These qualitative data offer evidence of the linguistic and cultural equivalence of the Spanish translation of the PRO-CTCAE. Results provide a foundation for quantitative validation studies, and support the use of PRO-CTCAE to assess symptomatic toxicities in cancer clinical trials that include Spanish-speakers. (PRO-CTCAE NCI funding support: Contract HHSN26120100 0063C)

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52

Qual Life Res (2014) 23:1–184

Table 1 . Characteristics

Pooled (N = 107)

Round 1 Round 2 (N = 77) (N = 30)

Age in year (SD) (range)

58 (± 13) (23–82))

55 (± 12) (29–79))

65 (± 12) (23–82))

n (%)

n (%)

n (%)

51 (48 %)

34 (44 %)

17 (58 %)

B High school

59 (55 %)

39 (51 %)

20 (67 %)

[ High school

48 (45 %)

38 (49 %)

10 (33 %)

Less acculturated

99 (92 %)

71 (92 %)

28 (93 %)

More acculturated

8 (8 %)

6 (8 %)

2 (7 %)

Gender Male Education

Acculturation*

Region of Birth**

of answer scales in LIBRAS; 3. the translation by a bilingual group; 4. the reconciling version; 5. the first retrotranslation; 6. the LIBRAS’ version production to be provided to focal groups; 7. the making of the focal groups; 8. the review by a monolingual group; 9. the review by the bilingual group; 10. the syntactic/semantic analysis and second retrotranslation; 11. the retrotranslation’s reevaluation by the bilingual group; 12. the final version’s studio video making for the software; 13. the software’s development of the WHOQOL-BREF and WHOQOL-DIS instruments in LIBRAS’ version. RESULTS: Particular traits of the deaf showed the need of adaptations in the focal groups’ applied methodology when composed by deaf people who communicate through sign language. To measure this population’s life quality it is necessary to provide instruments translated and adapted to this population. In the end it was possible to build a WHOQOL-BREF and WHOQOL-DIS software in LIBRAS. CONCLUSIONS: The software containing the WHOQOL-BREF and the WHOQOL-DIS’ instruments in LIBRAS will empower the deaf to autonomously express themselves in terms of life quality, offering more precision to investigations aimed at the matters pertained to deaf people’s life quality. These instruments will partly integrate the World Health Organization’s life quality evaluation instruments.

Mexico and USA

42 (39)

34 (44)

8 (27)

Central and South America

34 (32)

19 (25)

15 (50)

Cuba, Domnican Republic 30 (28) and Puerto Rico

24 (31)

6 (20)

Europe

1 (1)

0 (0)

1 (3)

(209.3) At what point are existing translations considered to be outdated?

Breast

27 (25 %)

23 (30 %)

4 (13 %)

Lung/thyroid

14 (13 %)

7 (9 %)

7 (23 %)

Valeska C. Kantzer, Health Research Associates, Inc., Mountlake Terrace, WA, United States; Yulia Galperina, Health Research Associates, Inc.; Sarah Basse, Health Research Associates, Inc

Prostate

11 (10 %)

7 (9 %)

4 (13 %)

Colorectal

8 (8 %)

7 (9 %)

1 (3 %)

Cancer site

Lymphoma

7 (6 %)

6 (8 %)

1 (3 %)

Head and neck

6 (6 %)

6 (8 %)

0 (0 %)

Other

34 (32 %)

21 (27 %)

13 (43 %)

* Recommended cut–score of 2.99 (Wallen 2002) was applied to categorize respondents as less vs. more acculturated ** Central and South America includes Costa Rica, El Salvador, Honduras, Nicaragua, Argentina, Colombia, Ecuador, Peru, Uruguay, Venezuela

(209.2) Translation Methodology for Brazilian Sign Language of the WHOQOL-BREF and WHOQOL-DIS Life Quality Evaluation Instruments Adriana Ribeiro Freitas, Professora, Pontifı´cia Universidade Cato´lica de Goia´s, Goiaˆnia, Brazil; Neuma Chaveiro, Federal University of Goias, Goiaˆnia, Brazil; Soraya Bianca Reis Duarte, Ms, Instituto Federal de Educac¸a˜o, Cieˆncia e Tecnologia-IFG, Goiaˆnia, Brazil; Maria Alves Barbosa, PhD, Nursing Faculty of Federal University of Goias, Goiania, Brazil; Valeska C. Kantzer, Health Research Associates, Inc., Mountlake Terrace, WA, United States; Marcelo P. Fleck, PhD, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil AIMS: To present the translation methodology of the instruments (World Health Organization Quality of Life—Bref) and WHOQOLDIS (World Health Organization Quality of Life—Disability) for Libras—Brazilian Sign Language (LIBRAS) in order to investigate Brazilian deaf population’s life quality. METHODS: WHO’s proposed methodology was used, adapted to deaf population and in tune with the criteria established with Brazil’s WHOQOL Group, fulfilling 13 steps: 1. the LIFE QUALITY’s sign creation; 2. the development

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AIMS: Developers and translation vendors occasionally have to address the question of whether well established translations become outdated if they have been developed decades ago and utilize terminology that is not common anymore. Respondents may be unable to relate to those translations, which will potentially impact data collection due to misinterpretation of the intended meaning. In cases of ongoing data-collection, it may be valuable to have an understanding of the factors that make an update to the wording advisable and justified. METHODS: In cases where copyright holders and vendors received repeated requests to revise a long-standing existing translation of a PRO, an evaluation was done to take inventory of the types of issues that caused the apparent anachronism. This process involved at least two translation consultants who agreed upon a more appropriate translation. If no agreement was reached, a third translator was consulted. In some cases further testing of the revised concept with the target population was needed in order to ensure appropriateness of the revised concept. RESULTS: The three main categories of issues that led to apparent outdatedness were the following : a) general evolution of language: new spelling and grammar, formal versus informal you, etc.; b) advancement of technology: technology items referenced in a translation are no longer in use (e.g. using a telephone with a dial); c) New terminology or words: medical terms become more colloquial, new terminology to describe a disease or concept. In most cases where repeated requests to update a translation were made all parties agreed on the need to revise the translation. Outdated concepts and old technology were the most problematic, as they could prevent a respondent from being able to provide an accurate response. CONCLUSIONS: Repeated requests to update a translation should be further investigated by the copyright holder/developer of a PRO measure translation. A thorough review and revision process should be employed to determine if a translation must be updated. If updates are required a collaborative revision process should be applied to implement any updates without affecting the integrity of data already collected.

Qual Life Res (2014) 23:1–184 (209.4) Feasibility and application of the Infant Toddler Quality of Life TM (ITQOL) in a community-based sample of healthy infants in China Sheri Volger, MS, RD, Nestle´ Nutrition, King of Prussia, PA, United States; Nicholas P. Hays, Nestle´ Nutrition; Robert Northington, Nestle´ Nutrition; Meng Mao, Chengdu Women’s and Children’s Central Hospital; John Ge, Wyeth Nutritional (China) Company Ltd; Jeanne Landgraf, MA, HealthAct CHQ Inc., Boston, MA, United States AIMS: Despite the importance of assessing infant health-related quality of life (HRQOL), there are no such instruments with robust measurement properties designed for use among Chinese infants. This study evaluated the feasibility and psychometric properties of the ITQOL, as a proxy measure of HRQOL in a community-based sample of healthy Chinese infants. METHODS: Mothers (n = 427) of healthy infants participated in a multi-center observational study in China. Linguistically validated translations of the ITQOL, SF-12v2 Health Survey and Infant Gastrointestinal Symptom Questionnaire (IGSQ) were completed at infant ages 42 and 90 days. Response rates, missing item analyses, and floor/ceiling effects were examined to assess ITQOL feasibility. Internal consistency and discriminant validity were assessed. RESULTS: The ITQOL was easily administered, and completed without difficulty by mothers (mean age [SD] 29.5 [3.8] years; infant mean age at enrollment 42.3 [3.5] days), with high response rates at infant ages 42 (100 %) and 90 (97 %) days. The percentage of missing items was \ 1 % for all ITQOL scales except, as expected physical abilities. Due to the skew, homogeneity and health of infant/mother pairs, floor/ceiling effects were examined at minimum and maximum values. Expectedly, ceiling effects were highest for Bodily Pain (65 %, 68 %) and Physical Abilities (48 %, 51 %). Moderate ceiling effects (22–34 %) were seen for all Parent/Family-centered concepts at ages 42 and 90 days. Internal consistencies were acceptable with all Cronbach’s a [ 0.70 except for General Health Perceptions (a = 0.67) at age 42 days. Discriminant validity was confirmed with moderate-to-strong positive Spearman’s correlation coefficients between Parent/Family-centered scales and the SF-12 Mental Health Summary Component at ages 42 and 90 days (0.29 to 0.49; all p \ 0.0001). A moderate positive relationship was observed between Parental impacttime and the SF-12 Physical Component Summary (0.36; p \ 0.0001); and all Parent/Family-centered scales and the SF-12 General Health scale (0.31–0.46; all p \ 0.0001) at age 90 days. Moderate correlations were observed between higher Growth and Development and Bodily Pain/ Discomfort scores and lower (better) IGSQ scores (-0.30; -0.34, p \ 0.0001) at 42 days. CONCLUSIONS: The ITQOL performed well in a community-based sample of healthy, Chinese infants with adequate psychometric properties and is a useful proxy HRQOL tool for use in China.

(209.5) Cross-Cultural Adaptation of a Health Measure for Me´tis Children and Youth Tara Paquette, Laurentian University, Greater Sudbury, ON, Canada; Jessica Boulard, Laurentian University, Greater Sudbury, ON, Canada; Annie Roy-Charland, Laurentian University, Greater Sudbury, ON, Canada; Nancy L. Young, PhD, Laurentian University, Sudbury, ON, Canada AIMS: To assess the appropriateness of the Aboriginal Children’s Health and Well-being Measure (ACHWM) for use with Me´tis children and youth in Northern Ontario. This population experiences poor health outcomes, despite living in a country known for good health outcomes. There is a lack of culturally appropriate measures for this population. This research is the first step towards a better understanding of their health to guide services. METHODS: The ACHWM is comprised of 58-multiple choice health and wellness-related

53 questions relevant to Aboriginal children. This questionnaire was translated into French for the Me´tis population, then back-translated. Afterwards, the discrepancies were adjudicated into a final accepted version. This French version was implemented in a detailed interviewing process with six self-identified Me´tis children and three parents. Detailed records were kept of the aspects of each question that the children had difficulty comprehending or reading. These results were analysed using a mix of quantitative and qualitative analyses to assess the effectiveness of the translation and the cultural relevance of the measure to Me´tis children. RESULTS: The iterative translation process resulted in a French translation that was generally well understood: Mesure de la sante´ et du bien-eˆtre des enfants autochtones. During the cognitive debriefing process, participants reported difficulty in understanding words typically related to Aboriginal culture. We were unable to identify effective alternatives to improve the cultural fit. This suggested the possibility that Me´tis children may identify more strongly with their Francophone cultural identity dominance. We explored this through an additional stage, in which participants completed questionnaires to assess to their integration into Francophone, Aboriginal, and Anglophone cultures. This supplementary data revealed that the children felt more integrated to the Francophone culture and the dominant Anglophone culture than to their Aboriginal culture. CONCLUSIONS: The translation process was successful in creating a French version. However, we later learned that the health of Me´tis children might be better reflected by typical western measures. This was an unexpected result, but may open doors to assessing the health of Me´tis children in Northern Ontario. The results underscore the importance of detailed qualitative methods to assess the cultural relevance of translated measures.

210: Advancing PROs: Patient-Centered Outcomes Research (210.1) Patient involvement in the development of Patientreported Outcome Measures: A literature review Bianca Wiering, TRANZO, Tiburg University, Tilburg, Netherlands; Dolf De Boer, NIVEL, Utrecht, Netherlands; Diana Delnoij, TRANZO, Tiburg University, Tilburg, Netherlands AIMS: Patient-reported outcome measures (PROMs) measure patients’ perspectives on health outcomes and are increasingly used in health care. To really capture the patient’s perspective it is essential that patients are involved in PROM development. The present paper reviews in what ways and to what extent patients are involved in the development of PROMs. Furthermore, this review also investigates whether patient involvement in PROM development has increased with time. METHODS: Literature was searched in PubMed using the mesh terms ‘‘Outcome Assessment (Health Care)/methods’’ and ‘‘Questionnaires’’. Studies were included if they described the development of a new PROM. Studies describing translations or alterations of PROMs were checked for references to original PROM development studies. Information was recorded about the author, publication year, the health problem, the health outcome measured, whether the health outcome was measured as an outcome of surgery, whether patients were involved in determining the health outcome measured, whether focus groups or interviews with patients were used as part of the item development and whether cognitive interviews were used. RESULTS: 95 studies, describing the development of 94 PROMs, were included. In the development of 29 PROMs no patients were involved. In most of the remaining PROMs focus groups or interviews were used for generating items. Cognitive interviews were less common, but still frequently used. Patients were least involved in determining which health outcomes should be measured. Patient involvement does not appear to have increased with time, as 7 out of 29 studies with a publication date before 2005 did not involve patients, while 22 out of 65 studies with a publication date of 2005

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54 and later did not involve patients. CONCLUSIONS: Although patient involvement in the development of PROMs is considered essential to develop valid patient-centered PROMs, patients are still not always involved. When patients are involved, their level of involvement varies considerably. While some PROMs are only checked for comprehensibility, other PROMs are developed with patient input from start to finish. These variations in involvement suggest that further attention to building and/or disseminating consensus on requirements for patient involvement in the development of PROMs is necessary.

(210.2) Conversion mixed design: a promising Mixed Methods Research approach to Patient-Centered Outcome questions in Clinical Research Fatoumata Fofana, Mapi; University of Nantes, Lyon, France; Ange´lique Bonnaud-Antignac, University of Nantes; Alexia Marrel, Mapi; Antoine Regnault, PhD, Mapi HEOR &Strategic Market Access, Lyon, France AIMS: Mixed methods research involves the methodical mixture of qualitative and quantitative approaches in a research process. This research paradigm may be the methodological solution to address many patient-centric clinical research questions using the extremely rich information on patients’ experience with their disease and treatment from patient interviews. Our objective is to illustrate how a mixed methods research design can be applied to patient-centered outcomes related research questions. More specifically, we investigated how a conversion mixed design approach can support with the formalization of concept elicitation from patient interviews, the demonstration of content validity of a PRO instrument or the determination of patient profiles. METHODS: Our approach is a conversion mixed design conducted using data from qualitative research studies involving exploratory or semi-structured interviews. In this setting, data collected during the interviews are coded by qualitative researchers. This coding is an analytic process to derive a list of concepts that have been elicited by the interviewees during their interview. Our approach consists in analyzing qualitative data using statistical tools. Different statistical techniques can be applied to these data, depending on the final objective of the research. For example, Partial-Least Square analysis regression is a method of choice to analyze quantitized data from qualitative studies. RESULTS: In a first example, a Partial-Least Square analysis was applied to a series of 12 nurse interviews on the impact of Clostridium difficile infection (CDI) on their work. It allowed the saturation to be documented and a better characterization of the elicited concepts. In a second illustrative example, the approach was applied to interviews of patients with gas-related symptoms and again allowed a better understanding and structuration of the concepts of importance for the patients. CONCLUSIONS: The conversion mixed design approach has shown great potential to address patient-centric questions in a clinical research setting. In particular, our research showed how a quantitative approach could capture highly variable and complex qualitative data and could provide clear and robust findings. Further research is still needed to explore this approach in other contexts.

(210.3) Evaluation of the patient-reported outcome (PRO) content of clinical trial protocols Derek Kyte, MSc, University of Birmingham, Birmingham, United Kingdom; Helen Duffy, University of Birmingham, United Kingdom; Benjamin Fletcher, University of Oxford, Oxford, United Kingdom; Adrian Gheorghe, University of Birmingham; Rebecca L. MerciecaBebber, The University of Sydney, University of Sydney, Camperdown, Australia; Madeleine T. King, PhD, Psycho-oncology Cooperative Research Group (PoCoG), Sydney, Australia; Heather Draper, University of Birmingham, Birmingham, United Kingdom;

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Qual Life Res (2014) 23:1–184 Jonathan CS Ives, PhD, The University of Birmingham, Birmingham, United Kingdom; Michael Brundage, MD, Queen’s University, Kingston, ON, Canada; Jane Blazeby, MD, University of Bristol, Bristol, United Kingdom; Melanie Calvert, PhD, University of Birmingham, Birmingham, United Kingdom AIMS: Qualitative evidence suggests that patient-reported outcome (PRO) information is frequently omitted from clinical trial protocols, leading to inconsistent PRO data collection and risking bias. Direct evidence regarding the extent and nature of PRO trial protocol content is lacking. We therefore aimed to systematically review the PRO-specific content of clinical trial protocols. METHODS: We conducted an electronic search of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme database (inception to August 2013). NIHR-HTA protocols were included if they described a randomized controlled trial that included a primary or secondary PRO (as judged by agreement between two independent investigators). A third reviewer was involved in the event of disagreement. Two investigators independently reviewed the content of each protocol, extracting data using a specially developed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) Checklist. Disagreements were resolved through discussion with a third investigator. RESULTS: The 75 most recent HTA trial protocols including a PRO primary/secondary outcome were evaluated. Protocols included a mean of 63 % (n = 32, range 4–18, SD 3.56) SPIRIT items and 33 % PRO checklist items (n = 11, range 16–41, SD 5.62). Over half (61 %) of the included PRO items were incomplete. Trials with a primary PRO endpoint generally included more PRO checklist items in their protocols, but standards were still poor (mean 43 %). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. CONCLUSIONS: The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/ hypothesis, data collection methods, training and management was often incomplete or missing completely. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings also suggest a number of PRO protocol checklist items are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols.

(210.4) Patient-Reported Outcomes In Randomized Controlled Trials of Colorectal Cancer treatment. Methodological Quality and Impact on Clinical-Decision-Making Jonathan R. Rees, MSc PhD FRCS, University of Bristol, Clifton, United Kingdom; Katie Whale, University of Bristol; Daniel Fish, Memorial Sloan Kettering Cancer Centre, New York, NY, United States; Peter Fayers, PhD, University of Aberdeen, Aberdeen, United Kingdom; Valentina Cafaro, GIMEMA, Rome, Italy; Andrea Pusic, MD MHS FRCSC, Memorial Sloan Kettering Cancer Ctr, New York, NY, United States; Jane Blazeby, MD, University of Bristol, Bristol, United Kingdom; Fabio Efficace, PhD, Italian Group for Adult Hematologic Diseases, GIMEMA, Rome, Italy AIMS: Treatments for colorectal cancer (CRC) include surgery, chemotherapy ± radiotherapy. These have major impacts on patients’ wellbeing due to effects on gastrointestinal, genitourinary, sexual and psycho-social function. Randomised controlled trials (RCTs) are the most robust study design measuring outcomes of CRC treatments, but for results to influence practice high quality patient-reported outcome (PRO) trial design is necessary. This work assessed the quality of PRO assessment of CRC therapy RCTs, examined the impact of these studies on clinical decision making and assessed if methodological quality

Qual Life Res (2014) 23:1–184 improved over time. METHODS: A systematic review from January 2004 to March 2012 identified RCTs of CRC treatment reporting PROs and clinical outcomes. Relevant abstracts were screened and data extracted from eligible trials to an online form. RCT characteristics were recorded and differences in outcomes between trial groups identified. PRO methodological quality were assessed using the ISOQOL standards for PRO reporting in RCTs[1], RCTs reporting at least two-thirds of the ISOQOL standards were classified as high-quality. Changes in reporting quality were established by comparison with previous systematic review[2]. Risk of bias was assessed using the Cochrane tool. RESULTS: 66 RCTs were identified. PROs were primary endpoints in 12 studies (18 %) and a secondary endpoint in 44 trials. 25 (38 %) studies were international and 32 (49 %) industry supported. Seven studies (10 %) reported survival benefit favouring the experimental treatment, whilst 35 trials (53 %) identified a significant difference in PROs between treatment groups. The clinical significance of PROs was discussed in 19 studies (29 %). Improvements in the documentation and handling of missing data and the clinical significance of PROs occurred over time. Thirteen trials (20 %) had high-quality reporting of PROs and two (3 %) high-quality studies had consistently low-risk of bias. CONCLUSIONS: A fifth of RCTs are likely to inform patients and clinicians regarding the effects of CRC treatments on PROs, however only two studies with low risk of bias will be fully informative. Poor quality reporting mean conclusions from most eligible RCTs are unreliable and won’t inform clinical practice. To improve the quality, relevance and utility of RCTs, trial protocols should adhere closely to the SPIRIT recommendations and study reports must follow the CONSORT statement including its PRO extension. References 1. Brundage, M., et al., Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards. Qual Life Res, 2013. 22(6): p. 1161–75. 2. Efficace, F., et al., Methodological issues in assessing healthrelated quality of life of colorectal cancer patients in randomised controlled trials. Eur J Cancer, 2004. 40(2): p. 187–197.

(210.5) Methodological Quality of Patient-Reported Outcomes (PROs) In Breast Cancer Trials According to the CONSORT PRO Extension: Evidence from 122 Trials enrolling over 8,300 patients Fabio Efficace, PhD, Italian Group for Adult Hematologic Diseases, GIMEMA, Rome, Italy; Yeliz Cemal, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Andrea Pusic, MD MHS FRCSC, Memorial Sloan Kettering Cancer Ctr, New York, NY, United States; Peter Fayers, PhD, University of Aberdeen, Aberdeen, United Kingdom; Alfonso Piciocchi, GIMEMA Data Center, Rome, Italy; Jonathan R. Rees, MSc PhD FRCS, University of Bristol, Clifton, United Kingdom; Jane Blazeby, MD, University of Bristol, Bristol, United Kingdom AIMS: To investigate the methodological quality of Patient-Reported Outcomes (PROs) in randomized controlled trials (RCTs) of breast cancer. METHODS: A systematic review performed between 2004 and 2012 in Pub Med and the Cochrane Controlled Trials Register identified RCTs of breast cancer that included PRO as an endpoint and enrolled, overall, at least 50 patients. Each study was evaluated by two independent reviewers to avoid any risk of convergence in data extraction. Methodological criteria were assessed using the recently published CONSORT PRO Extension (Calvert et al. 2013). Clinical endpoints and PROs were systematically analyzed to evaluate consistency and relevance for supporting decision-making to aid in the planning of future medical treatments. RESULTS: A total of 122 RCTs, enrolling overall 83,312 patients, were identified. A PRO

55 was a primary endpoint in 38 (31 %) of these studies. Out of all the RCTs identified, 52 (42 %) were conducted on an international basis and 57 (46 %) were industry supported. Overall survival difference, favouring the experimental treatment, was found in 13 (11 %) RCTs while a PRO difference between treatment arms was found in 60 % of studies. PRO was identified as an outcome in the abstract in 88 (71 %) of the studies and PRO hypothesis was reported in 11 RCT (9 %). The mode of administration of the PRO tool and the methods of collecting data were described in 35 (28 %) of the studies. Ninety-one studies 91 (74 %) used validated PRO instruments but only 19 RCTs (15 %) documented statistical approaches for dealing with missing data. The limitations of the PRO components of the trial was discussed in 38 (31 %) of the studies and generalizability issues, uniquely related to the PRO results, were discussed in 28 (23 %) of RCTs. CONCLUSIONS: The recently published CONSORT PRO extension aims to bridge the gap between PRO-trial based outcomes and clinical practice and we provide state of the art evidence based data on current levels of reporting in breast cancer RCTs.

(210.6) Routine Clinical Quality of Life Measurement for Head and Neck Cancer Patients: Example from a Province-wide Oncology Initiative Jolie Ringash, MD, The Princess Margaret Cancer Centre, Toronto, ON, Canada; Alyssa Macedo, The Princess Margaret Cancer Centre, Toronto, ON, Canada; Madeline Li, The Princess Margaret Cancer Centre and The University of Toronto, Toronto, ON, Canada; Terri Stuart-McEwan, The Princess Margaret Cancer Centre, Toronto, ON, Canada; Anita Archer, The Princess Margaret Cancer Centre, Toronto, ON, Canada; Andrew Hope, The Princess Margaret Cancer Centre and The University of Toronto, Toronto, ON, Canada; Brian O’Sullivan, The Princess Margaret Cancer Centre and the University of Toronto, Toronto, ON, Canada; John Waldron, The Princess Margaret Cancer Centre and The University of Toronto, Toronto, ON, Canada AIMS: Ontario (Canada) has led the integration of routine quality of life (QOL) measurement in oncology. We report our experience within the Head and Neck (H&N) Site at a large, quaternary care cancer centre. METHODS: An intelligently programmed electronic self-reported tool, the Distress Assessment and Response Tool (DART) became standard care for all ambulatory oncology patients at Princess Margaret (PM) in 2013. DART measures physical, emotional and practical concerns using validated instruments: Edmonton Symptom Assessment System Revised (ESASr), ECOG performance status, Social Difficulties Inventory, Patient Health Questionnaire-9 and Generalised Anxiety Disorder Assessment-7. H&N specific concerns were captured with the 28 item MD Anderson Symptom Inventory (MDASI-HN). Prior to each visit, patients were asked to complete DART at computer kiosks or on a paper version (ESAS/ECOG only). Personalized reports were printed and sent to the electronic medical record in real time. A change management campaign encouraged clinicians to review results and address concerns. Prevalence of symptoms, process (completion rates), satisfaction (surveys) and staff response (chart audits) were assessed. RESULTS: Over 2013–2014, PM led 14 cancer centres provincially in number of completions, achieving a 74 % rate (6410/8617, January 2014). H&N typically exceeded these rates. For January 2014, 98 % (848/866) of H&N patients completed DART, 52 % electronically and 48 % on paper, with at least one MDASI-HN in 123/866 (14 %). Across all cancer sites (n = 346), 78 and 82 % of patients surveyed reported enhanced communication of emotional and physical concerns; H&N patients (n = 36) reported 85 and 92 %, respectively. The most prevalent H&N symptoms were tiredness (45 %), dry mouth (43 %), fatigue (38 %), poor well-being (37 %) and lack of appetite (36 %). Seventy randomly selected charts of H&N patients scoring [ 4 on at

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56 least one ESAS item were audited. A higher rate of response (discussion ± intervention) documentation was seen for physical symptoms (pain 100 %, appetite 90 %, nausea 60 %) than for emotional concerns (depression 30 %, anxiety 10 %). CONCLUSIONS: Integration of routine QOL measurement is feasible in a large, quaternary care cancer centre. Ongoing challenges include addressing barriers to electronic data capture, and accurate assessment of response to reported symptoms. Nevertheless, the majority of patients report enhanced communication.

301: Advancing Measurement in Cognitive and Neurological Disorders (301.1) Quantifying Cognition in HIV by Combining Patient Report and Neuropsychological Testing Using Rasch Analysis: The Shoe Fits Nancy E. Mayo, PhD, McGill University Health Centre, Montreal, QC, Canada; Lisa R. Palladini, Msc (c), Division of Clinical Epidemiology, Montreal, QC, Canada; Marie-Josee Brouillette, McGill University, Montreal, QC, Canada; Lois Finch, McGill University, Montreal, QC, Canada; Lesley Fellows, McGill University, Montreal, QC, Canada AIMS: One of the challenges in the field of cognition is reconciling criteria used to classify cognitive impairment and the need to have accurate measurement to track change over time. Neuropsychological testing is the gold standard for diagnosing cognitive impairment but it is so resource intensive that it is not routinely accessible in clinical practice. Clinician’s can use simple paper-and-pencil cognitive screening tests or can ask the patient to report on cognitive function but this latter information is mostly considered to be suspect. We challenged this perception by estimating the extent to which patientreported cognitive symptoms and results on standard cognitive tasks form a unidimensional construct, such that these two sources of information can be combined in a single measure of cognitive ability. METHODS: This was a secondary analysis of 202 people HIV ? . A partial credit Rasch analysis was conducted using RUMM 2030. Fit to the Rasch model was tested first for the items from a paper-and-pencil cognitive screening test (MoCA). To this model was added the computerized test items followed by the self-report items (PDQ) for a total of 62 items. RESULTS: The full model did not fit as many items had disordered thresholds or were highly correlated, two items showed extreme misfit, and four items showed differential item functioning. After rescoring and trimming, the final model was unidimensional with included 37 items (28 test items and 9 self-report items) and fit the Rasch model (Global Fit: DF 76; ?2 96.3 p = 0.06). The item set covered a broad spectrum of ability (9.9 logits or SDs) with good internal reliability (PSI = 0.73) and assessed several cognitive domains, including speed of information processing, memory, attention, executive functioning, visuospatial function, and language. CONCLUSIONS: This global approach may be a particularly appropriate in HIV, where cognitive deficits are likely the result of diffuse brain dysfunction, rather than focal injury. The self-report items that contributed to the construct were also clinically meaningful, including such items as forgetting medications, appointments, or to turn off the stove, and having difficulty making decisions. The fit of the self-report items with the test items validates the value of hearing from the patient

Qual Life Res (2014) 23:1–184 University of Florida; Robert Prather, University of Florida; Jill Herndon, PhD, University of Florida; Keith Muller, PhD, University of Florida; Jason Lee, University of Florida; I-Chan Huang, PhD, University of Florida, Gainesville, FL, United States; Elizabeth Shenkman, PhD, Univ of Florida College of Medicine, Gainesville, FL, United States AIMS: The Engaging Consumers in Health and Healthcare in Communities Framework postulates that patient activation (PA) is important to changing health behaviors. Activation is the capacity and confidence to manage one’s health. Strong PA is associated with decreased health risk behaviors, improved patient-reported outcomes (PROs), and reduced healthcare expenditures. Individuals must possess motivation to engage in their health and the executive functioning (attention, working memory, information synthesis) to correctly interpret complex health information. Medicaid enrollees with chronic co-occurring physical and mental (CCPM) diagnoses account for 42 % of healthcare expenditures, often have poor health outcomes and likely suffer from cognitive impairment related to their conditions/treatment. Little is known about the role that executive functioning plays in PA and subsequent PROs. The objective of this study was to examine the mediating impact of PA on the relationship between executive functioning and PROs among lowincome CCPM individuals. METHODS: As part of a longitudinal randomized trial examining the effects of health navigation and financial support on health risk behaviors, baseline data was collected from 468 CCPM Medicaid enrollees. Baseline variables include demographic (age, gender, race, education), patient activation measure (PAM), 3 tests of executive functioning (semantic fluency, digit backwards, digit forwards) and PROs for physical and mental health (SF-12-V2R). We hypothesized that: (1) executive functioning would have a direct effect on PROs and (2) PA would mediate the relationship between executive functioning and PROs. Separate path analyses were conducted for each sub-score of the PROs (Table 1). RESULTS: Executive functioning was not directly associated with Physical Health (Fig. 1; R(2) = 0.0083, p = 0.435) but was associated with Mental Health (Fig. 2; R(2) = 0.0521, p \ 0.001). Both models supported PA as a mediating variable between executive functioning and PRO (Physical Health: R(2) = 0.0082, p = 0.054; Mental Health: R(2) = 0.0237, p = 0.001). PA was not correlated to any demographic variables. CONCLUSIONS: PAM plays a role in the relationship between executive function and quality of life, suggesting that interventions designed to improve PA should also incorporate strategies to address variations in cognitive functioning. Attention to cognitive differences may aide patients in feeling more confident about self-management as PA is critical to engaging patients in wellness programs to make long-lasting health changes.

Table 1 Partial regression models Outcome variable

Physical SF-12 Mental SF-12

Model

Delta R2

Total R2

Delta R2

Total R2

(301.2) The Effects of Cognition on Patient Activation and Subsequent Patient-reported Outcomes among Patients with Co-Occurring Physical and Mental Health Disorders

Demographic

0.1104 0.1104 0.0419 0.0419

Executive function|demographic

0.0083 0.1187 0.0512 0.0931

Kimberly Case, PhD, University of Florida, Gainesville, FL, United States; Sara Jo Nixon, PhD, University of Florida; Martin Wegman,

PAM|executive function and demographic

0.0082 0.1269 0.0237 0.1168

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Fig. 1 Path analysis: effects of PAM and executive function on physical health quality of life

57 satisfaction with functioning). RESULTS: 996 (48 %) TBI survivors with mild, moderate or severe TBI completed the 6-month questionnaire. Functional outcome and HRQOL after moderate or severe TBI was significantly lower than after mild TBI. Patients with moderate TBI showed greatest improvement. At one year follow-up, the mild TBI group reached outcomes comparable to general population norms. TBI of all severity levels highly affected SF-36 domains physical and social functioning, and physical and emotional role functioning. GOSE scores were highly related to all SF-36 domains and PQOL scores. Female sex, co-morbidity and high injury severity were strongest independent predictors of decreased HRQOL at 6 and 12 months after TBI. CONCLUSIONS: HRQOL and recovery patterns differ for mild, moderate and severe TBI. The strong association of GOSE with HRQOL endorses use of HRQOL as valuable addition to established instruments assessing disability following TBI. Influence of TBI severity on recovery, together with female sex, comorbidity and high injury severity should be considered in long-term follow-up and intervention programs.

(301.4) An empirical based model of dementia specific quality of life—results of a meta-synthesis of qualitative studies

Fig. 2 Path analysis: effects of PAM and executive function on mental health quality of life

(301.3) Health-related quality of life after mild, moderate and severe traumatic brain injury: patterns and predictors of suboptimal functioning during the first year after injury Annemieke C. Scholten, Erasmus MC, Rotterdam,; J A. Haagsma, ErasmusMC, Rotterdam, Netherlands; T MJC Andriessen, Radboud University Medical Center; P E. Vos, Slingeland Hospital; Ewout Steyerberg, Erasmus University Medical Center, Rotterdam, Netherlands; E F. Van Beeck, Erasmus University Medical Centre, Rotterdam, Netherlands; S Polinder, Erasmus University Medical Centre, Rotterdam, Netherlands AIMS: The Glasgow Outcome Scale Extended (GOSE) is the established functional outcome scale to assess disability following traumatic brain injury (TBI). Although clinically relevant, the GOSE fails to capture the subjective perspective of TBI patients. Healthrelated quality of life (HRQOL) does capture the individual’s perception of disability after TBI, and has therefore been recognized as an important outcome in TBI. In contrast to the GOSE, HRQOL enables comparison of health outcome across various disease states and with healthy individuals. We aimed to assess functional outcome, HRQOL, recovery, and predictors of 6- and 12-month outcome in a comprehensive sample of patients with mild, moderate or severe TBI, and to examine the relationship between functional impairment (GOSE) and HRQOL. METHODS: A prospective cohort study was conducted among a sample of 2.066 adult TBI patients who attended the Emergency Department (ED). GOSE was determined through questionnaires or structured telephone interviews. Questionnaires 6 and 12 months after ED treatment included socio-demographic information and HRQOL measured with the Short Form Health Survey (SF-36; reflecting physical, mental and social functioning) and the Perceived Quality of Life Scale (PQOL; measuring degree of

Martin Nikolaus Dichter, MScN, German Center for Neurodegenerative Disease (DZNE), Witten, Witten, Germany; Rebecca Palm, German Center for Neurodegenerative Diseases (DZNE), Witten, Germany; Margareta Halek, German Center for Neurodegenerative Diseases (DZNE), Witten, Germany; Sabine Bartholomeyzcik, School of Nursing Science, Witten/Herdecke University, Witten, Germany; Gabriele Meyer, Institute of Health &Nursing Science, Martin-Luther-University Halle-Wittenberg AIMS: Development of a dementia-specific quality of life model based on a meta-synthesis of qualitative research studies exploring the perspectives of people with dementia on quality of life (QOL). METHODS: The meta-synthesis (PROSPERO 2013:CRD 42013005014) followed four methodological steps: (a) comprehensive search in relevant databases (Medline, CINAHL, PsychINFO, EMBASE) without time limit including forward and backward citation tracking (Google Scholar, Web of Science, SCOPUS), (b) data extraction using the template form of the Qualitative Assessment Review Instrument, (c) Quality appraisal using formal criteria from the Critical Appraisal Skills Programme, (d) synthesis of findings based on principles and procedures of grounded theory. In particular, the constant comparative method leads the coding, identification of categories and synthesis. Two independent reviewers carried out all four methodological steps. RESULTS: The comprehensive search and removal of duplicates revealed 2.716 abstracts; 58 full texts were screened for eligibility. Nine studies from seven countries, published between 1996 and 2011, were included. The papers comprised reports on the perspectives of 308 people with dementia in all stages of dementia on their QOL. The studies were based on narrative and semi-structured interviews and focus group interviews, the latter partly supported by music and art therapy.A total of 14 different QOL domains were identified: family, social contact and relationships, self-determination and freedom, living environment, positive emotions, negative emotions, privacy, security, self-esteem, health, spirituality, care relationship, pleasant activities and future prospects. Presently, the relationship between the domains is analyzed aimed to develop the final QOLmodel. The results will be available until May 2014. CONCLUSIONS: The meta-synthesis will contribute to the theoretical development of the concept of QOL of people with dementia. The resulting dementia-specific model will provide a framework for the development, adaption and validation of dementia-specific QOL measurements and development of psychosocial interventions.

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58 (301.5) Evaluation of the Patient Health Questionnaire (PHQ-9) Depression Scale for Differential Item Functioning according to Demographics and Disease Severity Across Neurological Diseases: Results from the Cleveland Clinic Neurological Institute Irene Katzan, Cleveland Clinic, Cleveland, OH, United States; Sandra D. Griffith, PhD, Cleveland Clinic, Cleveland, OH, United States; Lara Jehi, Cleveland Clinic, Cleveland, OH, United States; Hubert Fernandez, Cleveland Clinic, Cleveland, OH, United States; Erik Pioro, Cleveland Clinic, Cleveland, OH, United States; Stewart Tepper, Cleveland Clinic, Cleveland, OH, United States; Paul K. Crane, MD MPH, General Internal Medicine, Harborview Med Ctr, Seattle, WA, United States AIMS: There is clinical concern that the Patient Health Questionniare-9 (PHQ9) depression scale may be impacted by the presence of disease-based symptoms (differential item functioning (DIF)) in patients with neurological conditions. We evaluated the PHQ-9 for the presence and impact of DIF in large clinical samples from the Cleveland Clinic Neurological Institute. METHODS: PHQ-9 items and disease severity measures were systematically administered to patients seen in ambulatory clinics with epilepsy (n = 2,811), stroke (n = 2,112), headache (n = 8,221), amyotropic lateral sclerosis (ALS, n = 440) and Parkinson’s disease (n = 5,022). We evaluated PHQ-9 items for DIF with respect to age, sex, race, and marital status for each condition and for DIF with respect to disease-specific severity in 4 conditions. We calculated sum scores for remaining items, and categorized severity tertiles as mild, moderate, or severe. For each evaluation, we used the difwithpar iterative hybrid item response theory/ordinal logistic regression framework to identify and account for items with DIF. A threshold of 0.3 logit units was used to characterize salient DIF impact. RESULTS: There were 0/2,112 people with stroke with salient DIF impact with respect to demographic characteristics (0 %), 2/2,811 with Epilepsy (0.07 %), 0/8,221 with Headache (0 %), 2/440 with ALS (0.45 %), and 0/5,022 with Parkinson’s disease (0 %) (overall total: 4/18,606, 0.02 %). Two items showed DIF with respect to stroke severity, but resulting DIF impact was not salient. One item each showed DIF with respect to Headache and ALS severity, but severity DIF impact was salient for only 1/8,221 people with Headache (\\1 %), and 13/440 people with ALS (3 %). For Parkinson’s disease severity, 103/2202 (5 %) had salient DIF impact using UPDRS 1b and 1/2820 people (\\1 %) had salient DIF impact using UPDRS 2a. CONCLUSIONS: PHQ-9 items function consistently across demographic groups for people with 5 neurologic diseases. Salient levels of DIF with respect for disease severity were found only for a very small proportion of people among the 4 diseases evaluated. These results suggest that the PHQ-9 works well in ambulatory neurological settings, providing a consistent measure of depression severity, even among people with neurological conditions associated with somatic symptoms that overlap with depression

(301.6) Quality of Life Assessments in Persons with Spinal Cord Injury with Neurogenic Bowel and Bladder Denise G. Tate, PhD, University of Michigan, Ann Arbor, MI, United States; Martin Forchheimer, University of Michigan; David Tulsky, PhD, Kessler Foundation, New York, NY, United States; Pamela A. Kisala, University of Michigan; Gianna Rodriguez, University of Michigan; Anne Cameron, University of Michigan; Anthony Chiodo, University of Michigan AIMS: Most persons with spinal cord injury (SCI) and neurologic impairment also have associated bladder and bowel dysfunction. Very few studies have focused on the impact of loss of bladder

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Qual Life Res (2014) 23:1–184 and bowel functions on quality of life (QOL) for persons with SCI. Furthermore, QOL measures designed to assess the impact of these losses are almost non-existent. A new measure has been developed by Tulsky et al., the SCI-QOL, to assess these domains of QOL. This study assesses the validity of the SCI-QOL in SCI and compares it to other measures of QOL. The SCI-QOL is a SCIspecific patient-reported outcome system. METHODS: A sample of 126 persons with SCI and neurogenic impairments were tested using the SCI-QOL short form item banks for: bowel management (SCI-QOL-BWM); bladder management (SCI-QOL-BLM); bladder complications (SCI-QOL-BLC); and ability to participate in social roles and activities (SCI-QOL-AbP). They were also tested with the Life Satisfaction Index Z (LSI-Z) and the SF-Qualiveen, a measure of bladder related QOL. In addition to testing data, demographic information and data on actual complications and satisfaction with methods of management was also collected. Pearson correlations and ANOVAs were conducted for data analyses. RESULTS: The selected SCI-QOL item banks correlated significantly with both the LSI-Z and the Qualiveen. The SFQualiveen had robust correlations (p \ 0.0005) with all measures except SCI-QOL BWM. Correlations were highest with SCI-QOL BLM (0.603; p \ 0.0001); SCI-QOL-AbP (0.497; p \ 0.0001); and SCI-QOL-BLC (0.419; p \ 0.0001). Significant correlations were also observed between the LSI-Z and the SCI-QOL-AbP (0.343; p \ 0.0001). Bowel management was correlated with bladder management, complications and the LSI-Z. Additional group differences were shown for bladder and bowel incontinence as well as satisfaction with methods of management bowel and bladder. CONCLUSIONS: The selected SCI-QOL item banks show good indication of validity with other measures of QOL and the ability to significantly discriminate among subgroups with SCI. These findings suggest that the SCI-QOL has excellent measurement properties and appears to be valid in patients with SCI.

302: Assessing Well-Being and Health Across Cultures (302.1) DIF analysis to tease out average differences in mental well-being in Scotland and Catalonia Carlos Garcia Forero, PhD, IMIM, Barcelona, Spain; Nuria Duran Adroher, IMIM (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Pere Castellvı´, Hospital Del Mar Research Institute, Barcelona, Spain; Gemma Vilagut, MSc, IMIM (Hospital del Mar Medical Research Institute); UPF, Barcelona, Spain; Sarah StuartBrown, University of Warwick; Jordi Alonso, MD PhD, IMIMHospital del Mar Medical Research Institute, Barcelona, Spain AIMS: Mental well-being is gaining importance for evaluating health policies; however this construct may vary due to cultural factors. In previous work we reported important differences in mental well-being scores between Scotland and Catalonia, with substantial score differences (Cohen’s d = 0.84), indicating better values in the latter. Here we assess whether differences are real or due to bias. METHODS: We assessed Differential Item Functioning (DIF) in the Warwick-Edinburg Mental Well-being Scale (WEMWBS) in two general population samples in Scotland (N = 779) and Catalonia (N = 1,900). DIF was assessed by applying ordinal logistic regression on WEMWBS IRT scores obtained as Maximum Likelihood estimates of the logistic version of Samejima’s Graded Response model. DIF was tested with likelihood-ratio tests and effect measures (McFadden’s Pseudo-R2 [ 0.09, Relative Parameter Change [ 0.09), and Differential Test Functioning (DTF) by plotting differences between full-test and purified (i.e., without DIF items) score estimates. Country impact on WEMWBS scores was quantified as average score differences between countries using Cohen’s d, and stratified by sociodemographic characteristics. RESULTS: A large

Qual Life Res (2014) 23:1–184 ceiling effect was found in the case of Catalonia, where more than a 10 % of the sample yielded the maximum raw test score (versus 0.5 % in the case of Scotland). 3 out of 14 WEMWBS items showed small DIF (Pseudo-R2 value 0.02 for all flagged items; relative parameter change ranging 0.06 to 0.12). DIF did not add up to DTF, as shown by intraclass correlation coefficient (ICC = 0.99) and small case-by-case differences between total and purified scores. Country differences remained across sociodemographic characteristics, but they decreased dramatically as perceived health worsened (effect sizes from d = 1.14 in the best health to d = 0.13 in the worst health status). CONCLUSIONS: Well-being, as measured by the WEMWBS, is similarly understood in Scotland and Catalonia, which supports WEMWBS as a valid measure for cross-country comparisons. Both countries are effectively different in the distributions of mental well-being. Results suggest that mental well-being might be understood differently depending on self-perceived health. Funding: ISCIII CDI12/00440; AGAUR 2009 SGR 1095; NHS Health Scotland commissioned the HEPS.

(302.2) Correlates of Mental Well-Being: a cross-country analysis in Scotland and Catalonia Nuria Duran Adroher, IMIM (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Carlos Garcia Forero, PhD, IMIM, Barcelona, Spain; Pere Castellvı´, Hospital Del Mar Research Institute, Barcelona, Spain; Jordi Alonso, MD PhD, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain AIMS: Research on determinants of positive mental health is necessary for reducing the burden of mental disease. We assessed the correlates at the individual level of mental well-being (WB) in two countries. METHODS: We analyzed samples from general population surveys in Scotland (N = 779) and Catalonia (N = 1,900) conducted in 2006 and 2011, respectively. Mental WB was measured with the WarwickEdinburg Mental Well-being Scale, a 14 item Likert-questionnaire. Other than country, independent variables were: (I) sociodemographics (gender, age, civil status, study level, employment, and social class); (II) health indicators (active chronic condition, functional limitations, self-perceived health and (III) health behaviors (smoking, drinking, and sedentarism). Associations with a latent factor of mental WB (higher scores representing higher WB) were obtained from a multiple-indicators/multiple-causes model as standardized regression coefficients (which coincides with Cohen’s d metric in case of categorical variables) and adjusted by mental distress level (measured by the GHQ12) and collinearity between independent variables. Parameters were estimated using robust Maximum Likelihood. Fit was assessed with comparative fit and Tucker-Lewis indices, and Root Mean Square Error of Approximation, obtained with Diagonally-Weighted Least Squares. RESULTS: The model had good fit (CFI = 0.97; TLI = 0.97; RMSEA = 0.034), and accounted for a total 41 % of mental WB variance. After adjustment by the remaining variables, country was a significant predictor of mental WB, being it higher in Catalonia (d = 0.18, se = 0.02). Sociodemographic indicators positively associated with mental WB were: being employed (d = 0.06, se = 0.03), and married (d = 0.06, se = 0.03). Significant health indicators were good perceived health (very good vs poor d = 0.27, se = 0.05; good vs poor d = 0.16, se = 0.06), and not having functional limitations (d = 0.09 se = 0.03). Negative correlates of mental WB were presence of psychopathology (d = -0.18, se = 0.02) and higher mental distress scores (standardized beta = -0.31, se = 0.02). Heavy drinking was the only health behavior associated with mental WB (d = -0.04, se = 0.02). CONCLUSIONS: Physical and mental health are the main correlates of mental WB followed by social factors, while health behaviors have little impact on mental WB. After

59 adjusting by individual factors, a substantial amount of mental WB was explained by country differences. Funding: ISCIII CDI12/00440, PI13/00506; AGAUR 2009 SGR 1095; NHS Health Scotland commissioned the HEPS.

(302.3) Assessment of the psychometric equivalence of the PROMISÒ anxiety item bank and its German translation Inka Wahl, PhD, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Joshua Rutsohn, Northwestern University Feinberg School of Medicine, Chicago, IL, United States; David Cella, PhD, Northwestern University, Chicago, IL, United States; Bernd Lo¨we, University Medical Center Hamburg-Eppendorf &Scho¨n Klinik Hamburg Eilbek; Matthias Rose, MD PhD, Charite´ Universita¨tsmedizin Berlin, Worcester, MA, United States; Elmar Bra¨hler, Leipzig University; Paul Pilkonis, University of Pittsburgh School of Medicine, USA; Benjamin Schalet, Northwestern University, Chicago, IL, United States AIMS: A key purpose of the Patient-Reported Outcomes Measurement Information System (PROMIS) is to provide comparability of measurement results across domains and conditions. To enable a common use of PROMIS measures in international research, standard procedures should be used to assess and ensure sufficient comparability of the PROMIS source measure and its translations. Applying differential item functioning (DIF) and IRT linking, Paz, Spritzer, Morales & Hays (2013) provide an approach to accomplish this. The aim of our study is to apply this procedure to the PROMIS anxiety item bank and its German translation. METHODS: A state-ofthe art German translation of the PROMIS anxiety item bank (Pilkonis et al. 2011; Wahl et al. 2011) was administered to a German sample composed of a representative sample of the general population and a clinical sample. The representative general population sample (N = 2,504) was randomly selected by a national polling firm (USUMA) in 2010. Items of the PROMIS anxiety item bank were answered within household surveys. The clinical sample (N = 642) comprised patients with somatic disorders and mental comorbidities and patients with mental disorders (depressive- and anxiety disorders amongst others), who answered the PROMIS anxiety item bank as part of the clinic’s routine psychometric assessment. We also obtained the PROMIS calibration data (N = 800; Pilkonis et al. 2011) to allow testing for DIF by language. Psychometric diagnostics were assessed through classical item analyses, unidimensionality testing with CFA fit indices, monotonicity testing, and IRT parameter calibration. We will compare DIF due to language (English vs. German) using Lordiff (Choi et al. 2011). Following Paz et al. (2013), we will recommend that items without DIF adopt US-American item parameters, while items with DIF should be scored with German parameters. The German parameters, however, will be linearly transformed to the US-American metric (Weeks 2010) so that each version of the instrument is on a common metric. RESULTS: Diagnostic results illustrated that the German anxiety item bank fulfilled the criteria to be classified as internally valid, monotone, and unidimensional. DIF results and transformed parameters will be presented at the ISOQOL 21st Annual Conference in Berlin. CONCLUSIONS: Conclusions will be drawn.

(302.4) Psychometric Validation of an EORTC Measure of Spiritual Wellbeing in patients with advanced cancer Teresa E. Young, BSc, Mount Vernon Hospital, Northwood, United Kingdom; Bella Vivat, PhD, Health Sciences and Social Care, Uxbridge, Middlesex, United Kingdom; Julie B. Winstanley, PhD, University of Sydney, Sydney, Australia; Juan Ignacio Arraras, PhD,

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60 Servicio Navarro de Salud, Pamplona, Navarra, Spain; Anne Bredart, PhD, Institut Curie, Paris, France; Anna Costantini, Sant’Andrea Hospital. Sapienza University of Rome, Italy; Sheila E. Fisher, PhD MBCh FRCS, University of Leeds, Leeds, West Yorkshire, United Kingdom; Jingbo Guo, Shenyang; M Eliza Irarrazaval, Instituto Oncologico Fundacion Arturo Lopez Perez; Kunihiko Kobayashi, MD, PhD, Saitama International Medical Center, Saitama Med. Univ., Hidaka, Saitama, Japan; Kruizinga R., MA, Academic Medical Center, University of Amsterdam, Medical Oncology, Amsterdam, Netherlands; Hanneke W.M. van Laarhoven, MD PhD; Academic Medical Center, University of Amsterdam, Medical Oncology, Amsterdam, Netherlands; Navarro M., Instituto Nacional de Cancerologia, Division de Investigacion Clinica, Mexico City, Mexico; Omidvari S., Mental Health, IHSR (Health Metric Research Center), ACECR & Cancer Research Center, TUMS, Iran; Rohde G.E., University of Agder & Sorlandet Hosptial, Faculty of Health and Sport Sciences, Kristiansand, Norway; Serpentini S., Az. ULSS 3, Psycho-Oncology Service/Palliative Care Unit, Bassano del Grappa, Italy; Yang G.M., National Cancer Centre Singapore, Palliative Medicine, Singapore, Singapore, on behalf of EORTC Quality of Life Group AIMS: No existing measures of spiritual wellbeing (SWB) have been developed cross culturally. However, in 2002 the EORTC Quality of Life (QL) Group began an international study to develop a measure of SWB for palliative patients following the group’s four phase process. Phase IV field-testing and validation of the measure was completed in July 2013. METHODS: During field testing participants completed a 36-item provisional measure and then a structured debriefing interview exploring the suitability of items. EORTC QLQ-C15-PAL, socio-demographic and clinical data were collected, and test–retest data from a sub-group of patients. Principal Component Analysis (PCA) was used to identify items to form subscales. Scale reliability was assessed using Cronbach’s alpha coefficients and Rasch analysis was used to explore the unidimensionality of the subscales. RESULTS: 458 patients from 14 countries on 4 continents took part. 188 were Christian, 50 Muslim, 23 Buddhist, and 158 followed no religion or belief system but only 89 patients were identified as ‘non believers’. (Did not and have never believed in God or a greater power). All items showed good distribution of scores across response categories. 275 patients (60 %) did not find any items problematic, but small percentages of respondents found 6 items difficult. PCA identified 4 scales explaining 53 % of variance. (Relationships with others, with self and with greater power plus existential). 8 items had poor fit following Rasch analysis but were considered to have clinical value (including indentifying ‘‘believers’’). A further 2 items with poor fit were also known to be confusing and were considered for deletion. One item was redundant. No remarkable differential item functioning (DIF) was found. Goodness of fit measures were within expected guidelines. CONCLUSIONS: This EORTC Phase 4 study demonstrates how the application of classical test theory and IRT methods complement one another, aid decision making in the item selection process and enhance the psychometric integrity of new QL scales. The new EORTC measure of SWB for palliative patients is now available for use in research and clinical practice.

(302.5) Quality of life of people living with HIV/AIDS: A cross-country comparison study of Finland and Portugal Nuno Nobre, University of Helsinki, Faculty of Medicine, Helsinki, Finland; Marco Pereira, Universidade de Coimbra, Coimbra, Portugal; Maria C. Canavarro, Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal; Jussi Sutinen, Aurora Hospital, Helsinki, Finland; Harri Sintonen, Faculty of Medicine,

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Qual Life Res (2014) 23:1–184 University of Helsinki, Finland; Risto P. Roine, Faculty of Medicine, University of Helsinki, Finland AIMS: The premises underlying the development of the World Health Organization Quality of Life (WHOQOL) measures provide a convincing rationale for comparing quality of life (QOL) across countries. The purpose of this study was to compare the QOL among patients with HIV infection in Finland and Portugal, and to examine the contribution of the QOL domains to the explanation of overall QOL in these two countries. METHODS: The sample consisted of 323 Finnish HIV-infected patients (80.8 % male; mean age = 48.37 years) and 328 Portuguese HIV-infected patients (68.9 % male; mean age = 40.61 years). Quality of life was assessed with the World Health Organization Quality of Life in HIV infection instrument (WHOQOL-HIV-Bref). RESULTS: Significant country differences were found in QOL domains and specific facets. Adjusting for sociodemographic and clinical variables, Finnish HIV patients reported significantly higher scores on the six QOL domains, compared to their Portuguese counterparts. With respect to the specific facets of the WHOQOL-HIV-Bref, Finnish HIV patients also reported significantly higher scores on 25 out of 31 facets. The exceptions were dependence on medications and treatment (p = 0.600), positive feelings (p = 0.394), sleep and rest (p = 0.119), sexual activity (p = 0.996), and the specific facets of the HIV module spirituality (p = 0.088) and forgiveness (p = 0.486). Regression analyses showed that physical, psychological, independence and social relationships contributed to overall QOL in Finnish patients (R2 = 0.62), whereas in Portuguese patients the significant domains associated with Overall QOL were psychological, independence and environment (R2 = 0.43). CONCLUSIONS: The country differences in QOL domains and specific facets, even controlling for sociodemographic and clinical variables, seem to reflect the socio-cultural differences between south and north Europe. Supporting its cross-cultural perspective, the WHOQOLHIV-Bref is a valid instrument that can be used in future cross-cultural comparison studies as a reference measure of QOL in people living with HIV infection.

(302.6) Quality of life of Japanese and Austrian mothers: Differences and impact factors in East-Asia and Central Europe Eva Mautner, Medical University Graz, Graz, Styria, Austria; Chie Ashida, Graduate School of Education, Hiroshima University, Hiroshima, Japan; Eva Elfriede Greimel, PhD, Medical University Graz, Graz, Austria; Uwe Lang, Medical University Graz; Christina Kolman, Department of Obstetrics and Gynaecology, Medical University of Graz, Austria; Daniela Alton, Department of Obstetrics and Gynaecology, Medical University of Graz, Austria; Wataru Inoue, Graduate School of Education, Hiroshima University, Hiroshima, Japan AIMS: The aim of this cross-cultural study was to investigate quality of life outcomes and depression of mothers in Austria and Japan in connection with changes due to children. Additionally, the impact of internal resources (e. g. sense of coherence, values and attitudes, social and gender roles and perceived stress) and external resources (e. g. financial situation and social support from family, friends and important others) were examined. METHODS: A total of 397 women in Austria and Japan with children in kindergarten answered the same cross-culturally validated questionnaires. Used were the quality of life questionnaire from the WHO (WHOQOL-Bref), two items for depression from the Patient Health Questionnaire (PHQ-2), the Sense of coherence scale, the Multidimensional Social Support Scale, a perceived stress scale and other questions to measure for example gender orientation. RESULTS: Japanese women had much lower scores on the physical, psychological, social and environmental scales of the WHO quality of life instrument. Seven percent of women in both countries experienced major depression. An important impact factor on all

Qual Life Res (2014) 23:1–184 dimensions of QOL and depression in both countries was sense of coherence. Additional impact factors in both countries were the experienced stress level, satisfaction with income, social support and gender roles. CONCLUSIONS: In Japan it seems that mothers still don’t have enough control over their lives and less support which could have caused exceptionally low quality of life. We suggest QOL research in mothers globally to find out where needs of improvement can be found. Another step is to develop strategies to improve QOL and reduce depression in mothers. Creating an environment where fathers could be more involved in childrearing and mothers have more possibilities to choose between life styles and working and social environments could improve not only QOL in Japanese mothers, but also in other countries. 303: Advancing Measurement of Physical and Mental Health in General Populations (303.1) Inpatients experience response shifts between admission and discharge from psychosomatic ward Sandra Nolte, PhD, Charite´—Universita¨tsmedizin Berlin, Berlin, Germany; Annett Mierke, Charite´—Universita¨tsmedizin Berlin, Berlin, Germany; Matthias Rose, MD PhD, Charite´ Universita¨tsmedizin Berlin, Worcester, MA, United States AIMS: Patients admitted at the Medical Clinic, Department of Psychosomatic Medicine, Charite´ University hospital in Berlin, Germany, receive comprehensive psychodynamic therapy developed for the treatment of both mental and somatoform disorders. The treatment concept includes a wide range of individual and group-based sessions. As psychosomatic treatment is intensive where inpatients often build considerable rapport with both clinical staff and fellow inpatients, it was hypothesized that patients experience a range of response shifts during their hospital stay. METHODS: A total of 1,530 patients completed the ICD-10 Symptom Rating (ISR) scale consisting of five factors (depression, anxiety, obsessive compulsive disorder, somatoform disorder, eating disorder). Data were collected at admission and discharge, on average 24 days after intake. Redefinition, reprioritization, and recalibration response shifts as defined by Schwartz and Sprangers were explored by employing tests of measurement invariance. In this itemlevel approach model parameters were constrained to be equal between pre-test and post-test. If non-invariance was detected these were then linked to the different types of response shift following the Oort Model. RESULTS: When fully constraining ISR pre-test and post-test model parameters, model fit worsened significantly, with the Satorra-Bentler Chi square difference test suggesting substantial non-invariance. After constraints were successively relaxed, multiple types of response shift were detected. The most common types were non-uniform recalibrations, with eight items showing non-tenable constraints on error variances. Further, three reprioritization response shifts were detected indicated through non-tenable constraints on factor loadings, with each of these items belonging to a different factor. Finally, one lower-level reconceptualization response shift was found, with a residual covariance detected between two items at post-test that were not present at pre-test. CONCLUSIONS: Our study suggests that inpatients of the psychosomatic ward at Charite´ hospital experienced several response shifts during their hospital stay. Most types were non-uniform recalibrations. Hence, while several items of the ISR were affected by patients’ response shifts, the type of non-invariance is mostly not critical for an unbiased comparison of factors means. Hence, mean comparisons of ISR data are still warranted, with at least partial invariance established in all five ISR factors.

(303.2) Characterizing the unwell-beings in England Antonieta Medina-Lara, BSc (Hons), MSc, PhD, University of Exeter Medical School, Exeter, United Kingdom; Ruben E. Mujica-Mota, BSc, MSc, PhD, University of Exeter, Exeter, United Kingdom

61 AIMS: Instigated by the UK government, the Office of National Statistics has recently started to collect and report data on subjective well-being of the general population. Results have been reported in aggregated form without discussing the characteristics of sub-groups of the population with the lowest levels of well-being. The aim of this paper is to characterize those individuals that are at higher risk of reporting low levels of multi-dimensional well-being. METHODS: We used data from the Health Survey for England for 2012 to group individuals by their level of well-being according to their responses to multiple questions, using lantent class models. Characteristics related to education, employment, income, marital status, household size, multi-morbidity, physical activity, diet and health-related quality of life (EQ-5D) were used to identify the different well-being classes. We analyse the implications for our results of two different specifications for the latent class model, one where the well-being indicators are conditional independent versus the alternative where they are correlated. RESULTS: Data on 8,290 respondents, age 16 and older were included in the analysis. Multi-morbidity and income were the most discriminating characteristics between classes especially among those over 35 years old. Allowing for dependence across well-being indicators increases the discriminating power of EQ-5D in the younger group (= 24 years old) and diminishes the explanatory power of gender. CONCLUSIONS: This research illustrates the importance of developing a construct that distinguishes among qualitatively different states of individual well-being. In so doing it highlights the importance of clearly articulating public policy targets.

(303.3) Satisfaction with life and mental distress in people living alone or with a partner Jocelyne M.R. Clench-Aas, PhD, Norwegian Institute of Public Health, Oslo, Norway; Ragnhild Bang Nes, Norwegian Institute of Public Health AIMS: Living with a marital or equivalent partner is associated with higher and even increasing levels of life satisfaction. This study compares levels of life satisfaction and distress in individuals living with a partner or alone, and examines the associations between life satisfaction and mental distress across marital status. Additionally, the mediating roles of sense of mastery and social support on these associations are explored. METHODS: Analyses were based on data from a large (N = 4,823) and nationally representative sample of Norwegian males and females aged 15–79, collected in 2008. Only those who were single or currently in a partnered relationship, but not separated, divorced or widowed were kept for further analysis (N = 3,694). Life satisfaction (LS) was measured by a single question on overall satisfaction with life (10 point scale), whereas psychological distress was measured by The Hopkins Symptom Check List (HSCL). Structural equation modeling using AMOS 19 was conducted to i) explore the relationships between LS and HSCL-25 as influenced by selected determinants including sense of mastery (SM) and perceived social support (SS) and ii) to compare the measured associations between those living in a relationship or not. Analyses were controlled for gender, age and socio-economic status. RESULTS: Generally, levels of LS were higher, and HSCL lower among individuals living with a partner than those living alone/single. There are relatively large differences in development with age in the two groups. The association between HSCL and LS was stronger in singles. Furthermore, the association between SM and both HSCL and SWL was also stronger in singles, although the absolute levels of LS and HSCL did not differ. Sense of mastery, but not social support provides a mediating role in this association. CONCLUSIONS: There are significant differences in life satisfaction and mental distress among individuals living in a relationship and those who are single. Sense of mastery is an important mediator of these relationships.

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62 (303.4) Common patterns of morbidity and multi-morbidity and their impact on health-related quality of life: evidence from a national survey Ruben E. Mujica-Mota, BSc, MSc, PhD, University of Exeter, Exeter, United Kingdom; Martin Roberts, University of Exeter; Gary Abel, University of Cambridge; Mark Elliott, RAND Corporation; Georgios Lyratzopoulos, University of Cambridge; Martin Roland, University of Cambridge; John Campbell, University of Exeter AIMS: We investigated the impact of multi-morbidity on healthrelated quality of life using a large adult sample survey METHODS: We used data from the English General Practice Patient Survey 2011–2012. We defined multi-morbidity as the presence of two or more of 12 self-reported conditions or another (unspecified) long term health problem. We investigated differences in HRQOL (EQ-5D scores) associated with combinations of these conditions after adjusting for age, gender, ethnicity, socio-economic deprivation, and the presence of a recent illness or injury. Analyses were based on 831,537 responses from patients aged 18 years or older in 8,254 primary care practices in England. RESULTS: 23 % of respondents reported two or more chronic conditions (ranging from 7.5 % of those under 45 years of age to 51.1 % of those 65 years or older). Multimorbidity was more common among women, White individuals, and in respondents from socio-economically deprived areas. Neurological problems, mental health problems, arthritis and longterm back problem were associated with the lowest health-related quality of life. The presence of three or more conditions was commonly associated with greater reductions in quality of life than that implied by the sum of the differences associated with the individual conditions. Mental health problems were negatively associated with quality of life, especially in combination with other physical conditions. The decline in quality of life associated with an additional condition in people with more than three physical conditions was less for older people than for younger people. Multi-morbidity was associated with a substantially worse HRQOL in diabetes than in other long-term conditions. CONCLUSIONS: Patients with multimorbid diabetes, arthritis, hypertension, and long-term mental health problems, have significantly lower health quality than other people. Integrating mental and physical health approaches to care should be seen an essential component in the delivery of high quality care for people with long-term health conditions.

(303.5) Health-related quality of life and well-being Clara Mukuria, PhD, University of Sheffield, Sheffield, United Kingdom; John E. Brazier, PhD, Univ of Sheffield, Sheffield, United Kingdom AIMS: There is increasing interest in the relationship between health and wellbeing in public policy. Previous work using self-reported preference-based health measures like EQ-5D have been limited to one measures of happiness or life satisfaction (e.g. Mukuria and Brazier 2013). This paper aims to take the research forward by estimating the relationship between EQ-5D and a wellbeing VAS (based on the EQ thermometer) and the 4 item Office for National Statistics (ONS) UK wellbeing measure (ONS4). METHODS: Data have been collected in a cross sectional survey of former inpatients from a large hospital in Wales, United Kingdom. 4110 respondents had returned questionnaires as of end of January 2014. The survey is collecting data health-related quality of life and wellbeing questions. Regression analysis was undertaken with EQ-5D-5L (overall index or the five EQ-5D dimensions) and EQ-VAS as explanatory variables and wellbeing measured using ONS-4 (four 11 point scales from 0 to 10 on life satisfaction, happiness, worthwhile and anxiety), and the wellbeing VAS as the dependent variables. OLS regressions have

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Qual Life Res (2014) 23:1–184 been used in the first instance to model these relationships. RESULTS: The mean population EQ-5D (UK) score was 0.66 (0.29), EQ-5D VAS was 68.11 (23.07) and 68.95 (24.49) for the wellbeing VAS. Correlations were moderate to strong (|0.4 to [ 0.6|) between EQ-5D utility, EQ-VAS scores and the wellbeing measures. As expected, the anxiety and depression dimension had the strongest correlations with the wellbeing measures (| [ 0.5|). The self-care dimension had the weakest correlations (|0.3| to |0.45|). Regression models suggest that the overall EQ-5D utility score is associated to a similar extent with the 4 items of the ONS-4 with a unit change in EQ-5D being associated with a 5 unit change in these measures. Depression/anxiety is more important for wellbeing compared to other dimensions followed by usual activities with mobility, self-care and pain having less importance than suggested in TTO or VAS value sets. CONCLUSIONS: These results indicate the EQ-5D has a significant impact on wellbeing, but the relative importance of the dimensions is different to the preference-based algorithms currently being used.

304: Advancing Measurement in Children (304.1) How qualitative methods can be used to ensure content validity in a PRO instrument for patients with cleft lip and/ or palate who vary by age and culture: development of the CLEFT-Q Elena Tsangaris, McMaster University, Hamilton, ON, Canada; Karen W.Y. Wong, MD MSc FRCSC, Hospital for Sick Children, Toronto, ON, Canada; Christopher R. Forrest, MD, The Hospital For Sick Children, Toronto, ON, Canada; Andrea Pusic, MD MHS FRCSC, Memorial Sloan Kettering Cancer Ctr, New York, NY, United States; Stefan J. Cano, PhD CPsychol AFBPsS, Plymouth University Peninsula Schools of Medicine & Dentistry, Plymouth, United Kingdom; Tim Goodacre, Oxford Radcliffe Hospitals, Oxford, United Kingdom; Anne Klassen, D Phil, McMaster University, Hamilton, ON, Canada AIMS: Cleft lip and/or palate (CLP) is the most common congenital craniofacial anomaly. The CLEFT-Q is a PRO instrument designed to measure outcomes that matter to patients with CLP. Content for a set of 13 scales with 164 items were developed from qualitative interviews with 138 patients with CLP from 6 countries (Canada, USA, UK, India, Kenya, Philippines). CLEFT-Q scales measure the following concepts: appearance, speech, psychological, social and functional issues. The aim of this study was to use qualitative methods (cognitive interviews with patients and experts) to ensure maximum content validity based on two key variables, patient age and country, hypothesized to cause group-level differences in responses. The overall goal is to identify items of the CLEFT-Q that are relevant to all patients or are age- and/or country-specific. METHODS: We completed two separate rounds of data collection in Canada, USA and Philippines using individual interviews with patients 5–29 years of age and focus groups or individual feedback with healthcare providers. Input has helped us revise the instructions, response options, item wording, and identify missing content. RESULTS: Round 1 involved 17 patients and 13 experts. All found the instructions easy to understand. Feedback identified changes required to the response options and items (e.g., 8 items were kept without revision; 101 were revised; 47 were dropped; 2 new scales added). Round 2 involved 26 participants and 5 experts. This round clarified the best response options to use, and identified 52 problematic items that required further change. The average Flesch-Kincaid grade level was 1.5. Interestingly, patients from the Philippines had fewer problems with item comprehension than those from Canada and USA. Younger patients experienced more difficulty with items compared to older patients. CONCLUSIONS: Cognitive interviews identified problems that led to substantial revisions to the CLEFT-Q.

Qual Life Res (2014) 23:1–184 Discrepancies in item comprehension between the Philippines, Canada and the USA may be due to variable access to care. We plan to conduct at least 2 more rounds of feedback from patients and experts in UK, India and Kenya to ensure the CLEFT-Q has maximum content validity before field-testing in a larger sample.

(304.2) Model Testing of the Children’s Quality of Life Questionnaire Shulamith Kreitler, Tel-Aviv University, Tel-Aviv, Israel; Michal M. Kreitler, Tel-Aviv University; Yasmin Alkalay, Tel-Aviv University AIMS: The purpose of the study was to construct and test a measurement model based on a new measure of quality of life for children and adolescents. The measure was designed to cover major domains of life of a broad section of the population. METHODS: The total number of participants was 3574, of four age groups: 6–8 years (n = 223), 9–11 years (n = 1,008), 12–14 years (n = 949), 15– 18 years (n = 539). The sample included males (n = 1,295) and females (n = 1,387), inhabitants of small towns (n = 1,213), medium-size cities (n = 1,008) and big cities (n = 1,122) in Israel, with different ethnic background (Jewish = 2734; Arab = 840). The Children’s Quality of Life Questionnaire was administered to all participants. The questionnaire included 53 items, each with three response alternatives represented graphically and in words, yielding scores in the following 15 scales: functioning at school, Social functioning, Cognitive functioning, Functioning in the family, Physical state, Worries, Basic needs, Body image, Sense of Mastery, and independence, Self image, Negative feelings, Stress, Positive feelings, Fun, and Motivation Results: The initial search resulted in 1082 studies; 22 of these studies fulfilled our inclusion criteria (Fig. 1). Four studies were prospective and 18 were retrospective. Of these studies, 12 used ad hoc questionnaires alone; 10 used 14 HRQOL instruments either alone or in combination with an ad hoc questionnaire. In only 1 study was a breast reconstruction-specific instrument used. Different studies evaluated different HRQOL domains. Only 4 studies compared HRQOL between patients who had reconstruction post BPM with those that did not. Vulnerability and psychological distress were found to be significant negative predictors of quality of life post BPM. Preoperative cancer distress predicted a negative body image post BPM and reconstruction. CONCLUSIONS: The conclusions are that the measurement model validates the questionnaire structure, and shows that it is stable across subsamples defined in demographic terms and still sensitive enough to present differences in the standardized regression weights of the subsamples.

63 (304.3) Development and Validation of a Generic Scale for use in Transition Programs to Measure Self-Management Skills in Adolescents with Chronic Health Conditions: The TRANSITION-Q Anne Klassen, D Phil, McMaster University, Hamilton, ON, Canada; Christina Grant, McMaster University, Hamilton, ON, Canada; Ronald Barr, MD, McMaster Univ., Hamilton, ON, Canada; Herbert Brill, McMaster University, Hamilton, ON, Canada; Gabriel M. Ronen, MD, MSc, McMaster University, Hamilton, ON, Canada; Constantine Samaan, McMaster University, Hamilton, ON, Canada; Abbey Schlatman, McMaster University, Hamilton, ON, Canada; Elena Tsangaris, McMaster University, Hamilton, ON, Canada; Uma Athale, McMaster University, Hamilton, ON, Canada; Natasha Wickert, McMaster University, Hamilton, ON, Canada; Jan Willem Gorter, McMaster University, Hamilton, ON, Canada AIMS: Healthcare transition has been described as the purposeful, planned journey of adolescents with chronic physical and medical conditions from child-centred to adult-oriented health care systems. Preparing adolescents for transition should start early (12 years of age) and make use individualized transition plans. There is currently a lack of scientifically sound scales available for use in transition programs. Therefore, aim of this study was to develop a generic selfmanagement skills scale for use with adolescents diagnosed with a chronic health condition who are aged 12 to 18 years. METHODS: Adolescents aged 12 to 18 years with a broad range of chronic health conditions, including developmental disabilities, were recruited from May to August 2013 from nine outpatient clinics at McMaster Children’s Hospital (Canada). Thirty-two participated in a cognitive interview, and 337 completed a questionnaire booklet. The interviews were used to develop the content of the scale. Rasch Measurement Theory (RMT) analysis was used to identify items that represent the best indicators of self-management skills. Traditional psychometric tests of measurement performance were also conducted. RESULTS: The response rate was 92 % (369/402). RMT analysis resulted in a 14-item scale with 3 response options that measured frequency. A non-significant Chi squared value was achieved (Chi Square = 88.17, degrees of freedom = 70, p value = 0.07), supporting data fit to the Rasch model. Other tests supported the scale as scientifically sound, e.g., Person Separation Index = 0.82; good item fit statistics; no differential item function by age or gender; low residual correlations between items; Cronbach’s alpha = 0.85; test–retest reliability = 0.90; and tests of construct validity that showed, as hypothesized, fewer skills in younger participants and in participants who required assistance to complete the scale. Finally, participants who agreed to them being ready to transfer to adult healthcare reported higher TRANSITION-Q scores than did participants who disagreed. CONCLUSIONS: The TRANSITION-Q is a short, clinically meaningful and psychometrically sound scale. This scale can be used in research and in pediatric and adolescent clinics to help evaluate readiness for transition.

(304.4) Rasch Analysis of the PedsQL 3.0 Diabetes Module Timothy EI Pickles, BSc (Hons) MSc, South East Wales Trial Unit, Cardiff University, Cardiff, United Kingdom; Rebecca Playle, South East Wales Trial Unit, Cardiff University, Cardiff, United Kingdom; Kerenza Hood, South East Wales Trial Unit, Cardiff University, Cardiff, United Kingdom; Jonathan Gillard, Cardiff School of Mathematics, Cardiff University, Cardiff, United Kingdom

Fig. 1 Flow diagram for systematic review methodology in line with PRISMA guidelines

AIMS: Rasch analysis is an increasingly popular approach to questionnaire reduction and the validation of outcome measures, and is rapidly overtaking the standard classical test theory approaches of Cronbach’s alpha and Factor Analysis. Data from outcome measures,

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64 in which the items are intended for summation to create an overall ordinal score, are tested against the expectations of the Rasch measurement model. Rasch analysis provides numerous fit statistics to show how well the various items describe the group of individuals, and how well those individuals fit the group. Further issues include person separation, targeting, threshold ordering, differential item functioning, local independence and unidimensionality, which can be explored and interpreted from the output generated by software package RUMM2030. METHODS: Rasch analysis was undertaken on data from the PedsQL 3.0 Diabetes Module (PQDM), which consists of 28 items, which fall into the following 5 scales: •Diabetes symptoms; 11 items; •Treatment barriers; 4 items; •Treatment adherence; 7 items; •Worry; 3 items; • Communication; 3 items. Each item has 5 response categories: Never, Almost Never, Sometimes, Often and Almost Always. The PQDM was completed by patients, and carers of patients, as part of a large randomised controlled trial for a behaviour change intervention in paediatric type 1 diabetes patients. RESULTS: Results suggest that the PQDM in its current format is not an adequate measure of diabetes-specific health-related quality of life, with all 10 scales showing some form of misfit to the Rasch measurement model. Attempts to improve fit will be presented, demonstrating how Rasch analysis can be utilized to amend the outcome measures. In this case, only one of the scales could be improved a suitable form, though still proved problematic. CONCLUSIONS: This first analysis will be validated by conducting a second Rasch analysis of the PQDM in a separate randomised controlled trial of a home or hospital management intervention, again for paediatric patients with type 1 diabetes. By reworking this measure, and indeed any other measure, via Rasch analysis, we will have increasingly more psychometrically relevant, numerically valid and statistically reliable measures to use as trial endpoints, making greater use of accrued trial data in secondary analyses.

(304.6) Global mobility and quality of life in accompanying children Maria M. Bellinger, Federal Foreign Office, Berlin, Germany; Heiko Ru¨ger, Federal Institute for Population Research, Wiesbaden, Germany; Stine Waibel, Federal Institute for Population Research, Wiesbaden, Germany; Silvia Ruppenthal, Federal Institute for Population Research, Wiesbaden, Germany; Herbert Fliege, PhD, Health Service, Federal Foreign Office of Germany, Berlin, Germany AIMS: In a globalised world more and more people spend part of their working life abroad. The term ‘‘third culture kids’’ (TCKs) refers to the children of highly mobile parents who have lived in different countries and grown up in different cultures. Numerous field reports and qualitative studies reveal that TCKs are less likely to feel at home in one single country. They have a large circle of friends, often spread across the globe, yet their contacts are defined by repeated separations and losses. Their school career gives them many opportunities (multilingualism, intercultural skills), but their emotional development is often marked by experiences of alienation and loss. Quantitative empirical data on the health-related quality of life (HRQOL) of TCKs has not been available until now. A study conducted by the German Federal Foreign Office in cooperation with the German Federal Institute for Population Research examined the risks and opportunities of a mobile life in the diplomatic service for children accompanying their parents abroad. METHODS: An online questionnaire was applied to survey n = 258 children of German diplomats who were still living at home at the time of the investigation (age range 8 to 21 years). Aims of the study were to determine the children’s HRQOL (using the KIDSCREEN-10), identify

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Qual Life Res (2014) 23:1–184 potential risk factors (e.g. problems with language acquisition) and potential protective factors (e.g. self-efficacy, mobility competence). RESULTS: The children’s HRQOL was higher if they had a positive attitude to moving around, if they had no problems learning the language after their most recent move and if they were convinced that they can solve problems themselves (high self efficacy). They then find it easier to adapt to a new environment. No differences were observed between boys and girls. Children who had negative experiences of their last move were more likely to have problems settling into a new environment. CONCLUSIONS: Overall the HRQOL of the children was significantly lower when compared to kids of the same age in the general German population. We discuss possible explanations for our findings and provide recommendations for organizations posting staff around the world to improve the well-being of children accompanying their parents abroad.

305: Evaluating Impact of Cancer on Quality of Life (305.1) Relationship between Quality of Life, Distress, and Immune Biomarkers among Cancer Survivors Lari Wenzel, PhD, University of California, Irvine, Irvine, CA, United States; Kathryn Osann, Ph.D., University of California, Irvine, Irvine, CA, United States; Susie Hsieh, University of California, Irvine, Irvine, CA, United States; Jo Anne Tucker, University of California, Irvine, Irvine, CA, United States; Edward Nelson, University of California, Irvine, Irvine, California, United States AIMS: Chronic stress is often reported as severe or prolonged psychological distress or quality of life (QOL) disruptions. Heightened and sustained stress can disrupt the psychneuroimmune axis in a variety of domains. Certain cancer survivor populations are especially vulnerable to a chronic stress response. In this study, we describe the longitudinal relationship between cervical cancer patient-reported heightened distress, compromised QOL, and stress-related immune biomarkers. METHODS: Patient-reported outcomes (PROs) and biological specimens were collected at baseline, four and nine months post trial enrollment (N = 204). PROs included quality of life, as measured by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx), and PROMIS short forms for depression and anxiety. Changes over time in PROs were analyzed using multivariate analysis of variance methods for repeated measures adjusting for age and baseline values. Associations between cytokines and PROs were investigated across all subjects by comparing mean change in PROs between subjects with decreasing or increasing cytokines. RESULTS: After adjusting for baseline score and age, the patients who experienced decreasing Th2 cytokines IL-4 (p = 0.001), IL-5 (p = 0.013), and IL-13 (p = 0.002) between baseline and the four month assessment had significantly greater improvement in QOL, compared to those who had increasing cytokines. These significant relationships held for the FACT-G total score, as well as the Additional Concerns subscale score. A similar pattern of association was observed with decreasing IL-10 (p = 0.003), a counter-regulatory cytokine. Further, patients with decreasing IL-6 had an average decrease (improvement) in depression of 4.4 whereas patients with increasing IL-6 experienced no change in depression (decrease of 0.3) (difference associated with IL-6 = -4.1, p = 0.010). Similarly, decreasing IL-6 was associated with an improvement in anxiety of 4.1, where patients with increasing IL-6 had no change in anxiety (difference associated with IL-6 = -3.8, p = 0.023). CONCLUSIONS: TH2 cytokines decrease with improved QOL and improved distress. In addition, IL-6 decreases with improvements in depression and anxiety. This provides support for a biobehavioral paradigm for future inquiry in vulnerable cancer survivor populations.

Qual Life Res (2014) 23:1–184 (305.2) Psychiatric morbidity and survival following oesophageal cancer surgery Anna Wikman, Karolinska Institutet, Stockholm, Sweden; Ylva V. Hellstadius, Molecular Medicine and Surgery, Stockholm, Sweden; Mohammed A. Johar, B.Sc.(Hons), M.Sc., Karolinska Institutet, Stockholm, Sweden; Pernilla Lagergren, Professor, Karolinska Institutet, Stockholm, Sweden AIMS: There is limited knowledge of the psychological consequences of oesophageal cancer. We aimed to determine the prevalence of, and risk characteristics for, post-operative new-onset psychiatric morbidity and to establish the impact on survival among surgically treated oesophageal cancer patients. METHODS: A nationwide Swedish cohort of 1615 patients, who underwent surgery for oesophageal cancer between 1987 and 2011, was linked to national health registries for information on psychiatric morbidity (hospitalization for psychiatric disorders and prescribed psychotropic drugs). Standardised prevalence ratio (SPR) was calculated to compare the prevalence of psychiatric morbidity in the cohort to that of the general population. Multivariable logistic regression was used to determine potential risk characteristics. Cox proportional hazard model with psychiatric morbidity status (any hospitalization for psychiatric disorders versus none, and any prescribed psychotropic drugs versus none) as a time dependent covariate, providing adjusted hazard ratios (HR) with 95 % confidence intervals (CI), was used to analyse the overall survival, while age, sex, tumour stage, tumour histology, education and marital status. RESULTS: In patients without previous psychiatric morbidity, 2 % were hospitalized with a psychiatric disorder, and 31 % were prescribed psychotropic drugs, following oesophageal cancer surgery, with a substantially elevated SPR of psychiatric morbidity (ranging from 2.17 to 3.89). None of the clinical (tumour stage and histology) or sociodemographic variables (sex, age, educational level and marital status) were associated with new-onset psychiatric morbidity following surgery. Post-operative new-onset psychiatric morbidity was associated with statistically significantly increased mortality (HR 1.82, 95 % CI 1.24–2.69, and HR 3.19, 95 % CI 1.88–5.41, for psychiatric diagnoses and users of psychotropic drugs, respectively). CONCLUSIONS: These results highlight the importance of recognizing and addressing the psychiatric morbidity which may be experienced by surgically treated oesophageal cancer patients.

(305.3) Healthcare-Related Financial Distress is Associated with Symptoms in US Adult Cancer Survivors Arnold L. Potosky, PhD, Georgetown University, Washington, DC, United States; Roxanne E. Jensen, PhD, Georgetown University, Washington, DC, United States; Grace Zhou, Georgetown University; Carol M. Moinpour, PhD, Fred Hutchinson Cancer Research Center, Seattle, WA, United States AIMS: Assess the demographic and clinical factors associated with financial distress related to healthcare and the association of that distress with anxiety, depression, and fatigue. METHODS: We enrolled a randomly sampled group of 5,500 persons ages 21–84 diagnosed with one of 7 cancers between 6 and 13 months after initial diagnosis (median = 9 months) in a PROMIS Network study entitled Measuring Your Health (MY-Health). Between 2011 and 2013, subjects completed mailed surveys that included a 4-item subscale on financial burden related to healthcare costs from the RAND Patient Satisfaction Questionnaire (PSQ-III). We defined serious financial distress as having a score on this scale of greater than 65 (on a 0–100 sub-scale score). PROMIS domains were administered on symptoms. We linked all survey variables to clinical variables from cancer registries. We used 3 multiple logistic regression models to assess the association of financial

65 distress on each symptom controlling for all other personal and clinical variables. For each symptom (0–100 scale) we used a binary outcome with a t-score of 55 or greater (5 points or ‘ SD above the U.S. population mean) as a measure of having clinically meaningful symptoms. RESULTS: In 4,975 survivors with complete information, we found that 19 % reported serious financial distress related to healthcare. In our cohort, 34, 30, and 41 % reported having anxiety, depression, and fatigue, respectively. Higher financial distress was strongly associated with the following demographic factors: younger age at initial diagnosis, black or Hispanic race-ethnicity, and lower income (all p \ 0.001). Persons under age 65 reporting no insurance coverage reported the highest financial distress. Higher financial distress was significantly associated with increased anxiety (OR 1.5, 95 % CI 1.3–1.8), depression (OR 1.6, 95 % CI 1.3–2.0), and fatigue (OR 1.7, 95 % CI 1.4–2.1) after controlling for multiple other sociodemographic and clinical variables. CONCLUSIONS: Financial distress related to healthcare is prevalent within the first year following a new cancer diagnosis, and occurs disproportionately among the most vulnerable subgroups. Financial distress is independently related to increased levels of psychological and physical symptoms in a heterogeneous study cohort with excellent generalizability to adult cancer survivors in the US healthcare system.

(305.5) Quality of life spillover among spouses with and without cancer Kristin Litzelman, National Cancer Institute, Rockville, MD, United States AIMS: Poor health of one spouse can adversely influence the partner’s health outcomes (‘‘spillover’’). This study aimed to estimate quality-oflife spillover among spouses, and to determine how presence of cancer influenced these effects. METHODS: We examined data on husbandwife dyads from 11 panels of the 2000–2011 Medical Expenditures Panel Survey (n = 23,120 dyads without cancer; n = 606 dyads, cancer diagnosed in wife; n = 645 dyads, cancer diagnosed in husband), a population-based survey of the U.S. Mental and physical health-related quality of life (HRQOL, Short-form 12) were reported at two time points 6–12 months apart (T1 and T2). Depression was measured in dyads surveyed after 2004 (Patient Health Questionnaire, cutpoint = 3). Dyadic multilevel models evaluated the cross-lagged impact of HRQOL and depression at T1 on spouses’ HRQOL at T2, controlling for age and health conditions. RESULTS: Small but statistically significant spillover

Husband Mental HRQoL

4.7*

Husband Mental HRQoL

(per standard deviation)

Wife Mental HRQoL

4.7*

Wife Mental HRQoL

(per standard deviation)

T1

T2

Fig. 1 Mental HRQoL spillover between spouses. *p \ 0.0001; estimates represent change in T2 HRQoL per standard deviation increase in T1 HRQoL; HRQoL health-related quality of life (SF-12); T1 and T2 were 6–12 months apart; data are from the Medical Expenditures Panel Survey, 2000–2011, US; n = 23,120 dyads without cancer

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66

Qual Life Res (2014) 23:1–184 Mental HRQoL Husband Depression

-4.0*

Physical HRQoL

Husband Mental HRQoL

Husband Depression

Wife Mental HRQoL

Wife Depression

Husband Mental HRQoL

Husband Depression

Wife Mental HRQoL

Wife Depression

-2.1*

Husband Physical HRQoL

No Cancer (n=13,581 dyads)

Wife Depression

Husband Depression

Wife Cancer (n=365 dyads)

Husband Cancer (n=410 dyads)

Wife Depression

Husband Depression Wife Depression T1

-2.4*

-6.9*

-3.8*

-1.3

-6.0*

Husband Mental HRQoL

Husband Depression

Wife Mental HRQoL

Wife Depression

T2

T1

-1.8*

-0.2

-3.7*

0.5

1.0

Wife Physical HRQoL

Husband Physical HRQoL Wife Physical HRQoL

Husband Physical HRQoL Wife Physical HRQoL T2

Fig. 2 Depression spillover onto spousal HRQoL. *p \ 0.05; HRQoL health-related quality of life (SF-12), T1 and T2 were 6–12 months apart; data are from the Medical ExpendituresPanel Survey, 2004–2011, US; red text indicates spouse with cancer was observed for HRQOL. A one standard deviation (10 point) increase in husbands’ mental HRQOL at T1 was associated with a 1.1 point increase in wives’ mental HRQOL at T2 (p \ 0.0001). Similarly, for each 10 point increase in wives’ mental HRQOL, husbands had T2 HRQOL that was 0.9 points higher (p \ 0.0001). There were similar spillover effects for physical HRQOL and depression (Fig. 1). HRQOL spillover did not differ significantly when one spouse had been diagnosed with cancer. However, the spillover of depression onto HRQOL was greater when one spouse had cancer (Fig. 2). Specifically, when wives had cancer, women whose husbands were depressed at T1 had mental HRQOL 4.5 points lower at T2 than women with non-depressed husbands (p \ 0.01). When husbands had cancer, men with depressed wives had mental HRQOL that was 3.6 points lower and physical HRQOL that was 5.4 points lower than men with non-depressed wives. Further, depression in these men was deleterious to wives’ physical HRQOL (beta = -2.9, p \ 0.05). CONCLUSIONS: Differential spillover effects for dyads with and without cancer were observed for depression but not HRQOL. Depression may adversely influence spouses’ ability to care for their partners with cancer, or may be a stronger emotional contagion than poor HRQOL. Screening for and treating depression in cancer survivors and their spouses may substantially improve HRQOL in both spouses.

(305.6) A longitudinal study on the impact of active surveillance for prostate cancer on anxiety and distress levels Lionne DF Venderbos, Erasmus University Medical Center, Rotterdam, Netherlands; Roderick CN Van Den Bergh, Erasmus University Medical Center, Rotterdam, Netherlands; Monique J. Roobol, Erasmus University Medical Center, Rotterdam, Netherlands; Fritz H. Schro¨der, Erasmus University Medical Center, Rotterdam, Netherlands; Marie-Louise Essink-Bot, PhD, University of Amsterdam, Amsterdam, Netherlands; Chris H. Bangma, Erasmus University Medical Center, Rotterdam, Netherlands; Ewout Steyerberg, Erasmus University Medical Center, Rotterdam, Netherlands; Ida J. Korfage, PhD, Erasmus MC, Rotterdam, Netherlands AIMS: Patients with potentially indolent prostate cancer (PC) can be managed with active surveillance (AS). Living with untreated cancer may result in increased levels of anxiety and distress. Our objective was to analyse how anxiety and distress develop in men with untreated PC and whether men with high levels of anxiety or distress

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quit AS. METHODS: The Prostate cancer Research International: Active Surveillance study (PRIAS) is a protocol-based, multicentre, prospective, observational trial on the value of AS for PC. Within 6 months following their diagnosis we invited 150 Dutch PRIAS participants to participate in an additional prospective, longitudinal quality of life (QOL) study. Participants completed questionnaires with validated measures on anxiety and distress at inclusion (t = 0), 9 (t = 9) and 18 (t = 18) months after diagnosis. We assessed changes in scores on depression (CES-D), generic anxiety (STAI-6), PC specific anxiety (MAX-PC), and decisional conflict (DCS) about patients treatment choice between t = 0, t = 9 and t = 18 using repeated measures analysis. RESULTS: Response rates for patients still on AS at t = 0, t = 9 and t = 18 assessments were 86, 90 and 96 %. Nine patients (7 %, 9/129) between t = 0 and t = 9, and 33/108 patients (31 %) between t = 9 and t = 18 stopped AS; mostly (86 %) due to protocol-based reasons. CES-D, total MAX-PC, and DCS scores did not change significantly (p [ 0.05) when comparing t = 18 with t = 9 and t = 0 scores, but generic anxiety (STAI-6; p = 0.033) and fear of disease progression (sub-score of the MAXPC; p = 0.007) decreased significantly. These differences, however, were clinically modest (0.089 SD and 0.281 SD, both \ 0.5 SD). Eight of 26 men who were highly anxious at baseline became less anxious while on AS and two of 26 men stopped AS because of anxiety. Overall, 6/129 men (5 %) discontinued AS due to anxiety and distress. CONCLUSIONS: Levels of anxiety and distress remained low for men opting for AS during at least 18 months. Only 6 out of 129 men discontinued AS due to anxiety or distress, suggesting that negative QOL-effects are limited in men who are carefully selected for AS. (Registered trial number, NTR1718.)

Poster Session 1001: Thursday Poster Session 1 Cancer (1003) Comparison of different generic and lung cancer specific quality of life instruments for their predictive ability of survival in patients with advanced lung cancer Sultan Eser, Hacettepe University, Institute of Public Health, Ankara, Turkey; Tuncay Go¨ksel, Ege University, Faculty of Medicine, Department of Chest Diseases, Izmir, Turkey; Ahmet Emin Erbaycu, Dr Suat Seren Chest Diseases and Thoracic SER Hospital, Izmir, Turkey; Erhan Eser, MD, Celal Bayar University, School of Medicine, Dept. Public Health, Manisa, Turkey; Burcu Basarik, Ege University, Faculty of Medicine, Department of Chest Diseases, ¨ z, Celal Bayar Univ. Faculty of Medicine, Izmir, Turkey; Aysen O Manisa, Turkey; Kader Kiyar Gu¨rsul, Izmir Dr Suat Seren Chest Diseases and Thoracic SER Hospital, Izmir, Turkey; Pinar C¸elik, Celal Bayar Univ. Faculty of Medicine, Manisa, Turkey; Ebru C¸akir Ediz, Trakya University, Faculty of Medicine, Department of Chest Diseases, Edirne; Osman Hatipoglu, Trakya University, Faculty of Medicine, Department of Chest Diseases, Edirne; Bedriye Atay Yayla, Pamukkale University, Faculty of Medicine, Department of Chest Diseases, Denizli; Sevin Bas¸ er, Pamukkale University, Faculty of Medicine, Department of Chest Diseases, Denizli; Hakan Baydur, Celal Bayar University School of Health Sciences, Manisa AIMS: Several studies have recently reported that baseline health-related quality of life (HRQOL) is a prognostic factor for survival in lung cancer patients. Most of these studies used only one HRQOL instrument. The objective of this study was to examine the relationship of different generic and lung cancer specific QOL instruments such as EORTC QLQc30, QLQ-LC13; FACT-L, LCSS, EQ-5D and survival in patients at stage 3b and stage 4. having various types of lung cancer undergoing a variety

Qual Life Res (2014) 23:1–184 of treatments. METHODS: This study was carried out within the framework of the national multicenter Project titled ‘‘the Lung Cancer Quality of Life Project (AKAYAK)’’ and totally 299 lung cancer patients were included in this study who were recruited from five comprehensive centers in Turkey. The scores of the HRQOL instruments and clinical variables at baseline were analyzed using Cox’s proportional hazard regression to identify factors that influenced survival. Univariate and multivariate models were for each of the EORTC QLQc30, QLQ-LC13; FACT-L, LCSS, EQ-5D scales. RESULTS: Mean and median survival of these 229 patients were 12.5 and 8.0 months respectively. After adjustment for age, sex, clinical stage (as TNM) and comorbidity, symptom scales of fatigue, insomnia, appetite loss and constipation were associated with survival in lung cancer patients. After adjustment, Global scale and physical functioning and role functioning scales of the QLQc30 instrument; physical well-being, functional well-being scales LCS and TOI scores of the FACT-L instrument; and four of five dimensions (mobility, self-care, usual activities and pain) of the EQ-5D were also significantly associated with survival. None of the scales of the LC13 and LCSS were remained statistically significant after adjustment. The results of multivariate analysis showed that Mobility and Usual activities dimensions of the EQ-5D; Constipation symptom scale of the QLQ-c30; and LCS and TOI scores of the FACT-L remained statistically significant after adjustment. CONCLUSIONS: HRQOL serves as an additional predictive factor for survival that supplements traditional clinical factors such as age, gender, stage and comorbidity in lung cancer patients. FACT-L and the EQ-5D are the most promising QOL instruments for this purpose.

(1005) Patient-centered evaluation of treatment outcomes in cml patients after 12 months of secondline treatment: quality of life and symptom burden Tatiana I. Ionova, Multinational Center for Quality of Life Research, St. Petersburg, Russian Federation; Denis A. Fedorenko, PhD, National Medical Surgical Center, Moscow, Russia; Tatiana Nikitina, PhD, Multinational Ctr for QOL Research, Saint Petersburg, Russia; Kira Kurbatova, Multinational Center for Quality of Life Research, Saint-Petersburg, Russian Federation AIMS: The efficacy and safety of the second-line therapy with dasatinib in patients in chronic phase chronic myeloid leukemia (CML) was been reported from physician’s perspective. In order to provide comprehensive information about the risks and benefits of new treatment modalities in this patients’ population evaluation of patient’s perspective is worthwhile. We aimed to study the efficacy and safety of dasatinib in CML patients with imatinib resistance or intolerance both from physician’s and patient’s perspective. METHODS: 75 CML-CP patients resistant or –intolerant to imatinib were enrolled in the study (mean age—51.3 years old, SD 15.4; male– female – 37/38). The median of disease duration was 5.8 years (0.75–17 years). All the patients received dasatinib as the second-line therapy. Median follow-up was 12 months. For quality of life (QOL) and symptom assessment patients filled out the SF-36 and Comprehensive Symptom Profile in Chronic Myeloid Leukemia Patients (CSP Leuk-CML) before and at 12 months after treatment start. Mean symptom severity and percentage of patients with moderate-to-severe (ratings = 5) symptoms was evaluated. RESULTS: After 12 months of dasatinib treatment 22 patients (35.5 %) achieved or maintained complete hematologic and complete cytogenetic response. Among them 17 patients (77.3 %) had QOL improvement or stabilization, 5—QOL worsening (22.7 %). The following distribution according to symptom severity was observed: 10 patients (45.5 %) experienced

67 either no or mild symptoms; 12 patients—a number of moderate-tosevere symptoms. In the latter group physicians reported dasatinib side effects only in 7 patients (headache, artralgya/myalgia, palpitation, superficial edema). Self-reported list of problems was broader than in physician’s reports. The most frequent and severe symptoms reported by patients were dizziness, fatigue, decreased work energy, bloating, sleeping problems. All these symptoms may be caused by treatment side effects as well as by disease impact; both contribute to symptom burden and QOL worsening and may be considered by physicians in their decision-making during the follow-up. CONCLUSIONS: Complete remission in CML is not always accompanied with QOL improvement; a number of patients experience moderateto-severe symptoms which are underestimated by physicians. Patientoriented approach to evaluate treatment outcomes may be of value to improve quality of care of this patient population.

(1007) Symptoms and biomedical factors show who is at risk of poor quality of life and high cost in multiple myeloma—a systematic review and metaanalysis Christina Ramsenthaler, Cicely Saunders Institute, King’s College London, London, United Kingdom; Pauline M. Kane, Cicely Saunders Institute, King’s College London, London, United Kingdom; Richard J. Siegert, Auckland University of Technology, Auckland, New Zealand; Wei Gao, Cicely Saunders Institute, King’s College London, London, United Kingdom; Polly Edmonds, Department of Palliative Care, King’s College Hospital; Steve Schey, Department of Haematological Medicine, King’s College Hospital; Irene J. Higginson, Cicely Saunders Institute, King’s College London, London, United Kingdom AIMS: Multiple myeloma is associated with a higher burden of disease than other haematological cancers. To target services towards those in need of intervention, we need to understand who is at risk of developing a poor outcome. The aim of this meta-analysis is to systematically review and analyse the strength of association between risk factors and the outcomes health-related quality of life (HRQOL), cost and health care utilization in multiple myeloma. METHODS: We searched Medline, Embase, PsycINFO, Cinahl, Assia, the Cochrane library and NHS EED database, journals and citations using keywords/subject headings for myeloma and QOL or cost/health care use. Inclusion criteria: Studies reporting associations in samples [ 50 % myeloma. Two independent reviewers assessed methodological quality using Hayden’s checklist for prognostic studies. Data synthesis used Fisher’s z method for meta-analysis of correlation coefficients and random effects models for combining effect sizes per independent factor. RESULTS: Of 24,953 references, 49 studies totaling 18,206 participants were included. No study reported associations for both outcomes. The largest effect sizes were found for nutritional risk and fatigue (r = -0.54, 95 % CI -0.73 to -0.35; and r = -0.52, 95 % CI -0.57 to -0.47), associated with poor HRQOL. Other symptoms and physiological parameters like M-protein level, creatinine, C-reactive protein, tumour necrosis factors and proinflammatory cytokines showed medium associations. High haemoglobin was a moderate protective factor for HRQOL (r = 0.39, 95 % CI 0.33 to 0.44). Demographic, disease- and treatment-related factors showed weak associations only, except for response to treatment (achieving at least a partial response, r = 0.29, 95 % CI 0.24 to 0.34). Treatment-related factors were the main drivers of cost (days in intensive care, number of laboratory procedures). A higher platelet count was weakly associated with lower costs (r = -0.22, 95 % CI 0.38 to -0.05). CONCLUSIONS: Traditionally considered risk factors (age, ethnicity, gender, response to treatment) are not major drivers of HRQOL/cost. Early detection of those at risk for developing poor HRQOL or higher cost/health care usage should consider

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68 symptoms as well as biochemical factors and cannot focus on response to treatment and assessment of paraproteins alone. Routine assessment of symptoms/HRQOL should complement biochemical monitoring to promote patient-centred care.

(1011) Patient-Reported Outcomes in a Randomized Trial of Bevacizumab in the Treatment of Advanced Cervical Cancer: a Gynecologic Oncology Group Study Richard T. Penson, Massachusetts General Hospital; Helen Q. Huang, MS, GOG Statistical & Data Center, Buffalo, NY, United States; Lari Wenzel, PhD, University of California, Irvine, Irvine, CA, United States; Krishnansu Tewari, University of California, Irvine, Irvine, CA, United States; Bradley J. Monk, St. Joseph’s Hospital; Michael Sill, GOG Statistical & Data Center; Sharon Stockman, University of Iowa, United States; Lois Ramondetta, Univ. of Texas, MD Anderson Cancer Center, Houston, TX, United States; Lisa Landrum, Oklahoma University Health Science Center, United States; Ana Oaknin, GEICO Barcelona; Thomas Reid, Kettering Med Center, Mario Leitao, Memorial Sloan-Kettering Cancer Center, New York, NY, United States AIMS: A recent randomized phase 3 trial concluded that chemotherapy (Ctx) (cisplatin-paclitaxel (CP); topotecan-paclitaxel (TP)) plus bevacizumab (Bev) significantly improves overall survival (OS), progression-free survival (PFS), and response rates compared to Ctx alone in recurrent/persistent/metastatic cervical cancer. In this study we examine the patient-reported outcomes (PROs) of this trial. METHODS: The PROs included the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index (FACT-Cx TOI), the FACT/GOG-Neurotoxicity (Ntx) subscale, and one item of the Brief Pain Inventory (BPI). Assessment time points were pre-cycle 1, 2, and 5 and at 6 and 9 months post-cycle 1. Differences in the FACT-Cx TOI scores were assessed using a linear mixed model adjusting for baseline score and age. A mixed effects mixed distributions (MEMD) model was fitted to evaluate treatment differences of likelihood to report neurotoxicity and pain, and severity of these symptoms. Because the original study design tested two independent hypotheses (impact of Bev; substitution of topotecan for cisplatin), the significance level for the FACT-Cx TOI and the FACT/GOG-Ntx was set to 0.0125, and the level for the BPI was set to 0.05 for exploratory purposes. RESULTS: 452 patients were accrued from 4/6/09 to 1/3/ 12. 96 % completed baseline PROs assessment, with declining completion rates to 63 % at 9 months post-cycle 1. The completion rates were not statistically different among the treatment regimens over the assessment points (p = 0.67). The fitted mixed model estimates indicated that patients receiving Ctx ? Bev reported 1.2 points (98.75 % CI -4.1–1.7; p = 0.3) lower QOL on average than those with Ctx alone, although this was not a significant difference. The fitted MEMD model estimates indicated that there was no significant difference between patients with and without Bev on reported symptoms of neurotoxicity (overall odds ratio: 0.58; 98.75 % CI 0.29–1.17; p = 0.053), or the severity of neurotoxicity symptoms (p = 0.7). The model estimates also indicated that Bev had similar effects on the odds of reporting pain (odds ratio = 0.89; 95 % CI 0.36–1.42; p = 0.7) and pain severity (p = 0.16). CONCLUSIONS: Improvements in OS and PFS attributed to Bev were not accompanied by any significant deterioration in QOL.

(1013) Comparison of three longitudinal analysis models for the healthrelated quality of life in oncology: a simulation study Ame´lie Anota, Quality of Life in Oncology Platform, France, Besanc¸on, France; Antoine Barbieri, Biometrics Unit, ICM—Val

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Qual Life Res (2014) 23:1–184 D’Aurelle, Montpellier, France, Montpellier, France; Marion Savina, Institut Bergonie´, Bordeaux, France; Alhousseiny Pam, University Hospital of Besanc¸on, Besanc¸on, France; Sophie Gourgou-Bourgade, CRLC Val D’Aurelle, Montpellier, France; Franck Bonnetain, PhD, University Hospital of Besanc¸on, Besanc¸on, France; Caroline Bascoul-Mollevi, ICM | Val D’Aurelle, Montpellier, France, Montpellier, France AIMS: Most clinical trials now integrate Health-related Quality of Life (HRQOL) as one of the major endpoints to investigate the clinical benefit of new therapeutic strategies for the patient and the health system. However, longitudinal analysis of HRQOL remains complex and unstandardized. Moreover, it is necessary to propose accessible statistical methods and meaningful results for the clinician. The objective was to compare three strategies of longitudinal analyses for HRQOL data in oncology clinical trials through a simulation study. METHODS: The methods proposed were the score and mixed model (SM), the longitudinal partial credit model (LPCM) and survival analysis approach based on the time to HRQOL score deterioration (TTD). Simulations compared the methods regarding the type I error and statistical power of the test of an interaction effect between treatment arm and time. Longitudinal HRQOL data were performed using a LPCM considering that the latent trait (HRQOL) follows a multivariate normal distribution. Several scenarios of simulations were explored based on the EORTC HRQOL questionnaires and varying the number of patients (100, 200 or 300), items (1, 2 or 4) and response category per item (4 or 7). Five or 10 measurement times were considered with a low to high correlation between each measure. The impact of informative missing data on these methods was also studied to reflect most of clinical trials. RESULTS: With complete data, type I error rate were closed to the expected value (5 %) for all methods and SM method was the most powerful method. The power of the TTD is low for uni-item dimension because only four possible values exist for the score. When the number of items increases, the power of TTD method increases while the power of LPCM and SM remains stable. For 10 measurement times, the LPCM is less efficient. With informative missing data, the results for SM and LPCM are similar whereas the power of TTD method increases. CONCLUSIONS: To conclude, SM method is as efficient as LPCM. Moreover, the TTD approach, which began to be used extensively in HRQOL data analysis, could be optimal for phase III clinical trials with a multi-item scale.

(1015) Symptom Burden and Health-Related Quality of Life in Patients with Unresectable or Metastatic Melanoma: Results from the IMAGE Study Susan D. Mathias, MPH, Health Outcomes Solutions, Winter Park, FL, United States; Srividya Kotapati, Bristol-Myers Squibb; T Kim Le, Bristol-Myers Squibb; Amy P. Abernethy, Duke Comprehensive Cancer Center AIMS: Advanced melanoma is an aggressive malignancy, representing significant unmet medical need. Common cancer-related symptoms include fatigue, pain, weight loss, loss of appetite, and bowel problems, all impacting health-related quality of life (HRQOL). IMAGE is an ongoing multinational, prospective, observational study of unresectable or metastatic (advanced) melanoma in a real-world setting; baseline HRQOL results were compared to other cancer types. METHODS: EORTC-QLQ-C30 and EQ-5D scores (unadjusted) for individuals upon enrollment into IMAGE were compared with published data (2009–2013) from studies of stage III melanoma, metastatic colorectal, metastatic breast, prostate, advanced renal cell, lung cancer, and an overall cancer group. RESULTS: Baseline data were available for 357 IMAGE patients (mean age: 62 ± 13 years; 61 % male; 96 % Stage IV cancer; 75 % co-morbid

Qual Life Res (2014) 23:1–184 Table 1

69

Mean baseline (first) EORTC scores by cancer type

Measure

IMAGE

Resected

Metastatic Finnish

Patients

Stage III

Colorectal Metastatic Breast

Refractory

receiving

Colorectal receiving

Prostate

after full

first line

(n = 110)

(n = 280)

lymphade-

treatment

chemo-

nectomy

(n = 137)

therapy

(n = 357) Melanoma

(n = 1,256)

Metastatic

palliative

Hormone-

in Korea (n = 199)

EORTC

conditions; 81 % ECOG performance status of 0 or 1; mean time since diagnosis: 42 ± 42 months). Mean EORTC scale scores (see Table 1) at baseline for IMAGE patients appeared lower (worse) on functioning and higher (worse) on symptom scores than patients from these published studies with only a few exceptions. The largest numeric differences in functioning were in global health status (57 vs 70), physical functioning (73 vs 85–90), and social functioning (66 vs 82) versus patients with resected Stage III melanoma; and role functioning (63 vs 80) and emotional functioning (68 vs 80) for Finnish metastatic colorectal patients. Symptom experience was also different. IMAGE patients reported lower (worse) EQ-5D Index and VAS scores compared to advanced renal cell, metastatic colorectal, metastatic breast, prostate, lung, and an all cancer patient group, with the exception that Index scores for the prostate and lung cancer groups were lower (see Table 2). CONCLUSIONS: Patients living with advanced melanoma appear more negatively impacted by symptoms, and physical and psychological aspects of HRQOL than many other advanced cancer patient populations. Longitudinal patient-reported data from an effective treatment for advanced melanoma has the potential to provide important information reflecting symptom and HRQOL improvement.

57

*70

66

*70

53

60

73

*85 to *90

73

*80

65

69

63

*70 to *73

27

*80

59

66

68

*78

25

*80

66

74

80

*91

11

*90

70

77

66

*82

24

*80

58

72

Cardiovascular

Fatigue

42

*22

31

*30

48

42

Nausea and

10

*3

5

*5

19

9

(1017) The most frequently reported symptoms of heart failure, their impacts on daily life, and why these matter with respect to clinical outcomes

31

*20

21

*15

35

34

Global health status Physical functioning Role functioning Emotional functioning Cognitive functioning Social functioning

vomiting Pain Dyspnoea

23

*6

19

*10

29

22

Insomnia

32

*19

29

*20

34

27

Appetite loss

23

*5

21

*10

35

20

Constipation

18

*7

14

*15

24

23

Diarrhoea

11

*4

20

*15

16

10

Table 2 Mean baseline (first) EQ-5D scores by cancer type Study population

EQ-5D Index EQ-5D VAS

IMAGE patients (N = 335)

0.7 ± 0.29

60.8 ± 21.47

Advanced renal cell carcinoma (Stage 0.72 ± 0.25 IV), treatment naı¨ve or cytokine pretreated (N = 430)

64.6 ± 23.69

Metastatic colorectal receiving first line 0.81 ± 0.22 treatment (N = 137)

72.5 ± 19.8

Finnish metastatic colorectal (N = 110)

0.82 ± 0.198 73.9 ± 17.7

Metastatic breast receiving palliative chemotherapy in Korea (N = 199)

0.82 ± 0.160 N/A

Hormone-refractory prostate (N = 280)

0.635

N/A

Stage III or IV lung cancer patients that 0.67 ± 0.22 had received at least 2 cycles or 1 month of chemotherapy (N = 50)

68 ± 18

All stage III or IV cancer patients that 0.72 ± 0.22 had received at least 2 cycles or 1 month of chemotherapy (N = 534)

68 ± 20

Renee F. Pierson, MBA, Janssen Pharmaceutical, Raritan, NJ, United States; Shana Traina, PhD, Janssen Research & Development, LLC, Raritan, NJ, United States; Lauren Braam, MIH, Health Research Associates, Inc., Seattle, WA, USA; Donald M. Bushnell, III, MA, Health Research Associates, Inc., Mountlake Terrace, WA, United States; Kelly P. McCarrier, PhD, MPH, Health Research Associates, Inc., Mountlake Terrace, WA, United States; Mona L. Martin, RN MPA, Health Research Associates, Inc., Mountlake Terrace, WA, United States AIMS: Heart failure (HF) is associated with poor health-related quality of life (HRQOL) resulting from the experience of diseaserelated symptoms and their impacts on physical functioning. The goal of HF treatment is to improve the patient’s condition and reduce the risk of mortality and hospitalization. Clinicians primarily rely on clinical indicators to determine a patient’s condition and gain an understanding of the disease trajectory; however, the patient can also provide information not available from clinical measures that can predict the probability of survival and need for future services. For example, lack of improvement in HRQOL after discharge from the hospital has been shown to predict re-hospitalization and mortality. METHODS: To explore the most frequently reported symptoms and impacts of HF, adults with clinician verified HF (NYHA class II-IV) for [ 1 year were recruited from 7 clinical sites across the US to participate in individual qualitative interviews. A semi-structured interview guide was used to elicit both symptoms and impacts relevant to the patient experience of HF. Interviews were audio-recorded, transcribed, and coded using Atlas.ti software to organize concepts by similar content. RESULTS: Thirty subjects participated in the interviews. The average age was 64, with 40 % female, and 67 % white (non-Hispanic), with an average left ventricular ejection fraction of 27.5 %. Swelling/fluid retention was the most frequently mentioned symptom (experienced by 87 % of interviewed patients and representing 13 % of symptom expressions), and was followed by shortness of breath (83 % of patients; 12 % of symptom expressions), and tiredness (73 % of patients; 11 % of symptom expressions). The

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70 greatest impacts of these HF symptoms were reported in the areas of physical activity/body movement limitations (100 % of patients and representing 26 % of impact expressions) and difficulty doing daily activities (97 % of patients; 17 % of expressions). CONCLUSIONS: Swelling, shortness of breath, and tiredness associated with HF limit physical activity and the ability to perform daily activities and may be predictive of mortality and hospitalization. When treating patients with HF, improvement and decline in these HRQOL concepts should be considered in addition to traditional results from more costly and invasive clinical tests to gain useful supplementary information.

(1019) An educational program to improve healthrelated quality of life in patients initiating oral anticoagulant therapy: a randomized controlled trial Fla´via M. Pelegrino, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Fabiana Bolela, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Rejane K. Furuya, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing, Ribeira˜o Preto, Brazil; Ma´rcia A. Ciol, School of Medicine, University of Washington, Seattle, WA, United States; Jeanne M. Hoffman, School of Medicine, University of Washington, Seattle, WA, United States; Andre´ Schmidt, School of Medicine of Ribeira˜o Preto, University of Sa˜o Paulo; Lidia A. Rossi, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil; Rosana Spadoti Dantas, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil AIMS: To test an educational program with telephone follow-up to improve health- related quality of life (HRQOL) in patients initiating oral anticoagulant therapy (OAT). METHODS: Patients initiating OAT in a Brazilian hospital were enrolled in the study from April 2011 to August 2012, and randomized to either an educational program with telephone follow-up (N = 40) or a control group (N = 40), stratified by their bleeding risk (low, medium, high). The intervention group received face-to-face counseling, booklets, and telephone follow-up, while the control group received only routine instructions given by the hospital. Two months after discharge HRQOL was measured by the Duke Anticoagulation Satisfaction Scale (DASS), which has 25 items addressing three domains: Limitation, Hassles and Burdens, and Psychological Impact, with a possible total score of 25–75 (lower scores indicate better HRQOL). At hospitalization and at two months post discharge, symptoms of anxiety and depression were assessed with the Hospital Anxiety and Depression Scale (HADS; range 0–21, higher scores indicating more symptoms in both subscales). Data were analyzed using descriptive statistics and t-tests. Significance level was set at 0.05. RESULTS: The groups were similar in mean age (59 years) and years of education (5 years), with more females in the intervention (65 %) than the control group (52.5 %). During hospitalization, there were no differences between the intervention and control groups in symptoms of depression (mean [SD] = 4.3 [3.5] vs. 5.2 [3.5]; p = 0.22) and anxiety (6.3 [5.0] vs. 6.7 [3.6]; p = 0.65). Two months after discharge, the intervention group had significantly less anxiety symptoms than the control group (4.4 [3.0] vs 6.9 [4.1]; p = 0.003) and similar depression symptoms (3.3 [3.6] vs 4.2 [3.5]; p = 0.23). HRQOL was significantly better in the intervention group than the control group for all domains: Total score (48.5 [12.0] vs. 60.0 [16.0]; p \ 0.001), Limitation (16.4 [6.1] vs. 21.2 [8.6]; p = 0.006); Hassles and Burdens (13.1 [4.1] vs. 16.5 [6.0]; p = 0.004); and Psychological Impact (19.0 [4.7] vs. 22.3 [5.7]; p = 0.007). CONCLUSIONS: The educational program with telephone follow-up is a promising intervention to improve HRQOL and reduce anxiety symptoms in individuals starting OAT. Sa˜o Paulo Research Foundation (FAPESP), Grant 2010/10006-8, sponsored this study.

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Qual Life Res (2014) 23:1–184 (1021) The effect of hypertension diagnosis on change in quality of life: therole of personality, social support and initial chronic disease status Eithne Sexton, Royal College of Surgeons in Ireland, Dublin, Ireland; Bellinda L. King-Kallimanis, PhD, TILDA, Trinity College Dublin, Dublin, Ireland; Richard Layte, Economic and Social Research Institute; Anne Hickey, Royal College of Surgeons in Ireland AIMS: Hypertension is one of the most common chronic conditions among older adults; however, evidence concerning its effects on quality of life (QOL) is inconsistent. The aim of this paper was to examine the effect of an incident hypertension diagnosis on change in QOL over two years, and the extent to which this effect varied according to baseline chronic disease status, social support and personality METHODS: Data was obtained from two waves of the Irish Longitudinal Study of Ageing (TILDA), a study of community dwelling adults aged 50 ? (n = 4,355). QOL was measured using two dimensions of the CASP-R12—control/autonomy and self-realization/pleasure. The effect of a hypertension diagnosis on each QOL dimension at Wave 2 was examined using linear regression, adjusting for baseline QOL, and stratified by baseline chronic disease (0, 1 or [ 1). Interaction terms for social support (having a supportive spouse, relative or friend; community participation) and personality (NEO-PI Extraversion and Neuroticism) were examined. Age, sex, education, smoking, and obesity were adjusted for. RESULTS: Among participants who had no chronic conditions at baseline (n = 957), a hypertension diagnosis was associated with significant decline in control/autonomy (p = 0.01). The effect was significantly smaller for those who reported having a supportive friend (p = 0.02) and for those higher on Extraversion (p = 0.02). When both interaction terms were included, the effect was significantly different for Extraversion score only (-0.93 at 1 SD below the mean, compared with 0.17 at ?1 SD). Hypertension diagnosis was not associated with change in control/autonomy for participants with a single existing condition (n = 1,209) or existing multimorbidity (n = 2,189) at baseline, and had no effect on self-realization/pleasure, regardless of baseline chronic disease status. CONCLUSIONS: This analysis highlighted the complexities of how hypertension, a chronic disease which is common but not associated with significant symptoms or disability, can affect QOL among older people. In general, hypertension does not have a negative effect on QOL. However, it can have a negative effect on control dimensions among initially healthy people with more introverted personalities. This supports the importance of personal resources and characteristics as a filter of the chronic disease experience.

(1023) Minimal clinically important differences in Health-Related quality of life at 1-year post discharge in patients with heart failure Antonio Escobar, PhD MD, Hospital Universitario Basurto, Bilbao, Bizkaia, Spain; Amaia Bilbao, U. Investigacio´n Hospital Universitario Basurto. REDISSEC; Marta Gonzalez-Saenz de Tejada, Hospital Universitario Basurto; Ziortza Trancho, U. Investigacio´n Hospital Universitario Basurto; Raul Quiros, Hospital Costa del Sol, Marbella. REDISSEC; Lidia Garcia-Perez, FUNCIS. Servicio de Evaluacio´n. Servicio Canario de la Salud; Gema Navarro, Hospital Parc Taulı´. Sabadell; Iratxe Lafuente, Hospital GAldakao-Usansolo AIMS: The main objective of the present study was to provide data on values for the MCID at 12 months post discharge in patients with HF through the Minnesota Living with Heart Failure questionnaire (MLHFQ). Cut-off scores are provided in total sample and split up by readmissions on the previous 6 months

Qual Life Res (2014) 23:1–184 METHODS: This is a prospective study with 497 patients admitted by HF in Spain. Patients completed questionnaires during their hospitalization and at 12 months. The MLHFQ is a specific instrument which has 21 items with an overall scale, physical (8 items) and emotional (5 items) subscales. MLHFQ items are scoring from 0 (best) to 5 (worse). Total score ranges from 0 to 105, physical domain from 0 to 40 and emotional from 0 to 25. At 12 months patients fulfilled again the MLHFQ and two separate anchor transition questions, one in each domain with five responses (much worse, worse, equal, better and much better). MCID was estimated by the mean change score for those patients who at 12 months declared changes as ‘‘better than before’’. In addition we have calculated MCID in patients who were readmitted and no readmitted in the previous six months. RESULTS: Mean age was 76.5 (SD = 10.4) and there were a 56.1 % of men. In the physical dimension the estimated MCID was 10.6 and in the emotional one was 2.5 points. In the overall score the mean improvement was 19.3 points. However there was important differences between patients readmitted (n = 100) and no readmitted (n = 397). MCIDs in physical domain were 0.5 vs 12.7 points and in the emotional domain—1.4 vs 3.4 points respectively. CONCLUSIONS: This study provides new insights into the MCID of MLHFQ in patients with HF. However it should be taken into account the status of previous readmissions of these patients

(1025) Responsiveness of EQ-5D-5L in patients with stroke Dominik Golicki, MD PhD, National Institute of Public Health, Warsaw, Poland; Maciej Niewada, Dept. of Experimental and Clinical Pharmacology, Medical University of Warsaw; Anna Karlinska, Institute of Psychiatry and Neurology, Warsaw, Poland; Julia Buczek, Institute of Psychiatry and Neurology, Warsaw, Poland; Adam Kobayashi, Institute of Psychiatry and Neurology, Warsaw, Poland; M.F. Janssen, Dept. of Medical Psychology and Psychotherapy, Erasmus MC, Erasmus University, Rotterdam, Netherlands; Simon Pickard, PhD, University of Illinois at Chicago, College of Pharmacy, Chicago, IL, United States AIMS: To assess responsiveness of EQ-5D-5L index in patients experiencing acute stroke. METHODS: We performed observational longitudinal cohort study of patients acute stroke. At 1 week and 4 months post-stroke, patients were administered the modified Rankin Scale (mRS) Barthel Index (BI), and self-completed the EQ-5D-5L and EQ-5D-3L, including the EQ-VAS. We classified patients according to two external criteria, based on mRS or BI, into ‘improvement’, ‘stable’ or ‘deterioration’ category. To assess responsiveness, we used following techniques: effect size (ES), standardized response mean (SRM), paired t-statistics, relative efficiency and area under the receiver operating characteristic curve (AUROC). RESULTS: A total of 112 patients (52 % females; mean age 70.6 years; 93 % ischemic stroke) completed all the instruments at both occasions. EQ-5D-5L change scores were strongly correlated with EQ-5D-3L (r = 0.74), moderately with EQ VAS (r = 0.48), and BI (r = 0.43), and poorly with mRS (r = - 0.31). Surprisingly, the correlation between mRS and BI change scores was only moderate (r = - 0.42). According to predefined mRS and BI criteria of change: 38.4 and 33.0 % of patients improved and 17.0 and 13.4 %, deteriorated, respectively. Looking at the whole sample, all indices of responsiveness pointed at the EQ-5D-5L index as the most responsive (ES 0.33; SRM 0.43), followed by EQ-5D-3L index (ES 0.31; SRM 0.36), EQ VAS (ES 0.26; SRM 0.30) and BI (ES 0.19; SRM 0.27). In subjects who improved according to BI external criterion, EQ-5D-3L index appeared to be more responsive (ES 0.82; SRM 1.06) than EQ5D-5L index (ES 0.71; SRM 0.86), and the last one being more responsive than EQ VAS (ES 0.65; SRM 0.69). An analysis according to mRS external criterion gave similar results. CONCLUSIONS: The

71 EQ-5D-5L proved to be responsive in patients with stroke, when measured four months after disease onset.

Nephrology/Urology (1027) Changes in depression from dialysis to transplantation: a longitudinal follow-up study Nanna Von der Lippe, University of Oslo, Oslo, Norway; Ba˚rd Waldum, University of Oslo, Oslo, Norway; Amin Amro, RN, MSN, Oslo University Hospital, Oslo, Norway; Fredrik B. Brekke, University of Oslo, Oslo, Norway; Ingrid Os, MD PhD, University of Oslo Medical School, Oslo, Norway AIMS: Depression is prevalent in all stages of chronic kidney disease, up to 30 to 40 % in dialysis patients. Cross-sectional studies have shown that kidney transplanted patients (RTX) have less depressive symptoms than patients dependent on dialysis, and that women report more depressive symptoms than men. Given the paucity of longitudinal data, the aim of our study was to assess depression in the transition from dialysis to transplantation. METHODS: A cohort of patients (n = 110, 37 females, median age 54 (IQR 39–62) years, GFR 54 (45–72) ml/min) was followed in a prospective study with measurements of depressive symptoms using Beck Depression Inventory (BDI) during the time in dialysis and after renal transplantation. Cut-off for clinical significant depressive symptoms was = 16. All analyses were performed separate for females and males. RESULTS: The cohort was followed for a median time of 55 (IQR 50–59) months, while the time after transplantation was 41 (34–51) months. There was no reduction in the proportion of patients with clinical depressive symptoms (12/71 vs. 11/71, p = 1.0). Fewer depressive symptoms were reported after transplantation compared to dialysis when BDI was used linearly (median 5.0 (2.0–10.0) vs. 8.0 (5.0–15.0), p = 0.004). In gender separate analyses, males had fewer depressive symptoms after transplantation than in dialysis (median 5.0 (1.5–5.5) vs. 8.0 (5.5–14.5), p \ 0.001), whereas there was no significant change in females (7.0 (3.0–15.5) vs 7.0 (4.0–16.0). No gender differences were revealed in the proportion of patients with clinically significant depression. There was no significant reduction in the proportion of patients with clinical depression even if lower cut-off values for BDI were used (=14 or =11). The latter cut-off is often used in the general population. CONCLUSIONS: Male patients only reported less depressive symptoms in the transition from dialysis to transplantation. The proportion of patients with clinical depression did not change from dialysis to transplantation. This finding is in contrast to most cross-sectional studies, and has to be further investigated in larger longitudinal studies.

(1029) Symptom perception from dialysis to renal transplantation. a longitudinal study Amin Amro, RN, MSN, Oslo University Hospital, Oslo, Norway; Ba˚rd Waldum, University of Oslo, Oslo, Norway; Nanna Von der Lippe, University of Oslo, Oslo, Norway; Fredrik B. Brekke, University of Oslo, Oslo, Norway; Ingrid Os, MD PhD, University of Oslo Medical School, Oslo, Norway AIMS: Patients on dialysis experience multiple concurrent symptoms and reduced health-related quality of life (HRQOL). Although, most studies indicate reduced symptoms and improved HRQOL after renal transplantation (RTX), data are inconsistent. Longitudinal data are scarce. The aim of the current study was to assess changes in kidney specific symptoms in the conversion from dialysis to RTX.

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72 METHODS: A cohort of patients (n = 110, 66 % males, median age 54, IQR 39–62, years) was followed in a prospective study with measurements of HRQOL in dialysis and after RTX using Kidney Disease and Quality of Life Short Form (KDQOL-SF). Patients rated eleven kidney specific symptoms listed in the KDQOL-SF in a Likert scale (converted to 0–100 scale, 100 best perceived). Wilcoxon test was used to assess changes. Minimal clinical important difference was set to[5 points. RESULTS: Follow-up time was 55 (IQR 50–59) months, and time after RTX was 41 (34–51) months. Post RTX GFR 54 ml/min (45–72). After RTX, number of perceived symptoms were reduced (6.5 ± 2.6 vs. 4.7 ± 3.0, p = 0.001). Seven symptoms had clinical important improvement after RTX,; itching (85 ± 21 vs. 61 ± 30, p = 0.001), cramps (87 ± 21 vs. 66 ± 32, p = 0.001), feeling squeezed out (73 ± 31 vs. 65 ± 30, p = 0.002), muscle soreness (73 ± 28 vs. 63 ± 33, p = 0.003), dry skin (71 ± 29 vs. 63 ± 31, p = 0.005), numbness (78 ± 29 vs. 69 ± 31, p = 0.008) and dizziness (88 ± 20 vs. 80 ± 25, p = 0.008). Perceived nausea, lack of appetite, shortness of breath and chest pain did not change after RTX. CONCLUSIONS: Although symptom perception improved in the conversion from dialysis to RTX, symptom burden remained high. Increased awareness and alleviation of symptoms in RTX patients may improve self-perceived HRQOL.

(1031) Knowledge of chronic kidney disease among pre dialysis patients Virginia V. Brasil, PhD, Nursing Faculty of the Federal University of Goias, Goiaˆnia, Brazil; Katarinne L. Moraes, Universidade Federal de Goia´s, Goiaˆnia, Brazil; Jacqueline Andre´ia B L Cordeiro, Federal University of Goias, Goiania, Brazil; Gabriela Ferreira De Oliveira, Federal University of Goias, Goiania, Brazil; Antonio Ma´rcio Teodoro Cordeiro, Pontifical Catholic University of Goias; Luiz Antonio Brasil, Federal University of Goias, Goiania, Brazil; Maria Alves Barbosa, PhD, Nursing Faculty of Federal University of Goias, Goiania, Brazil; Isabela C F Fernandes, Federal University of Goias, Goiania, Brazil; Carla P. Bernardes, Federal University of Goias, Goiania, Brazil; Ruth Minamisava, Nursing Faculty—Federal University of Goias AIMS: Patients must have adequate knowledge of their own disease to improve health-related quality of life. The prevalence and protective factors of knowledge of information related to chronic kidney disease (CKD) among pre dialysis patients were examined. METHODS: A cross-sectional study was conducted with 55 chronic kidney disease stage 2–5 outpatients of hospitals of Goiania municipality, Brazil, from November 2013 to March 2014. The hospitals were financed by Brazil’s Unified Health System and attended the poorest population segment. The outcome was the patient knowledge related to CKD and knowledge of CKD was assessed using 21 questions of Canhestro (2010) based on U.S. National Kidney Foundation guidelines. Knowledge scores were converted to a scale ranging from 0 to 100 % correct. Among exposure variables, the Short Test of Functional Health Literacy in Adults (STOFHLA) was used to measure patients’ ability to read and understand health-related materials. STOFHLA scores are classified into categories: inadequate (score, 0–53), marginal (score, 54–66) or adequate (score, 67–100). Simple and multiple linear regressions were performed to estimate association between knowledge and exposure variables. RESULTS: Patients were mainly female (53.1 %), mean age 64.28 (±12.95) years, married, CKD stages 3/4 (84.6 %), ambulatory follow up 6–240 months and less than 9 years of schooling. Most of patients (76.5 %) presented insufficient knowledge scores (mean 53.28 %) and 97.1 % had inadequate functional health literacy level, mean 26.88 (±12.73). Older age was associated with better knowledge related to CKD

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Qual Life Res (2014) 23:1–184 scores but health literacy level not. Results also indicated that years of schooling was not protective factor. CONCLUSIONS: There is a lack of knowledge among pre dialysis patients and only age was positively associated with the outcome. It’s possible that health-related information strategies provided by health professionals are inadequate for patients with low functional health literacy level. That situation may be compromising pre dialysis patients health-related quality of life.

(1033) Comparison of quality of life in hemodialysis patients receiving either acetate-based or acetate-free citrate dialysate Hideaki Ishikawa, Tokai, Gifu, Japan; Saori Tukushi, Tokai Central Hospital of Japan Mutual Aid Association; Junichi Sakamoto, Tokai Central Hospital of Japan Mutual Aid Association AIMS: Quality of life (QOL) is a major factor affecting the outcome of patients on maintenance hemodialysis (MHD). Several studies have recently reported that acetate-free citrate dialysate hemodialysis (AFD) has advantages in MHD patients, including an improvement in nutritional status. The aim of this study was to assess whether the type of dialystate also had an impact on the QOL of MHD patients. METHODS: We performed a prospective study to compare clinical parameters with acetate-based dialysate or AFD (CARBOSTAR). We assessed the efficacy of changing the type of dialystae on the QOL of our MHD patients, evaluated using the Kidney Disease Quality of Life -Short Form 1.3 (KDQOL-SFTM 1.3). The observation period was six months, with clinical parameters such as dry weight, dialysis efficiency, and use of medications including erythropietin stimulating agents and vitamin D being recorded. RESULTS: Twenty-five patients were enrolled in the study. Their mean age was 69.8 ± 9.5 yr, male/ female ratio16/9, average duration of dialysis 9.7 ± 5.3 yr, with 40 % having diabetic nephrophaty. We compared several parameters before and after AFD. As expected, the geriatric nutritional risk index (GNRI) improved significantly (93.9 ± 6.4 vs. 96.2 ± 6.7, p = 0.001). Although the GNRI was associated significantly with total KDQOL (r = 0.5, p = 0.01), symptoms/ problems showed the strongest correlation with total KDQOL (r = 0.8, p \ 0.0001). In contrast, symptoms/problems were not associated significantly with GNRI (r = 0.4, p = 0.2). The total KDQOL score showed no significant change during the study (57.9 ± 14.5 vs. 55.2 ± 13.8, p = 0.5). CONCLUSIONS: Although we have demonstrated previously that nutritional status improves significantly following the use of AFD and certainly contributes to a better prognosis in MHD patients, the current study did not detect marked changes in the QOL of patients after the introduction of AFD. Further research is therefore necessary on the clinical factors that may contribute to improved QOL in MHD patients.

(1035) Health-Related Quality of life of adults and seniors with chronic renal insufficiency on hemodialysis: associated factors Je´ssica Maria Lopes, Universidade Federal de Sa˜o Carlos; Raiana Fukushima, Universidade Federal de Sa˜o Carlos; Ana Carolina Ottaviani, Universidade Federal de Sa˜o Carlos, Brasil, Sa˜o Carlos, Brazil; Fabiana Souza Orlandi, PhD, Universidade Federal de Sa˜o Carlos, Sa˜o Carlos, Brazil AIMS: To characterize adults and seniors with Chronic Renal Insufficiency (CRI) under hemodialysis treatment according to sociodemographic, clinical and economic aspects, in addition to assessing

Qual Life Res (2014) 23:1–184 the Health-Related Quality of Life (HRQOL) and identify associated factors METHODS: The study used a descriptive, correlational and cross-sectional design which was conducted at the Service of Nephrology of Sa˜o Carlos, where subjects who had the inclusion criteria previously established, were interviewed. The instruments used were: Characterization of the Subjects and Kidney Disease and Quality of Life-Short Form (KDQOL-SF). The project was approved by the Federal University of Sa˜o Carlos Research Ethics Committee. RESULTS: Of the 101 subjects evaluated, 68 % were male, 49.5 % were Caucasian, 55.5 % were married, 76 % were from Sa˜o Carlos, 27.7 % had primary school education and 30.8 % had a monthly income of 1–2 minimum wages. The age ranged between 24 and 88 years, mostly adults (57 %). In relation to underlying disease, there was predominance of hypertension (59.4 %). Results: Regarding associated factors with HRQOL of the interviewees, it was observed that men had better HRQOL than women, black people reported better HRQOL than white and mulatto, respondents with a stable partner had better HRQOL than those without a stable partner, participants with elementary education reported better HRQOL than those who had incomplete primary education, and individuals who practiced any religion had better HRQOL than non-practitioners. CONCLUSIONS: The HRQOL of adults and seniors with CRI was compromised in certain areas. Furthermore, an association with socio-demographic, clinical and economic factors was observed, which must be considered when planning and implementing interventions aiming to improve the HRQOL of CRI patients undergoing hemodialysis.

(1037) Renal transplantation in Spain—Utility and HealthRelated quality of life of five (5) profiles of transplantation Angeles Crespo, LASER Analytica; Carmen Dı´az-Corte, Hospital Universitario Central de Asturias; Jesu´s Cuervo, LASER Analytica; Pablo Rebollo, PhD, LASER ANALYTICA, Oviedo, Spain; Erika deSousa, Hospital La Paz de Madrid; Ramo´n Romero, Hospital Germans Trias I Pujol de Badalona; Ma Carmen Cantarell, Hospital Vall D’Hebron de Barcelona; Frederic Cofan, Hospital Clinic de Barcelona; Laura Ferna´ndez, Hospital Universitario Central de Asturias; Estefania Pe´rez, Hospital Universitario de Tenerife; Julia Kanter, Hospital Doctor Peset de Valencia; Red Tema´tica de Investigacio´n Renal (REDinREN), RD 06/0016/1009, Instituto de Salud Carlos III AIMS: Compare the utility value and Health-related Quality of Life (HRQOL) of kidney transplant (KT) patients who receive an organ from an expanded criteria donor (ECD), from a living donor (LD) and from one out of three special kinds of standard cadaveric donor (SCD). An ECD is a donor aged 60 or older or 50–59 years old, with (meets 2 of 3): History of hypertension, serum creatinine [1.5 mg/dL or cerebrovascular cause of death. Nowadays, the percentage of KT recipients in Spain with ECD accounts for 50 % of total. METHODS: Prospective, multicenter, observational study, carried out in 7 University hospitals from Spain. 5 KT profiles were evaluated (n = 156): P1, ECD; P2, SCD in recipient \ 65 years without Diabetes Mellitus (DM); P3, SCD in DM patients; P4, SCD in recipient = 65 years without DM; P5, LD. Patients were assessed at baseline (transplantation), at 3 (3 m) and at 12 months (12 m). Socio-demographic, clinical variables were collected along with the EQ-5D (utility and HRQOL). The mean values of the EQ-5D Utility Index Score (UIS) and Visual Analogic Scale (VAS) at 3 m and 12 m were calculated for each profile and compared between the two moments (Wilcoxon test), and among the profiles at each follow up (Kruskal–Wallis test). RESULTS: Mean age (SD) of patients was 54.37(13.62) years, 60 % males, 24.80 % showed early allograft dysfunction and 7.5 % episode of acute rejection. Mean scores (SD) for UIS and VAS were 0.87 (0.18) and 78.33 (16.31) respectively at 3 m and 0.86(0.21) and 81.96(17.88) at 12 m. The change in the VAS was

73 statistically significant (p = 0.002). No statistically significant differences were found for each profile in the IUS at 3 m and 12 m. However, statistically significant improvement (p \ 0.05) at 12 m was found in VAS scores of P2. Significant differences (p \ 0.05) were found at 3 m follow-up in IUS among different profiles. Dunnett-T3 multiple comparisons confirmed differences between P1 and P5: the mean IUS of P5 patients (0.94) was higher than that of P1 patients (0.79). CONCLUSIONS: HRQOL of patients of the different studied KT profiles is similar during the first year after transplantation. Furthermore, HRQOL values obtained were slightly higher than the Spanish normative values

Neurology (1039) Development of a questionnaire assessing the cognitive dimension of HRQOL—the COGQOL (cognitive quality of life) Nicole Von Steinbuchel-Rheinwall, Prof., University of Goettingen, Gottingen, Germany; Martin L. Werkmeister, Institute of Medical Psychology and Medical Sociology, Go¨ttingen, Germany; Joy C. Backhaus, Institute for Medical Psychology and Sociology in Go¨ttingen, Germany, Go¨ttingen, Germany AIMS: Only very few generic HRQOL instruments assess the cognitive domain together with the dimensions Daily Life Activities, Social Life, Relationships and Emotions. Although cognitive impairments are one of the most prevalent symptoms of dementia under which patients suffer no instrument explicitly measuring cognitive aspects of HRQOL comprehensively is yet available. METHODS: 61 items were generated from focus group discussions performed in elderly brain healthy persons, experts and patients, predominantly suffering from the Alzheimer‘s and vascular dementia. This questionnaire together with other variables (medical data, SF-12, QOL-AD, MMSE, GDS, etc.) was administered to 161 patients with dementia. Applying an Ant Colony Optimization Algorithm (ACO) the final version of the COGQOL was developed. The ACO outperforms largest factor loadings and maximum test information item selection methods. Furthermore Cronbach’s avalues, largest factor loadings produced by Confirmatory Factor Analysis, model fit values and aspects of validity can be integrated in this computation automatically. RESULTS: Starting with 61 items, the ACO reduced response burden to 37 items loading on eight scales. Internal consistency ranged from alpha = 0.71–0.81 for the subscales and test–retest reliability between alpha = 0.63–0.85. All items loaded highly significantly on the subscales (lambda = 0.365–0.812).Moderate significant relationships (r = 0.13–0.40) were found for the COGQOL, the QOL-AD, and the SF-12. The investigation of clinical predictors showed, that patients with low GDS scores reported better HRQOL then persons with high grades of depression. Patients with Alzheimer‘s Dementia rated the ‘‘Attention’’ subscale of the COGQOL significantly higher than persons with Vascular or Mixed Dementia. Interestingly for the relation of the COGQOL with the MMSE a cubic relation was noted. In this context the interaction of self-awareness, cognitive functioning and self-reports of HRQOL in persons with dementia will be highlighted. CONCLUSIONS: The final version of the COGQOL provides a comprehensive psychometrically robust measure for the cognitive dimension of HRQOL; it may be useful especially in clinical contexts and research where there is no time for neuropsychological assessment; however self-awareness reports have to be included additionally to fully understand the outcome.

(1041) Development of computerized adaptive test (CAT) item bank for assessing quality of life in multiple sclerosis: preliminary results from a european multi-center study Pierre Michel, Aix Marseille Universite´, Marseille, France; Karine Baumstarck, Faculte´ de Me´decine, AMU, Marseille, France;

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74 Mohamed Boucekine, Self-Perceived Health Assessment Research Unit, Marseille, France; Laurent Boyer, PhD, Aix-Marseille University, Marseille, France; Anderson Loundou, EA3279, SelfPerceived Health Assessment Research Unit, Marseille, France; Jean Pelletier, Neurology, Timone University Hospital, Marseille, France; Badih Ghattas, Faculte´ Des Sciences de Luminy, Marseille, France; Pascal Auquier, Public Health Department, University Hospital of Marseille, France AIMS: Quality of life (QOL) measurements are considered central outcome measures for both research and clinical practice in multiple sclerosis (MS). Computerized adaptive testing (CAT) can improve measurement precision of QOL instruments while reducing item burden on the individual patient. Moreover, taking a cross-cultural approach is also necessary to guarantee the wide applicability of CAT. The MusiQOL study group has a strong focus on cross-cultural applicability of a QOL item bank in MS. This preliminary work aimed to develop a calibrated unidimensional item bank on a major QOL subdomain in MS (i.e., mental health) and to conduct a simulation study for a CAT based on this bank. METHODS: In this international, multicenter, cross-sectional study, 1,992 patients with different subtypes of MS from 15 European countries patients answered a specific (MusiQOL) and a generic QOL questionnaire (SF36). Socio-demographic data and clinical information were collected for each patient. Psychometric properties of a pool of 22 candidate items for the mental health subdomain, including evaluations of unidimensionality, item response theory (IRT) model fit, and differential item functioning (DIF) on several sociodemographic variables, were assessed. RESULTS: The 22 items showed satisfactory item characteristics (missing values rate 2.9 % and skewness -0.32). Confirmatory factor analysis showed that the 22 items could be included in a unidimensional model (RMSEA = 0.07, CFI = 0.95). Eight of the 22 initial items in the bank were recoded in order to respect the monotonicity assumption, and all items showed a good fit (INFIT statistic ranges from 0.76 to 1.27). No large DIF was detected. CAT simulations were then used, showing strong correlations between simulated CAT scores and those from the full item bank. CONCLUSIONS: This work demonstrated favorable psychometric characteristics and preliminary evidence of validity for a QOL item bank and CAT in MS.

(1043) What matters to women living with ms in saudi arabia Alaa M. Arafah, MSc, School of Physical and Occupational Therapy, McGill University, Montreal, Canada, Riyadh, Saudi Arabia; Mona M. Alkhawajah, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia; Shahnaz Shahrbanian, McGill University, Montreal, QC, Canada; Asma Alkusayer, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; Nancy E. Mayo, PhD, McGill University Health Centre, Montreal, QC, Canada AIMS: Multiple sclerosis is becoming more common in Saudi Arabia where specialized health services are developing. Many people with MS look for help where they can and risk getting information from unreliable sources. In such a context, self-management would be crucial to reducing the impact of MS. Self-management refers to the patients’ involvement in taking control over their health, that is, they become active participants in the treatment with the guidance of their health care professionals. Success at self-management requires the individual to acknowledge specific problems and recognize that solutions are possible. A self-management program also has to fit the context of the individual in their culture. Therefore, the objective of this study is to identify what matters to women living with MS in Saudi Arabia to inform a culturally adapted self-management program. METHODS: A qualitative study using focus groups and individual interviews was conducted. Both inductive and deductive

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Qual Life Res (2014) 23:1–184 thematic analyses were used to identify common themes around the impact of MS, and needs and solutions for self-management. Transcripts were examined independently by two researchers using an inductive analysis to ensure a thorough and systematic review of all themes. Deductive analyses mapped the themes to the Wilson-Cleary model. RESULTS: Women (n = 23) with MS identified a range of symptoms affecting their lives including urinary incontinence, fatigue, visual impairments, and muscle weakness; the majority identified difficulties in walking. However, emotional burden predominated. All were linked to role participation in work, family, and social interactions. A common theme was the inadequacy of the health care system to address these needs. Many had sought help elsewhere using internet sources. Some differences were noted in the nature and severity of the concerns raised by this sample in comparison to women elsewhere. CONCLUSIONS: The themes identified mapped to all the rubrics of the Wilson-Cleary model indicating that this would be a good framework to show the commonalities of concerns across all stakeholders in the MS arena: people living with MS, physicians, rehabilitation professionals, and other health care professionals. It is also a useful framework to plan for future MS services in Saudi Arabia and to inform content for self-management material.

(1045) Reliability of the original and short versions of the falls efficacy scale-international (fes-i) in people with parkinson’s disease Stina B. Jonasson, RPT MSc, Department of Health Sciences, Lund University, Lund, Sweden, Lund, Sweden; Maria H. Nilsson, MSc, Lund University, Lund, Sweden; Jan Lexell, Lund University, Lund, Sweden AIMS: To evaluate the reliability of the original and short versions of the Falls Efficacy Scale-International (FES-I) in people with Parkinson’s disease (PD). METHODS: The FES-I is a selfadministered questionnaire that assesses concerns about falling. Respondents answer how concerned they are about the possibility of falling in relation to different activities. The original version contains 16 activities; 7 of these are included in the short version. Response categories are: not at all, somewhat, fairly, or very concerned (scored 1 to 4, respectively). For both versions, a total score (higher = worse) is calculated by summing the included items. The original FES-I has a total score that ranges from 16 to 64, whereas it ranges from 7 to 28 for the short version. The original FES-I was mailed to 174 non-demented persons with PD. Responders received a second survey after two weeks. Reliability for each FES-I version was studied in terms of internal consistency (Cronbach’s alpha) and test–retest reliability (Intraclass Correlation Coefficient, ICC). The standard error of measurement (SEM) and smallest detectable difference (SDD) were calculated. Both SEM and SDD were also expressed as percentages of possible scoring ranges, to facilitate comparisons. RESULTS: One hundred and one persons (57 % men) responded to the questionnaire (response rate 58 %). Mean time between responses to the first and second questionnaire was 17 (SD 3.8) days. Mean (SD) age and PD duration were 73 (7.7) and 7 (5.6) years, respectively. Fifty-five percent were afraid of falling, according to a dichotomous question. Mean (SD, range) total score for the first test occasion was 30 (12.0, 16–59) for the original FES-I and 13 (5.1, 7–25) for the short FES-I. Cronbach’s alpha was 0.96 for the original version and 0.89 for the short version (first as well as second test occasion). Corresponding ICC values were 0.92 and 0.91, respectively. SEM was 3.4 (7 %) for the original FES-I and 1.6 (7 %) for the short FES-I, whereas corresponding SDD values were 9.6 (20 %) and 4.3 (20 %), respectively. CONCLUSIONS: The present findings indicate that both the original FES-I and the

Qual Life Res (2014) 23:1–184 short FES-I are reliable for assessing concerns about falling in people with PD.

(1047) Perception of quality of life in people with spinal cord injury in yogyakarta, indonesia Astri Ferdiana, University Medical Center Groningen, Groningen, Netherlands; Ute Bultmann, University Medical Center Groningen, Groningen, Netherlands; Jac JL van der Klink, University Medical Center Groningen, Groningen, Netherlands; Marcel W. Post, de Hoogstraat/UMCU, Utrecht, Netherlands AIMS: This study aims to explore the perception of quality of life (QOL) and identify important domains of QOL in people with SCI in Yogyakarta, Indonesia. METHODS: Eight males and four females (age range 22–67 years old) with traumatic SCI were in-depth interviewed using qualitative methods. SCI duration ranged from 1 to 20 years. Socioeconomic level was mostly low. Interview questions included the following: 1) How do you define QOL? and 2) Can you mention 5 things that are important for your QOL? Interviews were done in mixed Indonesian and Javanese and transcribed verbatim. Analysis was conducted on the translated English transcripts. Thematic analysis was used, in which inductive codes were developed into categories and themes. ATLAS.ti software was used for data management. RESULTS: The term QOL was not well-understood by the respondents, thus it was replaced by the term life satisfaction or happiness during the interview. Views on life satisfaction or happiness were different among respondents. The majority of the respondents referred life satisfaction or happiness as things they need to do in order to achieve life satisfaction or happiness, i.e. financial independence, being with family and being useful to others. Few respondents regarded life satisfaction or happiness is an end or a state. It was also mentioned that life satisfaction is subjective and cannot be quantified with material resources and that human being can never be fully satisfied. Most respondents felt less satisfied after SCI compared to before SCI. Important domains of life satisfaction or happiness included two components mentioned with the meaning of life satisfaction or happiness, i.e. financial independence (meeting basic needs, being able to work and earn income) and being useful to others. Additionally, relationship with God (being closer to God, praying, and accepting condition as God’s will), social support (family, friends and community), community integration were also regarded important. CONCLUSIONS: QOL is a concept that is not well-understood and accepted by people with SCI in Indonesia. Five important domains of life satisfaction or happiness were identified, which reflected the sociocultural values embedded in the lives of people in Central Java that may not be fully captured by current QOL measures.

(1049) Patient-Reported outcomes in randomized controlled trials of primary brain tumour patients: methodological quality and impact on clinical decision-making Linda Dirven, PhD, VU University Medical Center, Amsterdam, Netherlands; Martin Taphoorn, MD PhD, Medical Center Haaglanden, Dept of Neurology, the Hague, Netherlands; Jaap C. Reijneveld, VU University Medical Center, Amsterdam, Netherlands; Jane Blazeby, MD, University of Bristol, Bristol, United Kingdom; Marc Jacobs, Academic Medical Center, Amsterdam, Netherlands; Andrea Pusic, MD MHS FRCSC, Memorial Sloan Kettering Cancer Ctr, New York, NY, United States; Edoardo La Sala, Italian Group for Adult Hematologic Diseases (GIMEMA); Peter Fayers, PhD,

75 University of Aberdeen, Aberdeen, United Kingdom; Fabio Efficace, PhD, Italian Group for Adult Hematologic Diseases, GIMEMA, Rome, Italy, on Behalf of the EORTC Quality of Life Group (Patient Reported Outcome Measurements Over Time in OncologyPROMOTION Registry) AIMS: To determine the net clinical benefit of new treatment strategies, information on both survival and patient-reported outcomes (PROs) are required. However, to make an adequately informed decision, quality of PRO evidence should be sufficient. The aim of this study was to investigate the methodological quality of PRO evidence in randomized controlled trials (RCTs) in patients with primary brain tumors. Secondary objectives were to assess the likely impact of these studies on clinical decision-making and to explore possible quality improvements over time in PRO reporting. METHODS: Systematic literature search was conducted in several databases covering January 2004 to March 2012. Relevant RCTs were selected and the following data retrieved: (1) basic trial demographics and PRO characteristics, (2) quality of PRO reporting based on recommendations of International Society for Quality of Life Research, and (3) risk of bias, assessed with Cochrane Risk of Bias Tool. Studies likely to impact clinical decision-making were systematically analyzed. Lastly, level of reporting of some key selected PRO issues were compared over time. RESULTS: Fourteen RCTs were identified which enrolled [3000 glioma patients. Only two RCTs (14 %) satisfied a sufficient number of key PRO methodological criteria, thus providing high-quality PRO evidence. Hence, these studies are likely to robustly inform clinical decision-making. Important methodological limitations were lack of reporting of the extent (42.9 %) and reasons of missing data (85.7 %) and statistical approaches to handle this (71.4 %). Also, PRO results were not interpreted in 78.6 % of the studies and clinical significance was often not discussed (85.7 %). Studies with high-quality PRO evidence generally showed a lower risk of bias. Lastly, level of reporting of some key selected PRO issues has not improved over time. For example, documentation of missing data was poor in 60 and 57.1 % in studies published before 2002 and from 2004 onwards, respectively. CONCLUSIONS: Although important for clinical decisionmaking, quality of PRO evidence was poor in many RCTs. To determine the net clinical benefit of a new treatment strategy, high-quality PRO evidence is valuable. Researchers should therefore become aware of the recommendations for conducting and reporting PRO-related outcomes, in order for their results to be valuable for clinical decision-making.

(1051) Factors associated with quality of life in the 18 months following stroke. a longitudinal study using a specific questionnaire Sylvia Cael, University of Dijon, Salins Les Bains, France; Herve´ Devilliers, University Hospital, Inserm, CIE1, Dijon, France; Abderrahmane Bourredjem, University Hospital, Inserm, CIE1, Dijon, France; Odile Troisgros, University Hospital Dijon France; Maurice Giroud, University Hospital, Neurology Dept., Dijon, France; Christine Binquet, University Hospital, Inserm, CIE1, Dijon, France; Mariette Mercier, University Hospital of Besancon, Besancon, France AIMS: Health-related quality of life (HRQOL) is frequently impaired in stroke patients. To date, no longitudinal study has been conducted with a specific questionnaire to describe stroke-related HRQOL. To describe HRQOL evolution and its associated factors during the 18 months following stroke using the Stroke Impact Scale (SIS). The SIS is a stroke-specific HRQOL questionnaire whose domains include physical health, emotion, memory, communication, and social participation. METHODS: 195 consecutive patients who had suffered stroke were recruited in 2010 in two French hospitals, and followed for 18 months. They were asked to complete the SIS, the Duke Health Profile, the Barthel index, the HADS and numerical pain scale during the first month following the stroke, then at 3 months and 18 months.

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76 The evolution of HRQOL and its associated factors were analyzed using a multivariate mixed model, taking into account the full structure of the data. Backward selection was applied and factors influencing SIS scores, namely age, sex, stroke localization, initial NIHSS score, HADS score, pain score and their interactions with time were proposed in the model. Variables with an adjusted p value \ 0.10 were kept in the model. RESULTS: We included 195 patients in the study, whose mean age (SD) was 65(16). There were 105 men (54 %). Median initial NIHSS (IQR) score was 4(6). SIS significantly improved over time in the physical (p \ 0.001), social (p = 0.0225) and. A higher NIHSS score was independently associated with a lower quality of life over time in all domains except for memory (adjusted difference from -13 to -21 points in the physical domain, p \ 0.0001). The effect of the NIHSS score decreased over time in both physical and social domains (p for interaction with time: 0.007 and 0.040, respectively). Male sex, older age, dominant hemisphere lesion, and anxiety/depression according to HADS were also independently associated with lower HRQOL scores over time, depending on the domain. CONCLUSIONS: The improvement in QOL over time after stroke is strongly associated with the initial NIHSS score. Other treatable factors such as anxiety and depression may influence QOL and should be considered early in the management of stroke patients.

Children (1053) Health-Related quality of life in children and adolescents in germany Ute Ellert, Berlin, Germany; Anna K. Brettschneider, Robert Koch Institute; Ulrike Ravens-Sieberer, MPH, University Medical Center Hamburg-Eppendorf, Hamburg, Germany AIMS: In recent years, a change in the health and disease spectrum among children and adolescents has taken place, with an increase in mental health problems and a shift from acute to chronic illness. In this phase, the health-related quality of life (HRQOL) has increased in importance as a dimension of subjective health. The aim of this study is to describe the HRQOL of children and adolescents measured with the internationally standardized screening instrument KIDSCREEN-10. METHODS: In the follow-up of the KiGGS-study in 2009–2012 (KiGGS Wave 1), 2,567 parents of children aged 7 to 10 years and 4,878 adolescents aged 11 to 17 years responded with the KIDSCREEN-10 questionnaire. Data collection was carried out by telephone interviews. The calculation of the mean KIDSCREEN T-scores (with confidence intervals) was based on socio-demographic characteristics like age, gender and social status as well as health parameters. Separate linear regression models were carried out for the children, whose parents assessed their quality of life, and for the adolescents, who assessed their quality of life themselves. All socio-demographic characteristics and health parameters were taken into account. RESULTS: Whereas 65.0 % (95 % confidence interval 62.2–67.8) of parents reported the HRQOL of their 7- to 10-year old children to be good, 81.9 (80.6–83.2) of 11- to 17-yearolds rated their health good. 29.0 % (26.3–31.8) parents reported the HRQOL of 7-to 10-year olds to be very good. That was about twice as high as the percentage provided by 11- to 17-year-olds in their self-assessments. Age, health restrictions, pain, mental problems, a poor health status or a suboptimal body image affected the perceived HRQOL negatively. In the regression, the negative correlation between mental problems and HRQOL was most conspicuous. Potential differences in HRQOL by social status were not confirmed in multivariate models. CONCLUSIONS: The HRQOL of the examined children and adolescents is predominantly very good or good. Interventions to improve the HRQOL of children and

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Qual Life Res (2014) 23:1–184 adolescents with diseases and psychopathological problems are necessary, regardless of their social status.

(1057) Reliability and validity of the colombian version of kidscreen-52 for the child and adolescent student population of bucaramanga (colombia) Diana M. Camargo Lemos, MSc, Universidad Industrial de Santander, Bucaramanga, Santander, Colombia; Martha J. Rodriguez, Universidad Industrial de Santander, Bucaramanga, Colombia; Luis Carlos LC Orozco, Universidad Industrial de Santander AIMS: To assess the reliability and validity of the Colombian version of the Kidscreen-52 in school children and adolescents ages 8–18 in the city of Bucaramanga (Colombia). METHODS: An evaluation of diagnostic technology was done with 1,334 children and adolescents who filled out the Colombian version of the Kidscreen-52. Both institutions and children were randomly selected, first by cluster sampling in 30 public and private schools and second, by simple random sampling. The test–retest reliability was assessed in 121 randomly selected students on two separate times two weeks apart. The analyses were conducted on the entire sample as well as for age groups (8–11 years and 12–18 years), gender and socioeconomic conditions (low and high). The internal consistency of the item responses was estimated via Cronbach’s alpha coefficient as a measure of reliability of the Kidscreen scores; the test–retest reliability was evaluated by Intraclass Correlation Coefficient (ICC 2.1), values of 0.7 or higher were considered acceptable. The Rasch Rating Scale Model was used to establish the infit and outfit mean square, values between 0.6 and 1.4 indicated a good fit to the Rasch model. Differential Item Functioning (DIF) by age groups, gender and socioeconomic condition were identified. Stata version 12.0 and Winsteps software were used. RESULTS: The mean age was 12.3 ± 2.7 years, 54.8 % were women and 88.5 % of the sample belonged to public schools. Cronbach’s alpha ranged from 0.62 (Selfperception) to 0.90 (Parent Relation) and ICC from 0.70 (Social Acceptance) to 0.90 (Parent Relation). Infit ranged from 0.72 to 1.30 and outfit from 0.71 to 1.27 for the 10 dimensions of the questionnaire. Two items showed uniform DIF by gender and four items showed it by age groups. Non-uniform DIF was not observed. CONCLUSIONS: The Colombian version of the Kidscreen-52 showed good levels of reliability and satisfactory levels of validity having in mind that six items displayed DIF.

(1059) Validation for Brazil of DISABKIDSÒ– cystic fibrosis module, proxy version, for parents or caregivers of children and adolescents with cystic fibrosis Danielle Maria S S Dos Santos, PhD, University of Rio de Janeiro, Macae´—RJ, Brazil; Keila C. Deon, PhD, Federal University of Rio Grande Do Sul, Porto Alegre, Brazil; Maria Fernanda Cabral Kourrouski, University of Sa˜o Paulo, Ribeira˜o Preto, Brazil; Monika Bullinger, PhD, Inst for Medical Psychology, Hamburg Univ, Hamburg, Germany; Claudia Benedita Dos Santos, PhD, MISPEERP-USP, Ribeira˜o Preto, Brazil AIMS: To validate the proxy version of Health-related Quality of Life questionnaire DISABKIDS-Cystic Fibrosis Module for Brazilian parents or caregivers of children and adolescents with cystic fibrosis between 8 and 18 years old. METHODS: Methodological study, with a sample of 113 parents or caregivers of children and adolescents with cystic fibrosis of four Brazilian states, Sa˜o Paulo, Parana, Minas Gerais and Distrito Federal. The sample consisted of a pilot study in 2009 (51 participants) and field sample, conducted from June 2011 to

Qual Life Res (2014) 23:1–184 January 2013 (62 participants). It was verified the possible presence of floor and ceiling effects, reliability accordingly to Cronbach’ Alpha coefficient and reproducibility through test–retest assessed by Intraclass Correlation Coefficient (ICC). The construct validity of the questionnaire was measured according to convergent and discriminant validity using Multitrait-Multimethod analysis (MTMM). RESULTS: The questionnaire didn’t show floor and ceiling effects for any dimensions, Impact and Treatment, with four and six items, respectively. This study presented reliability with satisfactory internal consistency (a = 0.87 for the Impact dimension and 0.84 for Treatment) and reproducibility, with ICC = 0.627 (p = 0.003) and 0.677 (p = 0.001) for Impact and Treatment dimensions, respectively. Regarding construct validity, convergent validity was observed for both dimensions, with values for Pearson correlation coefficient between items and their dimension higher than 0.56, except for item 6 of Treatment dimension (r = 0, 37). For divergent validity it was found scale fit values of 100 % for two dimensions. CONCLUSIONS: The process presented positive results. That way, this phase was very important to continue the validation process of a questionnaire to a new culture. The study’s next step aims to verify the confirmatory factor analysis and in order to do that it is necessary to increase the sample size which demands more time for data collection because this is a rare disease in Brazil.

Elderly (1061) Challenges of measuring physical function for randomized control trials of seniors: to pro or not? Sabrina M. Figueiredo, McGill University, Montreal, QC, Canada; Nancy E. Mayo, PhD, McGill University Health Centre, Montreal, QC, Canada AIMS: Physical functioning can be assessed from patient-reported outcome (PRO) or by direct clinical measurement, (CLINRO). Large number of psychometrically sound PROs producing one score across the many domains of physical function exist. However, for elders, score validity can be affected by social desirability, response shift, and misinterpretation of content. CLINROs yield highly accurate information, however, a large number of tests need to be administered to capture all relevant domains of performance. Trials reporting on multiple measures are in violation of best-trial practice as set out by CONSORT guidelines. Summarizing across multiple measures, all of which would be on a different scale, is statistically complex. Even if one score is produced, mean change for a group could be the result of few individuals with large changes or numerous individuals with small changes. We aim to illustrate a method of summarizing change on two or more outcomes using a change matrix which yields a single ordinal outcome variable which would be analysed using ordinal regression models. METHODS: Data came from a pilot randomized trial evaluating the potential for improving outcomes through a selfmanagement program for elderly. A PRO, the Lower Extremity Functional Scale (LEFS), and two CLINROs, gait speed and chair stand, were the measures used. RESULTS: Despite 100 % of participants having gait speed below their age-norm, only 11 and 42 %, respectively, reported difficulty walking between rooms or walking 2 blocks. Similarly, while 99 % of elders are below the norm for 30-s Chair Rise, only 58 % reported difficulty managing stairs. An RCT with the PRO as the outcome could fail to show a response. A composite categorical ordinal variable (Change Matrix) was created based on the number of MCIDs gained after an intervention on gait speed cross-tabulated against the number of MCIDs gained on chair stands. This matrix has a possibility of 9 categories if the maximum number of MCIDs gained is 3. CONCLUSIONS: With elderly, the

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Fig. 1 .

Table 1 Results on self-report and directly measured mobility outcomes Assessment of mobility at baseline of MMOVES trial (N = 32) Self-reported difficulty (LEFS)

% With difficulty

Walking between rooms

11

Walking 2 blocks Walking a mile

42 90

Going up/down stairs

58

Performancebased measures mean (SD) range

% of Persons below the norm

Gait speed (m/s)

100

0.66 (0.12) 0.33 to 0.86 30-s Chair rise (# of reps)

99

7 (2) 1–11

LEFS lower extremity functional scale

use of PROs alone for evaluating interventions may underestimate effect. A change matrix permitting more than one CLINRO would provide additional information for effectiveness. The response to treatment is expressed as an OR, which is interpretable both at group and individual levels and can be used to calculate number needed to treat. The Matrix is a new way of reporting change on multiple measures in one value, optimizing statistical analysis (Table 1; Fig. 1).

(1063) Is the WHOQOL-OLD a good add-on module to the whoqol-bref? a study from the elderly people of taiwan Grace Yao, PhD, National Taiwan University, Taipai, Taiwan; Cheng Chun Chien, National Taiwan University AIMS: The WHOQOL-OLD is said to be an add-on module to the WHOQOL-BREF. This study investigated the incremental validity of the WHOQOL-OLD to the WHOQOL-BREF by using the elderly people in Taiwan. METHODS: The WHOQOL-BREF, the WHOQOL-OLD, and five visual analogue scales (VAS) that measure physical, psychological, social, environmental and total QOL were used in this study. Data were collected from 524 Taiwan elderly people (M = 76.2, SD = 7.5, ages ranged from 60 to 99). Five hierarchical regression analyses were conducted respectively to predict the five VAS criterion variables first from fitting the four WHOQOL-BREF domains and then the six WHOQOL-OLD domains. In addition, hierarchical regression analyses were also conducted to compare the incremental validity of the WHOQOL-

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78 OLD to WHOQOL-BREF when the sample were divided into two groups by their age, gender and self-perception on health. RESULTS: The results revealed that after controlled the four domains of the WHOQOL-BREF, the six domains of the WHOQOL-OLD could increase R squared (incremental validity) by 11–17 % (p \ 0.001). The groups of older age ([76.2, the mean age), female, and worse subjective health have higher incremental validity in comparison to the opposite groups (p \ 0.01). CONCLUSIONS: In general, the WHOQOL-OLD is a good add-on module to the WHOQOL-BREF in elderly people. However, we should use the WHOQOL-OLD with caution when we explain the results in the groups with different age, gender and health conditions.

(1065) Surgical Elderly Patients´ QOL After ICU Treatment Carla Carneiro, Hospital Professor Doutor Fernando Fonseca, Lisbon, Portugal; Dulce Oliveira, Hospital Pof.Dr Fernando Fonseca, Amadora, Portugal; Sabrina Tavares, Hospital Prof. Dr Fernando Fonseca, Amadora, Portugal; Ricardo Rocha, Hospital Prof.Dr. Fernando Fonseca, Amadora, Portugal; Rui Marinho, Hospital Prof.Dr. Fernando Fonseca, Amadora, Portugal; Antonio Gomes, Hospital Prof. Dr. Fernando Fonseca, Amadora, Portugal; Marta Sousa, Hospital Prof. Dr. Fernando Fonseca, Amadora, Portugal; Teresa Branda˜o, Hospital Prof. Dr. Fernando Fonseca, Amadora, Portugal; Isabel Braga, Hospital Prof. Dr. Fernando Fonseca, Amadora, Portugal; Vitor Nunes, Hospital Prof. Dr. Fernando Fonseca, Amadora, Portugal AIMS: the Number of Elderly Patients Requiring Intensive Care Unit (ICU) Is Rising. This Treatment Is Costly, with a High Social Burden and with Important Consequences on Quality of Life (QOL).Our Aim Was to Evaluate QOL of Elderly Patients (65 or Older) Treated in ICU and to Study Predictive Factors for QOL in These Patients. METHODS: We conducted a retrospective cohort study followed by a QOL survey on surgical elderly patients treated in ICU for organ dysfunction from January 2011 to December 2013. We analyzed patients´ demographic and clinical parameters, number of ICU days, total hospitalization days, number of mechanical ventilation days, SAPS II, survival time since ICU.We applied EORTC QLQ-C30 (version 3.0) questionnaire to all living patients that consented on answering the survey by phone. Parametric and non-parametric tests and logistic regression were used. RESULTS: During this period our surgical ICU treated 669 elderly patients of which 115 died in the ICU. 392 were further excluded because they were admitted for medical reasons, post-surgical surveillance or transferred to another hospital. 117 patients were then analyzed. 70 males (69 %), mean age 77,5y (range 65–93 year). 64 % were admitted for sepsis/SIRS and 13 % for Hypovolemic Shock. SAPS II 47.3 (range 11–111). Mean days of mechanical ventilation of 5 days (range 1–53). Mean days of ICU stay 12 (range 1–73). We correlated EORTC QLQ-C30 with demographic variables, reason for admission, days of ICU stay, SAPS II and survival time since ICU. CONCLUSIONS: Elderly patients are an increasing population in health care systems. Judicious use of resources should be evaluated according to results and benefits to patients, making of paramount importance the evaluation of QOL in these patients.

(1067) The effects of autobiographical disclosure on quality of life in older adults—a preventive approach Simone Freitag, PhD, University of Greifswald, Greifswald, Germany; Stefanie Hahm, University of Greifswald, Greifswald, Germany; Carolin Wendt, University of Greifswald; Katrin

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Qual Life Res (2014) 23:1–184 Stegemann, University of Greifswald; Silke Schmidt, PhD, University of Greifswald, Greifswald, Germany AIMS: Guided autobiographical writing, life review therapy and expressive writing are all forms of reviewing ones own life or life stages. These approaches are mainly applied by older adults with psychological disorders like traumata, depression or dementia. Biographical writing has shown positive effects on well-being and decrease of psychiatric symptoms in old age. This study aims to investigate whether biographical disclosure affects quality of life (QOL) in older adults from a short and long-term perspective. It is hypothesized that writing or talking about ones own autobiography positively affects in late life. METHODS: An intervention investigating the effects of autobiographical writing vs. diary writing in German older adults was developed and implemented. Elders with severe signs of posttraumatic stress disorder or major depression were excluded. Participants were randomly assigned to the study conditions: biographical writing/group talk, diary writing, control group. QOL was assessed twofold: first, subjective global QOL (Eurohis-8) and second, health-related QOL (WHO-QOL-OLD). Outcomes were assessed pre and post intervention as well as three and nine months after intervention. Expressive biographical writing and talking groups were compared to a diary group and non-intervention group. Statistical analysis comprised repeated-measures ANOVAs. RESULTS: A German sample of N = 210 older adults without clinical psychological disorders were recruited. All four points of measurement were available for 124 participants, mean age 75,1 years. All groups disclosing biographical and daily experiences showed increased levels of subjective QOL. Biographical disclosure whether written or oral significantly increased short-term QOL. Written biographical disclosure lead to a long-term increase of QOL, in terms of increased feeling of autonomy, satisfaction with past, present and future and less fear of death and dying. Daily writing about everyday life also positively affected QOL. Non-participation lead to a decline in QOL. There were no signs in the subjective QOL that biographical disclosure is superior to diary writing. CONCLUSIONS: Autobiographical disclosure approaches are useful to maintain QOL in older adults. Reflecting about ones own life is positively associated with QOL whether it is autobiographical or daily. These approaches therefore can be considered preventive non-therapeutic methods to maintain health and well-being in late life.

Health Policy (1071) The Ugandan patient perception of quality of life and living with hiv: qualitative study Doris M. Mwesigire, MD, Makerere University, Kampala, Uganda; Janet Seeley, Medical Research Council; Faith Martin, MA, University of Bath, Bath, United Kingdom; Achilles Katamba, Makerere University AIMS: The aim of this research was to describe the quality of life perceptions and associated factors among people living with HIV/ AIDS attending an urban clinic in Uganda METHODS: Twenty participants were purposively enrolled and in-depth interviews were conducted at initial visit, three month and six month intervals. All interviews were transcribed verbatim and translated for analysis. Data were analysed manually using the framework approach to content analysis. RESULTS: Individuals experienced the four qualities of life: livability of the environment, utility of life, life ability of a person and appreciation of life. These individuals had hope for the future, with multiple expectations. However, they still suffered from stigma, non disclosure and poverty that negatively affected quality of life. CONCLUSIONS: Individuals living with HIV and on treatment

Qual Life Res (2014) 23:1–184 experienced an improved quality of life in this setting but this experience was still rather fragile.

(1073) The impact of extreme weather events on the quality of life: levels of perception Raluca I. Antonie, Babes-Bolyai University, Cluj-Napoca, Romania; Adina E. Croitoru, Babes-Bolyai University, Cluj-Napoca, Romania AIMS: Building a model that can explain the levels of perception of the impact of extreme weather events on the quality of life (especially on health) is the main objective of our study. Our research question: Is the perception level of extreme weather events impact on health explained by a fusion of socio-demographic variables, media exposure and the knowledge factor? Among the subsequent aims are: (1) identifying the most relevant indicator and indices for measuring the impact of extreme weather events on the quality of life and (2) testing the model in Cluj-Napoca area. METHODS: Step no.1: a literature review of existing models and indicator systems that can measure and estimate the impact of extreme weather events on the quality of life. We examined 5 models that have been chosen between the most actual and with considerable impact. Step no.2. consisted in seizing the existing overlaps in terms of indicators in the systems under analyze. Step No.3: we added some community-relevant features and indicators that could explain the impacts measured. Step No. 4: we have built a questionnaire starting from the resulted indicator system. Step No.5: We have tested the model by applying the questionnaire in Cluj-Napoca. Step No.6: We analyzed, interpreted data and validated the model. RESULTS: The model consisting in 10 main indicators has been successfully tested, according to scientific rigors. Among the results, we have identified significant associations between the perception level of extreme weather events impact on health and socio-demographic variables, media exposure and the knowledge factor. CONCLUSIONS: The results of the study indicate a range of factors explaining the level of perception of the impact of extreme weather events, especially of heat waves and cold waves, on the health dimension of quality of life.

Patient-Centered Research (1075) Using PROs and PROMs for different purposes: a discussion of the dilemma’s Anna Beurskens, PhD, Zuyd University of Applied Sciences, Heerlen, Netherlands; Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands; Lotte Haverman, PhD, Emma Children’s Hospital— Academic Medical Centre, Amsterdam, Netherlands; Jolanda De Vries, Tilburg University, Tilburg, Netherlands; Raymond Swinkels, Zuyd University of Applied Sciences, Heerlen, Netherlands; Henrica C.W. de Vet, Sr., PhD, EMGO Institute VU Medical Center, Amsterdam, Netherlands AIMS: Nowadays Patient-reported Outcomes (PROs) are used in different contexts: in research, in daily clinical practice to support individual patient care and as performance measurement of quality of care in health care organizations. The selection of PROs and corresponding measurement instruments (PROMs) for these different contexts leads often to discussions and dilemmas. The Dutch affiliation of ISOQOL is involved in the development of a step-by-step plan for the selection of PROs and PROMs for different contexts. The aim of this presentation is to zoom in on three dilemmas in selecting PROs and PROMs. METHODS: A discussion of the dilemmas and the methodological and practical consequences in different contexts.

79 RESULTS: Dilemma 1: Are the same PRO of interest for the different contexts and how can we come to the best selection of instruments? For example, in research disease-specific domains may be most relevant because they are most sensitive to change; for patient care, more individually identified domains are often more appropriate; and for performance measurement disease-specific but also generic domains might be of interest. Dilemma 2: How do we deal with different requirements on the measurement properties in the different contexts? For example, a higher reliability than in research is required for use of PROMs to monitor progress in individual patients in clinical practice. On the other hand, large measurement error may not be a big problem in clinical practice if the instrument is only used to improve communication and support decision making. Dilemma 3: What are the requirements of the PROMs with regard to feasibility issues in the different contexts? For example, for routine patient care it is important to use short questionnaires that are easy to interpret, administer, analyze and integrate in electronic medical records. However, most instruments are developed for research and are lengthy and complex. CONCLUSIONS: We will conclude with the most important points for future research directions and to explore ideas for an international ISOQOL step-by-step plan for the selection of PROs and PROMs for different contexts.

(1079) Development of the revised McGill quality of life questionnaire for people with life-threatening illnesses Richard Sawatzky, PhD RN, Trinity Western University, Langley, BC, Canada; S. Robin Cohen, PhD, McGill University and Jewish General Hospital, H366, Montreal, QC, Canada; Javad Shahidi, Bayer HealthCare Canada; Andrew Day, Kingston General Hospital; Xuran Jiang, Kingston General Hospital AIMS: The 16-item McGill Quality of Life Questionnaire (MQOL) was developed in the 1990s to assess the quality of life of people with life-threatening illnesses. As part of an effort towards ongoing improvement of the MQOL, we set out to evaluate its construct validity in additional samples while concurrently determining whether improvements could be obtained by revising, adding or removing some of its items. METHODS: Data from the following samples in Canadian healthcare settings were used: 98 oncology patients receiving outpatient care or palliative homecare, two samples of 304 and 216 patients receiving palliative care at various stages of their disease trajectories, 368 patients receiving end of life care, and 219 oncology patients receiving outpatient care. Several new and reworded items were administered together with original MQOL items in the different samples. The samples were merged with the original instrument validation data (N = 497) to comparatively evaluate differences in psychometric properties. New or revised items that were not included in all samples were imputed using multiple imputation. Confirmatory factor analyses (CFA) and regression analyses of the Global QOL item were conducted to comparatively evaluate modifications of the original MQOL. RESULTS: The CFA results suggest that: (a) the three physical symptom items could be replaced by a single item without loss in model fit and with substantial improvement in Global QOL prediction; (b) model fit is not improved when using the reworded items—thus the original item wording was retained; and (c) psychometric properties are improved when replacing the original support subscale with a new subscale that combines one of the original items with new items pertaining to patients’ relationships with others. CFA of the MQOL-revised with four correlated factors resulted in good model fit in the pooled sample (RMSEA = 0.041; CFI = 0.94). It consists of 14 items measuring physical, psychological, existential, and relational well-being (internal consistency reliability estimates were 0.63, 0.83, 0.71 and 0.82, respectively). CONCLUSIONS: The results suggest that better QOL

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assessments may be obtained when using the MQOL-Revised. Analyses are ongoing to develop a short form and a comprehensive version of MQOL that includes additional domains.

Statistical Analysis of PROs (1083) Evaluating the invariance of the hyperhidrosis quality of life index (HidroQOL): a comparison of two paradigms, confirmatory factor analysis vs. rasch analysis Paul Kamudoni, Cardiff University, Cardiff, United Kingdom; Berno Mu¨ller, Riemser Pharma GmbH; Sam Salek, BSc RPh PhD FFPM, Cardiff University, Cardiff, United Kingdom AIMS: The HidroQOL is a disease-specific quality of life measure in hyperhidrosis, developed and validated using both classical test—and modern test theories. The aim of the current study was to assess whether the HidroQOL remained invariant when used across different patient populations. METHODS: Patients were recruited through online social networking communities related to hyperhidrosis [U.S.A, n = 559, Canada n = 36 and the U.K., n = 115]. Rasch item paratemeter estimates were compared using Scatterplot. Confirmatory factor analyses were carried out for each patient population separately. RESULTS: Rasch analyses showed that four items were more difficult for the UK patients than for patients from U.S. and Canada. Nonetheless, parameter estimates for all items were within 95 % confidence interval lines of the scatterplot (Fig. 1). Confirmatory analyses results supported metric invariance of the HidroQOL CONCLUSIONS: The findings of this study suggest that the construct of QOL being assessed by the HidroQOL is interpreted in a similar way between North America and the UK. This suggests that a single English version for the different Anglo-Saxon cultures is realistic.

and Cleary’s model was tested using structural equations modeling including: biological variables, symptom status, functional health, oral health perceptions, oral health-related quality of life and sociodemographic information. The biological variable was edentulism assessed by a clinical exam. Symptom status was assessed using the question: Are you satisfied with the appearance of your teeth or dental prostheses? Functional status was assessed using the question: ‘‘Have you decreased or changed the type and/or amount of food because of problems with your teeth or dental prostheses? Oral health perception was measured using the question: Compared with others your age, how would you rate the health of your mouth overall? Oral healthrelated quality of life was assessed with the Oral Health Impact Profile-14 (OHIP-14). Structural equation modeling (SEM) was used for the data analysis. SEM consists of two sub-models: the measurement model which establishes how the latent constructs are measured and the structural model which analyzes the structural relationships, corresponding to associations between variables. RESULTS: : In the final model, edentulism was negatively correlated to dissatisfaction of appearance of their dental prostheses (r = -0.25). The worse functional status was correlated with poor oral health perception (r = 0.24). Having [68 years of age (r = 0.25), being a female (r = 0.39) and living in rural areas (r = 0.15) had a direct effect on the edentulism. Age had a direct effect on OHIP-14 (r = -0.15). There was an indirect effect of sex on OHIP-14 via functional status (r = 0.12). The final model showed adequate fit (CFI = 0.98, TLI = 0.98 RMSEA = 0.03, WRMR = 0.90). CONCLUSIONS: The present findings partially support Wilson and Cleary’s model framework, but suggest that further conceptual development requires the inclusion of demographic and socioeconomic variables.

(1087) Quality adjusted survival in oncology: a review of the q-twist method used these twenty past years Item difficulty estimate s in logits (UK sample)

Anais Jouin, Centre Oscar Lambret, Lille, France; Bastien Cabarrou, Institut Claudius Regaud; Thomas Filleron, Institut Claudius Regaud; He´le`ne Behal, Universite´ de Lille 2, Equipe D’Accueil 2694; Alain Duhamel, Universite´ de Lille 2, Equipe D’Accueil 2694; Andrew Kramar, PhD, CRLC Val D’Aurelle, Montpellier, Herault, France

Item difficulty estimates in logits(US and Canada Sample)

Fig. 1 . (1085) Testing the Applicability of a Conceptual Model of Oral Health-Related Quality of Life in Older Adults Camila M. Dos Santos, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; Roger K. Celeste, Federal University of Rio Grande do Sul; Juliana B. Hilgert, Federal University of Rio Grande do Sul; Fernando N. Hugo, Federal University of Rio Grande do Sul, Porto Allegre, Brazil AIMS: To test Wilson and Cleary’s model of the direct and mediated pathways between clinical and nonclinical variables in relation to oral health-related quality of life in community-dwelling older people. METHODS: A random sample of 578 elderly was evaluated. Wilson

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AIMS: Quality of life (QOL) of cancer patients is being used more and more in the evaluation of new therapeutic strategies, especially targeted therapies which have shown to increase survival, but to the detriment of side effects. One method, Q-TWiST, is of particular interest since it is a quantitative method for evaluating quality adjusted survival. It was derived from the TWiST method (‘‘Time spent Without Symptoms or Toxicity’’) and was first developed for cytotoxic agents by splitting overall survival time into three components: Toxicity, No Toxicity and Relapse each one weighted with utility scores. The aim of this paper is to review the use of this method and to highlight its advantages and disadvantages in the analysis of QOL studies. METHODS: A Pubmed literature search between 1991 and 2013 was performed targeting clinical trials which used the Q-TWiST method. Differences between treatments were estimated by overall survival (OS), relapse-free survival (RFS) and by quality adjusted survival (Qolsa). RESULTS: 55 papers dealing with the Q-TWiST method were found. Among them, 35 reported the application of the method to a clinical trial, of which 30 concerned supplementary analyses of previously published randomized phase 3 trials and five dealt with general methodology. The Q-TWiST method was used in several fields of oncology, notably breast cancer (34 %) and hematology (20 %) whether for chemotherapy treatment assessments (37 %), for targeted therapies (34 %) or for radiotherapy (14 %). The median gains were 12.9 months for OS, 17.9 months for RFS and 11.3 months for Qolsa. The results of our review found a mean Qolsa

Qual Life Res (2014) 23:1–184 difference of 11.15 % which is above the recommended clinically relevant difference of 10 %. CONCLUSIONS: Few studies used health utilities derived from patients or the general public, most studies relied on sensitivity analyses with no prospective collection of utility scores. Sensitivity analysis allowed the trade-off between treatment toxicity and increased disease-free survival depending on patient preferences on QOL and prognostic situation. The analyses with the Q-TWiST method should be planned prospectively in order to collect utilities and to have more relevant results. The Q-TWiST method first developed for cytotoxic agents is appropriated to targeted therapies.

(1089) A Guttman’s errors based method for response-shift detection at the individual level: algorithm and comparison with the ahmed’s procedure Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France; Myriam Blanchin, University of Nantes, Nantes, France; Veronique Sebille, ScD, University of Nantes, Nantes, France AIMS: Response Shift (RS) is a phenomenon affecting individuals for whom the perception of the items of a questionnaire changes across different times of measurement. Today, several methods have been proposed in order to detect RS. A majority of methods allow detecting RS at a group level. Nevertheless, it is expected that, among a sample of individuals, only some of them could be potentially affected by RS, and the others might not be. More, among individuals affected by RS, it can be displayed according to several types (recalibration, reprioritization, reconceptualization), RS can also affect different items and to different extent. METHODS: We propose a new method for RS detection based on Guttman’s errors (GE) to detect RS at an individual level. GE represent each incoherent combination of responses to two items for a patient, and were computed by ordering all the possible answer’s categories (of all of the answered items) from the easiest (the most prevalent) to the most difficult (the least prevalent). A GE occurred as soon as a patient responded to an answer’s category for one item of the questionnaire and simultaneously did not respond to an easier answer’s category to another item. In this work, the order of the answer’s categories has been determined from the patients’ responses observed at the first time of measurement. The number of GE was subsequently determined for each individual at each time of measurement. Individuals with many incoherent responses at a given time were subsequently suspected to interpret the items differently compared to the whole sample, and to present RS. RESULTS: This approach will be compared to the procedure defined by Ahmed based on latent trajectory models performed on the residuals of a longitudinal model using a simulation study. An application of this approach on the SATISQOL study, aiming at studying links between satisfaction of the patients and quality of life will also be performed. CONCLUSIONS: The proposed approach is simple to understand and to implement by using a Stata module on the free and online PRO-online software (http://pro-online.univ-nantes.fr/). A limit of this approach is to consider only recalibration RS.

(1091) Confirmation of the factor structure of the PROQOL-HIV questionnaire in han and uygur HIV 1 patients Christophe Lalanne, DRCD Hospital Saint-Louis, Ivry, France; Rena Maimaiti, Xinjiang Medical University, Xinjiang, Peoples Republic of China; Rune Andersson, Sahlgrenska Academy, University of Gothenburg, Sweden; Olivier Chassany, MD PhD, Direction de La Politique Medicale, Paris, France; Martin Duracinsky, MD PhD, Hospital Bicetre, AP-HP, Paris, France AIMS: To confirm the validity of the four-factor structure of the PROQOL-HIV questionnaire for measuring health-related quality of life in Chinese HIV ? patients. METHODS: A total of 679

81 outpatients (age, 40 ± 9 years; 61 % males; 67 % IDUs) were assessed on the 43-item PROQOL-HIV questionnaire on four domains specific of VIH infection (PHS, physical health and symptoms; COG, health concerns and mental distress; REL, social and intimate relationships; TRT, treatment-related impact), where HRQOL scores are summarized on a 0–100 points scale (higher scores mean a better HRQOL). A confirmatory factor analysis (CFA) was used to verify the hypothesized four-domain scaling scheme. A multi-group CFA (MIMIC model) was used to assess the equivalence of factor mean scores across Uygur (74 %) and Han (23 %) patients. Kruskal–Wallis ANOVAs were used to compare HRQOL scores, and Wald tests for group comparisons between factor scores. Statistical analyses were done in R and Mplus. RESULTS: Like for the international validation study, Chinese patients exhibit low HRQOL compared to Western countries, but this was more pronounced on the COG dimension (PHS: 60.1 ± 10.2; REL: 58.6 ± 10.9; COG: 29.9 ± 10.2; TRT: 58.1 ± 9.2). The CFA indicated acceptable fit to the factor structure (RMSEA = 0.029, 90 % CI [0.026;0.033]; NNFI = 0.795). Uygur and Han patients had comparable HRQOL on all four domains, including the COG dimension (Uygur: 30.0 ± 10.3 vs. Han: 29.0 ± 10.1; F(1,642) = 0.89, p = 0.346). The same applies at the level of factor scores (PHS: p = 0.594; REL: p = 0.620; COG: p = 0.656; TRT: p = 0.991). CONCLUSIONS: The PROQOL-HIV questionnaire is a valid and reliable questionnaire to assess HRQOL in HIV ? Chinese patients, independent of their country of origin.

(1093) Validscale: a free module to validate a uni- or multidimensional pro-based questionnaire Bastien Perrot, University of Nantes, Vertou, France; Emmanuelle Anthoine, University of Nantes, Nantes, France; Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France AIMS: Validation of multidimensional scales measuring Patientreported Outcomes (PRO) is a fastidious work in order to define the psychometric properties (validity, reliability and sensitivity) of the questionnaire. The validation steps are numerous and actually, no software exists in order to perform them as a whole. The objective of the module validscale is to provide in an easy way all the required analyses to validate a uni- or multi-dimensional questionnaire. METHODS: The module is composed of several options in order to specify the analyses to be performed and their associated parameters. Validscale is available in Stata and is implemented on the free and online interface PRO-online (http://pro-online.univ-nantes.fr) which allows using this module in a user-friendly interface and without programming knowledge. RESULTS: The module computes elements to assess structural validity (multitrait analysis, Confirmatory Factor Analysis), convergent and divergent validity, reproducibility, known-groups validity, internal consistency, scalability and sensitivity. Missing data can be automatically imputed or not. Graphs and highlighted results are provided to help with the interpretation of the results. CONCLUSIONS: The module validscale is an easy way to assess the validity and the reliability of a subjective measurement scale. It is implemented on Stata and on PROonline in a user-friendly interface.

Measure Development (1095) Generating items for the oxford participation and activities questionnaire (Ox-PAQ) Laura Kelly, University of Oxford, Oxford, United Kingdom; Sarah Dummett, University of Oxford, Oxford, United Kingdom; Jill Dawson, University of Oxford, Oxford, United Kingdom; Raymond Fitzpatrick, PhD, Univ of Oxford, Dept of Public Hlth, Oxford, United Kingdom; Crispin Jenkinson, Health Services Research Unit,

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82 Oxford, United Kingdom; David Morley, University of Oxford, Oxford, United Kingdom AIMS: To generate items for a new patient-reported outcome measure: the Oxford Participation and Activities Questionnaire (OxPAQ). Grounded in the World Health Organisation International Classification of Functioning, Disability and Health (ICF), the OxPAQ is specifically designed for the assessment of participation and activity in patients experiencing a range of health conditions. METHODS: Semi-structured interviews were conducted with 41 participants spanning a range of conditions to identify how their condition impacted on their ability and desire to participate in meaningful activities. Participants were recruited via a number of charitable support organizations representing conditions including arthritis, cancer, chronic back pain, diabetes, motor neurone disease, multiple sclerosis, Parkinson’s disease and spinal cord injury. Transcripts were analysed using the Framework method. RESULTS: Key themes relevant to participation in everyday life were identified and informed an initial pool of 222 items. This item pool was refined by the research team to retain 95 generic items. Items were mapped onto all nine chapters of the ICF construct detailing activity and participation. CONCLUSIONS: Using a clear conceptual basis to inform item generation, 95 candidate items have been produced that are currently undergoing expert and patient review. A large-scale postal survey will follow in order to refine the instrument further and to assess its psychometric properties. The final instrument is intended for use in clinical trials and interventions targeted at maintaining or improving activity and participation.

(1097) Development of an item bank to measure economic quality of life (ECQ) for individuals with disabilities David Tulsky, PhD, Kessler Foundation, New York, NY, United States; Allen W. Heinemann, Northwestern University, Chicago, IL, United States; Jin-Shei Lai, PhD, Northwestern University, Chicago, IL, United States; Noelle Carlozzi, University of Michigan; Pamela A. Kisala, University of Michigan; Patrick Semick, Rehabilitation Institute of Chicago AIMS: The economic burden of a disability is a significant factor affecting quality of life. Individuals with disabilities often have significant medical bills, need accessible housing and transportation, and are faced with reduced opportunities for employment. Unfortunately, there is no measure of perceived economic quality of life to assess these issues. METHODS: In phase 1, we analyzed data from 48 focus groups using a grounded theory based approach to identify issues relevant to perceived economic QOL. In phase 2, we recruited a sample of 305 individuals with TBI, stroke, and traumatic SCI. We used confirmatory factor analyses to confirm unidimensionality followed by Rasch analyses. In phase 3, we administered the items to a new sample of 604 community-dwelling adults with spinal cord injury, stroke, and traumatic brain injury. RESULTS: In Phase 1, we winnowed an existing pool of 91 potential items to a subset of 37 items. In Phase 2, we dropped 9 items based upon a low R-square (e.g., \0.3 for 3 items) and local item dependency (residual correlations [0.20 for 4 items, and potential dependency issues (residual correlations 0.15 to 0.20 for 2 items). The final set of 28 items was thought to be the best measures of Economic QOL although 4 of the items were included in the next phase of calibration testing. In Phase 3, we obtained a larger sample and analyzed the data finding additional items that could be removed using Rasch Analyses. We also identified that several items had low frequency to some response choices and our first step was to combine categories yielding an item pool that contained 4 response choices. We completed Rasch analyses on the 32 items in an iterative fashion and flagged 12 items for potential removal.

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Qual Life Res (2014) 23:1–184 CONCLUSIONS: This project marks the first time items the construct of perceived economic resources and burden has been developed as a patient-reported outcome tool. The next steps are to examine and reconcile differences between the research findings between the two samples. We will expand the sample and examine the results in a larger and more robust sample. In addition, items have been administered in two other studies with 504 individuals with traumatic brain injury and 87 individuals with spinal cord injury. The next steps are to combine samples and examine the item bank in a larger sample using a 2-PL model.

(1099) From Apathy to Motivation: an Exploration of a Construct Christiane B. Lourenco, PhD, McGill University, Montreal, QC, Canada; Lesley Fellows, McGill University, Montreal, QC, Canada; Nancy E. Mayo, PhD, McGill University Health Centre, Montreal, QC, Canada AIMS: Apathy is a primary motivational syndrome relevant in many neurological conditions as it is associated with cognitive impairment, depression, slower recovery of function, higher dependence on others. Apathy has both diagnostic and measurement components. The latter has not been optimized in light of modern psychometric theories. Having an accurate conceptualization and metric for the apathy construct is important to target and evaluate interventions. The prevalence of apathy in stroke has ranged from 15 % to 50 % depending on how it is measured. Existing measures of apathy are difficult to administer because of complex wording and response options. The lack of a suitable measure for apathy is a barrier to optimizing stroke recovery. The objective of this study is to refine the measurement approach to apathy in people with stroke. METHODS: Eighty-two people with stroke were followed longitudinally, at four time points, from onset to one year post stroke. Rasch analysis was applied to the most commonly used apathy questionnaire, he Apathy Scale (AS). Group-based trajectory modeling was used to identify how the refined measures, resulted from Rasch analysis, behaved longitudinally and impacted on participation. Magnetic Resonance Images were analysed to estimate the extent to which apathy was associated with brain lesion location. RESULTS: Rasch analysis of the AS resulted in a new measure comprising 10 of the original 14 items reflecting three of the four essential components of the apathy construct. As such, it best reflects the latent construct of motivation. Three emotional function items were added to the motivation measure to form a valid measure of apathy that spans the construct with improved psychometric properties. Five trajectories of motivation and four trajectories of apathy were identified with the majority of participants showing moderate levels of apathy and motivation that remained stable over time; both had an important impact on participation. Finally, brain lesion mapping provided evidence that the symptoms of the apathy construct, rather than motivation symptoms, have some association with brain lesions, more specifically, lesions in the right frontal hemisphere. CONCLUSIONS: Both motivation and apathy are relevant constructs for stroke outcomes and this work provides some tools to move the field forward.

(1101) Patient benefit measurement in dermatology: using qualitative interviews to explore the content of treatment goal items Christine Blome, PhD, University Medical Center HamburgEppendorf, Hamburg, Germany; Kathrin Von Usslar, University Medical Center Hamburg, Hamburg, Germany; Matthias Augustin, MD, University Medical Center Hamburg, Hamburg, Germany

Qual Life Res (2014) 23:1–184 AIMS: In the development of patient-related outcomes, questionnaires are often tested qualitatively in cognitive debriefing interviews which usually focus on comprehensibility. In contrast, our study aimed at gaining a more detailed knowledge on the patients’ understanding of items in a pilot version of the ‘‘Patient Benefit Index 2.0’’ (PBI 2.0). The PBI 2.0 measures patient-relevant treatment goals and benefits in dermatology and had been developed on the basis of open patient surveys on treatment goals. METHODS: We conducted 16 semi-structured interviews with patients with four different skin diseases. The patients were presented 15 pilot items on different treatment goals (e.g., ‘‘to be less of a burden to relatives and friends’’), asking them to elaborate on their understanding of each goal and to state whether any important treatment goal was missing. All interviews were transcribed verbatim. Two independent researchers extracted the relevant statements and summarized the key content, with subsequent comparison and consensus building. The analysis focused on item content, completeness of treatment goals and unambiguity of item wording. RESULTS: The sample was heterogeneous regarding gender (9 female, 7 male), age (29–86 years), and education. The task seemed to be easy to understand for the patients, and each of them shared detailed information on the different treatment goals. On the basis of these analyses, some items remained unchanged, whereas others were reformulated or deleted. To give an example, the goal ‘‘to be able to lead a normal everyday life’’ did not include leisure activities for some patients; therefore, this topic was added in a separate item. The goal ‘‘to gain enjoyment of life’’ was reported to include positive emotions and the absence of negative emotions and cognitions, but also specific impairments causing these emotions; the item was therefore reworded to relate more explicitly to feelings in order to reduce inter-item redundancy. The final item set included 12 treatment goals. CONCLUSIONS: Qualitative interviews provide a good means of gaining detailed insight into item content and understanding and have helped improve the PBI 2.0.

(1103) Improving the Individual Work Performance questionnaire using rasch analysis Linda Koopmans, Netherlands Organisation of Applied Research TNO, Leiden; Claire Bernaards, Netherlands Organisation of Applied Research TNO, Leiden; Vincent H. Hildebrandt, Netherlands Organisation of Applied Research TNO, Leiden; Stef Van Buuren, Netherlands Organisation of Applied Research TNO, Leiden; Allard J. Van Der Beek, Dept of Public and Occupational Health, VU University Medical Center, Amsterdam; Henrica C.W. de Vet, Sr., PhD, EMGO Institute VU Medical Center, Amsterdam, Netherlands AIMS: Disciplines such as organizational psychology, human resource management and occupational medicine are interested in improving Individual Work Performance (IWP). IWP is defined as behaviors and actions of employees that are relevant to the goals of an organization. It comprises three dimensions: task performance (TP), contextual performance (CWP) and contraproductive work behaviour (CWB). We developed Individual Work Performance Questionnaire (IWPQ) version 0.2 using Rasch analysis. It appeared that the TP and CP scales (4 and 5 items respectively) showed ceiling effects (not enough difficult items) and the CWP scale (5 items) showed floor effects (not enough easy items) in healthy workers. The current study aimed to improve targeting of the IWPQ scales by including additional items. METHODS: We formulated 13 new items: 3 for TP, 5 for CP and 3 for CWB, and changed the response options of the CWB scale from ‘‘seldom, sometimes, frequently, often, always’ to ‘never, seldom, sometimes, frequently, often’’. We tested the model fit, and the key measurement requirements: reliability, category ordering, unidimensionality, and differential item functioning. Targeting of the scales was examined by

83 looking at the person-item threshold distribution and the range of the information curve. Items that showed misfit or did not improve targeting were removed from the IWPQ 0.3 to obtain IWPQ version 1.0. We used RUMM2020 for all Rasch analyses. RESULTS: The scales showed good model fit and fulfilled key measurement requirements. Examples of the added items were: My planning was optimal (TP); I actively participated in work meetings (CP) and I did less than was expected of me (CWB). An additional 2 items in the TP scale and 3 items in the CP scale helped improving the targeting of these scales. The 3 items added to the CWB scale did not improve the targeting, and floor effects remain. CONCLUSIONS: Compared to its previous version, the IWPQ 1.0 version showed improved targeting for two out of three scales. As a result, it can more reliably measure workers at all levels of ability, discriminate between workers at a wider range on each scale, and detect changes in individual work performance.

(1105) Rasch analysis of the Spanish version of the oral health impact profile (ohip) in periodontal patients Karina J. Espinoza, MSc, Distrito Federal, Mexico; Luz Dary LD Upegui, MSc, Universidad Industrial de Santander, Mexico City, Mexico; Ingris Pelaez, Universidad Nacional Auto´noma de Me´xico; Gloria A. Moreno, Universidad Nacional Auto´noma de Me´xico AIMS: To validate the Spanish version of the Oral Health Impact profile (OHIP) in periodontal patients using Rasch analysis. METHODS: Cross sectional study. One hundred forty-five patients mean age 52.3 (SD:12) completed the OHIP and a comprehensive periodontal examination recording clinical parameters such as bleeding on probing, plaque, probing atcahment level, probing dept and tooth mobility. Rasch analysis was performed to assess category function, person and item separation reliability, estimate INFIT and OUTFIT, person-item fit and unidimensionality. The sociodemographic analysis of the sample was performed with SPPS software and Winsteps for the Rasch modeling. RESULTS: The Rasch analysis confirms an initial person-item separation of 3.21 and 6.33 respectively, 0.91 person correlation and 0.98 for the items. When assessing the response scale it showed an unclear distribution of the measures given by the item categories, and decided to narrow the scale from 01234 to 01112, resulting into 3 response categories and improved measurement coherence percentage. The item 9 (prothesis adjustment) and 18 (prothesis discomfort) did not fit the criteria and were excluded. CONCLUSIONS: The resulting 47 items of the 49 OHIP fitted the Rasch criteria suggesting construct unidimensionality. The use of three response categories is advised in order to obtain better coherence of the measurements (Table 1; Figs. 1, 2).

Table 1 Rasch fit statistics and item measure for the OHIP 49 Item

Measure

Infit MNSQ

Outfit MNSQ

Painful gums

1.67

-0.09

1.36

Unable to eat (dentures)

1.19

1.45

1.63

Financial loss

0.41

1.39

1.31

Sensitive teeth

-1.35

1.22

1.31

Unable to brush teeth

-0.18

1.27

1.29

0.68

1.28

1.23

-0.54

1.26

1.17

Trouble pronouncing words Taste worse Headaches

0.75

1.14

1.22

Noticed toth wich doesn’t look rigth

-2.26

1.14

1.14

Self-concious

-2.45

0.75

1.11

Food catching

-2.05

1.11

1.11

0.27

1.11

1.00

-0.60

1.02

1.09

Digestion worse Sore spots

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Table 1 continued Item Sleep interrupted

Measure

Infit MNSQ

Outfit MNSQ

0.92

1.08

0.94

Difficulty chewing

-1.56

1.06

1.04

Toothache

-0.88

1.05

1.03

Sore jaw

0.27

1.04

0.99

Trouble getting along with others

1.14

1.03

0.93

Life unsatisfying

0.71

0.93

1.02

Breath stale

-1.48

1.01

1.00

Avoid smiling

-0.45

1.00

0.92

General appearance

-1.10

1.00

0.97

Health worsened

0.96

0.99

0.81

Others misunderstood

1.28

0.99

0.92

Speech unclear

0.71

0.98

0.92

Avoid eating certain food

-0.80

0.93

0.98

Painful aching

-1.21

0.96

0.96

Irritable with others

1.38

0.95

0.87

Difficulty doing jobs

1.83

0.82

0.94

Less tolerant

1.23

0.94

0.88

Diet unsatisfatory

0.41

0.93

0.78

Unable to function

2.50

0.93

0.63

Interrupt meals

0.68

0.92

0.92

Unable to enjoy people’s company

0.68

0.92

0.82

Miserable

-0.54

0.91

0.85

Unconfortable to eat

0.88

-1.56

0.91

Less flavor in food

1.05

0.90

0.71

Depressed

0.24

0.90

0.82

Difficult to relax

0.49

0.90

0.80

Tense

-0.66

0.89

0.84

Been embarrassed

-0.36

0.87

0.82

Avoid going out

2.17

0.84

0.55

Concentration affected

0.84

0.84

0.69

Teeth appearence

-1.35

0.83

0.80

Upset

-0.63

0.81

0.78

Worried

-2.73

0.74

0.74

2.03

0.69

0.38

Unable to work

Fig. 2 Person-item wright map

(1107) Interview administered versus self-administered PROQOL-HIV scale in India

Fig. 1 Category probability curves showing left original five response categories (01234), right modified three response categories (01112)

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Rewa Malhotra Kohli, Research Scientist, National AIDS Research Institute, Pune, Maharashtra, India; Christophe Lalanne, DRCD Hospital Saint-Louis, Ivry, France; Ramesh S. Paranjape, National AIDS Research Institute, Pune, India; Amit Nirmalkar, National AIDS Research Institute; Manisha Ghate, National AIDS Research Institute; Susan Herrmann, Murdoch University, Perth, Australia; Olivier Chassany, MD PhD, Direction de La Politique Medicale, Paris, France; Martin Duracinsky, MD PhD, Hospital Bicetre, AP-HP, Paris, France AIMS: Health research relies largely on collecting patient-reported data. Attention is increasingly being paid to the mode of data

Qual Life Res (2014) 23:1–184 collection and validity of such data. Comparison between two different modes of administration: self-reported and interview-based, for assessing quality of life using PROQOL-HIV Scale is reported from Indian setting. METHODS: A randomized two-period crossover design study among both ART naı¨ve and on ART HIV positives, was conducted from September 2010-February 2013 in Pune, India. Information was collected from 297 consenting individuals. Individuals less than secondary educated [non readers N = 101] were interview-administered the scale, while those above secondary education [reader N = 196] were randomly assigned to either selfinterview (N = 88) or interview-administered (N = 108) groups stratified by gender and ART status. Repeat assessment was made a fortnight later with cross over in mode of administration. Wilcoxon Signed Ranks test and two way ANOVAs was used to compare PROQOL scores. RESULTS: Majority of the positives were women 52.5 %, middle aged (mean 36 yrs), married 65.7 %, educated up to secondary school 56.2 %, professionally active 76.4 %, followed by housewives 20.2 %. The baseline median score for self-interview mode was (76.50) and for interview-administered mode (77.50). Scores were not significantly different (p = 0.759) when patients were interviewed first and self-interviewed in follow up whereas significant differences (p \ 0.001) were found when the patients were self-interviewed first and interviewed in follow-up. Similarly, education was found to influence the scores in self first group (p = \0.05). Domain Scores were also compared with order of administration. Self-interview first found significant results for physical health domain both for on ART (99) & no ART (97) (p = \0.05), while for relationship domain it was significant for on ART group (p B 0.01) and feelings domain it was significant for on ART (p B 0.05). Comparison of interview-administered scores for readers (baseline) and nonreaders were non significant (p = 0.479). CONCLUSIONS: Interviewed-administration is a better mode of PROQOL administration for collection of quality of life data from all types of population irrespective of the literacy levels of the respondents. Education plays an important when information is collected through self- interviewing as some questions may not have been properly understood. Besides, respondents are unlikely to be accustomed to filling questionnaires.

(1109) Quality of life assessment in menstrual problems Pamela Warner, University of Edinburgh, Teviot Place, United Kingdom AIMS: Menstrual problems encompass three main variants—heavy menstrual bleeding (HMB), period pain and cycle-related mood/ physical symptoms—which frequently co-occur but are mostly researched separately. In the UK prevalence of menstrual problems is believed to be over 25 %. Menstrual problems manifest in females only and in an episodic/cyclic pattern, are not progressive/lifethreatening, but in the absence of treatment often become ‘chronic’. They are unusual in being self-limiting (because menstruation ceases at menopause). Nevertheless they can accumulate to substantial health deficit—up to a quarter of ‘prime of life’, between ages 16 to 50 years. The profound impact of menstrual problems is on quality of life and role functioning. The UK NICE Guidelines for HMB (2007) define it as ‘‘excessive menstrual blood loss which interferes with a woman’s physical, emotional, social and material quality of life’’, and advocate that ‘‘interventions should aim to improve quality of life’’. Despite this, use of quality-of-life measures in routine clinical practice remains unusual. Could this be due to discordance between the ethos of individual clinical care, and research? The aim is to describe the multivariate inter-relationships between (idiopathic) patient reports of menstrual problem impact, and

85 (essentially nomothetic) research measures. METHODS: Menstrual problems pose clinical and research conceptual/assessment challenges because: there is not clarity as to where ‘female lot’ ends and health problem starts; there are socio-cultural barriers to discussion of menstruation; if no pathology is evident that can be presumed to be causative ‘diagnosis’ often has to be based on subjective account; and symptom reporting is related to aspects of personality. This paper will report analyses of data from a survey of 952 women referred with menstrual problems to three Scottish hospital gynaecology clinics. Measures include SF-36, Eysenck Personality Inventory and General Health Questionnaire, plus questionnaire items addressing menstrual history and current symptoms, as well as idiopathic measures of problems experienced with menstruation. RESULTS: Detailed findings describe the inter-relationships within the data. For example, principal components derived from nomothetic items were differentially related to subscales of SF36. CONCLUSIONS: To improve population health, differing QOL assessment is required for clinical and research purposes.

Poster Session 1002: Thursday Poster Session 2 Cancer (1002) Health-Related quality of life and mental health in long term survivors with brain tumour, hodgkin’s or Non-Hodgkin’s lymphoma: a registry based study in Schleswig–Holstein, germany, based on adults Annika Waldmann, University of Luebeck, Institute of Social Medicine and Epidemiology, Luebeck, Germany; Dorothea Bethge, Inst. of Social Medicine and Epidemiology; Eva M. Fick, Inst. of Social Medicine and Epidemiology; Judith Gebauer, Experimental and Clinical Endocrinology; Georg Brabant, Experimental and Clinical Endocrinology AIMS: Prognosis of most cancer diseases has improved during the last decades leading to a growing cohort of long term cancer survivors. Not only diagnosis and treatment of cancer but also long term effects of treatment and comorbidity may impact health-related quality of life and mental health. We aimed to investigate healthrelated quality of life and mental health in a large cohort of adult cancer survivors with brain tumours (BT), Hodgkin’s (HL) and nonHodgkin’s lymphoma (NHL). METHODS: We included 1035 subjects with a diagnosis of BT (9 %; ICD-10 C71, D33.0–33.2), HL (22.5 %; C81) or NHL (68.5 %; C82–84) 5–15 years ago and notification to the epidemiological cancer registry Schleswig–Holstein. They were asked to participate in a survey targeted on endocrine late effects, quality of life and mental health. For the latter purposes, SF-36 (V1.0; analyzed: t-score, standardized to US population) and WHO-5 were included in the study questionnaire. RESULTS: Of all potential participants, 558 subjects (54 %) took part whereas 72 subjects had deceased and 62 actively refused participation. Their mean age at tumour diagnosis was 52.7 ± 14.6 yrs and mean time of follow-up was 9.6 ± 3 yrs. 72 % of all subjects reported a satisfying or good wellbeing during the last 2 weeks, while the presence of a clinical manifest depression was highly likely in 13 % of all subjects. Compared to HL and NHL patients, BT patients were nearly three times more likely to have low WHO-5 scores being indicative for depression. In contrast, mean SF-36 scores for the mental component scale did not differ between the three groups, but was considerably low (*30 points). Compared to HL and NHL patients, BT patients had higher scores for vitality, social functioning, general mental health, but not for role limitations caused by emotional problems. CONCLUSIONS: Our study is the largest population based survey on endocrine

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86 function, health-related quality of life and mental health in adult cancer survivors in Germany. With limitations of a questionnaire approach our data support reduced mental health in long term survivors of brain tumours, Hodgkin’s and non-Hodgkin’s lymphoma.

(1004) Working and occupational condition after esophagectomy for cancer Eleonora Pinto, PsyD, Veneto Institute of Oncology, Padova, Italy; Marco Scarpa, Veneto Institute of Oncology, Veneto, Italy; Francesco Cavallin, Veneto Institute of Oncology, Veneto, Italy; Rita Alfieri, Veneto Institute of Oncology, Veneto, Italy; Matteo Cagol, Veneto Institute of Oncology, Veneto, Italy; Luca M. Saadeh, Veneto Institute of Oncology, Veneto, Italy; Silvia Mantoan, Veneto Institute of Oncology, Veneto, Italy; Carlo Castoro, Veneto Institute of Oncology, Veneto, Italy AIMS: The aim of the current study was to evaluate the impact of esophagectomy for cancer on patients’ occupation. We also evaluated the association between the job condition and perceived quality of life at one year after esophagectomy. METHODS: We retrospectively evaluated all consecutive patients referring to our department between 2009 and 2012 for esophageal cancer. Inclusion criteria was esophagectomy for cancer. Patients not suitable for work (due to psychiatric disease or tetraplegia) and patients with missing information about their job were excluded. Working condition at diagnosis, at one month before surgery and at one year after surgery was collected. Patient’s and tumor characteristics— along with therapeutic strategies—were also collected. Quality of life was evaluated at one year after surgery using Financial Difficulties (FI), Social Functioning (SF), Role Functioning (RF) and Global health status (QL2) scores of EORTC QLQ-C30 questionnaire. RESULTS: One hundred twenty-six consecutive patients referred to our department between 2009 and 2012 for esophageal cancer and 89 of them underwent surgical resection. Fifty-one patients were active workers at the diagnosis, 29 were retired and 6 were housewives, whereas job information was not available in 3 patients. Among patients working at diagnosis, 64 % still worked at one year after surgery whereas 36 % quit their job. At one year after surgery, the SF score (92.9 ± 13.1 vs. 85.5 ± 17.6, p = 0.32), FI score (16.7 ± 27.9 vs. 24.6 ± 27.0, p = 0.53), RF score (71.4 ± 28.4 vs.87.7 ± 22.0, p = 0.12) and QL2 score (84.8 ± 18.3 vs. 83.2 ± 22.4, p = 0.55) were similar between patients who quit and those who not quit their job. CONCLUSIONS: A considerable number of patients quit their job after esophagectomy for cancer. Adequate welfare strategy should be implemented for esophageal cancer survivors.

(1006) Quality of life related to health in patients with myeloproliferative syndromes in colombia Martin Romero, MD PhD(C), Universidad Nacional de Colombia, Bogota, Colombia; Ruben Marrugo, Fundacion Salutia AIMS: Determine the quality of life related to health (HRQOL) of patients of patients with MFP in Colombia, with different instruments measuring both specific and general pathology. METHODS: Given an estimated 1–3 cases per 100,000 inhabitants of myeloproliferative syndromes in Colombia, a survey measuring socio demographic variables and HRQOL was applied on a sample of 46 patients distributed nationwide with the following distribution: 6 in Manizales, 3 in Bogota, 2 in Cali, 1 Jamundı´, 1 in Buga and 33 in Medellin to ensure a complete representation. Three instruments (i) the FACTLym scale (Cella et al. 2005) that 42 items combined in 5 sub scales were used; (ii) the FACIT -fatigue scale that includes 13 items related

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Qual Life Res (2014) 23:1–184 to fatigue and (iii) a visual analog scale (VAS). The estimation of HRQOL of each scale was analyzed by categories according to the number of symptoms (three or less symptoms, three to six, and more than national level six). The results were analyzed using measures of central tendency and correlation between scales through a simple linear regression. RESULTS: The sample has a mean age of 62, a distribution of 59 % women, 76.0 % of them within a contributive health system similar to those reported in the international literature. Mean HRQOL measure through the Fact- Lym, reported values between 0 and 168; having better HRQOL within the highest scores and averaging 136.5 (95 % CI 147 -125 0.6). Patients with symptoms up to 3, from 3 to 6 and over 6 symptoms have Fact- Lym 143.4 (12.2) 129.9 (19.7) and 87.6 (28.0) respectively; These values show statistically significant differences between groups (p \ 0.0001). Similar results were obtained with the FACIT -fatigue 133.3, 117.8 and 87.9 for the same groups with a maximum of 160 HRQOL. EVA was taken as control resulting in a mean for the target population of 79.56. The data between EVA, Fact- Lym -Fatigue and FACIT presented correlation 80.16. No significant variations by gender and age were found. CONCLUSIONS: The instruments allow properly assess HRQOL. As the number of symptoms experienced by patient increases, HRQOL decreases both using Fact- Lym as FACIT -fatigue and EVA; may be useful to assess the evolution of the disease holistically.

(1008) The Burden of pain and fatigue in Multiple Myeloma: results of a systematic literature review Colleen A. McHorney, Covance Market Access, Inc., Gaithersburg, MD, United States; Bhumi Trivedi, Covance; Andrew Palsgrove, Covance, San Francisco, CA, United States; William B. Jones, Sanofi; Peter Trask, Sanofi AIMS: Multiple myeloma (MM) is a hematologic malignancy of plasma cells. Bone disease is a hallmark of MM, and pain is one of its most distressing features. Anemia is also a common symptom which tends to be manifested as fatigue and tiredness. We conducted a systematic review to compare MM patients’ scores with the general population on health-related quality of life (HRQOL) instruments to understand the burden of pain and fatigue in MM. METHODS: Studies assessing pain and fatigue in MM were identified through a search of specific terms in the medical-subject headings and keywords in PubMed. Inclusion criteria were: English-language studies published between January 1, 1996 and March 31, 2014; diagnosis of MM; and availability of data on pain and/or fatigue as measured by HRQOL instruments. A total of 251 articles were identified and their abstracts were reviewed. Full-text articles from germane abstracts were retrieved for eligibility assessment, and 23 articles were selected for inclusion in the analysis. RESULTS: A total of 21 of the 23 studies reported data for the EORTC QLQ-C30 pain scale. In 100 % of these studies, the pain score for MM was lower (worse) than that of the general population. For 82 %, the QLQ-C30 pain score was 0.50 standard deviation (SD) units below and for 17 % the QLQ-C30 pain score was a full 1.00 SD unit below that of the general population. A total of 22 of the 23 studies reported data for the EORTC QLQ-C30 fatigue scale. In 100 % of these studies, the QLQ-C30 fatigue score was lower (worse) than that of the general population. For 96 %, the QLQ-C30 fatigue score was 0.50 SD units below and for 25 % QLQC30 fatigue score was a full 1.00 SD unit below that of the general population. Data will also be presented for other instruments, including the EORTC QLQ-MY20, the SF-36, and FACT-Fatigue. CONCLUSIONS: The burden of pain and fatigue in MM is substantial. Pain and fatigue are easily quantified using HRQOL instruments. MM clinicians should routinely assess pain and fatigue in practice and implement treatment strategies to ameliorate their negative effects on patients’ HRQOL.

Qual Life Res (2014) 23:1–184 (1010) Effect of Completion-Time windows in the analysis of Health-Related quality of Life (HRQOL) outcomes in radiotherapy clinical trial Divine Ewane Ediebah, PhD (c), EORTC Headquarters, Brussels, Belgium; Warren Grant, Oncology Centre, Cheltenham General Hospital, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, Gloucestershire, United Kingdom; Corneel Coens, MSc, EORTC Headquarters, Brussels, Belgium; Chantal Quinten, MSc, EORTC Headquarters, Brussels, Belgium; Efstathios Zikos, MS MA, EORTC Headquarters, Brussels, Belgium; Bryce B. Reeve, PhD, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Carolyn C. Gotay, PhD, Univ. of British Columbia, School Pop & Pub Health, Vancouver, BC, Canada; Jolie Ringash, MD, The Princess Margaret Cancer Centre, Toronto, ON, Canada; Charles S. Cleeland, PhD, Univ. of Texas-MD Anderson Cancer Center, Houston, TX, United States; Henning H. Flechtner, PhD, Otto-von-Guericke University (KKJP), Magdeburg, Sachsen-Anhalt, Germany; Eva Greimel, PhD, Obstetrics and Gynecology, Medical University Graz, Graz, Austria; Galina Velikova, MD PhD FRCP, of Psychosocial and Medical Oncology, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom; Joseph Schmucker-Von Koch, Medical Ethics, Philosophical Faculty, University of Regensburg, Regensburg, Germany; Carla Van Herpen, Department of Medical Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands; Jan B. Vermorken, Emeritus Professor, Department of Medical Oncology, Antwerp University Hospital, Belgium; Martin Taphoorn, MD PhD, VU Medical Center/Medical Center Haaglanden, Amsterdam/The Hague, Netherlands; Andrew Bottomley, PhD, EORTC Headquarters, Brussels, Belgium AIMS: To evaluate the impact of interventions on cancer patients’ lives, the timing of the health-related quality of life (HRQOL) assessments is important. Previous research found wide variation in the timing of the HRQOL questionnaire completion in EORTCsponsored chemotherapy trials. The ‘time window’ of data collection—before, during or after treatment—had a statistically and potentially clinically significant effect on outcome. Here we investigate whether this finding holds for a trial using radiotherapy (RT). METHODS: Analysis was based on EORTC 24971, a trial in unresectable locoregionally advanced squamous cell carcinoma of the head and neck (N = 358). Patients were randomized to induction cisplatin ? fluorouracil ± docetaxel. Patients without progressive disease received radical RT. HRQOL was assessed via the global health status (GH), fatigue (FA), pain (PA) and physical functioning (PF) scales of the EORTC-QLQ-C30 questionnaire at baseline, during and after completion of RT. To investigate the effect of questionnaire completion before and during RT, ‘completion-time window’ variables were created to indicate when the EORTC-QLQ-C30 was completed relative to start of RT defined as ‘before’ (before RT to 8 days after RT start), ‘during’ (8 days after RT start to the end of RT plus 15 days), and ‘after’ (15–90 days after RT). HRQOL mean scores were calculated using generalized linear models including treatment and completion-time window variables adjusted for demographic and clinical factors. RESULTS: The number of questionnaires collected within the defined completion-time window ‘before’, ‘during’ and ‘after’ RT was 852, 264 and 9, respectively. We found statistically significant mean HRQOL differences comparing ‘‘before’’ and ‘‘during’’ scores: decreased GH (-3.04, p = 0.04) and increased PF (2.38, p = 0.04). The RT effects (from ‘before’ RT to ‘during’ RT) for PF changed from not statistically significant (1.81, p = 0.07) to statistically significant (-2.12, p = 0.03) by addition of the completion-time window variable. CONCLUSIONS: Results indicated that the timing of scores during radiotherapy may affect conclusions about efficacy of treatment regarding PF. This may reflect the impact of acute effects of radiotherapy. We recommend that

87 future RT clinical trials examine potential outcome bias due to completion-time variation.

(1012) Combining survival and toxicity effect sizes from clinical trials into an interpretable Quality-Adjusted survival effect size estimate of treatment efficacy Jeff Sloan, PhD, Mayo Clinic, Rochester, MN, United States; Brittny Major, Mayo Clinic, Rochester, MN, United States; Paul J. Novotny, Mayo Clinic-Rochester, Rochester, MN, United States; Axel Grothey, Mayo Clinic; Randolph Marks, Mayo Clinic; Daniel Sargent, Mayo Clinic; Amylou C. Dueck, PhD, Mayo Clinic, Scottsdale, AZ, United States AIMS: How can a clinician combine survival and toxicity data to interpret treatment benefit? Quality adjusted life years (QALYs) attempts to account for both the quality and quantity of life lived but interpretation and power considerations are barriers to implementation. We developed a new method by extending the ‘ standard deviation approach to assessing clinical significance to combine survival and toxicity clinical trial data into a single quality-adjusted survival effect size (QASES). METHODS: QASES is a weighted combination of the survival and toxicity effect sizes based on differences in survival and toxicity using the ‘ standard deviation method. We demonstrate the QASES method on 20 exemplary oncology clinical trials involving brain, breast, colorectal, lung, melanoma and pancreatic tumors. One example is a phase III clinical trial carried out by the North Central Cancer Treatment Group, NCCTG 89-20-52 (Alliance), which randomized patients to once-daily thoracic radiotherapy (ODTRT) versus twice-daily treatment of thoracic radiotherapy (TDRT) for the treatment of lung cancer. RESULTS: The ODTRT (TDRT) arms had non-significantly different median survival times of 22(20) months (p = 0.49) but strikingly different toxicity rates of 39 % (54 %), (p \ 0.05). The combined QASES of 0.18 standard deviations is equivalent to a significant 5.7 months advantage in quality-adjusted survival for the ODRT arm over the TDRT treatment arm (22(16.3) months, p \ 0.05). Similar results will be presented for the four possible case combinations of significant/non-significant differences in survival and toxicity data using 20 completed clinical trials including the CLEOPATRA and FLAGS trials. CONCLUSIONS: The QASES approach allows for an intuitively appealing and mathematically simple and robust approach to combining survival and toxicity data. Clinicians can use QASES to interpret and communicate the findings of oncology clinical trials to patients by weighing both the survival and toxicity information into a single quality-adjusted estimate of survival.

(1014) Normative data and clinically significant effect sizes for single-item numerical linear analogue Self-Assessment (LASA) scales Jasvinder a. Singh, MD MPH, University of Alabama at Birmingham, Birmingham, AL, United States; Daniel Satele, Mayo Clinic; Suneetha Puttabasavaiah, Mayo Clinic; Jan Buckner, Mayo Clinic; Jeff Sloan, PhD, Mayo Clinic, Rochester, MN, United States AIMS: To provide normative data for the single-item numerical linear analogue self-assessment (LASA) scale for overall quality of life (QOL). METHODS: We analyzed baseline data from 36 clinical trials and 6 observational studies from various populations, including healthy volunteers, cancer trial patients (patients with advanced incurable cancer and patients receiving treatment with curative intent), and hospice patients. The QOL LASA was rated 0

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88 (as bad as it can be) to 10 (as good as it can be). We calculated the summary statistics and the proportion of patients reporting a clinically meaningful deficit (CSD) of a score equal to 5 or less on the 0–10 scale. RESULTS: For the collective sample of 9,295 individuals, the average overall QOL reported was 7.39 (SD = 2.11) with a markedly skewed distribution. Roughly 17 % reported a score of 5 or below indicating a clinically significant deficit in overall QOL. Hospice patients report a much lower average score of 5.7 upon entry to hospice; hospice caregivers average 7.4. Cancer patients vary within these two extremes with most patient scores averaging in the 7 s on the 0–10 scale (range, 0 to 10). Men and women’s QOL distributions were virtually identical (average of 7.6 and 7.5, respectively). Overall baseline QOL was weakly related to performance status with a Spearman correlation coefficient of -0.29. Overall QOL varied across tumor type and was not related to tumor response, i.e. patients with a full or partial response reported a CSD in 11.4 % of cases compared to 14.4 % among those with stable disease and 18.5 % among those with disease progression. CONCLUSIONS: This study provides normative data for cancer patients and healthy volunteers for overall QOL using the LASA, indicating that overall QOL is independent of performance status and tumor response. These data can serve as benchmarks for future studies.

Cardiovascular (1016) Impact of a symptom management program on HealthRelated quality of life for patients with heart failure Viviane P. Ferreira, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Carina A.M. Dessotte, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Rafaela O. Monzato, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Luma N. Silva, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Rejane K. Furuya, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing, Ribeira˜o Preto, Brazil; Ma´rcia A. Ciol, School of Medicine, University of Washington, Seattle, WA, United States; Jeanne M. Hoffman, School of Medicine, University of Washington, Seattle, WA, United States; Lidia A. Rossi, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil; Rosana Spadoti Dantas, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil AIMS: To test the impact of a symptom management program to improve health-related quality of life in Brazilian patients with heart failure. METHODS: We conducted a nonrandomized controlled clinical trial with patients who were hospitalized for decompensated heart failure between July 2010 and June 2013. Randomization was not possible due to the logistics of the hospital where the study was performed. To prevent contamination between the two groups, the first patients were allocated to the intervention group and, once the intervention group discharged, the next patients were allocated to the control group. The intervention group (N = 47) received routine instructions plus an educational intervention for symptom management while the control group (N = 42) received only routine instructions given by the hospital. Health-related quality of life was assessed with the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at hospitalization and three months after discharge. The MLHFQ total score ranges from 0 to 105, and smaller values indicate better health-related quality of life. We used repeated measures analysis of variance to assess changes in the outcome, using time (at hospitalization vs. three-month follow-up), group (intervention vs. control), and an interaction of time by group as factors. Significance level was set at 0.05. RESULTS: There was an effect of time (p \ 0.001), but no group effect or interaction between group and time. There was an

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Qual Life Res (2014) 23:1–184 improvement in health-related quality of life from hospitalization to three-month follow-up for both groups. In the intervention group, the mean MLHFQ was 61.3 (SD = 19.1) at baseline and 24.8 (SD = 15.2) at three months. In the control group the means were 62.8 (SD = 21.2) at baseline and 30.1 (SD = 21.5) at three months. CONCLUSIONS: Health-related quality of life of patients with heart failure improved three months after hospital discharge, regardless of the group to which they were assigned. Although not statistically significant, the intervention group had a slightly larger improvement, showing some promise. Examination of additional outcomes such as symptom reduction and self-efficacy for symptom management may allow for further assessment of the impact of the educational program. Sa˜o Paulo Research Foundation (FAPESP), Grant 2010/100068, sponsored this study.

(1018) Factors associated with quality of life and anxiety among brazilian patients undergoing percutaneous coronary intervention Liege L S Vieira, Federal University of Goias, Brazil, Goiaˆnia, Brazil; Maria Alves Barbosa, PhD, Nursing Faculty of Federal University of Goias, Goiania, Brazil; Virginia V. Brasil, PhD, Nursing Faculty of the Federal University of Goias, Goiaˆnia, Brazil; Lizete M A C Oliveira, PhD, Federal University of Goia´s, Goiania, Brazil; Isabela C F Fernandes, Federal University of Goias, Goiania, Brazil; Karina M. Siqueira, Federal University of Goias, Goiania, Brazil; Alcides P S Neto, Federal University of Goias, Goiania, Brazil; Katarinne L. Moraes, Universidade Federal de Goia´s, Goiaˆnia, Brazil; Carla P. Bernardes, Federal University of Goias, Goiania, Brazil; Jacqueline Andre´ia B L Cordeiro, Federal University of Goias, Goiania, Brazil AIMS: The improving survival rates for acute myocardial infarction have raised concerns about patient´s quality of life. We assessed the factors associated with quality of life and anxiety among patients undergoing percutaneous coronary intervention. METHODS: A cross-sectional study was conducted with all adults and elderly who had perform percutaneous coronary intervention in four tertiary hospitals in a urbanized municipality of central Brazil. Data were collected through face-to-face home interviews with patients undergoing primary, elective or rescue coronary angioplasty. They completed the Short Form-36 Health Status Questionnaire (SF-36) and the Beck Anxiety Inventory four months after coronary intervention. The association between exposure variables and outcomes (quality of life and anxiety) was estimated using t test or ANOVA. We performed stepwise multivariate linear regression to determine which factors were associated with better quality of life and lower level of anxiety. RESULTS: A total of 169 patients were enrolled, 61 % were male, and the mean age was 65.3 years (sd = 10.2). Lowest scores were obtained from Role Physical (RP) (38.9; 95 %CI 32.7–45.2) and Role Emotional (RE) (44.8; 95 % CI 37.9–51.6) domains of SF-36. After adjustment, working adults were significantly and positively associated with all domains of SF-36. High education was associated with Physical Functioning (PF) and Bodily Pain (BP). Elective angioplasty with PF and General Health (GH); living with partner with PF, GH, Vitality (VIT), Social Role (SR) and Mental Health (MH). Being male was associated with BP; no religious practice with VIT and; have private health insurance was positively associated with SR. Being male and having private health insurance were independently associated with less anxiety level. CONCLUSIONS: Patients undergoing percutaneous coronary intervention with better socioeconomic conditions were more likely to improve their quality of life and level of anxiety. Return to work as soon as possible may be an indicator for patients of recover of health. Studies which assess the effectiveness of encouraging being back to work are required.

Qual Life Res (2014) 23:1–184 (1020) A quality check of patient-reported outcome measures for intermittent claudication. room for improvement! Anne P. Conijn, MD, Academic Medical Center Amsterdam, Amsterdam, Netherlands; Sjoerd Jens, Academic Medical Center Amsterdam, Amsterdam, Netherlands; Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands; Mark JW Koelemay, Academic Medical Center Amsterdam, Amsterdam, Netherlands AIMS: To critically appraise, compare and summarize the quality of the measurement properties of all published disease specific patientreported outcome measures (PROMs) on health-related quality of life (HRQOL) and functional status (FS) validated in patients with intermittent claudication. METHODS: Systematic search of Embase and Medline until 18 November 2013. The quality of the identified studies was judged per measurement property according to the COSMIN checklist, and data was extracted on the measurement properties. From this, a level of evidence per measurement property per instrument was established. RESULTS: We found 41 studies evaluating 10 HRQOL and 3 FS instruments, mostly with small patient samples, and over half was rated as poor quality. For many measurement properties there is a complete lack of evidence. For most HRQOL instruments an assessment of structural validity and internal consistency was lacking. We found evidence for positive content validity for the VascuQoL, PADQOL and ICQ. Internal consistency is positive for the CLAU-S, PADQOL and ICQ, and for reliability we only found positive evidence on the ICQ, and the CLAU-S in French and Flemish. Evidence for positive construct validity was found for some CLAU-S and VascuQoL subscales, and one PADQOL subscale. Responsiveness was only studied for the VascuQoL, with limited evidence for positive responsiveness in some subscales. We found no evidence for positive content validity in any FS instrument. For the WIQ we found moderate evidence for positive reliability and construct validity. For the EACH-Q and ALDS there was evidence for positive construct validity, but evidence on other measurement properties was mostly lacking. CONCLUSIONS: Currently, the PADQOL, ICQ, VascuQoL, WIQ and EACH-Q seem the best instruments to use in research and clinical care, although there is a lack of information on their measurement properties, which needs to be addressed in future research. By focusing on a limited number of instruments we can increase their quality and the uniformity in outcome reporting.

(1022) Concepts most relevant to patients with heart failure to inform clinical decision making Shana Traina, PhD, Janssen Research & Development, LLC, Raritan, NJ, United States; Renee F. Pierson, MBA, Janssen Pharmaceutical, Raritan, NJ, United States; Lauren Braam, MIH, Health Research Associates, Inc., Seattle, WA, USA; Donald M. Bushnell, III, MA, Health Research Associates, Inc., Mountlake Terrace, WA, United States; Kelly P. McCarrier, PhD, MPH, Health Research Associates, Inc., Mountlake Terrace, WA, United States; Mona L. Martin, RN MPA, Health Research Associates, Inc., Mountlake Terrace, WA, United States AIMS: Patient-centered care is defined by the Institute of Medicine as care that is respectful of and responsive to individual patient preferences, needs, and values, and ensures patient values guide all clinical decisions. This type of care has been associated with increased patient engagement and in turn, better outcomes, including shorter hospital stays and fewer readmissions. The best way to learn what patients value most is to ask them directly. Therefore, we performed focused

89 interviews to discover the concepts most relevant to people with heart failure (HF). METHODS: Adults with clinician verified HF (NYHA class II-IV) for [1 year were recruited from 7 clinical sites across the US to participate in individual qualitative interviews. A semi-structured interview guide was used to elicit both symptoms and impacts relevant to the patient experience of HF. Interviews were audiorecorded, transcribed, and coded using Atlas.ti software to organize concepts by similar content. Relevance of concept was determined by multiple factors, including predominance of expression, being offered more spontaneously versus by probes, and having greater mean descriptive values for severity, bother, and difficulty ratings. RESULTS: Thirty subjects participated in the interviews. The average age was 64, with 40 % female, and 67 % white (non-Hispanic), with an average left ventricular ejection fraction of 27.5 %. Within the symptom domain, the concepts meeting the above criteria included: low energy, tiredness, weakness, breathing difficulties, shortness of breath, chest pain and discomfort, and swelling and fluid retention. Within the impact domain, the concepts meeting the above criteria included: walking/running, climbing stairs, and general difficulties with physical limitation. Other areas of impact that met most of the criteria included housework, work and volunteering, leisure activities, social activities and overall frustration with their situation. Each concept was offered by between 30 % to 87 % of the interviewed sample. CONCLUSIONS: Although HF disease management programs have recently received much attention, little focus has been paid to the process of how patients actually make decisions or to how their providers can help to frame their choices. These findings can be used to inform patient-centered clinical decision-making that includes consideration of patient-relevant concepts.

(1024) Collection of Health Utility Data in a Clinical Setting: Comparison to a nationally-representative sample Janel Hanmer, MD PhD, University of Pittsburgh, Pittsburgh, PA, United States; Rachel Hess, MD, University of Pittsburgh, Pittsburgh, PA, United States; Sarah Sullivan, University of Pittsburgh; Jeffrey Teuteberg, University of Pittsburgh; Suresh Mulukulta, University of Pittsburgh; Dio Kavalieratos, PhD, University of Pittsburgh, Pittsburgh, PA, United States AIMS: There are recommendations to use standardized, generic health utility measures to understand the health status of clinical populations. We compare SF-6D results from a single health system’s Cardiology practices to nationally representative normative values. METHODS: Through the Patient-reported Information Clinical Intake System (PRIcis), all patients presenting to any outpatient Cardiology practice within our health system from March 2012 to April 2013 were asked to complete clinical intake information, including the RAND-36, electronically prior to their visit. We compared these results to the 2011 Medical Expenditures Panel Survey (MEPS) which administers the SF-12v2 to one adult member of each household in the sample. We performed analyses for the entire MEPS sample and those who reported seeing a cardiologist in 2011. We used Walsh’s t-test to compare SF-6D scores by age strata (18–44, 45–54, 55–64, 65–74, 75?), adjusted for gender. All MEPS analyses were weighted to be nationally representative. RESULTS: There are 1513 patients in the PRIcis database, and 1,436 successfully completed enough information to calculate the SF-6D. There are 22,515 adults in MEPS eligible to complete the SF-12v2, including 430 people who report a visit to a Cardiologist. Of these, 21,959 and 414 completed the SF-6D. The clinical sample is 41 % female with a mean SF-6D score of 0.76; the MEPS- Cardiology sample is 43 % female with a mean SF-6D score of 0.72. SF-6D scores in the health system sample were statistically significantly higher than scores in MEPS-Cardiology for four of the five age groups and were clinically significantly

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90 higher in three of the five age groups. For example, mean SF-6D scores for those aged 55–64 was 0.77 in the PRIcis sample, 0.76 in the whole MEPS sample, and 0.73 in the MEPS-Cardiology sample. CONCLUSIONS: Routine collection of health utility data is feasible in clinical samples and adds an important dimension to our understanding of clinical care. Subgroups can be created from national samples for better comparison to clinical populations. Further work is necessary to understand the differences between clinical and national samples.

Nephrology/Urology (1026) Understanding long-term outcomes in living kidney donors: the impact of Health Outcomes on psychosocial aspects of kidney donation Kathe Meyer, RN MScN, Oslo University Hospital, Oslo, Norway; Marit Helen Andersen, Oslo University Hospital, Oslo, Norway; Astrid K. Wahl, PhD, University of Oslo, Oslo, Norway; Anders Hartmann, Oslo University Hospital, Oslo, Norway; Armon Ayandeh, DeltaQuest Foundation; Carolyn E. Schwartz, ScD, DeltaQuest Foundation, Inc., Concord, MA, United States AIMS: End stage renal disease is an escalating health problem worldwide, with kidney transplantation as the gold standard treatment. Transplantation is performed with both live donors and deceased donors, and there is some evidence suggesting that live donation impacts donor quality of life (QOL). We sought to investigate the psychosocial impact of kidney donation, and whether QOL is associated with psychosocial impact. METHODS: We conducted a long-term follow-up study of 217 Norwegian kidney donors ten years after donation. Linear and logistic regression modeling was used to examine predictors of the following psychosocial aspects of kidney donation: getting recognition from family members, friends, and health care professionals; whether the recipient’s outcome was worse than expected; feeling responsible for the recipient’s outcome. Predictors included patient-reported outcomes (SF-36 physical and mental component scores; Multidimensional Fatigue Index subscales) and relevant covariates (relationship to recipient, education, age, gender, years since surgery). RESULTS: Ten years following living kidney donation, donors reported normal physical and mental health (mean PCS = 53.5, SD = 8.6; MCS = 54.6, SD = 8.6). Donors reporting worse physical or mental health were, however, more likely to receive recognition from others (p \ 0.05 and 0.02, respectively), after adjusting for covariates. Fatigue was not related to recognition, but donors who reported feeling very responsible for the recipient’s health reported more general fatigue (p \ 0.005), and substantially lower physical fatigue (p \ 0.02) if they felt little responsibility for the recipient’s health, after adjusting for covariates. No patient-reported outcomes predicted recipient health outcome being worse than expected. CONCLUSIONS: Our results suggest that living kidney donors’ health outcomes ten years after donation are related to aspects of psychosocial burden. Feeling responsible for the other’s health appeared to impact their fatigue, whereas those whose health suffered were more likely to receive recognition for their generosity. Thus, despite the passage of time, the psychosocial repercussions of kidney donation are related to physical and mental health and energy. Implications of these findings for clinical interventions will be discussed.

(1028) Sleep complaints in dialysis and kidney transplanted patients Fredrik B. Brekke, University of Oslo, Oslo, Norway; Nanna Von der Lippe, University of Oslo, Oslo, Norway; Amin Amro, RN, MSN, Oslo University Hospital, Oslo, Norway; Ba˚rd Waldum, University of Oslo, Oslo, Norway; Ingrid Os, MD PhD, University of Oslo Medical School, Oslo, Norway

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Qual Life Res (2014) 23:1–184 AIMS: Sleep complaints in dialysis patients are common and associated with depression, reduced health-related quality of life (HRQOL) and mortality. Transplanted patients may have less depression, better HRQOL and better sleep quality (SQ) compared to dialysis patients, but few longitudinal studies have evaluated HRQOL and none has looked at SQ. The aim of the present study was to assess the prevalence of sleep complaints and associations to depression and HRQOL in the transition from dialysis to renal transplantation. METHODS: A total of 301 dialysis patients were included and followed for 55.0 ± 6.5 months. Out of these patients 110 were transplanted and re-examined 40.3 ± 14.3 months after transplantation. The Kidney Disease and Quality of Life—Short Form (KDQoLSF) was used to assess HRQOL at baseline and after transplantation. Physical (PCS) and mental component summary scores (MCS) were computed. The Pittsburgh Sleep Quality Index (PSQI) was used to measure SQ and Beck Depression Inventory (BDI) to measure depressive symptoms. RESULTS: After transplantation, 59 % of the patients were characterized as poor sleepers (i.e. PSQI-score [ 5), compared to 75 % prior to transplantation (p = 0.016), and the total PSQI-score improved from 8.8 ± 4.6 to 6.6 ± 3.9, p = 0.001. The median change in PSQI (? PSQI) was -1.0 (IQR -6.5 to 2.0), but 20.8 % experienced a clinically significant deterioration of their SQ. In a multivariate logistic regression model, a clinically significant deterioration in SQ was associated with higher age, higher posttransplant GFR and less depressive symptomatology measured by BDI before transplantation. CONCLUSIONS: Renal transplantation improved SQ for most, but not all patients. As the prevalence of sleep complaints is high even after transplantation, physicians should routinely assess the SQ in all renal transplanted patients.

(1030) Health-Related quality of life and clinical and laboratory data among pre dialysis patients Virginia V. Brasil, PhD, Nursing Faculty of the Federal University of Goias, Goiaˆnia, Brazil; Jacqueline Andre´ia B L Cordeiro, Federal University of Goias, Goiania, Brazil; Antonio Ma´rcio Teodoro Cordeiro, Pontifical Catholic University of Goias; Katarinne L. Moraes, Universidade Federal de Goia´s, Goiaˆnia, Brazil; Luiz Antonio Brasil, Federal University of Goias, Goiania, Brazil; Lizete M A C Oliveira, PhD, Federal University of Goia´s, Goiania, Brazil; Maria Alves Barbosa, PhD, Nursing Faculty of Federal University of Goias, Goiania, Brazil; Isabela C F Fernandes, Federal University of Goias, Goiania, Brazil; Rafaela Peres Boaventura, Federal University of Goias, Goiania, Brazil; Gabriela Ferreira De Oliveira, Federal University of Goias, Goiania, Brazil AIMS: Timely recognition of clinical and laboratory data may retard chronic kidney disease progression and may affect health-related quality of life of pre dialysis patients. Clinical, laboratory and demographic variables were investigated to evaluate factors associated with health-related quality of life of pre dialysis patients. METHODS: A cross sectional survey was conducted with 130 pre dialysis outgoing CKD stage 4–5 outpatients of hospitals of Goiania municipality, Brazil, from March 2012 to November 2013. The hospitals were nanced by Brazil’s Unified Health System and attended the poorest population segment. Laboratory data, medical history, comorbid conditions were collected and the Kidney Disease Quality of Life Short Form (KDQOL-SF) was used to measure kidney disease specific quality of life. The scores for the KDQOL-SF scales are based on a 0 to 100 scale (worst to best possible). Student’s t Test was applied to variables stratification, with a confidence interval of 95 %. Internal consistency reliability was estimated by Cronbach´s alpha. RESULTS: Patients were mainly male (57.7 %), mean age 63.9 (±15.7) years, CKD stage 4 (77.7 %), smoker (50.0 %), with five or more children (25.4 %). Most of them had hypertension (93.1 %) and

Qual Life Res (2014) 23:1–184 abnormal levels of urea, creatinine, parathyroid hormone, calcium, phosphorus and hemoglobin. Cronbach´s alpha was [0.8 for all KDQOL-SF scales. The worse quality of life scores were obtained in the Work Status (25.38) and Physical Function (28.08) scales. The scales Clinic Staff Encouragement (88.37) and Cognitive Function (86.00) had the best quality of life scores. Women had statistically significantly reduced scores except in Sexual Functioning and Role Physical scales. Hypertensive and obese patients, with uremic and creatinine elevation had worse scores than the others. Diabetes and alterations of sodium and potassium did not influenced quality of life. CONCLUSIONS: We concluded that pre dialysis patients quality of life was adversely affected by uremic and creatinine elevation, by hypertension, female gender, number of children and obesity, by low income and unemployment. Adequate management of these factors could influence patient outcomes and health-related quality of life.

(1032) Usefulness of the adaptive measurement of change in the assessment of individual changes in HRQOL of hemodyalisis patients Nacho Castejo´n, LASER Analytica; Dolores Arenas, Servicio de Nefrologı´a. Hospital Perpetuo Socorro; Pablo Rebollo, PhD, LASER Analytica, Oviedo, Spain; Jesu´s Cuervo, LASER Analytica AIMS: Evaluate the usefulness of Adaptive Measurement of Change (AMC) in the assessment of individual changes with the generic Health-related Quality of Life (HRQOL) computer adaptive test CAT-Health, in hemodialysis patients. METHODS: All patients in a hemodialysis unit were interviewed twice in the course of a study about restless leg syndrome (RLS): at baseline and at 3 month follow up visit. Those diagnosed with RLS received a treatment, and were evaluated at follow up for clinical improvement. Due to the limited prevalence of RLS, acute conditions both at baseline and follow-up were retrieved from clinical records as an additional indicator of clinical change. To assess generic HRQOL the CAT-Health questionnaire was used with its regular stopping rules in baseline, but for the follow-up it was set up to allow for a longer test and stop at statistically significant change. RESULTS: 165 patients completed the test at baseline, 117 completed the follow-up. 26 patients were diagnosed with RLS, but only 7 of those received a treatment until follow-up. 12 patients developed an acute condition during the study, for 6 of them the system individually detected a significant deterioration of QOL. 8 patients were suffering an acute condition at baseline, but not on follow-up. The system detected individually a significant improvement of QOL in 7 of them. 6 of the treated patients improved in their RLS symptoms, only 2 significant improvements in QOL were individually detected in this group. CONCLUSIONS: AMC is a promising technique for monitoring the condition of individual patients. In the reported experience, it was especially useful at detecting individual improvements in QOL. However, these results are limited because the usable sample was very limited and the chosen population is prone to changes for a variety of reasons. Future studies should focus on changes in chronic conditions.

(1036) Quality of life in patients on different peritoneal dialysis modalities: a longitudinal study in singapore Haikel A. Lim, BSocSci(Hons), National University of Singapore, Singapore, Singapore; Zhenli Yu, Khoo Teck Puat Hospital; Augustine W. C. Kang, National University of Singapore; Marjorie W. Y. Foo, Singapore General Hospital; Konstadina Griva, National University of Singapore AIMS: QOL impairments are common in dialysis and are associated with higher morbidity and mortality, but little is known about the

91 course of QOL over time, especially for patients on peritoneal dialysis (PD). With the emphasis on care shifting away from hospital to homebased dialysis, the current study was set up to explore prevalence of QOL impairments and change in QOL over 12 months in PD patients, and to compare outcomes between different PD modalities (continuous ambulatory PD [CAPD] and automated PD [APD]). METHODS: 115 patients on PD (63 CAPD; 52 APD) in Singapore completed the SF -12 and the Kidney Disease Quality of Life Short Form on two occasions 12 months apart. The Physical and Mental Component Summary scores (PCS and MCS) and Kidney Disease Component Summary scores (KDCS) were calculated to provide measures of physical, mental, and disease-specific QOL. PCS and MCS scores that fell below one standard deviation from population norms were considered impaired. RESULTS: 74–80 % of patients were noted to have impairments mainly in physical QOL, as compared to 29–33 % who had impairments in mental QOL. PCS and MCS scores remained unchanged over time in both PD modalities and case-mix differences. Significant changes over the 12-months were noted in KDCS domains. Patient satisfaction (T = -2.4, p = 0.017), staff encouragement (T = -2.3, p = 0.023), and social support (T = -2.0, p = 0.045) decreased over time, whereas kidney disease burden improved from baseline to 12 months follow up (T = -2.1, p = 0.038). Deterioration in total KDCS scores (t[51] = 2.3, p = 0.027), patient satisfaction (T = -2.7, p = 0.007) and staff encouragement (T = -2.7, p = 0.008) were greater in APD relative to CAPD. CONCLUSIONS: PD offers the convenience of homebased care but is associated with persisting QOL impairments and diminishing QOL over time especially in domains related to quality of care and support. This highlights the need for improving or maintaining standards of care and support for patients as they become increasingly established on home-based dialysis.

Neurology (1038) Using multi-group confirmatory factor analysis to develop a cognitive health-related quality of life instrument applicable across Diseases—the COGQOL Joy C. Backhaus, Institute for Medical Psychology and Sociology in Go¨ttingen, Germany, Go¨ttingen, Germany; Martin L. Werkmeister, Institute of Medical Psychology and Medical Sociology, Go¨ttingen, Germany; Nicole Von Steinbuchel-Rheinwall, Prof., University of Goettingen, Gottingen, Germany AIMS: Whereas cross-cultural equivalence of health-related quality of life (HRQOL) measurement is emphasized whereas minor attention is paid to realizing cross-disease equivalence of HRQOL measurement. With this contribution we would like to contribute to closing this psychometric gap by 1. outlining the necessity of invariance testing across diseases, 2. providing an implementation guide for the statistical software Mplus (7), 3. presenting results from our questionnaire development of the COGQOL (cognitive quality of life scale) across the neurological disorders dementia and Traumatic Brain Injury (TBI). METHODS: An easy to implement method from cross-cultural research is applied to the creation of a reliable crossdisease research tool to assess the cognitive dimension in HRQOL research. A multi-group Confirmatory Factor Analysis (MGCFA) was computed in Mplus 7 for the COGQOL. First tested in individuals with dementia the corresponding Structural Equation Model (SEM) was applied to 252 persons (17 till 68 years of age), who sustained a mild, complicated mild, moderate and severe TBI. RESULTS: Chi Square-Difference-Test confirmed configural invariance between the two patient groups legitimating to perform cross-disease group comparisons with the COGQOL. This will be presented for the COQOL. CONCLUSIONS: The COQOL is a psychometrically robust tool which can be used to assess cognitive

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aspects of HRQOL comprehensively in TBI as well as dementia and to draw comparisons between the two diseases. In line with the proposed methodological MGCFA approach we argue that a generic instrument should prove to be configuraly invariant to be used for cross-diseases comparisons.

(1040) Younger onset dementia: an overview of service and research issues Janet E. Sansoni, MSc, University of Wollongong, Fadden, Australia; Cathy Duncan, Centre for Health Service Development, University of Wollongong, Wollongong, Australia; Pam Grootemaat, Centre for Health Service Development, University of Wollongong, Wollongong, Australia; Anita Westera, Centre for Health Service Development, University of Wollongong, Wollongong, Australia; Jacquelin Capell, Centre for Health Service Development, University of Wollongong, Wollongong, Australia; Peter Samsa, University of Wollongong AIMS: Younger onset dementia (YOD) is any form of dementia that occurs in those \65 years and includes people with early onset Alzheimer’s disease, vascular dementia, fronto-temporal dementia and dementia associated with other conditions such as Huntington’s disease, Down syndrome, HIV/AIDs dementia, alcohol related dementia and other rare neurological conditions. The focus of the literature review was to examine the service needs of people with YOD and to provide a guide to service design and development. METHODS: Searches of ten relevant bibliographic databases were undertaken (e.g. including Medline, CINHAL, Scopus, and Proquest Central). Searches were restricted to articles published since 2000 in English. Search strategies were supplemented with ‘snowballing’ methods. A rigorous approach to accessing information from non-academic sources (‘grey’ literature) was also applied (e.g. from international ‘peak’ organizations, health departments, relevant conferences etc.). RESULTS: Searches identified 301 articles considered to be of major relevance and these were rated concerning their strength of evidence. Relatively few studies made use of research designs which included appropriate comparison/control groups or used standardized outcome measures. The literature identified the need for: \BR[ • • • •

•

•

More timely and accurate diagnosis and increased support immediately following diagnosis \BR[ Individually tailored services addressing life cycle issues and providing age-appropriate programs \BR[ Examination of the service needs of those living alone with YOD \BR[ More systematic evaluation of services and programs including more selective use of validated standardized measures, in particular, to assess cognitive status \BR[ Further examination of service utilization, costs of illness and the cost effectiveness of non pharmacological interventions and \BR[ Current clinical catchment surveys to estimate prevalence, incidence, and life expectancy. Most Australian prevalence estimates were based on pooled data arising from meta-analyses of Western European and Northern American studies conducted in the nineties. Limited data were available concerning the prevalence and incidence of YOD in Indigenous communities but it suggested that the prevalence of dementia for this group was much higher than estimated. CONCLUSIONS: There is a need for studies with stronger research designs, larger sample sizes, a triangulation of methods of outcome assessment and consideration of the control of potentially confounding factors.

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(1042) Generic preference-based measures for use with people with multiple sclerosis: are they appropriate? Annie Hawton, University of Exeter Medical School, Exeter, United Kingdom; Colin Green, PhD, University of Exeter, Exeter, United Kingdom AIMS: Generic preference-based measures (PBMs), the EQ-5D and the SF-6D, are commonly used in policy decision-making to assess healthrelated quality of life (HRQOL), and the effectiveness and cost-effectiveness of healthcare interventions. However, little research has investigated the appropriateness of either instrument in relation to Multiple Sclerosis (MS). The aim of this research was to assess the psychometric properties of the EQ-5D and the SF-6D in providing health state values (or QALY weights) for health states experienced by people with MS. METHODS: Analyses were undertaken using data from a prospective, longitudinal, cohort study of people with MS in the South West of the UK (SWIMS) (n = 1,441). Psychometric assessments included: i) content validity of the measures’ descriptive systems; ii) construct (convergent and discriminative) validity of the instruments’ descriptive systems and health state values of MS health states; iii) responsiveness to change and; iv) feasibility. RESULTS: Specific content domains important to people with MS are not included in these generic PBMs. This is particularly the case for the EQ-5D, whilst the SF-6D may include some redundant content. Convergent validity was high for both measures in relation to other indicators of HRQOL. Correlations with scores on the Multiple Sclerosis Impact Scale-29 indicated that the SF-6D performed marginly better (correlations from 0.34 [p \ 0.001] for ‘vitality’ to 0.78 [p \ 0.001] for ‘physical functioning’) than the EQ-5D (correlations from 0.34 [p \ 0.001] for ‘anxiety/depression’ to 0.66 [p \ 0.001] for ‘usual activities’). Discriminative validity, in terms of disease disability, was good for both measures, until the most severe health states, at which the EQ-5D discriminated more clearly. Statistically significant differences were found between PBM scores at different stages of disease severity on the Expanded Disability Status Scale (EQ-5D: F = 60.15, df = 9, p \ 0.001; SF-6D: F = 23.85, df = 9, p \ 0.01). Potential ceiling effects on the EQ-5D and floor effects on the SF-6D were apparent. CONCLUSIONS: These findings suggest the need for careful consideration of the use of generic PBMs when assessing the HRQOL of people with MS, and making policy decisions regarding health service delivery. This work has also highlighted that psychometric criteria conventionally used to judge instruments may be limited for the assessment of PBMs.

(1044) Coping and quality of life in a 2-Year Cohort of patients with multiple sclerosis: a structural equation modeling approach Mohamed Boucekine, Self-Perceived Health Assessment Research Unit, Marseille, France; Anderson Loundou, EA3279, Self-Perceived Health Assessment Research Unit, Marseille, France; Pierre Michel, Aix Marseille Universite´, Marseille, France; Jean Pelletier, Neurology, Timone University Hospital, Marseille, France; Patricia Minaya Flores, MA, Laboratoire de Sante Publique EA3279, Marseille, France; Badih Ghattas, Faculte´ Des Sciences de Luminy, Marseille, France; Laurent Boyer, PhD, Aix-Marseille University, Marseille, France; Pascal Auquier, Public Health Department, University Hospital of Marseille, France; Karine Baumstarck, Faculte´ de Me´decine, AMU, Marseille, France AIMS: Knowledge of which factors are determinants of quality of life (QOL) in patients with multiple sclerosis (MS) would assist clinicians in choosing the most appropriate interventions. To examine the relationships among sociodemographic/clinical factors, coping and QOL in a 2-year cohort of patients with Relapsing-Remitting Multiple Sclerosis (RR-MS) using structural equation modeling (SEM).

Qual Life Res (2014) 23:1–184 METHODS: The study had a multi-center, multi-regional, and longitudinal design. Main inclusion criteria were: patient with a RR-MS subtype (McDonald criteria) and an Expanded Disability Status Scale (EDSS) score lower than 7.0. Sociodemographic (age, gender, education level, marital and employment status) and clinical (baseline disability, disease duration) data were recorded. The QOL was assessed using the SF-36 (generic) questionnaire. The coping (COP) was based on the dimension score of the MusiQoL (disease-specific) questionnaire. Hypothetical relationships among the variables were constructed by examining previously published research. SEM was performed using Mplus software. RESULTS: Five hundred twentysix patients were enrolled in the present study. The model showed a good fit (indices: RMSEA = 0.065, CFI = 0.91, SRMR = 0.058, p value chi2 = \0.001). The coping score was significantly linked to the 2 composite (physical and mental) scores of SF-36 both at baseline (M0) and 24-month (M24). But the M0 coping was not related to the M24 QOL. Having a job and a less severe disability supported satisfactory coping levels at M0 and M24. Additionally, EDSS was significantly associated with the 2 composite QOL scores at M0 and M24, but the relationship was stronger on the physical scores than the mental scores. CONCLUSIONS: These findings suggested that the relationships between sociodemographic/clinical factors and QOL were moderated by coping. Special attention should be given to individuals with severe disability and with loss of employment to ensure optimal management.

(1046) Predictors of therapeutic benefit from treatment of Parkinson’s disease with rasagiline in the real world setting Paul Kamudoni, Cardiff University, Cardiff, United Kingdom; Biju Muhamed, Rookwood Hospital & University Hospital Wales, Cardiff, United Kingdom; Chris Thomas, Rookwood Hospital & University Hospital Wales, Cardiff, United Kingdom; Sandip Raha, Princess of Wales Hospital, Bridgend, South Wales, United Kingdom; Samuel Salek, BSc RPh PhD FFPM, Cardiff University, Cardiff, United Kingdom AIMS: To assess the therapeutic benefit from treatment of Parkinson’s disease (PD) with rasagiline. In addition, to assess patient factors that predict therapeutic benefit. METHODS: Data from the Welsh Movement Disorder eNetwork (WDeN) disease register were retrospectively analysed. All patients diagnosed with PD and treated with rasagiline (Azilect) from 2006 to 2012 were included (n = 182). The primary outcome of the study was clinician’s global impression (CGI) i.e. whether a patient was rated as improving, not-changing or worsening by a clinician. RESULTS: The mean age of the patients was 67 (range: 28–88) years for monotherapy, 69 (range: 47–89) years for combination therapy and 69 (47–89) years for adjunct therapy. The share of patients above 65 years was 63.2, 66.1 and 67 %, respectively. Proportion of patients rated as improved/unchanged were 74 % (n = 36), 78.6 % (n = 12), and 81.3 % (n = 71) for adjunct therapy. In monotherapy and combination therapy the likelihood of improving vs. remaining unchanged was predicted by patient’s baseline H & Y score alone [monotherapy, OR 0.1; combination therapy, OR 0.11]. In adjunct therapy, the duration of PD therapy was the only significant [1 additional year: OR 1.36]. A trend towards improvement vs. remaining unchanged was noted for monotherapy and combination therapy in patients = 65 years relative to those \65 [monotherapy: 36.4 % vs. 29.4 %; combination therapy: 52.6 % vs. 12.5 %]. In adjunct the reverse was observed [32.8 % vs. 45.2 %, respectively]. Analysis was carried out separately for monotherapy (early disease treated with rasagiline only), combination therapy (where a second therapy was added to rasagiline) or adjunct therapy (rasagiline added to a current therapy). CONCLUSIONS: The data provided by the WMDeN registry permitted the assessment of the therapeutic effect from rasagiline, in the real world setting. The findings of

93 this study indicate that treatment of PD with rasagiline has clinically relevant benefit for most patients, including those aged above 65 years. The results suggest that rasagiline remains well tolerated and that its effect may be cumulative.

(1050) Quality of life in patients with glaucoma and its relation with binocular visual field Olı´via Pujol, Parc de Salut Mar, Barcelona, Spain; Clara Mora, Parc de Salut Mar, Barcelona, Spain; Silvia Gudin˜a, Parc de Salut Mar, Barcelona, Spain; Laia Pastor, Parc de Salut Mar, Barcelona, Spain; Robert Maull, Parc de Salut Mar, Barcelona, Spain; Zaida Vega, Parc de Salut Mar, Barcelona, Spain; Alfonso Anton, Parc de Salut Mar, Barcelona, Spain AIMS: To assess the quality of life (QOL) in glaucoma patients and normal subjects METHODS: 359 subjects were included in the study. 55 were normal subjects (normal intraocular pressure, optic disk and visual fields). 89 were ocular hypertension subjects (untreated intraocular pressure [21 mmHg, normal optic disk and visual field) and 215 were glaucoma patients (with untreated intraocular pressure [ 21 mmHg, abnormal optic disk and abnormal visual fields). Patients with myopia \-5D or with other retinal or neurological diseases were excluded. All subjects completed 3 different questionnaires. Global quality of life was evaluated with EuroQol-5D (EQ-5D). Vision related quality of life was assessed with Visual Function Questionnaire (VFQ-25). Finally, quality of life related to ocular surface disease was measured with Ocular Surface Disease Index (OSDI). Estimated binocular field was calculated with the ‘‘Integrated Visual Field (IVF)’’ (Crabb 2005). QOL indices were compared between normal and glaucoma subjects with analysis of variance. The relation between IVF score (IVFS) (Crabb 2005), mean defect in each visual field zone and global mean defect in the best and the worst eye with quality of life indices was analyzed with Pearson Test. RESULTS: VFQ-25 showed that global vision rating and difficulty with near and distance vision activities were associated with inferior hemifield IVFS (all p \ 0.05), superior and inferior 10 and 20 central degrees IVF (all p \ 0.002). Driving difficulties were not associated with IVFS but were associated with upper hemifield IVF (r = -0.234, p = 0.05). Limitations with peripheral (r = -0.178) and color vision (r = -0.157) were associated with IVFS (both p \ 0.05). In terms of global QOL, EQ-5D demonstrated mobility problems in glaucoma patients which were significantly greater in patients with higher IVFS values and patients with deeper defects in 10 central degrees of IVF (p = 0.05). Anxiety was associated with lower (p = 0.01) and upper (p = 0.008) hemifield IVF and also with 10 (p = 0.008) and 20 (p = 0.015) central degrees of IVF. OSDI was not significantly related to any yield index. CONCLUSIONS: QOL was decreased in glaucoma patients. Several QOL parameters were significantly related to IVF.

(1052) Factors Associated with Self-Rated health after Lacunar Stroke: findings from the secondary prevention of small subcortical strokes (SPS3) trial Carole L. White, PhD, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States; Leslie A. McClure, University of Alabama at Birmingham; Helena Lau, Boston Medical Center, Boston, MA, United States; Mandip S. Dhamoon, Mount Sinai School of Medicine, New York, NY, United States; Kamakshi Lakshminarayan, University of Minnesota Medical Center; Donna J. Brauer, PhD, Minnesota State University, Ramsey, MN, United States; Oscar R. Benavente, University of British Columbia, Vancouver, BC, Canada

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AIMS: Lacunar stroke is generally associated with favorable short-term outcomes, but with increased risk of cognitive decline and recurrent stroke over time. Although a number of studies have examined quality of life (QOL) following stroke, less is known about how stroke survivors rate their health, particularly among those with lacunar stroke. The aim of this study was to characterize self-rated health after lacunar stroke among participants in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. METHODS: The international SPS3 trial evaluated therapies for prevention of recurrent stroke and cognitive decline in patients with lacunar stroke. Patients were randomized on average at 3 months after lacunar stroke. Self-rated health was measured at the 3-month follow-up and for purpose of these analyses, was categorized as good (excellent, very good, or good) or poor (fair, poor). Demographic characteristics, vascular and other co-morbidities, strokespecific QOL, and functional status (physical, psychological, and cognitive) were examined for their association with self-rated health. Logistic regression models were fitted to examine the likelihood of poor self-rated health. RESULTS: The mean age of participants was 63 years and the majority reported good functional recovery from stroke (67 %). Of the 2383 participants self-rating their health at approximately 6 months after stroke, 84 % reported good and 16 % reported poor health. After multivariable adjustment, lower education, coronary artery disease, depressive symptoms, and reduced ability to perform instrumental activities of daily living were associated with an increased likelihood of poor self-rated health. Increasing age, living in Latin America, current alcohol use, higher stroke-specific QOL, and higher cognitive scores were associated with a decreased likelihood of poor self-rated health (see Table 1). CONCLUSIONS: Lacunar stroke has been regarded as a relatively benign stroke subtype, in part related to the low prevalence of physical disability. These findings indicate the importance of factors beyond physical function such as ability to perform instrumental activities of daily living, cognition, and depression on the stroke survivor’s perception of their health. Identification of factors associated with poor self-rated health can lead to more focused strategies to improve long-term outcomes after lacunar stroke. Table 1 Factors associated with poor self-rated health Variable

Odds ratio (95 % CI)

Age*

0.98 (0.97, 0.99)

Region North America

REF

Latin America

0.52 (0.30, 0.92)

Spain

0.85 (0.51, 1.4)

Education \9 years

1.7 (1.2, 2.3)

9–12 years

1.3 (0.79, 1.6)

Some college

REF

Current alcohol use

0.67 (0.48, 0.95)

Coronary artery disease

1.7 (1.1, 2.5)

Depressive symptoms

2.3 (1.7, 3.1)

Stroke-specific QoL*

0.41 (0.33, 0.51)

Decreased instrumental activities of daily living

1.7 (1.2, 2.4)

Cognitive abilities screening index Z-Score*

0.93 (0.83, 1.0)

Adjusted for all variables in model and sex, race, co-morbidities (smoking status, diabetes, hyperlipidemia, number of medications), and functional recovery; *per one-unit increase

Children (1056) Unidimensional colombian version of Kidscreen-52: a 33-Item new proposal applying rasch model Martha J. Rodriguez, Universidad Industrial de Santander, Bucaramanga, Colombia; Diana M. Camargo Lemos, MSc, Universidad Industrial de Santander, Bucaramanga, Santander,

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Colombia; Luis Carlos LC Orozco, Universidad Industrial de Santander AIMS: To validate the Colombian version of Kidscreen-52 using the Rasch measurement model by establishing four out of six aspects of validity suggested by Messick and interpreted by Wolfe & Smith. METHODS: An evaluation of diagnostic technology was done. The Colombian version of Kidscreen-52 was filled out by 1334 children and adolescents aged 8 to 18 years old. A cluster sampling was carried out and the students were randomly selected from third grade to high school graduation from Bucaramanga (Colombia). Gender, age groups (8–11 and 12–18 years) and socioeconomic conditions (low and high) were analyzed for the entire sample. With the use of Rasch Rating Scale Model, the substantive, content, structural and generalizability aspects of validity were evaluated. The rating scale structure, item quality, participant ability, invariance structure and unidimensionality were analyzed. Invariance structure was tested via Differential Item Functioning (DIF) by gender, age groups and socioeconomic conditions. Stata version 12.0 and Winsteps software were used for the analysis. RESULTS: The mean age was 12.3 ± 2.7 years, 40 % belonged to 8–11 years group and 54.8 % were women. Four of the eight guidelines recommended by Linacre were met. Rasch item curves indicated disorder between the five response categories so it was necessary to collapse two of them resulting in three response categories. Forty-four items showed good fit (infit and outfit mean square 0.67 to 1.35); the 8 items that misfit the model were dropped. Uniform DIF was observed in eleven items with regard to interest groups. Nonuniform DIF was not found. The Rasch measures explained 35.5 % of the total variance with the first residual contrast accounting for 6.2 %. The strength of the first residual contrast was 3.2 eigenvalues. According to the Wright map, these 33 items did not target some participants, indicating that this sample had a better Health-related Quality of Life than the questionnaire was able to evaluate. CONCLUSIONS: The resulting 33-item version of Kidscreen supported the substantive, content, structural and generalizability aspects of validity in this Colombian scholar population. Future studies are needed to assess responsiveness and a discussion in Latin-American countries should be proposed in order to evaluate the new 33-item questionnaire.

(1058) Measuring health-related quality of life in children: reliability and validity of the portuguese version of the activities scale for kids (ASK) Luis Manuel Cavalheiro, PhD, Centre for Health Studies and Research of the University of Coimbra, Coimbra, Portugal; Daniela Paixa˜o, Polytechnic Institute of Coimbra, Coimbra Health School, Coimbra, Portugal; Rui Soles Goncalves, PhD, Centre for Health Studies and Research of the University of Coimbra, Coimbra, Portugal; Pedro L. Ferreira, PhD, University of Coimbra, Coimbra, Portugal AIMS: The Activities Scale for Kids (ASK) is a self-reported measure of childhood physical disability (5–15 years), consisting in two scales: the ASK performance (ASK-p) and the ASK capacity (ASKc). The objective of this study was to translate and culturally adapt the ASK to the Portuguese language and to test its reliability and validity. METHODS: The Portuguese version of the ASK was obtained with forward/backward translations, consensus panels and a pre-test. This version of the ASK, the KINDL questionnaire and a form for the socio-demographic and clinical parameters of the participants were applied to 88 children (10 ± 3 years) with functional limitations. RESULTS: After obtaining the semantic and content equivalence, the Portuguese version of ASK showed good levels of reliability with Cronbach’s alpha coefficients between 0.98 (ASK-p) and 0.97 (ASKc), and intraclass correlation coefficients (ICC) ranging from 0.98

Qual Life Res (2014) 23:1–184 (ASK-c) to 0.99 (ASK-p). Construct validity was supported by the correlations between ASK domains and KINDL total score (r between 0.52 and 0.63). The validity was also corroborated by the confirmation of predefined hypotheses involving clinical parameters. CONCLUSIONS: According to our results the Portuguese version of ASK is semantically equivalent to the original measure, and offer acceptable levels of reliability and validity. It can be used in clinical and research settings in Portugal.

Elderly (1062) Validation of the modified diet-related quality of life scale for gerontological research Yoshimi Suzukamo, PhD, Tohoku University, Sendai, Japan; Hajime Iwasa, Fukushima Medical University; Yuko Yoshida, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan AIMS: The Diet-Related Quality of Life Scale (DRQOL) was developed by Suzukamo Y et al. (2000) to assess the quality of daily diet including the psychosocial dimension. This scale has 5 subscales consisting of 19 items, and was validated for the general adult population in Japan. However, it is not clear that the structure of this scale is applicable to aged people. This study aims to modify the DRQOL for gerontological research and to evaluate its psychometric properties. METHODS: We surveyed a random sample of communitydwelling older Japanese adults (aged 60–84). A total of 884 (390 men, 454 women; mean age, 70.5 years old) were used for this analysis. For construct validity, exploratory factor analysis was performed. We then calculated the subscale or total score of the DRQOL. For knowngroups validity, DRQOL scores of some subgroups divided by sex, live-alone or with-family, economic status, and problem of eating habits were compared using a t-test or ANOVA. RESULTS: The response rate for each item was more than 97 %. After excluding 4 items, factor analysis with promax rotation extracted 3 factors that explained 62.6 % of the variance. These factors (subscales) were named ‘‘sufficiency of eating (SE),’’ ‘‘social function of diet (SF),’’ and ‘‘diet diversity (DD).’’ Cronbach’s alphas for the subscales were 0.874, 0.853, and 0.712, respectively. Correlation analysis showed that this scale has high convergent validity with item-scale correlation coefficients greater than 0.4 for all items and good discriminant validity with item-scale correlation coefficients less than 0.4 for all items. In comparison with men, women’s DRQOL scores were significantly higher in SE, SF, DD, and total score. The live-alone group had significantly higher SF scores than the with-family group. The wealthier group had significantly higher scores for all scales. The group with problem of eating habits had lower scores for all scales. CONCLUSIONS: We called this scale the Diet-Related Quality of Life Scale for gerontological research (DRQOL-G). This study showed that the DRQOL-G had sufficient psychometric properties. Aged people seemed to have less constructs of diet-related quality of life.

(1064) Interference in life quality and functionality of elderly with chronic pain in sa˜o carlos city, brazil Marielli Terassi, Universidade Federal de Sa˜o Carlos, Sa˜o Carlos, Brazil; Fernanda Nascimento Costa, Universidade Federal de Sa˜o Carlos; Karina Gramani-Say, Universidade Federal de Sa˜o Carlos AIMS: The aim of the study was to verify the functionality and quality of life in the elderly population by scales as: Functional Independence of Measure (FIM) and World Health Organization Quality of Life Instrument (WHOQOL-OLD) METHODS: Were volunteers evaluated with 60 or more years, of both genders, in Sa˜o Carlos-SP, Brazil. The sample consisted of 50 participants, of which

95 25 belonged to the group of elderly with chronic pain (ECP), with averaging age of 71.6 year, and 25 the elderly without chronic pain (EWCP) averaging 67.8 years. Statistical analysis was performed using the Mann–Whitney test, with significance of p = 0.05. The study was approved by human Ethics committee the Federal University of Sa˜o Carlos (no 190.266). RESULTS: The FIM Motor shows difference between the ECP (76.76 ± 14.68) and EWCP (85.72 ± 4.22) (p = 0.0137), FIM Cognitive statistical difference being the ECP (29.08 ± 7.35) and EWCP (33.88 ± 2.59) (p = 0.0004). With the WHOQOL-OLD all areas showed statistical differences in sensory functioning domain being ECP (46.8 ± 25.63) and EWCP (80.32 ± 20.89) (p = 0.000036), in the field of past, present and future activities being ECP (47.4 ± 14.94) and EWCP (71.76 ± 12.50) (p = 0.000002) in the domain of social participation being ECP (40, 88 ± 15.60) and EWCP (67.88 ± 13.45) (p = 0.000001), in the domain of autonomy being ECP (47.6 ± 19.88) and EWCP (69.84 ± 14.68) (p = 0.000038), domain the death or die being ECP (50.24 ± 29.91) and EWCP (78.16 ± 18.12) (p = 0.001211), domain the intimacy ECP (47.36 ± 21.89) and EWCP (74.08 ± 21.63) (p = 0.000108), with total score ECP (274.68 ± 59.33) and EWCP (384.60 ± 55.89) (p = 0.000147). CONCLUSIONS: In the experimental conditions, it is observed that the presence of chronic pain negatively impacts the functionality and quality of life of the elderly population. The pain also causes changes in quality of life and cognitive domain, so the elderly with chronic pain need psychological and social support, being necessary more multidisciplinary approach to the prevention of pain from primary care.

Health Policy (1068) Quality of Life for Strategic Planning Raluca I. Antonie, Babes-Bolyai University, Cluj-Napoca, Romania; Calin E. Hintea, Babes-Bolyai University, Cluj-Napoca, Romania AIMS: Building a model that can be used in community strategic planning process is the main objective of our study. Among the subsequent purposes are: (1) identifying the most relevant indices for measuring QOL at community level and (2) testing the model in ClujNapoca City as a base for the strategic planning process. METHODS: We use the multi-method paradigm, combining qualitative and quantitative approaches. The first step consisted in a comparative analysis of existing indexes and indicator systems. We evaluated three of the most relevant QOL indexes: Gallup-Healthways Well-Being, OECD Better Life Index, Eurofound Life. Step no.2. consisted in seizing the existing overlaps in terms of indicators in the three systems under analyze. Step No.3: we added some community-relevant QOL indicators. Step No. 4: we have used a panel of 12 experts working on Cluj-Napoca Development Strategy in order to rank the resulted indicators. Step no. 5: we have split the indicators, according to their nature into : objective indicators-that are going to be measured using existing data and statistics and perception indicators that were going to be measured quantitatively, by applying a questionnaire. Step no.6: we have built a questionnaire starting from the resulted perception indicator system. Step no.7: We have tested the model by applying the questionnaire in Cluj-Napoca, on a representative sample of citizens. Step No.8: We analyzed, interpreted data and validated the model. Step no.9: We included the results in the Cluj-Napoca City Development Strategy. RESULTS: The model consisting in 100 indicators has been successfully applied, according to scientific rigors and the results were used in the Strategic Planning Process which adopted QOL as the main development direction. Data indicated the main chapters where the community still has to strive in order to acquire quality, and the main fields where the trend is positive and has to be encouraged and maintained. CONCLUSIONS:

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96 The results of the study recommends Cluj-Napoca as a city with good standards regarding QOL and other studies confirmed our conclusions and helped validating the model.

(1070) Patient-reported outcome measurement in primary care for people with long-term conditions: stakeholders views Elizabeth J. Gibbons, MSc, University of Oxford, Oxford, Oxon, United Kingdom; Crispin Jenkinson, Health Services Research Unit, Oxford, United Kingdom; Raymond Fitzpatrick, PhD, Univ of Oxford, Dept of Public Hlth, Oxford, United Kingdom; Michele Peters, PhD, University of Oxford, Oxford, United Kingdom AIMS: Since 2009 in the NHS in England, patient-reported outcome measures (PROMs) are used to assess outcomes in four elective surgical procedures. The role of PROMs in Long Term Conditions (LTCs) is more challenging due to the complexity of problems patients experience and diverse services they require. In 2012 a feasibility study was conducted to evaluate the usefulness of using PROMs in LTCs in primary care using mixed methods. Stakeholder’s views and experiences of collecting PROMs in people with LTCs was explored in a qualitative study. METHODS: The quantitative approach was a cohort study in which people with six LTCs (asthma, COPD, diabetes, epilepsy, heart failure and stroke) completed a generic and diseasespecific PROM at two points in time, 1 year apart. Stakeholder’s views and experiences of collecting PROMs in people with LTCs was explored in the qualitative study. This poster presents these findings. A convenience sample of 19 stakeholders were interviewed. A report of the quantitative study which included response rates and scores for the PROMs was presented to the participants prior to the interview. Framework analysis, based around feasibility, value and usefulness of PROMs results, was conducted using NVivo V.9 qualitative analysis software. RESULTS: Most stakeholders were positive about collecting PROMs specifically for individual patient monitoring and decision making but were concerned about resources. Some stakeholders viewed PROMs data as useful as it provided a different method to assess individual or population health which may lead to health improvements. Furthermore, some could see the value of PROMs data for service improvement and commissioning. Others did not feel they knew enough about PROMs to provide comments about the usefulness of PROMs data. All participants agreed that the report was too detailed and advised that it may be better to produce a different summary of results for different stakeholders. CONCLUSIONS: Stakeholder’s views were mixed about the feasibility and usefulness of PROMs data. Views seemed to be underpinned by their level of engagement and knowledge of PROMs. Consideration needs to be given to appropriate presentation of the data and education which would give them more insight into what the data might be useful for.

(1072) The Effect of tailored sasang constitution healthcare program for vietnamese Jonghyang Yoo, Korea Institute of Oriental Medicine, Daejeon, Korea; Jihye Kown, Korea Institute of Oriental Medicine, Daejeon, Korea AIMS: This study is a randomized controlled clinical study for Vietnamese to find out that tailored Sasang constitution healthcare program is effective in improving health state for Vietnamese. Sasang constitutional medicine (SCM) is a unique Korean traditional medicine and humans are classified into four constitutions based on their body shape, facial appearance and psychological characteristics.

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Qual Life Res (2014) 23:1–184 METHODS: Subjects are collected from adults who are more than 20 years old without severe disease. The applicants are separately diagnosed by two Sasang constitution specialists and then taken part in the study if the diagnosis results are matched each other. The participants are randomly assigned to an experimental group who takes tailored constitution healthcare education and to a control group without special care. While the experimental group is trained for the program at the designated hospital four times for 8 weeks and checked how they get the training well, the control group is tracked for 8 weeks without separate training. Both groups are commonly conducted through measurement of questionnaire on quality of life (SF-36). The final analysis is made for 64 samples in the experimental group and 66 samples in the control group. T-test is utilized to know how the training is effective and ANCOVA is employed to understand the difference between the experimental group and the control group. RESULTS: The experimental group with the tailored Sasang constitution healthcare program shows improvement in physical component scale (PCM) from 73.3 ± 20.4 at baseline 78.6 ± 14.2 at last visit. In control group form 77.7 ± 14.4 to 80.6 ± 12.9. But there was no statistically significant difference between two groups (p value = 0.408). In experimental group Mental component score (MCS) increased from 81.9 ± 17.5 at baseline to 87.0 ± 11.3 at last visit.. In control group form 84.2 ± 12.7 to 87.0 ± 10.4. But there was no statistically significant difference between two groups (p value = 1.00). CONCLUSIONS: This study helps to find out that tailored Sasang constitution healthcare program is effective in improving the quality of life for Vietnamese. Based on this study, more detailed and quantitative training program is expected to be followed so that this study is likely to be basic materials to spread Sasang constitution medicine to other foreign states except Vietnam. This randomized controlled pilot trial did not find that Sasang constitution healthcare program was more effective than usual care in increasing the quality of life. It is needed to do subsequent in larger clinical trial

Patient-Centered Research (1074) PRO/QOL-related articles by clinical specialty Kikuko Miyazaki, PhD, Kyoto University, Kyoto, Japan; Miwa Hinata, Kyoto University School of Public Health, Kyoto, Japan; Toshimitsu Ikeuchi, Kyoto University School of Public Health, Kyoto, Japan; Takeo Nakayama, MD PhD, Kyoto University School of Public Health, Kyoto City, Kyoto, Japan AIMS: In clinical settings, it is necessary to consider patient-reported outcomes (PRO)/quality of life (QOL). How much consideration is given to patient QOL in each specialty? We aimed to examine the degree of interest in patient QOL/PRO by specialty and how it changes over time based on the percentage of articles with themes related to QOL/PRO among articles published in each specialty. METHODS: PubMed was used as the search database. Literature searches were performed for every 10 years starting from 1960 using the search string ‘‘human[mh] AND name of specialty [majr]’’. We then searched for articles with a title and abstract containing the term ‘‘QOL’’ using this search string, and determined the percentage of articles with QOL as a theme in each specialty, as well as changes in these percentages over time. The search was performed independently by two researchers, and results were matched and compared. RESULTS: The search string was constructed using ‘‘OR’’ and ‘‘NOT’’ to avoid duplication (of specialties), and 49 clinical specialties were surveyed. Articles containing ‘‘QOL’’ were found in the following (in decreasing order): ‘‘Psychiatry,’’ ‘‘Nervous System Diseases,’’ ‘‘Medical Oncology,’’ ‘‘Respiratory Tract Diseases,’’ and ‘‘Cardiovascular Diseases.’’ The percentage of articles containing

Qual Life Res (2014) 23:1–184 ‘‘QOL’’ among articles in each specialty were ‘‘Physical Medicine OR Rehabilitation’’ (6.44 %), ‘‘Palliative Care OR Terminal Care’’ (6.06 %), and ‘‘Geriatrics OR Aged’’ (3.58 %).’’ ‘‘Nuclear Medicine’’ and ‘‘Emergency Medicine’’ had the lowest percentage, at 0.14 %. The percentage of QOL articles in ‘‘Palliative Care OR Terminal Care’’ was the highest up to the 1990s, but in the 2000s, the percentage in ‘‘Physical Medicine OR Rehabilitation’’ was the highest. CONCLUSIONS: Percentages of articles regarding QOL were high in specialties dealing with diseases for which the goal is not a complete cure. This is likely because a heavy emphasis is placed on PRO associated with each person’s values when assessing outcomes. In addition to the keyword ‘‘QOL,’’ it will be necessary in the future to examine the contents of QOL assessments as well.

(1076) Is the vignette method used to assess quality of life in practice? Monika Szkultecka-Debek, Military Institute of Medicine, Warsaw, Poland; Mariola Drozd, Department of Applied Pharmacy, Medical University of Lublin, Lublin, Poland; Marta Bem, Warsaw University of Life Sciences—SGGW, Poland AIMS: To define how extensive is the use of vignettes method for quality of life assessment. Despite the great variety of existing QOL questionnaire there are still areas when more information is needed. A tool to be used to fill the gap for capturing, often a sensitive information, are vignettes. The objective of our search was to define if in real life the vignettes are used for quality of life and utilities assessment and if yes how extensive is their use. METHODS: We performed a literature review to identify studies where vignettes have been used to assess quality of life or utilities. The Medline-PubMed and Cochrane internet databases have been reviewed. The search was focused on quality of life and the use of vignettes studies for QOL assessment. We searched publications within the period 2011–2014. RESULTS: The literature review identified in total 105 articles in Medline PubMed and 6 at Cochrane database. 28 publications from Medline and 2 from Cochrane databases corresponded to analyzed time period and only 7 fulfilled the pre-defined criteria and were related to use of vignettes for QOL or utilities assessment. Most of the articles described use of vignettes for utilities elicitation; only 2 were related to quality of life assessment. CONCLUSIONS: The rating of vignettes is a promising additional technique to measure changes in QOL and utilities and it can be considered for use as supplementary method to standard QOL measurement methods.

97 with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve both trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. Our aim was to review and summarize the current PRO-specific guidance for clinical trial protocol developers. METHODS: We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts in the field. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. RESULTS: 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from the included documents. A further 10 PRO recommendations were identified which related to other supporting trial documentation. Only 5/162 (3 %) recommendations appeared in more than half of the guidance documents reviewed, indicating a lack of consistency. CONCLUSIONS: PROspecific protocol guidance is difficult to access, lacks consistency and is unwieldy; with over 160 recommendations spread across 54 different publications. It is therefore extremely challenging to implement in practice. There is a need to develop easily accessible consolidated, and consensus-driven, PRO protocol guidelines. Guidance should aim to ensure key PRO information is routinely included in trial protocols with a PRO endpoint, in order to facilitate the rigorous collection and reporting of PRO data, thus maximizing its capacity to effectively inform patient care.

(1080) Feasibility of Patient Reporting of Symptomatic Adverse Events via the PRO-CTCAE in a Radiation Therapy Oncology Group (RTOG) Cooperative Group Clinical Trial

Melanie Calvert, PhD, The University of Birmingham, Birmingham, United Kingdom; Derek Kyte, MSc, University of Birmingham, Birmingham, United Kingdom; Helen Duffy, University of Birmingham, UK; Adrian Gheorghe, University of Birmingham; Rebecca L. Mercieca-Bebber, The University of Sydney, University of Sydney, Camperdown, Australia; Jonathan CS Ives, PhD, The University of Birmingham, Birmingham, United Kingdom; Heather Draper, University of Birmingham, Birmingham, United Kingdom; Michael Brundage, MD, Queen’s University, Kingston, ON, Canada; Jane Blazeby, MD, University of Bristol, Bristol, United Kingdom; Madeleine T. King, PhD, Psycho-oncology Cooperative Research Group (PoCoG), Sydney, Australia

Ethan Basch, MD, University of North Carolina—Chapel Hill, Chapel Hill, NC, United States; Stephanie L. Pugh, NRG Oncology Statistics and Data Management Center; Amylou C. Dueck, PhD, Mayo Clinic, Scottsdale, AZ, United States; Sandra A. Mitchell, PhD CRNP AOCN, National Cancer Institute, Bethesda, MD, United States; Lawrence Berk, MD PhD, University of South Florida, United States; Lauren Rogak, MA, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Marcha Gatewood, Emory University, Atlanta, GA, United States; Bryce B. Reeve, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Tito R. Mendoza, PhD, Univ. of Texas MD Anderson Cancer Ctr., Houston, TX, United States; Ann O’Mara, PhD, National Cancer Institute, Bethesda, MD, United States; Andrea Denicoff, RN, MS, National Cancer Institute, Bethesda, MD, United States; Lori Minasian, MD, National Cancer Institute, Bethesda, MD, United States; Shannon Fogh, MD, Univ. of California San Francisco, San Francisco, CA, United States; Kevin Roof, MD, Southeast Cancer Control Consortium, Inc. CCOP; Joan K Moore, RN, York Cancer Center; Thomas Gergel, MD, Geisinger Medical Center CCOP; Kevin Stephans, MD, Cleveland Clinic Foundation; Andreas Rimner, MD, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Albert DeNittis, MD, Main Line CCOP; Deborah W. Bruner, RN, PhD, FAAN, Emory University, Atlanta, GA, United States

AIMS: Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in some clinical trials, which may limit the use of these data to inform patient care. For trials

AIMS: To assess study site participation and patient compliance with self-reporting of symptomatic adverse events (AEs) using the PatientReported Outcomes version of the Common Terminology Criteria for

(1078) Patient-Reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers

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98 Adverse Events (PRO-CTCAE) in a phase 2 randomized trial, supported by RTOG grant U10-CA21661, NCI CCOP grant U10CA37422, and NCI contract HHSN261201000063C. METHODS: English-speaking patients enrolled in RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) self-reported 53 PRO-CTCAE items representing 31 symptomatic AEs at baseline and weekly during treatment. Reporting was conducted via wireless tablet or desktop computers in clinic waiting areas. Site clinical research assistants (CRAs) contacted patients who missed PRO-CTCAE reports within 72 h for backup data collection. PRO-CTCAE reports were not shared with staff. Compliance was defined as the proportion of patients completing the PRO-CTCAE at each of the five scheduled study visits. RESULTS: Among 226 study sites participating in RTOG 1012, 100 % completed 35-min PRO-CTCAE training for CRAs; 80 sites ultimately accrued patients of which 34 required iPads to be provided. Among 159 patient participants in RTOG 1012 (median age 65; 46 % female; 84 % white), 154 (97 %) consented to provide PRO-CTCAE data. Average duration for CRAs to teach patients how to report PRO-CTCAE data electronically was 16 min (range 12–24). Patient compliance was similar across the five visits with an overall average of 84 % (range 83–87 %); for example 130/154 (84 %) participants at baseline and 116/139 (83 %) at visit 5. The most common mutually exclusive reasons for non-compliance were institutional errors (forgetting to provide computer; staff unavailable) (41 %), and technical (computer/internet) problems (40 %). Less commonly, patients were ‘‘Too Sick/Refused’’ (16 %). Notably, 11 missing PRO-CTCAE reports occurred at a single site where staff misinterpreted the protocol. For visits where patients did not complete the PRO-CTCAE electronically, staff successfully recovered data within 72 h in 64 % of cases. CONCLUSIONS: Most study sites and patient participants are willing and able to participate in electronic collection of PRO-CTCAE symptomatic adverse event data in a cancer trial. Principal reasons for missing data relate to technical difficulties and staff error, which are being addressed in ongoing studies.

(1082) Patient-Reported Outcome (PRO) Assessment in Multiple Myeloma (MM): a review of Cancer-Specific PROs according to food and drug administration (FDA) PRO guidance criteria Colleen A. McHorney, Covance Market Access, Inc., Gaithersburg, MD, United States; Andrew Palsgrove, Covance, San Francisco, CA, United States; Bhumi Trivedi, Covance; William B. Jones, Sanofi; Peter Trask, Sanofi AIMS: Multiple myeloma (MM) is a hematologic malignancy of plasma cells. Myriad clinical trials have been conducted in MM, many of which have included PROs as a study endpoint. Five PROs have been used as endpoints in MM trials and/or have been developed for MM patients, including the EORTC QLQC30, the EORTC QLQ-MY20, the FACT-MM, the FACT GOGNtx, and the MDASI-MM. We conducted a review of the development and validation process of the PROs to assess how well they align with the FDA PRO guidance. METHODS: We reviewed the development and validation studies of the five PROs to assess how well they align with the FDA PRO guidance criteria with regard to: (1) content validity, including patient input in concept elicitation, item generation, and cognitive debriefing; and (2) psychometric testing, including construct validity, internal-consistency and test–retest reliability, and responsiveness. RESULTS: We reviewed six development and validation articles and 49 articles on the application of the PROs

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Qual Life Res (2014) 23:1–184 in MM. The EORTC-QLQ-C30 was not developed with patient input in terms of concept elicitation, item generation, or cognitive debriefing. The other four PROs had variable, uneven, and often inadequately documented evidence of content validity in terms of concept elicitation, item generation, or cognitive debriefing. Internal-consistency reliability estimates in MM samples were available for all PROs except the FACT-MM. None of the PROs had evidence of test–retest reliability in MM samples. Evidence of construct validity and responsiveness in MM samples was available for all PROs except the FACT-MM. CONCLUSIONS: Based on our review, the EORTC QLQ-C30 does not appear satisfy the FDA criteria for content validity. The FDA favors test–retest reliability over internal-consistency reliability, and none of the five PROs have such evidence in MM samples. Evidence of construct validity and responsiveness was lacking for the FACT-MM and was available in only one study for the MDASI-MM. None of the five PROs appear to have accumulated sufficient evidence to support a PRO labeling claim. Further qualitative and quantitative research is required to address the identified gaps before the five PROs would satisfy FDA guidance for inclusion as a measure for a PRO label claim.

Statistical Analysis of PROs (1084) Assessing Oral Health-Related quality of life and missing data using ohip-14 Manoharan Andiappan, King’s College London, London, United Kingdom; Stephen Dunne, King’s College London, London, United Kingdom; Nora Donaldson, King’s College London, London, United Kingdom AIMS: The main aim of this study is to assess the oral healthrelated quality of life of patients having various dental problems using Oral Health Impact Profile (OHIP-14) and to study the missing data in using OHIP-14. METHODS: At baseline 360 patients were asked to fill in OHIP with 14 items when they came for treatment at King’s College Dental Hospital, London. The total OHIP score between various demographic variables were compared. The missing data mechanism at baseline was explored using Little’s MCAR test and they were filled using different methods (Regression, Estimation maximization (EM), Multiple imputation etc.). The mean OHRQoL scores obtained from various methods were compared. RESULTS: Out of 360 patients, 277 (76.94 %) provided data on all items and the remaining 83 had one or more items missing. Little’s MCAR test showed that the missing data in OHIP-14 followed Missing Completely at Random (MCAR) (p = 0.16). The percentage of missing data ranged between 1.4 to 7.5 % among the items. The completed cases analysis showed an average score of 22.81 with a sd of 16.10 out of the maximum score of 70. The mean score did not differ significantly between males and females (p = 0.10). The estimated mean severity scores were 21.61, 21.71 and 21.69 based on EM (expectation and maximization) algorithm, regression method and multiple imputation respectively. All three methods estimated the mean OHIP-14 scores which are close to each other. CONCLUSIONS: The missing data in measuring OHRQoL using OHIP-14 follows Missing Completely At Random pattern. The dental problems do affect the quality of life of individuals of both sex equally. Since all the three methods of filling missing data provided similar results, any one of the methods can be employed to fill in the missing data so that the power of the study in Oral Health Research can be improved, especially with small samples.

Qual Life Res (2014) 23:1–184 (1086) The Functional assessment of Cancer Therapy-Prostate (FACT-P) & Trial Outcomes Index (TOI): a Rasch analysis Adam B. Smith, York Health Economics Consortium, University of York, York, United Kingdom; Kim Cocks, University of York, York, United Kingdom; David Parry, AstraZeneca Pharmaceuticals Ltd; Matthew Taylor, York Health Economics Consortium AIMS: The Functional Assessment of Cancer Therapy-Prostate (FACT-P) is a patient-reported outcome measure (PROM) that is commonly used in oncology clinical trials to assess the impact of treatment on patients. The measure comprises a core set of 27 questions (FACT-General) and an additional 12 prostate-cancer specific (PCS) items. A subset of domains from the FACT-G (Physical and Functional Well-being, PWB/FWB) may be summed with the PCS to form a trial outcomes index (TOI). The aim of this study was to evaluate the psychometric properties of the TOI using a Rasch Model analysis. METHODS: Data was extracted from two randomisedcontrolled trials involving patients with metastatic castration-resistant prostate cancer (N = 1,579). The Partial Credit Model Rasch Model was applied to the baseline TOI data. Category disordering, fit statistics (infit mean square \ 1.30), unidimensionality (principal components analysis (PCA), eigenvalue 1st contrast \ 2.0), and person separation/reliability were determined (criterion [ 2 and [ 0.8 respectively). Differential item functioning (DIF) was also assessed by age group (2 levels) and treatment arm (2 levels) (criterion difference [ 0.5 logits). A subset of data (N = 991) was used to evaluate the effect sizes for a Rasch-derived index compared to the TOI. RESULTS: There was considerable misfit with 46 % of items not fitting (12/26): 1 item from the PWB, 2 FWB and 9 PCS. Only the pain items from the PCS remained. The 14 items fit the model and demonstrated good person reliability. There was a degree of multidimensionality (eigenvalue 3.5) present. There was no DIF by treatment arm at baseline, although some was present across age groups. The effect sizes for the 14-item Rasch-derived index were greater than those for the FACT TOI both overall and by age group. CONCLUSIONS: The results from this analysis suggest the TOI does not form a unidimensional scale and its use in trials to assess the impact of an intervention on patients may produce misleading results. A Rasch-derived index based on the PWB/FWB domains with additional pain items was shown to be more responsive than the TOI.

(1088) Differential item functioning in the SF-36 physical functioning and mental Health Sub-Scales: a Population-Based analysis from Canada Lisa M. Lix, University of Manitoba, Winnipeg, MB, Canada; Xiuyun Wu, University of Manitoba, Winnipeg, MB, Canada; Wilma Hopman, Clinical Rsrch Ctr, Kingston General Hospital, Kingston, ON, Canada; Nancy E. Mayo, PhD, McGill University Health Centre, Montreal, QC, Canada; Tolulope T. Sajobi, PhD, University of Calgary, Calgary, AB, Canada; Juxin Liu, University of Saskatchewan; Richard Sawatzky, PhD RN, Trinity Western University, Langley, BC, Canada AIMS: The SF-36 is often used to compare health status across populations. Differential item functioning (DIF), which occurs when individuals with the same underlying level of health do not interpret scale items in the same way, can contribute to a lack of scale comparability. The study purpose was to test for DIF in the SF-36 (version 1) physical functioning (PF) and mental health (MH) sub-scales in Canadian population-based data. METHODS: Study data were from the Canadian Multicentre Osteoporosis Study (CaMos), a prospective cohort study that provides national prevalence and incidence estimates for osteoporosis; individuals were recruited regardless of disease history. To test for DIF by age group (\65 years, 65? years) and sex, we adopted a multiple indicators multiple causes framework

99 and applied a two-parameter graded response model separately to the ten PF and five MH items. DIF was tested using likelihood ratio statistics with Bonferroni adjustment. RESULTS: The CaMos cohort (N = 9,423) was primarily female (68.7 %) and almost equally represented in 25 to 64 years (51.9 %) and 65 ? years (48.1 %) age groups. Almost one-quarter of the sample indicated they were never limited in vigorous activities and 18.5 % indicated they were happy all of the time. For the PF sub-scale, six of the 10 items contained uniform DIF by age group or sex; effects were observed in items about moderate activities, vigorous activities, lifting or carrying groceries, climbing stairs, and bathing or dressing. The odds of item response for females relative to males were smallest for lifting/carrying groceries (odds ratio [OR] = 0.38) and largest for bathing/ dressing (OR 1.75). For the MH sub-scale, three of five items contained uniform DIF by age group or sex, with effects observed in questions about feeling down in the dumps, happy, and downhearted/ blue. Item responses were higher for females than males and for younger than older ages. CONCLUSIONS: This study revealed DIF in population-based SF-36 data, suggesting that PF and MH subscales may not be comparable across populations defined by age and sex. The implications of these DIF effects when testing the association between health and disease outcomes requires further examination.

(1090) Power and Type-I-Error of global assessment of response shift occurrence using Likelihood-Ratio test or information criteria in Oort’s Procedure: a simulation study Antoine Vanier, MD, University Pierre et Marie Curie Paris 6, Paris Cedex 13, France; Veronique Sebille, ScD, University of Nantes, Nantes, France; Myriam Blanchin, University of Nantes, Nantes, France; Alice Guilleux, University of Nantes, Nantes, France; JeanBenoit Hardouin, PhD ScD, University of Nantes, Nantes, France AIMS: Oort’s procedure (OP), a statistical method relying on Structural Equation Modeling, has been successfully used to detect response shift (RS) on several clinical datasets. However, its performance as a function of sample characteristics remains unknown. A simulation study was designed to provide data on the behavior of OP realized at the item level. A specific objective was to assess the impact of using different information criteria (IC), as alternatives to the Likelihood-Ratio Test (LRT), for global assessment of response shift occurrence (Model 2 versus Model 1). METHODS: Responses to 5 binary items (unidimensional instrument), at two times of measurement were simulated using a Rasch model. Forty-eight combinations of different levels of sample characteristics (sample size (n = 100, 200 or 300), ‘‘true change’’ (a = 0 or -0.2), correlations between the latent variables at the two times (? = 0.4 or 0.9) and presence or absence of uniform recalibration RS (rs on 0, 1, 2 or 3 items)) were considered. A thousand datasets were generated for each combination. RS detection was performed on each dataset following OP. Global assessment of RS occurrence was performed with the 2 different strategies: using either an LRT or an IC (AIC, BIC or SABIC). Type-I-Error and power of the global assessment of RS occurrence were estimated for each combination of sample characteristics. RESULTS: Overall, the estimated Type-I-Error was close to 5 % for the LRT, and lower than 5 % for the IC. Overall, the estimated power was higher for the LRT than those estimated for the AIC, which was the highest among the other IC. An increase in n and rs was associated with an increase in power, regardless of the assessed criteria. Especially for the LRT, the estimated power for n = 100 and the combination of n = 200 and rs = 1 was below 80 %. Otherwise, for other combinations of sample characteristics, the estimated power was above 90 %. CONCLUSIONS: For the LRT, higher values of power were estimated compared to IC with appropriate values of

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100 Type-I-Error. Those results were consistent with Oort’s proposal to use the LRT as the criterion to assess global RS occurrence.

Measure Development (1092) Development of Patient-Reported outcomes measure of pharmaceutical therapy for quality of life (PROMPT-QoL) Phantipa Sakthong, PhD, Chulalongkorn University, Bangkok, Thailand; Phattrapa Suksanga, Faculty of Pharmaceutical Sciences, Chulalongkorn University; Rungpetch Sakulbumrungsil, Faculty of Pharmaceutical Sciences, Chulalongkorn University; Win WinitWatjana, College of Clinical Pharmacy, University of Dammam, Dammam, Saudi Arabia AIMS: To develop a novel quality of life instrument for a patient’s medication use: Patient-Reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life, PROMPT-QoL, and to evaluate its content validity and preliminary psychometrics using a Rasch model. METHODS: A 43-item PROMPT-QoL questionnaire was developed using the theories of health-related quality of life and patient-centered pharmaceutical care, and individual in-depth interviews of 120 adult outpatients who took their medicines continuously at least three months at two university hospitals in Bangkok, Thailand, during October 2012–September 2013. After the item generation, 15 experts including 10 physicians and 5 pharmacists were asked to rate on each of the 43 items to create a content validity index (CVI). Further cognitive interviews of 50 patients in five rounds (10 patients of each) were conducted to ensure patients’ understanding of the questionnaire. A preliminary quantitative analysis using the Rasch model, such as Fit Statistics and person and item reliabilities, was performed. RESULTS: The 43-item PROMPT-QoL comprised 10 domains including General Attitude toward Medication Use, Drug Information, Disease Information, Medication Effectiveness, Impact of Drug Side-effects, Psychological Consequences of Medication Use, Convenience, Availability and Accessibility, Therapeutic Relationship with Healthcare Providers, and Overall QoL with 1, 7, 2, 3, 8, 9, 3, 4, 3, and 3 items, respectively. The CVI of each item ranged from 0.87 to 1.00, which was greater than the acceptable value of 0.80. For 5-round cognitive interviews, 43 problems identified in Round 1 were reduced to five in Round 5 after modest amendments in wordings, meanings or formats. The remaining issues were that some patients could not differentiate among the impacts of drug side-effects, disease, or advancing age on their QOL. The Rasch analysis revealed 32 out of 42 items, excluding General Attitude, provided reasonable item mean-square ranges, 0.7–1.3, for INFIT and OUTFIT. Two domains (Drug Information and Psychological Consequences of Medication Use) possessed person and item reliability values greater than 0.8 and 0.9, respectively. CONCLUSIONS: The newly developed 43-item PROMPT-QoL rendered favorable content validity and preliminary quantitative results. Further studies in large patient groups are required to test its psychometric properties.

(1094) The Validity study for the development of Health-Related Questionnaire—Korea Eunsu Jang, Korea Institution of Oriental Medicine, Daejeon, Korea; Siwoo Lee, Korea Institute of Oriental Medicine, Daejeon, Korea; Younghwa Baek, Korea Institute of Oriental Medicine, Daejeon, Korea; Kihyun Park, Korea Institute of Oriental Medicine, Daejeon, Korea AIMS: We developed Korean Health-related Questionnaire (KH-Q) to measure Korean traditional health concept with physical and psycho-social health components and revealed its reliability before. In

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Qual Life Res (2014) 23:1–184 this study, we tried to evaluate it’s validity comparing with other established methods. METHODS: Data of KH-Q divided into two parts; physical part (PP) and psycho-social part (PSP) were collected from 344 eligible participants between 40 and 60 years old. Short form (SF) 12 and the people’s subjective healthy level by visual analog scale (VAS) were also collected. The convergent validity of the KSH-Q was compared with SF12 and self-estimated VAS using Pearson correlation. Data were divided into 4 groups quarterly to reveal discriminative ability of KSH-Q. Discriminative ability of each group was compared by SF 12 and self-estimated VAS. One way analysis of variance was conducted to compare the scale scores among four different groups and post-hoc pair comparisons were used by Scheffe´’s test. The level of significance was considered to be p \ 0.05 RESULTS: 1. The PP was significantly correlated with RF (r = 0.340), GH (r = 0.452), VT (r = 0.380), and MH (r = 0.340) of SF-12, and PSP was significantly correlated with VT (r = 0.454) and MH (r = 0.407) of SF-12 (p \ 0.05). KSH-Q and its sub-scales showed significant relations with the self-estimated health VAS ranged from 0.305 to 0.404 for PP and from 0.343 to 0.365 for PSP (p \ 0.05). 2. PP score in each four groups was gradually increased in both PCS (p \ 0.000) and MCS (p \ 0.000) of SF 12. PSP score was gradually increased in PCS (p \ 0.000) but was not significant in MCS (p = 0.135) in SF 12 accordingly. PP and PSP score was gradually increased in self-estimated VAS (p \ 0.000). CONCLUSIONS: The KH-Q shows that it has an acceptable validity compared with other established methods and it could be a good measurement to suggest a Korean traditional health concept. Further study to reveal its accordance with a health expert in Korean medicine is needed.

(1096) Core outcome measures in effectiveness trials (COMET) initiative: an international delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘Core Outcome Set’ Cecilia AC Prinsen, VU University Medical Center, Amsterdam, Netherlands; Sunita Vohra, University of Alberta; Michael R. Rose, King’s College Hospital, London, United Kingdom; Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands AIMS: The COMET Initiative concentrates on the development and application of agreed standardized sets of outcomes, also known as Core Outcome Sets (COS), that should be measured and reported in all clinical trials of a specific disease or trial population. As part of this initiative a guideline will be developed for the selection of outcome measurement instruments to be included in a COS. The aim of this Delphi study was to agree on the methods for selecting outcome measurement instruments to be included in a COS. METHODS: A international Delphi study was performed among a panel of experts (clinimetricians/psychometricians, epidemiologists, medical doctors, statisticians, etc.). A total of 481 experts were invited to participate. Informed by a literature review to identify potentially relevant tasks in instrument selection, a web-based Delphi questionnaire was developed. The Delphi study took place in a series of rounds. Panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments (for example, highly recommended, desirable, not relevant, not my expertise). Consensus was reached when at least 70 % of the panelists considered tasks ‘highly recommended’ or ‘desirable’. RESULTS: A total of 120 experts agreed to participate (24.9 %), of which 95 completed the first questionnaire (79.2 %). Consensus was reached on three main steps of outcome measurement instrument selection: 1) Conceptual considerations in the selection of outcome measurement instruments, for example agreement on the construct to be measured and the target population before starting to search for instruments; 2) Finding all relevant outcome measurement instruments, for example by performing a systematic review or by

Qual Life Res (2014) 23:1–184 updating a literature search; and 3) Evaluation of outcome measurement instruments, for example the evaluation of the measurement properties of the identified instruments and the consideration of feasibility aspects in the selection of instruments. The Delphi study is currently ongoing and it is expected to have consensus on the methods in the second quarter of 2014. CONCLUSIONS: The results of the Delphi study can be used in the development of a guideline for outcome measurement instrument selection for outcomes to be included in a COS.

(1098) Cognitive Debriefing of clinical outcomes assessment questionnaires with subjects aged 65 and older Matthew Talbert, Corporate Translations, Chicago, IL, United States; Barbara A. Brandt, MA, Corporate Translations, Inc., East Hartford, CT, United States; Shawn McKown, MA, Corporate Translations, Inc., East Hartford, CT, United States; Mary C. Gawlicki, MBA, Corporate Translations, Inc., East Hartford, CT, United States AIMS: To test the hypothesis that subjects aged 65 and above are less likely to comprehend Clinical Outcomes Assessment (COA) questionnaire items during cognitive debriefing. METHODS: Seven (7) COAs were translated into 45 languages. Cognitive debriefing interviews were conducted on 5 subjects each per language, during which the subjects may point out concepts that they do not understand. The total numbers of misunderstood items were tallied for each subject per debriefing interview. The standard deviation of the sample was used to organize the subjects into age groups. The average number of misunderstood items per age group was calculated. An ANOVA test was used to determine the statistical significance between the age groups. RESULTS: Out of the sample of 225, the standard deviation was 13.6, creating five (5) age groups. The 20–32 age group (n = 17), averaged 0.47 misunderstood items per subject. The 33–46 age group (n = 40), averaged 0.36 misunderstood items per subject. The 47–59 age group (n = 78), averaged 0.35 misunderstood items per subject. The 60–73 age group (n = 69), averaged 0.32 misunderstood items per subject. The 74 and older age group (n = 21), averaged 0.29 misunderstood items per subject. The ANOVA test yielded a p value of 0.064. Analysis of misunderstood concepts tended to be primarily medical or technical concepts, such as stiffness, visual analog scale and the term global. CONCLUSIONS: Review of the average number of misunderstood items per subject in the various age groups indicates that the subjects in the upper age groups may be more likely to comprehend items than the younger age groups. However, the p value of 0.064 demonstrates no statistical significance between one’s age and ability to comprehend items in translated COAs. Upon further analysis of the commonly misunderstood items, it was observed that there was no relationship between comprehension of those items and age, as a lack of understanding of those concepts was prevalent throughout the sample.

101 sexual problems over time and facilitating communication about an important topic. However, instruments designed for research are typically too long to be practical in clinical practice. We developed and tested multiple single-item screeners and related responses to robust sexual function scores from the PROMIS Sexual Function and Satisfaction (SexFS) measure. METHODS: We collected items currently used on clinic intake forms by members of the Scientific Network on Female Sexual Health and Cancer and wrote 3 candidate screener items. We refined items through cognitive interviews (n = 7) and tested them in a probability-based random sample of US adults from GfK’s KnowledgePanel (n = 3,517). The items were: 1) a yes/no item with no recall period asking about any sexual problems or concerns (‘‘general screener’’), 2) a yes/no item asking about any problems experienced for three months or more in the past 12 months with a detailed list of examples (‘‘long list screener’’), and 3) an item identical to the long list screener except the examples appeared individually as response options and respondents could check all that apply (‘‘checklist screener’’). RESULTS: Percentages of women and men endorsing the screeners were: 10 and 15 % (general); 20 and 17 % (long list); and 38 and 30 % (checklist), respectively. People who endorsed the general screener or a specific problem on the checklist screener had decreased function on the PROMIS SexFS compared to those who did not endorse it (Table 1). Differences in PROMIS means were medium or large and statistically significant (with one exception). CONCLUSIONS: All three screeners demonstrated basic validity, but there were large differences in the Table 1

Scores and differences in PROMIS SexFS domain scores for sexually active men and women who did and did not endorse a

general (yes/no) screener and specific sexual problems on a checklist style screener

PROMIS

PROMIS SexFS

Difference

Check

PROMIS SexFS score

Difference

SexFS

score mean (SE)

in means

list screener

mean (SD)

in means

(95 % CI)

response

domain

Kathryn E. Flynn, PhD, Medical College of Wisconsin, Milwaukee, WI, United States; Stacy T. Lindau, University of Chicago, Chicago, IL, United States; Li Lin, Duke Clinical Research Institute; Jeanne Carter, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Diana Jeffery, Department of Defense; Jennifer B. Reese, Johns Hopkins University School of Medicine, Baltimore, MD, United States; Emily M. Abramsohn, University of Chicago, Chicago, IL, United States; Kevin P. Weinfurt, PhD, Duke Clinical Research Institute, Durham, NC, United States AIMS: Brief self-assessment of sexual problems in a clinical context has the potential to improve care for patients by allowing tracking of

Did not

Endorsed

Did not

general

endorse

specific

endorse

screener

general

response

specific

screener

response

Women (N = 1,178) Interest in sexual activity

Women (N = 392) 46.68 (0.72)

Vaginal lubrication

43.39 (0.93)

Vaginal discomfort

56.75 (0.85)

Vulvar discomfort— Labial Vulvar discomfort— Clitoral

(1100) Development and validation of a single item screener for Self-Reported sexual problems

(95 % CI)

Endorsed

55.03 (1.05) 53.55 (1.10)

Orgasm—ability

43.58

Satisfaction with sex life

42.58

(1.01)

(0.58)

51.77

5.09 (3.52, 6.66)

51.97

8.58 (6.63, 10.53)

(0.39) 48.41 (0.32) 48.84 (0.34) 49.10

(0.90) -8.71 (-10.55,

41.96 (0.63)

Orgasm—ability

46.70 (0.79)

Satisfaction with sex life

Pain

-6.88) -6.62 (-8.77,

62.96 (0.78)

Pain

58.83

Pain

55.53

5.52 (3.34, 7.70)

No orgasm

39.12

8.47 (6.99, 9.95)

No enjoyment

39.92

-4.46) -4.71 (-6.96,

(1.56)

-2.46)

(1.67)

(0.47) 51.05

38.18

(1.25)

(0.48)

(0.79)

51.24

7.08 (4.92, 9.23)

(0.80) 46.97

8.79 (6.36, 11.22)

(0.84) 52.25

-10.71 (-12.90,

(0.80) 51.77

-8.52 -7.06 (-10.58,

(0.88) 51.82

-3.53) -3.71 (-7.47,

(0.95) 46.93

0.06) 7.81 (4.63, 10.99)

(1.03) 44.30

4.38 (2.33, 6.43)

(0.68)

MEN (N = 375) 51.25 (0.57)

Erectile function

Dryness

(0.37) 48.04

44.16 (0.75)

MEN (N = 1,423) Interest in sexual activity

No interest

(0.36)

43.72 (0.67)

55.99

4.73 (3.52, 5.94)

No interest

(0.23) 53.81 (0.29) 53.96

(0.82) 11.85 (10.49, 13.21) 7.26 (5.62, 8.91)

Erection difficulties No orgasm

(0.27) 52.17 (0.35)

46.56

39.61 (0.60) 42.38 (1.33)

8.45 (6.98, 9.92)

No enjoyment

42.70 (2.31)

54.61

8.05 (6.24, 9.87)

(0.44) 48.89

9.28 (7.31, 11.25)

(0.80) 48.92

6.54 (3.59, 9.49)

(0.71) 44.55

1.85 (-2.81, 6.50)

(0.54)

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102 prevalence of sexual problems reported depending on the screener used, suggesting they are not interchangeable. The general screener is extremely brief; the long list screener adds length without specificity. We recommend the checklist screener for its specificity and ability to identify specific problems associated with decreased sexual function. Future analyses will compare the severity of problems among people who endorse the general screener compared to the checklist screener.

(1102) Experience of pain in patients with moderate to severe plaque psoriasis Dennis Revicki, PhD, Evidera, Bethesda, MD, United States; Hilary D. Wilson, Evidera, Bethesda, MD, United States; Lionel A. Pinto, Amgen, Inc., Thousand Oaks, CA, United States; Hema Viswanathan, Amgen, Inc., Thousand Oaks, CA, United States AIMS: The Psoriasis Symptom Inventory (PSI) is an 8-item measure of psoriasis symptom severity and includes an item on pain. The aim of this analysis was to describe the frequency and severity of pain in moderate to severe plaque psoriasis patients, and to evaluate the relationship between pain measured by the PSI and other clinician and patient-reported measures of psoriasis symptoms and pain. METHODS: A secondary analysis of pooled Phase 2 clinical trial data collected from 186 patients with moderate to severe psoriasis was conducted. The measures used included the PSI pain item, item 1 (how itchy, sore, painful, or stinging has your skin been) of the Dermatology Life Quality Index (DLQI), the Short-form 36 (SF-36) bodily pain scale, and Static Physician’s Global Assessment (sPGA). Mean PSI pain scores among patients with varying degrees of psoriasis severity as defined by the sPGA at Baseline and Week 12 were compared using an Analysis of Variance. Spearman correlations between the PSI pain item and PSI total, DLQI item 1, DLQI total scores, and SF-36 bodily pain were examined at Baseline and Week 12. RESULTS: The sample was 36 % female, 89 % Caucasian, and averaged 42.9 (12.2) years. Pain as measured by the PSI was reported by the majority of subjects at Baseline (none = 13.0 %, mild = 21.1 %, moderate = 35.7 %, severe = 17.3 %, very severe = 13.0 %). Mean pain scores were significantly higher in patients with greater psoriasis severity, based on sPGA groups (mild = 0–2, moderate = 3, severe = 4–5) at Baseline and Week 12 (all p \ 0.001). Pain was highly correlated with the PSI total score (Baseline r = 0.83; Week 12 r = 0.78), and moderate to highly correlated with the SF-36 bodily pain scale (Baseline r = -0.49; Week 12 r = -0.49), the DLQI item 1 (Baseline r = 0.60; Week 12 r = 0.75), and the DLQI total score (Baseline r = 0.54; Week 12 r = 0.73). CONCLUSIONS: Moderate to extremely severe pain was experienced at baseline by the majority of patients. The frequency and severity of the experience of pain warrants inclusion of pain in an overall symptom measure of psoriasis.

(1106) Establishing the conditions for the development of a prom for children and adolescents born with esophageal atresia Michaela Dellenmark Blom, PhD-Student, Queen Silvia Children’s Hospital, Gothernburg, Sweden; Kate Abrahamsson, MD, Sahlgrenska Academy at University of Gothenburg; John E. Chaplin, PhD AFBPsS C. Psychol, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden

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Qual Life Res (2014) 23:1–184 AIMS: The aim of the study is to develop a patient-reported outcome measure (PROM) for children and adolescents with esophageal atresia (EA) which follows the DISABKIDS methodology. EA is a birth defect which requires surgical reconstruction or replacement of the esophagus. In Sweden, the incidence of EA is 40/100,000 infants. Survival rates are 90–95 %, but respiratory and esophageal morbidity remain common. METHODS: A comprehensive systematic literature search was conducted. Individual in-depth interviews were carried out with specialist health care personnel. A retrospective review of patient records was conducted by an expert group in order to define criteria for severity categorization of post-operation EA. RESULTS: The systematic literature review identified twenty-five articles but no generic or condition-specific PROM instruments were found. The moderators of QOL in EA that emerged from our literature review and interviews were: activities around meal times, the relationship to food, expression of respiratory symptoms, the family’s independence and attitudes to health care. Mediators of QOL were also identified; these included the frequent presence of additional abnormalities and well-developed coping strategies. From the patient records in health registries we identified 135 children and young people matching our inclusion criteria. The severity of the condition varies but we were able to categories the post-operative symptoms according to four criteria into mild-moderate and severe. Of this group, 55 % have severe medical problems. CONCLUSIONS: PROM development in children and adolescents with EA is needed and there are currently no PROM instruments that are suitable and available. PROM development in rare medical conditions is often not undertaken due to the small population sizes. We are exploring methods used to overcome challenges of PROM development in rare diseases. The study will lead to the development of a condition-specific PROM module.

(1108) Validation of a new Disease-Specific EPRO measure to support dysmenorrhea clinical trials: the dysmenorrhea daily diary (DysDD) Josephine M. Norquist, MS, Merck Sharp & Dohme Corp., North Wales, PA, United States; Tjeerd Korver, Merck & Co., Inc., Whitehouse Station, NJ, United States; Fang Chen, Merck & Co., Inc., Whitehouse Station, NJ, United States; Rob Arbuckle, Adelphi Values, Cheshire, United Kingdom; Alice Turnbull, Adelphi Values, Bollington, United Kingdom; Allison M. Nguyen, Merck & Co., Inc., Whitehouse Station, NJ, United States AIMS: A new 10-item ePRO, the Dysmenorrhea Daily Diary (DysDD), was previously shown to meet content validity standards. The DysDD includes items assessing menstrual bleeding severity, sanitary protection use, pelvic pain (via an 11-point NRS), rescue medication use, and impact of dysmenorrhea (via 5-point scale) on physical activities, work/school, leisure/social activities and sleep. This abstract summarizes a psychometric evaluation of the DysDD to support use as a primary endpoint in dysmenorrhea randomized controlled trials (RCT). METHODS: Blinded data from a 2-cycle, multi-national, RCT among women [ 18 years with primary dysmenorrhea were used to assess reliability, validity, and responsiveness. Anchor- and distribution-based analyses to define minimal important difference (MID) for the pain NRS were also performed. In addition to the DysDD, the Menstrual Distress Questionnaire (MDQ-T), SF-36v2 and a Global Assessment of Change (GAC) were also administered. The DysDD and MDQ-T were administered daily; the SF-36v2 at baseline and end of cycle 2; and the GAC at end of study. Daily data from days -1 to 3 of the menstrual period during each cycle were used in the analyses. RESULTS: 335 patients were included in the per-protocol dataset. Examination of DysDD data on days -1 to 3 during baseline and cycle 2 showed full use of the response scales with minimal floor/

Qual Life Res (2014) 23:1–184 ceiling effects. Intra-cycle test–retest reliability for the pelvic pain NRS was acceptable (0.7 kappa) and the item discriminated among known-groups defined by tertiles of rescue medication use. Concurrent validity of the DysDD was supported by low/moderate correlations with SF-36 Bodily Pain (0.38–0.62) and moderate/high correlations with MDQ Pain (0.41–0.70). Significant differences in scores between GAC-defined responders and non-responders were observed for all DysDD items, supporting responsiveness. Finally, MID analyses indicate a change on the pain NRS of 2 to 4 points to be meaningful and above the inherent variability of the measure. CONCLUSIONS: The analyses reported here provide strong evidence that the DysDD is a valid, reliable and responsive tool for assessing dysmenorrhea. The DysDD, developed and validated according to recognized standards, should be acceptable as a primary endpoint to support dysmenorrhea clinical trials

(1110) Assessing patient-reported impact of endometriosis pain using a 7-day versus daily recall period Adam Gater, Adelphi Values Ltd, Bollington, Cheshire, United Kingdom; Kamonthip Wichmann, Bayer Pharma AG; Christian Seitz, Bayer Healthcare; Christopher Gerlinger, Bayer Pharma AG; WenHung Chen, RTI; Anna Filonenko, Bayer Pharma AG AIMS: Use of the ‘most appropriate’ recall period is critical for the content validity of patient-reported outcomes (PROs) measures. The most appropriate recall period depends on the PRO’s concept of interest and intended context of use and requires balancing maximization of data quality while minimizing respondent burden. As part of the development of a new PRO assessing the impact of endometriosis pain, the appropriateness of a ‘7-day’ recall period (versus a ‘24-h’ recall period) was investigated. METHODS: Data were collected during an observational study for the quantitative validation for the newly developed Endometriosis Impact Scale (EIS). Participants completed 8 items regarding the impact of endometriosis pain on their ability to perform physical activities (5-point scale). Items were administered daily for 28 days with a 24-h recall and also at the end of each 7-day period with a 7-day recall. Pearson correlations were calculated for each item between the item scores of the 7-day recall and the average of the daily item scores over the same periods. Items scores were also correlated with those from the previous day and with the worst score during the 7-day period, to assess potential ‘recency’ and ‘saliency’ effects respectively. Differences between the item scores of the 7-day recall and the average daily item scores over time were also examined. RESULTS: Correlations between item scores of the 7-day recall and mean daily scores over the same period were excellent for all 8 items (r = 0.84–0.91). Further, these correlations were higher than the correlations with the item scores from the previous day (r = 0.73–0.81) or for the worst day during the same period (r = 0.60–0.76). The 7-day recall item scores were slightly higher than the daily average scores, but equivalent in detecting change over time. CONCLUSIONS: It is important that recall periods correspond to the characteristics of the concept of interest and context of use. Findings suggest that, for the EIS, use of a 7-day recall period provides data that is consistent with daily administration of the same items (with a 24 h recall period) over the same time period.

Poster Session 2001: Friday Poster Session 1 Cancer (2001) The impact of demographic, medical and nutritional factors on quality of life in advanced cancer patients

103 Shulamith Kreitler, Tel-Aviv University, Tel-Aviv, Israel; Frida Barak, Barzilai Medical Center, Ashkelon, Israel; Nava DanieliSiegelman, Maccabi Health Service, Oncology Line; Arie Ostrowsky, Leumit Health Service; Yasmin Alkalay, Tel-Aviv University AIMS: The objectives of the study were to examine the impact of medical, demographic and nutritional characteristics in advanced cancer patients on quality of life. Nutritional difficulties constitute a common source of medical, psychological and nursing difficulties in advanced cancer patients. METHODS: The participants were 61 cancer patients of both genders, with advanced disease, living at home, getting mostly palliative treatment, but no parenteral nutrition. They were administered a questionnaire about demographic and medical background, a questionnaire about nutritional habits and difficulties and the Multidimensional Quality of Life Inventory for Adults (QOL-A)—version 1 (Kreitler & Kreitler) which provides information about 12 scales, e.g., social functioning, cognitive functioning, functioning in the family, health, positive emotions, negative emotions. Medical information was extracted from the files. RESULTS: A factor analysis based on the scale scores of the QOL-A scales yielded in the present sample three factors labeled as ‘emotional adjustment’, ‘cognitive adjustment’ and health adjustment’. An index measure of Difficulties in Eating, based on variables, such as amount of food and liquids consumed, bizarre taste, or nausea was defined. Its mean value was 3.24 (SD = 2.98; range: 0–10). Regression analyses were done with the index of nutritional difficulties, age, gender, mobility, diagnosis (GI or non-GI) and disease stage (1–2 vs 3–4) as predictors and the patients’ QOL- A as the dependent variable. The findings were that the QOL factor of emotional adjustment was predicted by gender and mobility (R = 0.608, R2 = 0.369 F = 5.271, p \ 0.001, df = 6/54), the QOL factor of cognitive adjustment by gender (i.e., being female) (R = 0.497, R2 = 0.247, F = 2.954, p \ 0.05, df = 6/54), the QOL factor of health adjustment by mobility (R = 0.543, R2 = 0.294, F = 3.755, p \ 0.01, df = 6/54), and the sum total of QOL-A by all predictors except Age (R = 0.614, R2 = 0.377, F = 5.410, p \ 0.001, df = 6/ 54) (see Table 1). CONCLUSIONS: The conclusions are that nutritional difficulties, lack of mobility, disease diagnosis (GI), advanced disease stage (stages III–IV) and gender (being male) affect negatively overall QOL, and that mobility and gender affect negatively also the constitutive factors of QOL. For improving QOL in advanced cancer patients it is advisable to help patients to reduce nutritional difficulties and increase mobility.

Table 1 Results of regression analyses with demographic and medical variables and nutritional difficulties as predictors and quality of life—total score as the dependent variable Variables (predictors)

Gender

Unstandardized coefficients

Standardized t coefficients

B

SE

Beta

-0.243

0.100

-0.283

Age

0.009

0.005

0.203

Mobility

-2.428* 1.769(p

0.301

0.124

0.348

2.420*

Index of nut. Difficulties -0.036

0.019

-0.232

1.925*

GI

-0.249

0.104

-0.286

2.392*

Disease stage

-0.255

0.116

-0.291

2.195*

= 0.08)

2

R = 0.614, R = 0.377, F = 5.410*** (df = 6/54) * p \ 0.05; ** p \ 0.01; *** p \ 0.001

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104 (2003) Distress, problems, and wish for referral in esophageal cancer patients prior to treatment Marc Jacobs, Academic Medical Center, Amsterdam, Netherlands; Maarten C.J Anderegg, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands; Annuska Schoorlemmer, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands; Estelle M. Altena, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands; Ellen M. Smets, Department of Medical Psychology, Academic Medical Center, The Netherlands; Mirjam AG Sprangers, PhD, Academic Medical Center, Amsterdam, Netherlands; Mark I. Van Berge Henegouwen, Department of Surgery, Academic Medical Center, Amsterdam, Netherlands; Hanneke C.J.M. De Haes, Department of Medical Psychology, Academic Medical Center, The Netherlands; Jean H.G Klinkenbijl, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands AIMS: To: (1) estimate the level of distress in esophageal cancer patients, (2) identify problems that are of particular concern to them, and (3) assess patient’s wish for referral. Based on the data, we build prediction models to estimate distress, referral, and overall survival respectively METHODS: We conducted a retrospective cohort study using electronic patient records. The Distress Thermometer (DT; 1-item, 11-point range, cut-off = 5) and Problem List (PL; 46 binary items across 5 domains) were offered to patients at their first visit to an outpatient’s clinic. Missing data were replaced by multiple imputation. Predictor selection was based on literature and exploratory analyses. For distress, we selected age, sex, total number of problems (overall, and on the emotional, practical, and physical domain), pain, fatigue, and eating. For referral, we selected age, sex, and total number of problems (overall, and on the emotional, practical, and physical domain). For overall survival, we selected age, sex, histology, World Health Organization performance score, Charlson comorbidity score, curative/palliative treatment, clinical N stage, distress, and pain. To obtain odds (OR) and hazard ratios (HR), all variables were entered simultaneously into a Generalized Linear (logit link) and Cox regression model, respectively. Model performance was assessed by the area under the curve (AUC). RESULTS: Responders (n = 187; 47 %) and non-responders had similar characteristics. The median DT score was 5 (IQR = 4). We identified 112 distressed patients (59 %) and 91 patients (49 %) who (maybe) wished to be referred. Most common problems were: eating (74 %), weight change (59 %), tension (59 %), fatigue (44 %), and fear (37 %). For distress, pain was the only predictive factor (OR 3.518 [1.227–10.088], p = 0.019), and the predictive model performed well (AUC = 0.826 [0.764–0.888]). No significant predictors for referral emerged, and the model did not perform well (AUC = 0.660 [0.583–0.738]). For overall survival, curative treatment was the only prognostic factor (HR = 0.179 [0.107–0.299], p = 0.000). CONCLUSIONS: The majority of esophageal cancer patients are distressed prior to treatment, and many want to be referred. Distress does not predict patients’ wish for referral and is not a prognostic factor for overall survival.

(2005) QOL assessments in clinical practice: usefulness of ERORTC-QLQC-30 and the SEIOQL Lena Ring, PhD, Medical Products Agency (MPA) and Uppsala University, Uppsala, Sweden; Lena Wettergren, PhD, Karolinska Institute, Chevy Chase, MD, United States; Hanna Fagerlind, the Swedish Agency for Health and Care Services Analysis; Bengt Glimelius, Uppsala University; Mathilde Hedlund Lindberg, Uppsala ˚ sa Kettis, Planning Division, Uppsala University, Uppsala, Sweden; A University

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Qual Life Res (2014) 23:1–184 AIMS: The aim was to evaluate the effectiveness of quality of life instruments as a means of individualizing cancer care and treatment. In gaining access to patients’ views and to facilitate communication and problem detection, instruments adopting an individual approach might be at least as effective as disease-specific instrument. METHODS: A two-armed, prospective, open label, randomised, controlled intervention study was performed. The computerized versions of the EORTC-QLQ-C30 and the SEIQOL-DW were administered in a clinical oncology setting. In arm A patients filled out the EORTC– QLQ-C30 and in arm B patients filled out the SEIQOL–DW. Both instruments were filled out at baseline and at all planned consultations during four months and patients brought a printout of the results to the consultation with the physician. Patients diagnosed with gastro-intestinal cancer (colorectal, pancreatic, gastric and hepato-biliary cancer) were asked about participation. From Uppsala University Hospital 233 patients were included and of those 130 (60 SEIQOL, 70 EORTC) completed to study, and at Karolinska University Hospital 157 were included and 94 patients (49 SEIQOL, 45 EORTC) completed the study. Primary outcome was the FACIT-Sp. Secondary outcomes were: Satisfaction with communication and care, Global quality of life, Change in quality of life and Medical Interview Satisfaction Scale. RESULTS: Preliminary results show no difference between the two arms on FACIT-Sp, and further QOL scores were maintained over time for both groups. CONCLUSIONS: Previous studies in the Swedish setting have shown that patients using the SEIQOL-DW perceived the doctors as unaccustomed to deal with the outcomes of the questionnaire; this was not evident for those filling in the EORTCQLQ-C30. This indicated that using the SEIOQL-DW might have required even more training and monitoring than was done. Another study limitation is that it was not possible to include a control group. However, previous studies have shown that EORTC contributes to increasing quality of life for cancer patients compared to not having this type of support. Assuming that the EORTC would have the same impact in a Swedish setting our result indicates that SEIOQL-DW have the same impact.

(2007) Enhancing standards and ensuring good Long-Term use of data in quality of life research: an update on the EORTC QLG data repository project Francesca Martinelli, MSc, EORTC, Brussels, Belgium; Deborah Fitzsimmons, Swansea University, Swansea, United Kingdom; Colin Johnson, Mchir, Dept of Surgery, Southampton, Hants, United Kingdom; Galina Velikova, MD PhD FRCP, University of Leeds, Leeds, United Kingdom; Mogens Groenvold, MD, PhD, University of Copenhagen, Copenhagen, Denmark; Andrew Bottomley, PhD, EORTC Headquarters, Brussels, Belgium AIMS: The percentage of cancer survivors has increased over the years and the survivorship agenda requires attention to Quality of Life (QOL) outcomes beyond clinical trials. Robust data are needed for QOL studies and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a core questionnaire supported by tailored modules to measure QOL in cancer patients. To develop a new module a well-established and rigorous approach is followed, the last phase of which is a large-scale test (field study). The Data Repository project ensures standardization and consistency in this important phase. METHODS: The Data Repository project was initially organized into three key steps: the establishment of a policy for preservation and sharing of

Qual Life Res (2014) 23:1–184 data, the preparation of a standard protocol template and a minimum dataset form for field studies and the recovery, harmonization and storage of data from closed field studies. Each step was planned with and reported to a panel of experts, i.e. the QLG Executive Committee. RESULTS: The Data Preservation and Sharing Policy is publicly available on the QLG website (groups.eortc.be/qol/). A Standard Protocol Template and a Standard Case Report Form have been drawn up and are being used in new field studies to ensure consistency. Data from 13 closed field studies have been collected, harmonized and combined into a single dataset, which is continually maintained and updated with data from new studies. This currently includes a total of over 6,000 patients from 33 countries with different cancer sites. These data can be made available to investigators to conduct secondary research according to the rules defined in the above-mentioned policy. CONCLUSIONS: The Data Repository project contributes to the need for high-quality QOL data by setting up standard procedures for developing EORTC QLG modules and by ensuring the preservation and quality of data collected through field studies. During the coming years we expect the data repository to be used to conduct new research, enhancing the long-term value of data and giving an additional contribution to QOL research.

(2009) EORTC QLQ-C30 transversal and longitudinal analyses with stata procedures Caroline Bascoul-Mollevi, ICM | Val D’Aurelle, Montpellier, France, Montpellier, France; Antoine Barbieri, Biometrics Unit, ICM—Val D’Aurelle, Montpellier, France, Montpellier, France; Ame´lie Anota, Quality of Life in Oncology Platform, France, Besanc¸on, France; Marion Savina, Institut Bergonie´, Bordeaux, France; David Azria, ICM | Val D’Aurelle, Montpellier, France; Franck Bonnetain, PhD, University Hospital of Besanc¸on, Besanc¸on, France; Sophie GourgouBourgade, CRLC Val D’Aurelle, Montpellier, France AIMS: Health-related quality of life (HRQOL) has become one of the priority objectives of the clinical trials in cancer research to evaluate efficiency of care. The European Organization for Research and Treatment of Cancer (EORTC) has developed the cancer-specific QLQ-C30 self-questionnaire which allows to estimate 5 functional dimensions, 9 symptoms dimensions and the Global Health Status. In clinical trials, questionnaires are collected at different times predefined in the study protocol during the treatment and the follow-up in order to analyze the HRQOL evolution. In this perspective, specific transversal and longitudinal analyses are required. The aim of this work is to propose STATA macro-programs (and scripts) to automatically process the data coming from EORTC QLQ-C30 questionnaire. METHODS: Two kinds of STATA macro-programs were proposed. First, an automatic descriptive analysis of EORTC QLQ-C30 was computed, as well as profile plots by visit and longitudinal plots by dimensions. The scoring procedures were processed according to the algorithms recommended by the EORTC (Fayers et al. 2010). Then, a STATA macro-program (and scripts) was also shown to implement the three longitudinal strategies which currently compete for the longitudinal HRQOL analysis. These longitudinal methods are based on either classical linear mixed model, either time to event approach (A Anota 2013) or parametric latent trait models coming from IRT method (LPCM, longitudinal partial credit model). RESULTS: The STATA macro-programs were applied on the COHO-RT clinical trial. The CO-HO-RT trial (COncomitant HOrmonoRadioTherapy) is a randomized phase II clinical trial (Azria et al. 2010) which evaluates acute and late radiation-induced skin toxicities for 150 postmenopausal patients with early-breast cancer. CONCLUSIONS: The analysis of HRQOL data in clinical cancer trial are

105 still under-exploited and will be easier to perform with standardized programs as proposed. The descriptive methodology is actually not optimal and the exploration of longitudinal methods is essential and would provide a better assessment of the HRQOL experienced by the patient.

(2013) Development of an adherence to Iron-Chelation Therapy measure through a qualitative study: patient and caregiver perspectives in transfusion-dependent anemias and myelodysplastic syndrome Kathryn E. Lasch, PhD, Pharmerit International, Cambridge, MA, United States; Erica G. Horodniceanu, Pharmerit International; Vasudha Bal, Novartis Pharmaceuticals Corporation; Isabelle Cote, Novartis Pharmaceuticals Corporation; Amy Dorgan, Novartis Pharmaceuticals Corporation; Isabelle Malet, Novartis Pharmaceuticals Corporation AIMS: Treatment adherence to iron chelation therapy (ICT) is essential for patients with transfusion-dependent anemias (TDA) (e.g., sickle cell disease [SCD], thalassemia), myelodysplastic syndromes (MDS), and myelofibrosis (MF) to prevent iron overload. Adherence to ICT while associated with increased survival and less adverse consequences of iron overload has been suboptimal with earlier ICT formulations. Deferasirox (DFX) is the newest of 3 agents currently used to treat iron overload. Available data on DFX adherence, however, is currently limited with minimal information from the patient or caregiver perspective. In order to develop a measure of adherence to ICT, a qualitative study was conducted to better understand patient and caregiver experiences. METHODS: Semi-structured cognitive interviews including an open-ended component were conducted to elicit subjects’ (patients with TDA, MDS, or MF or caregivers thereof) experiences with ICT. Audio recordings of the interviews were transcribed and coded using Atlas.ti. Analysis and interpretation of the coded text was done descriptively according to grounded theory. Institutional Review Board approval was granted. RESULTS: Four interviewers conducted 11 patient and 10 caregiver interviews in 6 US cities. Patients were 73 % male, aged 14 to 81 (mean = 43). Caregivers were 90 % female aged 35 to 65 (mean = 48). Children of caregivers were 60 % female, aged 2 to 17 (mean = 9). Conditions of subjects (patients and children of caregivers) included: MDS (n = 3), SCD (n = 13), thalassemia (n = 3), MF (n = 1), and aplastic anemia (n = 1). Reported reasons for adherence included perceived effect on health and longevity, support from clinicians/caregivers, and having a routine. Reasons for non-adherence included taste (e.g., bitterness), texture (e.g., chalky), side effects, GI symptoms, activities limitation, ‘‘wanting to feel normal’’, and mealtime restrictions. Subjects reported better adherence if they demonstrated an understanding of iron overload and witnessed their iron levels decrease. While few subjects reported non-adherence, some reported modifying how the medicine was taken to change or mask the taste, aftertaste, or texture (e.g., drinking additional orange juice and ‘‘dose splitting’’ during the day). CONCLUSIONS: Factors associated with adherence and nonadherence to ICT were identified which can be used to develop an accurate measure of adherence and interventions to improve adherence to ICT.

Musculoskeletal/Rheumatology (2015) Humanistic Burden of Disease in Rheumatoid and Psoriatic Arthritis: a Qualitative Synthesis Stacie Hudgens, MA (AbD), Clinical Outcomes Solutions, Tucson, AZ, United States; Aki Shiozawa, Takeda Pharmaceuticals

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106 International, Inc, Deerfield, IL, United States; Michael Hagan, Takeda Pharmaceuticals International AIMS: In ongoing clinical trials in autoimmune indications such as rheumatoid and psoriatic arthritis, patient-reported outcomes have been included as secondary and tertiary efficacy endpoints. The purpose of this study was to synthesize published literature on the humanistic burden including patient-reported outcomes associated with these indications. METHODS: A systematic literature review for this study focused on identifying articles that examine patient-reported burden of illness utilizing patient-reported outcomes measures. This review included full search on MEDLINE, PsychInfo, Embase, ISPOR Outcomes Research Digest, and Google Scholar. In addition, a conceptual framework and endpoint model was designed to hierarchically position patient symptoms and impacts to ensure identified PROs were fit for purpose under their context of use as well as to offer insight in the relationship between PROs and clinical outcomes. RESULTS: PROs are frequently positioned in clinical and observational research studies as secondary and tertiary endpoints. The OMERACT 8 Patient Perspective working group evaluated outcomes measures relevant to measuring patient-reported efficacy in psoriatic arthritis which have been widely adapted from outcomes measured in rheumatoid arthritis. These outcomes include the hierarchical evaluation of pain, patient’s global assessment, physical function, and fatigue. In a systematic literature review in rheumatoid arthritis, 109 clinical and observational studies were evaluated (45 % were randomized control trials). Outcomes measured in these studies included: function, 83 % (most frequent tool, health assessment questionnaire), patient global assessment, 61 % (most frequent tool, visual analogue scale, VAS); pain, 56 % (VAS); and morning stiffness 27 %. In a systematic literature review in psoriatic arthritis, 58 clinical and observational studies were evaluated (29 % were randomized control trials). Outcomes measured in these studies included: skin, 55.2 %, physical function, 48.3 %, pain, 46.6 % (VAS); patient’s global assessment, 39.7 %, and quality of life, 37.9 %. For most studies reviewed, age and disease severity were correlated with change in quality of life, disability and symptoms. CONCLUSIONS: Aspects of patient-reported burden of illness for patients with rheumatoid and psoriatic arthritis includes physical, work and social limitations. It is critical to understanding outcomes associated with this burden in order to assess treatment risk/benefit in a clinical setting.

(2017) A Spanish validation of the ASES-P questionnaire for shoulder pathologies Kalliopi Vrotsou, MSc, Research Unit, AP-Osi Gipuzkoa, Osakidetza, Donostia-San Sebastian, Spain; Antonio Escobar, PhD MD, Hospital Universitario Basurto, Bilbao, Bizkaia, Spain; Ricardo Cuellar, Orthopaedic Surgery Department, Donostia University Hospital; Miguel Angel Rodriguez, Orthopaedic Surgery Department, Cruces University Hospital; Gorka Busto, Orthopaedic Surgery Department, Mendaro Hospital; Daniel Garay, Orthopaedic Surgery Department, Galdakao Hospital; Felix Silio, Orthopaedic Surgery Department Basurto University Hospital; Ziortza Trancho, U. Investigacio´n Hospital Universitario Basurto AIMS: Spanish data estimate that around 70–200 per 1000 adults suffer from shoulder pathologies, indicating a frequent health problem. However, up to date no Patient-reported Outcome (PRO), specifically designed for shoulder, has been constructed or validated for use in our setting. The objective of this study was the cultural adaptation and validation of the most appropriate questionnaire. METHODS: A systematic review was performed. In total 52 PRO instruments related to shoulder pathologies were identified. Eleven instruments fulfilling the inclusion criteria underwent a standardized evaluation implementing

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Qual Life Res (2014) 23:1–184 the EMPRO tool. The self-evaluation section of the American Shoulder and Elbow Surgeons questionnaire (ASES-p) resulted in having the best overall score (77.4 out of 100). ASES-p is an 11-item questionnaire: 10 items are scored on a 4-point Likert scale and 1 on a VAS. Total score ranges from 0 to 100 points. ASES-p was culturally adapted, pilot tested and subsequently used in our study. Recruited patients were [ 18 years and underwent surgery, infiltration or conservative treatment for their shoulder problem in 5 participating hospitals. The questionnaire along with a battery of other tools (Constant, Barthel, SF-36) was administered pre and 6 months post intervention. All subjects provided informed consent. Cronbach´s alpha, confirmatory factor analysis (CFA), convergent and divergent validity as well as reliability were tested. Known groups of: age, Constant and PCS of SF36 were studied. RESULTS: Preliminary data based on a subgroup of patients (n = 83) are presented. Mean (SD) age was 57(12) years; 46 % were females; 59 % suffered from rotator cuff tears and 24 % of shoulder tendinitis. Most patients consumed anti-inflammatory drugs (81 %) and underwent various physiotherapy sessions (76 %). Cronbach´s alpha for ASES-p was 0.94. Factor loadings in a one factor model were [0.50. Correlations with other scales Constant r = 0.61; PCS of SF36 r = 0.69; MCS of SF36 r = 0.21; Barthel r = 0.34. Furthermore, mean score comparisons were significant for the considered known groups (p \ 0.01). Finally test– retest data indicated an ICC = 0.75 with 95 % Bland and Altman´s Limits of Agreement oscillating between ± 29 points. CONCLUSIONS: The preliminary data indicate that the Spanish version of ASES-p is a valid tool for evaluating shoulder pathology problems.

(2019) Quality of life is not a predictor of Long- Term mortality in patients with low-energy hip fractures! Gudrun Rohde, PhD, University of Agder, Kristiansand, Norway; Andreas P. Diamantopoulos, Department of Rheumatology, Sorlandet Hospital; Glenn Haugeberg, Sorlandet Hospital, Kristiansand, Department of Rheumatology AIMS: Previous studies have identified quality of life (QOL) as a predictor of mortality. However, there is a lack of studies investigating QOL as a potential predictor of mortality in patients with hip fractures. We therefore aim to study QOL as a potential predictor of long-term mortality in patients with low-energy hip fractures. METHODS: Patients with a low-energy hip fractures were invited to a prospective QOL life study in Southern Norway in a two years period. Ninety-one patients (66 women and 25 men) with a mean age of 75 (9.7) years were included in the study. Patients in the study were younger and healthier compared to the excluded patients and the patients unwilling to be included. At inclusion the patients were asked to describe their situation and rate their QOL before the fracture occurred. Global quality of life (GQOL) was measured by Quality of Life Scale and health-related quality of life (HRQOL) by SF-36- including the eight domains and the physical component summary scores and mental component summary scores. Mortality was determined by matching the death data to those of the Norwegian census. No data on death causes was collected. Chi square, independent samples t tests and multiple logistic regression analyses were applied. RESULTS: Five years after inclusion in the QOL study 27 patients (14 women and 13 men) with low-energy hip fractures were dead and 64 (52 women and 12 men) were still alive. In the bivariate analysis, patients which were dead tend to be significantly older, 79 (9.8) years versus 73 (9.3) years, p = 0.017, more men than women, 52 % versus 21 %, p = 0.004 and report lower SF-36 physical function scores, 64 (30) versus 59 (22), p = 0.011. In the multivariate analyses mortality was not predicted by HRQOL or GQOL, however by old age (OR 0.91, 95 % CI 0.83–0.99, p = 0.029) and male gender (OR 4.43, 95 % CI 1.12–17.5, p = 0.029). CONCLUSIONS: GQOL and HRQOL before fracture could not predict long-term mortality in patients with low-energy hip fractures. Previously identified predictors

Qual Life Res (2014) 23:1–184 of mortality, old age male gender, were confirmed. Our results might be influenced by a relatively healthy population of patients with lowenergy hip fractures.

(2021) Gender based differences in experiences of patients receiving pain medications in carpal tunnel release Vanitha Arumugam, PT, MPT, University of Western Ontario, London, ON, Canada; Joy MacDermid, PhD, McMaster University, Hamilton, ON, Canada; Margaret Lomotam, McMaster University, Hamilton, ON, Canada; Kathyrn Corbett, McMaster University, Hamilton, ON, Canada AIMS: The purpose of this qualitative study is twofold: firstly, to identify gender differences in patient perceptions towards pain medications. Secondly, to describe the experience of receiving pain relief medications before and after carpal tunnel release surgery using a descriptive phenomenology approach. METHODS: Twenty participants who had undergone carpal tunnel release surgery (\1 year) were interviewed using a semi-structured questionnaire guide. Interviews were recorded, transcribed into text and a thematic analysis was used to qualitatively code the transcripts. RESULTS: This study has identified some of the gaps in patient-clinician communication in the prescription and use of pain medication. Women tend to take more pain medications than men. Analysis revealed these vital themes: 1) non-prescription pain medications are used to reduce pain and sensory disturbances prior to surgery, 2) patients prefer not to use pain medication unless necessary, 3) patients were often motivated by others to take pain medications, 4) the trust placed on surgeon was enormous, 5) post-operative instructions important in pain management, 6) lack of shared decision-making. CONCLUSIONS: Insights gained indicate there is a lot of need in educating the patients, the do’s and don’t s after the surgery. Difference in perceptions of male and female participants need to be explored further.

(2025) Racial Differences in Quality of Life in Patients with Gout Jasvinder A. Singh, MD MPH, University of Alabama at Birmingham, Birmingham, AL, United States; Puja Khanna, University of Michigan; Cleopatra Aquino-Beaton, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States; Jay E. Persselin, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States; Erin Duffy, University of California Los Angeles, Los Angeles, CA, United States; David Elashoff, University of California Los Angeles, Los Angeles, CA, United States; Dinesh Khanna, MD MS, University of Cincinnati, Cincinnati, OH, United States AIMS: Due to limited/no data for race/ethnicity, our objective was to assess whether HRQOL functional ability and health care utilization in gout patients differs by race/ethnicity. METHODS: This prospective cohort study included 186 veterans with gout (predominantly male) recruited at Veterans Affairs (VA) rheumatology and primary care clinics at the West Los Angeles, CA and Birmingham, AL facilities. We assessed HRQOL (with short-form 36 and the Gout Impact Scales (GIS) of the Gout Assessment Questionnaire (GAQ)); functional ability with Health assessment questionnaire-disability index (HAQ-DI); and health care utilization (patient self-reported University of California at San Diego (UCSD) Health Care Utilization Questionnaire) every 3 months for a 9-month period. Comparisons were made using the student’s t test or the Chi square, Wilcoxon rank sum test or Fisher exact test, as appropriate. RESULTS: Race/ethnicity data were available for 167 patients, 107 Caucasian and 60 African-American. The cohort mean age was 64.6 years, 98 % were men, 13 % Hispanic or Latino, 6 % did not graduate high school, 21 % had gouty tophi, the mean serum urate was

107 8.3.Compared to Caucasians, African-American gout patients were younger (61.1 vs. 67.3 years, p = 0.0003), had higher serum urate (9.6 vs. 7.9 mg/dl, p = 0.005), but similar patient (6.0 vs. 5.4, p = 0.27) and physician assessment (3.3 vs. 2.9, p = 0.53) of gout severity. HRQOL Differences: African American patients with gout had lower scores on SF-36 mental health, role emotional, social functioning domains and MCS (but not PCS) relative to White patients (p = 0.04 for all; Table 1). On the GIS, African American scored higher in the areas of gout concern overall, unmet treatment need, well-being during attacks, concern during attacks, and overall average GIS (Table 2), but not medication side effects. Functional limitation: Compared to Caucasians, African American had higher/worse HAQ scores overall and lower scores in 5 of the 8 activity domains of Dressing & Grooming, Arising, Eating, Walking, and Grip, indicating more difficulty with these tasks (Table 1). CONCLUSIONS: This is the first prospective cohort study to show that AfricanAmerican patients with gout have significantly worse emotional, social, and mental wellbeing/HRQOL and functional ability than Caucasians. Further research is needed into the determinants of this poorer HRQOL and function to target interventions to modifiable mediators of this relationship.

Table 1

SF-36 (higher score indicates better health) and HAQ scores (higher score indicates worse health) by race SF-36 T-score values

Mean (SD)

African American T test p value N = 60 Mean (SD)

37.3 (12.1)

34.1 (12.4)

0.12

Role limitation physical 37.5 (12.4) (RP)

33.8 (12.1)

0.06

Pain (BP)

42.6 (12.2)

39.6 (12.6)

0.13

General health (GH)

43.3 (5.1)

43.5 (4.9)

0.82

Emotional well-being (MH)

46.3 (12.6)

40.8 (12.9)

0.008

Role limitation Emotional (RE)

40.6 (16.0)

31.3 (17.0)

0.0005

Physical functioning (PF)

White N = 107

Social functioning (SF)

41.5 (12.3)

37.3 (12.8)

0.04

Energy fatigue (VT)

45.8 (11.3)

45.2 (8.4)

0.71

Physical health Component (PCS)

38.7 (10.4)

38.1 (10.0)

0.72

Mental health component (MCS)

46.2 (14.2)

39.5 (12.9)

0.003

HAQ

White N = 105

African American N = 60

Wilcoxon rank sum p value

Mean (SD) [Median (IQR)]

Mean (SD) [Median (IQR)]

Dressing and grooming

0.58 (0.74) [0.00 (1.00)]

0.87 (0.70) [1.00 (1.00)]

0.005

Arising

0.68 (0.69) [1.00 (1.00)]

0.98 (0.89) [1.00 (2.00)]

0.04

Eating

0.31 (0.67) [0.00 (0.00)]

0.52 (0.65) [1.00 (1.00)]

0.01

Walking

0.73 (0.81) [1.00 (1.00)]

1.10 (1.02) [1.00 (2.00)]

0.03

Hygiene

0.70 (0.89) [0.00 (1.00)]

0.80 (0.92) [1.00 (1.00)]

0.41

Reach

0.81 (0.82) [1.00 (1.00)]

0.82 (0.70) [1.00 (1.00)]

0.70

Grip

0.44 (0.72) [0.00 (1.00)]

0.95 (0.90) [1.00 (1.50)]

0.0001

Activities

1.10 (0.99) [1.00 (2.00)]

1.33 (1.13) [1.00 (2.00)]

0.23

HAQ composite score

0.67 (0.55) [0.63 (1.00)]

0.93 (0.68) [0.88 (1.13)]

0.02

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108 Nephrology/Urology (2027) A systematic review of Heath-Related quality of life and patient preferences in patients with urinary stone disease Zara Hekmati, Cardiff; Aditya Raja, University Hospital of Wales, Cardiff, United Kingdom; Hrishi Joshi, Cardiff University, Cardiff, United Kingdom; Sam Salek, BSc RPh PhD FFPM, Cardiff University, Cardiff, United Kingdom AIMS: To examine the evidence from all studies including an element of HRQOL measurement and patient treatment preference in patients with urinary stone disease. METHODS: Ovid MEDLINE(R) 1946 to present, Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, EMBASE 1947-Present, SCOPUS, EconLit and Web of Science 1900–2014 with no language restriction were searched. All study designs with adult participants were included. Two independent authors individually assessed the studies and extracted the data. Narrative data synthesis was performed. RESULTS: 9 abstracts and 31 full-text articles were assessed. 27 studies met the inclusion criteria (5 RCTs and 22 observational studies) from 12 countries, including 3833 patients. 11 studies showed that stone formers had worse HRQOL than the general population or controls and 1 study showed stone formers were more likely to suffer with depression. 2 studies showed this to be true for those without active stone disease. Domains of HRQOL affected by stone disease were general health, physical function, role limitations due to physical health problems, bodily pain, general health perception, social function, trouble ‘‘looking after the home’’, lower urinary tract symptoms and sleep disturbance. Women have significant lower HRQOL than men and this was seen in 6 studies. No studies showed better HRQOL scores in women. 20 studies used a generic (validated) HRQOL measure and 7 a disease-specific, none of which have been validated (one is in the process of validation). Studies with regard to patient preference were heterogeneous. CONCLUSIONS: There is a need to shift the paradigm of treatment outcome for urinary stone disease from achieving high SFR to a more patient-centric view. A well-constructed, validated, robust, disease-specific outcome measure is required for urinary stone disease.

Qual Life Res (2014) 23:1–184 sublingual bacterial vaccine. Study Groups: -GA: women treated with antibiotics (n = 495): subgroups GA1 (n = 417): non-smokers, GA2 (n = 78): smokers. -GB: women treated with vaccine (n = 360): subgroups GB1: non-smokers (n = 263), GB2: smokers (n = 97). Anamnesis, physical examination, diagnostic tests (urine analysis and culture, sonography; cystoscopy, urodynamics, voiding cystourethrogram/pyelography) were performed. Excluding factors: urinary incontinence = grade2, cystocele, urinary stones, neurogenic bladder. Variables: number of rUTI prior to treatment; control at 1, 3 and 12 months and yearly; answer to the SF-36 quality-of-life questionnaire at the first visit and controls, disease-free time (DFT), microbial species, sensitivity and resistance(R). RESULTS: Median age 56.51 years (17–85), similar in both groups (p = 0.2141). No differences in the number of previous rUTI (p = 0.1329) nor in the distribution of microbial species (p = 0.7471). DFT was greater in B subgroups (vaccine) than in A(antibiotics). Urine cultures in GA1: Ecoli 62.71 %, with 8.10 % R (33 % towards quinolones, 33 % cotrimoxazol, 33 % quinolones ? cotrimoxazol); in GA2: Ecoli 72.72 %, with 75 % R (16.66 % quinolones, 33.33 % quinolones ? cotrimoxazol, 16.66 % amox-clavulanic, 16.66 % quinolones ? cotrimoxazol ? amox-clavulanic, 16.66 % erythromycin ? fosfomycin ? clindamycin). More resistant strains in GA2 (p = 0.0133). No differences between patients treated with cotrimoxazole and nitrofurantoin in GA1 and GA2 (p = 0.8724). Urine cultures in GB1: Ecoli 63.01 %, with 28.26 % R (38.45 % quinolones, 15.38 % cotrimoxazole, 38.45 % quinolones ? cotrimoxazole, 7.69 % amox-clavulanic). In GB2 Ecoli 70 %, with 61.90 % R (30.76 %quinolones, 30.76 % cotrimoxazole, 30.76 % quinolones ? cotrimoxazole, 17.69 %amox). There are more resistant Ecoli in GB2 (p = 0.0144). The same resistance tendency was found in the other bacteria cultivated. With SF-36 QOL questionnaire, a significant improvement of the QOL related with rUTI in the 3–39 months after the bacterial vaccine treatment was found (p = 0.0049), but this benefit disappeared after the control at month 45 (p = 0.4002) (Graph 1). CONCLUSIONS: Smoker women with rUTI are more likely to have resistant bacteria, which could lead into a worse response to any preventive treatment (antibiotics or vaccine). Women who followed a preventive treatment based on bacterial vaccine have better results on QOL questionnaires.

(2029) Influence of smoking in the bacterial resistance and the quality of life of women treated because of recurrent urinary infections Ba´rbara Padilla-Ferna´ndez, University Hospital of the Canary Islands ´ lvaro Julio Virseda(Tenerife), Santa Cruz de Tenerife, Spain; A Rodrı´guez, Urology Department of the University Hospital of Salamanca, Salamanca, Spain; Maria Tatiana Santos-Antunes, Surgery Department of the University of Salamanca, Salamanca, Spain; Marı´a Begon˜a Garcı´a-Cenador, Surgery Department of the University of Salamanca, Salamanca, Spain; Jose´ Antonio Miro´nCanelo, Department of Preventive Medicine of the University of Salamanca; Marı´a Fernanda Lorenzo-Go´mez, Surgery Department of the University of Salamanca, Salamanca, Spain; Ba´rbara PadillaFerna´ndez, University Hospital of the Canary Islands (Tenerife), Santa Cruz de Tenerife, Spain AIMS: To investigate the influence of tobacco in the response to the preventive treatment of recurrent urinary tract infections (rUTI) with antibiotics or bacterial vaccines, with special attention to the bacterial spectrum and the detection of resistant strains. METHODS: Retrospective multicentre study of 855women with rUTI treated between Sept-2009 and Dec-2013 with suppressive antibiotics standard [cotrimoxazole (80 %) or nitrofurantoin (20 %) 6 months] or Uromune

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160 140 120 100 80 60

Group A Group A1

40

Group A2

20

Group B

0

Graph 1 Results of the SF-36 QOL questionnaire in GA, GA1, GA2 and GB

Qual Life Res (2014) 23:1–184 (2031) Lived experience of patients receiving hemodialysis treatment for end stage renal disease: a qualitative study Chantira Chiaranai, RN, PhD, Institute of Nursing, Suranaree University of Technology, Muang, Nakhonratchasima, Thailand AIMS: This study aimed to gain a better understanding of what it is like for Thai patients with End Stage Renal Disease to live on hemodialysis. METHODS: Phenomenology was chosen as the method for this study. Using a semi-structured interview guide, Thai men and women with End Stage Renal Disease undergoing hemodialysis were purposively recruited from a hemodialysis unit at one hospital in Thailand. Inclusion criteria included: 1) patients with End Stage Renal Disease receiving hemodialysis for treatment; 2) all were Thaispeaking; and 3) over 18 years of age. Participants were asked to describe their problems, feelings, thoughts, attitudes, and how they experienced their lives. Data were analyzed using thematic analysis. RESULTS: Data reached the saturation after 26 interviews. The following themes emerged from the data: 1) facing the limitations of life, 2) living with uncertainty, and 3) dependence upon medical technology. CONCLUSIONS: The findings may increase understanding of healthcare providers about what patients with End Stage Renal Disease experience when they are on hemodialysis treatment.

Rehabilitation (2033) Measuring Patient-Specific complaints in physiotherapy goal setting. what are the patients experiences? Anita Stevens, Zuyd University of Applied Science, Heerlen, Netherlands; Anita Stevens, Zuyd University of Applied Science, Heerlen, Netherlands; Anna Beurskens, PhD, Zuyd University of Applied Sciences, Heerlen, Netherlands; Albere Ko¨ke, Zuyd University of Applied Sciences, Heerlen, Netherlands; Albine Moser, Zuyd University of Applied Sciences, Heerlen, Netherlands; Trudy van der Weijden, Maastricht University, Netherlands AIMS: The Patient Specific Complaints (PSC) instrument facilitates patient participation in effective identification of their individual problems. However, the use of the PSC in daily practice does not seem optimal and patients are not always aware of their potential role. More information about the feasibility of the PSC through the patients’ eyes, is warranted. The aim of this study is to explore the patients’ experiences with the feasibility of the PSC in daily physiotherapy practice. METHODS: An explorative qualitative study with observation of physiotherapy consultations and semi structured interviews with patients with a chronic condition. Field notes were taken during the observations. Data were fully transcribed and analyzed with directed content analysis. RESULTS: We observed 19 different physiotherapists applying the PSC among 23 patients. The PSC was applied in various ways, regarding the use of the activity list, integration in the history taking or administered as a separate instrument, besides a more or less active role of the patients. Stepwise analysis revealed two main themes of feasibility: the process of administration and the perceived usefulness for the patients. Patients had difficulties to identify problem activities when pain was dominant and to score their burden when their performance fluctuated. They regarded the PSC useful for their awareness, motivation and the upcoming therapy. The non-awareness of some patients about the PSC purpose or its relation with the therapy, was striking. The results varied according to different patients’ characteristics such as their attitude towards physiotherapy and questionnaires, role preferences and health literacy. CONCLUSIONS: Overall, the PSC was approved for its individual focus. Informing the patients about the purpose of the PSC and their potential role in therapy is of great importance. Using the PSC in a more conscious way in daily practice may contribute to effective patient participation in client-centred care.

109 (2035) Effect ofExercise on Cycle Ergometer and conventional exercises in the quality of life of elderly patients with total hip arthroplasty Mariana Ka´tia Rampazo-Lacativa, State University of Campinas; Maria Jose D’Elboux, PhD D’Elboux, Unicamp State University of Campinas, Campinas, Brazil; Maria Jose D’Elboux, PhD D’Elboux, Unicamp State University of Campinas, Campinas, Brazil AIMS: To evaluate the effect of the exercise on cycle ergometer associated with conventional exercises on health-related quality of life (HRQOL) in the elderly patients after total hip arthroplasty (THA). METHODS: A preliminary parallel randomized clinical trial. Patients (n = 15) with 60 years and older in the postoperative phase after primary unilateral THA, for hip osteoarthritis, were consecutively recruited and randomly allocated to two treatment groups. Group 1 (n = 8) performed the exercise on cycle ergometer combined with conventional exercises and group 2 (n = 7) received only conventional exercises program. The sessions were performed twice a week for 8-weeks. The HRQOL was evaluated by specific instrument for hip and knee osteoarthritis: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and generic: The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Assessments were made at baseline (2 weeks postoperatively), after intervention (10 weeks postoperatively) and, at 6 months of followup (24 weeks postoperatively). Data collectors were blinded and were not had contact with participants during the interventions. The study followed Consolidated Standards of Reporting Trials (CONSORT) guidelines. RESULTS: The baseline characteristics of the two groups were similar. Both groups improved after the surgery and interventions; however all of the outcome measures were superior in the cycle ergometer group after intervention. The physical activity dimension as measured with of WOMAC was significantly better in Group 1, who performed the cycle ergometer, at 10 weeks postoperative (13.7 compared with 25.9, p = 0.015) and at 6 months of follow-up (9.7 compared with 11.3, p = 0.029) in relation to elderly that performed conventional exercises only. There were no significant differences between the groups in respect to pain and stiffness evaluated by WOMAC and in the dimensions the SF-36. CONCLUSIONS: This preliminary study showed that the exercise on cycle ergometer associated with conventional exercises program may be more effective in the recovery of function of the elderly after THA than the conventional exercises program only. Studies with larger samples are needed to assess the impact of this rehabilitation strategy after THA in the HRQOL of these elderly. (Trial Registration: NCT01622465) (Table 1).

Table 1 Measure

Health-related quality of life results: secondary outcomes measurements (WOMAC e SF-36) for the Group 1 and the Group 2

Group 1

T1

Group 2

T2

T3

T1

ANOVA main effects

T2

T3

WOMAC Pain 17.50 ± 7.56

6.88 ± 7.53

1.25 ± 2.31

21.43 ± 6.90

7.86 ± 8.59

Pw \ 0.001

Pg = 0.325

Pi = 0.880

Pw = 0.065

Pg = 0.652

Pi = 0.774

Pw \ 0.001

Pg = 0.029

Pi = 0.010

Pw \ 0.001

Pg = 0.722

Pi = 0.138

2.86 ± 2.67

Stiffness 6.25 ± 6.68

1.56 ± 4.42

4.69 ± 9.30

12.50 ± 17.68

3.57 ± 6.10

3.57 ± 6.10

33.01 ± 16.96

13.97 ± 5.88a

9.74 ± 2.60b

38.19 ± 12.74

25.95 ± 10.19

11.33 ± 6.26b

27.50 ± 9.64

60.00 ± 15.12

65.63 ± 13.21

23.57 ± 10.29

50.00 ± 25.66

72.14 ± 16.55

15.63 ± 18.60

59.38 ± 26.52

70.00 ± 9.26

17.86 ± 18.90

42.86 ± 27.82

61.43 ± 24.10

Physical Activity

SF-36 Functional capacity Physical aspects

Pain

General health status

46.63 ± 12.75

74.31 ± 17.71

83.88 ± 17.88

43.00 ± 14.39

61.14 ± 22.91

68.86 ± 26.80

78.38 ± 17.27

79.00 ± 14.6

81.63 ± 15.31

73.14 ± 13.69

71.57 ± 16.68

78.00 ± 11.06

Pw \ 0.001

Pg = 0.309

Pi = 0.184

Pw \ 0.001

Pg = 0.202

Pi = 0.458

Pw = 0.155

Pg = 0.494

Pi = 0.240

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110

Qual Life Res (2014) 23:1–184 (2039) Predictors of Quality of Life of People with Chronic Wounds

Table 1 continued Measure

Group 1

Group 2

ANOVA main effects

T1

T2

T3

T1

T2

T3

65.63 ± 18.79

81.88 ± 11.00

82.50 ± 3.78

51.43 ± 17.01

72.86 ± 10.75

72.86 ± 17.29

Vitality

Social aspects 40.63 ± 22.90

73.44 ± 22.60

89.06 ± 10.43

46.43 ± 17.25

69.64 ± 23.78

82.14 ± 20.23

70.82 ± 37.54

87.49 ± 24.81

95.83 ± 11.79

47.61 ± 46.57

80.94 ± 26.23

85.71 ± 17.82

Emotional aspects

Mental health 69.50 ± 13.85

84.50 ± 10.13

84.75 ± 11.90

65.71 ± 17.41

83.71 ± 13.49

Pw \ 0.001

Pg = 0.070

Pi = 0.916

Pw \ 0.001

Pg = 0.621

Pi = 0.640

Pw = 0.002

Pg = 0.321

Pi = 0.860

Pw = 0.001

Pg = 0.530

Pi = 0.910

80.29 ± 12.24

Values are mean ± SD for each variable. ANOVA analysis of variance, T1 test before intervention (2-weeks postoperative), T2 test after intervention (10-weeks postoperative), T3 test follow-up (24-weeks postoperative). Pw Pg e Pi = probability for difference within and between groups and for interaction, respectively a

Differences between the groups at T2 (Tukey test), p = 0.005

b

Differences within groups (contrast test): T1 = T2, T1 = T3, T2 = T3

(2037) Randomized controlled clinical trial on telephone followup in rehabilitation of burn patients: impact on health status Nata´lia Gonc¸alves, University of Sa˜o Paulo; Rosana Spadoti Dantas, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil; Ma´rcia A. Ciol, School of Medicine, University of Washington, Seattle, WA, United States; Jayme A. Farina-Junior, University of Sa˜o Paulo; Noelle O. Freitas, Ribeira˜o Preto College of Nursing University of Sa˜o Paulo; Marina Caltran, Ribeira˜o Preto College of Nursing University of Sa˜o Paulo; Lidia A. Rossi, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil AIMS: To test an educational program with telephone follow-up to improve self-care in Brazilian burn victims METHODS: Burn patients admitted at a Burn Unit in a Brazilian hospital between January, 2011 and October, 2012, and who were over 18 years of age, able to perform self-care after discharge, and had access to a telephone were included in the study. At hospital discharge, participants were randomized to either an intervention or a control group. The intervention group received an educational program tailored to the individuals according to their needs regarding burn care, followed by three telephone calls during six months. The control group received the routine recommendations at discharge. We performed a block randomization stratified by total body surface area burned (\20 % vs. = 20 %). The primary outcome measure was perceived heath status, assessed by the Burns Specific Health Scale-Revised (BSHS-R). Secondary outcomes were symptoms of anxiety and depression, and impact of event, measured by the Anxiety and Depression Hospital Scale (HADS) and Impact of Event Scale (IES), respectively. RESULTS: Among the 104 participants, 89 completed the interview at 6-month follow-up (intervention n = 43, control n = 46). The total score of the BSHS-R at 6-month follow-up was not statistically different between the two groups (t-test, p = 0.52). Scores were highest for treatment regimens, affect and body image, and skin sensitivity. Symptoms of anxiety were statistically lower for the intervention group (p = 0.03), while symptoms of depression were not (p = 0.48). IES total score was statistically higher (more stress) for the control group (p = 0.02), though the difference was probably due to intrusive thoughts (p = 0.002) instead of avoidance (p = 0.18). Although some of the outcomes were not statistically different, after the end of the intervention period, all outcomes tended to diverge at 6-month follow-up with the intervention group having better results than the control group. CONCLUSIONS: The educational program for improvement of self-care of burn victims seems to improve symptoms of anxiety and impact of the event immediately after the intervention. Although not statistically significant, perceived health status and symptoms of depression were also improved. Future studies should continue to develop this simple and inexpensive intervention. This study was sponsored by FAPESP (2010/10006-8) and CNPq

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Alciclea Dos Santos Oliveira, MS, Beneficencia Portuguesa Hospital/ Sa˜o Paulo, Sa˜o Paulo, Brazil; Vera Lucia CG Santos, PhD, University of Sa˜o Paulo, Sa˜o Paulo, Brazil; Ana Fla´via Santos Amaral, Hollister; Jaqueline Betteloni, Hospital Universita´rio Da Universidade de Sa˜o Paulo; Erika Tihemi Nishi, Universidade de Sa˜o Paulo, Sa˜o Paulo, Brazil; See Hee Park Kim, Coloplast AIMS: Introduction: Quality of life (QOL) has been evaluated in patients with chronic wounds due to their negative impacts in several dimensions affected by different factors. Aims: Evaluate the QOL and associated predictive factors of outpatients with chronic wounds. METHODS: Methods: prospective, quantitative and secondary study of Ferrrans & Powers Quality of Life Index-Wound Version (FPQLIWV) responsiveness study developed by Oliveira and Santos.3 The sample was composed by 27 patients, mostly venous (48.2 %) and diabetic (29.6 %) ulcers, in two specialized outpatient services, in two Brazilian cities. The patients were interviewed at two moments: baseline and after 60 days. Instruments: demographic and clinical data, FPQLI-WV, Numerical Pain Scale and Global Change Assessment Scale. The data were analyzed through Mann–Whitney test, Spearman correlation and linear regression. RESULTS: Results: The average scores of Total QOL in baseline were 21.4, and 24.5 after 60 days. Significant improvements (p \ 0.001) were observed in the outpatients after 60 days comparing to their baseline: Total QOL (Effect Size = 0.89), Health Functioning domain (Effect Size = 1.01) and Socio-Economic domain (Effect Size = 0.66). Pain was associated as a significant predictor of QOL, and a reduction of 1 unit of the worst pain over the week increased 0.21 Total QoL score. Pain was associated with health/functioning and psychological/spiritual domains as well. CONCLUSIONS: Conclusion: Total and Physical QOL improved after 60 days in patients attended at a specialized outpatient care. Pain negatively impacts on QOL.1,4 This study contributes for a better understanding of the main predictive factors related to changes in QOL of people with chronic wounds under specialized care.

Quality of Care/Patient Satisfaction (2041) Validating the Spanish Version of the Nursing Homes Survey on Patient Safety Kalliopi Vrotsou, MSc, Research Unit, AP-Osi Gipuzkoa, Osakidetza, Donostia-San Sebastian, Spain; Mo´nica Macho´n, Research Unit APOSI of Gipuzkoa, Osakidetza; Carmen Silvestre, Quality Unit, Osakidetza, Donostia-San Sebastian; Pastora Pe´rez, Sanitary Quality Agency of Andalucia; Gorka Alias, Matia Fundazioa—Matia Gerontologic Institute, Donostia-San Sebastian; Enrique Peiro, Health Programs and Patient Safety, Sanitary Assistance, Osakidetza; Lena Ferru´s, Consorci Sanitary Integral; Naroa Amiama, Matia Fundazioa—Matia Gerontologic Institute, Donostia-San Sebastian; Ine´s Gamio, Matia Fundazioa—Matia Gerontologic Institute, Donostia-San Sebastian; Itziar Vergara, Research Unit AP-OSI of Gipuzkoa, Osakidetza AIMS: Nursing home residents are usually older people with functional, cognitive or other impairment, requiring special attention. However, research on safety culture is limited in this context. In response to this need, the Agency for Health Care Research and Quality developed in 2008 the Nursing Home Survey on Patient Safety Culture (NHSOPS). Our objective was the cultural adaption and validation of NHSOPS into Spanish. METHODS: The NHSOPS consists of 42 items in 4 sections: A. Working in this nursing home; B. Communications; C. Your supervisor; D: Your nursing home and 2

Qual Life Res (2014) 23:1–184 overall rating questions. The questionnaire was culturally adapted following translation, back translation and a pilot study. Basque Country´s (Spain) nursing homes with [ 15 beds were invited to participate. Professionals working \ 1 year in their centres were excluded. The questionnaire could be filled in on paper or an online application. Ethics committee approval was obtained. Correlations among items, Chronbach´s alpha, confirmatory factor analysis and test–retest reliability were studied. RESULTS: So far 27 of 252 centres accepted participation and 218 subjects have participated. Most participants were females (84 %) with a mean age of 42 (SD = 10.6) years. The majority had vocational training (44 %); followed by university education (41 %). Geriatric nursing assistants was the most frequent job profile (38 %) and 71 % of the professionals spend [ 50 % of its working hours with the residents. Overall, participants worked between 1 and 39 years in the current centre. Certain items of section A presented low correlations with the rest of the items (\0.30); correlations were adequate between items of the other sections ([0.40). Chronbach´s alpha were: 0.74; 0.83; 0.90 and 0.89 for each section respectively. A 4-factor confirmatory analysis model suggested that most items load with their assigned factor, with the exception of some section A items. Test–retest with available data suggests good agreement between consecutive applications, but lack of a sum score (total or per section) renders reliability difficult to evaluate. CONCLUSIONS: Overall, preliminary data suggest that the Spanish version of NHSOPS is valid, though some items do not seem to load with their respective factor. Lack of a total score might be a limitation of NHSOPS.

(2043) Development and psychometric testing of a barriers to HIV testing scale in a swedish context Lars E. Eriksson, PhD, Karolinska Institutet, Huddinge, Sweden; Maria Wiklander, PhD, Karolinska Institutet, Huddinge, Sweden; Johanna Bra¨nnstro¨m, Karolinska Institutet; Veronica SvedhemJohansson, Karolinska Institutet AIMS: The aims of the study were to further develop and test an extended barriers to HIV testing scale in a Swedish context. METHODS: An 18-item scale was developed, based on twelve adapted items from an existing barriers to HIV testing scale (Awad et al. 2004) and six new items. The scale by Awad et al. (2004) was evaluated and translated into Swedish by a panel of bilingual HIV experts. Six new items were added, based on the literature and clinical experiences from the Swedish setting, to expand on different feared personal and psychosocial consequences of being diagnosed with HIV. The items are phrased as statements that the respondents are instructed to rate on a three-point Likert scale (not important, somewhat important, and very important). The scale’s psychometric properties was investigated by asking a sample of adults who had recently been diagnosed with HIV infection to answer the 18 item scale. The scale was evaluated regarding missing values, floor and ceiling effects, exploratory factor analysis and internal consistencies. RESULTS: Two-hundred and ninety-two individuals (18–70 years; 39 % females; 63 % heterosexual transmission route) responded to the instrument, of which 285 had completed more than half of the items and were included in the present analysis. All items had less than 3 % missing values. All scales had large floor effects. The data was feasible for factor analysis (KMO 0.92) and a four-factor solution was chosen, based on level of explained common variance (59 %) and interpretability of factor structure; personal consequences, structural barriers, social and economic security and confidentiality. The scales were internally consistent (Cronbach’s ? 0.78–0.91). CONCLUSIONS: The developed barriers to HIV testing scale appears to be a feasible, reliable and valid instrument to systematically identify different types of barriers to HIV testing. Since it is estimated that one-third of people living with HIV in Europe are unaware of their infection and as many as

111 50 % are diagnosed late, systematic assessment of barriers to HIV testing could be an important base for forming interventions aiming at earlier diagnosis of HIV.

(2045) Self-reporting hand-foot syndrome (HFS) is practical in cancer patients with chemotherapy-induced dermatological toxicity Tatiana I. Ionova, Multinational Center for Quality of Life Research, St. Petersburg, Russian Federation; Denis A. Fedorenko, PhD, National Medical Surgical Center, Moscow, Russia; Tatiana Nikitina, PhD, Multinational Ctr for QOL Research, Saint Petersburg, Russia; Kira Kurbatova, Multinational Center for Quality of Life Research, Saint-Petersburg, Russian Federation AIMS: Chemotherapy (CT) side effects related to skin, especially Hand and Foot Syndrome (HFS), are frequent during treatment of patients with solid tumors and have a negative impact on quality of life (QOL). To enhance quality of supportive care in this patient population self-reporting of HFS is helpful. We aimed to assess practicability of the new instrument—Comprehensive Symptom Profile in patients with HFS (CSP-HFS) for effective control of CTinduced dermatological toxicity. METHODS: 53 cancer patients (renal, colorectal and breast cancer) receiving CT including capecitabine or target therapy were enrolled in the study: mean age 62.1 ± 10.3; male/female—21/32. All the patients experienced HFS, II-IV WHO grades and received supportive treatment of HFS using best available therapy (BAT, n = 23) or new antioxidant-containing ointment Mapisal (n = 30). The patients filled out the CSP-HFS before and 2 months after the start of supportive treatment. CSP-HFS consists of 14 numerical rating scales, scored from 0 (no symptom) to 10 (most expressed symptom). To show practicability of the CSPHFS its validity, reliability and sensitivity were assessed. Statistical analysis was made using general liner model with adjustment for age and gender. RESULTS: All the patients acknowledged the comprehensiveness of the tool. Three clinically meaningful symptom domains (inflammation, desquamation and erosion) have been extracted by factor analysis explaining 69 % of the variability. HFS severity scores differed in patients with II and III-IV HFS grades demonstrating good known-groups validity (total score—3.56 vs 5.64, p \ 0.001). Reliability has been proven by acceptable internal consistency: coefficient Cronbach a = 0.79–0.88. Responsiveness of the tool was shown by comparison of symptom severity changes in the groups with HFS improvement and worsening: symptom severity scores reduced in patients with HFS improvement and increased in patients with HFS worsening (p \ 0.05). In the group with HFS improvement the vast majority of HFS symptoms reduced (ES = 0.29–1.03); the improvement was twice pronounced in patients on Mapisal versus in patients on BAT (? 1.68 vs 0.8; p \ 0.05). CONCLUSIONS: The CSP-HFS is a practical tool to enhance control of CT-induced dermatological toxicity in cancer patients. Benefits of new antioxidant-containing ointment Mapisal to control HFS from patient’s perspective have been shown.

Caregivers (2049) Quality of life among parents of adult patients with congenital heart disease Misa Takegami, RN, PhD, MPH, National Cerebral and Cardiovascular Center, Suita, Japan; Kenji Yasuda, Shimane University, Izumo, Japan; Hideo Ohuchi, National Cerebral and Cardiovascular Center, Osaka, Japan; Jun Negishi, National Cerebral and Cardiovascular Center, Osaka, Japan; Kanae Noritake, National Cerebral and Cardiovascular Center, Osaka, Japan; Aya Miyazaki,

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112 National Cerebral and Cardiovascular Center, Osaka, Japan; Osamu Yamada, National Cerebral and Cardiovascular Center, Osaka, Japan; Yoshihiro Miyamoto, National Cerebral and Cardiovascular Center, Osaka, Japan; Isao Shiraishi, National Cerebral and Cardiovascular Center, Osaka, Japan AIMS: The quality of life of parents whose children have congenital heart disease has become increasingly important as survival rates have increased. This study aims to describe the health-related quality of life (HRQOL) of parents whose adult children are suffering from congenital heart disease and to identify determinants of their HRQOL. METHODS: The study design was cross-sectional, and data were collected consecutively. We performed a questionnaire survey consisting of the 36-item Short-Form Health Survey (SF-36), which was scored using the physical component summary (PCS), mental component summary (MCS), and role component summary (RCS), based on the three-component model of SF-36 scores. Multivariable linear regression models were used to examine the impact of disease severity as defined by the New York Heart Association functional class on the HRQOL of the parents, and to analyze the difference in parents’ HRQOL scores stratified by the HRQOL scores of adult patients with congenital heart disease. RESULTS: The cross-sectional analysis included 157 adult patients with congenital heart disease (41.4 % male, mean age = 28.2) and their primary caregivers (14.9 % male, mean age = 57.5). SF-36 summary scores were not significantly lower in adult patients with congenital heart disease than in the general population except for PCS scores. On the other hand, MCS and RCS scores in parents of adult patients with congenital heart disease were significantly lower than in the general population. The multivariate analyses revealed, however, that HRQOL in adult patients with congenital heart disease was more important in explaining the reduced RCS in the parents than parental gender and disease severity (p for trend, p = 0.002). CONCLUSIONS: HRQOL in parents of adult patients with congenital heart disease was significantly impaired and independently associated with HRQOL in their children. Social support and psychological interventions should be focused on parents of adult patients with congenital heart disease for HRQOL of the patients and their parents.

Qual Life Res (2014) 23:1–184 group validity was assessed by comparing scores between patients who were treated with subcutaneous (sc) chelation and those with oral chelation using t-test (hypothesis: sc significantly lower than oral). Internal consistency was assessed using Cronbach’s alpha and test– retest reliability by random effects intra-class correlation coefficient (ICC). RESULTS: Seventy-one children with thalassemia major were enrolled at five thalassemia treatment centres. The mean age was 11.2 years (range 2–18) and 49 % were male. Sixty-eight parents completed both questionnaires at baseline. There was substantial correlation (r = 0.75) between TranQol scores (mean score 64.5 SD 13.3) and PedsQL Family Impact Module scores (73.6 SD 18.6) (see Graph 1). The mean PedsQL score was identical to previously reported scores for parents of children with severe sickle cell disease (73.6). We were not able to detect a difference in scores between patients requiring sc chelation and oral chelation on either measure. Internal consistency of the TranQol was excellent (0.94). On repeat administration, 40 parents rated the child’s QOL as being the same and the test–retest reliability for these patients was acceptable (ICC = 0.81) (see Graph 1). There were no noted ceiling or floor effects. CONCLUSIONS: The burden of care for parents with thalassemia major is similar to that of severe sickle cell disease. The TranQol parental burden tool demonstrated construct validity, was internally reliable and had acceptable test–retest reliability. This tool can be used in future studies of children with thalassemia major to assess the impact of the disease on parents.

(2051) Validation of the TranQoL Parental Burden Measure: a New Tool for Parents of Children with Thalassemia Major Robert Klaassen, MD, Children’s Hospital of Eastern Ontario, Ottawa, ON, Canada; Nicholas Barrowman, Children’s Hospital of Eastern Ontario Research Institute; Manuela Merelles-Pulcini, Hospital for Sick Children, Toronto, ON, Canada; Elliott P. Vichinsky, Children’s Hospital Oakland Research Institute; Melanie Kirby-Allen, Hospital for Sick Children, Toronto, ON, Canada; Ellis Neufeld, Boston Children’s Hospital, Boston, MA, United States; Janet Kwiatkowski, Children’s Hospital of Philadelphia, Philadelphia, PA, United States; John Wu, British Columbia Children’s Hospital; Victor Blanchette, Hospital for Sick Children, Toronto, ON, Canada; Nancy L. Young, PhD, Laurentian University, Sudbury, ON, Canada AIMS: Thalassemia Major is a life-threatening disease that requires monthly blood transfusions and expensive iron chelation therapy for long-term survival. Parents of children with this disorder are affected as well but this has not previously been well described. This study was designed to validate a disease-specific tool called the Transfusion-Dependent Quality of Life questionnaire (TranQol) that includes a 38 item parent-burden version. METHODS: Questionnaires were administered to parents during routine clinic visits as part of a multicentre North American study specifically designed to validate the TranQol. Note that higher scores indicate lower burden. Construct validity was assessed using Pearson’s correlation with the PedsQL Family Impact Module (hypothesis: correlation of 0.4–0.6). Known

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Fig. 1 .

Qual Life Res (2014) 23:1–184 (2053) The Quality of Life of Family caregivers of cancer patients: a comparison between caregivers of patients in ambulatory and home hospice care settings in singapore Haikel A. Lim, BSocSci(Hons), National University of Singapore, Singapore, Singapore; Konstadina Griva, National University of Singapore; Mabel Q. H. Leow, National University of Singapore; Moon Fai Chan, National University of Singapore; Sally W. C. Chan, National University of Singapore; Rathi Mahendran, National University of Singapore AIMS: Home hospice services have been shown to benefit patients with cancer but family caregivers’ outcomes have not been explored in detail. Previous work indicates that disease progression and general hospice care is associated with diminishing quality of life (QOL) for caregivers, who may be better off in ambulatory care settings, but these have been limited to US settings with no control/adjustment for the stage of cancer. This study set out to compare the QOL between caregivers of advancedstage mixed-cancer patients receiving care in home hospices and caregivers of those on outpatient treatment. METHODS: Data was pooled from two studies conducted between 2011 and 2013 on 258 caregivers of advanced-stage cancer patients. The sample included 182 caregivers of patients receiving care in four home hospice organizations (70 % female; Mdn Age = 41–50 years, 60 % caring for a parent; stage IV cancers), and 76 caregivers of cancer patients receiving treatment at a national cancer centre (59 % female; Mdn Age = 41–50 years, 47 % caring for a parent; stage III/IV cancers). All participants had filled in either the English or Mandarin versions of the Caregiver Quality of Life Index—Cancer (CQOLC) and a basic sociodemographic form. RESULTS: Independent sample t tests revealed that caregivers of home hospice patients had significantly higher CQOLC total and subscale scores as compared to those whose patients were receiving outpatient treatment, ts(256) = -2.30 to -3.69, all ps \ 0.02. Sensitivity analyses controlling for stage of cancer and other significant case-mix differences (i.e., gender) replicated the QOL advantage for these caregivers of home hospice patients, F(1,255) = 8.13, p = 0.005. CONCLUSIONS: Study findings indicate QOL advantage for caregivers of patients in hospice care relative to caregivers of patients treated in tertiary care, contrary to work conducted in the US. This expands the previously documented patient benefits of home hospice services to caregivers alike, therefore supporting the expansion of such hospice-care schemes in Singapore and perhaps even elsewhere. More work is required to unravel the reasons for these effects, with issues related to costs of care and/or sociocultural norms around caregiving obligations and filial piety being particularly pertinent.

(2055) The Cultural Dimension of Quality of Life and Religious Experiences of Hispanic Family Caregivers of Patients with Advanced Cancer Gloria Juarez, PhD, RN, MSN, City of Hope, Duarte, CA, United States; Joan J. Branin, PhD, University of La Verne, La Verne, CA, United States AIMS: Although Hispanics are the fastest growing ethnic group in the US and cancer the second leading cause of death among Hispanics, few studies have documented the influence of cancer diagnosis on the quality of life and caregiving experiences of Hispanic family caregivers. The influence of culture has been seen by healthcare and community-based providers as important in the development and delivery of culturally congruent care and support services for cancer patients and their caregivers. The aim of this study was to examine the influence of the cultural values and beliefs on the caregiver role, caregiving experiences, and perceptions of QOL of Hispanic family caregivers of adults with advanced cancer. METHODS: This qualitative descriptive study was conducted in the ambulatory care setting of an NCI-Comprehensive cancer care center in the United States.

113 Twenty Hispanic family caregivers of patients with advanced cancer participated in qualitative interviews. Thematic analysis of the interviews and the conceptual model of Quality of Life Well-being developed by Ferrell, Wisdom, and Wenzel (1989) were used to characterize the caregiving experience and the effects of caregiving on QOL of Hispanic cancer family caregivers. RESULTS: In general, the caregiving experience and the meaning of QOL of these caregivers was centered on spiritual or religious beliefs and practices, concern for providing quality home care, inclusion of extended family support, and desire to fulfill cultural role and responsibility expectations. Overall, Hispanic caregivers emphasized that their caregiving experience had more positive than negative outcomes. The caregiver’s QOL was primarily affected by the patient’s advanced disease, the consequences of the cancer treatment and related side effects, and the patient’s emotional/psychological needs. Secondarily, the caregiver’s overall perception of quality of life was affected by their physical, social, emotional and spiritual needs. CONCLUSIONS: These findings provide insight into the cultural and religious dimensions inherent in the family caregiving experience and perceptions of QOL of Hispanic family caregivers. It is imperative to recognize the influence of culture on the overall QOL and caregiving experiences of Hispanic family caregivers in developing culturally relevant interventions to reduce the burden of cancer family caregiving and improve overall caregiver QOL.

(2057) Quality of life of informal caregivers of patients in the terminal stage of cancer at home in Brazil Maria Alves Barbosa, PhD, Nursing Faculty of Federal University of Goias, Goiaˆnia, Brazil; Antoˆnio Gomes Teles, Federal University of Goias, Goiaˆnia, Brazil; Marine´sia Aparecida Prado, Federal University of Goias, Goiaˆnia, Brazil; Isabela C F Fernandes, Federal University of Goias, Goiaˆnia, Brazil; Neuma Chaveiro, Federal University of Goias, Goiaˆnia, Brazil; Cla´udia Zanini, Federal University of Goias, Goiaˆnia, Brazil; Virginia V. Brasil, PhD, Nursing Faculty of the Federal University of Goias, Goiaˆnia, Brazil; Lizete M a C Oliveira, PhD, Federal University of Goia´s, Goiaˆnia, Brazil AIMS: The aim of the study was to evaluate the quality of life of informal caregivers of patients with terminal cancer at home, assisted by the Support Group Palliative Oncological Patient Brazil. METHODS: WHOQOL-BREF Portuguese version was used. Statistical analysis was performed using SPSS for Windows version 16.0 program. For the sociodemographic profile in relation to the domains of the WHOQOL-BREF used the Student t test, ANOVA and Tukey test for normal data. To compare the facets of the WHOQOL-BREF questionnaire regarding sociodemographic patterns for significant profile variable domain was often used Chi Square test. For correlation between the domains of the WHOQOL-BREF used the Pearson correlation coefficient. It was considered as the significance level value 5 % (p \ 0.05). RESULTS: It was found that 79.1 % of caregivers were women and married (65.1 %). Approximately 27.9 % of the caregivers had 50 years, 39.5 % of respondents considered Caucasians, 55.8 % had primary education and 67.4 % were Catholic. The time acting as caregiver interfered with the psycho-emotional wear. 60.4 % reported time as a caregiver less than one year, 41.8 % worked 24 h a day, and 97.7 % were unpaid. The daily workload in the WHOQOL-BREF was considered significant physical and psychological domains. CONCLUSIONS: It was concluded that the income indicator compromised on the quality of life of caregivers; tended to intense pain, need for medical treatment, walking ability, energy expenditure and the ability to perform daily activities and compromise work output. The correlation of variables between the WHOQOL-BREF showed up moderately and all highly significant. The activities performed by informal caregivers of this population

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affect the quality of life. This indicates the need for inclusion of caregivers in the care plan of the healthcare team.

Linda Rainey, Amsterdam, Netherlands; Ruth van Nispen, PhD, VU University Medical Center, Amsterdam, Netherlands; Lisette M. van Leeuwen, MSc, VU University Medical Center, Amsterdam, Netherlands; Ger van Rens, VU University Medical Center, Amsterdam, Netherlands

Children

AIMS: Although the capacity of low vision to impact the lives of children and adolescents is well recognized, a structural and systematic understanding of which personal life domains are affected is lacking. Therefore the aim of the present study is twofold: 1) develop a comprehensive, conceptual framework, detailing the aspects of a child’s life affected by low vision at different stages in their lives; and 2) develop self-report and parent proxy-report questionnaires measuring the rehabilitation needs of children and adolescents (0–18 years) with a visual impairment. METHODS: Construct operationalization and item generation was achieved through concept mapping workshops with low vision professionals and parents of children with a visual impairment. Interviews were conducted with visually impaired children and adolescents. The acquired data was analysed by two researchers independently. Questionnaire items were drafted using simplicity and brevity criteria. RESULTS: Four age bands were discerned: 0–2, 3–6, 7–12, 13–18 years old. Concept mapping generated 67, 112, 131, and 128 concepts for each age band respectively, covering rehabilitation needs of visually impaired children and adolescents. Two self-report (for children aged 7–12 and 13–18 years) and four parent-proxy report (for age bands: 0–2, 3–6, 7–12, 13–18) questionnaires were developed. For children aged 0–2 Items were clustered into 10 subscales: attachment, stimuli, visual attention, orientation, play, independence, recreation, mobility, communication and social interaction. With each progressive age band, the subscales acceptance, finance, and intimate relations were added, respectively. The questionnaires were reviewed by all stakeholders and redundant or ambiguous items were removed. CONCLUSIONS: Concept mapping has ensured a solid, standardized foundation for the developed Participation and Activity Inventory for Children and Youth, supporting content validity. The instrument will improve the registration of rehabilitation needs and evaluation of rehabilitation progress of visually impaired children and adolescents, by increasing the comprehensiveness and standardization of measurement in this field.

(2059) Quality of life in chronically Ill Children: first results from clinical application of the computer adaptive test kids-cat Marcus O. Klein, University Hospital Schleswig–Holstein—Campus Kiel, Kiel, Germany; Ute Thyen, MD, Universitaetsklinikum Schleswig–Holstein, Luebeck, Germany; Dana Barthel, University Medical Center Hamburg, Hamburg, Germany; Christiane Otto, Dr.Rer.Hum.Biol., University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Kirsten Gulau, University Medical Center Hamburg-Eppendorf; Sigrid Reisinger, University Medical Center Hamburg-Eppendorf; Michaela Dabs, University Medical Center Hamburg-Eppendorf; Matthias Rose, MD PhD, Charite´ Universita¨tsmedizin Berlin, Worcester, MA, United States; Sandra Nolte, PhD, Charite´—Universita¨tsmedizin Berlin, Berlin, Germany; Ulrike Ravens-Sieberer, MPH, University Medical Center HamburgEppendorf, Hamburg, Germany AIMS: Patient-reported outcomes (PRO) can aid screening and treatment in pediatric health care. However, pediatric PRO measures assessing Health-Related Quality of Life (HRQOL) are far from being used routinely in clinical practice. Assessment of HRQOL via Computerized Adaptive Tests (CATs) promises to provide greater measurement precision coupled with a lower test burden for patients. Furthermore, CATs make feedback-reporting of the HRQOL-scores for clinicians immediately available. However, there is still a lack of assessing HRQOL via CATs in chronically ill children. This project aims at evaluating the usefulness and feasibility of the first Germanspeaking CAT to assess HRQOL of chronically ill children: the KidsCAT. METHODS: Kids-CAT was developed along the European KIDSCREEN-27 QOL domain structure and five Kids-CAT item banks were built (26 to 46 items per bank). Those item banks assess five dimensions of HRQOL namely ‘physical well-being’, ‘psychological well-being’, ‘parent relations’, ‘social support & peers’, and ‘school well-being’. The Kids-CAT was applied in a multi-centered prospective longitudinal study to a clinical sample of 300 children (aged 7–11 years) and adolescents (aged 12–17 years) suffering from chronic diseases (asthma, diabetes, and rheumatoid arthritis) at two German pediatric medical centers. Focus groups with pediatricians and children were conducted in order to evaluate the usefulness and user-friendliness of the Kids-CAT. RESULTS: The median item response time varied according to age and reading abilities (2 to 3 min per item bank) while the average numbers of presented items did not differ. In focus groups, N = 9 pediatricians gave feedback concerning the usefulness and feasibility of the Kids-CAT-report containing feedback-reporting of the HRQOL-scores. Pediatricians stressed the benefit of the structured and systematic feedback-reporting of the HRQOL-scores provided by the Kids-CAT-report for daily clinical routine, emphasizing the enhanced communication with the children. Focus groups conducted with children demonstrated high user-friendliness of Kids-CAT. CONCLUSIONS: The newly developed Kids-CAT seems to be an innovative approach for assessing HRQOL in routine pediatric care since it allows a very precise and efficient way of measurement and simultaneously reduces the test burden for patients.

(2061) A validity driven approach to the comprehension of the impact of low vision on the lives of children and adolescents: the development of the participation and activity inventory for children and youth

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(2063) Improving Health-Related quality of life in children, adolescents and young adults with achondroplasia Julia Hannah Quitmann, University Medical Center HamburgEppendorf, 20246 Hamburg, Germany; Anja Rohenkohl, University Medical Center Hamburg-Eppendorf, Department of Medical Psychology; Rachel Sommer, Universita¨tsklinikum HamburgEppendorf; Sabine Kahrs, German Association for People of Short Stature and Their Families; Karl-Heinz Klingebiel, German Association for People of Short Stature and Their Families; Ruzena Klingebiel, German Association for People of Short Stature and Their Families; Monika Bullinger, PhD, Inst for Medical Psychology, Hamburg Univ, Hamburg, Germany AIMS: Since rare diseases such as Achondroplasia (prevalence: 4.5/ 100.000) might affect the subjective wellbeing and functioning, this study aimed at developing a self-help supported counseling concept to improve health-related quality of life of affected patients (8–28 years) and parents of affected children/adolescents (8–18 years). METHODS: Within a cross-sectional qualitative and quantitative need analysis using focus groups with 34 families and a written survey (including the generic KISDCREEN Index, the chronic generic DISABKIDS Index and the disease specific QoLISSY Questionnaire)

Qual Life Res (2014) 23:1–184 with 89 families the problems and resources of patients and parents were identified. Results were used to develop the self-help supported counseling concept, which was then offered to 76 families, who were asked to fill out the questionnaires mentioned above before and after the intervention once again. RESULTS: The results of the longitudinal data show a greater increase of quality of life in the active intervention group compared to a control group (p = 0.009). The increase in the self-reported quality of life of affected patients was significantly greater than for parents (p = 0.002). Group comparisons show that older patients were better adapted and reported less difficulties (p = 0.008). CONCLUSIONS: Results of this study, in particular, the socio-emotional consequences for affected families, especially for families with young children, indicate their need of adequate support, such as the developed self-help supported counseling concept, which now needs to be tested with a larger sample with patients from outside the German Association for People of Short Stature and their.

(2067) Is there any possibility to improve the quality of life in children with atopic dermatitis besides medical treatment? Yusuke Tanaka, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Sho Matsui, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Ryo Yoshioka, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Kazunori Tanaka, PhD, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Yuto Hayashi, Japanese Society of Quality of Life Research, Hyogo, Japan; Youko Kataoka, MD PhD, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, JAPAN; Haruyasu Fujita, MD PhD, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Michiko Kobayashi, MD, Japanese Society of Quality of Life Research, Kobe, Japan; Tomotaka Sobue, MD PhD, Graduate School of Medicine, Osaka University, Osaka, Japan; Takashi Mandai, MD PhD, Japanese Society of Quality of Life Research, Kobe, Japan AIMS: The purpose of this study was to investigate the quality of life (QOL) in children with atopic dermatitis. METHODS: Thirty children with atopic dermatitis (AD) participated in this study. Our new original self-administered QOL questionnaire including 39 questions divided into 7 categories with 9 AD-specific questions was used. RESULTS: Cronbach’s alpha coefficients of our questionnaire were excellent enough to accept for clinical use: 0.90 in dermal symptoms, 0.78 in social participation, 0.76 in mental problems etc. after treatment, and 0.83 in social participation, 0.83 in psychological problems, 0.81 in dermal symptoms etc. before one, respectively. Our QOL questionnaire contained 9 main factors and cumulative contribution was 0.85 after treatment. The one also contained 12 main factors and cumulative contribution was 0.88 before treatment, too. There was significant improvement in mean total QOL of children after treatment, compared with before one (p \ 0.01). Almost all children improved in total QOL after treatment, compared with before one. Compared with before treatment, significant improvements of mean QOL were demonstrated in 5 categories, i.e. in dermal symptoms, in social participation, in mental problems, in facial eczema, in disease acception (p \ 0.01) after one. There was significantly positive correlation between mean children’s QOL before and after treatment. (r = 0.42, p \ 0.05). There were significantly positive correlations between total QOL and bullying problems both before (r = 0.55, p \ 0.01) and after (r = 0.51, p \ 0.01) treatment. There were also significantly positive correlations between total QOL and consulting

115 problems both before (r = 0.43, p \ 0.05) and after treatment (r = 0.70, p \ 0.01). There was significantly positive correlation between mean total QOL changes and mean medical treatment QOL changes (r = 0.996. p \ 0.01). CONCLUSIONS: These findings indicate that our QOL questionnaire has excellent enough reliability and potency of validity to investigate the QOLs in children with atopic dermatitis. The QOLs in children with atopic dermatitis were significantly improved mainly by medical treatment and additionally by their surroundings. So, we must pay more attention to improve the QOLs from the view point of both medical and social heart-warming support.

Cross-Cultural Adaptation (2069) A Study of health-related quality of work life and workrelated anxiety among industrial workers with high levels of anxiety in northeast thailand Anootnara Talkul Kuster, PhD, Khon Kaen University, Muang District, Thailand; Jiamjit Saengsuwan, Khon Kaen University, Khon Kaen, Thailand; Ratthaphol Kraiklang, Khon Kaen University, Khon Kaen, Thailand; Kessarawan Nilvarangkul, Khon Kaen University, Khon Kaen, Thailand; Anthony Charles Kuster, Khon Kaen University, Khon Kaen, Thailand AIMS: There is a paucity of data about work-related anxiety among bluecollar industrial workers with high levels of anxiety in the low-income developing country of Thailand. This ongoing funded pilot study aims to examine associations between quality of working life, general well being, and anxiety among blue-collar industrial workers. METHODS: Subjects were recruited from either indoor or outdoor physical hazards working conditions, including at least one of the following: (1) loud noise, (2) uncomfortably high temperature, (3) vapors/fumes/dust, (4) handling dangerous/chemical products, (5) electronic operation. Seventy-five workers were classified as having high level of anxiety measured by STAIState Anxiety (M = 45.15, SD = 6.92). A structural questionnaire included demographics, physical hazards working conditions and medical history, WHO Quality of Life-BREF –THAI (WHOQOL-BREF-THAI), and the Work-Related Quality Of Life Scale (WRQLS-THAI). RESULTS: Our preliminary analyses reveals that most (67.1 %) workers with high level of anxiety were categorized as having average quality of working life on the WRQLS-THAI scale (M = 118.37, SD = 12.40). The mean WHOQOL-BREF-THAI score was 90.16 (SD = 13.99), indicating an average quality of life. However, a significant negative relationship was observed between STAI-State Anxiety and WHOQOL-BREF-THAI (r = -0.512, p \ 0.001) and WRQLS-THAI (r = -0.53, p \ 0.001), as well as sub-scales of the WRQLS-THAI: general well being (r = -0.55, p \ 0.001), working condition (r = -0.50, p \ 0.001), home-work interface (r = -0.49, p \ 0.001), stress at work (r = -0.38, p \ 0.001), and employee engagement (r = -0.31, p \ 0.001). The top five selfidentified causes of distress were colleagues (42.5 %), authority (39.2 %), over-commitment (28.4 %), no reason (28.4 %), and poor working condition (27 %). Lack of maintenance (25 %), location (25 %), feeling unsafe (20 %), and dirty/vector nuisance (15 %) were identified as causes of poor working condition. CONCLUSIONS: This is one of the first studies that utilized WRQLS-THAI in blue-collar industrial workers with high levels of anxiety in order to examine associations of quality of working life, general well being, and anxiety. The study identified a significant negative relationship between STAI-State Anxiety and working condition, which warrants further study. Working conditions are an area of work-related quality of life that businesses have stronger control over, which may be an important focus for reducing anxiety in blue-collar workers (Fig. 1).

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Qual Life Res (2014) 23:1–184 Characteristicsof outdoor physical hazards working conditions of industrial workers with high level of anxiety (N=75)

30 Percent (%)

25 20 15 10 5 0

Note: subjects canreport more than one

Characteristicsof indoor physical hazards working conditions of industrial workers with high level of anxiety (n=75)

40

Percent (%)

35 30 25 20 15 10 5 0

Note: subjects can report more than one

Self reports of potential cause of w ork related stress of ind ustrial workers with high level of anxiety ( n=75)

45 40 Percent (%)

35

AIMS: To evaluate the methodologies for the development of a reconciled forward translation as part of the process of linguistic validation of patient-reported outcome measures. METHODS: Two methodologies for the development of reconciled forward translations were selected. These were as follows : (1) Two individuals carry out the forward translations and one of these, the lead translator, carries out the reconciliation and (2) The source is translated by two individuals and a third person (the lead translator) carries out the reconciliation. 207 linguistic validation reports were analyzed to ascertain how the reconciled version had been determined. RESULTS: Methodology 1: 47 % of the time the lead translator selected their own translation (that is either using their original translation (FT1) or a completely new translation). Of this 47 % the lead translator favours their original translation 91 % of the time. 52 % of the time the lead linguist selected a translation that was influenced, or agreed with, by the other linguist (that is either using the second forward translation (FT2), a combination of FT1 and FT2, or the two translations are identical). Of this 52 %: 22 % of the time FT2 was selected; 31 % of the time they used a combination; and 42 % of the time FT1 and FT2 were identical. Methodology 2: 22 % of the time the lead translator selected a translation of their own (that is different to either FT1 or FT2). 78 % of the time the lead translator selected a translation that was influenced, or agreed with, by another linguist (that is either FT1, FT2, a combination of FT1 and FT2, or the two translations were identical). Of this 78 %: 28 % of the time FT1 was selected; 25 % of the time FT2 was selected; 10 % of the time the lead linguist used a combination of FT1 and FT2; and 28 % of the time FT1 and FT2 were the same. CONCLUSIONS: The results suggest that that lead translators are appreciating the input of other linguists in the development of the translation. Without the decision making process itself being collaborative the translation will naturally reflect the opinion of the lead linguist.

30 25 20 15

(2073) Translation as a team-building effort: a cost-effective method for mass translation of quality-of-life tools

10 5 0

Note: subj ects can report more than one

Fig. 1 .

(2071) Reconciliation of forward translations as part of the linguistic validation process Diane J. Wild, MSc, Icon Plc, Oxford, United Kingdom; Helen Anderson, DPhil, Oxford Outcomes, Icon Plc, Oxford, United Kingdom; Laura Towns, Icon Plc, Oxford, United Kingdom; Sujyotee Newoor, Icon Plc, Oxford, United Kingdom

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Randi Andenæs, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Borghild Løyland, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Liv Halvorsrud, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Ingrid H. Ravn, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Sølvi Helseth, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Lisbeth Kvarme, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Astrid K. Wahl, RN, Department of Health Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway; Lis Ribu, RN PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Berit Valeberg, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Inger Utne, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Marit Leegaard, RN, PhD, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Nina Misvær, RN, Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Carolyn E. Schwartz, ScD, DeltaQuest Foundation; Departments of Medicine and Orthopaedic Surgery, Tufts University School of

Qual Life Res (2014) 23:1–184 Medicine; and Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway AIMS: Translation of measures is a necessary part of any crossnational collaboration, and is generally considered the jurisdiction of professional translation agencies. We developed an approach to translating patient-reported outcome (PRO) measures to assess key constructs for a new quality-of-life (QOL) research program at the Oslo and Akershus University College, Norway. This approach adhered to current rigorous standards for translation, and responded to other project needs, including team-building, cost-effectiveness, and feasibility testing. This presentation will describe this approach to inexpensive translation and its perceived impact on team cohesion, cost, feasibility, and research training. METHODS: We translated seven QOL measures for a web-based longitudinal survey of the general Norwegian population. EORTC guidelines for PRO translations were followed. Nursing faculty (n = 11) implemented the translation process; undergraduate nursing students pretested the questionnaires with community-based volunteers. Forward translation from English into Norwegian of each questionnaire was first done by a team of 2–3 faculty members and then by one professional translator. Both versions of the questionnaire translations were compared and one final version was agreed upon. Two independent professional translators did the backward translation, which was shared with the instrument developers; the process was repeated until culturally-equivalent tools were ready for use. The web-survey with the instrument was pre-tested as part of undergraduate nursing students’ practice, recording completion time and respondent feedback for each questionnaire. RESULTS: Forward translation/reconciliation and backward translation/reconciliation were completed at a cost of $4400 USD for the professional forward and back translations. Undergraduates’ pretesting (n = 16) revealed cultural differences related to leisure activities, and QOL content areas that were missing (e.g., sexuality, nutrition, income constancy, and physical activity). Students engaged in research were interested and enthusiastic. CONCLUSIONS: In addition to creating a shared goal among the faculty members, mass translation can be a teambuilding effort that is efficient and cost-effective approach. By capitalizing on available resources in an academic training environment, this approach not only yielded a number of rigorously translated measures, but also perceived gains in team cohesion, protocol pre-testing, and undergraduates’ exposure to and interest in research.

(2075) Project WHOQOL/Libras—Analysis for focus group of WHOQOL/BREF translated into Brazilian sign language Soraya Bianca Reis Duarte, Ms, Instituto Federal de Educac¸a˜o, Cieˆncia E Tecnologia -IFG, Goiaˆnia, Brazil; Neuma Chaveiro, Federal University of Goias, Goiaˆnia, Brazil; Adriana Ribeiro Freitas, Professora, Pontifı´cia Universidade Cato´lica de Goia´s, Goiaˆnia, Brazil; Celeno Porto Celmo, PhD, Universidade Federal de Goia´s; Maria Alves Barbosa, PhD, Nursing Faculty of Federal University of Goias, Goiaˆnia, Brazil; Marcelo P. Fleck, PhD, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil AIMS: OBJECTIVE: to analyze the Brazilian Sign Language (Libras) version of the World Health Organization instrument for assessing quality of life (WHOQOL-BREF) in a study involving focal groups. METHODS: METHODS: transversal type descriptive and exploratory qualitative research using the technique of focal groups in three groups distributed as follows: 1) deaf people; 2) deaf people families; and 3) Libras interpreters. Two meetings were held with three focal groups. The first aimed to explain all the details of the research, delivery of a DVD, signing

117 of the Term of Free and Informed Consent and application of a sociodemographic questionnaire. The second aimed to discuss and analyze the Libras version of the WHOQOL-BREF. Data were analyzed based on the technique of analysis of categorical and thematic content proposed by Bardin. RESULTS: RESULTS:100 % of the participants of the three GF understood and considered the questions relevant to the QOL of the deaf. In the category of suggestion, GF1 came with 76.94 %, GF2 presented 65.39 % and GF3 came with 73.08 % of the questions that needed changes. CONCLUSIONS: CONCLUSIONS: the scarcity of scientific research on the use of focal groups with deaf people was considered a challenging factor. This study showed that the technique of focal groups with deaf people will have better success if it consists of a maximum of six members per group.

(2077) Translation and Cross-Cultural adaptation of the Portuguese version of the Patient-Reported outcomes measurement information System—PROMISÒ—Physical Function Diana A.C. Braga, Universidade Federal de Uberlaˆndia, Uberlaˆndia, Brazil; Roge´rio M C Pinto, Federal University of Uberlaˆndia; Tania Maria Silva Mendonca, UFU, Uberlaˆndia, Brazil; Helena Paro, MD, Uberlaˆndia, Brazil; Nivea da Macedo Oliveira Morales, MD, Universidade Federal de Uberlaˆndia, Uberlaˆndia, Brazil; Carlos Henrique Martins Silva, Sr., Universidade Federal de Uberlaˆndia— FAMED, A. Alexandre R. Guimaraes,315, Brazil AIMS: To translate and culturally adapt the PROMIS Physical Function Items to Portuguese. METHODS: The process of translation and cultural adaptation included eight stages determined by the universal methodology proposed by the Functional Assessment of Chronic Illness Therapy (FACIT). In the seventh stage, pretest included 50 individuals older than 18 years. Respondents answered the items by self-application, using a verbal qualitative survey technique in which all participants read the items aloud and the researcher registered any difficulties related to answering. A Cognitive Interview was taken to evaluate the understanding of the content of each item. Participants also answered a Retrospective Interview Clarification to detect limited understanding, offensive or irrelevant items. RESULTS: FACIT methodology allowed a version with adaptations since the beginning of the process, ensuring semantic, conceptual, cultural and operational item bank equivalence. During the cognitive interview and retrospective clarification stages, possible difficulties in understanding the items were reported by 24 % of participants, 22 % of them suggested changes to improve understanding. Respondents reached 100 % understanding of terms and concepts in 87 % of the items. Only 3.3 % of the items had less than 70 % of understanding, requiring changes and achieving 100 % of equivalence to the original item and understanding by respondents after reapplication. During the pretest, respondents identified problems and suggested changes in seven items. As an example, the PFB44 item version for pretest was: ‘‘A sua sau´de atual limita voceˆ na realizac¸a˜o de atividades moderadas, como mover uma mesa, empurrar um aspirador de po´, ou jogar boliche ou golfe?’’. After the pretest, the term ‘‘golfe’’ (gulf) was changed to ‘‘bola’’ (ball), because the action of the second term is more culturally accessible. CONCLUSIONS: The process of translation and cultural adaptation of the PROMIS Physical Function Items into Portuguese was successful. This version should be subjected to linguistic validation before being made available to this population.

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118 eHealth (2079) Variation in Health States between users of paper and electronic pro administration Scott M. Gilbert, MD, H Lee Moffitt Cancer Center, Tampa, FL, United States; Carl Henriksen, University of Florida; Jeffrey S. Montgomery, University of Michigan, Ann Arbor, MI, United States; John M. Hollingsworth, University of Michigan, Department of Urology, Ann Arbor, MI, United States; Brent Hollenbeck, MD, MS, University of Michigan, Ann Arbor, MI, United States; Michael Poch, Moffitt Cancer Center, Tampa, FL, United States; Wade Sexton, Moffitt Cancer Center, Tampa, FL, United States; Paul B. Jacobsen, Moffitt Cancer Center & Research Institiute, Tampa, FL, United States AIMS: As patient-reported outcomes (PRO) have gained importance, there has been an increasing need to move from researchbased measurement to clinical tools that are integrated and available in clinical settings. Electronic PRO capture may facilitate more complete and timely assessment, broaden participation and allow more actionable data for PRO integration into clinical care pathways. Conversely, exclusive reliance on newer assessment methods may prevent some patients from participating in research studies or from realizing the benefits of PRO integration into their clinical care (i.e. digital divide). Patient preference for a particular format may also be associated with inherent clinical and demographic factors, as well as baseline health states. We therefore undertook an analysis to examine the relationship between PRO assessment format, and clinical and demographic factors, as well as baseline health states. METHODS: Candidates for cystectomy and urinary diversion were enrolled in the Bladder Cancer Outcomes and Impact Study (BCOIS), a prospective QOL and complication survey assessment, between April and December, 2013. Surveys were administered in either paper–pencil or electronic web-based formats based on patient preference for completion of study questionnaires. Baseline clinical and demographic information was collected at study intake prior to surgery. Baseline PROs, clinical variables and demographic factors were then correlated with PRO administration format to identify potential associations between health states chronicled on baseline questionnaires and format choice. Completed and missing questionnaire items and time to complete questionnaires were also compared between groups. A response burden survey was administered to capture the ease or difficulty of completing the paper and electronic surveys. Categorical variables were compared using Fisher’s Exact test. Continuous variables were compared using the Wilcoxon Rank Sum test. All statistical tests were performed with standard statistical software (SAS v9.3, Cary, NC). RESULTS: Clinical, demographic and PROs stratified by survey administration format are shown in the Table 1. There were no significant clinical or demographic differences between groups. Baseline SF36 physical well-beings was lower among participants using paper and pencil compared to electronic assessment. While PHQ8 scores were higher among the paper format group indicating a greater degree of depression related symptoms, differences were not statistically significant. Paper and electronic format PRO assessment were similar in terms of response burden, time to completion and missing items. CONCLUSIONS: Patients completing the paper format tended to have lower health states as measured by the SF36 and PHQ8. This suggests that electronic/computer access and/or competency may be associated with other factors that mediate health outcomes. Such associations may have implications on wide-spread implementation of electronic PRO capture in clinical and research contexts.

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Qual Life Res (2014) 23:1–184 Table 1 Baseline PROs and administration statistics stratified by format group Variable

Computer Paper–pencil p value PRO PRO administration administration

Baseline SF36 Physical score

51.4

34.0

0.007

Mental score

50.9

43.8

0.389

Baseline CSI Problem solving

28.0

28.0

0.878

Seeking support

23

21

0.671

Avoidance

17

19

0.486

SS score

3.5

5

0.334

Completion time (min)

35.0

40.0

0.315

Response burden indicator (sum of responses; max = 10, min = 2)

2

3

0.637

Missing items (average)

0.80

0.93

0.141

Baseline PHQ8

* SF36—higher scores indicate better health states; PHQ8—higher scores indicate higher levels of depression

(2081) PRO-Online: a free online software to analyse patientreported outcomes using various paradigms of data analysis Bastien Perrot, University of Nantes, Vertou, France; Tanguy Le Ne´el, Nantes University, Nantes, France; Jean-Francois Hamel, University Hospital of Angers, Angers, France; Myriam Blanchin, University of Nantes, Nantes, France; Veronique Sebille, ScD, University of Nantes, Nantes, France; Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France AIMS: Actually, a more and more important number of modules allowing performing specific analysis of Patient-reported Outcomes (PRO) are proposed in the published papers under specific or generalist (R, SAS, Stata) software. These modules scatter the methods of analysis among a large number of software, and it is more and more difficult for users to realize a complete analysis of PRO using last proposed methodologies under sole software. More, for occasional users, it could be difficult to have access to specific or generalist software which could be expensive. Our team propose since several years Stata modules and SAS macro-programs (available on http://www.anaqol.org) in order to provide Classical Test Theory (CTT), structural Equations Modeling (SEM) or Item Response Theory (IRT) based methods. Nevertheless, it is difficult to deploy all these modules under all the generalist software, but it seems us important to offer an easy access to all of them. METHODS: We propose on http://pro-online.univ-nantes.fr an access to several of these modules using an online user-friendly and free interface. When a request is run on this interface, the server executes the adapted software (Stata for example) and displays the results (tables, graphs) on the navigator of the user. This could be for an occasional user an opportunity to use advanced methods, without requirement in term of available software. RESULTS: Several modules have already been implemented online, in particular to validate a scale using CTT-based methods (assessment of reliability, knowngroups validity, confirmatory factor analysis, multitrait-multimethod matrices, etc.), to planning a study with a primary outcome measured

Qual Life Res (2014) 23:1–184 by a Rasch family model, to analyse data with (non-)parametric IRT models like Mokken models, Rasch models or Partial Credit Models, or to detect response shift using SEM. CONCLUSIONS: The PROonline project proposes several modules to perform analyses in the field of CTT, SEM and IRT on their own data without complex handling of the data. As perspective of this website, it will be possible to jointly use several techniques on the same dataset, even with modules programmed in different languages. This website can become a useful tool for research and for learning.

(2083) Conducting meaningful user acceptance testing for electronic patient-reported outcomes (ePROs): best practices Bhumi Trivedi, Covance; Catherine Sage, Covance Market Access Services, Inc.; Jill Platko, Covance Market Access Services, Inc AIMS: User Acceptance Testing (UAT) for electronic patient-reported outcomes (ePROs) is conducted to test a device’s functionality and adherence to agreed upon specifications between the sponsor and vendor. The intent of the UAT is to confirm that the PRO items completed through this device are properly displayed and in line with best practices. The purpose of this research is to discuss the value and best practices for conducting a UAT specifically for ePRO devices. It should be of interest to outcomes researchers who are interested in using ePRO devices to collect health-related quality of life information. METHODS: A literature search was completed to understand previously defined standards and best practices for conducting UATs from field workers. Also, feedback from the authors’ combined firsthand experience with conducting and observing UATs was used to create a set ‘‘lessons learned’’ from the field. RESULTS: Results from this analysis included insight into the following: (1) how to evaluate the device specifications document to ensure it aligns with best practices; (2) how to write good high-quality UAT scripts that test the functionality of the device; and (3) how to optimally conduct a UAT session for ePROs. The device specifications document should be reviewed thoroughly and be compared to the protocol at each stage, ensuring that the ePRO solution is in line with the study methodology. The UAT Scripts should be written with access to one of the devices or, if that is not possible, the ePRO vendor should go through each detailed step on a simulation. The UAT session should ideally be conducted with all parties in the room: the ePRO vendor, the ePRO specialist, the sponsor, and the CRO (if conducting a clinical trial). All participants should go through each stage in the software to ensure their comfort with the device and how it will operate when integrated into the study. Specific case examples were identified to demonstrate key points and offer practical insights on how to efficiently overcome challenges during the UAT process. CONCLUSIONS: UATs reveal a wealth of information if properly conducted. Following best practices can lead to maximizing the value of UATs.

(2087) Home-Based cancer symptom self-management: preliminary results DerShung Yang, PhD, BrightOutcome Inc., Buffalo Grove, IL, United States; Niina M. Haas, BrightOutcome, Buffalo Grove, IL, United States; Ana Maria Lopez, University of Arizona; Michael A. Kallen, PhD MPH, Northwestern University, Chicago, IL, United States AIMS: SymptomCareAnywhereTM (SCA) is designed to facilitate cancer symptom self-management. Using SCA, cancer patients can self-report symptoms online or via a touchtone phone, and SCA will connect them to professional symptom triage support. SCA automatically notifies the clinical team about any moderate to severe symptom reports via email alerts, which may trigger follow-up calls

119 to patients from the study nurse. Web-based patient users also receive individualized educational materials, tailored to their reported symptoms and severity levels. SCA’s covered symptoms include pain, fatigue, depression, anxiety, insomnia, nausea, numbness, fever, mouth sores, skin rash, dyspnea, diarrhea, constipation, and decreased appetite. This RCT’s aim is to assess the effectiveness of SCA in improving patient overall quality of life (QOL). METHODS: Patients of all cancer types about to begin chemo-, radiation, or hormonal therapy were recruited from the Arizona Cancer Center, and randomized equally to receive usual care (control) or use SCA for symptom management (intervention). Patients participated in the study for 3–4 months, depending on the length of their treatment regimen; they completed FACT-G QOL assessments at baseline (pretreatment), treatment mid-point, and end of treatment. Intervention arm patients were encouraged to regularly use SCA for symptom reporting (twice weekly). FACT-G group score differences and Cohen’s D effect sizes were calculated. RESULTS: To date, 96 patients (49 % women, 44 % men, 7 % unreported) have been recruited, with 76 completing all three FACT-G assessments (intervention: n = 26; control: n = 50). At baseline, average FACT-G scores for the intervention and control groups were similar (76.46 vs. 76.02, respectively; effect size (ES) = 0.03, p = 0.88). At treatment midpoint, QOL scores observably diverged between study groups, with intervention scores showing a small improvement and control scores decreasing (77.56 vs. 74.41; ES = 0.20, p = 0.36). At end of treatment, between-group QOL scores were, again, highly similar (79.73 vs. 78.68; ES = 0.07, p = 0.75). CONCLUSIONS: Early evidence suggests Symptom Care Anywhere can help patients and their care teams better manage treatment symptoms and thus alleviate some of these patients’ symptom burden in the midst of their cancer treatment regimens, when therapy side-effects tend to have the greatest impact. The second half of this study is currently underway to confirm these findings.

(2089) Online technology assessment for the prevention of NonCommunicable diseases, food control and balance, control and primary care for users of services of primary health care in two municipalities in the state of Sa˜o Paulo, Brazil Daniel G. Goroso, PhD, Physical Medicine and Rehabilitation Institute of Clinical Hospital, SP, Brazil, Sa˜o Paulo, Brazil; Tamara C. Iwanow, Mogi Das Cruzes University, Brazil; Silvia Bastos, Health Institute, Sa˜o Paulo, Brazil AIMS: Development of models for investigation of daily living conditions based on physiological signs of human beings is important for evaluating quality of life, prevention and control of the risk factors of chronic degenerative diseases (obesity and cardiovascular). This study aims to: i) monitor daily energy expenditure, heart rate variability and frequency, using FLEEM System tool, in overweight subjects of two municipalities in Sa˜o Paulo State, Brazil; ii) evaluate results and impact of this new technology on quality of life in these municipalities to determine the level of satisfaction. METHODS: For collecting physiological data online was used the FLEEM System, that consists in gauging via internet and 3G mobile phone technology the variables: daily expense of calories, calories consumed, energy balance, heart rate and heart rate variability. Quality of life was evaluated using WHOQOL-BREF form. All participants signed the consent form and underwent an initial assessment for socio demographic characterization, record vital signs, medications used and measurement of body mass index. In this study were included subjects diagnosed overweight, aged 18 and 19 years, of both genders. They were divided into two groups, the study group (SG) and the control group (CG). The subjects belonging to the SG were monitored online by FLEEM System. It was investigated the distribution of

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Qual Life Res (2014) 23:1–184 population) were: anxiety (48 vs. 46); depression (44 vs. 46); fatigue (55 vs. 44); pain interference and intensity (55 vs. 47); physical functioning (45 vs. 54); sleep disturbance (52 vs. —) and satisfactions in social roles (48 vs. 54). CONCLUSIONS: This patient population is highly satisfied with their chiropractic visit and present with lower quality of life compared to the general US population. We encourage further research in this area to examine the impact of chiropractic care on health outcomes in this specific patient population.

(2093) Validation of the PROMISÒ physical function domain in a large diverse cancer cohort

Fig. 1 . demographic data and initial and final assessment through statistical tests. RESULTS: Using this new online monitoring tool, it was possible to: (i) reduce the rates of obesity and associated factors combining prevention through the daily tracking of each subject in the SG when compared to GC (p = 0.02) (Fig. 1); (ii) identify the subject and at-risk populations to enable effective follow-up or treatment according to each case. (iii) As this is a prospective study, the experience and set of analyses and studies on technical, scientific, economic and social conditions of this reality helped to design, for the near future, a more effective and comprehensive strategy for the population under study. CONCLUSIONS: The results of this study intend to support criteria capable of contributing and reset the indicators and standards of quality of life, aiming at improvement of governmental and non-governmental structures, public policy processes.

PROMISÒ (2091) The use of PROMISÒ in pregnant patients presenting for care in a chiropractic practice-base research network Joel Alcantara, ICPA, Media, PA, United States; Jeanne Ohm, International Chiropractic Pediatric Association; Junjoe Alcantara, Alcantara Chiropractic AIMS: The use of alternative therapies during pregnancy continues to be popular with prevalence of use estimated from 13 % to 78 %. This is to address a particular health problem or condition or to maintain and promote health and wellbeing. Towards efforts to adopt effective and evidence-informed care healthcare strategies, we sought to examine the patient satisfaction and quality of life of pregnant patients presenting for chiropractic care within a practice-base research network. METHODS: This study received IRB approval from Life University (Marrieta, GA). In addition to patient sociodemographics, visit-specific satisfaction was measured using the RAND VSQ9 and their quality of life with the NIH’s Patient Outcome Measurement Information System (PROMIS-29). The VSQ9 Likert responses were converted (i.e., poor = 0 %; fair = 25 %; good = 50 %; very good = 75 %; excellent = 100 %) and averaged to create a VSQ-9 score. The PROMIS-29 data was analyzed via Assessment CenterSM with quality of life domains reported as T-score metrics. A higher T score indicates more of the domain measured. RESULTS: A total of 356 pregnant patients (average age = 30.9 years; average parity = 0.91; average gestation at 25 weeks) participated in this study. The majority presented for care to address pregnancy-related musculoskeletal pain complaints involving multiple locations of the spine and lower/upper extremities followed by low back pain. The T scores (in comparison to the US

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Roxanne E. Jensen, PhD, Georgetown University, Washington, DC, United States; Arnold L. Potosky, PhD, Georgetown University, Washington, DC, United States; Aaron C. Roberts, Georgetown University, Washington, DC, United States; Carol M. Moinpour, PhD, Fred Hutchinson Cancer Research Center, Seattle, WA, United States AIMS: Physical Function is a key patient-reported outcome used to characterize and better understand overall health, disability, and wellbeing. Decline in physical function is often associated with a cancer diagnosis and the ensuing initial treatment, and can have long-lasting effects extending into cancer survivorship. The Patient-reported Outcomes Information System (PROMIS) developed an item response theory-calibrated item bank and multiple short form options for physical function. Initial validation was done in rheumatoid arthritis, osteoarthritis populations, and normal aging cohorts in an internet-based, predominantly Caucasian sample. Study Aims: (1) Determine the generalizability of PROMIS physical function domain in a diverse, community-based sample by race/ethnicity and age, (2) Evaluate the performance of commonly-used short forms. METHODS: Cancer survivors (n = 4,840) recruited by the Measuring Your Health (MY-Health) study through 4 SEER cancer registries in three states and diagnosed with colorectal, lung, NHL, breast, gynecologic or prostate cancer. Outcomes were measured by PROMIS Physical Function domain were obtained from a survey competed 6–13 months after diagnosis. Reliability and Validity testing were conducted for the three PROMIS physical function short forms (4a, 6a, and 10a), and a custom 16-item MY-Health form evaluated separately across three age (21–49, 50–64, 65–84) and 4 race/ethnicity groups (White, Hispanic, Black, Asian). RESULTS: Standardized PROMIS physical function scores across all forms were within one point (range: 44.8 [6a]–45.7 [4a]). PROMIS physical function forms reported high internal consistency (Cronbach’s a = 0.92–0.96), convergent validity (Fatigue, Pain Interference, Physical Well-Being all r = 0.68), and discriminate validity (unrelated domains r = 0.3) across survey forms, age groups and race/ethnicity groups. Established known group differences by demographic, clinical, and disability performed as expected will little difference by survey form. Ceiling effects were identified across most forms. CONCLUSIONS: Overall the PROMIS physical function domain addresses a wide range of disability that is appropriate for multiple race/ethnicity, and age groups in a large community-based sample. While all short forms met high degrees of validity and reliability, the range and type of function and disability should be considered when selecting a short form.

(2095) Psychometric assessment of the PROMISÒ Global Health scale in a spanish-speaking sample of workers in uruguay Darı´o Padula, Facultad de Psicologı´a, Universidad de la Repu´blica, Uruguay; Juan J. Dapueto, MD, PhD, Faculty of Medicine, Universidad de la Repu´blica, Montevideo, Uruguay; Mario Luzardo, Facultad de Psicologı´a, Universidad de la Repu´blica, Uruguay;

Qual Life Res (2014) 23:1–184 Nicola´s Fiori, Facultad de Ciencias Sociales, Universidad de la Repu´blica, Uruguay; David Cella, PhD, Northwestern University, Chicago, IL, United States; Ronald D. Hays, PhD, RAND Corporation, Santa Monica, CA, United States AIMS: The PROMIS Global Health Measure (PGHM) includes 10 items that are used to create global physical health and mental health scales. A Spanish translation of the PGHM was included as part of a survey of health-related quality of life of workers of the Universidad de la Repu´blica in Uruguay. We summarize psychometric evaluation of the PGHM from a sample of 744 adults. METHODS: We conducted exploratory (EFA) and confirmatory factor analysis (CFA) of the PGHM items. Cronbach’s alpha coefficients were estimated for the two multi-item scales. In addition, the graded response model was used to estimate item threshold and discrimination parameters, and item and scale information. R software was used. RESULTS: A random sample of 994 subjects was drawn from a population of 14,598 university workers and 744 (75 %) completed the survey. The mean age was 42 years (SD: 12), 57 % were women, and 64 % had a university degree. EFA suggested the existence of a single factor (factor loadings range 0.52–0.89), first to second eigenvalue ratio 4.11, accounting for 49 % of the variance. As two eigenvalues [ 1 were observed in non-rotated data, an Oblimin rotation with polychoric correlations was performed extracting two dimensions, physical health (PH) (Global 1, 2, 3, 6 and 7) and mental health (MH) (Global 4, 5, 8, 9 and 10). Different from the original English version, items Global 1 (general health) and 2 (global quality of life) loaded in PH, while Global 8 (fatigue), and Global 9 (social role) loaded on MH. Models with 5 physical health (PH) and 5 mental health (MH) items fit the data well for PH (?2 = 2.64, df = 3.0, p = 0.45, RMSEA = 0.000, CFI = 1.0, NNFI = 1.0, GFI = 0.99) and MH (?2 = 4.69, df = 2.0, p = 0.096, RMSEA = 0.043, CFI = 1.0, NNFI = 0.99, GFI = 1.0). Cronbach’s alpha was 0.78 for both PH and MH. Item threshold parameters indicated a considerable range of the latent variable PH (range: -5.60 to 3.53), and MH (range: -4.57 to 2.63). CONCLUSIONS: This study is an initial evaluation of the PGHM in a Spanish speaking sample in Uruguay. Results indicate support for two underlying dimensions corresponding to PH and MH, but with some differences in the item loadings compared to the original English version. Internal consistency coefficients were adequate for group comparisons. IRT analyses showed that the items covered a wide range of the latent variable. Further analyses including estimates of the clinical important differences are forthcoming.

(2097) Portuguese translation and Cross-Cultural adaptation of the patient-reported outcomes measurement information system (PROMISÒ) global health items bank Carlos Henrique Martins Silva, Sr., Universidade Federal de Uberlaˆndia—FAMED, A. Alexandre R. Guimaraes,315, Brazil; Camila E. Zumpano, Federal University of Uberlaˆndia, Uberlaˆndia, Brazil; Roge´rio M C Pinto, Federal University of Uberlaˆndia; Tania Maria Silva Mendonca, UFU, Uberlaˆndia, Brazil; Helena Paro, MD, Uberlaˆndia, Brazil; Nivea M. O. Morales, MD MSc PhD, Federal University of Uberlaˆndia, Uberlaˆndia, Brazil AIMS: To translate and cross-culturally adapt the PROMIS Global Health Items Bank into Portuguese. METHODS: The Global Health consists of 10 self-administered items, which address general health perceptions, physical, emotional and social aspects. The translation method of these items was based on a systematic multistage process of forward, backward and universal approach, following the ISPOR recommendations, adopted by the coordinators of PROMIS. This process included the participation of native translators from Brazil and Portugal, as well as a native translator from the U.S.A., in the

121 back translation stage. The pre-final version was tested in 10 patients with chronic diseases followed at the Hospital of the Federal University of Uberlaˆndia, Brazil. This step was performed through retrospective and cognitive debriefing interviews using the verbal probing technique. RESULTS: The 10 patients in the pretest had a mean age of 35.6 years and 30 % had less than high school education. All participants considered the items relevant, not offensive, easy to understand and comprehended the response options. Items 5, 7, 8 and 9 needed adjustments after the conclusion of the pretest. These items were retested in a sample of 5 patients with chronic diseases and were understood by all participants, which ensured conceptual equivalence with the original version. CONCLUSIONS: The Portuguese version of the PROMIS Global Health Items Bank presented conceptual, semantic and cultural equivalence in relation to the original version. Linguistic validation of this items bank into Portuguese is underway in Brazil.

(2099) Fatigue and social function in persons with disability: a short-term longitudinal analysis Ivan Molton, PhD, University of Washington, Seattle, WA, United States; Mark Jensen, University of Washington, Seattle, WA, United States; Amanda E. Smith, University of Washington, Seattle, WA, United States AIMS: Fatigue is a common and disabling symptom in persons with post-polio syndrome. However, few studies have investigated the way that changes in fatigue might impact quality of life. Aims of the present study were to evaluate the impact of changes in fatigue over a 4 year period on satisfaction with social role functioning. METHODS: 389 individuals with post-polio syndrome completed a set of return by mail questionnaires at baseline and 4 years later. Measures included modern assessment tools from the NIH PROMIS system, including the PROMIS Fatigue and PROMIS Social Role Satisfaction measures. A cross-lagged, autoregressive panel design was analyzed using path modeling in Mplus software. RESULTS: The final model was a good fit to the data. Path results demonstrated that fatigue was negatively associated with social role satisfaction at both timepoints (p \ 0.05), after controlling for demographic confounds. Cross-lagged analyses revealed a bi-directional, reciprocal effect of fatigue and social role satisfaction on one another over time (ranging from -0.15 to -0.20, all p’s \ 0.01). CONCLUSIONS: Fatigue remains a significant detriment to social quality of life in persons with post-polio syndrome. Worsening fatigue over time is associated with decreases in satisfaction with social activities. Interventions to buffer the impact of fatigue on quality of life are needed in this population, especially as they age.

Measure Development (2101) Enabling and supporting people to live with Long-Term conditions: qualitative and conceptual development of a patient-reported outcome measure (PRO) Cheryl Hunter, PhD, University of Oxford, Oxford, United Kingdom; Raymond Fitzpatrick, PhD, Univ of Oxford, Dept of Public Hlth, Oxford, United Kingdom; Anne-Sophie Darlington, PhD, University of Southampton School of Medicine, Southampton, United Kingdom; Julien Forder, University of Kent; Angela Coulter, University of Oxford, Oxford, United Kingdom; Crispin Jenkinson, Health Services Research Unit, Oxford, United Kingdom; Michele Peters, PhD, University of Oxford, Oxford, United Kingdom

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122 AIMS: Health and social care services are keen to improve services to achieve better outcomes for long-term conditions (LTCs). A PRO could be an essential tool in the adaptation of services to this end. This research aimed to develop a conceptual framework for a PRO that would be valid and acceptable across LTCs, and useful across health and social care. METHODS: We conducted literature reviews to identify condition-specific and generic PROs for LTCs and the domains they covered, and examine how these have been used in health and social care settings. We also completed semi-structured interviews with 31 stakeholders in health and social care, including commissioners, policy makers, service providers, health and social care services managers, front-line clinicians and patient-focused voluntary groups. Interviews were analysed using a framework approach. RESULTS: Most LTC PROs focus on measuring functioning, especially physical functioning. In clinical practice, PROs have been used successfully to identify and monitor problems, but they are rarely seen as tools to help patients self-monitor their condition. Interviewees responded positively to the suggestion that PROs could be used at an individual level to enable and support people to manage their LTCs, and felt that PROs could be embedded within routine health and social care practice. Interviewees were positive about the potential for using PRO data to align services towards shared outcomes, and to inform commissioning decisions. They favoured PRO domains that reflected a biopsychosocial approach to LTCs; these included control over illness, social participation, empowerment, mental wellbeing and functioning. Some interviewees had concerns about the feasibility of using PRO data for multiple purposes, and ensuring stakeholder investment in PROs. An increased role for patients in identifying relevant PRO domains and in using PRO data was emphasized. CONCLUSIONS: A PRO that is relevant across conditions and reflects a biopsychosocial approach to managing LTCs was considered potentially useful by a range of stakeholders. Patient inclusion in the design, use and interpretation of a PRO was a desired feature. This framework will be used to inform interviews with a diverse range of patients in order to determine specific domain and item content.

(2105) Do cancer patients distinguish between the importance and severity of their quality of life concerns? Daniel S. J. Costa, PhD, Psycho-oncology Co-operative Research Group (PoCoG), Sydney, Australia; Madeleine T. King, PhD, Psychooncology Cooperative Research Group (PoCoG), Sydney, Australia; Neil K. Aaronson, PhD, The Netherlands Cancer Institute, Amsterdam, Netherlands; John E. Brazier, PhD, Univ of Sheffield, Sheffield, United Kingdom; David Cella, PhD, Northwestern University, Chicago, IL, United States; Peter Grimison, Chris O’Brien Lifehouse and University of Sydney, Sydney, Australia; Monika Janda, PhD, Brisbane, Australia; Helen McTaggart-Cowan, PhD, Canadian Centre for Applied Research in Cancer Control, Vancouver, BC, Canada; A. Simon Pickard, PhD, University of Illinois at Chicago, College of Pharmacy, Chicago, IL, United States; Rob Arbuckle, Adelphi Values, Cheshire, United Kingdom; Donna Rowen, University of Sheffield, Sheffield, United Kingdom; Tracey Di Sipio, Queensland University of Technology, Australia on behalf of the MAUCa Consortium AIMS: To determine whether cancer patients can distinguish between current severity of symptoms or functional limitations, versus the extent to which they view these symptoms and limitations as important, regardless of severity. METHODS: We employed mixed methods in which 18 patients with cancer were asked to complete a questionnaire in an interview setting. Using either the EORTC QLQC30 or the FACT-G questionnaire, they rated the severity of their symptoms/functional limitations in the preceding week. They also

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Qual Life Res (2014) 23:1–184 nominated the concerns that were most important to them generally, i.e., that most affect their lives (timeframe was not specified, but could be long-term). While completing these questionnaires, patients were asked to verbally report what they were thinking. Quantitative analyses examined the proportion of times a quality of life (QOL) concern within a questionnaire domain was ranked as most important and was also the most severe during the past week. Qualitative data analysis grouped patients’ interview responses into four groups according to a 2 9 2 table of high and low importance and severity. RESULTS: Qualitative analysis of interview responses revealed that 27 % of patients’ quotes indicated either low importance with high severity or low severity with high importance. This dissociation was common when participants assigned an item high severity but low importance because they either coped well with the QOL concern, or saw it as a temporary annoyance during treatment. The remaining 73 % of quotes indicated that items were/were not severe and therefore were/were not important to the patient. In the quantitative analysis, 61 % of responses to the EORTC QLQ-C30 and 62 % to the FACT-G indicated an association between the importance and severity ratings. CONCLUSIONS: Aggregates of self-reported severity of symptoms and functional limitations do not necessarily capture the extent to which these QOL concerns are important to patients. Nonetheless, in most cases we observed alignment between severity and importance, and coupled with the added scoring complexity and respondent burden imposed by weighting severity by importance, we conclude that aggregating severity scores without importance weightings is largely justified.

(2107) Phase 1 & 2 development of an EORTC QLG health-related quality of life questionnaire for patients with cancer Cachexia Sally J. Wheelwright, University of Southampton, Southampton, United Kingdom; Anne-Sophie Darlington, PhD, University of Southampton School of Medicine, Southampton, United Kingdom; Deborah Fitzsimmons, Swansea University, Swansea, United Kingdom; Jane B. Hopkinson, University of Cardiff, Cardiff, United Kingdom; Stein Kaasa, St Olavs University Hospital; Monica Pinto, Istituto Nazionale Tumori ‘‘Fondazione G. Pascale’’- IRCCS; Florian Strasser, Cantonal Hospital St Gallen; Colin Johnson, Mchir, Dept of Surgery, Southampton, Hants, United Kingdom AIMS: Cachexia is a multidimensional syndrome characterized by involuntary weight loss, muscle atrophy and metabolic changes that leads to progressive functional impairment. The health-related quality of life (HRQOL) issues which are important for patients with cancer cachexia are not covered by the most commonly used cancer-specific HRQOL tools, such as the EORTC QLQ-C30. The aim of this study was to develop a cachexia specific module to supplement the EORTC QLQ-C30. METHODS: The EORTC QLG module development guidelines were followed. HRQOL issues were extracted from papers identified by a systematic review of the literature. Patient interviews (n = 20) in the UK, Norway, Switzerland and Italy were then carried out until data saturation in the combined list was reached (no new issues arising in three consecutive interviews). In a second set of patient interviews (n = 18), patients rated the importance of each issue. Health care professionals from the four countries also rated the importance of issues and checked for omissions. Items were created from the issue list by consulting the EORTC QOL item bank and relevant questionnaires. RESULTS: Combining the issues from the literature review and the patient interviews produced a list of 90 issues. The combination of some issues, modifications and removal of issues with obvious overlap with the EORTC QLQ-C30 led to a reduced issue list of 50 issues. Issues which at least two patients suggested should not be included, those with low importance scores and

Qual Life Res (2014) 23:1–184 issues which were ambiguous in terms of whether HRQOL was good or bad, were removed, resulting in 44 issues, which were used to create questionnaire items. CONCLUSIONS: A provisional questionnaire to supplement the EORTC QLQ-C30 for patients with cancer cachexia has been developed. This questionnaire will now be pilot tested across Europe with the goal of reducing the number of items ahead of the international validation study.

(2109) Gastroparesis symptom severity between patients with idiopathic and diabetic gastroparesis: are there differences? Dennis Revicki, PhD, Evidera, Bethesda, MD, United States; Michael Camilleri, Mayo Clinic; Henry Parkman, Temple University AIMS: Patient-reported outcomes that assess gastroparesis symptom severity are needed as endpoints for clinical trials. The ANMS Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) was developed to assess daily symptom severity in patients with gastroparesis. To compare symptom severity between patients with idiopathic (IG) and diabetic gastroparesis (DG) to evaluate whether the symptom experience is comparable between patients with IG and DG METHODS: Five patient samples of IG and DG patients with were included in this secondary analysis: Revicki et al. (2003; n = 169), Revicki et al. (2012; n = 69), Phase 2 study (n = 79), Parkman et al. (2013; n = 18) and Arasu et al. (2013; n = 99). The gastroparesis diagnosis was based on delayed gastric emptying based on scintigraphy. Patients completed the GCSI-DD each day for 14 to 28 days or during a clinic visit (2 week recall), assessing 5 symptoms: severity of nausea, early satiety, postprandial fullness, and upper abdominal pain, and number of vomiting episodes. We compared the samples with idiopathic and diabetic gastroparesis by confirmatory factor analysis (CFA) and item response theory (IRT) analysis to assess unidimensionality of the GCSI-DD items, and differential item functioning (DIF), as measures of differences between the IG and DG samples. All analyses were performed in the combined, IG and DG samples. RESULTS: : 433 patients (229 IG, 204 DG, mean age 44 ± 15 yrs, 76 % women) completed the GCSIDD. Mean GCSI-DD composite scores were 1.9 (SD = 0.85) on the severity scale from 0 (none) to 4 (very severe). The CFAs demonstrated good model fit for both the IG (CFI = 0.94, factor loadings 0.62 to 0.87) and DG samples (CFI = 0.94, factor loadings 0.59 to 0.84) suggesting a unidimensional scale. The 5 symptom items fit the two-parameter IRT models in both the IG (slopes 0.81 to 4.33) and DG samples (slopes 1.07 to 2.85). Based on the IRT analysis, there was good reliability of measurement across a broad range of symptom severity for the IG and DG samples. No evidence of uniform or non-uniform DIF was detected between the IG and DG samples (p [ 0.05). CONCLUSIONS: IG and DG patients experience comparable levels of the GCSI-DD core symptoms. For both IG and DG, the core symptoms covered a good range of symptom severity. The DIF analysis demonstrated that item responses were based on overall symptom severity and not on gastroparesis etiology. These 5 symptoms (severity of nausea, early satiety, postprandial fullness, and upper abdominal pain, and number of vomiting episodes) represent a unidimensional concept for gastroparesis and may be useful as a symptom assessment endpoint for clinical studies in patients diagnosed with either IG or DG.

Poster Session 2002: Friday Poster Session 2 Cancer (2002) Sex does not appear to be strongly related to problems among childhood cancer survivors-findings from online focus groups

123 Lena Wettergren, PhD, Karolinska Institute, Chevy Chase, MD, United States; Anna Jervaeus, Karolinska Institutet, Huddinge, Sweden; Jenny Nilsson, Karolinska Institutet, Huddinge, Sweden; Claudia Lampic, Karolinska Institutet; Catarina Widmark, Karolinska Institutet; Lars E. Eriksson, PhD, Karolinska Institutet, Huddinge, Sweden AIMS: Sexual life is crucial for people´s health and an area of great concern during adolescence and young adulthood. How sexuality and sexual experiences may be impacted by cancer treatment during childhood has only been studied to a limited extent and there is particularly a lack of qualitative studies. The aim of the study was therefore to investigate how childhood cancer survivors’ think and how they reason about sexuality and sexual experiences. METHODS: Data was collected through written online focus group discussions. Survivors of childhood cancer (n = 400) were identified through the Swedish Childhood Cancer Registry; diagnoses were selected with regard to that the given treatment had a possible impact on fertility. A total of 133 (36 %; aged 16–25) young survivors participated in 39 online focus group discussions using a chat platform. Transcripts were analysed according to inductive content analysis. RESULTS: The analysis resulted in one main category, ‘Sex as a given part of life’ with four generic categories: Sex being fine, Feeling insecure and falling behind, Sex related to a stable relationship and Physical concerns. Many positive feelings concerning sexuality and sexual experiences were described. However, thoughts and worries regarding sexual matters were expressed including being shy, feeling insecure and falling behind peers. Physical concerns included vaginal dryness and difficulties related to erection and reaching orgasm. Experiences and thoughts were sometimes related to the cancer experience, but in many cases not. CONCLUSIONS: Even if the participants overall thought of sex as a natural and given part of life and communicated in a relaxed way about sex and sexual experiences, the possible needs of support remains unclear. What role the health care sector can take in supporting young cancer survivors is recommended to be further studied. Furthermore, research is also recommended, preferably with a quantitative design, focusing on psychological aspects and physical concerns such as vaginal dryness and erectile dysfunction.

(2004) Global quality of life in cancer patients is less impaired than specific components of quality of life Andreas Hinz, University of Leipzig, Germany, Leipzig, Germany; Anja Mehnert, University of Leipzig, Section of Psychooncology, Leipzig, Germany; Daniel Reissmann, Univ. Med Ctr Hamburg Eppendorf, Ctr Dent & Oral Med, Hamburg, Germany; Csaba De´gi, Babes-Bolyai University, Cluj-Napoca, Romania; Do¨rte Schotte, University of Leipzig, Clinic of Palliative Care, Leipzig, Germany; Thomas Schulte, Rehabilitation Clinic Bad Oexen, Bad Oyenhausen, Germany AIMS: The main aim of this paper was to test whether detriments in quality of life (QOL) in cancer patients were less pronounced in global assessments of QOL compared to more specific components. METHODS: A sample of 2,059 cancer patients diagnosed with mixed cancer sites were examined six months after discharge from a cancer rehabilitation clinic. QOL was measured with the EORTC QLQ-C30, which comprises a global QOL scale and 14 functioning and symptom scales and symptom items. A sample representative of the general population (n = 4,476) served as controls. Regression analyses were performed to calculate expected mean scores for the patients, based on their age and gender distribution. RESULTS: Global QOL in the cancer sample (M = 69.3) was very similar to that of the general population, while the mean scores of all functioning scales, symptom scales and symptom items indicated markedly worse

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124 QOL in the patients’ sample. This general relationship between global and specific QOL was found for 7 out of 8 cancer types. CONCLUSIONS: Global QOL is not the sum of the specific parts of QOL. This should be considered when treatment effects on QOL are to be examined. One suitable alternative is to use summarizing functioning and symptom scales of higher order.

(2006) Patients’ understanding of and preferences for graphical presentation formats for quality of life scores obtained with the EORTC QLQ-C30 Wilma Kuijpers, Netherlands Cancer Institute, Amsterdam, Netherlands; Johannes M. Giesinger, PhD, Innsbruck Medical University, Innsbruck, Tyrol, Austria; Teresa E. Young, BSc, Mount Vernon Hospital, Northwood, United Kingdom; Krzsystof Tomaszewski, Jagiellonian University Medical College, Krakow, Poland; Neil K. Aaronson, PhD, The Netherlands Cancer Institute, Amsterdam, Netherlands; Bernhard Holzner, PhD BE, Univ. Hospital, Innsbruck, Innsbruck, Tyrol, Austria AIMS: The use of patient-reported outcome measures in clinical oncology practice is increasing. Various formats are used to summarize the output from these questionnaires. Little information is currently available regarding which format is best understood and accepted by patients. In the current study we are investigating patients’ understanding of and preferences for different graphical formats for the EORTC QLQ-C30. METHODS: Patients (curative or palliative) are being recruited at the Netherlands Cancer Institute (NL), the Mount Vernon Cancer Centre (UK), Innsbruck Medical University (AT) and the Jagiellonian University Medical College (PL) both during and after treatment. They are approached either by mail or at the outpatient clinic and are randomly assigned to receive one of five graphical QLQ-C30 output formats (bar charts and line charts, with or without color coding, or a heat map). A questionnaire is used to assess the objective and subjective understanding of absolute QOL scores and change scores, as well as preferences and numeracy. RESULTS: To date, 236 patients (approached N = 400) have returned a completed questionnaire (recruitment target N = 600). Their mean age is 60.1 years (SD 12.1) and 52.3 % are female. The largest group of respondents are women with breast cancer (41.4 %), followed by patients with colorectal cancer (14.9 %). Eighty-eight percent of the respondents indicated that the graphs were very easy or quite easy to understand. However, the average number of correct answers to the 12 factual questions about the graphs was 7.3. There were no statistically significant differences between graphical formats in either objectively or subjectively assessed understanding. Within non-colored charts, preferences for bar and line charts were comparable (21 % vs. 18 %, respectively), with 61 % without a preference. Within color-coded charts, bar charts (30 %) were preferred over heat maps (24 %) or line charts (16 %). Numeracy was significantly related to self-rated understanding (r = 0.36, p \ 0.001). CONCLUSIONS: Understanding was similar for the different graphical formats. Self-rated understanding may give an overly optimistic impression of actual understanding, as most patients felt that the graphs were easily understood, but the average number of correct answers was only moderate. Data collection is still ongoing, and final results will be presented at the conference.

(2008) Measuring functional domains with the EORTC QLQ-C30 and MDASI in patients with cancer Qiuling Shi, PhD, University of Texas M.D. Anderson Cancer Center, Houston, TX, United States; Xin Shelley Wang, MD MPH, UT MD Anderson Cancer Center, Houston, TX, United States; Loretta A.

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Qual Life Res (2014) 23:1–184 Williams, PhD, RN, The University of Texas MD Anderson Cancer Center, Houston, TX, United States; Tito R. Mendoza, PhD, Univ. of Texas M.D. Anderson Cancer Ctr., Houston, TX, United States; Robert Z. Orlowski, UT MD Anderson Cancer Center, Houston, TX, United States; Charles S. Cleeland, PhD, UT-MD Anderson Cancer Center, Houston, TX, United States AIMS: The EORTC QLQ-C30 is a standard measure of multiple quality-of-life domains in cancer populations. The MD Anderson Symptom Inventory (MDASI) is widely used for cancer symptom assessment. The MDASI also includes six interference items that ask patients to rate how much their symptoms interfere with functional domains. The current study aimed to describe how MDASI interference scores represent the functional dimensions assessed by the EORTC QLQ-C30. METHODS: The EORTC QLQ-C30 and MDASI were administered to two patient cohorts: multiple myeloma (MM) and colorectal cancer (CRC). Linear transformation was applied to standardize five QLQ-C30 functional subscales: physical functioning (PF), role functioning (RF), emotional functioning (EF), cognitive functioning (CF), and social functioning (SF). The six MDASI interference scales (general activity, walking, work, mood, relations with others, and enjoyment of life) were revers coded and transformed. Thus, all scores ranged from 0 to 100, with a lower score representing greater functional impairment. Pearson correlation coefficients (r) were used to address the magnitude of correlation between QLQ-C30 functional subscale scores and MDASI interference scores in each patient cohort. RESULTS: We analyzed 329 MM patients and 393 CRC patients. QLQ-C30 PF and RF mean scores and all MDASI interference mean scores revealed greater functional impairment in MM patients than in CRC patients; no significant differences between cohorts were found in QLQ-C30 EF, CF, and SF scores. In both cohorts, MDASI general activity, walking, and work interference scores correlated highly with QLQ-C30 PF and RF scores (r [ 0.5, P \ 0.0001), MDASI enjoyment of life score correlated with QLQ-C30 RF and SF scores (r [ 0.5, P \ 0.0001), and MDASI mood scores correlated highly with QLQ-C30 EF scores (r [ 0.5, P \ 0.0001). All other MDASI scales showed moderate correlations (r [ 0.3, P \ 0.01) with QLQ-C30 scales. CONCLUSIONS: Moderate to large correlations between MDASI interference and EORTC QLQ-C30 functional subscales were found in both hematological and solid-cancer patients. The six-item MDASI interference scale demonstrated comparability in measuring cancer-related functional impairment as EORTC QLQ-C30. To apply MDASI interference scales in clinical trials examining functional impairment, further studies on clinically meaningful difference, cutpoints, and sensitivity to change are needed.

(2010) Understanding the age-dependent cancer burden on pretreated health-related quality of life (HRQOL) of cancer patients using the EORTC QLQ-C30: a pooled analysis of randomized controlled trials Chantal Quinten, MSc, Researcher-Quality of Life Department, EORTC Headquarters, Brussels, Belgium; Irina Ghislain, MSc, Researcher-Quality of Life Department, EORTC Headquarters, Brussels, Belgium; Efstathios Zikos, MS MA, Researcher-Quality of Life Department, EORTC Headquarters, Brussels, Belgium; Divine Ewane Ediebah, PhD, Researcher-Quality of Life Department, EORTC Headquarters, Brussels, Belgium; Corneel Coens, MSc, Researcher-Quality of Life Department, EORTC Headquarters, Brussels, Belgium; Francesca Martinelli, MSc, Researcher-Quality of Life Department, EORTC Headquarters, Brussels, Belgium; John Maringwa, PhD, Statistical Researcher, Quantative Solutions, Breda, Netherlands; Bryce Reeve, PhD, Psychometrician, Gillings School of Global Public Health, University of North Caroline at Chapel Hill,

Qual Life Res (2014) 23:1–184 Chapel Hill, NC, United States; Jolie Ringash, MD, Radiation Oncologist, the Princess Margaret Hospital, University of Toronto, Toronto oN, Canada; Carolyn Gotay, PhD, Canadian Cancer Society Chair in Cancer, School of Population and Public Health, University of British Columbia, Vancouver BC, Canada; Eva Greimel, PhD, Associate Professor, Obstetrics and Gynecology, Medical University Graz, Graz, Austria; Madeleine King, PhD, Cancer Australia Chair in Cancer Quality of Life, Psycho-Oncology Co-Operative Research Group, School of Psychology, University of Sydney, New South Wales, Australia; Charlie Cleeland, PhD, McCullough Professor of Cancer, Department of Symptom Research, University of Texas M.D. Anderson Cancer Center, Houston TX, United States; Henning Flechtner, PhD, Director, Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany; Joseph Schmucker-Von Koch, Professor, Medical Ethics, Philosophical Faculty, University of Regensburg, Regensburg, Germany; Martin Taphoorn, MD PhD, Professor of Neuro-Oncology, VU Medical Center/Medical Center Haaglanden, Amsterdam/the Hague,the Hague, Netherlands; Joachim Weis, PhD, Professor, Department of Psychooncology, University of Freiburg, Freiburg, Germany; Galina Velikova, MD PhD FRCP, Professor of Psychosocial and Medical Oncology, Faculty of Medicine and Health, University of Leeds, Leeds, the United Kingdom; Andrew Bottomley, PhD, Director, Quality of Life Department, EORTC Headquarters, Brussels, Belgium on Behalf of EORTC Patient Reported Outcomes and Behavioural Evidence and the EORTC Clinical Groups AIMS: As selected successful treatments allow us to think of certain cancers as chronic diseases, it is imperative to understand how cancer affects a patient’s pre-treated health-related quality of life (HRQOL) in an ageing population. The object of this study was to assess how cancer can affect a person’s HRQOL and whether his or her healthrelated quality of life is age-dependent. METHODS: EORTC used a large cohort of 25 closed ‘‘Randomized Controlled Trials’’ pooled together. HRQOL mean scores, using the EORTC QLQ-C30, were calculated for three previously defined age categories: \50; 50-70, [70. These were compared with cohorts of the German and Norwegian general population to assess the impact of cancer on the HRQOL of a cancer patient. Within the cancer cohort, linear regression models were used to investigate the association between each age category and HRQOL, adjusted for the well-established clinical factor gender, WHO performance status, extent of disease. RESULTS: The results indicated that increasing age had a negative influence on a cancer patient’s HRQOL. In the oldest and the youngest age category, certain HRQOL domains, although not the same, were significantly lower in cancer patients (p \ 0.05) as compared to the general population. There were significant covariates of worsening HRQOL, besides the increasing age, they included worsening metastatic disease, poorer performance status and gender. Women tended to have worse HRQOL than men (p \ 0.05). CONCLUSIONS: Our study provides information regarding the HRQOL of cancer patients with different age profiles and identified additional covariates influencing HRQOL. The results could be used to select or stratify patients for clinical trials in which HRQOL is an outcome and to target clinical assessment and decision making.

(2014) Translating Patient-Reported outcomes into DecisionMaking in Malignant Hematology Samuel Salek, Cardiff University, Cardiff, United Kingdom; Esther Natalie Oliva, Azienda Ospedaliera B-M-M, Hematology Unit, Reggio Calabria, Italy; Tatiana I. Ionova, Multinational Center for Quality of Life Research, St. Petersburg, Russian Federation; Robert Klaassen, MD, Children’s Hospital of Eastern Ontario, Ottawa, ON, Canada; Denis A. Fedorenko, PhD, National Medical Surgical Center,

125 Moscow, Russia; Anita Waldmann, Myeloma Patients Europe, Germany AIMS: During the last decade, patient-reported outcomes (PROs) have become increasingly important in blood cancer treatment. However, in everyday clinical practice physicians rarely incorporate PROs into their decision-making. Hematological malignancies include various acute and chronic, often incurable, diseases with variable prognoses. PROs are indicators for assessing the impact of disease and treatment for a given patient. Incorporation of PROs in decision making in malignant hematology provides solid ground for an individualized approach to treatment and for the improvement of quality of care of blood cancer patients. During the last few years the activities of the European Hematology Association Scientific Working Group ‘‘Quality of Life and Symptoms’’ have been focused on highlighting the importance of this topic and developing the approach to incorporate PROs into everyday clinical practice. METHODS: During initial assessment, which includes patient history and physical exam, the knowledge and experience of the physician, together with signs, symptoms and other patient reports, combine for an accurate medical diagnosis. RESULTS: Prognostic value of base-line QOL for survival in patients undergoing hematopoietic stem cell transplantation was demonstrated: overall and event-free survival was 78 and 68 % in patients with good QOL vs 66 and 58 % in patients with poor QOL (p = 0.02). The findings of the recent international survey of the former Myeloma Euronet (314 healthcare professionals from 43 countries and 260 myeloma patients from 21 countries) aimed to compare the opinions of healthcare professionals with that of patients’ and patient’s relatives/caregivers regarding myeloma treatment side effects and potential unmet patient needs revealed the discrepancies between the patients’ and clinician’s assessment of symptom burden in multiple myeloma patients: according to physicians and nurses, neuropathy has the most negative impact on a myeloma patient’s overall well-being, whereas stated that fatigue/weakness/dizziness/ somnolence/sedation/insomnia were the treatment side effects with the most negative impact. PROs have gradually been incorporated into pediatric research in hematology/oncology, but only rarely in the clinical setting. Preliminary data outline the potential pitfalls as well as the clear benefits of incorporating PROs into the pediatrician’s office. CONCLUSIONS: Thus, systematic routine use of the PRO in hematological clinical practice may provide useful patient-centered information to aid treatment decision-making.

Musculoskeletal/Rheumatology (2016) Treatment discontinuation in Rheumatoid Arthritis: a matter of HRQOL?—Development and Field-Test of a questionnaire Sandra Meyer-Moock, University Medicine Greifswald, Institute for Community Medicine, Greifswald, Germany; Julia Schiffner-Rohe, Pfizer Deutschland GmbH; Friedhelm Leverkus, Pfizer Deutschland GmbH; Thomas Kohlmann, PhD, University of Greitswald, Inst. For Comm. Med., Greitswald, Germany AIMS: For patients with rheumatoid arthritis (RA) with inadequate response to traditional disease-modifying anti-rheumatic drugs (DMARDs), a treatment with biologics is recommended to reduce disease progression and the degree of suffering and therefore ultimately improve the health-related quality of life (HRQOL). Nevertheless, up to 30 % of patients stop treatment on their own initiative. The aim of the study is to develop an instrument to assess treatment satisfaction, reasons for treatment discontinuation of biological therapy as well as to assess HRQOL in patients with RA. In addition targeted measures to improve patient adherence will be

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126 developed. METHODS: The study consists of three phases with qualitative and quantitative methods. Phase 1 (qualitative development phase), consists of expert interviews with rheumatologists (n = 5) in order to develop a questioning route for patient interviews. Subsequently we conducted focus group interviews with RA-patients (n = 2 with 15 patients) and developed a draft questionnaire based on this information. In a field-test (phase 2) patients were asked to complete the draft questionnaire and to comment on it briefly in an interview. Qualitative data analysis consists of content analysis methods (qualitative content analysis, Mayring); using MAXqda. RESULTS: Expert and focus group interviews showed that HRQOL aspects as well as treatment and working life aspects have an impact of treatment satisfaction or discontinuation. Particularly, patients mentioned information about treatment options, patient-doctor relationship and financial burden as important aspects. The developed questionnaire consists of 53 items covering socio-demographic aspects, HRQOL, history of treatment and disease, treatment information, expectations and satisfaction as well as reasons for discontinuation. The questionnaire has proven to be feasible and appropriate in field-test. CONCLUSIONS: Although HRQOL is important to patients, it does not seem to exhaustively reflect the reasons for treatment adherence. In addition to generic and diseasespecific HRQOL-questionnaires, an individually developed questionnaire is necessary to identify further reasons for treatment discontinuation, develop strategies for improved adherence and consequently increase treatment satisfaction and HRQOL. The pilot version of the questionnaire is currently validated in the field (phase 3), including factor analysis, distribution of properties, floor and ceiling effects, percentage of missing values and subgroup analysis.

(2018) Measuring Health-Related Quality of Life (HRQOL) in patients with Musculoskeletal Infections—a Systematic review You-Shan Feng, PhD, Institut for Community Medicine, Medical University Greifswald, Greifswald, Germany; Dawid Pieper, Institute for Research in Operative Medicine, Witten/Herdecke University; Michaela Eikermann, Institute for Research in Operative Medicine, Witten/Herdecke University; Thomas Kohlmann, PhD, University of Greitswald, Inst. For Comm. Med., Greitswald, Germany AIMS: Although musculoskeletal infections are often devastating for the patient and associated with serious health consequences, very little is known about patients’ quality of life and subjective health. This enormous lack of knowledge contrasts with the increasing importance of subjective health parameters and patientreported outcomes in medical research, clinical decision-making and health policy. We aimed to summarize and assess the available literature addressing HRQOL for patients with various types of bone and joint infections and the measurement tools that have been used to assess these patients. METHODS: Six electronic databases (Medline, Embase, Psycinfo, Psyndex, ISI Web of Science and CINAHL) were searched for relevant publications from inception through February 2011. Study selection was independently performed by two reviewers. Data extraction was conducted by one reviewer into structured summary tables and checked by a second reviewer for accuracy. All discrepancies were discussed until a consensus was reached. Information on the HRQOL instruments was extracted from identified studies. Source publications, validation studies and review papers, from which we extracted further information on HRQOL instrument, were then obtained. We evaluated the HRQOL instruments on eight broad attributes: measurement model, reliability, validity, responsiveness, acceptability, interpretability, administration and language adaptations. RESULTS: Sixty-two publications, representing 59 studies, were finally included in the review. Most studies dealt with infections of

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Qual Life Res (2014) 23:1–184 joints or long bones. There was much variety with respect to study designs and the timing of data collection. Forty-two HRQOL instruments were found in included studies, of which 18 were selected based on their wide applicability and frequent application in practice. We found SF-36 and SF-12 to be the most popular instruments, with the WOMAC and ODI the distant next most popular instruments. The majority of the 18 reviewed instruments have good evidence for psychometric properties. CONCLUSIONS: While many studies employing HRQOL instruments to measure outcomes for patients with skeletal infections were identified, there was no clear standard instrument that seemed to be preferred. Existing HRQOL instruments need to be tested in well-defined patient groups with skeletal infection and their applicability specifically tested.

(2020) Comparison of health outcome measures used with upper extremity Musculoskeletal Disorders: Health-Related quality of life of persons transitioning towards retirement Catherine P. Gelinas, University of Western Ontario, London, ON, Canada; Joy MacDermid, PhD, McMaster University, Hamilton, ON, Canada AIMS: Upper extremity musculoskeletal disorders (UED) are among the most common chronic conditions in today’s ageing population, having a substantial overall impact on levels of physical activity, mental health, and quality of life (QOL). Objective: to examine the health-related QOL of persons living with UED, aged 50–65, and transitioning into retirement. By gathering and assessing data on UED, barriers and limitations can be identified and potential health interventions developed, in turn, contributing towards a successful transition into retirement. METHODS: Data (1994–2011) collected from the Roth | McFarlane Upper Hand and Limb Clinic, London, Ontario, Canada identified 1386 patients, aged 50–65, with UED. A retrospective comparative and subjective assessment was undertaken testing correlations between multiple health outcome domains and the Medical Outcomes Study—SF-36 Health Survey. Scores for specific domains of Comorbidity, Pain, and Joint Specific Function were constructed by aggregating subscales of self-report SCQ, PREE, PRWE, ASES, Spadi, WORC health measures. Pearson’s correlation coefficients (r) were calculated, inclusive of R2 and ß effects while controlling for age, gender, and occupational status. RESULTS: Mobility, pain levels, and evidence of chronic disorder(s) were predicted scores on the SF-36 Physical Component; r = 0.199; p \ 0.05 with Joint Specific Function: ß -0.207; Pain: ß -0.085; Comorbidity; ß -0.077. Mobility measure of Joint Specific Function alone predicted scores on SF-36 Mental Component: r = -0.204, ß -0.156, p \ 0.05. CONCLUSIONS: Measures of multi-morbidity are often applied to source data on populations and health outcomes outside the scope of their original use. The co-existence of UED and chronic disease(s) involve pain, psychological, and physical limitations. Given the high prevalence and substantial impact on health-related QOL, there is a need to systematically begin answering important practical issues on health-related outcomes by developing health promotion tools that support people, aged 50–65, moving towards retirement.

(2022) Assessment of quality of life (QOL) in postmenopausal osteoporosis in poland Mariola Drozd, Department of Applied Pharmacy, Medical University of Lublin, Lublin, Poland; Monika Szkultecka-Debek, Military Institute of Medicine, Warsaw, Poland; Kazimierz Drozd, Lublin University of Technology, Lublin, Poland; Maria Michalik,

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Department of Hospital Pharmacy, AMG Medical Center, Ryki, Poland; Nina Kiepurska, Dermatology, Military Institute of Medicine, Warsaw, Poland AIMS: Postmenopausal osteoporosis is related to the changes in female body during menopause. Most of the factors predisposing to the development of osteoporosis in this period include estrogen deficiency, low physical activity, dietary deficiency or reduced absorption of calcium, diseases accompanying elder age, certain medications, and stimulants. The aim was to assess the quality of life of women in Poland suffering from postmenopausal osteoporosis. METHODS: The study has received a positive Ethical Committee opinion. Data were obtained from standardized osteoporosis QOL questionnaire—Qualeffo-41. The survey was conducted in April 2013 in a group of women with postmenopausal osteoporosis treated in ambulatory. RESULTS: In total 55 questionnaires were collected. Average age was 70 years (median 72, min. -54, max. -86). Last menstruation declared was between 40 and 56 years. Average age was 49 (median 50 years). 41 women were city inhabitants, which accounted for 74.5 %, while in rural areas inhabited 14, accounting for 25.5 %. 28 women were married (50.9 %), 25 widows (45.5 %) and 2 maidens, accounting for 3.6 %. Patients’ weight was between 42 and 102 kg. Average weight was 62 kg (median 60 kg). 45 patients weighted less than 70 kg, which accounted for 82 %. Lowest patient had 147 cm, the highest 170 cm (mean-158 cm, median 160 cm). The results of the individual domains of the questionnaire indicate that lowest rate was for overall health—an average of 20.45 ± 18.83 SD. The functioning during free time and opportunities for social contact were rated on an average of 36.23 ± 25.77 SD. Mental functions were assessed on average as 46.86 ± 14.15 SD. Pain assessment resulted in an average of 45.00 ± 25.36 SD. The highest result was for physical functioning with an average value of 54.65 ± 15.30 SD. CONCLUSIONS: The analysis showed that Polish women suffering from postmenopausal osteoporosis have rather a low quality of life, on average, 41.9 (median—40.48, min.—11.56, max.—85.77, SD—19.04). The results suggest further research to test QOL at beginning of therapy and to monitor during treatment, analyzing the domains that most needs improvement.

(2024) Ceiling effect limits Utility of the Multidimensional Fatigue inventory to detect clinical meaningful fatigue in chronic Fatigue Syndrome Xin Shelley Wang, MD MPH, Univ. of Texas MD Anderson Cancer Center, Houston, TX, United States; Qiuling Shi, PhD, Univ. of Texas MD Anderson Cancer Center, Houston, TX, United States; Suzanne D. Vernon, The CFIDS Association of America AIMS: Ceiling effect has been observed in the fatigue assessments in clinical studies of chronic fatigue syndrome (CFS). Stouten (2005) noted that over 40 % of items on the Checklist Individual Strength, Chalder Fatigue Scale, and Krupp Fatigue Severity Scale easily reached the extreme ends of their scales in evaluations of fatigue in CFS. The Multidimensional Fatigue Inventory (MFI-20) was validated in a population-based sample (Lin et al. 2009), without significant concern for ceiling effect among the CFS-like patients (13 % at ceiling on general fatigue and 6.5 % at ceiling on physical fatigue subscale). Although widely used, whether there is a ceiling effect on MFI-20 for CFS patients who are suffering from severe fatigue is unclear. METHODS: 240 CFS patients and 84 healthy controls enrolled in a CFS registry provided MFI-20 data. Operationally, chronic fatigue was defined as unusual fatigue lasting over 6 months. The scores from 5 subscales of the MFI-20 were calculated and ceiling effect was reviewed by percentage of patients reporting at

Fig. 1 . the extreme end of the scale. RESULTS: In CFS patents, the median of general fatigue and physical fatigue subscale were both 19 points, and reduced activity was 17 points, all of which were significantly higher than the control group at 8, 6, and 6 points on these 3 subscales (all P \ 0.001), see Fig. 1. Nearly all of the 4 individual items on the general fatigue subscale had at least 60 % of patients at the ceiling; for this subscale, 40 % were at the ceiling. Over 50 % were at ceiling for all 4 items on physical fatigue scale, with 37.5 % at ceiling for the subscale. On the reduced activity subscale, 67.5 % reached ceiling on one item, with the remaining items under 40 % at ceiling. Fewer than 40 % of patients at ceiling level on the reduced motivation and mental fatigue subscales of the MFI-20. CONCLUSIONS: Although it has favorable psychometric properties in CFS-like patients, the MFI-20, similar to other fatigue tools, the accuracy was compromised by ceiling effects on the critical subscales representing severe fatigue in CFS patients that is necessary to detect clinically meaningful fatigue for CFS clinical research. Acknowledgement: The CFIDS Association of America provided the data for this study.

Nephrology/Urology (2026) Using analytic morphomics to understand Short-Term convalescence After Bladder Surgery John M. Hollingsworth, University of Michigan, Department of Urology, Ann Arbor, MI, United States; Jeffrey S. Montgomery, University of Michigan, Ann Arbor, MI, United States; Scott M. Gilbert, MD, H Lee Moffitt Cancer Center, Tampa, FL, United States; Michael Engelsbe, University of Michigan; Stewart Wang, University of Michigan; Brent Hollenbeck, MD, MS, University of Michigan, Ann Arbor, MI, United States AIMS: When selecting patients upon whom to operate, surgeons must balance the indications for the procedure with their perception of the patient’s ability to recover from it. To help in their decision making, better risk assessment measures are needed. In this context, we evaluated for associations between preoperative imaging data and short-term convalescence following bladder surgery. METHODS: After identifying patients who underwent bladder removal for bladder cancer at our institution (2008 to 2013), we calculated their psoas muscle area from preoperative imaging using analytic morphomic techniques. We then determined early recovery among patients with high and low psoas muscle area using the Convalescence and Recovery Evaluation (CARE) questionnaire. CARE consists of 27

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Qual Life Res (2014) 23:1–184 (ICC) ranging from 0.73 to 0.92 for the KHQ domains. Construct validity was supported by the confirmation of predefined hypotheses involving expected significant correlations between KHQ domains, SF-36 dimensions (that covers similar constructs) and clinical parameters. CONCLUSIONS: The Portuguese KHQ exhibited suitable psychometric properties, in terms of internal consistency, reproducibility and construct validity.

Rehabilitation (2032) Do environmental factor measures identify distinct or Common Elements?

Fig. 1 Comparing changed in CARE scores from baseline after bladder surgery among women in high and low psoas muscle area groups items that are divided into 4 domains: activity, cognitive, gastrointestinal (GI) symptoms, and pain. Domain scores range from 0 to 100, with higher scores corresponding to a better health state; these scores can be combined to generate a total score. Finally, we assessed the relationship between psoas muscle area and changes in CARE scores with nested linear regression models. RESULTS: While there was no difference in recovery among men in the high and low psoas muscle area groups, women in the high group had smaller decreases in their pain scores postoperatively, and they returned to their baseline faster (Fig. 1). Although a similar pattern was observed for women with regards to their activity levels, cognitive and GI symptom scores did not vary between the high and low groups. After adjusting for patient age, there was a trend towards quicker recovery in postoperative pain among women with increasing psoas muscle area (p = 0.059). CONCLUSIONS: Psoas muscle area is potentially an important preoperative predictor of recovery for women undergoing bladder surgery. Analytic morphomics may represent a novel approach to better understand patient risk.

(2030) Measuring Health-Related quality of life in women with urinary incontinence: reliability and validity of the portuguese version of the king’s health questionnaire (khq) Rui Soles Goncalves, PhD, Centre for Health Studies and Research of the University of Coimbra, Coimbra, Portugal; Carla Gabriel, Alcoita˜o Health College; Carina Martins, Alcoita˜o Health College; Anto´nio Fernandes Lopes, Alcoita˜o Health College; Luis Manuel Cavalheiro, PhD, Centre for Health Studies and Research of the University of Coimbra, Coimbra, Portugal; Pedro L. Ferreira, PhD, University of Coimbra, Coimbra, Portugal AIMS: The objective of this study was to test the reliability and validity of the King’s Health Questionnaire (KHQ) to the European Portuguese language. METHODS: The Portuguese version was obtained after forward/backward translations, consensus panels and a cognitive debriefing pre-test. With the MAPI permission, the Portuguese KHQ-2 (21 items) were included into the Portuguese KHQ (21 ? 11 items). To test the validity of this new instrument, we also included in this study the Portuguese version of SF-36, as well as a socio-demographic and clinical questionnaire. RESULTS: We administered the questionnaire to a sample of 120 women with urinary incontinence. The reliability was good with Cronbach’s alpha coefficients between 0.76 and 0.93 [with the exception of ‘‘physical limitations’’ (0.67) domain], and the intraclass correlation coefficients

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Allen W. Heinemann, Northwestern University, Chicago, IL, United States; Ana Miskovic, Rehabilitation Institute of Chicago; Alex Wong, PhD, Rehabilitation Institute of Chicago, Chicago, IL, United States; David Gray, Washington University; Holly Hollingsworth, Washington University; Jin-Shei Lai, PhD, Northwestern University, Chicago, IL, United States; Susan Magasi, University of Illinois; Joy Hammel, University of Illinois; David Tulsky, PhD, Kessler Foundation, New York, NY, United States; Elizabeth Hahn, MA, Northwestern University, Chicago, IL, United States; Sofia Garcia, PhD, Northwestern University, Chicago, IL, United States; Sara Jerousek, Rehabilitation Institute of Chicago, Chicago, IL, United States AIMS: Environmental factors (EF) can profoundly affect quality of life for people with disabilities. Most EF measures have been developed using clinimetric or classical test theory methods. Contemporary mixed-methods approaches to instrument development allow improved measurement of EF constructs. The aims of this study were to evaluate the construct validity of two new EF measures that we developed using item response theory (IRT) methods; they measure the built and natural environment (BNE), corresponding to Chapter 2 of the ICF’s Environmental Factors, and systems, services, and policies (SSP, ICF Chapter 5). METHODS: We recruited a sample of 604 community-dwelling adults with spinal cord injury, stroke, and traumatic brain injury. We administered the 13-item BNE instrument and the 41-item SSP instrument using a computeradministered platform. We evaluated convergent validity with the Craig Hospital Inventory of Environmental Factors (CHIEF) short form, the Home and Community Environment Survey (HACE), the Measure of the Quality of the Environment (MQE), and four PROMIS instruments (Emotional, Informational, Instrumental support, and Social Isolation). The CHIEF assesses physical, attitudinal, and policy barriers that limit participation. The HACE measures aspects of home and community environments that influence participation. The MQE measures environmental influences on daily activities. We evaluated predictive validity with the PROMIS Ability to Participate and Satisfaction with Social Roles and Activities instruments. We computed Spearman correlation coefficients among the scores. RESULTS: The sample reported low levels of BNE (-2.5 ? 1.6 logits) and SSP barriers (-1.0 ? 1.4). Greater BNE barriers were associated with higher CHIEF (0.43) and PROMIS social isolation (0.31) scores (all p values \0.001). Greater SSP barriers were associated with the CHIEF (0.33), and PROMIS Informational Support (-0.41), Instrumental Support (-0.38), and Social Isolation (0.35). BNE and SSP scores correlated moderately (0.36). BNE and SSP barriers were associated with PROMIS Ability to Participate (-0.45, -0.32, respectively) and Satisfaction with Social Roles and Activities (-0.38, -0.34). CONCLUSIONS: The BNE and SSP measures demonstrate evidence of convergent and predictive validity. They measure distinct ICF EF domains reliably and can be considered for epidemiologic and clinical trials.

Qual Life Res (2014) 23:1–184 (2034) Gender differences in physical and mental HRQOL over the course of one year after musculoskeletal rehabilitation in Germany Kerstin Mattukat, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany; Inge Ehlebracht-Koenig, Rehazentrum Bad Eilsen der Deutschen Rentenversicherung Braunschweig-Hannover; Karin Kluge, Teufelsbad Fachklinik Blankenburg; Wilfried Mau, Martin Luther University Halle-Wittenberg AIMS: To investigate gender differences and additional influencing factors in the one-year-course of the physical and mental healthrelated quality of life (HRQOL) after inpatient rehabilitation of patients with inflammatory rheumatic diseases or back pain. METHODS: A study to promote physical activity after musculoskeletal rehabilitation assigned patients either to the usual programme or to a new intervention group. The patients were asked to fill in questionnaires at four points in time (t1 = baseline, t2 = discharge, t3 = 6-months-follow-up, t4 = 12-months-follow-up). In a first step, gender differences in the one-year-course of the physical (PCS) and mental component score (MCS) of the SF-12 were analyzed by variance analyses with repeated measures. Secondly, bivariate analyses identified other influencing factors of the one-year-course of HRQOL in addition to gender. Finally, gender differences were tested in multivariate covariance analyses, controlling for age, diagnosis and all other bivariate significant covariates. RESULTS: In univariate analyses, women (n = 167) had a lower MCS than men (n = 188) at all time-points (p \ 0.01), whereas their PCS showed no differences over time (n.s.). Both PCS and MCS of all patients increased over time (p \ 0.001). Controlling for gender, the one-year-courses of the PCS and MCS were differently related to socio-demographic, mental and physical health-related as well as work-related and motivational parameters at baseline. Highly correlated parameters of the PCS (pain, function, impairments of activities of daily living [ADL]) and MCS (anxiety, depression) were excluded from multivariate analyses due to multi-collinearity. In the multivariate analyses, a gender effect was detectable for PCS (p \ 0.01), whereas the univariate gender effect for MCS disappeared (n.s.) (Fig. 1). Controlling for gender and all bivariate significant covariates, influences over time were found for age (PCS), indicators of physical health (PCS, MCS), work-related factors (PCS) and exercise motivation (MCS). CONCLUSIONS: Male and female inpatients with musculoskeletal diseases differed substantially in their HRQOL in the course of one year after discharge. In addition to gender, age, physical function, and work-related factors were important predictors of physical HRQOL. No gender effect for MCS

129 remained after controlling for covariate influences. Instead, fatigue and impairments of ADL were predictors of MCS.

(2036) Confirmatory factor analysis and reliability of the burn specific Health Scale—Revised in burned adults in Brazil Noelle O. Freitas, Ribeira˜o Preto College of Nursing University of Sa˜o Paulo; Marina Caltran, Ribeira˜o Preto College of Nursing University of Sa˜o Paulo; Suleimy C. Mazin, University of Sa˜o Paulo at Ribeira˜o Preto School of Medicine, Sa˜o Paulo, Brazil; Rosana Spadoti Dantas, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil; Lidia A. Rossi, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil AIMS: To analyze the reliability and confirmatory factor structure of the Brazilian Portuguese Version of the Burn Specific Health ScaleRevised (BSHS-R) in a sample of Brazilian burns victims METHODS: Methodological study carried out at the Burns Unit of a University Hospital in Ribeira˜o Preto, Sa˜o Paulo, Brazil. The BSHS-R is a specific instrument to assess the perceived health status of burns victims. It contains 31 items, distributed in six domains, and measured on a 5-point Likert scale (higher score provide better indications of the assessment of the perceived health status). Inclusion criteria were individuals: over 18 years of age, undergoing rehabilitation burns, without preliminary psychiatric diagnoses and/or cognitive impairments. The internal consistency was analyzed by Cronbach’s alpha, considering coefficients = 0.70 as appropriate. The confirmatory factor analysis tested the hypothesis that the Brazilian Portuguese version of the BSHS-R has a similar factor structure to the original, using the AMOS IBM SPSS version 21.0 for Windows. The adjustment indexes used to establish model fit were RMSEA (= 0.08) and CFI (= 0.95). RESULTS: A sample of 299 burn victims was enrolled; most of them had low level of education (mean eight years of education), 55.5 % were men, and the mean age was 37.5 years (SD = 12.9). The mean of body surface area burned was 16.8 % (SD = 15.0 %). The BSHS-R Brazilian Portuguese version showed high internal consistency for the total scale (a = 0.93) and ranged from 0.74 to 0.91 for the domains. In general, the confirmatory factor analysis showed moderate to high factor loadings between the domains and their respective items (0.43–0.89). The confirmatory factor analysis showed greater co-variances between the domains ‘‘Affect/Body Image’’ and ‘‘Treatment Regimens’’; and between ‘‘Affect/Body Image’’ and ‘‘Interpersonal Relationships’’. The model fit indexes were RMSEA = 0.07 and CFI = 0.87. CONCLUSIONS: The BSHSR Brazilian Portuguese version showed high internal consistency coefficients and the model fit indexes proposed were satisfactory. The confirmatory factor analysis is another form of construct validity. The domains of the BSHS-R measure the construct perceived health status. (The study was sponsored by FAPESP: 2010/10006-8).

(2038) comparative study of the quality of life between people with vasculogenic ulcers and the general population Beatriz Farias Alves Yamada, Universidade do Estado do Amazonas, Brasil; Vera Lucia CG Santos, PhD, University of Sa˜o Paulo, Sa˜o Paulo, Brazil; Vera Lucia CG Santos, PhD, University of Sa˜o Paulo, Sa˜o Paulo, Brazil; Carol V. Serna Gonza´lez, Escola de Enfermagem da USP; Mily CM Ramos, Escola de Enfermagem da USP; Danielle C. Soares, Escola de Enfermagem da USP; Luciana A. Pacheco, Hospital Darcy Vargas

Fig. 1 .

AIMS: Comparatively analyze quality of life (QOL) and its associated social factors between people with vasculogenic ulcers (VU) and the general population (GP). METHODS: A quantitative, descriptive and cross-sectional study, secondary to Yamada and Santos, approved

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130 by the Ethics Committee. Convenience samples, composed by 222/362 people with VU and 208/624 of GP (paired sample from the Kimura database) were interviewed using, respectively, the Index of Quality of Life Ferrans & Powers, Wounds Version (Health-related Quality of Life -HRQOL 0–30 pts) and Generic III, demographic and clinical data (for UV). Samples were differed by educational level and partners presence (p \ 0.001, Chi square test). RESULTS: QOL scores were lower (p \ 0.001) for the VU group, in particular on the health and Functioning subscale (9.5 SD = 2.9, 95 % CI 9.2 to 9.9; student t test). Regression model explained variation from 4.10 to 13.20 % for the VU group using the variables age (p = 0.015), female sex (p = 0.021), religious practice (p = 0.038) and base disease CRF (p = 0.001). QOL scores in the group with VU and without companion was lower (20.7 points) compared with the group of PG (23.1 points) (p = 0.001). A variable without a family companion (p = 0.011) reduced 1.9 points HRQOL for the VU group, which was not observed in the GP group. CONCLUSIONS: Using previous categorization, we conclude that QOL is good for people in both groups, although worse for the VU group, especially on the Health and Functioning subscale, confirming the negative influence of vasculogenic ulcer on QOL. However, the presence of family companion may increase it, demonstrating the family social support importance in coping wound.

(2040) How well do environmental factor measures cover the international classification of functioning disability and health domains? Allen W. Heinemann, Northwestern University, Chicago, IL, United States; David Gray, Washington University; Rebecca Simon, MSOT/ S, Occupational Therapy Program, Washington University School of Medicine, St. Louis, MO, United States; Brittany Perez, OTR, Research Associate, Center for Inclusive Design and Environmental Access, University at Buffalo, State University of New York, Buffalo, NY, United States; Susan Magasi, University of Illinois; David Tulsky, PhD, Kessler Foundation, New York, NY, United States; Joy Hammel, University of Illinois; Elizabeth Hahn, MA, Northwestern University, Chicago, IL, United States; Sofia Garcia, PhD, Northwestern University, Chicago, IL, United States; Jin-Shei Lai, PhD, Northwestern University, Chicago, IL, United States; Sara Jerousek, Rehabilitation Institute of Chicago; Alex Wong, PhD, Rehabilitation Institute of Chicago, Chicago, IL, United States AIMS: The aim of the study was to link International Classification of Functioning Disability and Health environmental factor codes (ICF-EF) to items on newly developed, PROMIS, and legacy measures to examine coverage patterns. METHODS: We selected four legacy measures including the Facilitators and Barriers Survey/Mobility (FABS/M), Craig Hospital Inventory of Environmental Factors (CHIEF), the Home and Community Environment Survey (HACE), and the Measure of the Quality of the Environment (MQE), four PROMIS instruments (Emotional, Informational, Instrumental support, and Social Isolation), and six new environmental factor measures. We adopted Cieza and colleagues’ linking rules. Two raters coded EF items independently. In the case of discrepancies, raters closely examined codes and selected the best fitting one. Raters assigned multiple codes if more than one code was appropriate. RESULTS: Across all measures, raters assigned 211 codes to 603 EF items. All five ICF-EF chapters were represented, with the most (36 %) in ICF-EF Chapter 1 (products and technology) and the fewest (8 %) in Chapter 2 (natural environment/human-made changes to the environment). The new measures represented every ICF-EF chapter with the most (40 %) in Chapter 4 (attitudes). PROMIS measures reflect only Chapter 3 (support and relationships) and Chapter 4 (attitudes), with a heavy concentration (91 %) in Chapter 3. The legacy instruments link to all ICF-EF chapters, with the majority (54 %) in Chapter 1 (products and

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Qual Life Res (2014) 23:1–184 technology). CONCLUSIONS: ICF codes are a useful tool for sorting measures that cover specific aspects of the environment and for assessment of which areas are not covered by a measure. Knowing which measures cover specific ICF-EF codes allows investigators interested in the influence of environmental factors on the lives of people with disabilities to select measures that cover their interests. Conversely, knowing what areas of the ICF classification framework are covered by different measures allows for informed choices in selecting measures. The linked measures identify gaps in the current version of the ICF for describing the environment and may provide recommendations for more comprehensive descriptions and codes.

Quality of Care/Patient Satisfaction (2042) Assessment of Health-Related quality of life of the nurses in the intensive care unit of the city of Sa˜o Paulo—Brazil Luciana S. Costa Santos, Faculdades de Cieˆncias Me´dicas Da Santa Casa de Sa˜o Paulo, Sa˜o Paulo, Brazil; Miako Kimura, PhD, University of Sa˜o Paulo, School of Nursing, Sa˜o Paulo, State of Sa˜o Paulo, Brazil AIMS: Examining the relationship between working conditions and HRQOL of nurses in ICUs in the city of Sa˜o Paulo. METHODS: This is a descriptive study, sectional approach with quantitative data. Was used for evaluation of HRQOL instrument—Medical Outcomes Study 12-Item Short Form Health Survey. The data were collected in 18 hospitals in the city of Sa˜o Paulo (13 private, 03 public and 02 philanthropic). The sample of nurses was composed of 184 nurses. RESULTS: An analysis of the correlation between HRQOL and sociodemographic characteristics was significant for physical component to the variables sex and time of academic training. In the mental component of SF 12 correlation only for the age variable. CONCLUSIONS: It is noteworthy that, for a quality care, it is necessary that the professionals are also satisfied with the working conditions and who have a health condition that makes it possible to ‘‘take care’’ of another, therefore, the whole time our technical capacity in scientific is tested because in ICU decision-making is immediate requiring ever more of nurses their continuous training and effective in order to minimize errors.

(2044) Structured program for monitoring patients with heart failure and/or chronic obstructive pulmonary disease: one year results ´ lvarez, RN, Institut Catala` de La Salut, Barcelona, M. Clara Sala A Spain; Maria Luisa Marti Aguasca, Institut Catala` de La Salut; Jose´ Luis Del Val Garcia, Institut Catala` de La Salut; Mireia Boixadera Vendrell, Institut Catala` de La Salut; Enriqueta Borra`s Gallart, Institut Catala` de La Salut AIMS: Heart failure and Chronic Obstructive Pulmonary Disease (COPD) are two of the priority diseases of Catalonia 2011–2015 Health Plan and the Programme for Prevention and Chronicity Care of the Generalitat of Catalonia Health Department. In order to improve patient care for this population and to increase self-care and improve ` mbit Barcelona Ciutat their quality of life, the management team of A (Catalan Institute of Health), has implemented an structured monitoring program for these patients that includes an educational and/or watchful intervention depending on the clinical risk of readmission and that combines visits in clinic and telephone follow-up. The goal was to assess the effectiveness of the program in relation to the level of self-care, the use of health care resources and the perceived quality of life. METHODS: Community pilot study was implemented in 2012 in patients with HF and/or COPD. The following year, the program was evaluated in terms of coverage and analysis of self care levels, medication adherence, use of health care services and perceived quality of life (EuroQol). RESULTS: Coverage October 2013: 72.5 % in IC i

Qual Life Res (2014) 23:1–184 62.7 % in COPD. Increase of nursing activity, especially on the telephone (?26.7 % to ?23.4 % i IC and COPD) and decrease of visits to the health center (-4 to 1.3 % i IC COPD) and improvement of the perceived quality of life. CONCLUSIONS: The program allows each professional to stratify an assigned population based on the complexity and the risk of admission, emphasizing on self-care or monitoring depending on the state of the patient (stable or at risk), thus contributing to regulate the demand for care intervention. The measurement of variables such as quality of life, self-care rating scales and therapeutic management has led to a progressive increase of data collection, very useful in order to approach this specific population.

(2046) Generation of Post-Surgical concerns and expectations using concept elicitation interviews with patients with thyroid cancer Thomas M. Atkinson, PhD, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Elyse Shuk, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Dorothy Thomas, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Monica M. DiLorenzo, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Safina Ali, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Jamie S. Ostroff, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Snehal G. Patel, Memorial Sloan Kettering Cancer Center, New York, NY, United States AIMS: The incidence of thyroid cancer is increasing rapidly, with surgical resection the primary modality for clinical management. Patients show considerable variability in their post-surgical concerns and expectations, which can negatively influence their quality of life. The absence of a reliable and valid measurement tool is a barrier to identify and address the pre-surgical concerns of patients diagnosed with thyroid cancer. The initial step of the measurement development process was to determine the most relevant post-surgical concerns and expectations through one-on-one concept elicitation interviews with thyroid surgery patients. METHODS: Using a list of interview probes developed by an expert panel, 15 patients within 4-weeks prior to thyroid surgery were asked in semi-structured interviews to express their concerns and expectations about surgery for their malignant thyroid tumors. These same 15 patients were then interviewed within 8 weeks post-surgery to examine whether their surgical experiences and outcomes were congruent with pre-surgical concerns and expectations. The interviews were reviewed using thematic content analysis, and in this process inductive codes were developed and applied to the interview data. Subsequently draft items were generated representing salient post-surgical expectations and concerns identified by patients. RESULTS: Across 30 interviews, a total of 30 concepts representing concerns and/or expectations were identified by patients. Using structural coding, these concepts were placed into 25 unique subcategories (e.g., concerns about voice quality, expected need to adjust to new metabolism). Candidate items were then generated based on the subcategories, resulting in 41 items in 11 subcategories for surgery concerns and 22 items in 8 subcategories representing surgery expectations. CONCLUSIONS: Through interviews conducted with patients with thyroid cancer, 63 items were generated to represent their prominent post-surgical concerns and expectations. These items will be further refined through a process of cognitive interviewing, followed by validation of the final instrument, the Thyroid-Ex. The patient-driven process of developing this measure will greatly assist clinicians in developing educational interventions to best inform patient expectations while minimizing concerns prior to surgery, ultimately improving patient quality of life.

131 (2048) Assessing Patient-Reported adverse outcomes after hospital discharge Barbara M. Okoniewska, University of Calgary, Calgary, AB, Canada; Katy Eso, University of Calgary, Calgary, AB, Canada; Jayna Holroyd-Leduc, University of Calgary, Calgary, AB, Canada; Maeve O’Beirne, University of Calgary, Calgary, AB, Canada; Ward Flemons, University of Calgary, Calgary, AB, Canada; Deborah White, University of Calgary, Calgary, AB, Canada; Wrechelle Ocampo, University of Calgary, Calgary, AB, Canada; Nancy Clayden, University of Calgary, Calgary, AB, Canada; William A. Ghali, University of Calgary, Calgary, AB, Canada; AJ Forster, MD FRCPC MSc, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Maria-Jose Santana, PhD, University of Calgary, Calgary, AB, Canada AIMS: In a randomized clinical trial we collected patient-reported adverse outcomes (PRAOs) and explored the agreement amongst physicians rating these PRAOs as due to either the underlying illness or medical management (adverse events, AEs). METHODS: To asses AEs, we used a novel validated method that included three phases: 1) PRAO identification via a semi-structured telephone interview with patients to obtain patient-reported symptoms that developed and/or worsened within one month of discharge from hospital; 2) AE determination through the classification of PRAOs as either due to the underlying medical condition or medical management. PRAOs were classified by two physicians not involved in the care of the patient. When the PRAO was due to medical management, it was classified as an AE; 3) classification of AEs as preventable or ameliorable. When ratings differed reviewers discussed and reached consensus. To facilitate rating, we created individual case reports that included verbatim details of the PRAO, as well as discharge summaries related to the index hospital encounter and subsequent hospital visits within 1 month. Two physicians reviewed the reports independently to determine whether the PRAO was due to the underlying illness or the medical management. The reviewers then classified the AE type and severity. Type included: adverse drug events, procedure-related injuries, nosocomial infections, care-related falls, therapeutic errors, diagnostic errors, and other. Severity was measured in terms of impact on the patient and on amount of health services used. Agreement was assessed using a twoway random effect model for average measures. RESULTS: Preliminary results showed that raters agreed the majority of PRAOs were most likely due to the underlying disease rather than medical management. Out of the 47 PRAOs, 5 were classified as AEs. Two AEs were classified as ameliorable, two as preventable and one as both. Prior to discussion, the agreement between raters was good (89.4 %), after adjusting for chance, Kappa statistic, k = 0. 662 (p \ 0.001) 95 % CI (0.323, 0.921). After discussion full agreement was reached CONCLUSIONS: We highlighted the importance of using PRAOs in the determination of AEs and described the review process using a novel framework.

Caregivers (2050) Assessment of quality of life in caregivers of patients with mood disorders in a public outpatient service in the South of Brazil Mı´rian Cohen, Universidade Federal do Rio Grande do Sul; Ana Flavia da Silva Lima, PhD, UFRGS, Porto Alegre, Brazil; Sandro R P S Miguel, MD, Institute for Health Technology Assessment, Porto Alegre—Rio Grande Do Sul, Brazil; Jacques Zimmermann, MD MSc, Porto Alegre, Brazil; Luciane N. Cruz, MD, PhD, Federal University

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132 of Rio Grande do Sul, Porto Alegre, Brazil; Marcelo P. Fleck, PhD, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil AIMS: Assess quality of life in caregivers of patients with mood disorders. METHODS: A cross-sectional study in a public outpatient service in the South of Brazil. Groups were divided according the severity of the patient‘s symptoms in mild to moderate or severe measured by the Clinical Global Impression. Instruments applied: questionnaire on sociodemographic data, World Health Organization Quality of Life Instrument—Brief, Medical Outcomes Study Questionnaire 36-Item Short Form Health Survey, Beck Depression Inventory and Symptom Checklist-90-Revised. RESULTS: The preliminary sample included 80 caregivers, most females (68.8 %), spouses (26.3 %) or parents of patients (25.0 %), mean age 42.7 years (SD = 15.3). WHOQOL-Brief scores in this sample were lower than in Brazilian population in general. A tendency to lower scores in caregivers when the patient had a severe illness was evidenced—overall domain p \ 0.05. BDI scores were negatively correlated with the utility scores (SF-6D) and quality of life scores (WHOQOL-BREF, SF-36) in all domains (r = 0.45–0.77, p \ 0.01). CGI scores were negatively associated with WHOQOLBREF social and environmental domains (? = 0.416–0.436, p \ 0.05). Significant mean differences accordingly the disease severity, especially in overall, social and environmental quality of life domains were presented. CONCLUSIONS: This is the first Brazilian study to assess the quality of life in families of patients with mood disorders, demonstrating quality of life impairment, especially related to depression. Further studies are necessary to assess the association between the patient’s illness and how it interferes with the quality of life of caregivers.

(2052) Quality of life among patients with high grade gliomas and their principal informal caregivers: a study of dyadic adjustment to an unfavorable prognosis disease Tanguy Leroy, Aix-Marseille University, Marseille, France; Olivier Chinot, Timone University Hospital, Department of Neurooncology, Marseille; Karine Baumstarck, Faculte´ de Me´decine, AMU, Marseille, France; Zeinab Hamidou, Aix-Marseille University, Marseille, France; Themis Apostolidis, Aix-Marseille University, Marseille, France; Pascal Auquier, Public Health Department, University Hospital of Marseille, France AIMS: From diagnostic examinations and throughout the care pathway, cancer patients and their relatives repeatedly experience intense stress reactions which are all the more difficult to cope with as the prognosis of the disease is unfavorable (e.g. High Grade Gliomas). Yet, difficulties to cope with stress have been linked to anxious and depressive symptoms as well as an impaired QOL. Besides, as close relatives are much involved in patients’ care, to understand cancer patients’ experiences requires assessing the consequences of the efforts their relatives make to facilitate patient’s adjustment. It is all the more important to assess the experiences of the informal caregivers of HGG patients as such a disease may induce significant disturbances in their own daily life as well as a deterioration of both their health and QOL. Hence, the aim of this study is to assess QOL among HGG patients and their principal informal caregiver about a month after the diagnosis, according to what coping strategies each of them use. METHODS: Twenty patients with a newly diagnosed HGG in Marseille (France), who had not received a cancer treatment yet, agreed to take part in this study consisting in fulfilling validated questionnaires with no modification of their medical care. Moreover, those enrolled patients designated their principal informal caregiver who also filled in quite the same questionnaires. These self-administered questionnaires assessed QOL (QLQ-C30 for patients, CarGOQoL for caregivers, and PGI for both of them), coping

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Qual Life Res (2014) 23:1–184 strategies (Brief-COPE), and emotional distress (visual analogue scales). RESULTS: Preliminary dyadic analyses (APIM model) confirm that HGG patients and their caregivers’ QOL are interdependent and that the QOL and emotional distress of both the members of the dyad depend on the coping strategies each of them implements. Further analyses are in progress to identify which of the patients’ or their caregivers’ coping strategies have the better impacts on the QOL and emotional adjustment for both the members of the dyad. CONCLUSIONS: This study will finally provide innovative information about the social processes involved in the emotional adjustment to a life threatening disease and how to enhance psychological support for cancer patients and their relatives.

(2054) The impact of cancer patients’ emotional state on Caregivers’ quality of life Hui Yu Chan, Undergraduate, National University of Singapore, Singapore, Singapore; Haikel a. Lim, BSocSci(Hons), National University of Singapore, Singapore, Singapore; Simon Collinson, National University of Singapore; Rathi Mahendran, National University of Singapore AIMS: Cancer caregivers are often the primary source of both physical and emotional support for their care recipients (patients). Evidence has suggested that these caregivers’ quality of life (QOL) may be influenced by their patients’ depression (Nijboer et al. 1999), and their own perception of care burden (Yun et al. 2005); however, to date, no study has examined the role of caregiver burden on the relationship between patients’ anxiety and depressive symptomatology and their caregivers’ QOL. This exploratory study sought to address this lacuna, hypothesizing that caregivers’ burden would mediate the effect of patients’ emotional state on caregivers’ QOL. METHODS: Sixty-five cancer patient–caregiver dyads participated in this ethics-approved cross-sectional study. All caregivers (51 % female; Mage = 44.4 years) were caring for patients (75 % female; Mage = 49.6 years) with localized cancer and receiving treatment at a national cancer centre in Singapore. Most caregivers were living with their patients (86 %) and half shared a were their spouses (52 %). All participants filled in a sociodemographic questionnaire; caregivers completed measures of QOL (CQoLC; Weitzner et al. 1999) and burden of care (ZBI; Zarit et al. 1985), and patients filled in the Hospital Anxiety and Depression Scale (HADS; Zigmond and Snaith 1983). RESULTS: Because caregivers who resided with their patients reported significantly lower QOL, t(63) = 2.85, p = 0.006, this was controlled for in subsequent analyses. As expected, caregivers’ QOL was negatively correlated with patients’ distress, r(61) = -0.31, p = 0.015, and, as hypothesized, bootstrapping mediation analyses revealed that caregiver burden fully negatively mediated this relationship, 95 % CI [-0.96, -0.13], coefficient total = -0.80, SE = 0.32, p = 0.015, coefficient indirect = -0.29, SE = 0.29, p = 0.328. CONCLUSIONS: These results suggest that patients who are emotionally distressed may increase caregivers’ burden by requiring emotional support in addition to physical care; this heavy caregiving responsibility adversely affects caregivers’ QOL (Hudges et al. 1999). Therefore, psychosocial interventions which address caregivers’ perceptions of burden by encouraging positive reappraisal (Pitceathly and Maguire 2003) and benefit-finding (Kim et al. 2007) may protect or even enhance these caregivers’ QOL.

(2056) Balancing filial piety, family obligations, and personal goals: navigating the cancer Caregiving Terrain Hui Ying Ng, BA, National University of Singapore, Singapore, Singapore; Haikel a. Lim, BSocSci(Hons), National University of

Qual Life Res (2014) 23:1–184 Singapore, Singapore, Singapore; Joanne Chua, National University Hospital; Konstadina Griva, National University of Singapore; Rathi Mahendran, National University of Singapore AIMS: Studies on family caregiving in Asia frequently refer to the concept of filial piety (FP) as an implicit reason for better family bonding and cohesion. However, recent studies have suggested that it may instead contribute to greater caregiver burden and distress. Given that no studies have directly considered the role of FP and family obligations in caregivers’ adaptation to caregiving, we undertook a qualitative investigation of caregivers’ motivations for giving care. METHODS: Semi-structured interviews were conducted with family caregivers (n = 10) who had registered for an intervention at a national cancer center in Singapore (mean age = 49). Interview topics revolved around caregivers’ daily routine, personal goals, and caregiving challenges. Thematic analysis was used to identify motivations for caregiving, (any) conflicts between personal goals and caregiving, and challenges faced. RESULTS: Motivations for caregiving fell under two broad categories: externally regulated motivations (FP or family obligations) and intrinsic motivation (pleasure of caring). Intrinsically motivated caregivers expressed fewer caregiving challenges and greater control over challenges. Amongst caregivers who cited FP or family obligations, responses were mixed with some showing greater internalization of these values (values were personally important to caregivers) and some denoting less internalization (caregivers supported these values, but were primarily motivated by the consequences of not giving care). Caregivers in the first group cited personal goals to give care, reprioritized their goals, and described a continual process of adaptation and learning. Caregivers in the second group viewed their caregiving role as an unwanted family role and an obligation, and reported less support from family and more conflict over the quality and amount of care provided. CONCLUSIONS: This study suggests that FP and family obligations have mixed effects on caregivers’ adaptation to caregiving. When fully internalized, these values may act as protective factors that reinforce personal goals and provide a sense of prestige, but when not fully internalized, may create additional burden on caregivers who have to negotiate between personal goals and others’ expectations. Further research on the interaction between caregiving expectations and motivations may help us design interventions that improve adaptation amongst caregivers.

(2058) Quality of life in Caregivers for earthquake and tsunami disaster survivors in Fukushima, Japan Kazunori Tanaka, PhD, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Yuto Hayashi, Japanese Society of Quality of Life Research, Hyogo, Japan; Yuto Oiki, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Yusuke Tanaka, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Ichiro Nagano, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Yoshihiro Tairako, Touno Sangyou Sinkou Jigyou Cooperation, Iwaki, Fukushima, Japan; Michiko Kobayashi, MD, Japanese Society of Quality of Life Research, Kobe, Japan; Kozaburo Adachi, MD PhD, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Tomotaka Sobue, MD PhD, Graduate School of Medicine, Osaka University, Osaka, Japan; Takashi Mandai, MD PhD, Japanese Society of Quality of Life Research, Kobe, Japan AIMS: The purpose of this study was to investigate the quality of life (QOL) deteriorations in caregivers for 2011 Fukushima Japan disaster survivors. METHODS: Thirty-one caregivers, who helped earthquake and tsunami disaster survivors in 2011 Fukushima Japan, participated in this study. Our new original self-administered

133 QOL questionnaire including 40 questions divided into 13 categories with 7 disaster caregiver-specific questions and the Life Satisfaction Index questionnaire by Neugarten were used. RESULTS: Cronbach’s alpha coefficients of our questionnaire were excellent enough to accept for clinical use: 0.89 in social participation, 0.87 in mental function, 0.78 in dietary problems, etc. before disaster, and 0.87 in dietary problems, 0.85 in social participation, 0.82 in medical problems, etc. after disaster, respectively. Our original questionnaire contained 10 main factors and cumulative contribution was 0.90 before disaster. After disaster, our questionnaire also contained 10 main factors and cumulative contribution was 0.91. There were significantly positive correlations on mean QOLs between our original questionnaire and the Life Satisfaction Index questionnaire by Neugarten both before disaster (r = 0.62, p \ 0.01) and after disaster (r = 0.71, p \ 0.01). Compared with before disaster, there was significant deterioration of mean QOL (p \ 0.01) after disaster. Significant deteriorations were demonstrated in well-being (p \ 0.01), in sleep (p \ 0.05), in mental function (p \ 0.01), in physical function (p \ 0.01), in medical problems (p \ 0.05), in social participation (p \ 0.05), in sexual life (p \ 0.05), in environmental problems (p \ 0.01), and in work performance (p \ 0.01). Beyond our expectation, no significant deterioration in passion for life was observed after disaster, compared with before disaster. CONCLUSIONS: These findings indicate that our QOL questionnaire has excellent enough reliability and potency of validity to investigate the QOLs in caregivers for earthquake and tsunami disaster survivors. Though caregivers indicated significant QOL deteriorations by the disaster, we believe that the passion for life, no significant deterioration by the disaster, may play very important roles to reconstruct the brilliant society after the disaster again in the future.

Children (2060) Quality of life in minor siblings of childhood Leukemia survivors, Long-Term after diagnosis. a LEA study Julie Berbis, Department of Public Health, Medicine University, Marseille, France; Ge´rard Michel, Pediatric Haematology Departments, University Hospital of Marseille, France; Marine Alessandrini, EA 3279, Aix-Marseilles University, Marseille, France; Camille Vercasson, EA 3279, Aix-Marseilles University, Marseille, France; Claire Oudin, APHM; Vincent Barlogis, APHM; Herve´ Chambost, APHM; Pascal Auquier, Public Health Department, University Hospital of Marseille, France AIMS: To assess the quality of life (QOL) of child and adolescent siblings of childhood leukemia survivors in comparison to population controls, and to identify the determinants of sibling’s QOL. METHODS: The nearest aged siblings (8–17 years) of minor childhood leukemia survivors participating in the French LEA cohort (Childhood and Adolescent Leukemia—LEA—French Childhood Cancer Survivor Study for Leukemia), at the Marseilles center, were included. Siblings’ QOL was self-reported using the ‘‘Ve´cu et Sante´ Perc¸ue de l’Adolescent et de l’enfant’’ (VSP-A) questionnaire. Results were compared with those obtained for age- and sex- matched French controls subjects. Characteristics likely to be associated with sibling’s QOL (sibling’s and survivor’s sociodemographic, healthand cancer-related characteristics) were explored through multivariate analysis. RESULTS: Fifty-one siblings participated (mean age 12.7 ± 2.8 years, mean follow-up duration from diagnosis to evaluation 8.8 ± 2.5 years). They reported a significantly higher perception of QOL compared to the general population regarding the Self-esteem and Psychological well-being dimensions (psychological domain) and a lower perception regarding the Relationships with

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134 Friends and Leisure dimensions (social domain). In multivariate analysis, older age at diagnosis for both siblings and survivors was a risk factor for impaired psychological QOL. An elevated index of burden of the childhood AL was linked with sibling’s lower scores in the Self-esteem dimension, whereas having at least one late effect for the survivor was linked with sibling’s better scores in the Psychological well-being dimension. Low or middle affluence and older sibling’s age at diagnosis were risk factors for an impaired social QOL. Maximal R2 was 30 %. CONCLUSIONS: Minor siblings of childhood leukemia survivors reported a relatively good QOL, particularly in the psychological domain. Given the low proportion of QOL variability explained by the pilot study, other contributing factors (e.g., family functioning) must be explored.

(2062) Addressing the rehabilitation needs of visually impaired young adults in their transition to adulthood: a patient record study Lisette M. van Leeuwen, MSc, VU University Medical Center, Amsterdam, Netherlands; Linda Rainey, Amsterdam, Netherlands; Ruth van Nispen, PhD, VU University Medical Center, Amsterdam, Netherlands; Ger van Rens, VU University Medical Center, Amsterdam, Netherlands AIMS: The present study aims to gain qualitative insight into the rehabilitation goals of young adults (18–25 years) with a visual impairment, and how these goals relate to the structure of the International Classification of Functioning Disability and Health (ICF) and patient characteristics. METHODS: A patient record study analyzing written rehabilitation goals and patient characteristics of young adults who applied for multidisciplinary services between 2012 and 2013. Linking rules were used for assessing how the goals related to the structure of the Environmental, Body Functions and Activity and Participation (A&P) categories of the ICF. The relation between the rehabilitation goals and patient characteristics were assessed using regression analyses. RESULTS: Records of 172 patients were analysed, of which 40 % of the patients had low vision and 10 % of the patients were blind. An average of 2.3 rehabilitation goals per patient was reported. Prevalent goals were related to the ICF domains external factors (i.e. visual aids, lighting), communication (i.e. using communication devices and techniques), mobility (participate independently and safely in traffic) and major life areas (i.e. find a suitable traineeship or job). Regression analysis showed that visual acuity contributed significantly to the number of A&P goals (p \ 0.01). CONCLUSIONS: Compared with children and adolescents (\18 years), young adults are underrepresented in receiving multidisciplinary services. In addition, many A&P domains seem underrepresented in the records that do exist, e.g. self- care, peer interaction and social, community and civic life. Further research is required to gain insight into a suitable survey method for the population of visually impaired young adults containing rehabilitation domains and goals that are relevant to their lives and development.

(2064) Quality of life of caregivers of asthmatic children and adolescents Maria Alves Barbosa, PhD, Nursing Faculty of Federal University of Goias, Goiaˆnia, Brazil; Isabela C F Fernandes, Federal University of Goias, Goiaˆnia, Brazil; Karina M. Siqueira, Federal University of Goias, Goiaˆnia, Brazil; Virginia V. Brasil, PhD, Nursing Faculty of the Federal University of Goias, Goiaˆnia, Brazil; Lizete M A C Oliveira, PhD, Federal University of Goia´s, Goiaˆnia, Brazil; Katarinne L. Moraes, Universidade Federal de Goia´s, Goiaˆnia, Brazil; Alcides P S Neto, Federal University of Goias, Goiaˆnia, Brazil; Liege

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Qual Life Res (2014) 23:1–184 L S Vieira, Federal University of Goias, Brazil, Goiaˆnia, Brazil; Jacqueline Andre´ia B L Cordeiro, Federal University of Goias, Goiaˆnia, Brazil; Carla P. Bernardes, Federal University of Goias, Goiaˆnia, Brazil AIMS: To evaluate the quality of life of caregivers of asthmatic children and adolescents accompanied in a specialized outpatient care. METHODS: Cross-sectional, descriptive study with a quantitative approach, performed in outpatient clinic for asthmatic childhood in a public teaching hospital in the city of Goiaˆnia, Brazil. Data collection was conducted through a questionnaire containing questions related to social, economic and demographic aspects and the generic quality of life instrument for World Health Organization Quality of Life-Bref (WHOQOL-Bref). Cronbach’s alpha ranged from 0.63 to 0.85, implying good instrument reliability. RESULTS: The study population consisted of 89 caregivers, with the youngest aged 23 and the oldest 60 years. Predominantly, mothers (85.4 %) who had other children besides the asthmatic (72.9 %), with a steady partner (65.2 %) residing outside the metropolitan area of Goiaˆnia (53.9 %), with secondary or higher education (62.9 %), monthly personal income up to the minimum wage (57.3 %), monthly family income between two and three minimum wages (65.2 %) and belonging to Catholicism (47.2 %). The majority of caregivers (64.0 %) considered to have a good perception of quality of life and expressed satisfaction with their health. The median scores of the WHOQOL-Bref were higher in Psychological (70.83) and social relations (66.67) domains and the lower scores were obtained from the Environment (56.25) and Physical domains (60.71). Regarding potential factors associated with quality of life scores, it was concluded that there was a relationship with the following variables: bond caregiver, caregiver’s age, number of children and schooling. CONCLUSIONS: This study allowed identifying the dimensions of life of caregivers that are affected, emphasizing the need to establish new strategies for quality care for these patients. In this context, we highlight the role of health professionals, who need to be able to provide humanized care and collaborate in awareness and autonomy of the care process.

(2066) Health-related quality of life of children with a cleft lip and distress of their parents Lotte Haverman, PhD, Emma Children’s Hospital—Academic Medical Centre, Amsterdam, Netherlands; Anouck Splinter, Emma’s Children Hospital, Academic Medical Center; Hedy a. van Oers, MSc, Emma Children’s Hospital/Academic Medical Center, Amsterdam, Netherlands; Chantal MAM van der Horst, Department of Plastic, Reconstructive and Hand Surgery, Academic Medical Center; Martha Grootenhuis, PhD, Academic Medical Center, Amsterdam, Netherlands AIMS: Children with a cleft lip may have impaired functions and facial appearance which often results in reconstructions. This may have a psychological impact on these children and their parents. The aims of this study are to investigate the health-related quality of life (HRQOL) of these children and the distress of their parents. METHODS: Data were collected since December 2012 via the KLIK website (www.hetklikt.nu), designed for the use of Patientreported Outcomes in daily pediatric clinical practice. HRQOL was assessed using the TNO-AZL Preschool Children Quality of Life questionnaire (TAPQOL) for children 0–5 years (proxy-report) and the Pediatric Quality of Life Inventory (PedsQL) for children 6–7 years (proxy-report) and 8–18 years (self-report). All parents (of children aged 0–18 years) were asked to complete the Distress Thermometer for Parents (DT-P). The DT-P assesses overall distress experienced in the past week using a thermometer-score ranging from 0 to 10 (0 = no distress, 10 = extreme distress). It further

Qual Life Res (2014) 23:1–184 assesses problems across six domains: practical, social, emotional, physical, cognitive and parenting. Finally, it contains questions about social support and wish for referral. Descriptive analysis and two sample T-tests were used. RESULTS: In total, 76/113 (67 %) families participated. HRQOL data of 75 children (mean age 5.0, SD 4.3) was assessed and 68 parents (80 % mothers) completed the DT-P. In comparison with healthy children, children with a cleft lip (0–5 years and 8–12 years) scored lower on communication and children with a cleft lip (13–18 years) showed lower scores on school functioning. Twenty-one parents (35 %) reported levels of clinical distress (thermometer score = 4) and 17 parents (23 %) (maybe) wanted to talk to a professional about their situation. Fatigue (41 %), sleep (29 %) and feeling tense/nervous (27 %) were the most reported problems by parents. CONCLUSIONS: It seems that children with a cleft lip differ from their healthy peers on various HRQOL scales. Furthermore, over one-third of the parents show elevated levels of distress. Therefore, targeted interventions should be developed and provided.

(2070) Assessing quality of life in 5–6 year old children using illustrations shown on a tablet computer Tomoaki Kimura, PhD, MOA Health Science Foundation, Atami, Japan; Rika Hayashida, MS, University of Nagasaki, Siebold, Nagasaki, Japan; Michiko Kobayashi, MD, Japanese Society of Quality of Life Research, Kobe, Japan; Yoshiteru Maki, Korinkai Kagoshima Clinic; Yuta Okada, MOA Health Science Foundation; Seiya Uchida, MOA Health Science Foundation; Kiyoshi Yamaoka, MOA Health Science Foundation AIMS: A quality of life (QOL) questionnaire based on a card system has been developed for children, and its validity and reliability has been demonstrated with 5-year olds. A personal computer (PC) version of the same questionnaire was developed and distribution of responses and its reliability were investigated. METHODS: Computer-assisted data collection was conducted between 2010 and 2013 with 5–6 year old children in five nurseries and kindergartens in Japan. The card system questionnaire consisted of 24 illustrations that showed child’s daily life, such as eating, playing, and activities with parents. Children looked at an image displayed on the screen of a tablet PC and responded whether they liked, or disliked the image by touching the screen with a pen and responding using a 5-point scale. Data on children’s families, such as the number and constitution of members were also collected. RESULTS: Children (N = 215, 113 boys and 102 girls; 123, 5-year and 92, 6-year old children) participated in the study and completed the PC version of the questionnaire. The mean number of members in participants’ families was 4.3. The total scores (Range: 0–100) were distributed from 20 to 94, with a mean of 66.1 ± 11.9 (SD). The mode of responses for 19 images by using the 5-point scale was ‘‘I like it very much,’’ whereas for 5 images it was ‘‘neither like nor dislike.’’ Results indicated adequate reliability of the new system using 24 images (Cronbach’s alpha coefficient = 0.79.). Moreover, the total score of girls was significantly higher than that of boys (p \ 0.05). The total score was not associated with the number of family members. For 3 images, the responses of children with a single parent (n = 10) were different from other children. CONCLUSIONS: The results of the PC version of the questionnaire corresponded to a previous study of the card system questionnaire, which suggested the validity and reliability of the PC version. The PC version was considered to have an advantage over the card system, because the scores were little influenced by examiners’ skills or by examiners’ relationship with children.

135 Cross-Cultural Adaptation (2072) What does a decade matter? the evolution of translation activities in the EORTC quality of life group in the past 10 years Dagmara Kulis, EORTC, Brussels, Belgium; Cheryl Whittaker, EORTC; Eva Elfriede Greimel, PhD, Medical University Graz, Graz, Austria; Andrew Bottomley, PhD, EORTC Headquarters, Brussels, Belgium; Michael Koller, PhD, Center for Clinical Studies, Regensburg, Germany AIMS: In 2003, the EORTC Quality of Life Group founded the Translation Committee, recognizing the importance of quality-based translations of the questionnaires developed by the Group. After ten years we decided to compare the situation then and now in terms of methodology, quality standards and assurance, and practices, in order to see the progress made and to show the lessons learnt during the decade of translation practice. METHODS: We reviewed the database archives, files, presentations from the EORTC QLG meetings, and internal records, in order to retrieve data, descriptions of procedures, numbers and lists of ongoing projects, employment records and financial information. RESULTS: Since the first Translation Committee meeting, the translation practices of the Group, performed by the Translation Unit (TU) of the EORTC Quality of Life Department, changed dramatically. A representative of the Translation Committee became a full voting member of the QLG Executive Committee. The formalization of the translation procedure was laid down in the EORTC Translation Manual. While in 2003 there were 23 ongoing translation projects that on average took 1–2 years, now there are 150 projects that take maximum 8 months with better quality-assurance processes in place (e.g. additional proofreading). The number of language versions of the QLQ-C30 grew from 45 to 90. Furthermore, the TU is now closely involved in the module development process from the very beginning, performing translatability assessment of new modules and coordinating translations that are done by professional translation agencies (previously done by volunteers). This change brought an almost ten-fold increase in translation costs. The interaction with pharmaceutical companies and translation agencies became professionalized through a new business model. In terms of scientific contributions, the TU came up with conceptual papers on cultural adaptations, reconciliation and back translation processes. The growth in the number of projects led to an increase in the number of staff at the TU—from 1 FTE in 2003 to 2.5 FTE now. CONCLUSIONS: Thanks to increased staff, more comprehensive and formalized processes, modern technologies and tools, the TU was able to make the translation process faster, while improving quality and gaining importance in the methodological discussions in the field.

(2074) Cross-Cultural adaptation and validation of the portuguese version of the oxford shoulder score (OSS) Carolina Quintal Caldeira, Polytechnic Institute of Caselo Branco, ESALD, Castelo Branco, Portugal; Rui Soles Goncalves, PhD, Centre for Health Studies and Research of the University of Coimbra, Coimbra, Portugal; Mo´nica Vieira Rodrigues, Polytechnic Institute of Castelo Branco, ESALD, Castelo Branco, Portugal; Sabine Cardoso Felı´cia, Polytechnic Institute of Castelo Branco, ESALD, Castelo Branco, Portugal; Luis Manuel Cavalheiro, PhD, Centre for Health Studies and Research of the University of Coimbra, Coimbra, Portugal; Pedro L. Ferreira, PhD, University of Coimbra, Coimbra, Portugal AIMS: To translate and culturally adapt the Oxford Shoulder Score (OSS) to the European Portuguese language, and to test its reliability

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136 (internal consistency, reproducibility and measurement error) and validity (content and construct validity). METHODS: The OSS Portuguese version was obtained through translations, back-translations, consensus panels, clinical review and pre-test. The Portuguese OSS and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaires, and the visual analogue scales of pain at rest [VAS rest] and during movement [VAS movement] were applied to 111 subjects with shoulder pain (degenerative or inflammatory disorders) and recommended for physical therapy. A clinical and sociodemographic questionnaire was also applied. RESULTS: The reliability was good, with a Cronbach’s alpha coefficient of 0.90, an intraclass correlation coefficient (ICC) of 0.92, a standard error of measurement (SEM) of 2.59 points and a smallest detectable change (SDC) of 7.18 points. Construct validity was supported by the confirmation of three initial hypotheses involving expected significant correlation between OSS and other measures (DASH, VAS rest and VAS movement]) and between OSS and the number of days of work absenteeism. CONCLUSIONS: The Portuguese OSS version presented suitable psychometric properties, in terms of reliability (internal consistency, reproducibility and measurement error) and validity (content and construct validity).

(2076) Confirmatory factorial analysis of the BrazilianPortuguese version of the Duke Anticoagulation satisfaction scale (DASS) Fla´via M. Pelegrino, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Rejane K. Furuya, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing, Ribeira˜o Preto, Brazil; Eliane Nepomuceno, University of Sa˜o Paulo at Ribeira˜o Preto College of Nursing; Suleimy C. Mazin, University of Sa˜o Paulo at Ribeira˜o Preto School of Medicine, Sa˜o Paulo, Brazil; Lidia A. Rossi, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil; Rosana Spadoti Dantas, PhD, University of Sa˜o Paulo, Ribeirao Preto, Brazil AIMS: To evaluate the construct validity of the Brazilian-Portuguese version of the Duke Anticoagulation Scale Satisfaction (DASS), using Confirmatory Factor Analysis (CFA). METHODS: The DASS was developed in the USA to measure the quality of life and satisfaction of patients taking oral anticoagulants. The instrument addresses three dimensions related to anticoagulation: Limitation, Hassles/Burdens and Psychological Impact. The Brazilian-Portuguese version of the DASS was administered to 180 outpatients in the University of Sa˜o Paulo Public Hospital. Data were analyzed by using the Statistical Analysis System (SAS 9.2). First, we evaluated the fit indices of the CFA. Second, we performed the model modification considering the initial results of CFA, the exploratory factor analysis of the BrazilianPortuguese version of DASS (previously performed by the group and published elsewhere) and theoretical expectations. A good model fit was considered to be indicated by the following fit indices values: RMSEA \ 0.07, GFI [ 0.9 and AGFI [ 0.95. RESULTS: The first factor model had a RMSEA = 0.08, a GFI = 0.79, and an AGFI = 0.75. In the model modification process, the item 3 h (‘‘Overall, how confident are you about handling your anti-clot treatment?’’) was modified from Hassles/Burdens to Psychological Impact; the items 4d (‘‘How much do you worry about bleeding and bruising’’), and 4 g (‘‘Overall, how much has anti-clot treatment had a negative impact on your life?’’) were modified from Psychological Impact to Limitation; and the item 4i (‘‘Compared with other treatments you have had, how difficult is your anti-clot treatment to manage?) was modified from Psychological Impact to Hassles/Burdens. Greater fit indices were observed after the model modification: RMSEA = 0.07, GFI = 0.82, and AGFI = 0.79. The factor loadings also increased, with the respective initial and final values: 3 h (0.08 and 0.31), 4d (-0.28 and 0.50), 4 g (0.22 and 0.44), and 4i (0.17 and 0.52). CONCLUSIONS: The novel analysis proposed in this study

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Qual Life Res (2014) 23:1–184 demonstrated greater fit indices and greater factor loadings for the Brazilian-Portuguese version of the DASS compared to the original model, which suggests a need for changes in the factor model of the instrument.

eHealth (2078) An Evaluation of the measurement equivalence of electronic versions of Paper-Based Patient-Reported outcome measures Niloufar Campbell, Cardiff University, Old Coulsdon, United Kingdom; Faraz M. Ali, Cardiff University, Cardiff, United Kingdom; Andrew Finlay, FRCP, Univ. of Wales College of Medicine, Cardiff, United Kingdom; Mir-saeed S. Salek, Cardiff University, Cardiff, United Kingdom AIMS: The conversion of paper-based patient-reported outcome measures (PROMs) into electronic formats confers several benefits to users. However, any new electronic version should be validated before it can be reliably used: this can be achieved by demonstrating measurement equivalence between the formats. This review aimed to examine studies investigating measurement equivalence between electronic PROMs and their paper originals to identify methodologies used and to find out the extent of such validation. METHODS: Three databases (OvidSP, Web of Science and PubMed) were searched using a set of keywords. Results were examined for compliance with inclusion criteria. Articles or abstracts that directly compared screen-based electronic versions of PROMs with their validated paper-based originals, with regards to their measurement equivalence, were included. Publications were excluded if the only instruments reported were stand-alone visual analogue scales or interactive voice response formats; such data was excluded if reported as part of a larger study. Papers published before 2007 were excluded, as a previous meta-analysis examined papers published before this time. Data for each relevant instrument was recorded using a template. RESULTS: 55 studies investigating 79 instruments met the inclusion criteria. 73 % of these were full-text articles, 60 % examined only 1 instrument, 73 % reported adult patients and 85 % used a crossover design. 53 % of the 79 instruments studied were condition-specific, 23 % were generic measures and 24 % were specialty-specific. Several instruments, such as the SF-36, were examined in more than one publication. The most frequently reported formats for electronic PROMs were web-based versions, though PDAs, tablets and computers, including those with touch-screens, were also used. In 78 % of the publications, there was evidence of equivalence or comparability between the two formats as judged by study authors. Two publications found that the formats were not equivalent. Of the 30 publications that provided preference data, 87 % found that overall participants preferred the electronic format. None reported that participants preferred the paper version. CONCLUSIONS: When examining equivalence between paper and electronic versions of PROMs, formats are usually judged by authors to be equivalent. Participants prefer electronic formats. This literature review gives encouragement to the further widespread development and use of electronic formats of PROMs.

(2080) Use of BiblioPRO, the virtual library of Patient-Reported outcomes instruments Yolanda Pardo, Hospital Del Mar Medical Research Institute, Barcelona, Spain; Montserrat Ferrer, MD PhD MPU, Hospital Del Mar Research Institute (IMIM), Barcelona, Spain; Monica Avila, PharmD, MPH, IMIMI (Hospital Del Mar Medical Research

Qual Life Res (2014) 23:1–184 Institute), Barcelona, Spain; Scientific Committee BiblioPRO, CIBERESP, CIBERSAM, CIBERER AIMS: BiblioPRO is the Spanish free-access, virtual library of Patient-reported Outcomes (PRO). The library’s new website was launched in 2012, with an improved functionality for instrument selection and application for sublicenses. The website contents basic information on 747 instruments. It allows direct access to additional materials (manual, description, questionnaire or bibliography) and requesting a sublicense for 315 of these instruments. A sublicense allows using an instrument while ensuring the author’s copyright is respected. The goal is to evaluate the use of the library in providing information, registering and managing sublicenses in 2013. METHODS: A process evaluation was performed by recording the website’s metrics—number and duration of visitswith Google Analytics. Also, the number of registered users, number of sublicenses requested per instrument, institution requesting the sublicense, and the type of study were described. RESULTS: During 2013, the website received over 3,000 visits per month (45,300 visits during the year), 70–75 % of these being unique visitors. The number of visited pages was 21,000, and the depth (pages viewed per visit) ranged from 4.5 to 6 pages. The mean duration per visit was 3 min (SD = 0.4).A total of 2,190 users registered, and requested 416 sublicenses. The most requested instruments were: KDQOL-SF (Kidney Disease Quality of Life instrument), SF Health Survey, PedsQL (Pediatric Quality of Life Inventory), SGRQ (St. George Respiratory Questionnaire) and PSQ (Perceived Stress Questionnaire). Of these applications, 73 % were requested by academics (students and universities), 20 % by public institutions (hospitals and research centres) and 7 % by private companies. Regarding the study design, 52 % were cross-sectional studies, 15 % case–control studies, 16 % clinical trials, 5 % cohort studies and 12 % were unspecified. CONCLUSIONS: Since the launch of the new website, BiblioPRO has duplicated the number of visits received the previous year (2012), and has managed more than 400 sublicenses per year, which means that more than 200 studies have used the website to access the tools (assuming an average of 2 instruments per study). According to these indicators, BiblioPRO is offering a useful access to PRO instruments available in Spanish.

(2082) Mode of administration of Patient-Reported outcomes (PROs): a systematic review Claudia Rutherford, PhD, QOL Office, University of Sydney, Camperdown, NSW, Australia; Rebecca L. Mercieca-Bebber, The University of Sydney, University of Sydney, Camperdown, Australia; Holly Rice, University of Sydney; Madeleine T. King, PhD, Psychooncology Cooperative Research Group (PoCoG), Sydney, Australia AIMS: Technological advancements in recent decades have led to the availability of new modes to administer PROs. To assist researchers in selecting optimal modes of administration, we undertook a systematic review to determine: i) what administration methods are available and ii) whether differences in data quality, bias and response rate exist among modes (including size and direction of bias). METHODS: We searched five electronic databases from 2004 (date of last comprehensive review on this topic) to April 2014, crossreferenced, and contacted experts. No language restrictions were applied. We also searched reference lists from relevant systematic reviews. Original published research that compared two or more administration modes of a health-related PRO measure in adult samples were included. Two reviewers independently applied inclusion and quality criteria and extracted findings. Analysis considered data quality, bias and response rates associated with each mode of administration, and strengths and limitations of study design.

137 Synthesis of findings was reviewed by the team until reaching consensus. RESULTS: Of 5100 papers screened for relevance, 276 were considered potentially relevant and 56 met inclusion criteria. A range of modes have been used to administer PROs. Instrument design features that might influence data quality and bias are being considered (i.e. method of contacting respondents (e.g. by post, in person); presentation method (e.g. paper vs electronic); administration method (interviewer vs self-administered); sensory input channel (e.g. visual vs aural); and response mode (e.g. handwritten, keyboard, touch screen, telephone). Comparisons between modes offer mixed results; current evidence is inconsistent in determining superiority of any one mode in terms of quantity and quality of response. Data quality and bias issues (including size and direction of bias) associated with each mode will be compared and presented. CONCLUSIONS: As current evidence is inconsistent in determining a superior mode in terms of bias, response rates and quality of data, choice of mode of administration for any particular research context should be based on maximizing response rates, minimizing cost, consideration of data quality and bias associated with each administration, anticipated response rates, acceptability/patient preference, and time available. Equivalence of administration methods should be considered before studies use multiple methods.

(2084) Use of IPads to assess Health-Related quality of life: a feasibility study in outpatient home dialysis clinics Kara L. Schick Makaroff, PhD, RN, University of Alberta, Edmonton, BC, Canada; Anita Molzahn, PhD RN, University of Alberta, Edmonton, AB, Canada AIMS: In light of the growing importance of using of patient-reported outcomes for clinical and administrative purposes, clinical kidney research pertaining to electronic capture of patients’ reports of their health is valuable. It is particularly significant because health-related quality of life (HRQOL) for patients with end-stage renal disease is compromised and assessment by patients of their HRQOL in practice is rare. The aim of this study was to evaluate the feasibility of administering HRQOL and symptom assessment measures using iPads in outpatient home dialysis clinics. METHODS: Fifty-six patients from two home dialysis clinics participated in the study: 35 males (63 %) and 21 females (37 %) with a mean age of 66 ± 12 (36–91 years old) were included. Forty-nine participants were on peritoneal dialysis (87 %), 6 on home hemodialysis (11 %), and 1 on nocturnal home hemodialysis (2 %). Using an iPad, participants completed the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire online. Through the use of a newly created iPad app, they also completed two surveys: the Edmonton Symptom Assessment Scale (ESAS) and Participant’s Level of Satisfaction in Using a Tablet Computer. RESULTS: Participants’ satisfaction with using an iPad was high; 66 % were ‘‘very satisfied’’, 7 % ‘‘satisfied’’, 2 % ‘‘slightly satisfied’’, and 18 % ‘‘neutral.’’ On the 7-point Likert-type scale, the mean satisfaction score was 5.11 (SD = 1.6). Mean time to complete the measures was: Level of Satisfaction 1.15 min (SD = 0.41), ESAS 2.55 min (SD = 1.04), and KDQOL 9.56 min (SD = 2.03); the mean time to complete all three instruments was 13.19 min (SD = 2.42). There were no significant correlations between level of satisfaction and age, gender, HRQOL, time taken to complete surveys, computer experience, or comfort with technology, and none of these independent variables explained satisfaction. Comfort with technology and computer experience were highly correlated, r = 0.7, p (one-tailed) \0.01. CONCLUSIONS: It is feasible to administer HRQOL measures using iPads. Participants were satisfied with the platform and the time involved for completion of instruments was modest. Routine use of HRQOL for clinical purposes may be expedited through use of iPads. The ease of data collection

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138 may offer opportunities to use HRQOL data for patient care and/or quality improvement programs.

(2086) A web-based question prompt sheet for the initial followup consultation after esophageal cancer surgery Marc Jacobs, Academic Medical Center, Amsterdam, Netherlands; Inge Henselmans, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands; Derk Arts, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands; Mark I. Van Berge Henegouwen, Department of Surgery, Academic Medical Center, Amsterdam, Netherlands; Maud Ten Koppel, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands; Suzanne S. Gisbertz, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands; Sjoerd M. Lagarde, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands; Mirjam AG Sprangers, PhD, Academic Medical Center, Amsterdam, Netherlands; Hanneke C.J.M. De Haes, Department of Medical Psychology, Academic Medical Center, The Netherlands; Ellen M. Smets, Department of Medical Psychology, Academic Medical Center, The Netherlands AIMS: To develop and test the feasibility of a web-based list of questions (i.e., a question prompt sheet, QPS) designed to help patients prepare their initial follow-up consultation after esophageal cancer surgery. The QPS aims to increase patient participation and the discussion of patient’s health-related quality of life METHODS: We conducted three studies to examine (1) patients’ usability of the QPS (n = 8), (2) patients’ appraisal of the usability and usefulness of the QPS (n = 50), and (3) the clinical feasibility of the QPS (20 patients; 3 surgeons). Each study produced a modified QPS which was then tested in the subsequent study. For study 1 and 2, we purposefully selected patients who had already consulted with their surgeon after surgery. In study 1, we asked patients to think aloud whilst using the QPS. These interviews were audio recorded and patients were surveyed afterwards. In study 2, we asked patients to evaluate and use the new version of the QPS to create a list of questions. For study 3, we invited patients, who had just undergone surgery, to use the QPS to prepare their initial follow-up consultation. Patients were surveyed before and after the consultation, which were audio-recorded. Surgeons were also surveyed after each consultation. RESULTS: Study 1: eight patients (6 males, median age: 65) were interviewed (mean 1 h 45 m). Most comments and suggestions were related to the: (1) introduction, (2) navigation, (3) arrangement of example questions, (4) instructions, and (5) logging out procedure of the QPS. Study 2: 40 patients (80 %, 35 males, median age: 62) of which 37 used the QPS. The majority of patients did no encounter problems when using the QPS, and perceived it as a useful and usable tool. Study 3: preliminary analyses (n = 10) show that patients used the QPS to prepare their consultation and address patient-important topics. Surgeons used the QPS to guide the consultation and information provision, and perceived it as a useful and clinically feasible tool. CONCLUSIONS: Preliminary analyses show that we have developed a tool that can be used by esophageal cancer patients to prepare their initial follow-up consultation, and help them address important topics.

(2088) EVA-Online: development and preliminary testing of a guided online cognitive behavioral therapy (CBT) program for breast cancer survivors with climacteric symptoms Marieke Van Leeuwen, Netherlands Cancer Institute; Myra S. Hunter, King’s College London, London, United Kingdom; Neil K. Aaronson, PhD, The Netherlands Cancer Institute, Amsterdam, Netherlands

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Qual Life Res (2014) 23:1–184 AIMS: Breast cancer treatment can lead to earlier onset of menopause or an increase in menopausal symptoms. Treatment-induced menopausal symptoms are more severe than those that occur naturally. Hormonal replacement therapy, which is effective in alleviating vasomotor symptoms, is contraindicated in breast cancer survivors. The efficacy of Group CBT in reducing menopausal symptoms has been demonstrated in three recent randomized controlled trials. However, online-CBT might offer a more accessible way of delivering this treatment. Therefore we aimed to develop a guided online-CBT based on the same principles as the Group CBT. METHODS: We developed the online-CBT program in collaboration with a company specialized in developing and providing online treatment programs for health care organizations. We conducted two rounds of pilot-testing of the online-CBT among breast cancer survivors with menopausal symptoms. The first pilot (n = 9) was carried out to refine the program content and presentation. The second pilot (n = 22) provided a first indication of the efficacy of the internet-based program. All women were asked to complete pre- and post-program questionnaires assessing endocrine (FACT-ES) and vasomotor (Hot Flush Rating Scale (HFRS)) symptoms. Additionally, we assessed post- intervention patient satisfaction. RESULTS: The developmental trajectory resulted in ‘EVA-Online’, consisting of six modules including: psycho-education, homework assignments, videos and testimonials. Participants of the first round of pilot-testing were satisfied with the content of the program but indicated that there was insufficient opportunity for contact with and feedback from the therapist (a medical social worker). In the second pilot, the contact with the therapist was intensified from 2 to 6 brief contacts via email. We observed a substantial improvement over time in climacteric and menopausal symptoms, and there was high satisfaction with the program. CONCLUSIONS: Results of this pilot study suggest that Eva-Online is acceptable and may result in the hypothesized positive effects on menopausal symptoms. EVA-online is a promising approach to make this form of CBT more accessible to breast cancer patients.

PROMISÒ (2090) Diagnostic performance of co-calibrated PHQ-9 and PROMISÒ depression scales Sandra D. Griffith, PhD, Cleveland Clinic, Cleveland, OH, United States; Nicolas Thompson, Cleveland Clinic, Cleveland, OH, United States; Paul K. Crane, MD MPH, General Internal Medicine, Harborview Med Ctr, Seattle, WA, United States; Jaivir S. Rathore, University of Illinois Chicago, Chicago, IL, United States; Lara Jehi, Cleveland Clinic, Cleveland, OH, United States; George E. Tesar, Cleveland Clinic, Cleveland, OH, United States; Irene Katzan, Cleveland Clinic, Cleveland, OH, United States AIMS: Co-calibration between legacy and PROMIS measures facilitates transitions between scales and increases flexibility of scale deployment. Although such linkages are commonly used at the population level, little is known about their utility as screening tools at the individual patient level. Our objectives are to compare the diagnostic performance of scores obtained directly from the Patient Health Questionnaire-9 (PHQ-9) to PHQ-9 scores on the PROMIS metric (PHQ-9PROMIS) based on a co-calibration with PROMIS Depression and establish clinically-appropriate thresholds for the cocalibrated measure. METHODS: We co-calibrated PHQ-9 and PROMIS Depression using information from 1,329 neurological patients completing both scales. To assess diagnostic performance, we treated clinician-administered diagnostic interviews in another sample of 128 patients as the reference standard for major depressive disorder. We performed a receiver operating characteristic (ROC) analysis

Qual Life Res (2014) 23:1–184 and calculated the area under the curves (AUC). We assessed the optimal thresholds for each scale and the PHQ-9PROMIS threshold with sensitivity and specificity minimizing the Euclidian distance to the clinically-established PHQ-9 threshold for moderate depression (10). We describe the range of observed PROMIS depression scores corresponding to the candidate cut-points from the co-calibrated measures. RESULTS: Estimated AUC values were high (0.934 and 0.935 for PHQ-9 and PHQ-9PROMIS, respectively). We estimated an optimal cut-point for the PHQ-9 of 10 (corresponding sensitivity of 0.94 and specificity of 0.81) and 57.59 for PHQ-9PROMIS (sensitivity of 0.91 and specificity of 0.85). To achieve an estimated sensitivity equal to that of the clinically-established PHQ-9 threshold (0.94), the threshold on the PHQ-9PROMIS required a reduction to 51.61, resulting in specificity reduced to 0.66. The PHQ-9PROMIS threshold with sensitivity/specificity pair closest to that of the clinically-established PHQ-9 was 56.32 (sensitivity = 0.91, specificity = 0.81). Based on potential PHQ-9PROMIS cut-points 56–58, corresponding observed PROMIS depression scores ranged from 48.42 to 69.44, with 75 % of scores falling between 56.12 and 61.85. CONCLUSIONS: Our findings suggest that the overall diagnostic performance of PHQ-9, co-calibrated with PROMIS Depression, is similar to that of the PHQ-9; however, some differences were observed at the clinically-established threshold for moderate depression. Further evaluation is needed, but these findings support the notion that PROMIS Depression may have clinical utility as a depression screen.

(2092) Evaluating PROMISÒ item content validity in the context of HIV clinical care Todd C. Edwards, PhD, Univ. of Washington, Seattle, WA, United States; Rob J. Fredericksen, Univ. of Washington, Seattle, WA, United States; Leo Morales, MD, PhD, Group Health Research Institute, Seattle, WA, United States; Rosa Solorio, Univ. of Washington, Seattle, WA, United States; Frances M. Yang, Georgia Regents University; Heidi M. Crane, Univ. of Washington, Seattle, WA, United States; Paul K. Crane, MD MPH, General Internal Medicine, Harborview Med Ctr, Seattle, WA, United States; Donald L. Patrick, PhD MSPH, Seattle Quality of Life Group, Seattle, WA, United States AIMS: To assess the content validity of PROMIS Depression, Anxiety, Fatigue, and Alcohol Use items in the context of clinical care for people living with HIV?. METHODS: Concept elicitation interviews, item pool matching, prioritization focus groups, and cognitive interviews were conducted with people living with HIV (N = 394) across 4 clinical sites (Seattle, San Diego, Birmingham, Boston). Item review and prioritization were conducted with clinical providers. RESULTS: Patients and providers preferred PROMIS items that included specificity regarding correlates and impacts of the concept being assessed. These items were considered most ‘‘actionable’’ for clinical care. Additional items were developed to address this preference. For depression this included items related to suicide and other forms of self-harm, and for all domains it included items pertaining to correlates and impacts relevant to treatment and medication adherence. CONCLUSIONS: Existing PROMIS Depression, Anxiety, Fatigue, and Alcohol Use items were found to be content valid for patients living with HIV, especially those items with specificity useful for providing optimal clinical care (Table 1).

139 Table 1 Most important items for clinical care as ranked by HIV patients (English and Spanish combined) Depression (n = 51) (% patients selected)

Anxiety (n = 53) patients selected)

Fatigue (n = 68) Alcohol use (% (% patients (n = 55) (% selected) patients selected)

I felt I had no reason for living (53)

I felt like I needed help for my anxiety (60)

How often were you I was worried about too exhausted to how drinking was take your affecting my medication? (50) health (73)

I felt that I wanted to give up on everything (53)

I had difficulty sleeping (50)

To what degree did I drank so much your fatigue that I could not interfere with your remember what physical happened while I functioning? (31) was drinking (56)

I thought about I had sudden killing myself feelings of (51) panic (50)

How often did you feel tired? (28)

I drank until I passed out (56)

I felt depressed (45)

To what degree did you have to force yourself to get up and do things because of your fatigue? (28)

I drank until I got sick (55)

I felt anxious (46)

I felt so bad that I had How often were you I did things unpleasant bothered by your that I knew thoughts that fatigue? (28) would hurt would not me (43) leave my mind (46)

I drank to avoid my problems (51)

I felt desperate to escape how I feel (43)

I felt like I was How often did you going to pass wake up feeling out from my exhausted? (28) anxiety (44)

I used alcohol and other drugs together, to get high (38)

I felt no energy to do things (43)

I had trouble breathing (40)

I had trouble controlling my drinking (35)

I felt emotionally I felt pressure exhausted on my chest (41) (40)

How often did your body feel exhausted? (28)

How often were you I had to drink more so exhausted that to get the same you missed effect I used to get (35) appointments? (28)

Bold = new items developed in this study (2094) The Psychometric Performance of the PROMISÒ Smoking Assessment System: Comparisons of Simulated and Real-Data CATs, Short Forms, and Mode of Administration Brian D. Stucky, PhD, RAND Corporation, Santa Monica, CA, United States; Maria O. Edelen, PhD, RAND Corporation, Boston, MA, United States; Mark Hansen, UCLA-CRESST; Joan S. Tucker, RAND Corporation; William Shadel, RAND Corporation AIMS: The PROMIS Smoking Initiative has developed six items banks for assessment related to cigarette smoking among adult smokers (Nicotine Dependence, Coping Expectancies, Emotional and Sensory Expectancies, Health Expectancies, Psychosocial Expectancies, and Social Motivations). Using data from three sources, this paper evaluates the psychometric performance of the banks under a variety of administration modes. METHODS: Data are from a calibration sample of daily and nondaily smokers (N = 4,201), a followup subset of the calibration sample (N = 491) who completed both short forms (SF) and computer adaptive tests (CAT), and a community sample (N * 400) that completed either paper and pencil or

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140 computer administration of the SFs. Aim1: to evaluate CAT item administration rates, the results of simulated CATs from the calibration sample are compared to the real-data CATs from the followup sample. Aim 2: using the follow-up sample, the psychometric performance of the CAT administration is compared to the SF administration. Aims 3 & 4: Using the community sample, we will evaluate the overall effect of the mode of administration on scores (computer vs. paper and pencil) (Aim 3), and examine test re-test reliability for both administration modes (Aim 4). RESULTS: (Aim 1) Across the six domains the item selection for the real-data and simulated CATs were highly similar; the average number of administered items to achieve marginal reliabilities of 0.90 was 5.3 to 10.6 for the simulated CAT and 4.8 to 11.1 for the real-data CAT. (Aim 2) IRT-scores from SF and CAT administrations were correlated from 0.86 to 0.92 across the domains. Analyses for Aims 3 and 4 involve recently collected data and are ongoing. CONCLUSIONS: Preliminary results indicate that the SF and CAT administrations provide highly comparable scores, but preference for SF or CAT administration may vary by smoking domain. For example, in comparison to CAT administration the SFs for Social Motivations and Coping Expectancies required fewer items to achieve acceptable levels of score reliability. A discussion of these results will include graphical illustrations of the distribution of participant scores and standard errors. Additional analyses are needed to fully explore the effect of the mode of administration and test re-test reliability.

(2096) Translation and cultural adaptation of the emotional distress and social aspects domains of pediatric Patient-Reported outcomes measurement information system PROMISÒPEDIATRICOÒ (Version 1.0) to Portuguese Rogerio R. Morales, MD, Universidade Federal de Uberlaˆndia, Uberlaˆndia, Brazil; Marcia Ferreira Castro Pinto, Universidade Federal de Uberlaˆndia, Uberlaˆndia, Brazil; Nivea M. O. Morales, MD MSc PhD, Federal University of Uberlaˆndia, Uberlaˆndia, Brazil; Tania Maria Silva Mendonca, UFU, Uberlaˆndia, Brazil; Roge´rio M C Pinto, Federal University of Uberlaˆndia; Carlos Henrique Martins Silva, Sr., Universidade Federal de Uberlaˆndia—FAMED, A. Alexandre R. Guimaraes,315, Brazil AIMS: To translate and culturally adapt the banks item of the Emotional Distress and Social Aspects domains of the Pediatric PROMIS into Portuguese. METHODS: The study was conducted according to the FACIT methodology of universal translation recommended by the developers of Pediatric PROMIS. The multiple steps were composed of Forward Translations, Reconciliation, Back-Translation, Quality Control: Review Back-Translation, Independent Reviews, Finalization Process, pre-test and incorporation of the results of the pre-test in the process of translation. In this process we had Brazilian, Portuguese and Americans reviewers with strict observance of semantic and conceptual equivalence between the English and Portuguese language. The pre-test was conducted in a self-applied to 10 participants, aged between 8 and 17 years who experience chronic condition of health with cognitive ability to read and write. The participants then responded to the cognitive interview and retrospective clarification with a verbal probing technique of cognitive debriefing to identify the understanding of items, possible difficulties, suggestions, irrelevant or offensive items. RESULTS: In general, the items were well understood by children and teenagers. Only item 15 in the Anxiety required adjustments in the pre-test to achieve equivalence of meaning with the original version which was obtained by the substitution of the word ‘‘nervoso’’ to ‘‘agitado’’. CONCLUSIONS: This study enabled the translation and cultural adaptation of item

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Qual Life Res (2014) 23:1–184 banks of domains Emotional Distress and Social Relations of the PROMIS pediatric to Portuguese.

(2098) Translation, Cross-Cultural adaptation and validation of Mobility Item Bank of Patient-Reported outcomes Measurement Information System—Pediatric PROMISÒ into Portuguese Nivea M. O. Morales, MD MSc PhD, Federal University of Uberlaˆndia, Uberlaˆndia, Brazil; Aline Tavares Duarte, PostGraduate,Federal University of Uberlaˆndia; Tania Maria Silva Mendonca, UFU, Uberlaˆndia, Brazil; Carlos Henrique Martins Silva, Sr., Universidade Federal de Uberlaˆndia—FAMED, A. Alexandre R. Guimaraes,315, Brazil; Roge´rio M C Pinto, Federal University of Uberlaˆndia AIMS: Translate, cross-culturally adapt and validate the Mobility Item Bank of Pediatric PROMIS into Portuguese. METHODS: The translation methodology suggested by the PROMIS coordinators through Functional Assessment of Chronic Illness Therapy (FACIT) uses an universal translation process that includes all countries whose official language is Portuguese. This rigorous methodology, verifies the semantic and conceptual correspondence between English and Portuguese, ensuring that the instrument remains unchanged, through qualitative and quantitative methods. This translation process is based on the stages of: initial translation, Reconciliation, Retro- translation, original scale comparison, independent reviewers, Harmonization, pre-test and the incorporation of the results of pre-test in the translation process. The pre-test was self-administered in 10 participants, aged between 8 and 17 years old. RESULTS: In the translation process there was a good understanding of the items by the respondents. Twelve items were remade because they showed differences among reviewers of Portugal and Brazil, and have been rewritten in a understandable way in both countries without losing the correspondence with the original version. Two items had irreconcilable differences as there is no agreement, and were resolved after being rewritten with synonymous words such as ‘‘Desportos’’ and ‘‘Andarilho’’ used in Portugal and in Brazil is used ‘‘Esportes’’ and ‘‘Andador’’ respectively. Two items showed the same word with high register that is a difficult word to understand, such as ‘‘Locomover’’ and it was resolved after they have been rewritten using common words like ‘‘Andar de um lado para o outro’’. CONCLUSIONS: The Portuguese version of the Pediatric PROMIS Mobility Item Bank reached the correspondence to the original version, and they are in the process of linguistic validation in Brazil.

(2100) Psychometric evaluation of the PROMISÒ fatigue measure in an Ethnically/Racially diverse population-based sample of cancer patients Bryce B. Reeve, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Wen-Hung Chen, RTI; Laura C. Pinheiro, University of North Carolina; Molly K. McFatrich, University of North Carolina; Roxanne E. Jensen, PhD, Georgetown University, Washington, DC, United States; Jeanne A. Teresi, Columbia University Stroud Center; Arnold L. Potosky, PhD, Georgetown University, Washington, DC, United States AIMS: Fatigue is the most prevalent and distressing symptom related to cancer and its treatment affecting functioning and quality of life. In 2010, the NCI’s Clinical Trials Planning Meeting on cancer-related fatigue adopted the PROMIS Fatigue measure as the standard to use in clinical

Qual Life Res (2014) 23:1–184 trials. This study evaluates the psychometric properties of the PROMIS Fatigue measure in an ethnically/racially diverse population-based sample of adult cancer patients. METHODS: Patients were recruited from four US cancer registries with oversampling of minorities. Participants completed a paper survey 6–13 months post-diagnosis. The 14 fatigue items (5-point Likert-type scale; English-, Spanish-, and Chineseversions) were selected from the PROMIS fatigue short forms and larger item bank. Item response theory and factor analyses evaluated item- and scale-level performance. Differential item functioning (DIF) was evaluated using Wald test and ordinal logistic regression (OLR) methods. OLR-identified DIF items were further evaluated for their effect on the scale scores (threshold r^2 [ 0.13 being significant). RESULTS: Sample included 5507 patients (2278 non-Hispanic White, 1122 non-Hispanic Black, 1053 Hispanic, 917 Asian); 338 Hispanics took the Spanish version and 134 Asians took the Chinese version. One PROMIS item had poor discrimination as it was the only positively worded question in the fatigue measure. Among Hispanics, the Wald test found no DIF but OLR method identified 5 items with DIF between English and Spanish versions, but the effect of DIF on scores was negligible (r2 ranged 0.006–0.015). Between English and Chinese translations, no single item was consistently identified by both DIF tests. Among English language measures, comparisons among Whites, Blacks, Hispanics, and Asians yielded no item that presented significant DIF that would impact overall scale scores. However, greater numbers of DIF items appeared when comparing Asians with Whites, Blacks, and Hispanics. ‘‘How often were you too tired to think clearly’’ showed consistent DIF. CONCLUSIONS: Twelve of 14 PROMIS fatigue items performed well across the ethnically/racially diverse samples with minimal findings of DIF that would have any effect on comparing or combining scores across cancer populations. Supporting evidence of the validity and reliability of the PROMS measures will enhance the adoption of the measures in clinical research.

Measure Development (2102) Measuring the community Re-Integration of burn injuries in adults: conceptual foundation for future development of a computer adaptive test (CAT) Molly E. Marino, MPH, Boston University, Boston, MA, United States; Marina Soley Bori, MA, Boston University, Boston, MA, United States; Melinda Rossi, BA, Boston University, Boston, MA, United States; Flor Amaya, MPH, Boston University, Boston, MA, United States; Mary D. Slavin, PhD, Boston University, Boston, MA, United States; Alan Jette, PhD, Boston University, Boston, MA, United States; Colleen Ryan, MD, Massachusetts General Hospital; Amy Acton, RN BSN, The Phoenix Society for Burn Survivors; Jeffrey Schneider, MD, Massachusetts General Hospital; Lewis E. Kazis, ScD, Center for the Assessment of Pharmaceutical Practices, Boston, MA, United States AIMS: Adults who experience burn injuries face considerable physical, psychological, and social challenges throughout their recovery and return to everyday life. This project aims to develop a validated conceptual framework for understanding the social impact of burn injuries in adults and develop a large item pool for purposes of calibration using Item Response Theory (IRT) for the future development of a Computer Adaptive Test. METHODS: We performed a comprehensive literature review and consulted with clinical experts and burn survivors about social roles and life areas impacted by burns. We modified items from nineteen previously established and published generic, burn-specific, and other condition-specific measures. We enriched the item pool by adding original items for each of these content areas. Three investigators independently classified the items into each subdomain; the research team of investigators, clinicians, and a clinically trained burn survivor

141 reviewed the items to ensure appropriate classification, and reached consensus on inclusion, modification, removal and addition of new items. Focus groups with burn survivors and clinicians were conducted to validate the framework and revise and augment the initial item pool. Two investigators independently analyzed each transcript using deductive codes based upon the model, and subsequently met to agree on appropriate item classification. The research team revised items from the original item pool and crafted new items based upon feedback from the focus groups. RESULTS: Conceptually grounded in the World Health Organizations International Classification of Functioning, Disability and Health (ICF), the primary construct identified was role re-integration, which contains two major concepts—societal role and personal relationships—each with several subdomains. The eight subdomains chosen for item development were work related to employment, domestic work, recreation and leisure, relating to strangers, relationships consisting of romantic, sexual, family and informal. The final pool contains 242 items that are currently tested for clarity and interpretation by burn survivors. Qualitative results strongly suggest that the conceptual model fits the constructs for societal role and personal relationships with the respective subdomains. CONCLUSIONS: This work will lead to future calibration using IRT methods and the development of a CAT for monitoring the social impacts of burn injuries during recovery.

(2104) Impact of recall period on the accuracy of selected items from the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Tito R. Mendoza, PhD, Univ. of Texas M.D. Anderson Cancer Ctr., Houston, TX, United States; Antonia V. Bennett, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Sandra A. Mitchell, PhD CRNP AOCN, National Cancer Institute, Bethesda, MD, United States; Bryce B. Reeve, PhD, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Thomas M. Atkinson, PhD, Memorial Sloan Kettering Cancer Center, New York, NY, United States; Yuelin Li, PhD, Memorial Sloan-Kettering Cancer Ctr., New York, NY, United States; Lauren Rogak, MA, Memorial Sloan-Kettering Cancer Center, New York, NY, United States; Amylou C. Dueck, PhD, Mayo Clinic, Scottsdale, AZ, United States; Ethan Basch, MD MSc, University of North Carolina—Chapel Hill, Chapel Hill, NC, United States; on behalf of the National Cancer Institute PRO-CTCAE Research Group AIMS: The current approach to reporting symptomatic adverse events in clinical trials involves reporting at scheduled visits that are often weeks apart and may contribute to substantial memory degradation and information loss. Although a 7-day recall period was specified for PRO-CTCAE, longer periods may be desired. The goal of this study is to compare 7-day and 2-week, 3-week, and 4-week recall periods to daily reports of items from the PRO-CTCAE. METHODS: Englishspeaking participants completed 28 consecutive daily assessments with 24-h recall of 14 symptoms (27 Likert-scale items measuring symptom ‘‘at its worst’’) via an interactive voice response (IVR) telephone call. Patients also completed 4 weekly web-based assessments with 7-day, 2-week, 3-week, and 4-week recall periods. Pearson correlations between the average daily rating (over the 7-day period) and the 1-week recall rating were computed. This analysis was repeated to compare the average daily rating (over the 2-week, 3-week, and 4-week periods) and the corresponding weekly recall ratings. To compare item mean differences between the average daily rating and corresponding recall rating for each recall period, paired ttests with a Bonferroni adjustment were used. RESULTS: 82 patients (56 % male; median age 56.5 years; 72 % receiving daily radiation treatment) completed at least 4 daily IVR calls per week for 4 weeks,

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142 and 75–82 completed the weekly web surveys. The median Pearson correlations between average daily and past-week recall were: for Week1 = 0.76 (range, 0.51–0.92); Week2, 0.73 (0.56–0.85); Week3, 0.82 (0.63–0.92); Week4, 0.79 (0.62–0.90). The mean differences between average daily and past-week recall were: for Week1, 0.11 (SD = 0.08); Week2, 0.20 (SD = 0.09); Week3, 0.19 (SD = 0.11); Week4, 0.21 (SD = 0.12). Small but statistically significant differences (p \ 0.05/27) with average daily recall were seen for 5/27 items at Week1, 11/27 at Week2, 12/27 at Week3, and 12/27 at Week4. CONCLUSIONS: 7-day recall corresponded well to the average daily recall for most items. Although correlations with average daily recall of 2-week, 3-week, and 4-week recall were consistent with 1-week recall, there were larger mean differences in ratings for 2-week, 3-week, and 4-week recall, suggesting that longer recall periods introduce possible biases but may be acceptable for practical reasons in some clinical-trial contexts. NCI Funding: HHSN261200800043C & HHSN261201000063C.

(2106) Patients with metastatic renal cell carcinoma (MRCC) on Palliative Cancer treatment: relevant social and working life aspects of therapy Sandra Meyer-Moock, University Medicine Greifswald, Institute for Community Medicine, Greifswald, Germany; Berit Eberhardt, Das Lebenshaus; Sarah Schmitter, Pfizer Deutschland GmbH; Rainer Niedtner, Pfizer Pharma Deutschland; Viktor Gru¨nwald, Hannover Medical School; Ines Buchholz, University Medicine Greifswald; Christina Claußen, Pfizer Deutschland GmbH; Thomas Kohlmann, PhD, University of Greitswald, Inst. For Comm. Med., Greitswald, Germany AIMS: Treatment of mRCC is commonly palliative, since RCC is usually resistant to radiation and chemotherapy. However targeted therapies may improve the chance of a longer progression free and/or overall survival and a better health-related quality of life (HRQOL). To assess HRQOL of patients several generic and disease-specific instruments are available, but little is known about the impact on social and working life as well as treatment-related decisions of mRCC patients. The aim of this study is to identify relevant dimensions as well as to develop an instrument to close this gap. METHODS: The study consists of three parts with qualitative and quantitative methods. In part I (development), we conducted focus group interviews with in total 15 patients in 2 patient support groups in Germany. Based on this information a draft questionnaire was developed. In the subsequent pre-test patients were asked to complete the draft questionnaire and to comment on it briefly in an interview (part II). Qualitative data analysis (focus groups, pre-test) consisted of content analysis methods (qualitative content analysis, Mayring); software for qualitative data analysis (MAXqda) was used. RESULTS: Focus group interviews showed that disease and treatment have an impact on HRQOL, social and working life in aspects, which are not covered by existing HRQOL instruments. Particularly, patients mentioned social and familiar assistance, information about treatment options and patient support organizations also financial burden as important aspects which influence their life. Based on this information we developed a draft questionnaire consisting of 49 items including the dimensions identified in the qualitative part. This questionnaire has proven to be feasible and appropriate in a field test. CONCLUSIONS: The existing HRQOL instruments do not adequately represent the dimensions of social and working life in a palliative cancer treatment setting. Additionally, a specific questionnaire is necessary to investigate the importance of various aspects of social and working life, like social assistance and financial burden, due to disease and palliative treatment. The pilot version of the

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Qual Life Res (2014) 23:1–184 questionnaire is currently in the field to validate the psychometric properties of the questionnaire (part III).

(2108) Implementation of a PRO, brief pain inventory, in a large healthcare system Thomas E. Elliott, MD, HealthPartners Institute for Education and Research, Minneapolis, MN, United States; Colleen M. Renier, BS, Essentia Institute of Rural Health, Duluth, MN, United States; Jeanette A. Palcher, Essentia Institute of Rural Health AIMS: To describe the quality, quantity, and other attributes of a popular patient-reported outcome (PRO), the Brief Pain Inventory (BPI), in the electronic medical record (EMR) of a large health care system in the U.S. Upper Midwest that could be used in future patientcentered outcomes research projects and routine patient care. To explore effective methods to implement PROs in clinical practice. METHODS: This retrospective observational study used existing data in the health care system’s EMR from July 1, 2005 to June 30, 2013. All adult patients (age 18 or older) were included who were patients of any of the health care system’s providers. Study variables included all BPI data, patient demographics, diagnoses, and medications, and provider characteristics. All analyses were descriptive. RESULTS: Family Medicine providers created most of the BPI data (64 %). Over the 8 years studied, 49,939 BPI records were completed with large increases each year from 434 records in year 1 to 12,593 in year 8. Nearly all were collected in outpatient clinics (99 %). The BPI records were remarkably complete with 96 % to 99 % of the 12 BPI items recorded. The details of the BPI’s 12 items will be reported later, as will the demographics of the patients and providers, and the patients’ diagnoses and medications. CONCLUSIONS: BPI data in the health care system’s EMR were readily available in discrete, digital form. The BPI data were remarkably complete and robust. A 30-fold increase in BPI data recorded in the EMR occurred over the 8 years studied. This study demonstrates that health care systems with PRO data embedded in EMRs have both clinical care and patient-centered research opportunities. This study’s data have already generated many hypotheses. Explanations for the rapid implementation of the BPI in this health care system will be presented, which could be generalizable to other health care systems.

(2110) Development of the social activities and independence questionnaire in paediatric diabetes as Part of the DECIDE randomised controlled trial Timothy EI Pickles, BSc (Hons) MSc, South East Wales Trial Unit, Cardiff University, Cardiff, United Kingdom; Sue Channon, School of Psychology, Cardiff University, Cardiff, United Kingdom; John Gregory, School of Medicine, Cardiff University, Cardiff, United Kingdom; Lesley Lowes, School of Healthcare Sciences, Cardiff University, Cardiff, United Kingdom AIMS: Children and young people with type I diabetes and their families, have to balance numerous additional, condition-related demands alongside normal developmental tasks. Social development is a key aspect of maturation and social experience is an integral part of quality of life. We therefore wished to develop and validate a measure to assess the impact of a diagnosis of type I diabetes on children’s social activity, the Social Activities and Independence Questionnaire (SAIQ). METHODS: Qualitative interviews with children and parents/carers were conducted to generate the content of the questionnaire. Reliability and validity were assessed using 1 month data from the DECIDE trial, a randomised controlled trial of hospital versus home management at diagnosis of type I diabetes in 203 children. RESULTS: Thematic analysis of qualitative interviews

Qual Life Res (2014) 23:1–184 identified two activity domains affected: • school-related (six items); •non-school-related (eight items). Five-point response scales from ‘Not At All Affected’ to ‘Completely Affected’, plus ‘Not Applicable’, were provided to answer the question ‘How much does diabetes affect you/your child taking part in the following activities?’ Debrief interviews of the SAIQ provided evidence of content validity. Reliability and validity results were similar for both parents/carers and patients. Factor analysis scree plots indicated that a single factor solution was adequate and thus all 14 items were combined into a single score. Additionally, Cronbach’s alpha was high (0.940). However, the distributions of the scales were severely skewed, with a ceiling effect (‘Not at all affected’) of roughly 17 % in all cases, meaning that only non-parametric tests could be undertaken. These tests showed no difference between arms of the DECIDE trial. CONCLUSIONS: The ‘Not Applicable’ category was problematic in the analysis. Parents/carers of children under 5 had high rates of ‘Not Applicable’ and were excluded. ‘Not Applicable’ responses were replaced with the mean of the other responses. This did not alter the overall score but allowed these responses to be used in reliability and validity calculations. In this preliminary analysis a reliable single factor solution was found but the scores calculated were not normally distributed, casting doubt over the linearity of the scale. Further work to assess this could incorporate a Rasch analysis.

Poster Session 3001: Saturday Poster Session 1 Breast and Prostate Cancer (3001) Quality of life in long term premenopausic early stages breast cancer survivors. determinants of future perspective and global QOL Juan Ignacio Arraras, PhD, Servicio Navarro de Salud, Pamplona, Navarra, Spain; Jose Juan Illarramendi, Complejo Hospitalario de Navarra, Navarra, Spain; Esteban Salgado, Complejo Hospitalario de Navarra, Navarra, Spain; Susana de La Cruz, Complejo Hospitalario de Navarra, Navarra, Spain; Gemma Asin, Complejo Hospitalario de Navarra, Navarra, Spain; Ana Manterola, Complejo Hospitalario de Navarra Radiotherapeutic Oncology Department; Berta Iban˜ez, Fundacio´n Miguel Servet-NavarraBiomed (REDISSEC); Uxue Zarandona, Complejo Hospitalario de Navarra, Navarra, Spain; Koldo Cambra, Fundacio´n Miguel Servet-NavarraBiomed (REDISSEC; Miguel Angel Dominguez, Complejo Hospitalario de Navarra, Navarra, Spain AIMS: Cancer survivors’ Quality of Life (QOL) is a key research and intervention area nowadays. Few QOL studies have been performed in premenopausal breast cancer survivors METHODS: A consecutive sample of 259 stage I-III breast cancer patients was addressed. Patients were premenopausal at diagnosis and had finished treatment 5 to 20 years before. They were relapse-free. Patients might have received surgery, different adjuvant treatment modalities, and could be under hormonal treatment. Patients completed the EORTC questionnaires QLQ-C30 and QLQ-CR23 once during the treatment follow-up period. Sociodemographic and clinical data were also recorded. Sociodemographic and clinical data, together with QOL questionnaires results were summarized using descriptive statistics. To identify which patients’ characteristics are related with future perspective and with global quality of life, univariate logistic regression analyses were performed with the categorized scores as response variables and sociodemographic, clinical and QOL items as explanatory variables. Multivariate logistic regression models were also performed to complement the analyses, including in the model

143 those that resulted significant in the univariate, and using backward regression method. RESULTS: 243 patients from 259 candidates were evaluated; QOL mean scores were high in most QOL areas. Moderate limitations occurred in global QOL, sleep disturbance, future perspective, sexual functioning and enjoyment (affectation [ 30). Light affectation (between 20 and 29 points) appeared in emotional functioning, fatigue, pain and systemic therapy side effects. Main factors related to future perspective were emotional functioning (R2 0.52), fatigue (0.30), breast symptoms (0.29), body image (0.27) and social functioning (0.26); and related to global QOL fatigue (0.47), pain and physical functioning (0.31), emotional and social functioning (0.27). A model that includes the QOL areas of emotional, social functioning and breast symptoms offers an explanation of the future perspective variance (R2 0.56). A model that includes the QOL areas of physical and emotional functioning, fatigue, sleepiness and appetite loss, offers an explanation of the global QOL variance (R2 0.51). CONCLUSIONS: Patients’ QOL was adequate. Limitations appeared more in emotional aspects. QOL in premenopausic early stages breast cancer might benefit from a multidisciplinary treatment. These results are in line with those found in the literature.

(3003) Quality of life following mastectomy and breast reconstruction: learning from the QUEST feasibility randomised trials (CRUK/08/027) Zoe E. Winters, University of Bristol, Bristol, United Kingdom; Clare Griffin, Institute of Cancer Research; Judith Mills, Institute of Cancer Research; Penny Hopwood, Institute of Cancer Research; Natalie Bidad, University College London; Lindsay MacDonald, University College London; Philip Turton, Leeds NHS Trust; Robert Horne, University College London; Judith Bliss, Institute of Cancer Research AIMS: Breast reconstruction aims to improve Health-Related Quality of Life (HRQOL) after mastectomy, with poor evidence to guide patients and surgeons in shared-decision making concerning the optimal type or timing of surgery. The primary aim of the QUEST feasibility trials was to determine the acceptability of a randomised clinical trial in breast reconstruction amongst patients and HCPs. The secondary aim was to evaluate the optimal types and timings of LD breast reconstruction affecting clinical and patient-reported outcomes. METHODS: QUEST comprised two parallel feasibility phase III randomised controlled multicentre trials to assess HRQOL impact of the type and timing of latissimus dorsi breast reconstruction (LDBR) when post-mastectomy radiotherapy (PMRT) is unlikely (QUEST A), or highly probable (QUEST B). The primary endpoint for the feasibility phase was the proportion of women who accepted randomisation and would be feasible if patient acceptability rates exceeded 25 % of women approached. A companion qualitative QUEST Perspectives Study (QPS) of patients (both accepting and declining trial participation) and healthcare professionals (HCPs) assessed trial acceptability. PROMS included EORTC QLQ-C30, QLQ-BR23, Body Image Scale, EQ-5D and HADS. The first European PROM for breast reconstruction: the EORTC QLQ-BRR24. Questionnaires were completed at baseline, 3, 6, 9, 12, 15, 18 and 24 months. RESULTS: The QUEST trials opened in 15 centres across the UK. After 18 months of recruitment, 17 patients were randomised to QUEST A and 8 to QUEST B with overall acceptance rates of 19 % (17/88) and 22 % (8/36), respectively. QPS recruited 56 patients and 51 HCPs. Patient preference was the predominant reason for declining trial entry; affecting 47 of the 88 (53 %) patients approached for QUEST A and 22 of the 36 (61 %)

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144 approached for QUEST B. Both trials were closed to recruitment in December 2012 acknowledging the challenges of achieving satisfactory patient accrual.

Qual Life Res (2014) 23:1–184 PROs data is currently being analysed. CONCLUSIONS: Despite extensive efforts to overcome recruitment barriers, it was not feasible to reach timely recruitment targets within a feasibility study. Patient preferences for breast reconstruction types and timings were common thus rendering patients unwilling to enter the trial. Despite surgeons traditionally recommending and harbouring preferences for surgical options, qualitative research showed that they understood and supported randomization. To overcome the patient preference problem in future, we need to consider alternative trial designs such as parallel preference arms and the ‘cohort multiple randomised controlled trial’ design. The successful feasibility phase of QUEST would have meant changing current information provision procedures and shared clinical decision-making. The underlying premise of patient choice in this process should be built on high quality evidence ideally derived from trials; however this potential may now remain embedded in registry and cohort studies (Figs. 1, 2).

(3005) Patient-Reported outcomes (PROs) and treatment Decision-Making in Ductal Carcinoma in Situ (DCIS) of the breast: a systematic review

Fig. 1 QUEST trials design assessing the impact of the type (a) and timing of (b) breast reconstruction on HRQL

Claudia Rutherford, PhD, QOL Office, University of Sydney, Camperdown, NSW, Australia; Madeleine T. King, PhD, PsychoOncology Cooperative Research Group (PoCoG), Sydney, Australia; on Behalf of the DCIS PRO Collaborative Group, QOL Office, University of Sydney

Fig. 2 QUEST A & B screening flowcharts

AIMS: Decision-making in DCIS is complex; decisions are guided by clinical features of the tumour and patient preference. We undertook a systematic review to: 1) determine the relative benefits and harms of treatment options for DCIS, and 2) identify decision aids for DCIS. METHODS: We searched six electronic databases from inception, cross-referenced, contacted experts, and performed a web-based search. No language restrictions were applied. Studies that explored PROs associated with the diagnosis and treatment of DCIS or developed resources to support treatment decisions for DCIS were included. Two reviewers independently applied inclusion and quality criteria and extracted findings. A combined synthesis of qualitative and quantitative research was performed. Impact of treatment on PROs was compared and contrasted among treatment options and the extent to which available decision support tools covered PROs determined. RESULTS: Of 2124 papers screened for relevance, 287 were considered potentially relevant and 12 met eligibility criteria. These papers cast very little light on the differential impact of DCIS treatments: six pooled treatment groups and two pooled DCIS with invasive breast cancer (IBC) patients. Three assessed QOL cross-sectionally at long and variable times after initial surgical treatment (2- 15 yrs). One found that women with DCIS had poorer PROs on all domains of the SF-36, at 4–6 weeks after surgery, but no detectable deficits by one year. We found 15 decision aids: four for DCIS, nine for IBC, one for mammographic screening, and one for risk of IBC. Most decision aids for IBC address chemotherapy, which is not relevant to DCIS, so may invoke unnecessary anxiety. Importantly, there is limited PRO information in any of the 15 decision aids; five provide vague qualitative information about feelings based on a small number of patient stories and none present QOL important to women with DCIS in a quantitative format. CONCLUSIONS: Previous studies have examined PROS after a DCIS diagnosis, but all suffer considerable limitations. Thus, little is known about the acute recovery trajectory and long-term impacts of currently available treatment options. The few existing decision aids for DCIS are unacceptably limited in their scope and content.

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Qual Life Res (2014) 23:1–184 (3007) Determinants of quality of life among long-term breast cancer survivors Wai-on Chu, Centre Georges Franc¸ois Leclerc Comprehensive Cancer Centre, Dijon, France; Pegdwende Olivia Dialla, Centre Georges Franc¸ois Leclerc Comprehensive Cancer Centre, Dijon, France; Patrick Roignot, Pathology Centre, Dijon, France; MarieChristine Bone-Lepinoy, Centre Radiotherapie Du Parc, Dijon, France; Marie-Laure Poillot, Centre Georges Franc¸ois Leclerc Comprehensive Cancer Centre, Dijon, France; Charles Coutant, Centre Georges Franc¸ois Leclerc Cancer Care Center, Dijon, France; Patrick Arveux, Centre Georges Franc¸ois Leclerc Cancer Care Center, Dijon, France; Tienhan Sandrine Dabakuyo, PharmD PhD, Centre Georges-Francois Leclerc, Dijon, Burgundy, France AIMS: The aim of this study was to identify the impact of clinical and socio-economic determinants on quality of life (QOL) among breast cancer (BC) survivors five years after diagnosis. The secondary objective was to describe the QOL of this population using QOL questionnaires. METHODS: A cross-sectional survey was conducted in women diagnosed in 2007 for primary invasive non-metastatic BC and identified through the Coˆte d’Or BC registry. QOL was assessed with the SF-12, the EORTC-QLQ-C30 and the EORTC-QLQ-BR23 questionnaires. Social support was assessed with Sarason’s social support questionnaire and deprivation was assessed by the EPICES questionnaire. Clinical variables were collected through the registry database. Determinants of QOL were identified using multivariable mixed model analysis for each SF-12 dimension. A sensitivity analysis was conducted with multiple imputations on missing data. RESULTS: SF-12, EORTC-QLQ-C30 and EORTC-QLQ-BR23 revealed good QOL. Age was found to be a determinant of physical functioning (P \ 0.001) and role physical (p = 0.003) QOL. Comorbidity was found to be a determinant of physical functioning (p = 0.004) and global health (p = 0.003) QOL. Social support availability was found to be a determinant of vitality (p = 0.003) QOL. CONCLUSIONS: Five years after BC diagnosis, disease severity and the treatment received did not affect QOL

(3009) Health-Related quality of life in men undergoing radical prostatectomy and the relationship with psychosocial factors: preliminary data Lı´via Cristina de Resende Izidoro, Universidade Federal de Sa˜o Carlos, Sa˜o Carlos, Brazil; Glaucia B. Soares, Federal University of Sa˜o Carlos—SP—Brazil; Tamires C. Vieira, Federal University of Sa˜o Carlos—SP—Brazil; Fabiana Souza Orlandi, PhD, Universidade Federal de Sa˜o Carlos, Sa˜o Carlos, Brazil; Priscilla Hortense, Federal University of Sa˜o Carlos—SP—Brazil; Anamaria A. Napoleao, PhD, Federal University of Sa˜o Carlos—UFSCar—Brazil, Sa˜o Carlos, Brazil AIMS: To assess health-related quality of life (HRQOL) and relationships with psychosocial factors (self-esteem, anxiety and depression) in men undergoing radical prostatectomy (RP). METHODS: Cross-sectional, observational and correlational study conducted in a Brazilian city (221.936 inhabitants). Sample: 69 men aged over 18 years undergoing RP from three months to five years. The scales used were the European Organization for Research and Treatment of Cancer (EORTC)-QLQ C30 for HRQOL, the Rosenberg self-esteem scale (EAR) and the hospital anxiety and depression scale (HADS). For descriptive analysis averages and standard deviation were calculated. The Spearman correlation coefficient for the analysis of relationships between variables was used. The internal consistency of the instruments was assessed by Cronbach’s Alpha. RESULTS: The mean age was 65.78 years (±6.64) and the mean postoperative period 19.64 months (±14.20). The average self-esteem score

145 Table 1 Spearman’s correlation coefficients between the domains of the EORTC QLQ-C30 and the psychosocial variables (anxiety, selfesteem and depression) Domains

Psychosocial variables A

D

SE

QL2

0.41**

20.47**

0.25*

PF2

20.54**

20.37**

0.33**

RF2

20.37**

20.35**

0.13

EF

20.56**

20.26*

0.13

CF

20.16

20.35**

SF

20.43**

20.14*

-0.12

FA

0.46**

NV

0.02

PA DY SL

0.17

0.24

-0.19

-0.04

-0.08

0.24*

0.13

-0.13

0.27*

0.08

-0.14

0.38**

0.36**

20.18

AP

-0.11

0.11

20.18

CO

0.10

0.12

20.13

DI FI

-0.02 0.30*

0.14 0.13

-0.13 -0.08

QL2 Global health status/QoL, PF2 physical functioning, RF2 role functioning, EF emotional functioning, CF cognitive functioning, SF social functioning, FA fatigue, NV Nausea and vomiting, PA pain, DY dyspnoea, SL insomnia, AP appetite loss, CO constipation, DI diarrhoea, FI financial difficulties, A anxiety, D depression, SE selfesteem * p B 0.05; ** p B 0.01

obtained was 23.55 (±4.38) in a range from 0 to 30. The average anxiety score was 4.68 (±3.41) and depression was 3.94 (±3.31), classifying all subjects as ‘‘no cases’’ in an overall score ranging from 0 to 21 for each subscale. Regarding HRQOL scores of the scales may vary from 0 to 100. In the Global health status/QOL scale the average was 82.87 (±14.93); for the functional scale ‘‘social functioning’’ had the highest average, 91.52 (±21.87) and ‘‘role functioning’’ the lowest average, 80.10 (±23.70). For these scales higher scores reflect higher levels of functioning. In symptom scale ‘‘Insomnia’’ had the highest average, 21.23 (±31.85) and ‘‘Nausea and Vomiting’’ the lowest average, 2.43 (±9.64). For these scales higher scores reflect more symptoms. Two high and inverse correlations were observed between the total anxiety score and two domains of functional scale: ‘‘physical function’’ (r = -0.54) and ‘‘emotional functioning’’ (r = -0.56). Also it was possible to identify moderate to weak correlations between the domains of HRQOL with depression and selfesteem (Table 1). All instruments showed a [ 0.70. CONCLUSIONS: HRQOL was related to anxiety particularly in physical and emotional function, with an inverse and high correlation. Depression and self-esteem were also related to the HRQOL, although with a lower magnitude.

(3011) Domains of improvements in quality of life after testosterone recovery for high risk prostate cancer patients treated with long term androgen deprivation therapy Abdenour Nabid, MD, FRCP(C), Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada; Nathalie Carrier, Centre

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146 Hospitalier Universitaire de Sherbrooke; Andre´-Guy Martin, HoˆtelDieu de Que´bec; Jean-Paul Bahary, MD, FRCP, Centre Hospitalier de L’Universite de Montreal, Montreal, QC, Canada; Luis Souhami, Centre Universitaire de Sante´ McGill, Montreal, QC, Canada; Marie Duclos, Centre Universitaire de Sante´ McGill, Montreal, QC, Canada; Francois Vincent, Centre Hospitalier Re´gional de Trois-Rivie`res, Trois-Rivieres, QC, Canada; Sylvie Vass, CSSS de Chicoutimi; Boris Bahoric, Hoˆpital Ge´ne´ral Juif; Robert Archambault, Hoˆpital de Gatineau AIMS: To evaluate the magnitude and the domains of quality of life (QOL) improvement after testosterone recovery in high risk prostate cancer (HRPC) patients treated with androgen deprivation therapy (ADT) and radiotherapy (RT) in a prospective randomized phase III trial (PCS IV clinical trials, Gov. # NCT 00223171). METHODS: We analysed the 273 patients who recovered normal levels of testosterone, (median follow-up 92.1 months).QOL was assessed by two validated tools: EORTC30 version 3.0 (30 items) and PR25 (25 items). The 55 items were regrouped into 21 scales: 15 for EORTC30 and 6 for PR25. All items and scales scores were linearly transformed to a 0–100 points scale. All items and scales were compared with Wilcoxon signed rank test. p value \ 0.01 was considered statistically significant and a difference between groups in mean scores of = 10 points as clinically relevant. Patient-reported outcomes were filled out before treatments, every 6 months during ADT, 4 months after and then once a year for 5 years. RESULTS: Adherence to QOL questionnaires was 81 % (5010/6186). QOL was compared in each of the 273 patients between the time testosterone value reached a castrate level after ADT and the first time it normalised. 22/55 items (impact on family life or social activities, need to rest, weakness, fatigue, insomnia, constipation, diarrhoea, financial difficulties, pollakiuria, nocturia, urinary urgency, insomnia related to nocturia, need to be close to a toilet, urinary leakage, dysuria, limited activities/urinary problems, abdominal bloating, hot flushes, weight loss, interest in sex, sexually active,) and 10/21 scales (Social functioning, fatigue, insomnia, constipation, diarrhoea, financial difficulties, urinary symptoms, bowel symptoms, hormonal treatment related symptoms, sexual active) were statistically significant. 6 of these 22 items (pollakiuria, nocturia, urinary urgency, insomnia related to nocturia, dysuria, hot flushes) and 1/21 scales (urinary symptoms) were clinically relevant. 6/22 items (need to rest, weakness, fatigue, insomnia, diarrhoea, need to be close to a toilet) and 3/21 scales (fatigue, insomnia, diarrhoea) were close to clinical relevance. CONCLUSIONS: In HRPC treated with RT and ADT, recovery of testosterone to normal level is associated with major improvements in QOL in several domains.

Endocrinology/Diabetes/Obesity (3013) The relationship between fitness and health-related quality of life and the mediating role of self-determined motivation in adolescents with overweight Kirsti Riiser, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Yngvar Ommundsen, Norwegian School of Sport Sciences; Milada C. Smaastuen, Department of Nursing, Oslo and Akershus University; Knut Løndal, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Nina Misvær, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; Sølvi Helseth, PhD, Oslo and Akershus University College of Applied Sciences, Oslo, Norway AIMS: A number of studies have shown that children and adolescents with overweight and obesity have lower health-related quality of life (HRQOL) and are less physically active and less physically fit than their leaner peers. This knowledge supports the need of further investigation of if and how fitness might be related to HRQOL. The aim of the study

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Qual Life Res (2014) 23:1–184 was to examine the relationship between cardiorespiratory fitness and health-related quality of life (HRQOL) among overweight adolescents. Additionally we tested whether this relationship was mediated by body image and self-determined motivation for physical activity and exercise. METHODS: 120 adolescents identified as overweight were recruited through the school health service. The participants completed self-report instruments measuring HRQOL, body image and selfdetermined motivation for physical activity and exercise in addition to a 20-m shuttle-run test measuring cardiorespiratory fitness. Body mass index was calculated based on measurement of weight and height. Associations between the study variables were explored using univariate linear regression. Mediation was tested by a multistage regression approach. RESULTS: We revealed a statistically significant association between cardiorespiratory fitness and HRQOL (4.85 [1.17–8.54]; p \ 0.05). Cardiorespiratory fitness failed to affect body image in the first mediation equation, hence, body image was excluded from further analyses. However, self-determined motivation proved to mediate the relationship between cardiorespiratory fitness and HRQOL. CONCLUSIONS: Self-determined motivation can contribute to explain the association between cardiorespiratory fitness and HRQOL among overweight adolescents, suggesting that it is not the physiological effects of being fit as much as the motivational mechanisms related to fitness, which affects HRQOL.

(3015) Quality of life and health habits in patients with or without type 2 diabetes Jose Guadalupe Salazar Estrada, Sr., Psic, PhD, Uiniversidad de Guadalajara, Tlajomulco de Zuniga, Mexico; Norma A. Ruvalcaba, II, Universidad de Guadalajara, Guadalajara, Mexico; Gustavo Hidalgo-Santacruz, MA, Universidad de Guadalajara, Guadalajara, Jalisco, Mexico AIMS: To identify differences in health habits and in the self-perception of health for patients diagnosed as diabetics as compared with non-diabetics in patients with type popular insurance. METHODS: Transversal study of 380 [Mexican] primary care patients with popular insurance, 46 % of whom had been diagnosed with type 2 diabetes mellitus (DM2) for at least one year; the remaining 53 % of the participants did not have any kind of chronic disease. The sample was selected using a proportional distribution of diabetics versus nondiabetics. The EuroQOL 5D instrument was administered to evaluate information about patients_ quality of life; the instrument had a Cronbach alpha of 82. A separate questionnaire was developed and used to collect information about health habits, daily activities, and sociodemographics. The study resulted in a descriptive analysis and comparisons of statistical data using computer programs. RESULTS: Of the overall sample, 45.8 % of participants were diagnosed with DM2; of those, 64.3 % were women. The median age was 54.76 ± 6.8 years. Regarding civil status, 73 % of the diabetics and 75.6 % of the non-diabetics were married. Only 31.5 % of diabetics and 29.4 % of non-diabetics were working for pay. Only 29.1 % of the diabetic group had more than secondary level education [roughly the equivalent of US 8th grade], in contrast with 43.7 % of the nondiabetic group. The presence of problems in mobility was above 50 %, and the rate was higher in diabetics. There was a large difference between the groups in the measurement of anxiety/ depression- 94.4 % of diabetics versus 68.0 % of non-diabetics reported problems. The average value of the [EuroQOL] visual analog scale was 68.17 ± 9.9. Of the diabetic group, 22.5 % smoked versus 31.9 % of those who were not diabetic. CONCLUSIONS: Self-perception of health was not associated with being diabetic or not, nor was there a relationship between healthy habits and self-perception of health. The poor perception of health in the study sample could be associated with other factors such as age and education.

Qual Life Res (2014) 23:1–184 (3017) Quality of life in patients with benign non-toxic goitre as compared to the general population: baseline and 6 months post-treatment Per Cramon, MD, Copenhagen University Hospital, Copenhagen, ˚ se K. Rasmussen, Copenhagen University Hospital Denmark; A Rigshospitalet, Copenhagen, Denmark; Jakob B. Bjorner, MD PhD, QualityMetric; Steen J. Bonnema, Odense University Hospital, Odense, Denmark; Daniel M. Frendl, University of Massachusetts Medical School; Mogens Groenvold, MD, PhD, University of Copenhagen, Copenhagen, Denmark; Laszlo Hegedu¨s, Odense University Hospital, Odense, Denmark; Ulla Feldt-Rasmussen, Copenhagen University Hospital, Copenhagen, Denmark; Torquil Watt, MD PhD, Copenhagen University Hospital, Copenhagen, Denmark AIMS: The purpose of the present study was to evaluate thyroidrelated quality of life in patients with non-toxic goitre, as compared to the general population, before and 6 months after treatment. METHODS: Quality of life was assessed with the 85 item ThyPRO survey which is scored as 13 scales (range: 0–100). Data included baseline and 6 month post-treatment assessments from 123 patients with goitre who underwent radioiodine therapy (35 %), hemithyroidectomy (50 %), total thyroidectomy (11 %), and cyst aspiration with ethanol instillation (3 %). At baseline and 6 months after treatment, 90 and 85 % of the patients were euthyroid, respectively. The remaining patients had subclinical thyroid dysfunction. Normative data were collected from 754 Danish individuals for the 9 ThyPRO scales that do not make attributions to thyroid disease. ThyPRO score differences between patients and the general population were analysed with multivariate linear regression, adjusting for: age, gender, comorbidity and educational status. Changes in patient scores with treatment were analysed with the paired t-test. Magnitudes of score differences were evaluated as effect-sizes (0.2–0.5 indicating small, 0.5–0.8 moderate, and 0.8 ? large effects). RESULTS: Patients had worse scores than the general population at baseline on all 9 comparable ThyPRO scales, with large effects on the Goitre Symptoms and Anxiety scales. Patients’ ThyPRO scores improved 6 months after treatment on Goitre Symptoms (large effect), Anxiety (moderate effect), and Hyperthyroid Symptoms, Eye Symptoms, Tiredness, Emotional Susceptibility and Impaired Daily Life (small effects). However, the post-treatment scores remained worse than the general population on five scales, with large effects on Goitre Symptoms and small effects on Hypothyroid Symptoms, Tiredness, Depressivity, and Emotional Susceptibility scales. CONCLUSIONS: Patients had greatest impairment on the Goitre Symptoms and Anxiety scales, as compared to the general population, and the largest post-treatment improvements were also observed on these two scales. However, a quality of life deficit persisted 6 months after treatment.

(3019) Impact of irritable bowel syndrome with constipation on health-related quality of life among commercially insured patients in the united states Judith J. Stephenson, HealthCore Inc, Wilmington, DE, United States; Jessica Buono, Forest Laboratories, Jersey City, NJ, United States; William M. Spalding, Ironwood Pharmaceuticals; Qian Cai, HealthCore Inc; Hiangkiat Tan, HealthCore Inc; Robyn Carson, MPH, Forest Research Institute, Jersey City, NJ, United States; Jalpa A. Doshi, University of Pennsylvania AIMS: Few studies have examined the impact of irritable bowel syndrome with constipation (IBS-C), a chronic functional gastrointestinal disorder, on health-related quality of life (HRQOL). This study evaluated general and disease-specific HRQOL among a sample of commercially insured patients with IBS-C in the US. METHODS:

147 Patients aged = 18 years with continuous medical and pharmacy benefit eligibility (03/01/2011–02/28/2013) were identified from the HealthCore Integrated Research Database. IBS-C patients were those with = 1 medical claim for IBS (ICD-9-CM 564.1x) and either = 2 medical claims for constipation (ICD-9-CM 564.0x) or = 1 medical claim for constipation plus = 1 pharmacy claim for a constipationrelated prescription on different dates, without claims for potentially confounding diseases. Consenting patients were administered modified Rome III criteria via telephone or Internet to confirm IBS-C diagnoses. Only patients who met both claims and Rome criteria completed the full survey. General HRQOL was measured by the Short Form-12 version 2 (SF-12v2; all patients) and EuroQoL-5D (EQ-5D; phone interview only). SF-12v2 is comprised of a physical component summary (PCS) and mental component summary (MCS) score (range: 0–100; US normative mean = 50); EQ-5D consists of a utility score (range: 0 = death to 1 = perfect health). Disease-specific HRQOL was measured by the IBS Quality of Life (IBS-QOL) questionnaire, which includes an overall and 8 subscale scores (Dysphoria; Interference with Activity; Body Image; Health Worry; Food Avoidance; Social Reaction; Sexual; and Relationships), all ranging from 0 to 100. Higher scores on all measures indicate higher general or IBS-specific HRQOL. RESULTS: Of the 53 IBS-C patients who completed the survey (mean age: 40 ± 15 years; 84.9 % female), mean (±SD) PCS and MCS scores were 46.1 (±11.5) and 42.6 (±12.0), respectively. EQ-5D mean (±SD) utility score for patients who completed the telephone survey (n = 25) was 0.6 (±0.2). IBS-QOL mean (±SD) overall score was 62.9 (±21.5). Subscale scores ranged from 47.3 (±28.7) for the Food Avoidance subscale to 75.2 (±22.4) for the Relationship subscale. CONCLUSIONS: IBS-C patients report lower HRQOL based on certain HRQOL measures, such as the SF-12v2, for which scores are lower than US general population norm scores. Future research is needed to assess the impact of IBS-C treatment on HRQOL.

(3021) Contribution of significant life events to HRQOL assessment in a haemophilia sample Jean St-Louis, CHU Sainte Justine; Robert Klaassen, MD, Children’s Hospital of Eastern Ontario, Ottawa, ON, Canada; Nancy L. Young, PhD, Laurentian University, Sudbury, ON, Canada; Diana Urajnik, Laurentian University, Greater Sudbury, ON, Canada; Stephanie Cloutier, L’ Hoˆpital de L’Enfant-Je´sus; Bruce Ritchie, University of Alberta; Margaret Warner, Royal Victoria Hospital; Francine Menard, CHU Sainte Justine; Georges E. Rivard, Hoˆpital Ste-Justine; Victor Blanchette, Hospital for Sick Children, Toronto, ON, Canada AIMS: Our understanding of health-related quality of life (HRQOL) among boys and men with haemophilia has focused primarily on the impact of clinical events. However, we have observed within subject variation in HRQOL over time that is not fully explained by bleeding patterns or other significant medical events. This abstract explores the impact of significant non-medical life events on HRQOL scores in boys and men with haemophilia A (HA) during a key transition period. METHODS: Males, 14 to 29 years of age, with severe HA were recruited from 6 Haemophilia Treatment Centres in Canada and followed prospectively for 2 to 3 years. HRQOL was assessed at baseline at 6 month intervals using the SF-36. Patients were also asked to report significant life events in the preceding 6 month period using a novel survey: the Significant Life Event Questionnaire (SLEQ). The SLEQ required them to rate the positive or negative impact of these events on their life (-2 to ?2). This paper focuses on: describing the types of events that were reported in this population; the distribution of SLEQ scores; and the relationship between the SLEQ scores and the SF36 scores. RESULTS: A total of 46 participants completed the study (mean age = 21.4; range of 13.0 to 28.7 years). All were on regular preventive therapy (prophylaxis). The median index joint annualized

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148 bleeding rate (ABR) was 0.7. There were many significant life events reported in this group, with more diversity in young adults (average of 2.5 events at each time period) than youth (average of 1.9 events). The aggregate SLE scores ranged from -9 points to ?16 points. The 3 most prevalent events were related to work: change in responsibilities (104 reports in 36 months, median impact of 1 point); found a new job (79 reports, median impact of 1); changed employment (67 reports, median impact of 1). These were followed by: changing classes at school (62 reports, median impact of 0.5); and significant change in my romantic relationship (60 reports, median impact of 0). However, SF36 change scores for Physical and Mental Component Summary scores were not associated with SLEQ scores (r = -0.01 and r = 0.12 respectively). CONCLUSIONS: Participants experienced many significant life events during the study however these did not appear to impact HRQOL. Thus, changes in HRQOL are likely attributable to changes in patients’ clinical profiles.

Mental Health (3023) Measuring Recovery Orientation in People with Serious Mental Illness: application of modern methods to reveal the shortcomings of revised scales in mental health Skye P. Barbic, PhD, OT, University of Toronto, Toronto, ON, Canada; Sean Kidd, Centre for Addiction and Mental Health, Toronto, ON, Canada; Maria O’Connell, Yale University; Kwame McKenzie, Wellesley Institute; Larry Davidson, Yale University AIMS: In psychiatry, the recovery paradigm is increasingly identified as the overarching framework for service provision. Currently, the Recovery Self-Assessment (RSA), a 36-item tool, is commonly used to assess the uptake of a recovery orientation in clinical services. However, the consumer version of the RSA has been found challenging to complete due to length and the reading level required. In response to this feedback, a brief 12-item version of the RSA was developed (RSA-B). This paper describes the development of the modified instrument and the application of Rasch Measurement Theory to test the suitability of the RSA-B. METHODS: Data from a multi-site study of adults with serious mental illnesses (n = 1,256) who were followed by community support services were examined for reliability, clinical meaning, targeting, response categories, model fit, reliability, dependency, and raw interval-level measurement. Analyses were performed using SPSS and the Rasch Unidimensional Measurement Model (RUMM 2030). RESULTS: Adequate fit to the Rasch model was observed (?2 = 112.46, DF = 90, p = 0.06) and internal consistency was good (r = 0.86). However, Rasch analysis revealed several limitations of the 12-item version of the RSA in terms of both reliability (Person Separation Index of 0.69) and validity. Items covered 3.1 logits (-1.6 to ?1.5) or 39 % of the targeted theoretical continuum. Two items displayed misfit and reversed thresholds were observed for all 12 items suggesting the response categories were not optimal. CONCLUSIONS: Rasch analysis revealed several shortcomings of the 12-item RSA-B that had been overlooked in conventional analyses. A revisit of the initial 36-item bank is needed to improve the current measure so that it might be optimized for use in mental health research and practice.

Qual Life Res (2014) 23:1–184 AIMS: The Adolescent Mental Health Continuum-Short Form (MHCSF), developed by Keyes (2002), is a relatively new scale to measure positive aspects of adolescents’ positive mental health including positive feelings (emotional well-being), positive functioning in individual life (psychological well-being), and community life (social well-being). The purpose of the study was to evaluate the internal construct validity (latent factor structure) of the MHC-SF and to assess the external construct validity of the scale by association with sense of coherence (SOC) in Japanese and Norwegian adolescents, in order to facilitate Japanese/Norwegian comparative research on positive aspects of their mental health METHODS: Data were analyzed from two samples of adolescents aged 16–17 in Japanese and Norwegian high schools (n = 859 and n = 189, respectively). Multigroup confirmatory factor analysis (CFA) of the MHC-SF in Japanese and Norwegian samples was conducted to test the proposed threefactor structure consisting of emotional well-being (3 items), psychological well-being (6 items) and social well-being (5 items) cf. Fig. 1. Simultaneous latent structure analysis between Japanese and Norwegian was performed to examine the relationships between positive mental health measured by the MHC-SF and Sense of Coherence (SOC-13). SOC includes three sub dimensions: comprehensibility (5 items), manageability (4 items) and meaning (4 items) (Antonovsky 1979). RESULTS: The three-factor model of MHC-SF provided an adequate fit (CFI = 0.889, RMSEA = 0.074), although the fitness of the model was significantly worse than the preceding model by constraining parameters to be equal across the two samples (Japanese and Norwegian). As predicted, higher SOC was significantly related to better positive mental health in both samples, although a significant difference was found between Japanese and Norwegian for path coefficients of SOC to mental health. CONCLUSIONS: These findings support internal and external construct validity of the MHC-SF. Factor structure and factorial invariance (or stability) of the MHC-SF were supported in Japanese and Norwegian adolescents. Theoretically consistent associations were found between SOC and positive mental health measured by the MHC-SF in both groups, supporting external construct validity of the MHC-SF. Further study is required to validate the MHC-SF and to examine similarities and differences of positive mental health between Japanese and Norwegian adolescents (Fig. 2; Table 1).

(3027) Construct validation of the adolescent mental health Continuum–Short Form (MHC-SF) in Japanese and Norwegian high school students Junko Sakano, Okayama Prefectual University, Soja, Okayama, Japan; Eva Langeland, Bergen University College, Bergen, Norway; Ragnhild Sollesnes, Bergen University College, Bergen, Norway; Yuki Yajima, Niimi College; Shinichiro Sasahara, University of Tsukuba; Yoshihiko Yamazaki, Nihon Fukushi University

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Fig. 1 The MHC-Y factor structure model

Qual Life Res (2014) 23:1–184

149 analysis was performed. RESULTS: In multiple linear regression analyses, the models concerning autonomy, interpersonal relations, and leisure time were statistically significant. In patients on MS ? SGA, autonomy (Beta = 3.086, p \ 0.01), interpersonal relations (Beta = 2.807, p \ 0.01) and leisure time activities (Beta = 3.293, p \ 0.01) were affected negatively. Similarly total HAM-D score have negative effects on the same domains. CONCLUSIONS: Beside residual depressive symptoms, second generation antipsychotics used in the treatment seem to affect psychosocial functioning negatively.

Pulmonary Fig. 2 The relationship between SOC and mental health continuum

Table 1 Multiple group factor analysis with Japanese and norwegian samples X2

df

DX2

Ddf

p

CFI

RMSEA 0.067

Model I

720.9

148

0.000

0.925

Model II

766.5

159

45.6

11

0.000

0.921

0.066

Model III

789.6

162

23.1

3

0.000

0.918

0.067

Model IV

817.9

165

28.3

3

0.000

0.915

0.067

1,029.8

179

211.9

14

0.000

0.889

0.074

Model V

Model 1 configural invariance, Model II first order factor loadings invariant, Model III first- and second-order factor loadings invariant, Model IV first- and second-order factor loadings, and residual variance of measured invariant, Model V first- and second-order factor loadings, residual variance of measured variable s, and disturbances of first-order factors invariant DX2 Chi square difference, Ddf difference in degrees of freedom, p p value

(3031) The impact of second generation antipsychotics on psychosocial functioning in bipolar disorder Omer Aydemir, Celal Bayar University, Izmir, Turkey; Pinar Cetinay-Aydin, Bakirkoy Mazhar Osman Research and Training Hospital, Istanbul, Turkey; Demet Gulec-Oyeckin, Onsekiz Mart University, Canakkale, Turkey; Seref Gulseren, Ataturk Research and Training Hospital, Izmir, Turkey; Gulperi Putgul-Koybasi, Menemen State Hospital, Izmir, Turkey; Hasan Sahin, Bayindir State Hospital, Izmir, Turkey AIMS: Even though bipolar patients achieve remission, they do not reach premorbid psychosocial functioning. Factors such as residual depressive symptoms, number of episodes cause this effect. The impact of treatment modalities has not been adequately studied. The aim of this study is to evaluate the impact of treatment modalities on psychosocial functioning in remitted bipolar patients. METHODS: The study was carried out with 108 patients diagnosed with bipolar disorder. All patients were in remission and the remission state was confirmed scales. In the assessment of functioning, Functioning Assessment Short Test (FAST) covering the domains such as autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relations, and leisure time was applied. The treatment modalities are mood stabilizers (MS) versus mood stabilizers plus second generation antipsychotics (MS ? SGA). While 38 % (n = 41) of the patients were on MS only, 67 patients (%62) were on MS ? SGA. In the statistical analysis, multiple linear regression

(3033) Does the smoking cessation improve the smoker’s quality of life? Yuto Hayashi, Japanese Society of Quality of Life Research, Hyogo, Japan; Ryo Yoshioka, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Kazunori Tanaka, PhD, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Yusuke Tanaka, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Yuto Oiki, Japanese Society of Quality of Life Research, Sumaku, Kobe, Hyogo, Japan; Yuko Takahashi, MD PhD, Nara Women’s University, Nara, Nara, Japan; Michiko Kobayashi, MD, Japanese Society of Quality of Life Research, Kobe, Japan; Michiko Kobayashi, MD, Japanese Society of Quality of Life Research, Kobe, Japan; Tomotaka Sobue, MD PhD, Graduate School of Medicine, Osaka University, Osaka, Japan; Takashi Mandai, MD PhD, Japanese Society of Quality of Life Research, Kobe, Japan AIMS: The purpose of this study was to investigate the quality of life (QOL) improvement by smoking cessation. METHODS: Thirtyfour smokers treated by special out-patient department for smoking cessation at university and national hospital participated in this study. Our new original self-administered QOL questionnaire including 40 questions divided into 13 categories with 28 smoking cessation-specific questions and the Life Satisfaction Index questionnaire by Neugarten were used. RESULTS: Cronbach’s alpha coefficients of our questionnaire were excellent enough to accept for clinical use: 0.94 in environmental problems, 0.94 in dietary problems, 0.90 in mental problems, etc. before quitting, and 0.90 in environmental problems, 0.90 in mental problems, 0.89 in dietary problems, etc. after one, respectively. Our original QOL questionnaire contained 10 main factors and cumulative contribution was 0.87 before abstinence. Our original QOL questionnaire also contained 10 main factors and cumulative contribution was 0.86 after one, too. Compared with before quitting, almost two-thirds smokers showed the improved QOLs, but about three tenths ones indicated the deteriorated QOLs after abstinence. Compared with before quitting, there was significant improvement of mean QOL after abstinence (p \ 0.01). Compared with before quitting, significant improvements of QOLs were demonstrated in well-being, in medical treatment, in social participation (p \ 0.01), in dietary problems, in psychological problems, and in passion for life (p \ 0.05) after abstinence, respectively. Compared with before quitting, significant improvements of QOLs were indicated in well-being, in medical treatment, in social participation, in environmental problems (p \ 0.01) in male smokers, and in well-being, in medical treatment (p \ 0.01), in dietary problems, in psychological problems (p \ 0.05) in female ones after abstinence, respectively. Brinkman’s index may be useful to predict the QOL changes by quitting. CONCLUSIONS: These findings indicate that our QOL questionnaire has excellent enough reliability and potency of validity to investigate the QOLs on smoking cessation. We believe that smoking cessation plays important roles to establish the more excellent qualitative daily life from the view point of QOL.

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150 (3035) Self-Perceived sleep quality and quantity in adult subjects with asthma in a real world setting: findings from the costeasma study Pedro Ojeda, Clı´nica de Asma Y Alergia Dres, Madrid, Spain; Vero´nica Sanz de Burgoa, Medical Department, Pfizer, S.L.U., Alcobendas, Spain; Javier Rejas, Pfizer, S.L.U., Madrid, Spain AIMS: Asthma is a chronic inflammatory disease of the airways associated with airway hyperresponsiveness that leads to recurrent symptoms and exacerbations and reversible airflow obstruction. Nocturnal symptoms of asthma, frequently reported in uncontrolled/ partially controlled patients, are associated with poor sleep quality, excessive daytime sleepiness and poor daytime functioning. The objective was to assess the patient-self perceived sleep quality and quantity in subjects with asthma in a real-world setting according to different determinants of patient health status. METHODS: A crosssectional, observational, seasonal-waves survey was designed. Allergists nationwide selected at random were asked to consecutively survey asthmatic patients aged 18–65 years, evenly distributed by severity of asthma (GINA criteria) and different seasons of the year. Sleep quality and quantity were assessed using the self-administered Medical Outcome Study (MOS) scale for sleep (MOS-sleep scale). Level of control of asthmatic symptoms was assessed with the Asthma Control Test (ACT) scale, and disability with the Sheehan’s disability index. RESULTS: A total of 1,098 subjects [58.7 % females, mean age (SD); 41.2 (13.6) years] were eligible for this study. Youngest patients (\40 years) showed lower scoring than oldest (41–65 years) in the index sleep problems: 29.1 vs. 37.5 (p \ 0.05). Severity was related with poorer sleep quality, with higher scoring in more severe patients (p \ 0.001), who significantly had less hours of sleep per day: 0.3–0.5 h less on average (p \ 0.001). Degree of symptoms control and level of patient´s severity were both associated with poor index sleep problems: 25.3 (full control), 26.4 (controlled), 32.6 (partially controlled) and 44.6 (uncontrolled); p \ 0.001, and 48.4 (severe), 39.0 (moderate), 32.6 (mild) and 26.5 (intermittent), p \ 0.001. CONCLUSIONS: Sleep quality and quantity was significantly associated with poor health status in asthmatic patients. Guidelines should recommend both asking nocturnal asthma symptoms and advising clinicians about taking a global sleep history. A better control of nocturnal asthma symptoms could lead to improved sleep quality and a decrease in daytime sleep-related symptoms.

(3037) Development of E-Versions of the asthma quality of life questionnaire (Standardised) [AQLQ(S)] in twenty (20) languages for use on handheld devices Elizabeth Juniper, MCSP, MSc, McMaster Univ. Med Ctr, Hamilton, oN, Canada; Ge´raldine Grataloup, Mapi; Catherine Acquadro, Mapi Research Trust, Lyon, France AIMS: Adapting validated paper questionnaires for handheld electronic devices often requires questions and response choices to be presented on two or more screens and instructions reformulated. Before use on handheld device, the original English version of the Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] was required to be validated. The objective of this study is to present the methods used and the challenges faced during the adaptation of 20 language versions of the AQLQ(S) for a specific device, using the linguistically validated paper versions of these languages. METHODS: The following steps were performed in close collaboration with the AQLQ(S) developer and the e-provider: 1) Identification of changes made to the English paper version of the AQLQ(S) to achieve the valid electronic version on the specific device (handheld); 2) Creation of a document listing all changes made to the

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Qual Life Res (2014) 23:1–184 English paper version and corresponding changes to be made to the existing paper translations; 3) Creation of the coded files (e.g., xml) in each language and Translation of the requested changes; 4) Quality check; 5) Creation of the screenshots in each language; 6) Quality check; 7) Iteration of steps 5 to 6 to reach optimal quality. RESULTS: Several challenges were encountered, e.g., 1) Items that required split screens: translating new instructions and rewording questions into two sentences; 2) Languages that required more characters per question/ response choice than the original English; 3) Lack of availability of bolding; 4) Font size of some scripts; 5) Maintaining interval properties of response scale with no scrolling. Examples of all problems and their solutions will be presented. CONCLUSIONS: The Standardized Asthma Quality of Life Questionnaire was successfully implemented in an electronic format in 20 different languages. The close collaboration with the developer of the original instrument enabled the development of electronic versions conceptually equivalent to the paper version.

(3039) Identifying important domains of HRQOL for patients with COPD: the perspective of healthcare professionals Muirne CS Paap, University of Twente, Enschede, Netherlands; Christina Bode, University of Twente; Lonneke Lenferink, University of Twente; Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands; Job van der Palen, Medisch Spectrum Twente AIMS: In a recent study, we identified which HRQOL domains are most relevant with respect to COPD, from the patient perspective. Now we focus on the perspective of the healthcare professional. Integrating these two perspectives will enable researchers and clinicians to select to the most appropriate domains for their research or daily practice. Ultimately, we will develop a multidimensional Computerized Adaptive Test based on generic PROMIS item banks and a new, disease-specific, module for COPD. This approach combining disease-relevant generic domains and disease-attributed domains will ensure comparability with other patient groups, while at the same time providing the necessary sensitivity for measuring change within this specific patient group. Our approach can be used as a blue-print for professionals who want to combine PROMIS domains with a disease-specific module. METHODS: Thirteen Dutch healthcare professionals (HCPs; six pulmonologists, three pulmonology nurse practitioners, two physiotherapists and two general practitioners; 9 men; mean age 51.0 (SD = 10.6) years; mean years of experience 12.1 (SD = 7.2)) specialized in the field of COPD were recruited. The only inclusion criterion was that the HCP had to have extensive experience in treating COPD patients. The face-to-face interviews took 30–40 min. RESULTS: Physical health emerged as the most important theme from the spontaneous statements that HCP’s made when asked about HRQOL in relation to COPD, closely followed by social health and coping with COPD-related complaints and restrictions. The most frequently selected PROMIS domains were fatigue, physical function, emotional support and depression. If the related domains satisfaction with participation in social roles and activities and ability to participate in social roles and activities were to be combined, it would come in second place after fatigue. CONCLUSIONS: When comparing the outcomes of the patient study to the ones in this study, there is a high degree of overlap (with the exception of depression). Taking together patient and HCP perspective, the most disease-relevant (sub) domains of HRQOL for patients with COPD are: physical health (fatigue, physical functioning), social health (satisfaction with/ability to participate in social roles and activities, companionship, emotional support, and instrumental support), depression, and coping with COPD (Fig. 1).

Qual Life Res (2014) 23:1–184

151 Table 1 Ahmed and paap framework Recommended step

Examples of input/activity

Step 1: Define target domains and subdomains

COPD patients interviews

Product

A list of target domains, validated and prioritised by patients Literature review, impact of and clinicians COPD COPD clinician interviews

Wilson and Cleary, and PROMIS frameworks

Fig. 1 Number of times PROMIS-domains were selected. Note Ability to part. in soc. roles and act = ability to participate in social roles and activities; Satisfaction with part. in soc. roles and act. = satisfaction with participation in social roles and activities

(3041) Combining Disease-Relevant and Disease-Attributed measures to assess HRQOL in patients with COPD in the Netherlands and Canada Muirne CS Paap, University of Twente, Enschede, Netherlands; Sara Ahmed, PhD, McGill University, Montreal, QC, Canada; Owis J. Eilayyan, McGill University, Montreal, QC, Canada; Caroline B. Terwee, PhD, VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam, Netherlands; Job Van Der Palen, Medisch Spectrum Twente AIMS: We propose a framework (inspired by the Wilson & Cleary model and the PROMIS framework) that outlines which steps one can or should take to select or develop a computerized adaptive test (CAT) to measure HRQOL in a specific patient group. We apply this framework to the field of COPD in the Netherlands and Canada. In this presentation we introduce our collaboration and outline our joint process for developing the item bank and CAT. METHODS: We aim to create a multidimensional Computerized Adaptive Test based on generic PROMIS item banks and a new, disease-specific, module (item bank) for COPD. In addition to providing a very broad picture of QOL, it would ensure comparability with other patient groups through use of the existing PROMIS banks, while at the same time providing additional sensitivity for measuring change within this specific patient group (disease-specific bank). We would be able to take into account the correlation among the different domains to increase efficiency and measurement precision. A series of steps adapted from the PROMIS framework will guide and standardize the process that will be used by both groups. The appendix summarizes each of these steps in more detail. RESULTS: N/A CONCLUSIONS: Once a CAT version is created, future work will continue to test the reliability, validity and responsiveness of the CAT and short form versions. At each step, both groups (the Netherlands and Canada) will ensure that the same criteria are used to include or remove items. The framework will help ensure that the steps followed in each setting are consistent and will facilitate communication about the results and combined dissemination of the item bank. Joint development of the COPD item bank will provide a common standard to facilitate comparison of COPD PROs in clinical care, research, and population monitoring. The Wilson & Cleary model provides a theoretical approach to conceptualising health and quality of life that can be used to guide the evaluation of outcomes. Wilson & Cleary divided health outcome into five domains: biological & physiological variables, symptoms status, functional status, general health perception and overall QoL (1).

Step 2: Compose and/or PROMIS Item Banks select individual items Other generic for each (sub)domain questionnaires

A pool of potential items for each domain/ subdomain

COPD—specific questionnaires (e.g. SGRQ, CAT, CCQ, McGill COPD questionnaire) Cognitive interviewing to review readability, literacy, cultural harmonization and translatability (French and Dutch) Step 3: Construct item pool for each identified (sub)domain

Test that items cover breadth of (sub)domain, match conceptualization of target domain, and ensure adequate coverage for each language

Step 4: Determine psychometric properties of item banks

Calibrated item bank for Evaluate psychometric each (sub)domain characteristics of items in a representative sample of individuals with COPD, and test for potential DIF for key groups (COPD severity, language, etc.)

A pool of potential items for each (sub)domain ready for psychometric testing

Final version of multiStep 5: Develop a multi- Evaluate and compare dimensional psychometric properties dimensional computerized adaptive across different formats computerized testing of HRQOL and ensure comparability adaptive testing between paper and CAT (CAT) administrations

The PROMIS framework provides a further breakdown of the Physical, Mental, and Social Health domain into additional subdomains (2). References 1. Wilson IB, Cleary PD. Linking clinical variables with healthrelated quality of life. A conceptual model of patient outcomes. JAMA : the journal of the American Medical Association. 1995 Jan 4;273(1):59–65. 2. PROMIS. Domain Frameworks PROMIS Adult Self-Reported Health. 2014 [2/25/2014]; Available from: http://www.nihpromis.org/ measures/domainframework1 (Table 1).

(3043) A Prospective observational study of the impact of chronic obstructive pulmonary disease (COPD) on Health-Related Quality of Life (HRQOL) of Patients Receiving Indacaterol Paul Jones, MD PhD, St. George’s University of London, London, United Kingdom; Monica Hadi, PH Associates Ltd, Marlow; Ruth

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Uden, PH Associates Ltd, Marlow; Anzal Qurbain, Novartis Pharmaceuticals Ltd, Frimley, UK AIMS: Information about HRQOL is crucial for understanding treatment benefits for patients with COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend that the COPD Assessment Test (CAT) (Jones et al. 2009) is used in routine practice to optimise treatment; however, there is little evidence in its use to monitor treatment. The main purpose of this study was to measure the impact of indacaterol on patients’ HRQOL using the CAT, and explore changes in daily activity and overall health through newly developed patient-reported health transition questions. METHODS: We conducted a 6-month prospective observational study of COPD patients newly prescribed indacaterol. Patients from 39 UK GP practices completed the CAT at treatment initiation, 6–8 weeks and 6 months. Patients also completed the Daily Living Impact Questionnaire (DLIQ) and Global Evaluation of Treatment Effectiveness (GETE) measure. The DLIQ and GETE contained two health transition items; the DLIQ asked ‘‘what can you do now that you had difficulty doing before?’’ and GETE, ‘‘how is your COPD/ overall health since starting treatment?’’ Physicians also completed the GETE measure. RESULTS: 106 participants were recruited. There was a significant improvement in CAT scores (from baseline mean 19.7) to 6–8 weeks (mean = 15.6), which was maintained at 6 months (mean = 15.5). 67 % of patients had a reduction of = 2 CAT points at 6–8 weeks, again maintained at 6 months (63 %). The DLIQ responses indicated that 45 % were able to do things at 6–8 weeks that they had previously found difficult (e.g. physical activity and sleep). For GETE, 47 % reported improvements in COPD and 68 % reported improvements in overall health at 6 months. Similar improvements were reported by physician reported GETE. CONCLUSIONS: HRQOL of COPD patients was significantly improved over the 6 month period following the initiation of indacaterol. In routine practice, the CAT appears responsive to measuring the impact of treatment on HRQOL in mild to moderate COPD. Although the DLIQ and GETE are not validated health transition measures, they provide supportive insight into the impact of indacaterol treatment on daily activity and overall health of COPD patients (Table 1).

Table 1 . Baseline

6–8 weeks

6 months

CAT score (mean)

19.71 (n = 102)

15.44 (n = 96)

15.46 (n = 89)

Mean change in CAT score

–

-3.89, SD ± 5.51 p \ 0.001, (n = 93)

-4.22, SD ± 7.0 p \ 0.001, (n = 87)

C2 Points reduction in CAT score (clinically significant)

–

62 (67 %, n = 93)

55 (63 % n = 87)

DLIQ (number of patients reporting ability to do more daily activities)

–

45 (45 %, n = 100) –

Physician GETE reported improved COPD symptoms

–

66 (74 %, n = 89)

62 (71 %, n = 87)

Patient GETE reported improved lung disease

–

–

61 (69 %, n = 89)

Changes in COPD treatment

–

Subjects on indacaterol

106 (100 %, n = 106)

* Five patients lost of follow-up

123

4 Patients started ICS 22 changes in total –

82 (81 %*, n = 101)

Children (3045) Impact of Gastrointestinal Problems on Children with Autism Spectrum Disorders and Their Caregivers Nalin Payakachat, BPharm, MS, PhD, University of Arkansas for Medical Sciences, Little Rock, AR, United States; J. Mick Tilford, PhD, University of Arkansas for Medical Sciences, Little Rock, AR, United States; Erica Kovacs, Columbia University Medical Center Division of Child and Adolescent Psychiatry; Jeffrey M. Pyne, University of Arkansas for Medical Science; Karen A. Kuhlthau, PhD, Center for Child and Adolescent Health Research and Policy, Boston, MA, United States AIMS: A child with autism spectrum disorders (ASD) and an associated gastrointestinal disorder may have worse quality of life outcomes that spillover into caregiver health. The potential loss in health utility associated with gastrointestinal problems for children with ASDs has not been reported. This study compares health outcomes for children with ASDs and their caregivers to identify the impact of having a gastrointestinal problem. Both child and caregiver outcomes are analyzed to assess the potential spillover effects of gastrointestinal problems in relation to health utility lost by the child. METHODS: Families for the study were recruited from two Autism Treatment Network sites. Clinical data from clinic visits were combined with a postal survey that contained separate surveys for the child and the caregiver. Caregivers reported on the Health Utilities Index (HUI3) and Quality of Well-being Scale for the child as well as their self-reported health on the 12 Item Short-Form Health Survey (SF-12) Index (converted to SF6D scores) and the EQ5D. Clinical measures for the child included the child’s IQ, Vineland Adaptive Behavior Scale, and Autism Diagnostic Observation Schedule Severity Scores. The QWB scale was used to identify children with evidence of a gastrointestinal problem. 224 surveys were returned with a response rate of 57.1 %. RESULTS: Gastrointestinal problems were reported in 31.3 % of the children. We found that the average HUI3 scores were lower in children with ASDs who had a gastrointestinal problem (0.598; CI 0.54–0.65) compared to children with ASDs who did not have a gastrointestinal problem (0.688; CI 0.65–0.73). Caregivers of children with gastrointestinal problems also had lower SF6D scores and EQ5D scores compared to the same scores for caregivers of children who did not have a gastrointestinal problem. In multivariate analyses, the estimated impact for the EQ5D [-0.04 (0.019; p = 0.04)] was similar to the SF6D [-0.04 (0.018; p = 0.025)]. Based on the mean estimates for both the child and the caregiver, potential QALYs lost due to gastrointestinal problems increased by 50 % when caregiver spillover effects are included. CONCLUSIONS: Findings from this study suggest that a significant percentage of children with an ASD had an associated gastrointestinal problem that affected their quality of life as well as the caregiver. Cost-effectiveness estimates of treatment for gastrointestinal problems in children with ASD would significantly underestimate the benefits of services if caregiver outcomes are not included in the analysis.

(3047) Health-Related quality of life and its possible determinants among mothers of children with cerebral palsy Nivea M. O. Morales, MD MSc PhD, Federal University of Uberlaˆndia, Uberlaˆndia, Brazil; Ludmilla Rabelo Guimara˜es, Universidade Federal de Uberlaˆndia; Carlos Henrique Martins Silva, Sr., Universidade Federal de Uberlaˆndia—FAMED, A. Alexandre R. Guimaraes,315, Brazil; Anaı´sa R. Amorim, Universidade Federal de Uberlaˆndia; Rogerio R. Morales, MD, Universidade Federal de Uberlaˆndia, Uberlaˆndia, Brazil; Roge´rio M C Pinto, Federal University of Uberlaˆndia

Qual Life Res (2014) 23:1–184 AIMS: To evaluate the health-related quality of life (HRQOL) of mothers of children and adolescents with cerebral palsy (CP), in comparison with mothers of healthy children and adolescents; to investigate associations between clinical/demographic variables and the maternal HRQOL. METHODS: 100 mothers of children and adolescents with CP and 100 mothers of healthy children and adolescents responded the generic questionnaire of HRQOL SF-36 and Beck’s Depression Inventory (BDI). RESULTS: The mothers of the CP group presented lower scores than in the healthy group, in all SF-36 domains. Some associations were found between SF-36 and clinical/demographic variables: the BDI correlated with the SF-36 domains (r = -0.21 to -0.60; p \ 0.05); the mother’s age, patient’s age and mother’s schooling level showed correlations with the mental dimension of SF36 (p \ 0.05); unemployed mothers had lower scores in three SF-36 domains (p \ 0.05); mothers with children on medication had lower scores in the physical components, with a small effect size (p \ 0.05). Motor severity and type of CP did not show correlations with SF-36 (p [ 0.05). CONCLUSIONS: Mothers of children and adolescents with CP presented negative mental and physical impact in their HRQOL in comparison with mothers of healthy children and adolescents. The greater the intensity of depressive symptoms was, the greater the injury in the HRQOL of the mothers. The mother’s age, patient’s age, mother’s scholarity and employment situation presented association with the HRQOL of the mothers.

(3049) Improving transition of adolescents with chronic health conditions from pediatric to adult healthcare services: the effects of an educational program on self-management and healthrelated quality of life (HRQOL) Stefanie Hahm, University of Greifswald, Greifswald, Germany; Carsten Herrmann, Ernst-Moritz-Arndt-University, Greifswald, Germany; Franziska Bomba, University of Luebeck; Ute Thyen, MD, Universitaetsklinikum Schleswig–Holstein, Luebeck, Germany; Silke Schmidt, PhD, University of Greifswald, Greifswald, Germany AIMS: The transition from child-centered to adult-oriented healthcare systems poses a significant challenge for adolescents with chronic conditions. There is increasing evidence that inadequate transition arrangements can have adverse effects (e.g. higher morbidity). The aim of this study is to investigate the effect of an educational program designed to improve managing health and healthcare of adolescents with chronic conditions on self-management and HRQOL. METHODS: HRQOL (DCGM-10) and self-management (PAM13-D) were measured in a German sample of 246 adolescents and young adults from 13 to 28 years (M = 16.83 years) with chronic conditions (diabetes, inflammatory bowel disease [IBD], cystic fibrosis [CF]) at baseline (t0) and six months thereafter (t2; intervention group [IG], n = 131; control group [CG, no training], n = 115). Paired t-tests with t0-scores and t2scores in the IG and CG as well as independent t-tests with change scores (t2-t0) in the two groups (IG vs. CG) were calculated with the total sample and for each type of chronic condition. RESULTS: IG and CG differed significantly with regard to change of PAM13-D (p \ 0.05, d = 0.26), with a significant increase in the IG (p \ 0.001, d = 0.41). Looking at the specific types of chronic conditions, a significant increase in PAM13-D scores was found in the IG of adolescents with diabetes (p \ 0.05, d = 0.30) and IBD (p \ 0.001, d = 0.64), although the change score only differed significantly from the CG of IBD-patients (p \ 0.05, d = 0.47). Concerning DCGM-10 change scores, there was a significant difference between IG and CG specifically among IBD- (p \ 0.05, d = 0.25) and CF-patients (p \ 0.05, d = -0.85). While remaining stable in the IG of IBD-patients and decreasing significantly in the corresponding CG (p \ 0.05, d = -0.41), there was a significant decline in the IG of CF-patients (p \ 0.01, d = -0.78), while being stable in the corresponding CG.

153 CONCLUSIONS: The findings indicate a significant improvement concerning self-management as a result of the training (especially in the group of adolescents with IBD), while HRQOL remained stable. The improvement of healthcare competence and management (e.g. in terms of a better adherence to medication) might help to improve or at least stabilize HRQOL. CF-patients might not have profited from the training because of their already extensive knowledge about their condition.

(3051) Legal guardian’s proxy ratings of health-related quality of life and HIV stigma for their children living with earlyacquired HIV infection; a comparative study Lise-Lott Rydstrom, Karolinska Institutet, Huddinge, Sweden; BrittMarie Ygge, Karolinska Hospital; Lars Naver, Karolinska University Hospital, Department of Pediatrics, Stockholm, Sweden; Maria Wiklander, PhD, Karolinska Institutet, Huddinge, Sweden; Lars E. Eriksson, PhD, Karolinska Institutet, Huddinge, Sweden AIMS: To describe how legal guardians rate their children’s healthrelated quality of life (HRQOL) and HIV related stigma in relation to the children’s own ratings. METHODS: This was a cross-sectional study using two standardized questionnaires in versions for children and legal guardians (n = 39 dyads; the children’s age ranged between 9 and 18 years; 19 female and 20 male children). HRQOL was measured by the DISABKIDS Chronic Generic Module, 37 items; child and proxy versions, forming one overall HRQOL scale and six sub-scales. HIV stigma was measured with an eight-item short version of the HIV stigma scale; child and proxy versions, forming one overall and three HIV stigma sub-scales (Disclosure concerns, negative self-image, and public attitudes). Paired sample t-test was used to compare legal guardian and child ratings and independent samples t-test was used to analyze differences in delta scores (parent–child pairs) related to the child’s sex. RESULTS: The results showed no statistically significant differences between legal guardians and children’s ratings of the child’s HRQOL. However, in the HIV stigma dimension public attitudes, legal guardians rated that the children experience less stigma than the children themselves did. The child’s sex did not have any statistically significant relation to the delta scores (parent–child pairs) of the ratings of the children’s HRQOL or HIV related stigma. CONCLUSIONS: This study indicates that legal guardian’s HRQOL proxy ratings are in parity with their children’s own ratings. However, the parents seems to underestimate their children’s experience of HIV stigma related to public attitudes i.e. children’s conceptions of other people’s attitudes toward people with HIV infection.

(3053) Satisfaction with life and psychological distress in children as a function of parental life satisfaction and psychological distress Jocelyne M.R. Clench-Aas, PhD, Norwegian Institute of Public Health, Oslo, Norway; Ragnhild Bang Nes, Norwegian Institute of Public Health AIMS: This study explores associations between parents’ and children’s life satisfaction and mental distress using parent- and childreported data. Additionally, the role of marital satisfaction on these associations is examined. METHODS: Analyses were based on data from a large (N = 4,984) and nationally representative sample of Norwegian males and females aged 15 to 79, collected in 2005. Of this total sample, only those where information from parents and children (aged 13 to 15) in the same home was provided simultaneously were included (N = 460). LS in parents (self-report) was measured by Diener’s Satisfaction with Life Scale (LS). Psychological distress (PS), self-report, was measured by Hopkins Symptom Check List-25 (HSCL). Parents’ evaluation of their children’s

123

154 psychological distress was measured using HSCL-10 (PDP), and the children’s self-report evaluation of their own psychological distress using 12 HSCL questions (HSCL-12) (PDC) and life satisfaction with 4 questions (LSC) was measured. Marital Satisfaction (MS) (parent self-report) was measured using a 4-item version of the Relationship Satisfaction Scale. RESULTS: The absolute level of LSC in boys was higher than in girls, whereas levels of PDC and PDP were higher in girls than in boys. The correlation between the LSC and PDC in children was stronger (-0.33) than between LSC and PDP (-0.24), but weaker than the same association in their parents (LS vs. PD, 0.65). There was a strong, significant association between psychological distress in children as evaluated by the parents (PDP) and both parental PD and parental LS irrespective of children’s gender. However, the equivalent association between parental PD and LS on children evaluated psychological distress was borderline significant in boys and non-significant in girls. Parents Marital Satisfaction was not significantly associated with either PD (neither parental or children evaluated) or LSC. CONCLUSIONS: The role of parental psychological distress on children’s life quality needs further investigation, since the results differed significantly according to whether the parent or child evaluated the child’s mental health. The close relationship between LS and PD was not observed in childhood regardless of whether LS and PD were child or parent reported, and probably changes over the life sequence.

Population Health (3055) Measuring well-being: psychometrics, conceptual consistency and the plausibility of a gold standard Myles-Jay a. Linton, BSc, University of Exeter, Exeter, United Kingdom; Antonieta Medina-Lara, BSc(Hons), MSc, PhD, University of Exeter Medical School, Exeter, United Kingdom AIMS: Despite growing interest in the measurement of well-being, greater consensus on how to best go about it is needed. Critics have claimed that measuring well-being is still particularly difficult because of two specific concerns: an absence of conceptual clarity and a lack of methodological rigor. As existing reviews of well-being instruments have not addressed these criticisms directly, the current review aimed to investigate these concerns explicitly. METHODS: A systematic search of: PsychINFO, EMBASE, MEDLINE, CINAHL, EconLit and Cochrane Library databases was undertaken and complemented with internet searches in order to identify questionnaires that were developed to measure well-being. Questionnaires were included in the review if they were designed for adults and unrelated to any specific medical condition or context. We then examined the degree of overlap among the concepts that the questionnaires attempted to assess. The extent of psychometric testing during questionnaire development was also examined, as an indicator of methodological rigor. RESULTS: Sixty-one instruments from the search met the stated inclusion criteria. The slight majority were developed within the field of psychology, while the rest were developed within health/medical research or health economics. Diversity in the dimensions of the instruments was observed, however ‘positive affect’, ‘negative affect’, ‘anxiety’ and ‘life satisfaction’ were the most frequent dimensions assessed. Regarding psychometrics, instrument developers appear to investigate and report on internal consistency, factorial validity, convergent validity and temporal reliability far more frequently than content validity and sensitivity. Conceptual and psychometric differences between the psychology and medical instruments were observed. CONCLUSIONS: The number and diversity of instruments reviewed suggests there is still no gold standard for measuring well-being. As such, greater guidance for those hoping to measure well-being is needed. Researchers should consider the psychometrics, their objectives and the specific

123

Qual Life Res (2014) 23:1–184 dimensions they wish to measure, in order to take advantage of the variety in available measures.

(3057) Safety, health and quality of life in personal and organizational level in the manufacturing industry Jose Guadalupe Salazar Estrada, Sr., Psic, PhD, Uiniversidad de Guadalajara, Tlajomulco de Zuniga, Mexico; Norma S. Figueroa Villasen˜or, Universidad de Guadalajara, Guadalajara, Mexico; Raquel Gonzalez-Baltazar, PhD, University of Guadalajara, Guadalajara, Jalisco, Mexico AIMS: The aim of this study is to examine working conditions of manufacturing industry workers in order to identify factors such as safety, organizational risk and workers quality of life of their employment relationship, and organizational matters. METHODS: This was a descriptive cross-sectional and a random sample of workers based on the size of the industry in three industrial parks whereas the manufacturing industry accounts for 20 % of employment in the state of Jalisco and is classified by their number workers, the micro with fewer than 11 workers, the youngest of 11 to 50 workers, the median to 250 employees and over 250 is considered large. The study was performed in 24 industries in the three industrial parks for its size by selecting only the small-scale is 12, 7 medium and 5 large industry industries considered. The sample size was 369 workers 10 % of non-response rate, eventually obtained a total of 392 completed surveys. The questionnaire was administered according to a proportional distribution by the size of the industry, 200 (51 %) come from small industries, 118 (30 %) and 74 medium-sized industry (19 %) of large industry. The sample size of 369 workers was estimated at 95 % confidence level. Two instruments were used to run a business (24 in total) and another sample of workers with organizational perception variables, personal and quality of life as a worker. Statistical analysis included measures of frequency and X2 test for independence. The latter was used to establish associations between personal factors of satisfaction and motivation with all organizational factors studied. The base and data analysis will be performed in Excel and SPSS program 11.0. RESULTS: Of the 24 manufacturing industries studied and the four main branches of industry the sample was distributed proportionally at 51 % of small industries, medium industries 30 and 19 % of large industries. In the identification of safety standards or conditions that have to meet the industries we find that, compliance is closely related to the size of the industry, only 25 % of small industries are serviced by a part-time doctor, however in large, 100 % had full-time physician, and other professionals and specialists in full-time occupational health in small and medium industries the health professional is a part-time or at the request of an emergency. CONCLUSIONS: The lack of motivation, dissatisfaction over, is the personal factor that showed significant association with greater organizational factors. We conclude that the main problems related to safety and health are present in small and medium industries. The implementation of health programs, safety and working life is necessary to take us to promote positive organizational climate-oriented enough workers and that is reflected in their job security, quality of life and committed to a objective productive organization.

(3059) Sense of coherence among Japanese White Collar Workers participating in ‘‘Salutogenic Cafe´’’. a six months follow-up study Shin-Ichiro Sasahara, University of Tsukuba, Tsukuba-City, Japan; Junko Sakano, Okayama Prefectual University, Soja, Okayama, Japan; Eva Langeland, Bergen University College, Bergen, Norway; Ragnhild Sollesnes, Bergen University College, Bergen, Norway;

Qual Life Res (2014) 23:1–184 Yuichi Oi, University of Tsukuba; Kazuya Usami, University of Tsukuba, Japan; Shun Suzuki, University of Tsukuba; Yasuhito Hirai, University of Tsukuba; Hidetoshi Kaneko, University of Tsukuba; Yoshihiko Yamazaki, Nihon Fukushi University AIMS: The aim of the present study was to investigate development of sense of coherence (the main concept in salutogenesis) after participating in the interaction program ‘‘Salutogenic Cafe’’. Salutogenic interaction training programs are considered important for promoting stress coping ability in a work place. METHODS: A prospective design included a baseline assessment and two follow-ups. A total of 718 business Japanese white collar workers in a certain company participated in our program Salutogenic Cafe which is composed of 2-h group discussion at one time. The program is built on the Salutogenic Talk Therapy Group program (Langeland et al. 2006). The discussion was focused on how to cope with various difficulties in their work place. Sense of Coherence was measured by SOC-13 in Japanese version. RESULTS: A total of 409 persons (57.1 %, mean age; 39.7 ± 7.6 yrs.) completed self-administered questionnaires of SOC 13-items scale two weeks before, two weeks after and six months after of the program. SOC changed significantly from before to six months after the program (Fig. 1). However when controlling for gender it was revealed that SOC significantly increased only among men. In addition SOC did not significantly increase among participants between 50 and 59 years old. Cf. Table 1. CONCLUSIONS: This study indicates that The Salutogenic Cafe´ could promote Japanese white collar workers SOC in their workplace. However in lack of a control group we have to be cautious with our interpretation. The next step is to investigate the effect of Salutogenic Cafe´ in a randomized controlled trial.

155 (3061) Perceived neighborhood environment and adults health in three tunisian cities Khaled Hassine, ANCSEP/Ministry of Health, Montplaisir Tunis, Tunisia; Thouraya Annabi-Attia, ANCSEP/Ministry of Health AIMS: Few studies have examined the association between local environment and perceived health. This work aims to determine which perceived neighborhood environmental variables were associated with health status. METHODS: From May to June 2011 a crosssectional study was performed on residents (n = 1,523) living in three Tunisian cities through a face to face interview. The interviews included the whoqol-bref, a health questionnaire and a scale of 30 items about different attributes of the daily residential and environmental quality of life. Factor analysis was used to identify dimensions from the environmental quality of life characteristics. Self rated health and mental health constituted the outcome variables. Ordered regression was used to examine the relationship between health status and the environmental quality of life dimensions. RESULTS: The identified environmental quality of life dimensions were, Image of the neighborhood (Cronbach’s alpha = 0.83), Annoyance and pollution (Cronbach’s alpha = 0.84), and Shops and services (Cronbach’s alpha = 0.66), this solution explained 42.01 % of the variance. The confirmatory factor analysis showed the stability of the three factors in this model. Ordered regression analysis adjusted for locality, age, gender, educational level, type of housing, family status, years of residence in the neighborhood and household income, showed that only the factor annoyance and pollution was associated with two health outcomes. Additionally the image of the neighborhood had stronger association with mental well being CONCLUSIONS: This environmental perception scale appears as an interesting tool to better investigate the effect of local environmental pollution and shows how they are perceived by residents.Perceptions of local environmental characteristics were found to be associated with adult’s health .

(3063) Quality of life and perceived health in adult population. comparative study of three communities of an intermediate city of Colombia Jorge Garcia Ramirez, Medical Doctor, University of Caldas, Manizales, Colombia; Consuelo Velez Alvarez, Universidad de Caldas, Manizales, Colombia

Fig. 1 Change in SOC from before to 6 months after the intervention

Table 1 Changed in SOC from before to 6 months after the intervention

AIMS: To evaluate the perception of quality of life and health status of the population in three communities of an intermediate Colombian city METHODS: A descriptive correlational study. Sample of 440 households in three communities of the city of Manizales. Stratified sampling by optimum allocation and random selection. An instrument of socio-demographic variables and the quality of life form WHOQOL-BREF were used. Data were processed in SPSS version 19 RESULTS: The 61.4 % were women. The average age was 49 years ? /- 17.2 years. Persons per household averaged 3.6 ? /-2 persons. The average monthly household income was $974.3 ? /999.2 USD. 3 % belong to a low socioeconomic status, 8.2 % to medium and 88.9 % to high. A 61.6 % rate their quality of life as good or very good, 67.8 % consider that they are satisfied or very satisfied with their health. Within the domains of quality of life, 42 % said to be satisfied or very satisfied with their health services and 40.9 % indicated to have negative feelings vey often or always. Bivariate analysis shows statistically significant association (P \ 0.05) for the variables monthly household income level with the perception of quality of life, perceived health, how much people enjoy life, satisfaction with health services and their relationships. The variable community was associated with quality of life, the level of safety and health of the physical environment and the degree of satisfaction with the living place. Age had association with quality of life and its level of enjoyment and the perception that life

123

156

Qual Life Res (2014) 23:1–184

is meaningful and the satisfaction with access to health services, perceived health and the level of need for daily life medical treatment. Gender was related to quality of life, satisfaction with health, how much do people enjoy life, how safe do people feel in daily life and the need for medical treatment in daily life. CONCLUSIONS: Quality of life in the studied population is well perceived, varies by income level of households, age, gender and community of residence (Tables 1, 2, 3, 4, 5).

Table 3 Perceived socioeconomic position of the population participating in the study Perceived socioeconomic position

Frequency

Poor Regular

Percentage

2

0.5

56

12.7

Good

249

56.6

Very good

102

23.2

Excellent

31

7

Table 1 Sociodemographic characteristics of population participating in the study

Source: Researchers own elaboration

Variable

Category

Frequency Percentage

Table 4 Quality of life of the population participating in the study

Gender

Female

270

61.4

Male

170

38.6

Age

Youth (age 15–26)

64

14.5

Young adulthood (age 27–40)

75

17

Middle adulthood (age 41–64)

215

48.9

86

19.5

Elderly (age over 65) Community

Low SE level

13

3

Medium SE level

36

8.2

391

88.9

5

1.1

High SE level Education level

None at all Primary school Secondary school Technical studies Undergraduated Posgraduated

Socioeconomic level

Type of affilliation to health system

Type of job linkage

Monthly household income level

39

8.9

112

25.5

49

11.1

155

35.2

80

18.2

1

5

1.1

2

8

3

35

1.8 8

4

1

0.2

5

222

50.5

6

169

38.4

Contributive

368

83.6

Subsidized

26

5.9

Special

33

7.5

None at all

13

3

Unemployed

132

30

Independent

103

23.4

Job contract with Undefined term

77

17.5

Job contract with fixed term

26

5.9

Job Contract for services provision

23

5.2

Retired

79

17.9

Below 1 minimum wage 1–3 Minimum wage

23

5.2

102

23.2

3–6 Minimum wage

151

34.3

Over 6 minimum wage

164

37.3

Source: Researchers own elaboration SE Socioeconomic

Table 2 Perceived health of the population participating in the study Perceived health Poor

Frequency

Percentage

3

0.7

49

11.1

Good

165

37.5

Very good Excellent

121 102

27.5 23.2

Regular

Source: Researchers own elaboration

123

Frequency

Percentage

1 How would you rate your quality of life? Very poor 1 0.2 Poor 6 1.4 Neither poor nor good 162 36.8 Good 137 31.1 Very good 134 30.5 2 How satisfied are you with your health? Very dissatisfied 6 1.4 Dissatisfied 27 6.1 Neither satisfied nor dissatisfied 109 24.8 Satisfied 178 40.5 Very satisfied 120 27.3 3 To what extent do you feel that physical pain prevents you from doing what you need to do? Not at all 210 47.7 A little 79 18 A moderate amount 89 20.2 Very much 46 10.5 An extreme amount 16 3.6 4 How much do you need any medical treatment to function in your daily life? Not at all 195 44.3 A little 64 14.5 A moderate amount 112 25.5 Very much 52 11.8 An extreme amount 17 3.9 5 How much do you enjoy life? Not at all 3 0.7 A little 18 4.1 A moderate amount 152 34.5 Very much 177 40.2 An extreme amount 90 20.5 6 To what extent do you feel your life to be meaningful? Not at all 5 1.1 A little 93 21.1 A moderate amount 148 33.6 Very much 194 44.1 An extreme amount 7 How well are you able to concentrate? Not at all 1 0.2 A little 21 4.8 A moderate amount 206 46.8 Very much 163 37 Extremely 49 11.1 8 How safe do you feel in your daily life? Not at all 1 0.2 A little 17 3.9 A moderate amount 168 38.2 Very much 181 41.1 Extremely 73 16.6

Qual Life Res (2014) 23:1–184

157

Table 4 continued

Table 4 continued Frequency

Percentage

9 How healthy is your physical environment? Not at all 0 0 A little 15 3.4 A moderate amount 152 34.5 Very much 191 43.4 Extremely 82 18.6 10 Do you have enough energy for everyday life? Not at all 0 0 A little 15 3.4 Moderately 132 30 Mostly 161 36.6 Completely 132 30 11. Are you able to accept your bodily appearance? Not at all 1 0.2 A little 5 1.1 Moderately 66 15 Mostly 151 34.3 Completely 217 49.3 12. Have you enough money to meet your needs? Not at all 7 1.6 A little 34 7.7 Moderately 223 50.7 Mostly 99 22.5 Completely 77 17.5 13. How available to you is the information that you need in your day-to-day life? Not at all 1 0.2 A little 9 2 Moderately 95 21.6 Mostly 124 28.2 Completely 211 48 14. To what extent do you have the opportunity for leisure activities? Not at all 17 3.9 A little 51 11.6 Moderately 169 38.4 Mostly 133 30.2 Completely 70 15.9 15. How well are you able to get around? Very poor 1 0.2 Poor 8 1.8 Neither poor nor good 17 3.9 Good 72 16.4 Very good 342 77.7 16 How satisfied are you with your sleep? Very dissatisfied 8 1.8 Dissatisfied 59 13.4 Neither satisfied nor dissatisfied 139 31.6 Satisfied 105 23.9 Very satisfied 129 29.3 17 How satisfied are you with your ability to perform your daily living activities? Very dissatisfied 1 0.2 Dissatisfied 16 3.6 Neither satisfied nor dissatisfied 128 29.1 Satisfied 161 36.6 Very satisfied 134 30.5 18 How satisfied are you with your capacity for work? Very dissatisfied 8 1.8

Frequency

Percentage

Dissatisfied 18 4.1 Neither satisfied nor dissatisfied 121 27.5 Satisfied 166 37.7 Very satisfied 127 28.9 19 How satisfied are you with yourself? Very dissatisfied 3 0.7 Dissatisfied 5 1.1 Neither satisfied nor dissatisfied 84 19.1 Satisfied 147 33.4 Very satisfied 201 45.7 20 How satisfied are you with your personal relationships? Very dissatisfied 2 0.5 Dissatisfied 11 2.5 Neither satisfied nor dissatisfied 94 21.4 Satisfied 156 35.5 Very satisfied 177 40.2 21 How satisfied are you with your sex life? Very dissatisfied 28 6.4 Dissatisfied 23 5.2 Neither satisfied nor dissatisfied 154 35 Satisfied 119 27 Very satisfied 116 26.4 22 How satisfied are you with the support you get from your friends? Very dissatisfied 21 4.8 Dissatisfied 37 8.4 Neither satisfied nor dissatisfied 137 31.1 Satisfied 124 28.2 Very satisfied 121 27.5 23 How satisfied are you with the conditions of your living place? Very dissatisfied 1 0.2 Dissatisfied 12 2.7 Neither satisfied nor dissatisfied 63 14.3 Satisfied 144 32.7 Very satisfied 220 50 24 How satisfied are you with your access to health services? Very dissatisfied 30 6.8 Dissatisfied 74 16.8 Neither satisfied nor dissatisfied 148 33.6 Satisfied 103 23.4 Very satisfied 85 19.3 25 How satisfied are you with your transport? Very dissatisfied 4 0.9 Dissatisfied 14 3.2 Neither satisfied nor dissatisfied 113 25.7 Satisfied 147 33.4 Very satisfied 162 36.8 26. How often do you have negative feelings such as blue mood, despair, anxiety, depression? Never 66 15 Seldom 185 42 Quite often 136 30.9 Very often 44 10 Always 9 2

World Health Organization Quality of life—BREF results Source: Researchers own elaboration

123

123 0.091

Contingency Coefficient

SE socioeconomic

Source: researchers own elaboration

over 6 minimum wage

3–6 minimum wage

1–3 minimum wage

1 minimum wage

level: under

Monthly household income

Gender (male, female)

middle adulthood, elderly)

Age (youth, young adulthood,

have the opportunity for leisure activities?

the information

that you need

in your day-to-day life?

0.239

0.052

Contingency

coefficient

Contingency

p value

0.284

0

38.635

0.552

p value

Coefficient

1.187

0.132

Contingency Coefficient

Chi-square

0.249

p value

7.857

0.171

0.038

13.331

0.1

0.108

4.442

0.165

0.056

12.298

0.135

0.084

8.205

extent do you

26.751

14. To what

to you is

Contingency coefficient

Chi-square

0.337

0

13. How available

0

Chi-square

0.217

0.001

56.425

0.041

0.695

0.727

0.148

0.13

9.883

0.192

0.002

16.764

World Health Organization quality of life BREF

p value

Chi-square

Community (High SE level,

medium SE level, low SE level)

Statistical measures

Contingency Coefficient

p value

21.799

0.161

p value

Chi square

3.656

0.227

Contingency Coefficient

Chi square

0.001

23.947

p value

Chi square

0.05

Contingency Coefficient

Variable

minimum wage

3–6 minimum wage over 6

minimum wage 1–3 minimum wage

Monthly household income level: under 1

Gender (male, female)

adulthood. Elderly)

Age (youth, young adulthood. Middle

0.893

1.107

socioeconomic position

Perceived

Perceived Health

p value

Chi square

Community (high SE level, medium SE

level, low SE level)

Statistical measures

Bivariate analysis of sociodemographic variables and quality of life variables

Variable

Table 5

0.184

0.017

15.434

0.083

0.218

3.051

0.272

0

35.293

0.086

0.51

3.295

get around?

you able to

15. How well are

0.284

0

38.68

0.117

0.047

6.131

0.186

0.015

15.706

0.157

0.025

0.104

0.572

4.779

0.087

0.184

3.387

0.087

0.759

3.388

0.041

0.945

0.748

your sleep?

are you with

16 How satisfied

0.178

0.026

14.337

0.158

0.004

11.225

0.171

0.039

13.301

0.11

0.251

0.133

0.242

7.951

0.131

0.022

7.663

0.21

0.002

20.277

0.08

0.584

2.843

living activities?

your daily

perform

with your ability to

satisfied are you

17 How

0.088

0.755

3.42

0.067

0.375

1.963

0.097

0.647

4.22

0.157

0.026

11.094

your daily life?

you need to do?

5.376

function in

from doing what

11.123

treatment to

pain prevents you

your health?

0.141

0.18

8.893

0.051

0.561

1.156

0.218

0.001

21.86

0.071

0.696

2.214

for work?

capacity

with your

satisfied are you

18 How

0.074

0.875

2.443

0.158

0.004

11.2

0.343

0

58.561

0.096

0.393

4.096

any medical

feel that physical

are you with

do you need

4 How much

quality of life?

extent do you

3 To what

satisfied

2 How

you rate your

1 How would

World Health Organization quality of life BREF

0.164

0.057

12.232

0.067

0.369

1.997

0.164

0.059

12.131

0.137

0.079

8.366

you with yourself?

satisfied are

19 How

0.248

0

28.855

0.135

0.017

8.117

0.248

0

28.803

0.107

0.282

5.053

life?

you enjoy

much do

5 How

0.199

0.006

18.193

0.019

0.922

0.162

0.108

0.518

5.201

0.076

0.637

2.545

relationships?

your personal

are you with

How satisfied

20

0.118

0.402

6.192

0.062

0.422

1.725

0.234

0

25.442

0.139

0.07

8.665

meaningful?

life to be

do you feel your

6 To what extent

0.202

0.005

18.643

0.084

0.211

3.114

0.242

0

27.478

0.111

0.238

5.521

your sex life?

are you with

21 How satisfied

0.213

0.002

20.989

0.085

0.199

3.224

0.148

0.129

9.9

0.1

0.345

4.478

to concentrate?

are you able

7 How well

access to health services?

conditions of your living place?

support you get from

0.179

0.023

14.622

0.083

0.221

3.019

0.07

0.903

2.171

0.162

0.018

11.883

your friends?

with the

0.253

0

30.12

0.093

0.145

3.866

0.093

0.702

3.816

0.289

0

0.2

0.006

18.242

0.042

0.675

0.787

0.254

0

30.319

0.135

0.084

8.206

you with your

are you with the are you

40.081

satisfied are How satisfied

24 How

0.163

0.063

11.97

0.121

0.037

6.582

0.213

0.002

20.922

0.137

0.077

8.42

everyday life?

energy for

have enough

10 Do you

satisfied

0.33

0

53.92

0.017

0.937

0.13

0.093

0.7

3.825

0.353

0

62.487

environment?

physical

is your

healthy

9 How

23 How 22

0.172

0.038

13.339

0.134

0.018

8.049

0.155

0.095

10.8

0.243

0

27.56

daily life?

in your

do you feel

8 How safe

0.225

0.001

23.365

0.064

0.408

1.793

0.156

0.087

11.031

0.189

0.003

16.321

transport?

you with your

25 How satisfied are

0.082

0.814

2.961

0.015

0.954

0.095

0.143

0.16

9.243

0.099

0.356

4.391

appearance?

your bodily

able to accept

11. Are you

0.16

0.074

11.493

0.051

0.558

1.167

0.139

0.194

8.647

0.121

0.162

6.538

anxiety, depression?

such as blue mood, despair,

negative feelings

26. How often do you have

0

0

77.309

0.095

0.135

4.004

0.1

0.622

4.402

0.217

0

21.821

to meet your needs?

enough money

12. Have you

158 Qual Life Res (2014) 23:1–184

Qual Life Res (2014) 23:1–184 (3065) How experience immigrant parents of disabled or chronically ill children their own health and quality of life? Lisbeth G. Kvarme, PhD, Oslo and Akershus University College, Oslo, Norway; Elena Albertini Fru¨h, II, Oslo and Akershus University College, Oslo, Norway; Liv Halvorsrud, Oslo and Akershus University College of Applied Science, Norway, Oslo, Norway; Hilde Liden, IV, Institutt for Amfunnsforskning AIMS: The aim of this study is to contribute to a better understanding of how immigrant parents with disabled children experience their health and quality of life. Having a child with special needs requires the family to adapt and may have impact of health and quality of life among parents. There is reason to believe that the parents of disabled or chronically ill children who have immigrated to Norway are more vulnerable to physical and mental stress and health problems. METHODS: An explorative qualitative design was chosen, with individual and focus-group interviews. Data were collected in 2013 and 2014. The sample consisted of 24 parents, 17 mothers and eight fathers from Pakistan, Poland and Vietnam. Twenty-four individual interviews were conducted with the parents, 14 from Pakistan, seven from Poland and four from Vietnam. Two focus-group interviews were also conducted with Pakistani parents (separately). Interview guide was used and the responses were audiotaped, transcribed, and coded into themes. RESULTS: The parents reported the same kind of joy and challenges when having a disabled or chronically ill child. The main joy was that they loved their child. Almost all felt that the extra burden of dealing with a child needs, special treatment and care affected their health, both physically and mentally. They reported health problems such as headache, pain and depressive symptoms. The mothers were the primary caregiver and covered most of the child’s needs. The single mothers were in a special position of vulnerability, taking full responsibility alone. They reported that they felt very alone with concerns about the child’s health situation. They had trouble sleeping and felt exhausted. The lack of someone to talk to or to get support had an impact on their health. They also missed a social network and support. All mothers reported that they had little or no leisure on their own. CONCLUSIONS: The parents reported positive and negative effects of caregiver experience that can affect their quality of life and health. Despite all the challenges of having a disabled child, they also reported about the joy that the child gave them.

(3067) Quit Smoking Is Associated with Better Health-Related Quality of Life in the Spanish General Population Alfonso de Lossada, Health Economics and Outcomes Research, Pfizer, S.L.U., Spain; Javier Rejas, Pfizer, S.L.U., Madrid, Spain AIMS: Smoking is still a prevalent habit in the general population in Spain, and it has been associated with poor health-related quality- oflife (HRQOL). The National Health Survey (NHS) is carried out every five year and collect, among other, information regarding the HRQOL status of the general population. The aim of this work was to analyze the HRQOL status of the adult Spanish general population included in the NHS according to its smoking status. METHODS: The NHS is a cross-sectional survey carried out every five year and collect the health status of a sample of male and female subjects representative of the general population above 15 years old. We used data from the survey corresponding to year 2011/2012. Male and female 18 years of age or above were categorized into three exclusive groups according to their smoking status: smokers (daily smokers of any form of tobacco), ex-smokers of one or more years since quitting smoking and non smokers. HRQOL in the NHS was assessed with the Spanish version of the EQ-5D-5L questionnaire. Comparisons between groups were carried out by means of a multivariate general

159 linear model adjusting for the following covariates: sex, age, prior accidents, number of comorbidities, reduction in activity, body mass index and marital status. RESULTS: A total of 19,596 records were analyzed; 4,721 (24.1 %) smokers, 3,792 (19.4 %) ex- smokers, and 11,083 (56.6 %) non smokers. Ex- smokers showed significantly higher adjusted mean scores in both utility and index values than the other groups. Respectively, adjusted mean (95 % CI) scores were 0.903 (0.899–0.908) and 75.4 (74.9–75.8) in smokers, 0.924 (0.919, 0.929) and 76.8 (76.4, 77.3) in ex-smokers, and 0.902 (0.899–0.905) and 76.3 (76.0–76.5) in non smokers. Also, results showed worse scores in smokers and non smokers than in ex-smokers in the domains of perceived mobility, self care, usual activities, pain/discomfort, and anxiety/depression. CONCLUSIONS: In the Spanish general population, subjects who are ex-smokers showed better utility values and health-related quality of life scores in the domains of the EQ-5D-5L questionnaire, supporting the hypothesis that quitting smoking could be associated with an improvement of health-related quality-of-life.

Cross-Cultural Adaptation (3069) The Translatability of Fatigue Across Languages Barbara A. Brandt, MA, Corporate Translations, Inc., East Hartford, CT, United States; Shawn McKown, MA, Corporate Translations, Inc., East Hartford, CT, United States; Matthew Talbert, Corporate Translations, Chicago, IL, United States; Mary C. Gawlicki, MBA, Corporate Translations, Inc., East Hartford, CT, United States AIMS: The objective of this study was to analyze the translatability of ‘‘fatigue’’ and to explore its interpretation across languages. ‘‘Fatigue’’ may have a profound impact on patient quality of life and ability to carry out work and other daily tasks, deeming it significant for measurement. Past translation projects have indicated that while the term is well understood, some variation in interpretation exists. METHODS: The back-translations of a Clinical Outcomes Assessment questionnaire in nine (9) languages were analyzed to assess the translatability of ‘‘fatigue.’’ The translated questionnaires then underwent cognitive debriefing with five (5) subjects per language. All subjects were asked to paraphrase ‘‘fatigue’’ and to explain how the term differs from ‘‘tired’’ and ‘‘exhausted.’’ Linguists and cognitive debriefing subjects were also sent a follow-up questionnaire asking them to define ‘‘fatigue’’ in a variety of contexts, as translated into their native language. RESULTS: Although comprehension issues were not present when analyzing the translatability of ‘‘fatigue,’’ data shows variation of interpretation across subjects. While no subjects misunderstood or incorrectly paraphrased ‘‘fatigue,’’ analysis of cognitive debriefing results showed several differences in interpretation of the term. Out of 45 subjects, 7 classified ‘‘fatigue’’ as ‘‘chronic tiredness,’’ while 16 considered ‘‘fatigue’’ to be ‘‘extreme tiredness.’’ Five (5) subjects found ‘‘fatigue’’ to be indistinguishable from ‘‘tired,’’ and another 4 subjects felt it was not clear as to whether ‘‘fatigue’’ was meant in a physical or mental context. Thirteen (13) linguists responded to the questionnaire, and their responses did not indicate any translation issues pertaining to ‘‘fatigue.’’ Subject questionnaire responses provided further evidence that ‘‘fatigue’’ may be unclear as to whether it refers to mental or physical adverse affects, in addition to being indistinguishable from ‘‘tired’’ in certain languages. CONCLUSIONS: While translation of the term does not present significant difficulty, ‘‘fatigue’’ may have varied interpretations within and across languages. The results show that, in some languages, respondents questioned whether the term refers to mental or physical ‘‘fatigue.’’, and a number of respondents reported that ‘‘fatigue’’ and ‘‘tired’’ are not clearly distinguished. Due to these conclusions, additional investigation is recommended. A follow-up study on ‘‘fatigue’’ will further explore interpretive issues.

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160 (3073) Reporting of Methods Used for Translations of Pediatric Patient-Reported Outcomes (PRO) Mika Nokela, Covance Market Access; Anna-Karin Berger, PhD, Covance Market Access; Anders P. Ingelga˚rd, PhD Docent, Covance, Go¨teborg, Sweden AIMS: The quality of outcome data collected using translated PRO instruments requires respondents to understand instructions, items and scales as specified by the source documentation. One of many challenges when translating PRO instrument is inadequate procedural documentation of translation processes. Currently, however, reporting of translation processes is left to the discretion of authors and journal editorial boards. Inadequate documentation makes it difficult to assess the quality of translated PROs based on published data. The objectives of this study were to: • • •

Review the established methods for conducting (pediatric) translations, Evaluate the adequacy of details in the (pediatric) translation process descriptions, Describe areas where increases in the procedural details could improve the quality of (pediatric) PRO translations.

METHODS: A literature review was conducted to identify articles that report on the translation and cultural adaptation of the PedsQL published since 2006. The PedsQL was chosen because translators of the PedsQL scales are required by the originators to follow the MAPI research trust predefined translation process. The identified papers were critiqued using the standards set forth by ISPOR and to which the MAPI research trust standards conform. RESULTS: We identified 17 articles in Pubmed, published in English and meeting our inclusion criteria. A review of translation methods across these studies revealed that translation steps were inconsistently reported, both in terms of content and detail. The only consistently reported procedure was utilization of forward and backward translations. The use of cognitive debriefing interviews where mentioned in some cases but not others. Overall, level of details was sparse and including number of interviewees, or reference to cognitive interviewing. In only a few articles did descriptions indicate what elicitation technique(s) had been used (i.e. think aloud or verbal probing). Only two studies reported cognitive interviews across the whole age span to be covered by the translated version CONCLUSIONS: There is great diversity in how translation procedures are described in this literature. Often methodological details are missing, and assessment of the translation quality is difficult. We believe that a consensus document regarding the publication of translation procedures would improve both awareness and reporting quality of pediatric PRO translations.

(3075) Measurement of Self-Management Skills in Chronic Diseases: Translation and Psychometric Evaluation of an Italian Version of the Health Education Impact Questionnaire (HeiQTM) Using Rasch Models Anna Coluccia, University of Siena, Siena, Italy; Richard H. Osborne, PhD, Deakin University, Melbourne, Australia; Andrea Pozza, Siena, Italy; Fabio Ferretti, University of Siena, Siena, Italy AIMS: The Health Education Impact Questionnaire (heiQTM; Osborne et al. 2007) is a forty-item self-report measure, consisting of eight scales to assess self-management skills as proximal outcomes of health education programs for people with chronic diseases. The current study presented the adaptation process and preliminary psychometric properties of the Italian heiQTM using Rasch measurement models and concurrent validity procedures. METHODS: Three hundred sixty-three participants (mean age = 69.30; 56 % females) were

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Qual Life Res (2014) 23:1–184 recruited in outpatient community and inpatient settings in Italy. Participants were outpatients or inpatients with the following diagnoses of chronic diseases: Diabetes (30.10 % of the sample), Arthritis or Psoriasis (19.90 %), Kidney Diseases (11.10 %), Cardiovascular Diseases or Hypertension (10.50 %), Recurrent Depression or Bipolar Disorders (15.40 %), and Oncological Diseases (13 %). Participants completed the heiQTM and a quality of life measure, the MOS 36-item Short Form Health Survey (SF-36; Ware et al. 1992), which was used to assess concurrent validity. Construct validity of the eight heiQTM scales was examined using an item response theory-driven approach through Rasch measurement models to test the observed data fit to the measurement model. RESULTS: Seven of the scales showed a good item fit to the model, as residual means for items were close to 0 with standard deviations approximating to 1. These findings were also supported by the inspection of the data fit from the heiQTM items scales, which showed a non-significant item-trait interaction total Chi squared for each of the seven scales. However, the Emotional Distress scale showed a worse fit, as a significant total Chi squared was found. Internal consistency, measured through the Cronbach’s alpha indices, resulted good to very good for seven scales, whereas it was acceptable for the Insight and Monitoring scale. Moderate to large Pearson’s correlations were found between the heiQTM scales and the SF-36. CONCLUSIONS: Overall, the Italian heiQTM demonstrated good fit to the model, satisfactory reliability, and concurrent validity with quality of life domains. Future research should assess responsiveness of the heiQTM to programs promoting self-management skills.

(3077) The Stroke Impact Scale : Validation of the French Version Sylvia Cael, University of Dijon, Salins Les Bains, France; Pierre Decavel, CHU Besancon, Besancon, France; Christine Binquet, University Hospital, Inserm, CIE1, Dijon, France; Charles Be´naim, CHU Dijon; Marc Puyraveau, CHU Besancon, Besancon, France; Morgane Chotard, CHU Besancon, Besancon, France; Thierry Moulin, CHU Besancon, Besancon, France; Bernard Parratte, CHU Besancon, Besancon, France; Yannick Be´jot, CHU Dijon; Mariette Mercier, University Hospital of Besancon, Besancon, France AIMS: Almost 1 person in 1000 suffers from stroke annually in France. Health-related quality of life (HRQOL) measurement with specific questionnaires is useful to study the consequences of stroke. To date, no specific questionnaire was available in French. METHODS: Validation of the Stroke Impact Scale (SIS) French version in 288 stroke patients in 2 groups (158 acute, 130 chronic), by evaluating acceptability, reliability, construct, convergent and discriminant validity, and sensitivity to change. Acute patients were recruited during the first month post stroke and followed for 3 months. Chronic patients (stroke dating from [ 1 year) were recruited from outpatient consultations. The first 100 chronic patients were called back 15 days after inclusion for test–retest. Barthel index, Hospital Anxiety and Depression Scale (HADS) and Duke questionnaires were administered. RESULTS: The French version of the SIS was well accepted by all patients. It had good reproducibility, Cronbach’s alpha coefficients were [ 89 % for all scales. A ceiling effect was noted in the majority of scales. Physical domains were correlated to other measures of physical capacity (Barthel index and Duke), while the emotional and social domains were correlated to almost all domains of the Duke questionnaire. Responsiveness is good for physical domains, and the emotional domain. CONCLUSIONS: The French SIS version presents good psychometric properties, except for ceiling effect. This is the first specific questionnaire evaluating stroke to be available in France,

Qual Life Res (2014) 23:1–184 and could be useful for further investigations of HRQOL after stroke.

(3079) Recommended Guidelines for Accepting Changes that Affect Existing Translations Rosanna Sze, Health Research Associates, Inc.; Valeska C. Kantzer, Health Research Associates, Inc., Mountlake Terrace, WA, United States AIMS: Existing translations are commonly used as base versions for developing new translations when base and existing translations share similar or identical text strings. This scenario occurs when there are multiple related measures in a battery, when measures are updated to new formats, or when there are multiple versions of the same measure. When revising translations that stem from existing text strings, it is essential to consider whether the revision will affect the base version and consequently, whether the base version will need to be updated with the revision adopted for the new translation. METHODS: Documentation from the development of three translations based on existing translations was reviewed. All changes affecting the existing translations were recorded and placed into categories according to 1) the necessity of the update in order to render the existing translation grammatical, accurate, and consistent; 2) the likelihood that the update will jeopardize the integrity of the existing version. RESULTS: Four categories of changes resulted from the review: 1. Changes for stylistic purposes that do not point to any errors in the existing translation and would introduce inconsistencies between the existing and new translations; 2. Changes involving the formatting of text, such as underlining or bolding, which causes potential inconsistency with the focus or emphatic features of the product, but have a low probability of affecting conceptual understanding; 3. Changes involving spelling or grammar, which affect the presentation and professionalism of the product, but have a low probability of affecting conceptual understanding; 4. Changes involving consistency in similar or identical terminology within and between measures, which may cause multiple interpretations of a single concept; 5. Changes involving semantic or conceptual errors, which would indicate that the existing translation is inaccurate in how it conveys the meaning of the source language. CONCLUSIONS: It is essential to consider the many potential repercussions, such as the potential of jeopardizing the validity of data collected using existing versions, or the time and resource expenditures required to update existing translations to be consistent with the new versions.

Patient-Centered Research (3083) Engaging patients in developing outcome measures—does context of use drive methodological decisions? Anne Skalicky, MPH, Evidera, Bethesda, MD, United States; Susan Magasi, University of Illinois; Asha Hareendran, PhD, Evidera, London, United Kingdom AIMS: To explore how context of use drives methodological decisions in the qualitative phase of the PRO development process. when developing PROs. METHODS: Engaging patients in qualitative research is an integral part of the PRO instrument development process. Emerging standards for qualitative methods provide guidelines for establishing content validity of PROs. The ISPOR PRO Good Research Practice Taskforce for Content Validity sets out 5 good practices: 1) determine the context of use; 2) develop the research protocol; 3) conduct the concept elicitation

161 interviews; 4) analyze the qualitative data; 5) document the concept development and elicitation methodology and results. Case studies of PRO instrument development for use in different contexts were analysed to explore potential methodological decisions, pitfalls, and challenges for employing the best methods and truly capturing the patients’ voice. RESULTS: Two case studies were evaluated which engaged patients for PRO developed for distinct purposes: 1) for FDA label claim; and 2) for use in clinical practice. The case studies are reviewed in the context of the ISPOR Taskforce Guidelines to highlight how context and measurement framework determine qualitative strategy. The strengths, limitations and practical approaches to the qualitative approaches based on distinct context of use will be evaluated. Analyses of the case studies highlight innovative qualitative research methods and approaches to avoid common pitfalls. Specifically, the authors will address ‘‘contentious’’ issues in qualitative research for instrument development process including development of theory driven sampling strategies; determinations of data adequacy and saturation; choice of analytic approaches, specifically contrasting grounded theory versus phenomenology; and balancing patient and clinical expert perspective in the development of conceptual frameworks and instrument and item selection processes. CONCLUSIONS: A primary purpose of the use of qualitative methods in instrument development process is to ensure that measures are content valid and represent the issues and priorities of the people we serve. It is thus critically important that PRO retain their patient-centered focus as at the qualitative data are operationalized into item content. Methodological choices throughout the qualitative research process have lasting implications. Innovative qualitative approaches to support PRO instrument development are needed to support label claims.

(3085) Symptom distress profiles in hospitalized patients in Sweden—a point prevalence survey Ingela Henoch, University of Gothenburg, Gothenburg, Sweden; Richard Sawatzky, PhD RN, Trinity Western University, Langley, BC, Canada; Hanna Falk, University of Gothenburg, Institute of Neuroscience and Physiology, Gothenburg, Sweden; Isabel Fridh, University of Gothenburg, Institute of Health and Care Sciences, Gothenburg, Sweden; Eva Jakobsson Ung, University of Gothenburg, Institute of Health and Care Sciences, Gothenburg, Sweden; Elisabeth Kenne Sarenmalm, Research and Development Centre, Skaraborg Hospital, Sko¨vde, Sweden; Anneli Ozanne, University of Gothenburg, Institute of Neuroscience and Physiology, Gothenburg, Sweden; ¨ hle´n, Ersta Sko¨ndal University College, Palliative Research Joakim O Centre, Stockholm, Sweden; Kristin Falk, University of Gothenburg, Institute of Health and Care Sciences, Gothenburg, Sweden AIMS: Troublesome symptoms are the most common reason for seeking hospital care. Since many patients report multiple symptoms concurrently, symptom research needs to study symptom clusters. There are two conceptual approaches to symptom cluster research: (a) the identification of symptom clusters by investigating associations among different symptom reports; (b) the identification of subgroups of patients that reflect different symptom profiles. Symptom clusters and symptom profiles have been examined in patients with cancer. However, no studies have examined symptom profiles based on patients’ self-reported symptom distress in heterogeneous groups of hospitalized patients. Aim: To examine symptom distress profiles of hospitalized patients. METHODS: Symptom distress data were collected at two hospitals in Sweden via point prevalence surveys using numeric rating scales (NRS) of pain, dyspnoea, fatigue, sleeping difficulties, loss of appetite, depression and anxiety. Patients were grouped according to symptom experience using two

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162 approaches: (a) classification of patients with high versus low pain and fatigue distress scores; (b) classification based on a latent class analysis of symptom profiles. RESULTS: In the 710 patients, fatigue (76.2 %) and pain (65.3 %) were the most prevalent symptoms (median NRS 5 to 6). The group of patients experiencing high fatigue and pain distress were to a greater extent female, living alone and diagnosed with musculoskeletal diseases, and had a higher number of symptoms than the low pain and fatigue group. The latent class analysis revealed three latent classes that differed in ratings and symptom distress profiles. People in the low symptom distress class (LSDC) reported less distress on average than people in medium (MSDC) and high symptom distress classes (HSDC). Compared to LSDC, people in HSDC were more likely to be female and live alone. Latent class membership, reflective of different symptom distress profiles, was not substantially explained by different diagnoses. CONCLUSIONS: The majority of patients admitted to hospital experience symptom distress at a level that requires symptom management. Symptom distress is a subjective illness experience and needs to be treated as such, irrespective of diagnosis. Although symptom distress was analysed with two different approaches, the most distressed patients were women who were living alone.

(3087) Hidden pathways of chronic illness: a Patient-Generated Study Sandra Zelinsky, University of Calgary, Calgary, AB, Canada; Nancy Marlett, University of Calgary, Calgary, AB, Canada; Svetlana Shklarov, University of Calgary, Calgary, AB, Canada AIMS: The poster is presented by one of the patient engagement researchers who conducted this research as part of a year-long internship in Patient and Community Engagement Research (PACER) Program at the University of Calgary. It will depict the hidden pathways through chronic illness as uncovered in a patient engagement research project conducted by patient researchers representing a variety of common chronic conditions. METHODS: Twenty-two participants were included in this research study. The method consisted of: 1) arts-based research method (creating artistic concept maps), designed to enable the participants to think deeply about their journey though chronic illness, 2) focus groups that enabled patients to share their understandings as a result of their concept maps, and 3) narrative interviews to extend the stories that arose along the pathways identified. RESULTS: Six pathways were presented: alien land, search for answers as a way out, finding you are alone, search for meaning, representing yourself with a chronic illness, and you are not the boss of me. The poster will be largely graphic, with a representation of the six pathways, examples of patient art, and quotes. CONCLUSIONS: This study depicts the pathways through chronic illness as uncovered and represented by patients with various chronic conditions. We will also present a comparison of these patient-presented hidden pathways and clinical care pathways, as a way to understand the distinct challenges posed by chronic illness.

Qual Life Res (2014) 23:1–184 Table 1 . Domains

EQ5D- SF-36 WHOQOL HUI 5L

Analysis of domains in generic scales Decreased vision Impaired mobility Difficulty speaking

x x

x

x x

x x

Pain

x

x

x

x

Difficulty performing usual activities

x

x

x

x

x

x

x

x

Impaired memory

Changes in personal appearance Loss of life expectancy

x

x

AIMS: To identify the major domains associated with changes in quality of life related to health (HRQOL) and its variations by demographic characteristics, through analysis based on preferences in Colombia. METHODS: We designed a Survey of intersection including socio demographic characteristics and selected the top 20 generic domains from different scales measuring HRQOL, grouped in a four dimensions design; (strength and mobility, emotion and pain, sensory functions and social relations). Respondents were asked to sort the domains and dimensions according to the perceived relative importance with respect to the effect on HRQOL. As a control within the survey we applied a visual analogue scale (VAS). For the analysis we took into account the differences between the most preferred domain and each particular domain within each dimension and grouped them for the whole sample results. Thus, domains equally preferred had similar values and the most preferred accumulated this condition, ensuring an ordinal preference approach. The most influential domains were derived from the application of the theory of Pareto. RESULTS: 350 people were surveyed in different areas of the country with an average age of 38.3 years without sex differences. The greatest preferences where grouped in 8 domains (70 % of the total) in the following order : decreased vision, impaired mobility, difficulty speaking, impaired memory, pain, difficulty performing usual activities, changes in Personal appearance and loss of life expectancy. We compared them with domains included in the main generic scales (Table 1). Differences in the way preferences were sorted varied by gender, age, socioeconomic status and origin. Mean HRQOL measured by VAS was 79.3. CONCLUSIONS: You can use a preference -based method that identifies the domains that people value against expected changes in HRQOL, which vary by socioeconomic and demographic differences. This implies that the instruments designed to measure HRQOL should be sensitive to capture these variations. In Colombia at least 3 of the selected domains would not be present in the most frequently used scales in the region.

Utilities/Cost-Effectiveness Methods (3089) Domains associated with changes in quality of life related to health (HRQOL): a method based on preference Martin Romero, MD PhD(C), Universidad Nacional de Colombia, Bogota, Colombia; Nelson Alvis-Guzman, Universidad de Cartagena—Grupo de Investigacio´n En Economı´a de La Salud; Jannina Alvis-Zakzuk, Universidad de Cartagena—Grupo de Investigacio´n En Economı´a de La Salud; Ruben Marrugo, Fundacion Salutia; Lina Huerfano, Fundacion Salutia; Maritza Sanabria, Fundacion Salutia

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(3091) Fifth Wheel: evidence of disagreements between health scales and preferences in the EQ-5D Benjamin M. Craig, PhD, H. Lee Moffitt Cancer Center & Research Inst., Tampa, FL, United States AIMS: The aim of this study is to test whether the ordering of item labels in EQ-5D instruments disagrees with the preferences of US adults. METHODS: A preference inversion occurs when ‘‘worse’’ health along a scale or score is preferred. As a sub-study of the 2013

Qual Life Res (2014) 23:1–184 United States Measurement and Valuation of Health Study, we tested for 33 EQ-5D preference inversions using paired comparisons with unique samples of 50 or more US adults, age 18 or older. Specifically, we tested whether the ordering of EQ-5D item labels disagreed with preferences and whether US adults were indifferent to ‘‘worse’’ health along each item. RESULTS: The EQ-5D-3L and EQ-5D-Y item labels had no significant preference inversions. The EQ-5D-5L version had preference inversions between Levels 4 and 5. For example, 30 out of 59 respondents (51 %) preferred being ‘‘extremely’’ over ‘‘severely anxious or depressed,’’ contrary to the ordering of labels for that item. CONCLUSIONS: Concern about similar magnitudes between Levels 4 and 5 on the EQ-5D-5L were identified. To mitigate preference inversion, labels could be revised; a 4-level version could be considered or similar values for Levels 4 and 5 could be expected in a valuation study.

(3095) Rheumatoid Arthritis: Health States Utilities Cla´udia C. Ribeiro, Universidade Cato´lica Portuguesa, Viseu, Portugal; Augusta Marques, Universidade Santiago de Compostela; Isabel Santos, Hospital Santa Maria Da Feira; Ne´lio Veiga, MSc, Universidade Cato´lica Portuguesa; CIDETS; Beira Interior University, Portugal, Viseu,; Carlos Vasconcelos, Hospital Santo Antonio Centro Hospitalar Do Porto AIMS: Utility scores are used to estimate Quality Adjusted Life Years (QALYs), applied in determining the cost-effectiveness of health care interventions. In studies where no preference based measures are collected, indirect methods have been developed to estimate utilities from clinical instruments. Aim: Evaluate a published method of estimating the Short Form-6D (SF-6D) (preference based) in patients with rheumatoid arthritis (RA) and evaluate the impact of socio demographics economics and clinical characteristics on quality of life (QOL) and potential predictors for QOL improvements. METHODS: 329 patients selected by convenience with RA (226 women; mean age: 45.21), responders to the Portuguese Short Form-36 version 2 (SF-36v2) questionnaire and can be assigned an SF-6D score provided the 11 items used in the SF-6D have been completed using a computerized administration. To assess socioeconomic status, we use the Graffar´s scale, clinical and demographic variables were assessed by a questionnaire specifically designed for the study. RESULTS: The mean SF-6D utility value was 0.595. Male, gender, young, single, individuals with high educational attainment level and Graffar´s scale class high reported higher utility levels. As expected, those who takes therapeutics’ or have a higher length disease reported lower mean utility levels than those who were in a less severe stadium of the disease or without therapeutic. CONCLUSIONS: SF-6D is an effective tool for measuring HRQOL in RA patients. The normative values can be used economic evaluation and clinical studies as they incorporate patient´s preferences and translate the value attribute to patients´ health state.

Statistical Analysis of PROs (3097) The Empowerment Scale: a Factor Aalysis to Determine Multi- or Unidimensionality Jane Kass-Wolff, University of Colorado Anschutz Medical Campus, Aurora, CO, United States; Karen H. Sousa, RN PhD, University of Colorado Denver; College of Nursing, Aurora, CO, United States AIMS: The concept of empowerment has been incorporated into nursing’s health promotion strategies since the 1980’s. Nursing has defined empowerment as ‘‘a social process of recognizing, promoting

163 and enhancing people’s abilities to meet their own needs, solve their own problems and mobilize the necessary resources in order to feel in control of their own lives’’ (Gibson 1991, p. 359). Empowerment has been linked to the HRQOL model (Wilson and Cleary 1995). Rogers et al. (1997) developed the 28-item Empowerment Scale (ES) to assess empowerment in consumers of mental health services. Empowerment is proposed as 5 dimensions: self-esteem-self-efficacy, power-powerlessness, community activism and autonomy, optimism and control over future, and righteous anger. The purpose of this analysis was to test this assumption. METHODS: The sample consisted of 108 women from a nurse practitioner gynecology clinic. Confirmatory factor analysis (CFA) tests the hypothesis about the structure of the questionnaire and evaluates the extent to which a particular instrument actually measures the construct it is supposed to measure. Since validity is concerned with whether a variable measures what it is supposed to measure, CFA is an appropriate approach to further investigate construct validity. CFA is used when there is hypothesized knowledge of the underlying latent variable structure. In this case, it was hypothesized that the ES is a multidimensional instrument. Analyses were conducted using MPlus (Muthe´n and Muthe´n 2013). RESULTS: The overall fit of the ES within the fivefactor hypothesized model was poor (X2 = 552{345}, p \ 0.000; CFI = 0.795; RMSEA = 0.075; SRMR = 0.095). Modification indexes and qualitative itemmetric analyses suggested that this is not a unidimensional scale. The unidimensional model had a poorer fit (X2 = 751{350}, p \ 0.000; CFI = 0.613; RMSEA = 0.103; SRMR = 0.105. CONCLUSIONS: CFA evaluates the structural integrity of a measurement instrument. The hypothesized measurement structure of the ES had been previously tested and used heavily in mental health. We found problems with the hypothesized 5-factor structure and a single factor structure. To improve assessment of empowerment a qualitative analysis may be required. A larger sample for the CFA may also be necessary. Further implications will be discussed.

(3099) The analysis of multivariate longitudinal data: an application of the longitudinal three-mode model in healthrelated quality of life data Mathilde Verdam, University of Amsterdam, Amsterdam, Netherlands; F. J. Oort, University of Amsterdam; Y. M. Van Der Linden, Leiden University Medical Centre; Mirjam AG Sprangers, PhD, Academic Medical Center, Amsterdam, Netherlands AIMS: Our aim is to provide an instructive explanation of how the longitudinal three-mode model (L3MM) can be applied to the analysis of multivariate longitudinal data. Application of the L3MM not only facilitates the analysis of complex longitudinal data but also enhances the interpretation of change. METHODS: Assessment of change in patient-reported outcomes of health-related quality of life is often investigated using a design with a limited number of measurement occasions (e.g., two or three). Situations where there are many more measurement occasions (e.g., high frequency of measurement, or high number of follow up measurements) pose a challenge for the assessment of change, as standard techniques may be inappropriate with larger numbers of measurement occasions. One solution to this problem is the imposition of Kronecker product restrictions to take into account the three-mode structure of multivariate longitudinal data. The resulting L3MMs are more parsimonious and have attractive interpretation. RESULTS: We illustrate the use of the L3MM with data of a bone metastasis study (Van der Linden et al. 2004). Health-related quality of life was measured in 682 patients with painful bone metastasis treated with radiotherapy at thirteen measurement occasions; before and every

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164 week after treatment with radiotherapy. Kronecker product restrictions were imposed on (1) the factor loadings and intercepts to comply with longitudinal measurement invariance; (2) the residual factor covariances and correlations, including further restrictions to test equality of variances, correlations and covariances across occasions; (3) the common factor covariances and correlations, including further restrictions to test equality of variances, correlations and covariances across occasions; (4) the common factor means, including further restrictions to test equality of common factor means and that describe the means of the common factors using a linear trend. In addition, for each step we provided an example of how the resulting parameter estimates can be interpreted. CONCLUSIONS: We provide an instructive explanation of how the L3MM can be applied to multivariate longitudinal data. This will aid future researchers in their investigation of change in healthrelated quality of life outcomes.

(3101) The influence of a monetary incentive on (online) response, response time, and quality of life outcomes Nicole J. Horevoorts, MA, Tilburg University, Tilburg, Netherlands; Simone Oerlemans, Comprehensive Cancer Center Netherlands; Floortje Mols, Tilburg University, Tilburg, Netherlands; Pauline Vissers, Tilburg University, Tilburg, Netherlands; Lonneke van de Poll-Franse, Comprehensive Cancer Center South AIMS: Longitudinal studies are dependent of continuous cooperation of respondents. A monetary incentive can be used to stimulate respondents to fill out questionnaires. In the population-based Patient-reported Outcomes Following Initial treatment and Longterm Evaluation of Survivorship (PROFILES) lymphoma study we conducted an experiment to evaluate if a monetary incentive affects the response, response time, and the patient-reported outcomes of cancer survivors. METHODS: A gift card was sent to a random selection of survivors included in the PROFILES lymphoma study who were invited to our wave 3 questionnaire (n = 60). The other lymphoma survivors received a regular invitation (n = 65). The third wave was chosen because in our previous studies we observed a steep decline in participation in the third wave of a questionnaire. The gift card had a value of 10 Euros (approximately 13 US dollars). RESULTS:

Fig. 1 .

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Qual Life Res (2014) 23:1–184 Response rate differed significantly between the two groups: 90 % of those who received a gift card filled out the questionnaire compared to 66 % in the usual approach group (p = 0.006). Response time also differed significantly: 98 % of the respondents who received a gift card returned the questionnaire after the first invitation versus 73 % respondents in the usual approach group (p B 0.0001) (Fig. 1). Significantly more respondents in the usual approach group filled out the online questionnaire instead of the paper questionnaire compared to the experimental approach group (42 % vs. 11 %, p B 0.0001). No significant differences were found in health-related quality of life (HRQOL) outcomes between the groups. CONCLUSIONS: Including a monetary incentive improves not only the overall response but also quickens response time. The cost of the incentive can outweigh the cost of having to send reminders. Online response was lower in the experimental approach group, probably because a paper questionnaire was included with the invitation letter, as opposed to the e-mail invitation. More importantly, analysis of HRQOL outcomes show that the incentive can be used without influencing the results.

(3103) Response shift associated with the pediatric health status change on the rating of asthma-specific quality of life: an item-level analysis Pranav Gandhi, PhD, South College School of Pharmacy, Knoxville, TN, United States; Darren DeWalt, MD MPH, University of North Carolina, Chapel Hill, NC, United States; Carolyn E. Schwartz, ScD, DeltaQuest Foundation, Inc., Concord, MA, United States; I-Chan Huang, PhD, University of Florida, Gainesville, FL, United States AIMS: Limited studies examined the magnitude of response shift (RS) of health-related quality of Life (HRQOL) at the item level and how it influences the estimation for domain scores of HRQOL. This study aimed to examine RS associated with the change of asthma-related health status on the rating of items measuring asthma-specific HRQOL in children, after accounting for measurement bias and confounding variables. METHODS: Study sample comprises 238 asthmatic children who were 8–17 years and completed the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) capturing the domains of symptoms, emotion, and activity limitation at baseline and anytime in a three-month window whenever asthma control status changed. Oort’s structural equation modeling approach was implemented to assess item-level reconceptualization, recalibration and reprioritization RS associated with change in asthma control, global rating of change in breathing problems, and overall health. RS analyses adjusted for the influence of measurement bias and confounding variables (child’s age, race, gender, and body mass index). Measurement bias reflects the unequal ratings on the PAQLQ items for different levels of asthma-related health status given the same underlying HRQOL. The magnitude of item-level RS and its influence on the change of domain scores was estimated using the Cohen’s effect sizes (ES). RESULTS: The activity limitation domain evidenced recalibration RS corresponding to the change of asthma-related health status in one item, with a small magnitude (ES = 0.2). The symptom domain evidenced recalibration RS in two items, and reprioritization RS in one item. However, the magnitude of RS in the three items of symptom domain was small (ES = 0.2). The emotional function domain evidenced recalibration and reprioritization RS in one item each. The magnitude of recalibration and reprioritization was small (ES = 0.2) and moderate (ES = 0.5), respectively. RS led to a marginal increase in mean latent scores for activity limitation and emotional function domains, whereas a slight decline in scores for symptom domain. CONCLUSIONS: Recalibration and reprioritization RSs were identified at the item level in all domains of PAQLQ

Qual Life Res (2014) 23:1–184 measuring pediatric asthma-specific HRQOL. The magnitude of RS on item-score change was small to moderate, and thus will likely influence the responsiveness of this disease-specific tool.

(3105) Semantic primes: a possible way to avoid response shift? Antoine Vanier, MD, University Pierre Et Marie Curie Paris 6, Paris Cedex 13, France; Alain Leple`ge, MD, PhD, University of Paris Diderot, Paris, France; Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France; Veronique Sebille, ScD, University of Nantes, Nantes, France; Bruno Falissard, INSERM U669, Univ. Paris-Sud and Univ. Paris-Descartes AIMS: Patient-Reported Outcomes instruments are increasingly used in Randomized Control Trials to assess the direct effect of treatment on Health-Related Quality of Life (HRQOL). Response shift (RS) effects can be considered as a bias that is liable to compromise efficient assessment of the effect of treatment on HRQOL. METHODS: We hypothesize that there is a link between RS effects on HRQOL scores and the level of complexity of HRQOL conceptualization. RESULTS: 1. Reconceptualization and semantic primes. RS theory suggests that the respondent can understand the same questions differently over time. This raises the question of the extent to which a subjective construct can be interpreted differently, which is the question of semantics. Semantic primes theory describes different levels of complexity in the definition of concepts used in a language. The lowest level of complexity is made of semantic primes: core elements that can be used to define all complex concepts, with a meaning supposed to be universal. Then, semantic molecules are simple concepts that can be defined combining only a few semantic primes. We are postulating that some subjective constructs useful in health-related research have a linguistic definition as simple as a semantic molecule (e.g. pain intensity), and therefore could hardly be reconceptualized over time. Other subjective constructs have a more complex definition (e.g. HRQOL), thus reconceptualization is a matter of concern. 2. Reprioritization and multidimensionality. Reprioritization, according to its definition, implies a change in the relative importance in the respondent’s mind between at least two domains constituting the targeted construct. Therefore, a subjective construct operationalized as markedly unidimensional may not be a candidate for reprioritization. CONCLUSIONS: Theoretical proposals. We suggest that the impact of RS effects on HRQOL scores could be lessened if questionnaires were designed following a rule of ‘‘the least semantic and psychometric complexity’’. Indeed, we propose that once a PRO instrument assessing HRQOL is theoretically soundly conceptualized: •

to be broken down into items that can be equated as closely as possible to semantic molecules; -and to be operationalized in unidimensional form; it becomes possible to obtain: a score that will not be readily biased by reconceptualization and reprioritization.

(3107) Sample size determination when conducting a confirmatory factor analysis (CFA): how sample size, scale characteristics, data characteristics and estimation methods affect fit indexes? Emmanuelle Anthoine, University of Nantes, Nantes, France; Leila Moret, University Hospital of Nantes; Veronique Sebille, ScD, University of Nantes, Nantes, France; Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France AIMS: A recent literature review indicated that sample size determination in new PRO validation studies was very rarely done. Indeed,

165 practical considerations are often only used for this choice, as there is no consensus for its determination. A simulation study was performed to determine the impact of the sample size on the incorrect rejection rate (based on fit indices) of a well specified CFA model, and on the power to detect a bad specification of the model, also considering scale and data characteristic, as well as different estimation methods. To our knowledge, the existing literature has never reported the impact of sample size on CFA regarding type I error and power with such an important combination of parameters. METHODS: The simulation study was based on CFA with various sample sizes (100–1,000), numbers of factors (1–10), correlations between them (0.0–0.7), items per factor (3–10), answers categories (2–7), factor loadings values on the true factor (0.4–0.85), items responses distributions and estimation methods (ADF and ML). For each scenario, 500 random replications were drawn. Numerous fit indices were studied, including Chi square, CFI, RMSEA, IFI, NNFI, RNI and MCI. Rejection or acceptance of a CFA model depended on fit indices thresholds. Thresholds values proposed in the literature will be compared to values that will be determined to optimize, in each scenario, the type I error rate and power. RESULTS: We identified 17280 possible scenarios. High sample sizes compensated bad conditions (low factor loading, skewed items responses distributions, few items per factor and few answers categories) in terms of fit indices. On the contrary, low sample sizes are compensated by good conditions, and all estimation methods gave similar conclusions regarding goodness of fit in this case. CONCLUSIONS: This analyze will be complemented with the assessment of the type I error and power of the different combination of parameters used to reach a decision. This study will provide guidance for sample size planning when a CFA is performed. It will bring insights regarding the issue of size of studies for appropriate identification of questionnaires’ structure.

Poster Session 3002: Saturday Poster Session 2 Breast and Prostate Cancer (3004) Validation of the French version of the impact of cancer version 2 (IOCv2) questionnaire on a breast cancer survivors population Myriam Blanchin, University of Nantes, Nantes, France; Sarah Dauchy, Psycho-Oncology Unit, Department of Supportive Care, Gustave Roussy; Alejandra Cano, Psycho-Oncology Unit, Department of Supportive Care, Gustave Roussy; Anne Bre´dart, Psycho-Oncology Unit, Department of Supportive Care—DISSPO, Institut Curie; Neil K. Aaronson, PhD, the Netherlands Cancer Institute, Amsterdam, Netherlands; Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France AIMS: A large number of studies on psychosocial aspects among cancer survivors have brought out psychological distress like fear of recurrence, depression and anxiety and reported facing existential concerns as an opportunity for personal growth. The Impact of Cancer version 2 (IOCv2) is a 37-item questionnaire that measures the impact of the disease on quality of life and identifies positive or negative changes that long-term survivors attribute to their cancer experience. The validation of the French version of IOCv2 represents an opportunity to gain a cross-cultural understanding of feelings associated with the experience of cancer in the post-treatment phase. METHODS: After a forward–backward process of translation of the IOCv2 into French, the questionnaire was administered to 243 French breast cancer patients along with the MOS SF-12, the PostTraumatic Growth Inventory (PTGI) and the Fear of Cancer Recurrence Inventory (FCRI). Confirmatory factor analysis (CFA) was performed on the

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166 original IOCv2 8-factor solution. Convergent and divergent validities were evaluated by examining the item-rest score and item-score correlations. Differences or not of the scale scores across the patient characteristics were examined to evaluate known-group validity using correlation coefficients and t-tests. Concurrent validity was evaluated by correlating the IOCv2 scores with SF-12, PTGI and FCRI scores. Internal consistency was assessed using the Cronbach’s alpha coefficient. The ability of each scale to discriminate among individuals and scalability were evaluated with the Ferguson’s d statistic and Loevinger’s H scalability coefficient respectively. RESULTS: The good fit of the CFA suggests that the French version supports the 8-factor structure of the original version with four positive impact domains and four negative impact domains. The high values of psychometric indices indicate reliability and the correlation coefficient values suggest validity of the French version. The IOCv2 showed that it could discriminate accurately among patients according to their age and treatment. Patterns of association between IOCv2 scores with SF12, PTGI and FCRI scores indicate good concurrent validity. CONCLUSIONS: The French version of the IOCv2 has shown good psychometric properties and therefore it can be used as a validated tool for future studies assessing psychosocial interventions among breast cancer survivors.

(3006) Quality of Life and Symptom Concerns in Breast Cancer Survivors Receiving Hormonal Therapy Gloria Juarez, PhD, RN, MSN, City of Hope, Duarte, CA, United States; Joan J. Branin, PhD, University of La Verne, La Verne, CA, United States AIMS: Some studies indicate that for patients who have a low risk for breast cancer recurrence, the additional risk of recurrence imposed by hormone therapy may be relatively small compared to the problems of osteoporosis and the management of symptoms such as vaginal dryness and hot flashes experienced by women after breast cancer treatment. The importance of symptom assessment and management in the cancer population is indicated by the extraordinarily high prevalence of physical and psychological complaints and the impact of these symptoms on perceived quality of life. The aim of this study was to assess the impact of symptom concerns on the quality of life of cancer survivors receiving hormonal therapy. METHODS: This descriptive longitudinal mixed methods research study was conducted in the ambulatory clinics of an NCI-designated Comprehensive Cancer Center in the United States. Twenty breast cancer survivors who were receiving adjuvant hormonal therapy were followed at baseline prior to treatment and at 1 and 4 months post-accrual. Outcome measures included the COH-QOL tool and the Memorial Symptom Assessment Scale (MSAS), a patient-rated instrument for the comprehensive assessment of symptom prevalence, characteristics and distress used in clinical trials that incorporate quality of life measures. Descriptive analysis of demographic, QOL and symptom data was conducted followed by non-parametric McNemar tests to examine symptom occurrence over time. RESULTS: Overall QOL was moderate at baseline and changes over time were not statistically significant. Thirty-three symptoms commonly associated with breast cancer were evaluated across three dimensions: (1) severity of the symptom; (2) frequency with which it occurs; and (3) the degree of distress produced. Symptoms such as hot flashes, lack of energy, difficulty sleeping, and worrying were the most commonly reported by this cohort. Qualitative interview findings confirm that substantial levels of physical and psychological distress are common with hormonal treatments. CONCLUSIONS: Breast cancer survivors suffer from multiple symptoms related to hormonal therapies that places them at higher risk for diminished QOL. The identification of specific symptoms and QOL concerns in breast cancer survivorship will

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Qual Life Res (2014) 23:1–184 enhance clinical care and aid in future development of multidisciplinary interventions.

(3008) Health-related Quality of Life and Health Utilities in Prostate Oncology Pedro L. Ferreira, PhD, University of Coimbra, Coimbra, Portugal; Teresa Sequeira, CEISUC/UFP; Joana Teixeira, UFP Hospital; Lurdes Carvalho, Portuguese Oncology Institute, Porto, Portugal; Augusta Silveira, CEISUC/UFP AIMS: Prostate cancer is the second leading cause of cancer death in men. The incidence rate for prostate cancer has increased since 1980 with lower but increasing incidence in less developed countries. This study aimed to evaluate the HRQOL by different instruments and to obtain health utilities for prostate cancer after the implementation of a routine HRQOL assessed in the Portuguese Cancer Institute, in Porto (IPOP) in order to explore factors related to an impaired HRQOL. METHODS: Consecutive outpatients with prostate cancer admitted during three months at the IPOP’s Urology Unit were asked to complete a questionnaire including EORTC QLQ-C30, module PR25, SF-12, and EQ-5D-3L with VAS. The Portuguese value set was used to derive the EQ-5D index and the SF-12 summary scores were computed from a representative sample-based algorithm. Socio-demographic and clinical variables were also collected. RESULTS: A sample of 300 patients filled the questionnaire. Their mean age was 71.2 ± 8.9 years and had mainly two to four years after diagnosis and a low literacy. The overall quality of life measured by the EORTC QLQ-C30 reached 58.3 and patients’ functional state ranged between 80.0 and 84.6. The most adverse general symptoms were insomnia, fatigue and financial difficulties. The specific measure PR25 showed that the intensity of symptoms was higher in the sexual activity functional status.Physical and mental summary SF-12 components were 47.3 and 47.6 and the mean EQ-5D score was 0.80 ± 0.29 with mean VAS 54.6 ± 14.0. 1.33 % of patients scored utility values lower than death. Except for the role function, all QLQ-C30 mean scores were lower for the oldest. Only dyspnoea, pain, diarrhoea, and financial difficulties increased among the oldest. Accordingly, the EQ-5D index and the VAS decrease for this age group. CONCLUSIONS: This project evidenced the feasibility of a systematic quality of life measurement as part of a regular patient’s clinical file perfectly integrated on a clinical information system. Doing so, it is possible to measure the value a patient may gain in being treated in a clinical setting, with a particular organization, following a particular treatment and by a particular team.

(3012) Validation of the French Version of Expanded Prostate Cancer Index Composite (EPIC) for assessment of health-related quality of life, according to item response theory and classical analyses Anne-Sophie Mariet, University of Franche-Comte´, Besanc¸on, France; Ame´lie Anota, Quality of Life in Oncology Platform, France, Besanc¸on, France; Anne-Vale´rie Guizard, Centre Francois Baclesse, Caen, France; Pascale Grosclaude, Registre Des Cancers Du Tarn, Centre Claudius Re´gaud, Toulouse; Michel Velten, Epidemiology and Public Health Laboratory, College of Medicine, Strasbourg, Strasbourg, France; Mariette Mercier, University Hospital of Besancon, Besancon, France AIMS: With an estimation over than 365 000 new cases in France for 2011, prostate cancer is the most common cancer in France, irrespective of gender with over than 71 000 new cases. There are few French prostate cancer specific validated questionnaires to

Qual Life Res (2014) 23:1–184 assess health-related quality of life. The major aim of this study was to evaluate the psychometric properties of the French version of the Expanded Prostate Cancer Index Composite (EPIC) using item response theory (IRT) in a based-population study. METHODS: EPIC questionnaire includes 50 items organized in four domains: urinary, bowel, sexual, hormonal. EPIC was completed by 308 healed cases of prostate cancer for ten years from ten French cancer registers in the QaliPro case–control study. IRT analyses were conducted separately for each of the eight subscales of EPIC with partial credit model. We examined the fit of the data to the model expectations and tested whether the model assumptions of unidimensionality, monotonicity and local independence were respected. Classical test theory (CTT) analyses tested also the main psychometric properties: convergent and divergent validity, and internal consistency. RESULTS: The two less frequent response categories were combined in one category because of the low floor effect. Each subscales fitted poorly to the IRT model, except sexual bother subscale. Three items were redundant (fit residual \-2.5). The fundamental assumptions of the Rasch model were checked. The principal component analysis allowed to validate unidimensionality. Most of the local dependence concerns items of the urinary function, sexual bother and hormonal bother subscales. Monotonicity was not perfectly established for bowel and hormonal functions subscales and items (Loevinger’s H coefficients \ 0.30). Convergent and divergent validities were correct in all subscales. Internal consistency was good in the majority of subscales, except for hormonal and bowel functions subscales (Cronbach’s a were 0.50 and 0.54 respectively). CONCLUSIONS: This study highlighted some misfitting and redundant items in subscales of EPIC with IRT analysis. However, the CTT analysis revealed globally good psychometrics properties of EPIC domains. The IRT models can thus complement results of the CTT approach. Response categories and some items of EPIC have to be reformulated to improve its properties.

Endocrinology/Diabetes/Obesity (3016) Health-related quality of life in the cluster types of metabolic syndrome components among korean population Younghwa Baek, Korea Institute of Oriental Medicine, Daejeon, Korea; Kihyun Park, KIOM; Jonghyang Yoo, Korea Institute of Oriental Medicine, Daejeon, Korea; Siwoo Lee, Korea Institute of Oriental Medicine, Daejeon, Korea; Eunsu Jang, Korea Institution of Oriental Medicine, Daejeon, Korea AIMS: The purpose of this study is to estimate health-related quality of life (HRQOL) according to the number of each metabolic syndrome (MS) components and reveal the HRQOL score according to the different cluster types of 5 MS components. METHODS: We collected 3890 subjects (male = 1246, female = 2644, mean aged 46.3 ± 13.6) aged over 20 years recruited from 11 Korean medicine clinics from Aug. 2009 to Aug. 2013. HRQOL was assessed with physical and mental component summary (PCS and MCS) using the Health Survey Short-Form 12. The diagnostic criteria of MS were based on the National Cholesterol Education Program’s Adults Treatment Panel III and some criteria were modified. We classified into 5 cluster types with three components as considering higher prevalent combination of MS. Level of statistical significance was considered to be p \ 0.05 using SPSS 21.0 program. RESULTS: 1. The prevalence of MS was 25.7 % in male and 18.2 % in female, and both PCS and MCS mean score were higher in male than in female. 2. There was significantly different in PCS mean score as the number of MS components was increased in both gender, but there was no difference in MCS. 3. The number of type 2 (with abdominal obesity, high triglycerides, and hypertension) was highest as 61(30 %) in male

167 and the number of type 3 with abdominal obesity, low HDL cholesterol, and hypertension (26.8 %) was highest in female. 4. There was significantly different in PCS mean score among 5 cluster types with three components of MS. Especially type 4 (with abdominal obesity, hypertension, and diabetes mellitus) had lowest PCS score in both male (41.6 ± 11.3) and female (38.3 ± 11.1). The MCS mean score of 5 cluster types showed no difference. CONCLUSIONS: HRQOL is inversely associated with the increasing number of MS components, and the HRQOL score of MS types with 3 different combinations among 5 components seem to be different one after another.

(3018) Applying an ambulatory monitoring approach to investigate the relationship between well-being and the menstrual cycle Maxi Rahn, Ernst-Moritz-Arndt University of Greifswald, Germany; Pinar Kueucuekbalaban, Greifswald, Germany; Tim Rostalski, ErnstMoritz-Arndt University of Greifswald, Germany; Holger Muehlan, Ernst-Moritz-Arndt University Greisfwald, Germany, Greifswald, Germany; Silke Schmidt, PhD, University of Greifswald, Greifswald, Germany AIMS: According to a recent review including 47 studies (Romans et al. 2012), the relationship between well-being and the menstrual cycle has most often been investigated using retrospective assessment methods. Thus, we investigated this relationship applying an ambulatory assessment approach while addressing the following research questions: (a) does well-being of women vary in dependence of their menstrual phases, (b) do stress and self-perceived health have a greater impact on well-being than the menstrual cycle, (c) does cycle-related physical discomfort have an influence on well-being? METHODS: The study surveyed 37 women aged 19–38 years. Participants were prospectively assessed on well-being, health status, stress and cycle-related discomfort using mobile digital assistants. Self-assessment was applied three times a day over a time span of 35 days, resulting in 37 complete menstrual cycles based on 3.885 measurements for analysis. Multilevel analyses using STATA were conducted to capture the research questions. RESULTS: As opposed to expectancies frequently mentioned by lay persons and mass media, there was no significant relationship between well-being and the menstrual phases of the participants. Selfperceived health and stress were stronger predictors for well-being than the menstrual cycle. Cycle-related physical discomfort significantly affected well-being. CONCLUSIONS: Our results are in accordance with those from the systematic review. Ambulatory Assessment has proved to be an efficient method to collect data during the menstrual cycle, yet it has been used in very few cycle studies so far. Further research on well-being and the menstrual cycle is needed. Additional factors of influence should receive more attention.

(3020) Health-related quality of life among patients with chronic constipation in a commercially insured sample of united states adults Qian Cai, HealthCore Inc; Jessica Buono, Forest Laboratories, Jersey City, NJ, United States; William M. Spalding, Ironwood Pharmaceuticals; Judith J. Stephenson, HealthCore Inc, Wilmington, DE, United States; Hiangkiat Tan, HealthCore Inc; Robyn Carson, MPH, Forest Research Institute, Jersey City, NJ, United States; Jalpa A. Doshi, University of Pennsylvania AIMS: Chronic constipation (CC) is a common functional gastrointestinal disorder affecting approximately 15 % of the North American population. However, little is known about its impact on healthrelated quality of life (HRQOL) in the general population. This study aimed to assess general and disease-specific HRQOL among a sample

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168 of US commercially insured patients with CC. METHODS: Patients aged = 18 years with continuous medical and pharmacy benefit eligibility (03/01/2011–02/28/2013) were identified from the HealthCore Integrated Research Database. CC patients had = 2 medical claims for constipation (ICD-9-CM 564.0x) occurring = 90 days apart or = 1 medical claim for constipation plus = 1 constipation-related pharmacy claim occurring = 90 days apart. Patients with potentially confounding diseases were excluded. Consenting patients completed a 30-min survey via telephone or Internet in which they were administered modified Rome III criteria to confirm CC diagnoses. Only patients who met both claims and Rome criteria completed the full survey. General HRQOL was measured by the Short Form-12 version 2 (SF-12v2) and EuroQol-5D (EQ-5D; phone interview only). SF-12v2 includes physical component summary (PCS) and mental component summary (MCS) scores, ranging from 0 to 100 (US normative mean = 50); EQ-5D utility scores range from 0 = death to 1 = perfect health. Higher scores on both measures indicate better HRQOL. Disease-specific HRQOL was measured by the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire comprised of overall and 4 subscales scores (Physical Discomfort; Dissatisfaction; Worries/Concern; and Psychosocial Discomfort) each ranging from 0 to 4; higher scores indicate lower constipation-related HRQOL. RESULTS: A total of 125 CC patients completed the survey (mean age: 47 ±14 years; 86.4 % female). Mean (±SD) PCS and MCS scores were 45.5 (±13.0) and 47.8 (±11.5), respectively. EQ-5D mean (±SD) utility score for those completing the telephone interview (n = 62) was 0.7 (±0.2). The PAC-QOL mean (±SD) overall score was 1.37 (±0.62). Subscale scores ranged from 1.05 (±0.87) for the psychosocial subscale to 1.61 (±0.99) for the physical discomfort subscale. CONCLUSIONS: Patients with CC report lower HRQOL, as assessed by certain HRQOL measures, including SF-12v2 summary scores, which are lower than US general population norms. Future research is needed to evaluate the impact of CC treatment on HRQOL.

Mental Health (3022) Resilience in couples facing a psychiatric disorder acts as a protective factor against psychological distress and impaired quality of life Marco Pereira, Universidade de Coimbra, Coimbra, Portugal; Stephanie Alves, Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal; Sara Rodrigues, Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal; Catarina Janeiro, Faculty of Psychology, University of Lisbon, Portugal; Isabel Narciso, Faculty of Psychology, University of Lisbon, Portugal; Maria C. Canavarro, Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal; Frank M. Dattilio, Harvard Medical School, Boston, MA, United States AIMS: Research has supported the importance of resilience and its clinical significance in the context of psychiatric disorders. However, few studies have examined the resilience characteristics of both members of a relationship simultaneously as well as its relation to psychological distress and quality of life (QOL). The aim of this study was to examine the resilience characteristics of patients and their spouses diagnosed with psychiatric disorders. The association between resilience characteristics and patient and partner’s psychological distress and quality of life was also a point of investigation. METHODS: The sample consisted of 56 couples (n = 112), in which one member has been diagnosed with a psychiatric disorder (clinical group), and 56 couples (n = 112) from the general population who have no psychiatric diagnosis. Participants completed measures assessing resilience (Resilience Scale for Adults), psychological distress (Brief Symptom Inventory) and quality of life

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Qual Life Res (2014) 23:1–184 (EUROHIS-QOL 8-item index). RESULTS: Couples from the clinical group presented with lower levels of QOL, F(2, 105) = 24.99, p \ 0.001, and higher levels of depressive and anxiety symptoms, Wilks’ Lambda = 0.53, F(2, 104) = 19.11, p \ 0.001, compared to couples from the general population. Couples from the clinical group also demonstrated lower scores on all resilience dimensions, Wilks’ Lambda = 0.68, F(4,103) = 5.52, p \ 0.001. Overall, resilience characteristics were significantly associated with lower psychological distress and higher QOL. Among the clinical group, partner’s resilience characteristics were associated with patient’s lower psychological distress and greater QOL, particularly when the male spouse was the identified patient. CONCLUSIONS: For couples facing a psychiatric disorder, resilience can be considered as a protective factor against psychological distress and impaired quality of life. When delivering psychological interventions for couples, special attention should also be assigned to resilience characteristics as a resource to couples for improving their mental health as well as their overall quality of life.

(3024) Using the random forest method to detect a response shift in the quality of life of patients suffering from schizophrenia: a cohort study Mohamed Boucekine, Self-Perceived Health Assessment Research Unit, Marseille, France; Anderson Loundou, EA3279, Self-Perceived Health Assessment Research Unit, Marseille, France; Badih Ghattas, Faculte´ Des Sciences de Luminy, Marseille, France; Pierre Michel, Aix Marseille Universite´, Marseille, France; Patricia Minaya Flores, MA, Laboratoire de Sante Publique EA3279, Marseille, France; Karine Baumstarck, Faculte´ de Me´decine, AMU, Marseille, France; Pascal Auquier, Public Health Department, University Hospital of Marseille, France; Laurent Boyer, PhD, Aix-Marseille University, Marseille, France; Mondher Toumi, MD, Lundbeck SA, Paris, France AIMS: Interpretation of quality of life (QOL) scores over time can be difficult due to possible changes of internal standards, values and conceptualization of QOL by individuals. This phenomenon is called response shift (RS). The purpose of this study was to examine whether a RS phenomenon occurs in patients suffering from schizophrenia over a 24-month period. METHODS: The random forest method was applied to detect RS reprioritisation (i.e., a change in the importance attributed to component domains constituting QOL) from a multicentre cohort study. QOL was recorded using a generic questionnaire (SF36) at baseline (T0), 12 months (T12), and 24 months (T24). We estimated the average variable importance (AVI) of the QOL dimension according to 3 clinical profiles of patients (‘stable’, ‘improved’, and ‘worsened’ groups). RESULTS: A total of 124 (53.2 %) patients were defined as ‘stable’, 59 (25.3 %) as ‘improved’, and 50 (21.5 %) as ‘worsened’. The AVI of the ‘social functioning’ dimension became more important over time for the ‘stable’ group. The AVI of the ‘mental health’ dimension increased over time for the ‘improved’ group and decreased for the ‘worsened’ group. While ‘vitality’ dimension was more important than ‘mental health’ at T0, the relation was inverted at T24 in the ‘improved’ group. The AVI of the physical dimensions were globally stable over time in the 3 groups, except for the ‘bodily pain’ dimension, which increased in the ‘worsened’ group. CONCLUSIONS: These findings suggest that there is a change in the way patients are using the outcome scales overtime. Thus, patients may be using tools differently as function of treatment effect at reduce symptoms burden. Thus, the theory underlying the QOL measurement model would need to accommodate and consider response shift effects when estimating change over time as well as measurement tool responsiveness (Fig. 1).

Qual Life Res (2014) 23:1–184

169 Society of Quality of Life Research, Kobe, Japan; Takashi Mandai, MD PhD, Japanese Society of Quality of Life Research, Kobe, Japan

Fig. 1 . (3026) Literature Review of the Psychometric Properties of the Edinburgh Postnatal Depression Scale (EPDS) Rachel M. Wiens, Trinity Western University; Hillary L. McBride, Trinity Western University; Marvin J. McDonald, Trinity Western University; Daniel W. Cox, University of British Columbia, Vancouver, BC, Canada; Eric K. H. Chan, PhD, Trinity Western University, Langley, BC, Canada AIMS: Globally, the prevalence of women suffering from postpartum depression (PPD) is high. The Edinburgh Postnatal Depression Scale (EPDS; Cox et al. 1987) is a widely used psychometric instrument for assessing PPD. The objectives of this literature review were twofold: 1) to review the psychometric properties of the EPDS and 2) to examine the extent to which its psychometric evidence is aligned with contemporary views of validity (i.e., the work of Messick, Kane, and Zumbo, etc.). METHODS: A systematic search of articles was conducted using the following databases: Academic Search Premier, America: History & Life, Biomedical Reference Collection, CINAHL, Communication & Mass Media, eBook Academic Collection, eBook Collection, E-Journals, ERIC, Funk & Wagnalls New World Encyclopedia, GreenFILE, Information Science & Technology, MAS Ultra, MEDLINE, Military & Government Collection, MLA Directory, Primary Search, PsychINFO, PsychBooks, Google Scholar, and Sage Publication. Search terms included ‘‘Edinburgh Postnatal Depression Scale AND measurement OR psychometric OR psychometrics OR validity OR validation OR valid OR reliability OR Postpartum Depression’’ and searched titles, abstracts, and complete articles. Inclusion criteria included: Empirical psychometric studies, English language articles, postpartum women samples, and publication since the development of the scale in 1987. A coding form was developed and each article was independently coded by two of the authors to ensure accuracy. RESULTS: A total of 57 articles met our inclusion criteria and were included in this review. Internal consistency, test–retest, and split-half reliability were demonstrated, as was evidence on its content. Validity analyses revealed that the EPDS scores correlated well with a number of instruments, such as the Beck Depression Inventory (BDI), Patient Health Questionnaire (PHQ-9), General Health Questionnaire (GHQ˚ sberg Depression Rating Scale (MADRS). 12), and Montgomery-A Factor analyses supported undimensionality and multidimensionality. The instrument also showed good sensitivity and specificity. CONCLUSIONS: The EPDS possesses strong reliability and validity. However, certain sources of psychometric evidence are lacking and validation practices are not aligned with contemporary views of psychometric validity. Response processes and consequences are examples of the additional sources of validity evidence needed to strengthen the interpretation and use of EPDS scores. (3028) Quality of Life (QOL) Questionnaire for Schoolchildren (Part 2) Michiko Kobayashi, MD, Japanese Society of Quality of Life Research, Kobe, Japan; Minako Chibu, Saiseikai Nagasaki Hospital, Nagasaki City, Nagasaki, Japan; Michiko Kobayashi, MD, Japanese

AIMS: The purpose of this study was to develop a desirable original QOL questionnaire for schoolchildren. METHODS: Fifty-eight schoolchildren over 10 years of age participated in this study. The former QOL questionnaire completed in 2009 (30 questions divided into seven categories) had a sufficient reliability and potency of validity to use for schoolchildren. We have used an original, self-administered this questionnaire this time. RESULTS: The Cronbach’s alpha coefficients of our questionnaire were sufficient to accept for clinical use for schoolchildren over 10 years of age: 0.87 in consciousness of the other gender, 0.75 in family interaction, 0.71 in school life etc., respectively. In the former study, the Cronbach’s alpha coefficients of our questionnaire were sufficient to accept for clinical use for schoolchildren: 0.89 in consciousness of the other gender, 0.79 in family interaction, 0.75 in daily activities etc., respectively. Our questionnaire contains nine main factors which matched the seven categories precisely in this study. Its cumulative contribution was 0.64. There were significant positive correlations between school life and daily activities (r = 0.50, p \ 0.01), school life and self-evaluation (r = 0.50, p \ 0.01), family interaction and self-evaluation (r = 0.54, p \ 0.01) etc., respectively. There was a significantly higher level of QOL (in self-evaluation) in children who had less than 4 family members, as compared with children who had more than 5 family members (p \ 0.05). And there was a significantly higher level of QOL in children who didn’t have older brothers, as compared with children who had older brothers (p \ 0.05). There was a significantly higher level of QOL in daily activities (p \ 0.01) of boys as compared with girls. CONCLUSIONS: These findings indicate that our original QOL questionnaire has a sufficient reliability and potency of validity to use for schoolchildren. The most important point of this study is intimacy with family for schoolchildren. We think it’s important for schoolchildren to have a good environment (family life and school life), since the attitude of parents and siblings will have a positive effect on their child’s development. In the future, we must pay more attention to many kinds of problems that exist between children and their families at the various developmental stages of children. (3030) Quality of life in a community sample of young cocaine and/or heroin users: the role of mental disorders Antonia Domingo-Salvany, PhD, IMIM, Barcelona, Spain; Marcela Chahua, Escuela Nacional de Sanidad,. Instituto de Salud Carlos III., Madrid, Spain.; Albert Sa´nchez-Niubo`, IMIM; Marta Torrens, Hospital Del Mar Medical Research Institute, Barcelona, Spain; Luis Sordo, Centro Nacional de Epidemiologı´a, Instituto de Salud Carlos III, Madrid, Spain; M Jose´ Bravo, Centro Nacional de Epidemiologı´a, Instituto de Salud Carlos III, Madrid, Spain; M Teresa Brugal, Age`ncia de Salut Publica de Barcelona, Barcelona, Spain AIMS: Drug addiction and psychiatric disorders are frequently concomitant; together and separately they entail an important health burden. However, few studies have investigated the impact of psychiatric disorders other than substance use disorder (SUD) on the Health-Related Quality of Life (HRQOL) in drug users. We studied the association of psychiatric disorders other than SUD with HRQOL in a community sample of cocaine and/or heroin users. METHODS: Cross-sectional study in 287 young users (18–30 years) of cocaine and/or heroin recruited between 2001 and 2006 in Barcelona, Spain. HRQOL was assessed with the Nottingham Health Profile (NHP)(score range: 0, best-100, worse). Independent variables tested were socio-demographic, patterns of drug use and mental disorders which were assessed using the Spanish version of the Psychiatric Research Interview for Substance and Mental Disorders-IV (PRISM);

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170 and degree of dependence which was ascertained through the Severity of Dependence Scale (SDS). Bivariate analyses were done, and as NHP scores had a remarkable ceiling effect, the association of mental disorders with HRQOL, controlling for factors relevant in bivariate analyses, was assessed through a Tobit regression. RESULTS: The overall NHP score was 23.9 (SD = 20.5, range 0 to 91.7). Sixty-one percent of the sample had two or more SUDs; 22 % had at least one non-SUD Axis I disorder (anxiety, mood, psychotic and eating disorders) and 27.2 % had a Borderline or Antisocial Personality Disorder (BPD or APD). The Tobit regression model showed that the variables negatively associated with the global NHP score were psychosis (transformed beta coefficient: 13.93; 95 % CI 3.08–24.78), BPD (9.56; 95 % CI 2.97–16.14), severity of dependence (1.66; 95 % CI 0.89–2.42), having two or more SUDs (for two or three SUDs: 5.68; 95 % CI 0.88–10.47) (for four or more SUDs: 7.23; 95 % CI 1.26–13.21) and the intravenous use of some substance (5.97; 95 % CI 1.27–10.67). CONCLUSIONS: In illegal substance users in the community, HRQOL is not evenly distributed, with psychiatric comorbidity, especially psychosis and Borderline Personality Disorder, being particularly significant. These findings underscore the need to undertake integrated mental health programs in this population. Work supported by grants from DIUE de la Generalitat de Catalunya (2009 SGR 718); FIPSE (486 3035/99), Plan Nacional Sobre Drogas (PNSD-2001 and 2004) and RTA (RD12/0028/0018 and RD12/0028/0009).

Plumonary (3040) Using the Three Step Test Interview to understand How the SGRQ-C Is Interpreted by COPD Patients Muirne CS Paap, University of Twente, Enschede, Netherlands; Christina Bode, University of Twente; Lukas Lange, University of Twente; Job van der Palen, Medisch Spectrum Twente AIMS: The St George’s Respiratory Questionnaire (SGRQ) has acquired the status of legacy questionnaire for measuring HRQOL in patients with chronic obstructive pulmonary disease (COPD). In a recent study, we assessed several aspects of the validity of the SGRQ by using advanced psychometric methods; we investigated the underlying dimensionality of the SGRQ using IRT and bifactor analysis, and investigated the added value of the empirical weights used to calculate total scores. In this study, we continue assessing the validity of the SGRQ, but this time from a qualitative angle; the main objective of this study is to assess the experiences of COPD patients while completing the SGRQ-C. METHODS: Twenty patients with COPD were recruited by pulmonary physicians in Enschede, the Netherlands (13 women; mean age = 63.25 years (SD = 11.37)). A trained interviewer applied the Three Step Test Interview which encompasses three steps: concurrent thinking aloud (the interviewer merely observes), a retrospective interview to fill gaps in the observational data, and a semi-structured interview (the respondent is encouraged to add more data and explain their response behavior). These techniques allow the interviewer to gain understanding of the thought process or decision making of someone filling out the SGRQ-C. The official Dutch translation of the SGRQ-C was used. RESULTS: Respondents experienced minor problems with the interpretation of some items. For example, they missed a recall period for the first set of items (symptoms subscale). They were uncertain how to interpret specific words like ‘physical exercise’, ‘good days’, ‘hill’, ‘games’, and ‘housework’; moreover, patients were confused by long item stems that included a list of activities. With respect to response format, they were frustrated by the dichotomous format used for the majority of SGRQ items (true/false). CONCLUSIONS: Overall, respondents were satisfied with the SGRQ-C. Nevertheless, we recommend making some

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Qual Life Res (2014) 23:1–184 adjustments. This includes re-introducing a recall period in the first set of items such as used in the previous version, changing certain formulations to avoid confusion, and splitting up items consisting of multiple activities. Furthermore, we recommend using a fixed response format (4 or 5 response categories) for all items.

Children (3044) Correlates of cross-sectional and longitudinal healthrelated quality of life among children with autism spectrum disorders Karen a. Kuhlthau, PhD, Center for Child and Adolescent Health Research and Policy, Boston, MA, United States; Erin McDonnell, Massachusetts General Hospital; Daniel Coury, Nationwide Children’s Hospital; Eric Macklin, Massachusetts General Hospital AIMS: We seek to understand the characteristics of children with autism spectrum disorders (ASD) associated with baseline and longitudinal change in health-related quality of life (HRQOL). METHODS: We examined the PedsQL total scores for 6012children enrolled in the Autism Speaks—Autism Treatment Network (ASATN) followed for an average of 0.7 (range 0 to 4) years. We used longitudinal structural mean models to identify socio-demographic and ASD-related characteristics associated with HRQOL at enrollment and predictive of change in HRQOL over time. ASD-related characteristics included ADOS severity score, IQ, child behavior checklist (CBCL) total score, children’s sleep habits questionnaire (CSHQ), aberrant behavior checklist (ABC) subscale scores, diagnosis (autism, PDDNOS, and Aspergers), and gastrointestinal problems (by type). We adjusted for potentially informative loss to follow-up using inverse-probability weights estimated from the same predictors. RESULTS: Our sample at baseline was 6.3 ± 3.5 years old (range 2 to 18 years), 84 % male, 80 % Caucasian, 54 % covered by private insurance, and 59 % with an income of $50,000 or higher. Average ADOS severity score was 7.1 and average full-scale IQ was 78. Mean PedsQL score at baseline was 65.1 (Range = 44.4–100). In univariate models, age, race, diagnosis, IQ, CBCL internalizing and externalizing scores, and the ABC irritability subscore were associated with differences both at baseline and over time. PedsQL scores differed at baseline by gender, year of enrollment, number of parents in the household, household income, type of insurance, CSHQ, and GI symptoms; but these did not predict different HRQOL trajectories over time. In a multivariate model, age was associated with lower HRQOL at baseline (beta = -1.31, p \ 0.0001), but increasing HRQOL over time (beta = 0.39, p \ 0.0001). Higher CBCL internalizing scores were associated with lower baseline HRQOL (beta = -7.5, p \ 0.0001), but not with changes over time. Higher IQ was associated with both higher HRQOL at baseline (beta = 0.02, p = 0.0489) and increasing HRQOL over time (beta = 0.03, p = 0.0025). CONCLUSIONS: A number of child and family features are associated with differential HRQOL in autism when children are first seen at tertiary care sites, consistent with prior cross-sectional analyses, but these data suggest that most of those differences diminish over time.

(3046) Distress in parents of a child with down syndrome Hedy a. van Oers, MSc, Emma Children’s Hospital/Academic Medical Center, Amsterdam, Netherlands; Jan Pieter Marchal, Academic Medical Center/Emma Children’s Hospital, Amsterdam, Netherlands; Lotte Haverman, PhD, Emma Children’s Hospital— Academic Medical Centre, Amsterdam, Netherlands; Heleen Maurice-Stam, MSc, Emma’s Children’s Hosp, Academic Medical Center, Amsterdam, Netherlands; Paul aS van Trotsenburg, Academic

Qual Life Res (2014) 23:1–184 Medical Center/Emma Children’s Hospital, Amsterdam, Netherlands; Martha Grootenhuis, PhD, Academic Medical Center, Amsterdam, Netherlands AIMS: Parents of children with Down syndrome may experience a burden of care and psychosocial problems. We aimed to describe the levels of distress in these parents and to examine which problems were associated with parental distress. METHODS: Parental distress was assessed cross-sectionally using the Distress Thermometer for Parents (DT-P). The DT-P assesses overall distress experienced in the past week using a thermometer-score ranging from 0 to 10 (0 = no distress, 10 = extreme distress). It further assesses problems across six domains: practical, social, emotional, physical, cognitive and parenting. Finally, it contains questions about social support and wish for referral. We described mothers and fathers separately. Descriptive statistics and logistic regression analyses were used. The latter was not performed in fathers due to a limited sample size. RESULTS: Parents (76 mothers, 44 fathers) of 86 children (aged 11.5–13.7 years) participated. Mean thermometer-score was 3.7 (SD 2.8) for mothers and 3.2 (SD 2.7) for fathers. 46 % of mothers and 36 % of fathers reported clinical distress (thermometer-score = 4). 19 mothers (25 %) and 8 fathers (18 %) experienced a lack of social support. Further, 16 mothers (21 %) and 13 fathers (30 %) indicated to (maybe) want to talk to a professional about their situation. Most frequently reported problems by mothers were fatigue (62 %), sleep (41 %) and their child’s independence (39 %). Fathers most frequently reported problems with fatigue (41 %), depression (39 %) and sleep (34 %). Logistic regression in mothers showed that a clinical distress score was best predicted by the emotional domain score (OR 2.12, 95 % CI 1.27–3.56) and the age of the child (4.68, 95 % CI 1.13–19.36). CONCLUSIONS: Almost half of all parents reported clinical levels of distress. Systematic screening of parents of children with Down syndrome to detect problems at an early stage seems relevant.

(3048) Quality of life of children and adolescents with chronic kidney failure undergoing hemodialysis: construction of the Specific DISABKIDSÒ Module Isabella S. Abreu, Universidade de Sa˜o Paulo, Ribeira˜o Preto, Brazil; Maria Fernanda Cabral Kourrouski, University of Sa˜o Paulo, Ribeira˜o Preto, Brazil; Lucila Castanheira Nascimento, University of Sa˜o Paulo, Sa˜o Paulo, Brazil; Regina Aparecida Garcia de Lima, University of Sa˜o Paulo; Monika Bullinger, PhD, Inst for Medical Psychology, Hamburg Univ., Hamburg, Germany; Claudia Benedita Dos Santos, PhD, MISP-EERP-USP, Ribeira˜o Preto, Brazil AIMS: This study aimed at constructing an HRQOL measuring instrument for Brazilian children and adolescents with CKF undergoing hemodialysis. METHODS: This research is a methodological study aimed at constructing an HRQOL measuring instrument for Brazilian children and adolescents with CKF undergoing hemodialysis. The construction process of this instrument was based on the method developed by the European DISABKIDS group, which develops HRQOL measuring instruments for children and adolescents with CC. The 21 components of the instrument under construction were elaborated according to the dimensions of the DISABKIDS37 instrument, based on the relevant aspects identified through focal groups held with children and adolescents and their parents or caregivers and interviews with experts, and were analyzed by means of the thematic content analysis techniques, using the software MaxQDA for support. Next, the items were submitted to content and semantic validation. RESULTS: After the validation phase, the instrument under construction can serve as a valuable and reliable tool to measure the HRQOL of children and adolescents with CKF undergoing hemodialysis. CONCLUSIONS: Hence, the concepts and dimensions

171 addressed in this study and used to construct the Specific DISABKIDS Module for children and adolescents with CKF undergoing hemodialysis need to be considered in the elaboration and planning of actions focused on child and adolescent chronic kidney patients.

(3050) Problems in psychosocial functioning in the opinion of students with chronic conditions and their parents Agnieszka Malkowska-Szkutnik, PhD, Institute of Mother and Child, Warsaw, Poland; Joanna T. Mazur, PhD, National Research Inst. of Mother and Child, Warsaw, Poland AIMS: The aim of the study was to define social functioning problems among children with chronic conditions. Two points of view were used— those of the children and their parents. METHODS: The following research problems were defined: a) What are the most important problems in the social functioning among children with chronic conditions?; b) What are the most important ways of coping with these problems; c) Are there differences between the main social functioning problems in the perception of children and parents?; d) Are there differences between the means indexes of DISABKIDS questionnaires between: children and parents?; The study covered 300 students aged 10–18 with chronic conditions (asthma, arthritis, dermatitis, diabetes, cerebral palsy, epilepsy) and their parents. The study was conducted in 2012, within the framework of the Mother and Child Institute research project. The DISABKIDS chronic generic module (DCGM-37) and specific modules were used. The DCGM-37 consists of 37 Likert-scaled items assigned to six dimensions: independence, emotion, social inclusion, social exclusion, limitation, treatment. Additionally children and parents answered two questions about: 1) the most important problems arising from chronic conditions 2) ways of coping with these problems. Parents answered from the children’s perspective. RESULTS: Mean indexes of the DCGM-37 were measured. The evaluation of parents turned out to be worse than the children’s in the dimensions of: emotion, social inclusion, social exclusion and special limitations. The areas in which children with chronic conditions have social functioning problems were defined. The most important ones were: relations with parents, peer relations, coping with school duties, relationships with teachers. The differences between the perceptions of the main social functioning problems between children and parents were found. Differences in perceiving the ways of coping with the problems were also identified. It is most important for students to improve relationships with peers, while for parents macro system changes are essential. CONCLUSIONS: Specifying problem areas in psychosocial functioning for students with chronic conditions makes it possible to diagnose the needs of this group and improve cooperation between schools, medical service and families.

(3052) Development of a specific module of the DISABKIDSÒ to measure the health-related quality of life of children and adolescents living with HIV/AIDS Claudia Benedita dos Santos, PhD, MISP-EERP-USP, Ribeira˜o Preto, Brazil; Maria Fernanda Cabral Kourrouski, University of Sa˜o Paulo, Ribeira˜o Preto, Brazil; Monika Bullinger, PhD, Inst for Medical Psychology, Hamburg Univ., Hamburg, Germany; Neuza Collet, Universidade Federal da Paraı´ba; Keila C. Deon, PhD, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; Lucila Castanheira Nascimento, University of Sa˜o Paulo, Sa˜o Paulo, Brazil; Ana Carolina Gomes Martins Oliveira, University of Sa˜o Paulo; Roberta A. Reis, PhD, Universidade Federal do Rio Grande do Sul, Porto Alegre/RS, Brazil; Regina Aparecida Garcia de Lima, University of Sa˜o Paulo AIMS: To construct the specific module of DISABKIDS to measure Health-Related Quality of Life for Brazilian children and adolescents

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172 living with HIV. METHODS: Instrument development was based on the methodology proposed by the European DISABKIDS group, following the steps of the literature review; interviews with health professionals; focal groups with children, adolescents and their parents or caregivers; and elaboration of items. Participants were 11 health professionals, six children and their parents or caregivers, and 12 adolescents with their parents or caregivers. Children and adolescents were recruited from the Special Unit of Infectious Diseases of a teaching hospital, located in the state of Sa˜o Paulo. Data were analyzed using the MaxQDA software and were submitted to the thematic content analysis. Results were organized based on the domains of the quality of life proposed by Worldwide Health Organization (mental, social and physical) and the dimensions established by DISABKIDS Group. RESULTS: From the experience of health professionals caring for this population and from the experiences of children and adolescents with HIV and their parents or caregivers, we observed that the domains of quality of life were affected, in particular the emotional and social, more specifically as it regards to the need of the diagnostic secrecy, non-acceptance of the disease, feeling different from peers and mainly to the stigma and discrimination. We also observed the importance of treatment in these people’s lives, or by the need for medication adherence, which includes rigid schedules, reminding them of their HIV serostatus, or by the importance of that therapy has in health maintenance. Based on empirical data it was built HRQOL instrument consisting of 15 items, divided into dimension impact, with nine items, and dimension treatment, with six items. CONCLUSIONS: The assessment of HRQOL is essential for the best management of children and teenagers with HIV and it is indispensable a specific instrument of HRQOL developed based on their own perspectives.

(3054) Maternal well-being, stress and symptoms of depression in new mothers in the context of counseling Julia Hannah Quitmann, University Medical Center HamburgEppendorf, 20246 Hamburg, Germany; Anja Rohenkohl, University Medical Center Hamburg-Eppendorf, Department of Medical Psychology; Dagmar Brandi, Von Anfang an E.V.; Monika Bullinger, PhD, Inst for Medical Psychology, Hamburg Univ., Hamburg, Germany AIMS: The transition to motherhood portrays an incisive life event, which includes a variety of stress factors and impairments in maternal wellbeing. Still so far only very few studies focus on HRQOL in the transition to motherhood. The presented study tries to fill this gap. METHODS: All mothers who came to a counseling office in Hamburg were asked to give information about their condition and their ability to function as a mother in the context of counseling. Before (T0) and again right after (T1) and three months after (T2) counseling, 198 mothers filled out several questionnaires concerning their HRQOL (SF-8) as well as Depression (BDI) and Parenting Stress (PSI). RESULTS: The results of the examinations document the relation between the subjective maternal degree of stress and the child’s age, at the start and during consultations at the counseling office in Hamburg, Germany. Results show a negative connection between the subjective level of stress and HRQOL reported by the participating first time mothers. As expected the self-reported HRQOL of young mothers increased while maternal stress decreased significantly. CONCLUSIONS: On the basis of these findings, family, community and public counseling and intervention services need to be further included and developed to assist and support young parents and esp. affected mothers and to help building a steady and secure parent–child relationships. The present study contributes to our current understanding of maternal wellbeing in new mom’s.

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Qual Life Res (2014) 23:1–184 Population Health (3056) Quality of life of globally mobile employees: what harms, what helps and what is the role of accompanying partners? Herbert Fliege, PhD, Health Service, Federal Foreign Office of Germany, Berlin, Germany; Heiko Ru¨ger, Federal Institute for Population Research, Wiesbaden, Germany; Stine Waibel, Federal Institute for Population Research, Wiesbaden, Germany; Silvia Ruppenthal, Federal Institute for Population Research, Wiesbaden, Germany; Maria M. Bellinger, Federal Foreign Office, Berlin, Germany AIMS: International work assignments put a strain on employees’ health-related quality of life. Although Foreign Service staff is particularly exposed to global mobility, it is unclear if and how recurrent diplomatic relocations compromise QOL. This study investigates whether diplomats’ QOL, reconcilability of work and family life and their partnership satisfaction are affected by the exposure to international relocation mobility. Potential risk factors are the number of postings abroad, perceived stress, and employees’ attitudes towards working and living in diplomatic rotation. Potentially protective factors include cognitive coping, internal control beliefs, self-efficacy, preoccupation with the host country’s culture, and social support. As a key aspect, we take the accompanying partners’ perspective into account and investigate cross-over effects from partners’ evaluations on employees’ QOL. METHODS: A sample of N = 2.433 active diplomats in the German Foreign Service were surveyed online using standardized self-rated questionnaires. Corresponding assessments were obtained from N = 321 accompanying partners. QOL was assessed with scales from the EORTC’s QLQ-C30. RESULTS: Perceived stress had negative effects on all outcomes. However, contrary to expectations exposure to relocation mobility had no predictive value. A more negative perception of the disadvantages of global relocation mobility had negative effects. Cognitive coping, self-efficacy and social support had several positive effects on the outcomes. Additionally, cognitive coping moderated the negative effect of perceiving disadvantages of diplomatic rotation on QOL and social support moderated the negative effect of stress on partnership satisfaction. Cross-over effects revealed that accompanying partners’ stress levels and their attitudes towards living in diplomatic rotation are among the significant determinants of expatriates’ QOL outcomes. CONCLUSIONS: Examining this highly mobile group contributes to the understanding of QOL challenges for global workers. Implications are drawn for international human resource management and health promotion. Employer’s prevention strategies should include the perspective of the partners.

(3058) Effects of private insurance mandates on racial disparities in health and family outcomes for children with autism Pratik Doshi, Arkansas Children’s Hospital; Nalin Payakachat, BPharm, MS, PhD, University of Arkansas for Med Sciences, Little Rock, AR, United States; Dennis Kuo, University of Arkansas for Medical Sciences; Songthip Ounpraseuth, University of Arkansas for Medical Sciences; J. Mick Tilford, PhD, University of Arkansas for Medical Sciences, Little Rock, AR, United States AIMS: Few studies have examined racial disparities in the provision of services for children with autism. Racial disparities could be influenced by recent mandates requiring states to provide coverage for autism-related health care services. This study aimed to evaluate whether state private insurance mandates affected racial disparities in health and family economic outcomes for children with autism. METHODS: This study utilized two waves of data (2005/06 and 2009/10) from the National Survey of Children with Special Health Care Needs (NS-CSHCN). Children with a current parent-reported

Qual Life Res (2014) 23:1–184 diagnosis of autism were included in the analytical sample. The two waves were combined to permit a difference in difference analysis. Children and families from 15 states without a private insurance mandate in the first wave that implemented a private insurance mandate in the second wave, served as the treatment sample. The control sample came from 32 states that did not have a private insurance mandate in either wave. We excluded 4 states (CA, GA, IN, MD) that had the private insurance mandate in both waves from the analysis. Main study measures included 3 care quality indicators, 4 family economic measures, and 2 child health outcomes. A difference-in-difference-in-difference (DDD) approach was employed to assess the impact of the private insurance mandate on racial disparities between White and non-White children with autism. RESULTS: 1,414 children with autism were in the treatment group and 2,966 were in the comparison group. The average age of the affected children in both groups was 11 years old. The percentage of nonWhite children with autism was higher in the treatment group than the comparison group (26 % vs. 22 %). White families reported having better access to family- centered care (54.1 % vs. 40.2 %; p \ 0.001) and more coordinated care (27.6 % vs. 20.1 %; p = 0.0060. However, family economic outcomes tended to be worse for white families relative to non-white families. Estimates from the DDD model do not support private insurance mandates having any significant effect on non-White/White disparities in any family economic or child outcome measure. The point estimate for child unmet health care needs indicated a reduction in disparities for non-whites relative to whites, but failed to reach conventional levels of significance (p = 0.1). CONCLUSIONS: This study does not find strong evidence that state private insurance mandates affect racial disparities in outcomes for children with autism and their families. Mandates often do not influence the coverage decisions of larger companies, thus many families likely remain unaffected by such policies.

(3060) Validation of the General Oral Health Assessment (GOHAI) Index into Japanese adults Mariko Naito, DDS, PhD, Nagoya University Graduate School of Medicine, Nagoya, Japan; Yoshimi Suzukamo, PhD, Tohoku University, Sendai, Japan; Shino Suma, Nagoya University, Nagoya, Japan; Sayo Kawai, Nagoya University, Nagoya, Japan; Rieko Okada, Nagoya University, Nagoya, Japan; Asahi Hishida, Nagoya University Graduate School of Medicine, Nagoya, Japan; Emi Morita, Nagoya University, Nagoya, Japan; Nobuyuki Hamajima, Nagoya University, Nagoya, Japan; Kenji Wakai, Nagoya University Graduate School of Medicine, Nagoya, Japan AIMS: The General Oral Health Assessment Index (GOHAI), developed by Drs. K. Atchison and T. Dolan in the United States, is a self-reported, 12-item questionnaire used to assess the impact of the oral health status on quality of life (QOL). This questionnaire was initially designed to assess the oral health of older adults, but it has recently been used in populations of all ages. It has also been translated into languages other than English and used in many studies. A validation study of the Japanese version for the elderly population was conducted in 2004 (Naito et al., J Public Health Dent. 2006). Since then, this questionnaire has provided essential research findings regarding oral health-related QOL. The aim of the present study was to assess the psychometric properties of this version for Japanese adults of all ages. METHODS: The psychometric properties of the GOHAI were assessed among 4658 subjects in the community. We used baseline data of the Shizuoka area from the Japan Multi-Institutional Collaborative Cohort Study (http://www.jmicc.com/). In total, 3,164 males and 1,494 females were analyzed (age [mean ± standard deviation], 52 ± 9 years; range, 35–69 years). The self-administered questionnaire included

173 the GOHAI and the General Health Questionnaire (GHQ), which was used to measure the subjects’ mental health status. Information was also collected on each subject’s oral health status. RESULTS: All items had a response rate of [ 99 %. Exploratory factor analysis using varimax rotation identified two principle components that determined QOL at 56 % variance. Cronbach’s alpha was computed to assess the reliability of internal consistency; the alpha value was 0.89 for all 12 items. The alpha coefficient was 0.82 for the Physical subscale and 0.82 for the Psychological, Social, and Pain/Discomfort subscale. Item-scale correlations varied from 0.53 to 0.77. There was a statistically significant correlation between the GOHAI and the number of missing teeth (p \ 0.05). The GOHAI was inversely associated with GHQ questionnaire scores (p \ 0.001). CONCLUSIONS: The present study has shown that the Japanese version of the GOHAI is psychometrically valid and conceptually equivalent in Japanese adults.

(3062) A Proposal to improve Health-Related Quality of Life in the population of Aguachica (Colombia) Ethman a. Torres, MBA, Universidad Santo Tomas, Floridablanca, Colombia; Davyanis Vargas, Universidad Santo Tomas, Floridablanca, Colombia AIMS: To design a proposal for improving Health-related Quality of Life (HRQOL) in a population of Aguachica (Colombia) based on an objective diagnosis and perception of the healthcare system. METHODS: A descriptive observational study was done. Indicators recommended by the Pan American Health Organization were analyzed and 12-item from the short version of the SF-36 were filled out by 600 people to look for the HRQOL perception. In order to make the proposal public, health workshops and discussions with health service companies and the city council were performed. RESULTS: Population: 89.935 people: 51.5 % female, 60 % under 29 years. Birth rate: Crude birth rate: 32.9 per 1000 people, 30 % of pregnancies in women under 18 years. Morbidity: Gastric problems, common cold and infections. The 25 % population did not have quality public services. Mortality rate: 6.5 per 1000 people. High proportion of violent deaths and traffic accidents. Frequent events: Domestic violence: 36.9 %. Dengue fever: 26.8 %. Indicators of health standards:General physician: 2.5 days. Dentistry: 2.3 days. The rural area did not have any health service. Indicators of specialized medicine opportunity: from 7 to 10 days. There was no permanent pediatric or obstetric service. Vaccination: Only 38 % with full immunization scheme. Overall satisfaction reported by the Health Security System: 88 % of the people were satisfied with their healthcare service. Health service perception by the people: 70 % of the people considered they had a poor or fair health service; 80 % of the population considered their perceived health as good. The poor perception was due to lack of resolution of problems and poor infrastructure. CONCLUSIONS: The proposal was based on three pillars: (1) consider the patient as a priority by implementing centers of excellence in health care and increasing human resources and public services; (2) prevention as a social policy in all aspects of daily living with emphasis on domestic violence and teen pregnancy; (3) the optimal use of resources with frequent monitoring based on real information.

(3064) Health-Related quality of life and its association with mammography use in a nationally representative US Sample Erica Y. Lee, South College School of Pharmacy; Jeffery L. Kibert, II, South College School of Pharmacy; Whitney Jordan, South

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174

Qual Life Res (2014) 23:1–184

College School of Pharmacy; William M. Gentry, South College School of Pharmacy; Michael B. Bottorff, South College School of Pharmacy; I-Chan Huang, PhD, University of Florida, Gainesville, FL, United States; Pranav Gandhi, PhD, South College School of Pharmacy, Knoxville, TN, United States AIMS: Health-related quality of life (HRQOL) has shown to be an important predictor of future disability, morbidity and mortality. The purpose of this study was to determine the relationship between HRQOL and mammography screening in a US national representative sample. METHODS: Data were analyzed from the 2012 Behavioral Risk Factor Surveillance System among women aged 50–74 years. Per the recommendations of the United States Preventive Services Task Force, women were adherent to mammography screening guidelines if they received a mammogram within the previous 2 years. Four separate logistic regression models were conducted to examine the associations of HRQOL with mammography screening, where mammography screening \ 2 versus = 2 years was treated as the dependent variable and four aspects of HRQOL (physical health, mental health, general health status, and activity limitation caused by poor mental or physical HRQOL) as the main independent variables. Covariates such as demographics, socioeconomic status, smoking status, physical activity, body mass index (BMI), health care access, alcohol use, flu shot use, and seat belt use were controlled for in individual regression models. Statistical analysis specifically accounted for the complex sampling design of the BRFSS survey and a priori alpha error was set at p \ 0.05. RESULTS: The study sample comprised of 55,166 women where approximately 77 % of the women aged 50–74 years reported having a mammography screening within the previous 2 years. After controlling for covariates, three HRQOL items, physical health (OR 1.12 (95 % CI 1.08–1.25)), general health status (OR 1.23 (95 % CI 1.10–1.38)), and activity limitation caused by poor mental or physical HRQOL (OR 1.19 (95 % CI 1.06–1.35)) were significantly associated with mammography use, where those reporting better HRQOL were more likely to undergo screening. Age, smoking status, race, health care access, marital and employment status, alcohol use, flu shot use and seat belt use were significant predictors of mammography use in each of the four models. CONCLUSIONS: HRQOL is an important factor associated with mammography screening. It is important to explore mechanisms associated with an individual’s HRQOL and design interventions to influence adherence to mammography screening.

(3066) Validity of the Aboriginal Children’s Health and Well-Being Measure (Aaniish Naa Gegii) Nancy L. Young, PhD, Laurentian University, Sudbury, ON, Canada; Mary-Jo Wabano, Wikwemikong Health Centre; Brenda Pangowish, Wikwemikong Health Centre; Melanie Trottier, Laurentian University, Greater Sudbury, ON, Canada; Koyo Usuba, MS, Laurentian University, Sudbury, ON, Canada AIMS: This paper describes the validity of the Aboriginal Children’s Health and Well-Being Measure (ACHWM). This presentation builds on the ACHWM development research presented at the ISOQOL 2013 meeting. METHODS: We recruited First Nations children and youth from one First Nation reserve in Canada. Participants were asked to complete the ACHWM independently using a computer tablet that enabled those with low literacy levels to participate via a text-to-speech option. Participants also completed the PedsQL on paper. An overall summary score and scores for each of the quadrants of the Medicine Wheel (emotional, physical, mental and spiritual) were computed for the ACHWM. Overall and domain scores were also computed for the PedsQL. We hypothesised that to be valid; the ACHWM scores would correlate between 0.4 and 0.6 with the

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Fig. 1 Relationship between ACHWM and PedsQL parallel PedsQL domains with one exception. We did not predict a significant correlation between ACHWM spirituality and any of the PedsQL domains, because the absence of spirituality in existing measures was a key part of the justification for developing the ACHWM. RESULTS: Paired ACHWM and PedsQL data was available for 51 participants: 58.8 % girls; mean age of 14.7 (range of 7 to 21) years. The Pearson’s correlation between the overall ACHWM score and the overall PedsQL summary score was 0.54 (p \ 0.0001). The correlations with the Physical Health Summary Scores and the Psychosocial Health Summary Scores were slightly lower range (0.36 and 0.52 respectively, both p \ 0.009) but within the expected range. The ACHWM domain scores were moderately correlated with the parallel PedsQL domain scores: ACHWM-Emotional to PedsQL-Emotional Functioning r = 0.64; ACHWMPhysical to PedsQL-Physical Functioning r = 0.47; and Mental (cognitive functioning) to School Functioning r = 0.56. The spiritual domain of the ACHWM did not have a significant correlation with any of the PedsQL domains. CONCLUSIONS: These results establish the validity of the ACHWM and its summary score domains with one exception. We were not able to establish the validity of the spirituality domain, because there is no analogous PedsQL domain. However, the spirituality domain made a unique contribution to understanding the well-being in this population. This measure is now ready for implementation, and will contribute to a better understanding of the health of Aboriginal children in this region (Fig. 1).

(3068) A Multilevel Quantile Regression Analysis of SF-12 Physical and Mental Indexes Giulia Cavrini, Free University of Bolzano/Bozen, Bolzano, Italy; Sara Piombo, ISTAT; Rossella Miglio, Department of Statistical Science—University of Bologna; Alessandra Samoggia, Department of Statistical Science—University of Bologna AIMS: In the last decades multilevel modeling has received increasing attention as suitable methods to handle hierarchical data structure taking into account dependence between observations. Moreover there is an increasing interest in multilevel and comparative analysis applied to perceived health indicators. The main aim of our study is to evaluate how chronic diseases affect the perceived physical and mental well-being, applying multilevel quantile regression model to the ISTAT (National Italian Institute of Statistics) household survey on’’Health Condition and Use of Health Services’’. METHODS: Data are drawn from the Italian Health Survey carried out by Italian National Institute of Statistics in 2005. Our analysis take into account the hierarchical data structure and consider both individual characteristics than information related to socio-economic

Qual Life Res (2014) 23:1–184

175

conditions and household context. The sampling design is two-stage (municipalities and households) with stratification, by size, of the first stage units (municipalities). Due to the pronounced asymmetry of the response variables and not normally distributed residuals a more robust estimation methods like Linear Quantile Mixed Models. RESULTS: In this survey the PCS index range from 11.1 to 68.9 and the MCS index range from 7.5 to 72.3. In addition to the strong asymmetry of the outcome variables, heteroscedasticity on many conditional distributions (mainly with age and chronic diseases) has been found. We have adopted the procedure proposed by Geraci and Bottai to perform a multilevel quantile regression model with individual and family level. Independent variables considered in our models are age, gender, employment status, education, disability, chronic condition, bodymass index and sport practice at individual level, while household composition and household economic resources at household level; urban degree was insert as contextual independent variable. CONCLUSIONS: The multilevel linear quantile regression model (MLQR) give us the possibility to describe more generally the conditional distribution of the response through the estimation of its quantiles, while accounting for the dependence among the observations. This has represented a great advantage of our models (MLQR) with respect to classical multilevel regression (MLM) and it is more efficient than the mean regression in representation of the outcome central tendency (Tables 1, 2, 3, 4).

Table 1 continued P10n

Parkinson Ulcer Cancer in the past Alzheimer Stones Thyroid disease Asthma Diabetes Hypertension Bronchitis, emphys.

P25n

P33n

P50n

P67n

P75n

P90n

-2.48

-2.40

-2.67

-2.35

-2.63

-3.32

-3.55

-0.54

-1.06

-1.08

-0.42

-0.50

-0.43

-0.72

-1.17

-1.73

-1.75

-1.05

-0.52

-0.53

-0.66

-1.19

-1.36

-1.47

-1.76

-2.80

-2.80

-2.69

-1.34

-1.30

-1.42

-1.14

-0.60

-0.64

-0.65 -0.39

-0.63

-1.07

-0.93

-0.43

-0.25

-0.31

-1.15

-1.38

-1.48

-1.02

-0.86

-0.87

-0.94

-1.21

-1.84

-1.92

-1.81

-1.42

-1.14

-0.98

-0.81

-0.67

-0.62

-0.61

-0.45

-0.38

-0.39

-0.56

-1.15

-1.33

-1.45

-1.48

-1.18

-0.87

Household typology: ref. Living alone Childless couple Couple with children Other typology Insuff. econ. resources

0.27

-0.46

-0.32

-0.27

-0.07

-0.02

-0.26

-0.29

-0.59

-0.37

-0.30

-0.19

-0.16

-0.20

-0.02

-0.65

-0.43

-0.33

-0.10

-0.01

-0.02

-0.34

-0.77

-0.63

-0.27

-0.23

-0.14

-0.30

0.39

0.32

0.20

-0.03

0.16

0.07

0.24

0.65

0.52

0.41

0.07

0.25

0.15

0.28

Urban degree: ref. low Intermediate High

Interaction: disabled 9 disease Disabled-Ilness

Table 1

Estimates multilevel quantile models, two levels (individuals and housholds) for the PCS (physical component summary) methods normal [random effects non normals P10n

P25n

P33n

P50n

P67n

P75n

P90n

Disabled-Ac. disease

Age Age^2 Female

2.30

1.57

-1.59

-2.73

-4.39

-3.33

7.41

7.25

3.09

-1.50

-5.39

-6.34

5.80

3.83

2.27

0.01

0.02

0.20

0.00

0.67

1.60

1.98

2.19

1.85

1.57

0.66

6.70

6.75

6.68

6.18

6.23

6.60

6.67

Random effects 2-Household: sd(u)

Intercept

1.58 6.37

47.37

52.34

54.14

56.12

57.09

56.46

58.18

0.00

0.04

0.03

0.01

0.01

0.01

0.04

1-Residuals: sd(e)

0.00

0.00

0.00

0.00

0.00

0.00

0.00

AIC

-0.43

-0.60

-0.58

-0.38

-0.30

-0.21

-0.28

2.19

1.52

1.12

0.16

1.02

0.64

ALD scale (sd)

723,306

707,101

694,520

670,777

660,942

661,315

670,986

Qualification: ref. no educ. qualif. University

3.89

Upper secondary

3.72

2.05

1.43

0.97

-0.01

0.88

0.57

3.43

1.72

1.15

0.84

-0.05

0.83

0.40

2.48

1.18

0.65

0.43

-0.15

0.62

0.09

-0.31

-0.41

-0.38

-0.17

-0.15

-0.14

-0.27 Intercept

51.37

54.30

54.31

53.98

-0.18

-0.06

0.01

0.12

0.21

0.23

0.35

Age

-0.01

0.01

0.02

0.05

-0.35

-0.20

-0.13

-0.02

0.11

0.09

0.19

Age2

0.00

0.00

0.00

-6.06

-5.45

-5.24

-4.69

-3.98

-4.02

-3.74

-0.51

-0.66

-10.82

-11.98

-12.34

-10.96

-10.07

-8.46

-6.38

University

3.51

Upper secondary

3.11

Lower secondary Primary

Lower secondary Primary

Employment: ref. employed

Not work Unable to work Disabled

Disease: ref. no health problem Ilness Acute disease Sport Infarct Heart disease Depression Stroke Arthrosis, arthritis

Estimates multilevel quantile models, two levels (individuals and housholds) for the PCS (physical component summary)—metodo robust [random effects non normali P10r

Body mass index

Unemployed

Table 2

-2.64 -9.06 0.82

-2.54 -9.17 0.85

-2.19 -9.19 0.73

-1.14 -7.50 0.34

-0.55 -4.53 0.32

-0.36 -2.84 0.26

Female

P25r

P33r

P50r

P67r

P75r

P90r

56.03

57.37

57.45

0.02

0.03

0.03

0.00

0.00

0.00

0.00

-0.59

-0.38

-0.29

-0.31

-0.26

1.57

1.74

2.02

0.88

-0.05

0.52

1.47

1.60

1.94

0.75

-0.15

0.50

2.74

1.15

1.33

1.80

0.69

-0.19

0.38

1.98

0.61

0.76

1.26

0.47

-0.32

0.24

-0.39

-0.39

-0.33

-0.22

-0.17

-0.19

-0.21

Qualification: ref. no educ. qualif.

-0.44 -2.54 0.44

Body mass index

-3.43

-3.40

-3.36

-2.62

-2.42

-2.37

-1.89

Employment: ref. employed

-2.73

-2.91

-3.11

-3.14

-3.06

-2.62

-2.19

Unemployed

-0.08

-0.07

0.00

0.18

0.22

0.36

0.29

Not work

-0.44

-0.23

-0.12

0.17

0.12

0.16

0.19

-0.55

-0.66

-0.68

-0.40

-0.18

0.21

0.57

-3.11

-2.93

-2.92

-2.30

-2.52

-2.48

-1.62

Unable to work Disabled -5.74

-5.64

-5.63

-5.20

-3.69

-2.82

-2.35

-2.16

-2.25

-2.38

-2.64

-2.64

-2.25

-1.86

Ilness

-0.72

-2.79

-2.50

-2.76

-1.50

-1.21

-1.30

Acute disease

-3.38

-4.89

-4.57

-3.77

-3.42

-3.24

-2.48

Sport

-5.53

-5.50

-5.13

-4.70

-4.05

-3.57

-3.36

-13.30

-12.70

-12.34

-11.57

-10.51

-6.51

-9.19

Disease: ref. no health problem Osteoporosis Hepatic cirrhosis Cancer

-3.27

-2.68

-2.19

-1.04

-0.52

-0.32

-0.40

-10.63

-9.77

-9.18

-7.44

-4.43

-2.74

-2.15

1.00

0.75

0.63

0.42

0.30

0.32

0.36

123

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Qual Life Res (2014) 23:1–184

Table 2 continued

Table 3 continued P10r

Infarct

-2.80

P25r

P33r

-3.45

P50r

-3.24

P67r

-2.92

-2.64

P75r

P90r

-2.14

-1.96

Acute disease Sport

Heart disease

-2.18

-3.07

-3.12

-3.35

-3.03

-2.51

-2.35

Depression

-0.60

-0.79

-0.65

-0.60

-0.15

0.29

0.49

M10n

Infarct

M25n

M33n

M50n

M67n

M75n

-3.63

-3.51

-3.17

-2.56

-1.77

-1.36

0.73

0.90

0.75

0.71

0.68

0.60

0.62

-0.73

-0.80

-0.80

-0.65

-0.67

-0.53

-0.55 -0.22

Stroke

-1.92

-3.02

-2.92

-2.60

-2.66

-2.26

-2.42

Heart disease

Arthrosis, arthritis

-5.93

-5.69

-5.57

-5.09

-3.71

-2.93

-2.15

Depression

Osteoporosis

-2.15

-2.36

-2.31

-2.58

-2.57

-2.11

-2.12

Stroke

Hepatic cirrhosis

-2.05

-2.47

-2.50

-2.58

-1.43

-1.37

-1.09

Arthrosis, arthritis

-1.66

-1.52

-1.42

-1.11

Cancer

-3.65

-4.89

-4.54

-4.18

-3.75

-2.92

-2.91

Osteoporosis

-0.65

-0.36

-0.46

-0.42

-3.26

-2.49

-2.81

-2.29

-3.02

-2.98

-3.56

Hepatic cirrhosis

-2.97

-1.85

-2.38

-2.03

-2.06

Parkinson Ulcer

-0.77

-0.96

-0.96

-0.76

-0.59

-0.38

-0.55

Cancer in the past

-1.81

-2.06

-1.84

-1.37

-0.79

-0.27

-0.84

Alzheimer

-1.20

-1.19

-1.20

-1.64

-2.83

-2.75

-2.31

Stones

-1.13

-1.49

-1.38

-1.17

-0.78

-0.47

-0.79

Thyroid disease

-0.82

-0.93

-0.85

-0.65

-0.39

-0.16

Asthma

-1.36

-1.56

-1.33

-1.07

-0.90

-0.69

-0.83

-1.40

-1.85

-1.87

-1.81

-1.38

-0.94

-1.01

Hypertension

-0.84

-0.75

-0.69

-0.55

-0.47

-0.39

-0.40

Bronchitis, emphys.

-0.76

-1.22

-1.35

-1.53

-1.48

-1.21

-1.09

Household typology: ref. living alone 0.19

Couple with children

-0.45

-0.16

-0.01

0.03

-0.11

-0.06

-0.09

-0.35

-0.14

-0.01

-0.02

-0.26

-0.06

0.46

-0.50

-0.22

-0.01

0.02

-0.11

0.02

-1.00

-0.66

-0.45

-0.11

-0.14

-0.21

-0.16

Other typology

Intermediate

-0.04

0.21

0.19

0.09

0.10

0.20

0.15

0.43

0.46

0.35

0.17

0.17

0.29

0.22

High Interaction: disabled 9 disease Disabled-Ilness Disabled-Ac. disease

3.59

2.09

1.25

-0.72

-2.41

-6.30

-3.00

10.05

7.83

6.85

4.04

-1.20

-7.62

-5.79

Random effects 2-Household: sd(u)

0.00

7.08

5.35

0.00

0.02

0.27

0.00

ALD scale (sd)

0.67

1.53

1.83

2.19

1.84

1.57

0.62

1-Residuals: sd(e)

6.75

6.45

6.17

6.18

6.23

6.62

6.21

686,310

667,369

655,253

634,711

624,597

625,737

629,902

AIC

Table 3

Estimates multilevel quantile models, two levels (individuals and housholds) for the MCS (mental component summary)—age considered linear methods normal [random effects normals M10n

M25n

M33n

M50n

M67n

M75n

49.00

52.76

53.05

56.22

58.69

59.24

60.59

Age

-0.01

-0.02

-0.02

-0.03

-0.03

-0.03

-0.03

Female

-1.29

-1.48

-1.34

-1.11

-1.07

-0.93

-0.84

-0.74

-0.62

-10.72

-9.73

-7.74

-1.90

-2.17

-2.23

-2.20

-1.73

-1.53

-0.82

-0.69

-0.62

-0.33

-0.27

-0.24

0.05

-1.91

-1.85

-2.58

-3.35

-3.74

-3.25

-2.38

-1.88

-1.30

-1.98

-2.35

-2.52

-2.42

-2.74

-3.10

-3.46 -0.39

Ulcer

-1.42

-1.23

-1.19

-1.05

-0.78

-0.62

Cancer in the past

-0.09

-0.68

-0.53

-0.61

-0.33

-0.32

0.07

Alzheimer

-4.59

-5.84

-5.61

-5.34

-5.22

-5.32

-5.32

Stones

-0.81

-0.42

-0.42

-0.53

-0.31

-0.37

-0.11

Thyroid disease

-0.75

-0.67

-0.58

-0.71

-0.54

-0.55

-0.23

Asthma

-0.36

-0.37

-0.40

-0.35

-0.30

-0.29

-0.11

Diabetes

-0.83

-0.79

-0.87

-0.82

-0.66

-0.56

-0.39

Hypertension

-0.57

-0.42

-0.43

-0.36

-0.31

-0.38

-0.28

Bronchitis, emphys.

-1.08

-0.95

-0.87

-0.91

-0.86

-0.73

-0.49

0.17

0.17

0.59

0.37

0.10

0.05

0.25

-1.22

-0.23

0.11

-0.01

-0.38

-0.39

0.16

Household typology: ref. living alone

Other typology

-1.78

-1.38

-0.68

-0.53

-0.65

-0.50

0.03

Insuff. econ. resources

-1.98

-2.47

-2.24

-1.95

-1.64

-1.53

-1.30

Urban degree: ref. low Intermediate

-0.59

-0.51

-0.36

-0.37

-0.37

-0.27

-0.38

High

-0.67

-0.41

-0.37

-0.40

-0.39

-0.31

-0.41

Interaction: disabled 9 disease Disabled-illness

1.53

0.15

0.32

-0.02

-0.07

-0.13

-0.89

Disabled-Ac. disease

0.37

-0.27

-0.81

-2.09

-3.13

-3.39

-3.75

2-Household: sd(u)

8.02

6.89

6.05

4.62

0.00

0.00

3.82

ALD scale (sd)

0.82

1.86

2.22

2.49

2.16

1.80

0.81

1-Residuals: sd(e)

8.26

7.85

7.50

7.05

7.30

7.60

Random effects

0.92

0.47

0.97

0.38

0.03

0.22

-0.01

Upper secondary

0.78

0.37

0.90

0.32

0.04

0.19

-0.08

Lower secondary

0.70

0.43

0.89

0.37

0.08

0.22

-0.09

Primary

0.36

0.08

0.53

0.13

-0.08

0.11

-0.04

0.07

0.06

0.08

0.12

0.12

0.14

0.10

Employment: ref. employed -0.75

-0.52

-0.40

-0.28

0.05

0.07

0.22

0.02

0.17

0.24

0.33

0.38

0.40

0.32

Unable to work

-3.44

-2.76

-2.30

-2.62

-2.25

-2.08

-1.43

Disabled

-4.49

-4.08

-4.00

-3.23

-1.97

-1.40

0.11

755,470.7

739,449.4

729,862.8

727,815.8

8.16 728,408.4

M25r

M33r

M50r

M67r

M75r

M90r

Intercept

50.33

52.30

54.77

56.50

58.28

59.22

61.21

Age

-0.01

-0.02

-0.02

-0.03

-0.03

-0.03

-0.03

Female

-1.87

-1.44

-1.37

-1.15

-1.08

-1.02

-0.89

Qualification: ref. no educ. qualif. University

1.78

1.12

0.33

0.18

0.28

0.31

0.54

Upper secondary

1.73

1.10

0.31

0.15

0.29

0.34

0.54

Lower secondary

1.70

1.11

0.42

0.26

0.40

0.39

0.55

Primary

1.09

0.64

-0.03

0.01

0.24

0.28

0.46

-0.02

0.06

0.07

0.11

0.09

0.09

0.18

-0.44

-0.73

-0.53

-0.18

0.06

0.11

0.43

Body mass index Employment: ref. employed

Disease: ref. no health problem -1.81

764,378.6

Estimates multilevel quantile models, two levels (individuals and housholds) for the MCS (mental component summary)—age considered linear metodo robust [random effects non normals M10r

University

Body mass index

777,047.1

Table 4

Qualification: ref. no educ. qualif.

123

-1.03 -11.71

Cancer

M90n

Intercept

Ilness

-1.04 -11.61

Parkinson

AIC

Not work

-1.16 -11.41

Couple with children

Urban degree: ref. low

Unemployed

-1.14 -11.14

Childless couple

Insuff. econ. resources

-0.93

-0.47

Diabetes

Childless couple

M90n

-1.77

-1.65

-1.34

-1.04

-0.84

-0.70

Unemployed

Qual Life Res (2014) 23:1–184

177

Table 4 continued M10r

Not work

M25r

M33r

M50r

M67r

M75r

M90r

0.35

0.18

0.25

0.33

0.42

0.44

0.56

Unable to work

-1.49

-2.89

-2.68

-2.64

-2.47

-2.11

-0.94

Disabled

-4.65

-4.44

-4.37

-3.36

-2.10

-1.46

-0.67

Disease: ref. no health problem Ilness

-2.09

-1.83

-1.72

-1.25

-1.03

-0.94

-0.71

Acute disease

-4.17

-3.66

-3.30

-2.37

-1.72

-1.42

-0.94

Sport Infarct Heart disease Depression Stroke

0.69

0.93

0.74

0.69

0.69

0.61

0.42

-1.08

-0.83

-0.93

-0.72

-0.67

-0.58

-0.17 -0.31

-1.05

-1.21

-1.15

-1.03

-0.81

-0.59

-11.85

-12.21

-12.25

-11.98

-10.84

-9.88

-8.28

-2.29

-1.92

-2.20

-1.98

-1.79

-1.65

-1.16 -0.38

Arthrosis, Arthritis

-1.85

-1.72

-1.45

-1.06

-0.72

-0.66

Osteoporosis

-0.34

-0.50

-0.57

-0.55

-0.33

-0.11

0.04

Hepatic cirrhosis

-1.61

-2.42

-2.49

-2.18

-1.80

-1.93

-1.35

Cancer

-2.78

-3.21

-3.68

-3.13

-2.32

-2.02

-1.65

Parkinson

-2.09

-2.13

-2.29

-2.44

-2.82

-2.98

-4.07

Ulcer

-1.10

-1.13

-1.32

-1.07

-0.85

-0.81

-0.15

Cancer in the past

-1.37

-0.81

-0.72

-0.55

-0.44

-0.56

-0.03

Alzheimer

-3.81

-5.53

-5.37

-5.24

-5.29

-5.11

-5.33

Stones

-0.63

-0.38

-0.45

-0.46

-0.48

-0.26

-0.19

Thyroid disease

-0.43

-0.68

-0.71

-0.59

-0.57

-0.56

-0.43

Asthma

-0.29

-0.48

-0.49

-0.32

-0.30

-0.33

-0.30

Diabetes

-0.83

-0.94

-0.96

-0.80

-0.69

-0.70

-0.48

Hypertension

-0.45

-0.51

-0.38

-0.36

-0.33

-0.29

-0.25

Bronchitis, emphys.

-0.87

-0.89

-0.98

-0.92

-0.85

-0.72

-0.58

Dejection, 4) Fatigue-Inertia, 5) Anger-Hostility, and 6) ConfusionBewilderment. ‘‘Lively’’ (item 7) and ‘‘full of pep’’ (item 56) belong to the Vigor-Activity domain. The objectives of this study were to evaluate the difference in concept (if any) between these items and to translate them in 7 languages (Bulgarian, Estonian, French, German, Latvian, Portuguese and Slovakian). METHODS: The POMS was translated following the Mapi methodology in compliance with the ISPOR guidelines. The process consisted of: 1) definition of each concept behind each item with the developer of the measure, 2) two forward translations by native translators, reconciliation of the forward translations, 3) one back-translation by an English-speaker fluent in the target language, 4) final reconciliation, and 5) cognitive interviews with 35 native-speaking healthy subjects (n = 5 per country). RESULTS: The first step of the translation process, i.e., definition of concepts, helped to clarify the conceptual differences between ‘‘lively’’ and ‘‘full of pep’’. ‘‘Lively’’ had to be considered more as an action or behavior-based descriptor and ‘‘full of pep’’ as descriptive of the internal state. ‘‘Lively’’ was considered as the manifestation of feeling ‘‘full of pep’’: e.g., ‘‘Jane woke up today and felt full of pep—her co-workers kept saying, ‘Jane sure is lively today’,’’ i.e., the fact that Jane herself feels full of pep is manifested by her behavior which one could describe as ‘‘lively’’. With this definition in mind, each local team could find appropriate equivalents in each language. ‘‘Lively’’ was translated with literal wording in all languages. As for ‘‘full of pep’’, translations varied from ‘‘enthusiastic’’ (Bulgarian, Portuguese) to ‘‘full of vitality’’ (Estonian, Slovakian) or ‘‘peppy’’ (German), ‘‘full of spirit’’ in French and ‘‘full of energy ‘‘in Latvian. The translations were well understood. CONCLUSIONS: ‘‘Lively’’ and ‘‘full of pep’’ are two different concepts which could be easily translated with the help of the developers who provided clear definitions of the intent of each item.

Household typology: ref. living alone childless couple couple with children

0.52

0.69

0.46

0.48

0.29

0.25

-0.02

-0.03

0.28

0.10

-0.01

-0.08

-0.11

-0.19

other typology

-0.71

-0.63

-0.53

-0.45

-0.42

-0.34

-0.26

Insuff. econ. resources

-2.73

-2.00

-2.07

-1.66

-1.56

-1.52

-1.45

Urban degree: ref. low Intermediate

-0.21

-0.35

-0.53

-0.36

-0.27

-0.28

-0.30

High

-0.05

-0.24

-0.44

-0.42

-0.31

-0.34

-0.33

Interaction: disabled 9 disease Disabled-Ilness Disabled-Ac. disease

0.49

0.04

-0.09

-0.03

0.06

-0.19

-0.31

-0.59

-0.60

-0.97

-2.07

-2.93

-3.58

-2.87

Random effects 2-Household: sd(u)

13.87

12.00

10.47

8.33

7.23

0.00

7.08

ALD scale (sd)

0.85

1.91

2.26

2.48

2.14

1.78

0.82

1-Residuals: sd(e)

8.55

8.05

7.62

7.01

7.21

7.52

8.28

AIC

745,873.8

730,045.7

719,965.8

703,220.8

694,251.4

692,623

693,736.9

Cross-Cultural Adaptation (3070) Are ‘‘lively’’ and ‘‘full of pep’’ similar or different concepts? Challenges in translating these terms in seven languages Ire`ne Gil Campos, Mapi; Caroline Anfray, Mapi, Lyon, France; Catherine Acquadro, Mapi Research Trust, Lyon, France AIMS: Feeling ‘‘lively’’ or ‘‘full of pep’’ are common items used in PRO measures either generic or specific. The Profile of Mood States (POMS) identifies and assesses six fluctuating mood or affective states: 1) Tension-Anxiety, 2) Vigour-Activity, 3) Depression-

(3072) French adaptation and psychometric validation of the expanded prostate cancer index composite questionnaire for health-related quality of life of prostate cancer patients Anne-Sophie Mariet, University of Franche-Comte´, Besanc¸on, France; Ame´lie Anota, Quality of Life in Oncology Platform, France, Besanc¸on, France; Philippe Maingon, Centre George Franc¸ois Leclerc, Dijon, France; Florence Joly, Centre Francois Baclesse, Caen, France; Jean-Franc¸ois Bosset, Radiotherapy Department, Besanc¸on University Hospital, 25030 Besanc¸on, France; AnneVale´rie Guizard, Centre Francois Baclesse, Caen, France; Michel Velten, Epidemiology and Public Health Laboratory, College of Medicine, Strasbourg, Strasbourg, France; Mariette Mercier, University Hospital of Besancon, Besancon, France AIMS: Health-related quality of life (HRQOL) is an important endpoint in oncology. Thus, there is a need to validate some tools specific to cancer site. The objective of this study was to realize a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire and to validate the psychometric properties of the French version. METHODS: The EPIC questionnaire measured urinary, bowel, sexual and hormonal domains. The first step corresponds to transcultural adaptation of the EPIC original English version was performed according to the back translation technique. This adaptation was tested on a sample of patients. The second step corresponds to the validation of the psychometrics properties of the EPIC questionnaire with 300 patients: 200 patients under treatment for localized prostate cancer (treatment group) and 100 patients cured of their prostate cancer (cured group). HRQOL was assessed by the EPIC questionnaire, the EORTC QLQ-C30 and PR25 prostate cancer module. Patients of the treatment group assessed their HRQOL level before and at the end of the treatment. Patients of the cured group have to fill out all the questionnaires twice with two weeks interval

123

178 between the two assessments. Psychometrics properties were explored according to classical test theory. RESULTS: 46 patients were included in the first step. None of them considered the questionnaire too long. Five patients (11.6 %) reported at least one question disturbing. At this time, 235 patients were included in the second step. The present results are for the first 149 patients included: 70 patients in the treatment group and 79 patients in the cured group. Internal consistency was good for all domains (Cronbach’s a [ 0.70). Little floor effect was detected. Reproducibility assessed with cured group was acceptable (test–retest intra-class coefficient [ 0.70). Criterion validity (correlation between EPIC and PR25 module scales) was good. Multitrait analysis allowed to validate the questionnaire structure. CONCLUSIONS: The French EPIC questionnaire seems to have some good psychometrics properties. However, these properties should be confirmed on all patients included. The responsiveness to change will also be assessed with treatment group. Finally, modern psychometric analyses trough item response theory will complement these classical analyses.

(3074) The importance of the additional proofreading step and its impact on subsequent linguistic validation steps Beng Li Ting, Health Research Asia, Singapore, Singapore; Linda See, Health Research Asia; Grace Gao, Health Research Asia; Valeska C. Kantzer, Health Research Associates, Inc., Mountlake Terrace, WA, United States AIMS: There has been no previous study on the value of an additional proofreading for complex script languages as part of the linguistic validation process. A proofreading is usually done at the end of the linguistic validation process. However, this additional proofreading is done on the preliminary version of the translation, early in the linguistic validation process. This study aims to highlight the importance of this proofreading step and identify any impact on subsequent steps e.g., cognitive interviews, which have the purpose of evaluating respondents’ interpretation of each item and ensuring conceptual equivalency to the source text. METHODS: Documentation of the translation and linguistic validation of PRO measures was reviewed across 64 projects that included the additional proofreading, dating from 2008 to 2013. In each of these projects, the additional proofreading was conducted prior to the cognitive interviews. All accepted proofreading corrections were extracted and tabulated under these categories: formatting, inappropriate word usage, consistency, spelling/typographical, misrepresented concepts, punctuation, grammar, fluency, font rendering, concept clarity, pasting errors, missing/extra text, and colloquialism. They were then analyzed based on how likely the understanding of the intended concept will be affected if the issue were not corrected, in order to identify their impact on the subsequent step. RESULTS: 1,418 accepted suggestions were isolated from 138 translated measures across 19 Asian languages. The prominent issues having a higher conceptual impact were inappropriate word usage and misrepresented concepts, accounting for 22 % of the issues. These issues were missed prior to the additional proofreading because their back translation seems to reflect the intended concept. Two other notable yet low conceptual impact issues (accounting for 28 %) were formatting and consistency. CONCLUSIONS: Resolving issues that affect conceptual interpretation early allowed the testing of a translation that is closer to the intended concept during the cognitive interviews to further define the most appropriate word usage for the target population. The respondents of the cognitive interviews should then be able to focus on the fluency and concept of the translation without being distracted by any of the low conceptual impact issues that were already corrected.

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Qual Life Res (2014) 23:1–184 (3076) Developing the coeliac disease assessment questionnaire (CDAQ): an assessment of translatability Helen Crocker, MSc, University of Oxford, Headington, Oxford, United Kingdom; Hayley Simpson, PharmaQuest Ltd; Rebecca L. Two, BA, PharmaQuest Ltd., Banbury, United Kingdom; Crispin Jenkinson, Health Services Research Unit, Oxford, United Kingdom; Michele Peters, PhD, University of Oxford, Oxford, United Kingdom AIMS: The objective of this study was to assess the translatability of the Coeliac Disease Assessment Questionnaire (CDAQ) into other languages, and resolve potential translation issues as part of the development of this new measure. The CDAQ is a patient-reported outcome (PRO) measure which aims to assess health-related quality of life in adults with coeliac disease. METHODS: A translatability assessment of the CDAQ’s candidate items (n = 51) was conducted by PharmaQuest Ltd, a translation company specialising in the translation and linguistic validation of patient-reported outcome measures. A concept elaboration document was developed and sent to in-country translators, along with the English version of the CDAQ. The following six language-country combinations were selected: Arabic (Egypt), Finnish (Finland), French (France), German (Germany), Simplified Chinese (China), and Spanish (Argentina). Following a review of the translators’ comments, PharmaQuest Ltd suggested recommendations for improving the items. Amendments to the CDAQ were made based on these recommendations. RESULTS: The translatability assessment identified problems with the translation of certain words (e.g. ‘condition’, ‘loose bowels’) and phrases (e.g. ‘eating out’), where equivalents do not exist in other languages. In addition, certain words were problematic due to their alternative meanings in other languages. One item referred to following a glutenfree diet for weight loss purposes; this concept may not be understood in all other cultures. The sentence structure of some items was considered problematic and changes were recommended to improve the readability and aid translation of these items. The assessment also identified inconsistencies in the tenses used across items. Amendments were made where appropriate to resolve the translation issues identified, resulting in changes to 42 candidate items. The tense used was unified throughout. CONCLUSIONS: Assessing the translatability of the CDAQ as part of the development of the measure has resulted in an improved PRO. When the CDAQ is translated into other languages, there will be fewer translation issues as a result of the amendments made. As well as reducing the likelihood of translation issues, the English source version has improved as a result of feedback from the translators. Item reduction and scale generation of this new measure will follow.

(3078) The concept of neurological reserve in a norway: cultural and social differences revealed by cognitive interviewing Inger Utne, Oslo & Akershus University College of Applied Sciences, Oslo, Norway; Liv Halvorsrud, Oslo and Akershus University College of Applied Science, Norway, Oslo, Norway; Randi Andenas, PhD, Oslo and Akershus University College, Oslo, Norway; Carolyn E. Schwartz, ScD, DeltaQuest Foundation, Inc., Concord, MA, United States AIMS: Neurological reserve posits two components, passive and active. Passive reserve reflects past and premorbid indicators of brain reserve (e.g., childhood enrichment activities, educational and occupational attainment); active reserve encompasses current leisure activities that stimulate the brain (e.g., leisure and cultural activities, exercise). We aimed to explore similarities and differences in the conceptualization of cultural and social activities between the USA and Norway. METHODS: As part of a translation process of the DeltaQuest Cognitive Reserve Measure, we followed EORTC recommendations to pretest

Qual Life Res (2014) 23:1–184 the newly translated measure by conducting cognitive interviews. Fifteen community-based Norwegians (6 men and 9 female) provided feedback on the questionnaire items, as did faculty members from the research group. RESULTS: Both passive and active reserve have a different meaning in Norway as compared to the USA. Passive reserve activities as reflected by the educational system are both similar and different. Whereas the structure of education is quite similar across the two countries, the differences will affect normative values for the measure. For example, it is mandatory in Norway to play two musical instruments and to learn two foreign languages through schooling, whereas in the USA no musical education is mandatory and only exposure to one foreign language is required. Active reserve ‘‘leisure activities’’ has a different meaning in Norway and the USA. In Norway, such activities are closely related to nature (e.g., family cabins in the wilderness), spending time outdoors (e.g., skiing, swimming, hiking, fishing), and non-urban cultural activities (i.e., national-music, handicrafts). Further, volunteer work does not have the same meaning in the two countries. Whereas volunteer work for churches and political parties are common in the USA, in Norway the concept (‘‘dugnad’’) relates more to what one contributes to the closeness of the community, for example through sports or musical bands. CONCLUSIONS: The translation process revealed interesting and useful information about cultural and social differences in the concept of neurological reserve between the USA and Norway. These insights will inform the further development and validation of the Norwegian version of the measure.

Patient-Centered Research (3080) Update of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID): Integration of the New COA Taxonomy-the ClinRO Example Laure-Lou Perrier, MAPI Research Trust; Katrin Conway, BA, Mapi Research Trust, Lyon, France; Catherine Acquadro, Mapi Research Trust, Lyon, France AIMS: In 2002, PROQOLID was launched to provide an overview of existing PRO instruments and a facilitated access to the instruments and their developers through the structured presentation of synthesized, reliable, and constantly updated data. In October 2011, the term Clinical Outcome Assessments (COAs) was introduced at a FDA Workshop to better reflect the importance of the source of information in measurements. COAs depend on the cooperation and reporting of observations by patients (PROs), clinicians (ClinROs), and observers (ObsROs). In May 2013, a new category was added: Performance outcome assessments (PerfOs). With this evolving taxonomy, including and detailing information about all COAs might become a crucial step in developing PROQOLID. The objective of this study was: (1) To review how ClinROs are currently reported in PROQOLID; and (2) To propose (if needed) ways of clarifying and updating ClinRO information. METHODS: PROQOLID was searched on April 9, 2014 to retrieve current information about ClinROs using an advanced search engine. RESULTS: The ClinRO information was found under the category ‘‘mode of administration’’ in the subcategory ‘‘clinician-rated.’’ Out of the 801 questionnaires in the database, fifty-two (6.5 %) were identified as ClinROs. Out of these 52 questionnaires, nine were generic. Eight different therapeutic areas were identified (i.e., digestive system diseases, musculoskeletal diseases, neoplasms, nervous system diseases, respiratory tract diseases, psychiatric disorders, pathological conditions signs and symptoms, and skin and connective tissue diseases), representing 17 different indications, and 33.33 % of the therapeutic areas included in PROQOLID (n = 24). The most represented therapeutic area was psychiatry (23 questionnaires) followed by nervous diseases (n = 7). Within psychiatry, depression was the most represented (n = 6). Only two

179 questionnaires were specific to children: the Pediatric Evaluation of Disabilty Inventory (PEDI) and the WeeFIM instrument. To better individualize ClinRO information in PROQOLID, it is proposed to create a new meta-category, i.e., type of COA category (PRO, ClinRO, ObsRO and PerfRO). It is also recommended to expand PROQOLID to all COAs. CONCLUSIONS: This review has shown that PROQOLID already includes ClinRO information. Recommendations are given on how to modify the organization and content of the database to present the information on all COAs.

(3082) Partners in research: patients leading research initiatives on health experiences Svetlana Shklarov, University of Calgary, Calgary, AB, Canada; Nancy Marlett, University of Calgary, Calgary, AB, Canada; Deborah Marshall, University of Calgary, Calgary, AB, Canada; Maria-Jose Santana, PhD, University of Calgary, Calgary, AB, Canada; Tracy Wasylak, Alberta Health Services AIMS: PACER (Patient and Community Engagement Research) is a new program at the University of Calgary that grew out of a pilot Patients Matter project (2011–2013) funded through the Canadian Foundation for Healthcare Improvement in collaboration with the Alberta Health Services’ Strategic Clinical Networks. We are now observing the impact of the direct engagement of patients in designing and conducting health research. Patient-led research studies, based on specific qualitative methods, are seamlessly tied into larger, formal research programs and quality improvement initiatives conducted by research teams at the University and health service organizations. The innovative approach builds the capacity of patients to engage confidently and meaningfully in research on health experience. METHODS: The program is based on a rigorous one-year training and internship with students recruited among patients with a variety of chronic health conditions. Upon graduation, these patents become Patient and Community Engagement Researchers (PACERs) and are qualified to design and conduct studies based on qualitative methods specifically designed to engage patients, families and communities in peerto-peer research on health experiences. The methods include focus groups, field observation, creating questionnaires and surveys, and narrative interviewing. PACERs also learn to collaborate effectively with professional research teams to bring patients’ analytical perspective into health research. Outcomes were measured through semi-structured interviews, focus groups, observation, and documentation review, and assessed using Outcome Mapping and grounded theory data analysis. RESULTS: To date, five internship research projects have been completed and another four are underway. In addition, at least six formal, funded PACER studies have been completed in partnership with professional health teams. Twenty-one PACERs graduated with skills and capacity to conduct health-related research and collaborate effectively with health researchers, and additional 10 interns are going to graduate in December 2014. In total, 31 PACERS are now involved in collaborative research work. CONCLUSIONS: PACER introduced a new patient voice and new, dynamic patient roles that enable them to contribute to health experience research in meaningful ways. PACER methods have the potential to engage large groups of patients and promote their active role in health research.

(3084) Patient retention and response in longitudinal patientreported outcomes studies using a telephone interactive voice response system Loretta A. Williams, PhD, RN, Univ.of Texas MD Anderson Cancer Center, Houston, TX, United States; Qiuling Shi, PhD, Univ. of Texas M.D. Anderson Cancer Center, Houston, TX, United States; Tito R. Mendoza, PhD, Univ. of Texas M.D. Anderson Cancer Center, Houston, TX, United States; Araceli Garcia-Gonzalez, Univ. of Texas

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MD Anderson Cancer Center, Houston, TX, United States; Patricia Ault, Univ. of Texas MD Anderson Cancer Center, Houston, TX, United States; Nazim Ali, Univ. of Texas MD Anderson Cancer Center, Houston, TX, United States; Jorge E. Cortes, Univ. of Texas MD Anderson Cancer Center, Houston, TX, United States; Jonathan C. Trent, II, Univ. of Miami Sylvester Comprehensive Cancer Center; Dejka M. Araujo, Univ. of Texas MD Anderson Cancer Center, Houston, TX, United States; Charles S. Cleeland, PhD, Univ. of Texas MD Anderson Cancer Center, Houston, TX, United States AIMS: Retention of subjects and missing patient-reported outcome (PRO) data is increasingly recognized as a barrier to success in extended longitudinal clinical trials and drug registration studies. We developed M. D. Anderson Symptom Inventory (MDASI) modules for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST) and assessed patient symptom burden regularly for up to 12 months using a coordinator-monitored telephone interactive voice response system (IVRS). The aim of this retrospective analysis is to describe the rates of response and dropout of patients on these two studies. METHODS: 160 patients with CML and 150 patients with GIST were recruited and asked to complete the MDASI-CML or the MDASI-GIST respectively every 2 weeks by IVRS for one year (planned assessments = 27). Both versions of the MDASI contain 13 core symptom items, 7 disease-specific symptom items, and 6 core interference items. Symptoms and interference are rated on 0–10 numeric scales (0 = symptom not present or no interference; 10 = symptom severity as bad as you can image or complete interference). Research coordinators monitored subject response to IVRS calls and followed up with personal calls when subjects failed to respond. RESULTS: Patient demographics, disease, and treatment information are in Table 1. At the end of 10 months, almost 90 and 70 % of patients with CML and GIST respectively remained on study (Table 2). The most common reason Table 1

Patient demographic, disease, and treatment characteristics CML, N = 160

Age (years)

GIST, N = 150

Mean

SD*

Mean

SD*

51.2

13.6

59.2

11.7

Education (years)

14.6

2.3

14.6

2.2

Time since diagnosis (months)

73.4

57.0

48.3

63.2

N

%

N

Table 2 Months

Male

72

45

73

49

Female

88

55

77

51

Race

CML

GIST

Frequency

Percent

Cumulative percent

Frequency

Percent

Cumulative percent

\1

4

2.5

2.5

4

2.7

2.7

1

3

1.9

4.4

2

1.3

4.0

2

0

0.0

4.4

3

2.0

6.0

3

0

0.0

4.4

6

4.0

10.0

4

2

1.3

5.6

3

2.0

12.0

5

4

2.5

8.1

4

2.7

14.7

6

2

1.3

9.4

2

1.3

16.0

7

0

0.0

9.4

3

2.00

18.0

8

0

0.0

9.4

5

3.3

21.3

9

1

0.6

10.0

4

2.7

24.0

10

1

0.6

10.6

11

7.3

31.3

11

70

43.8

54.4

9

6.0

37.3

12

64

40.0

94.4

49

32.7

70.0

[12

9

5.6

100.0

45

30.0

100.0

160

100.0

150

100.0

Total

Table 3 Number of completed assessments by subjects Assessments

CML Subjects

GIST Percent

Cumulative percent

Subjects

Percent

Cumulative percent

0

0

0.0

0.0

1

0.7

1

4

2.5

2.5

5

3.3

4.0

2

5

3.1

5.6

9

6.0

10.0

3

4

2.5

8.1

8

5.3

15.3

4

2

1.3

9.4

5

3.3

18.7

5

1

0.6

10.0

10

6.7

25.3

6

2

1.3

11.3

8

5.3

30.7

7

3

1.9

13.1

5

3.3

34.0

8

2

1.3

14.4

10

6.7

40.7

9

2

1.3

15.6

6

4.0

44.7

10

2

1.3

16.9

13

8.7

53.3

11

2

1.3

18.1

5

3.3

56.7

12

6

3.8

21.9

13

8.7

65.3

13

4

2.5

24.4

9

6.0

71.3

14

7

4.4

28.8

11

7.3

78.7

%

Gender

Subject attrition rates by study month

0.7

White, non-hispanic

119

74

111

74

15

2

1.3

30.0

6

4.0

82.7

White, Hispanic

14

9

13

9

16

2

1.3

31.3

8

5.3

88.0

Black

14

9

22

15

17

7

4.4

35.6

10

6.7

94.7

18

6

3.8

39.4

2

1.3

96.0

19

2

1.3

40.6

3

2.0

98.0

20

9

5.6

46.3

1

0.7

98.7

21

8

5.0

51.3

0

0.0

98.7

22

6

3.8

55.0

1

0.7

99.3

23

Other

13

8

4

3

Employment Full or part time

93

58

70

47

Retired

27

17

57

38

Disabled

19

12

15

10

Unemployed

21

13

8

5

Disease stage at diagnosis Chronic phase/stage I

154

96

38

25

Accelerated phase/stage II–III

0

0

53

35

7

4.4

59.4

0

0.0

99.3

Blast crisis/stage 4

5

3

35

23

24

12

7.5

66.9

1

0.7

100.0

Not available

1

1

24

16

25

24

15.0

81.9

0

0.0

100.0

Current treatment with tyrosine kinase inhibitor

149

93

115

77

26

Imatinib

75

50

77

67

14

8.8

90.6

0

0.0

100.0

27

15

9.4

100.0

0

0.0

100.0

160

100.0

150

100.0

Other

74

50

38

33

Total SD standard deviation

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Qual Life Res (2014) 23:1–184 for attrition was the frequency of assessments for CML and worsening disease or death for GIST. Approximately 75 and 30 % of patients with CML and GIST respectively completed at least half of the planned assessments, while 80 and 40 % of the planned assessments were completed by 50 % of the patients with CML and GIST respectively (Table 3). The average number of assessments completed was 19 and 10 by patients with CML and GIST respectively. CONCLUSIONS: An IVRS for PRO assessments is feasible, retains patients, and produces reasonable rates of PRO assessment completion over extended time even in patients with advanced disease. Key factors in using an IVRS in longitudinal studies are brief, easily-understood PRO questionnaires, response monitoring, and follow up with subjects.

(3086) Functionality and feedback: a protocol for a realist synthesis of the collation, interpretation and utilisation of PRO data to improve patient care Joanne Greenhalgh, PhD, University of Leeds, Leeds, United Kingdom; Sonia Dalkin, University of Leeds; Judy Wright, University of Leeds; Nick Black, MD, London School of Hygiene and Tropical Medicine, Health Services Research, London, United Kingdom; Jose M. Valderas, MD MPH PhD, University of Exeter, Exeter, United Kingdom; Elizabeth J. Gibbons, MSc, University of Oxford, Oxford, Oxon, United Kingdom; David Meads, University of Leeds; Laurence Wood, PPI representative, University of Leeds; Chris Mills, Leeds West CCG; Ray Pawson, University of Leeds AIMS: We aim to carry out a realist synthesis of the evidence to understand by what means and in what circumstances the feedback of PRO data improves patient care. This poster will outline the protocol for our review. METHODS: We will carry out a realist synthesis which involves (1) identifying the ideas and assumptions (programme theories) underlying how PRO feedback is supposed to work and in what circumstances and then (2) reviewing the evidence to determine the extent to which these expectations are met in practice. We will identify programme theories through a review of policy documents, comments, letters and editorials and discussion with the healthcare stakeholders and patients. We will identify both qualitative and quantitative studies of PRO feedback through searching electronic databases including Medline, Embase and PsycINFO and HMIC. We will synthesise and integrate quantitative and qualitative evidence to (i) identify the implementation processes which support or constrain the successful collation, interpretation and utilisation of PRO data; (ii) identify the implementation processes through which the unintended consequences of PRO data arise and those where they can be avoided. RESULTS: We have provisionally identified a range of ‘functions’ of PRO feedback to structure our review (screening, monitoring, risk stratification, goal setting, patient involvement and activation, demand management, quality improvement and patient choice).We have developed a logic model of the implementation pathway of PRO feedback for each function. We have identified programme theories for each stage of the model and will present these to clinicians, patients, managers and commissioners in two workshops to assess their validity and prioritise theories for the next stage of the review. CONCLUSIONS: We will use the findings from this synthesis to identify what support is needed to optimise the impact of PRO feedback and distinguish the conditions (e.g. settings, patient populations, nature and format of feedback) where PRO feedback might work best. We will produce guidance to enable health care decision makers to tailor the collection and utilisation of PRO data to local circumstances and maximise its impact on the quality of patient care.

181 Utilities/Cost-Effectiveness Methods (3090) Non-trading response on time trade-off responses: individual’s values or logic violation? Andre´a L. Monteiro, MSc, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil; Monica A C T Cintra, MD, PhD, National Institute of Cardiology Brazil, Rio de Janeiro, Brazil; Marcelo Goulart, National Institute of Cardiology Brazil; Bra´ulio Santos, National Institute of Cardiology; Bernardo R. Tura, National Institute of Cardiology Brazil; Luciane N. Cruz, MD, PhD, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; Suzy A. Camey, Federal University of Rio Grande do Sul; Monica V. Andrade, Federal University of Minas Gerais; Kenya Noronha, Universidade Federal de Minas Gerais; Marisa Santos, MD, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil AIMS: Health states valuation is a burdensome task with comprehension difficulties. Non-trading response occurs when the respondent chooses 10 years in a sub-optimal health state rather than 10 years in a state described as ‘‘full health’’. It is possible that others reasons besides the misunderstanding of the task logic may contribute to the non-trading response. The objective of this study was to explore the non-trading response and to characterize both the subjects and health states implied in it. METHODS: A cross-sectional study was conducted in three urban centers aiming to derive QALYs based on estimates obtained from EQ-5D3L valuation. A probabilistic sample of the general population, aged from 18 to 64 years were interviewed. The study applied revised version of MHV protocol, with the exception that all 243 health states were valued. Each respondent valued seven health states using the Time Trade-Off in a household interview. For this study we classified as non-traders respondents individuals that in at least one choice task were unwilling to trade off any time. Logistic regression was used to adjust the data. RESULTS: For this analysis we counted with data from 6368 subjects, resulting on 44,576 valuations. Around 7 % of respondents refused to trade at least one health state, corresponding to 3.2 % of all the valuations. The majority of non-traded health (89 %) states were mild or moderate. The non-trading response was mainly determined by the social economic status (SES), sex and to have experience with sick people. Lower SES is associated with a higher chance to engage on non-trading response (OR 1.44 IC 1.26–1.58); To be woman is also a determinant of non-trading response (OR 1.30; IC 1.15–1.43). On the other hand, to have had prior experience with sick people reduces the chance of non-trading (OR 0.68; IC 0.56–0.83). CONCLUSIONS: This result shed light on the topic of logical inconsistencies and non-trading response and suggests that non-traders are different from traders. However, further research is needed in order to understand the reasoning behind the higher chance of nontrader response among lower SES and woman. The exclusion of these subjects may bias the results.

(3092) Tablet Versus Paper Questionnaire: EQ-5D Quality of Life Questionnaire Comparison for the Brazilian Population Angela M. Bagattini, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; Patricia K. Ziegelmann, Federal University of Rio Grande do Sul; Ana Fla´via B S Lima, Universidade Federal do Rio Grande do Sul; Sandro R P S Miguel, MD, Institute for Health Technology Assessment, Porto Alegre—Rio Grande Do Sul, Brazil; Monica V. Andrade, Federal University of Minas Gerais; Kenya Noronha, Universidade Federal de Minas Gerais; Marisa Santos, MD, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil; Monica A C T Cintra, MD, PhD, National Institute of Cardiology Brazil, Rio de Janeiro, Brazil; Carisi Polanczyk, Federal University of Rio Grande do Sul; Luciane N. Cruz, MD, PhD, Federal University of Rio Grande do Sul, Porto Alegre, Brazil

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AIMS: To assess the comparability and subject acceptability of paper and electronic (tablet) versions of the EuroQOL (EQ-5D) quality of life questionnaire for the Brazilian population. METHODS: Randomly selected sample of 509 (18–64 years old) literate individuals from the general population. A crossover design was applied to twothirds of the sample: subjects randomly allocated answered the tablet or paper questionnaires first and a crossover questionnaire 24 h later. The other one-third of the sample did a test–retest using the tablet version. Concordance between applications was evaluated using intraclass correlation coefficient (ICC) for EQ-5D utility scores and Visual Analogue Scale (VAS) values RESULTS: ICCs for EQ-5D were 0.70, (95 % CI 0.609; 0.769) for paper-tablet, 0.73 (95 % CI 0.658; 0.795) for tablet-paper and 0.79 (95 % CI 0.765; 0.866) for tablet-tablet. For VAS were 0.73 (95 % CI 0.646; 0.792) for papertablet, 0.68 (95 %: 0.593; 0.751) for tablet-paper and 0.79 (95 % CI 0.720; 0.838) for tablet-tablet. Ease of use was greater for the tablet administration (41 %), most subjects use computers daily (43.5 %) and found it very easy (46 %) or easy (47 %) to answer the questionnaire on tablet. All results are summarized in Table 1 and Figs. 1, 2, 3 (attached). CONCLUSIONS: The interviewed answers from the Table 2 and the paper versions of the EQ-5D Quality of Life

5%

2%

46%

very easy easy

47%

difficult very difficult

Fig. 1 Ease of use—tablet administration

11%

20%

28%

paper tablet both no response

41%

Table 1 Baseline characteristics of sample interviewers Application method sequence Paper–tablet (n = 164) Age Mean (±SD) Gender $ n (%)

Tablet–paper Tablet–tablet (n = 181) (n = 164)

Fig. 2 Easiest questionnaire application version 0,2%

43.29 (13.61) 42.31 (13.59) 42.51 (13.27) 116 (70.7)

106 (58.6)

103 (62.8) 30,4%

Education n (%) Elementary incomplete

17 (10.4)

Elementary complete

34 (20.7)

36 (19.9)

38 (23.2)

Middle school

40 (24.4)

60 (33.1)

53 (32.3)

High school

39 (23.8)

37 (20.4)

34 (20.7)

College

13 (7.9)

12 (6.6)

13 (7.9)

Under graduation

15 (9.1)

16 (6.6)

8 (4.9)

6 (3.7)

5 (2.8)

2 (1.2)

Graduation

19 (10.5)

daily 43,5%

16 (9.8)

once a week once a month

6,3%

less than once a month

5,1%

never 14,6%

no response

Fig. 3 Computer usage

Questionnaire are comparable. The test–retest of the tablet version demonstrated reliability and both methods have high acceptability by the interviewed sample.

Table 2 Intraclass correlation coefficient Application method sequence Paper–tablet (n = 164)

Tablet–paper Tablet–tablet (n = 181) (n = 164)

Visual Analogue Scale (VAS) ICC

0.727

0.680

0.786

95 % confidence (0.646|0.792) (0.593|0.751) (0.720|0.838) interval (lower bound/ upper bound) Utility Scores EQ-5D ICC

0.698

0.734

0.786

95 % confidence (0.609|0.769) (0.658|0.795) (0.765|0.866) interval (lower bound/ upper bound)

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(3094) Mapping of the OAB-SF questionnaire onto EQ-5D for overactive bladder patients in spain Miguel A. Ruiz, School of Psychology, Universidad Auto´noma de Madrid, Spain; Laura L. Gutie´rrez, School of Psychology, Universidad Auto´noma de Madrid, Spain; Javier Rejas, Pfizer, S.L.U., Madrid, Spain AIMS: The aim of this study was to map a disease specific scale, the Overactive Bladder Questionnaire, 5-dimensional health classification system (OAB-5D) onto a generic preference-based scale, the EuroQOL (EQ-5D-3L), in a sample of patients with Overactive Bladder. METHODS: An observational study was conducted among 246 patients at 18 clinics of Urology in Spain. A total of 43 out of 243 possible health states were identified and valued, using Visual Analog Scale (VAS) and Time Trade-off (TTO) scoring algorithms. General Linear Models (GLM) and Generalized Linear Models (GzLM) were

Qual Life Res (2014) 23:1–184 estimated using both individual and aggregated level data. The OAB5D system proposed by the original authors (measuring Urge, Urine, Sleep, Coping and Concern dimensions) was considered the baseline model. The original model, composed by a set of 5 specific OAB1-SF items, was re-estimated and other possible item-sets were tested. Resulting models were compared and the best one was selected in terms of goodness of fit measures, coefficient sing for each attribute level, regression coefficient magnitude and individual coefficient statistical significance. Finally, the internal validity of the best model was tested using bootstrap resampling. RESULTS: Mean age was 57.7 years (SD = 12.79); 76 % were women; 99 % Caucasian; 36 % were employees and 35 % reached primary studies. TTO utilities (mean = 0.789) differed from VAS utility scores (mean = 0.760; p \ 0.05). The baseline model only presented a dominant effect for the Urge dimension. An alternative model changing two of the original items attained significant coefficients for all dimensions (except Coping) using GLS estimation with VAS scoring and aggregated level data. Urge, Urine and Sleep dimensions were the most relevant, ad 12 out of 20 levels were significant. The mentioned model estimated through GLM (OLS regression) attained R2 value of 0.89. Bootstrap estimates were stable and attained standard error estimates close to the parametric values. CONCLUSIONS: A good fitting utility function was found to map the OABq-SF responses onto EQ-5D tariffs (using the OAB-5D system), but the items used in the utility function in Spanish population differs from the original in the item set used.

(3096) Breast Cancer: Health utilities and Health-Related quality of life Pedro L. Ferreira, PhD, University of Coimbra, Coimbra, Portugal; Augusta Silveira, CEISUC/UFP; Ana Eberhardt, ICBAS; Isabel Sequeira, IPOP; Teresa Sequeira, CEISUC/UFP AIMS: Breast cancer is the most prevalent cancer in women and, globally, the first cause of death from cancer among women. Despite its high incidence rates in Western countries, 89 % of women are still alive five years after their diagnosis. This study aimed to evaluate the HRQOL and to derive utilities for breast cancer patients after the implementation of a routine HRQOL assessment in the Portuguese Cancer Institute, in Porto (IPOP) in order to explore factors related to an impaired HRQOL METHODS: During three months, patients admitted at the IPOP’s Breast Unit were asked to complete the EORTC QLQ-C30, module BR23, SF-12, EQ-5D-3L with VAS. The Portuguese value set was used to derive the EQ-5D index and the SF12 summary scores were computed from a representative samplebased algorithm. Socio-demographic and clinical variables were also collected. RESULTS: A sample of 628 consecutive outpatients with breast cancer filled the questionnaire. Their mean age was 52.5 ± 10.0 years, 32.5 % had a diagnosis prior one year and 33.0 % have had a diagnosis between two and four years ago. The functional status dimensions measured by the QLQ-C30 showed high scores, ranging from 66.2 to 79.7 in a 0 to 100 scale. However, the overall HRQOL score 60.5 reveals high levels of symptom burden, especially insomnia, fatigue and financial difficulties. In what concerns breast cancer’s specific symptoms, the body image (78.1) and the upset by hair loss (39.5) were the worst symptoms. Both physical and mental summary SF-12 components were slightly lower than 50, mainly because of the low scored dimensions general health (40.8) and vitality (46.6). On the other hand, the EQ5D index was 0.62 ± 19.7 with 20 % of patients scoring higher than 0.8 and six (0.9 %) of patients scoring utility values worse than death.

183 Elderly breast cancer patients always showed lower QLQ-C30 functional status, higher symptom burden and lower health utility scores. CONCLUSIONS: In conclusion, the major evidence from this demonstration study, is that with a well-structured care organization and a good health information system, it is possible to monitor the health gained by patients under treatment.

Statistical Analysis of PROs (3098) Latent heterogeneity of factorial structure as a source of model misfit in confirmatory factor analysis Ljoudmila Busija, PhD, Deakin University, Burwood, Australia; Marita Mc Cabe, Deakin University; Matthew Fuller-Tyszkiewicz, Deakin University; John Reynolds, Deakin University AIMS: Poorly fitting confirmatory measurement models are indicative of problems with construct validity of a measure and are frequently encountered in the context of self-reported outcome measures. The aim of this study was to explore latent heterogeneity in the structure of responses to scale items as potential source of model misfit in confirmatory factor analysis (CFA). METHODS: The study utilised Body Image Dissatisfaction Scale (BIDS) data from 1581 respondents, who were ranging in age from 18 to 90 years (M = 55.3, SD = 16.4). The BIDS comprises 2 subscales: General Body Dissatisfaction (3 items), and Dissatisfaction with Specific Body Parts (7 items). Response options range from 0 (very happy) to 4 (very unhappy). Latent variable mixture modeling (LVMM) was used to identify latent classes heterogeneous with respect to factor structure of the BIDS. RESULTS: Initial 2-factor CFA model had poor fit with the data: ?2(32) = 680.1, p \ 0.001; CFI = 0.91 RMSEA = 0.11; SRMR = 0.06. LVMM identified 3 classes within the structure of the BIDS. For the largest of 3 classes (latent class 2, n = 1,006), the BIDS conformed to the hypothesised structure, with high, significant loadings (p \ 0.001) from all items on their respective factors. For latent class 1 (n = 461), General Body Dissatisfaction factor had significant loadings from 2 items only (weight and shape) while the Dissatisfaction with Specific Body Parts factor represented dissatisfaction with lower limbs (hips, thighs and legs). Latent class 3 was characterised by high general body satisfaction (negative loadings on the General factor) while the Specific factor represented high satisfaction with hips and abdomen and high dissatisfaction with thighs, legs, and arms. Class membership was related to age, with individuals in class 2 being oldest (M = 56.8, SD = 15.7), followed by class 1 (M = 54.2, SD = 17.1) and class 3 members (M = 47.2, SD = 17.8; F(2,1578) = 19.6, p \ 0.001), but was not associated with gender (?2(2) = 2.5, p = 0.283). Subsequent CFA for each latent class indicated poor model fit for classes 1 (?2(32) = 192.8, CFI = 0.87, RMSEA = 0.10, SRMR = 0.09) and 3 (?2(32) = 84.6, CFI = 0.82, RMSEA = 0.12, SRMR = 0.12) and acceptable fit for class 2 (?2(32) = 314.9, CFI = 0.96, RMSEA = 0.09, SRMR = 0.02). CONCLUSIONS: Latent heterogeneity of responses is a potential source of model misfit and may need to be considered during construct validation of a self-reported outcome measure.

(3100) Perceived own health state and health assessments of case-vignettes—is there a connection? Andreas Hinz, University of Leipzig, Germany, Leipzig, Germany; Winfried Ha¨user, Klinikum Saarbruecken, Germany; Heide Glaesmer, Department of Med. Psychol., University of Leipzig, Germany; Ru¨ya-Daniela Kocalevent, Institute of Medical

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184 Psychology, University Medical Center Hamburg, Germany; Elmar Bra¨hler, Leipzig University AIMS: Self-assessments of health states are related to individual frames of reference. The main aim of this study was to explore whether using case-vignettes may help to correct for such different frames of reference in the assessment of health. We expected a negative correlation between self-rated health and the assessment of the vignettes. METHODS: A representative sample of the German adult population (N = 2,409) was selected. Participants were asked to rate their present health state and the health states of two vignettes on a 0–100 scale. In addition, they rated their health state on year ago and filled in several questionnaires. RESULTS: The mean rating of the vignettes’ health state was M = 43.9 (SD = 14.8), and the mean score of self-assessed health was M = 76.2 (SD = 20.6). There was no negative, but a small positive correlation between the assessment of the vignettes (averaged across both vignettes) and the self-assessed health state (r = 0.12). The number of chronic diseases was only marginally associated with the assessments of the vignettes (0 conditions: M = 44.8; = 2 conditions: M = 42.2). The retrospective health state one year ago (M = 76.0) was very similar to the present state, with a correlation of r = 0.85. CONCLUSIONS: In contrast to the hypothesis, judgments of case vignettes used in this study cannot be utilized to correct for differences in frames of reference. The mean scores of the self-assessments can be used as reference values for groups of patients.

(3104) Response shift detection at item-level in longitudinal patient-reported outcomes studies with an optimal SEM-based method—a simulation study Alice Guilleux, University of Nantes, Nantes, France; Myriam Blanchin, University of Nantes, Nantes, France; Antoine Vanier, MD, University Pierre et Marie Curie Paris 6, Paris Cedex 13, France; Jean-Benoit Hardouin, PhD ScD, University of Nantes, Nantes, France; Veronique Sebille, ScD, University of Nantes, Nantes, France AIMS: Longitudinal data are often collected to analyse the evolution over time of Patient-Reported Outcomes (PRO) such as health-related quality of life. Due to the potential change of patient’s perceptions of the measured concept between the different times of measurement, longitudinal PRO data are often difficult to interpret. This phenomenon which is linked to the way the patients might adapt or cope with their disease experience is called Response Shift (RS). RS can take several forms: recalibration (changes in the patient’s internal standards of measurements), reprioritization (changes in the patient’s values) and reconceptualization (changes in the patient’s definition of what is being measured). As consequence of RS, observed patient’s evolutions may thus not properly reflect true perceived health changes. The Oort’s procedure (OP), based on Structural Equation Modelling (SEM), is an attractive method to detect all forms of RS and adjust analysis for RS as appropriate. Nevertheless, the implementation of the OP can be made in different ways and raises some methodological questions regarding its impact on the results. To our knowledge, the OP has been applied on data several times but has never been evaluated through simulation studies. Usually, the methods used to detect RS are applied at the dimension level. Here,

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Qual Life Res (2014) 23:1–184 the simulation studies were performed at the item level. METHODS: In order to assess different options regarding the execution of the OP, simulation studies have been carried out. These studies give a stand for several methodological choices such as the need to include a step to have a global indication of RS occurrence, the need to hierarchically test for the different forms of RS and the requirement to adjust p values for multiple comparisons. Eight different versions of the OP are compared to bring out an optimal SEM-based method. RESULTS: The comparison of the results of the 8 versions of the OP will help identifying which ones adequately detect RS on correct items. For each version, the type I error and the power are computed to detect the good form of RS on the correct items. CONCLUSIONS: This simulation study is used to determine the best version based on the SEM method for response shift detection at the item level.

(3106) MF-SAF: Re-validation of psychometric properties based on rasch model, and approaches to exploit multi-day measurements to improve measurement properties Lothar T. Tremmel, Incyte Corp, Wilmington, DE, United States AIMS: The MF-SAF is a patient-reported outcome instrument designed to measure the severity of myelofibrosis, from the patient’s point of view. It consists of 7 symptom items with 0–10 severity ratings. It was developed based on FDA’s PRO guidance, and implemented in a clinical study as a daily electronic diary. Baseline data from up to 7 consecutive days were used to determine reliability and validity based on traditional psychometric methods. The aim of this study is to explore the usefulness of Rasch measurement theory in assessing the properties of the scale in a more detailed way, including patient targeting, the functioning of the 11-category rating scales, assessment of learning across the 7 days, and ways to efficiently use the multiple baseline measurements. METHODS: The likelihood ratio test is used to determine which polytomous Rasch model is most appropriate for the data. Patient targeting is assessed by comparing the locations of patients with the locations of items as well as category boundaries. Various ways of collapsing categories are tried in an effort to further improve reliability and category threshold ordering. Learning over the baseline period is examined by using person-fit statistics to assess if the ratings are becoming less random over time. Various methods to integrate the baseline data into a single score with improved measurement properties are explored. RESULTS: The category boundaries cover the range of patients sufficiently. No scheme of collapsing categories was identified that improves the person separability index, but some schemes lead to better threshold ordering. Learning over the 7 days can be verified by a trend to improved person fit statistics. Baseline scores with better measurement properties can be formed by incorporating items from more than one day in the same Rasch model. CONCLUSIONS: The Rasch model further verifies the good psychometric properties of the MFSAF on a more detailed level. The results give no forceful reason to simplify the 11-category rating scales. The relatively long baseline period may be needed for learning, but not all data need to be used for deriving a reliable baseline score.