ORIGINAL RESEARCH: EMPIRICAL RESEARCH – QUANTITATIVE

The responsiveness of the International Prostate Symptom Score, Incontinence Impact Questionnaire-7 and Depression, Anxiety and Stress Scale-21 in patients with lower urinary tract symptoms Edmond P.H. Choi, Weng Yee Chin, Cindy L.K. Lam & Eric Y.F. Wan Accepted for publication 3 March 2015

Correspondence to E.P.H. Choi: e-mail: [email protected] Edmond P.H. Choi BNurs MPhil RN Research Assistant Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong Weng Yee Chin MBBS FRACGP Assistant Professor Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong Cindy L.K. Lam MBBS MD FHKAM Professor and Head Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong Eric Y.F. Wan MSc BSc Senior Research Assistant Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong

C H O I E . P . H . , C H I N W . Y . , L A M C . L . K . & W A N E . Y . F . ( 2 0 1 5 ) The responsiveness of the International Prostate Symptom Score, Incontinence Impact Questionnaire-7 and Depression, Anxiety and Stress Scale-21 in patients with lower urinary tract symptoms. Journal of Advanced Nursing 71(8), 1857–1870. doi: 10.1111/jan.12662

Abstract Aims. To examine the responsiveness of a combined symptom severity and healthrelated quality of life measure, condition-specific health-related quality of life measure and mental health measure in patients with lower urinary tract symptoms. Background. To establish the responsiveness of measures that accurately capture the change in health status of patients is crucial before any longitudinal studies can be appropriately planned and evaluated. Design. Prospective longitudinal observational study. Methods. 402 patients were surveyed at baseline and 1-year using the International Prostate Symptom Score, the Incontinence Impact Questionnaire-7 and Depression, Anxiety and Stress Scales-21. The internal and external responsiveness were assessed. Surveys were conducted from March 2013–July 2014. Results. In participants with improvements, the internal responsiveness for detecting positive changes was satisfactory in males and females for all scales, expect for the Depression subscale. The health-related quality of life question of the International Prostate Symptom Score was more externally responsive than the Incontinence Impact Questionnaire-7. Conclusions. The International Prostate Symptom Score and Anxiety and Stress subscales were more responsive in males than in females. The symptom questions of the International Prostate Symptom Score and Anxiety and Stress subscales were not externally responsive in females. The health-related quality of life question of the International Prostate Symptom Score outperformed the Incontinence Impact Questionnaire-7 in both males and females, in terms of external responsiveness. Keywords: assessment, instrument development, psychometric testing, quality of life, urology

© 2015 John Wiley & Sons Ltd

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Why is this research or review needed? ● Patient-reported outcomes such as symptom severity, health-related quality of life (HRQOL) and mental health care are commonly used as clinical outcomes in clinical trials and the outcomes of interest in epidemiological studies in patients with lower urinary tract symptoms. ● There is a lack of evidence to support the responsiveness of measures that are commonly used to assess patients with lower urinary tract symptoms. ● Despite the wide use of the International Prostate Symptom Scores (IPSS) in females, the internal and external responsiveness of the measure have not been evaluated and the responsiveness of mental health measure has never been investigated in patients with lower urinary tract symptoms.

What are the key findings? ● We found that the IPSS is not externally responsive in females, according to receiver operating characteristic (ROC) curve analysis. ● According to the ROC curve analysis, the Depression Anxiety and Stress Scale-21 (DASS-21) Anxiety and Stress scales are not externally responsive in females, while the DASS-21 Depression scale is not externally responsive in both males and females. ● The single-item IPSS HRQOL is more externally responsive than the Incontinence Impact Questionnaire-7 (IIQ-7).

How should the findings be used to influence policy/ practice/research/education? ● The single-item IPSS HRQOL is preferable to the IIQ-7 for longitudinal evaluations of the HRQOL in patients with lower urinary tract symptoms. ● The IPSS symptom questions and DASS-21 anxiety and stress scales should be used with caution when monitoring female patients with lower urinary tract symptoms over time. ● DASS-21 depression scale is not a responsive instrument and should not be used to evaluate the effectiveness of lower urinary tract symptom interventions or to monitor patients with lower urinary tract symptoms longitudinally.

Introduction Lower urinary tract symptoms (LUTS) are highly prevalent globally. It is estimated that the worldwide prevalence of LUTS will increase from 452% in 2008 (19 billion individuals) to 458% by 2018 (23 billion

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individuals) (Irwin et al. 2011). The high prevalence of LUTS imposes a heavy economic and health burden on patients and on the healthcare system (Speakman et al. 2014). Although LUTS are not life-threatening, they can lead to poorer mental health and health-related quality of life (HRQOL) (Coyne et al. 2009b, Choi et al. 2014a). Advanced medical technologies, including urodynamic study and imaging, can measure biomedical parameters; however, they do not capture the suffering experienced by patients. Patient-reported outcome measures (PROMs) are useful modality for assessing the severity of symptoms and the impact of LUTS on mental health and HRQOL, as perceived by the patient. In many population-based epidemiological studies (Coyne et al. 2003, 2009a, Kupelian et al. 2006), PROMs are commonly used to capture individuals’ LUTS severity and the adverse effects of LUTS on their health status. To more fully evaluate the impact of LUTS interventions, biomedical parameters, such as uroflowmetry, pelvic floor muscle strength and prostate-specific antigen, are often supplemented with PROMs to assess the treatment effects on symptom severity and health status (McVary et al. 2007, Stief et al. 2008, Cavkaytar et al. 2014). PROMs should ideally have well-established evidence of its psychometric properties such as validity and reliability before application in clinical settings (Revicki et al. 2000). It is also important that PROMs can detect change over time (responsiveness) because the responsiveness of PROMs can have a substantial impact on the conclusions for interventional studies (Revicki et al. 2006). The use of a PROM that is not responsive can lead to type II errors (false negative) (Testa & Nackley 1994). Therefore, establishing the responsiveness of PROMs is an essential pre-requisite for judging the effectiveness of interventions (Revicki et al. 2006). A responsive PROM should be able to assess changes in single groups of individuals over time such as in cohort studies and be able to assess differences between groups such as in clinical trials (Husted et al. 2000, Revicki et al. 2006). Two distinct approaches can be used to evaluate the responsiveness of PROMs, namely ‘internal responsiveness/ distribution-based’ approach, or ‘external responsiveness/ anchor-based’ approach. Internal responsiveness is the ability of a PROM to detect change over time as a result of receiving a treatment that has previously been shown to be effective. External responsiveness is the ability of a PROM to detect a clinically important change over time with reference to an external criterion of health status (Guyatt et al. 1987, Husted et al. 2000, Revicki et al. 2006, 2008).

© 2015 John Wiley & Sons Ltd

JAN: ORIGINAL RESEARCH: EMPIRICAL RESEARCH – QUANTITATIVE

Background The International Prostate Symptom Score (IPSS) The IPSS, a combined symptom severity and HRQOL measure, assesses both LUTS severity and their impacts on HRQOL (Barry et al. 1992). This measure has been most widely used in different clinical trials and epidemiological studies among males and females. Previous psychometric studies found that the IPSS is valid and reliable in males and females in different populations including Hong Kong Chinese (Choi et al. 2014c). Despite its wide use, only a few studies have evaluated the internal responsiveness of the IPSS in male patients. The internal responsiveness of the IPSS has not been previously tested in females. The external responsiveness of the IPSS has never been tested in males or females. The Incontinence Impact Questionnaire-7 (IIQ-7) The IIQ-7, which is a disease-specific HRQOL measure, has been recommended by the International Continence Society as a grade A measure (Shumaker et al. 1994, Uebersax et al. 1995, Gotoh 2007). The instrument has been validated in females and males in different cultures including Hong Kong Chinese (Chan et al. 2010, Choi et al. 2014b). Although the measure is predominately used in females with urinary incontinence, there is evidence to show that the measure is applicable to both males and females with different types of LUTS, not only with urinary incontinence (Choi et al. 2014b). Previous studies have only evaluated the responsiveness of the IIQ-7 in incontinent patients. The internal and external responsiveness of the measure in males and females with other types of LUTS has never been evaluated. The Depression Anxiety Stress Scales -21 (DASS-21) The DASS-21 is a generic mental health measure to assess depressive, anxiety and stress symptomology (Lovibond & Lovibond 1996). The measure has been translated into Chinese and validated in Hong Kong Chinese (Taouk et al. 2001). We chose the DASS-21 instead of other mental health measures because the measure can assess three types of major mental health problems in one short questionnaire. The measure has been used previously to evaluate the mental health of primary care patients in Hong Kong (Cheung et al. 2012). To date, there have been no studies conducted to evaluate the internal and external responsiveness of any mental health measures in male and female patients with LUTS.

© 2015 John Wiley & Sons Ltd

Responsiveness of PROMs for LUTS

The study Aim The aim of this study was to evaluate the internal and external responsiveness of the IPSS, the IIQ-7 and the DASS-21 in both male and female patients with LUTS.

Design A longitudinal observational cohort study was conducted from March 2013–July 2014.

Participants Participants were consecutively recruited from two different clinical settings: four nurse-led continence care clinics and four general outpatient clinic (GOPC) waiting rooms distributed across Hong Kong to recruit patients with different disease severity. Only new patients in continence clinics were recruited. For both settings, a modified International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form questionnaire (Avery et al. 2004) was used to screen for patient eligibility. Patients with scores ≥3 were considered to have LUTS. The exclusion criteria were: (1) aged

The responsiveness of the International Prostate Symptom Score, Incontinence Impact Questionnaire-7 and Depression, Anxiety and Stress Scale-21 in patients with lower urinary tract symptoms.

To examine the responsiveness of a combined symptom severity and health-related quality of life measure, condition-specific health-related quality of ...
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