Rheumatology
Rheumatol Int DOI 10.1007/s00296-015-3218-0
INTERNATIONAL
ORIGINAL ARTICLE - FOOD FOR THOUGHT
Randomized clinical trials as reflexive–interpretative process in patients with rheumatoid arthritis: a qualitative study Mercedes de Jorge · Sonia Parra · Jenny de la Torre‑Aboki · Gabriel Herrero‑Beaumont
Received: 9 October 2014 / Accepted: 10 January 2015 © Springer-Verlag Berlin Heidelberg 2015
Abstract Patients in randomized clinical trials have to adapt themselves to a restricted language to capture the necessary information to determine the safety and efficacy of a new treatment. The aim of this study was to explore the experience of patients with rheumatoid arthritis after completing their participation in a biologic therapy randomized clinical trial for a period of 3 years. A qualitative approach was used. The information was collected using 15 semistructured interviews of patients with rheumatoid arthritis. Data collection was guided by the emergent analysis until no more relevant variations in the categories were found. The data were analysed using the grounded theory method. The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category “Interactional Empowerment” emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: “weight of systematisation”, “working together”, and the significance of
M. de Jorge (*) · S. Parra · G. Herrero‑Beaumont Bone and Joint Research Unit, Department of Rheumatology, IIS ‑ Fundacion Jimenez Diaz, Universidad Autonoma, Av. Reyes Catolicos 2, 28048 Madrid, Spain e-mail: [email protected] S. Parra e-mail: [email protected] G. Herrero‑Beaumont e-mail: [email protected] J. de la Torre‑Aboki Rheumatology Department, Alicante General and University Hospital, Alicante, Spain e-mail: [email protected]
the experience: “the duties”. Simultaneously these categories evolved. The clinical trial monitoring activities enabled patients to engage in a reflexive–interpretative mechanism that transformed the emotional and symbolic significance of their disease and improved the empowerment of the patient. A better communicative strategy with the health professionals, the relatives of the patients, and the community was also achieved. Keywords Rheumatoid arthritis · Clinical trial · Grounded theory · Education · Empowerment
Introduction Clinical trial (CT) is a research study designed to ascertain the safety and efficacy of medicinal products or new therapeutic interventions for a specific disease. The CT design attempts to collect all data generated by the patients through a planned, prospective, and rigorous evaluation adjusted over the entire process. The intervention method is characterised by patient and professional cooperation for the advancement of knowledge in the development of new treatments and to quantify aspects of health-related quality of life from the perspective of the patient [1, 2]. The main objective of a phase III CT is to evaluate the efficacy and safety of the experimental treatment by trying to reproduce the normal conditions of use, having considered the therapeutic options available in the studied indication. Rheumatoid arthritis (RA) is defined as a chronic autoimmune disease that produces joint swelling and pain, which substantially decreases the patient’s quality of life and alters daily life activities. These facts conditioned the dependency of the patient on a wide variety of health care services [3, 4]. The burden of chronic diseases requires
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Table 1 Background details on participants
Rheumatol Int Nine participants in a randomized clinical trial and six usual care at the rheumatology department Age 24/75 years Gender 11 female/4 males Work activity 8 active/4 retirees/2 disability/1 housewife Likert scale (pain) 6 severe pain/6 mild and 3 painless
Table 2 Interview methodologies: both groups focused on the same questions on the main aspects in the disease process Thematic axes for the elaboration of the semi-structured interview script Process of adaptation to the disease from the first symptoms, diagnosis, and successive interventions to control the disease Perception of rheumatoid arthritis in patients during routine visits to their usual care at the rheumatology department Perception of rheumatoid arthritis in patients with prior experience of participation in a clinical trial Only the intervention group answered questions related to participation in the CT
special attention because of the increase of the expenditure in health care and the need of innovation in the care of patients. Several independent studies have shown that treatment decisions driven by quantitative rather than subjective monitoring of disease activity, result in significantly improved patient outcomes [5]. Elements such as information and participation are pivotal in patient educational practices [6]. In the past 10 years, there have been advances in the development of new biological therapies and biotechnologies, oriented towards the control of RA [7]. These new treatments have shown great efficacy, substantial improvement on symptoms and acceptable safety profile [8]. In addition, they promote a greater involvement of RA patients in the decision-making process regarding their treatment [9]. CT could provide an experimental environment appropriate for studying the interaction between the patient and health professionals, through the measurement, the systematisation, and the clinical assessment needed for performing such kind of study. Moreover, through experience within this CT framework, patients have shown an improvement of self-management strategies for their chronic disease process. Therefore, the main objective of our study was to explore the significance of the experience of patients with RA who had participated in a Phase III CT during 3 years. Patients and methods Design A qualitative approach was used. Symbolic interactionism was employed as a theoretical framework to contextualise the interaction of one group of people within a sociocultural process [10, 11]. The patients were drawn from two Madrid University Hospitals (Spain). The sample required a total of 15
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patients diagnosed with RA, nine of which had participated in the same phase III clinical trial (CT group) and six patients from usual care visit at the rheumatology department without a CT experience (control group). Thus, patients of the CT group were included in the current study after finishing the CT that had lasted 3 years without treatment interruption. Sampling was sequential. To understand the scenario of care, we conducted interviews with people with a RA diagnosis of at least 3 years attending followup visits (control group). None of the patients in this group had participated, nor invited to do so, in any previous clinical trial. As analysis proceeded the emergence of variations was favoured through theoretical sampling this emergence resulted in a sample detailed in Table 1. Data collection The data collection was performed through semi-structured interviews from 2009–2011. The interviews lasted 45–60 min and were recorded by audio and transcribed verbatim. The format of interviews was that of a conversation with a structure and purpose [12]. Both groups focused on the same questions on the main aspects in the disease process. Only the intervention group answered questions related to their participation in the CT Table 2. The sample size was not predetermined, but determined with theoretical saturation. This means that no new information emerged about a category or subcategory in the process of analysing the interviews [10, 11]. The inclusion criteria for both populations were adults, 21–75 years with a diagnosis of RA for at least 3 years. Patients in the CT group must just have finished their participation in the Phase III CT that lasted 3 years without treatment interruption. The exclusion criteria were the following: patients with cognitive deterioration or communication problems; or
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patients who deny signing the informed consent form; or patients currently participating in a CT (CT group). Data analysis Grounded theory analysis involves open, axial, and selective coding, the elaboration of memos and diagrams adjusted to the constant comparison method of Strauss and Corbin [13]. The interviews were transcribed, and then read line by line to identify and name recurring concepts or ideas that were later coded. As the analysis progressed, constant comparison and theoretical sampling was used to collect more focused information, identify and validate new data or elaborate on specific concepts. The categories were developed by grouping-related concepts Table 3. The next level of coding, axial coding, added depth, and complexity to the interpretation of the data and set the stage for a final synthesis analysis. The category “Interactional Empowerment” emerged as core category, as it represented the participative experience in a clinical trial. Along the process, reflexive notes were used to ensure the internal validity of the study; there were also diagrams, theoretical sampling and constant comparison of data. The research team had the opportunity to clarify or support the analysis through a reflexive process [13]. The review of the emergent categories, the data interpretation, and the control of biases were performed by the four members of the multidisciplinary research team (two anthropologists, a rheumatologist, and a specialised nurse). The principal investigator (MJ, anthropologist) carried out the surveys. The role played by the researchers in the data collection (reflexivity) and the proposed objectives were taken into account at all times. Ethical considerations: The Ethics Committee of the Foundation Jimenez Diaz approved the study. The patients provided written informed consent prior their involvement in the study. Data protection of the patients as well as anonymity regarding the interviews and transcribed tests was guaranteed.
Results The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category “Interactional Empowerment” emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: “weight of systematisation”, “working together”, and the significance of the experience: “the duties” Fig. 1.
The weight of systematisation Patients decided to participate in this CT during the course of their disease. Their decision was conditioned by past and present experiences regarding pain, limitations, and suffering inherent to the disease and perpetuated by failures of prior treatments. Patients were concerned due to the complexity of the informed consent, the uncertainty of not knowing the study arm in which they were included, and the possible outcome of adverse events. The personal motivations of the patients to take part in a trial were the impact of the pain in their daily life and the growing disability, together with their trust in the rheumatologist and the belief in the efficacy of a new treatment. One patient explained Patient CT (PCT1): “Before, in the pharmacy, there was almost nothing for this disease; now, it’s different”. (PCT5): “I participated because, let’s see, if it rains, you have to shelter some place not get wet; I was so bad that I needed an umbrella”. (PCT2): “I need to communicate my disease as soon as possible because I don’t want to suffer”. Patients in the CT had to adapt themselves to a restricted language that focuses on capturing the necessary information to determine the safety and efficacy of the new treatment through ordered and systematic activities. In contrast, during the interactions in routine visits to their usual care centre, most of the patients described their problems related to their condition; in return the professional suggested ways of dealing with these problems. Patient at the usual care rheumatology centre (PUC1): “My doctor told me…it is a very cruel disease, but you must go on”. (PUC5): “My doctor’s opinion was essential in helping me to come to terms with…” The clinical trials tools included the physical measurement of the disease, which were used by the patients on their own or in collaboration with the professionals: “The measurement of pain” was performed using the visual analogue scale (VAS) with the professional. The participants assessed this activity as complex as they were not used to explain their pain through numerical scales: (PCT2): “It’s difficult to grade the pain; I marked what I thought, and if it was normal I would put it halfway. I calculated it bad at first; I couldn’t distinguish it, now I can”. (PCT5): “I put some percentage, more or less what I thought; I set a “barometer” for myself and I calculated it according to how I found myself”. At the beginning patients have to commit themselves to do this measurement exercise but, at the end of the process,
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Table 3 Categories and subcategories in health care scenarios: analysis constant comparison Scenario Clinical Trial
Scenario Usual Care
Motivation “A path of hope”
Routine visits to their usual care at the rheumatology department
“…to participate, I was happy to take this forward for the sake of generations to come; this is progress” (PCT1) ■ To medical progress: “I believe in medical progress…it had already been tested in the United States… and Europe” (PCT1) “I was in good hands” (PCT6) ■ Confidence: “ I had enough confidence in him (the doctor)” (PCT7) ■ To control the disease: “I thought I had nothing to lose, as long as it provided a better quality of life, I’d do anything… I noticed that they were helping and protecting me at the same time ” (PCT4) ■ To Improve: “…I participated because, let’s see…if it rains, you have to shelter some place to not get wet; I was so bad that I needed an umbrella” (PCT5)
■ Confidence: “Of course, the doctors really helped me out a lot, they helped me to believe in the possibility of a better life and to see the illness as a thing of the past” (PUC4) ■ To control the disease: “… What scared me most…not knowing what was happening to me” (PUC4) ■ To Improve: “…I really felt the support, and above all, I felt that someone else understood me, and realized what was happening to me, and what type of medication I needed to take and how long the healing process was going to be” (PUC1)
Follow-up Care Active participation
Periodic reviews with the rheumatologist and rheumatology nurse
■ Joint liability: “…To take everything strictly was to complete that which was benefitting me” (PCT6) ■ Contractual relationship (CI): “It’s like a job; you have to dedicate yourself to it full time” (PCT6)
“They ask you how you see it: if you have had difficulties, how much pain there was… they bother to ask you how and then they explain the results to you” (PUC5) “…Most of the treatments work at first, but then stop working later” (PUC3)
Interactions through Systematic actions: shared communication
Subjective experiences
■ To fill questionnaires: “The questionnaires, the measurement, helped me to see myself” (PCT2) ■ The measure: “It’s difficult to grade pain ; I marked what I thought, and if it was normal I would put it halfway … I calculated it but at first, I couldn’t distinguish it ; now I can” (PCT2) “At first it was impossible, but you end up learning how to measure the pain , I learned how to grade how bad I felt” (PCT9) ■ The book treatment: “I found it difficult to keep records every day. At first I wanted my husband to do the writing, then later I wanted to do it myself” (PCT4) ■ Systematisation of language: “ It helps to think and intellectualise that you have to take care of yourself and ask for help (PCT3) My-self – Reflection: “I decided to focus on what had happened to me and what I was thinking, and that’s how I answered the questions on the questionnaires… when I saw that I was a little better, well, it encouraged me” (PCT7) – Self-observation: “In the surveys, those responses are a form of observing what effect the medication has on the patients” (PCT5) – Self-evaluation: “At first I couldn’t, but you end up identifying the pain measurement; I was adjusting to how I felt” (PCT9) ■ Reflexive /interpretative process: “ It helps to think and intellectualise that you have to take care of yourself and ask forhelp (PCT3)
“…Another thing… the burden feels gradually bigger, e.g., walking uphill, that kills me, it leaves my legs in a bad way, and don’t mention stairs, I can’t even look at them, I don’t even want to smell them. When I’m using the subway, I’m searching for an elevator everywhere.” (PUC3) “In fact, I could not talk to anyone … I went to my room and that was because I could not stand it” (PUC2) “…because at that time I was suffering from an acute depression, I saw myself in a wheelchair” (PUC1) “So far, the only thing that the new treatments have done to me is to reduce swelling in my hands. For instance, the other day my wife, my daughter and myself went to Cadiz for a walk (one-kilometer or one and a half kilometers), and the legs got like this (and he points), all swollen…I spent the next day lying down” (PUC3) Conversational relationships ■ Explanations: “My doctor told me…it is a very cruel disease, but you must go on” (PUC1) …“my doctor’s opinion was essential in helping me to come to terms with…” (PUC5) ■ Recommendations: “They recommended me to stop working” (PCH1) “…Yes, I believe they had been a little short on explanations for that, because they probably didn’t know how I was going to respond to the treatment” (PUC2)
Quality and Safety “…went like clockwork, everything in its place, it was all organised, everything really in order” (PCT8)
“Of course, yes, the doctors helped me a lot, a lot, to have confidence, and to think that the disease was in remission” (PUC1)
Learning ■ Assessment tool: from experience
■ With education programs
“…It taught me that in future, things would be self-controlled… You make an effort … to be more involved in the treatment and that in the very near future I would have complete responsibility” (PCT4) “…it was like going back to school in order to learn and improve” (PCT3) “I learned to maintain an order with the treatment, to take the control” (PCT2)
“Yes, the nurse played us a video that I…I cried and cried and cried and I had such a bad time until I really accepted all this” (PUC4) “They suggested I should participate in the association…didn’t feel able to share” (PUC1)
PCT Patient Clinical Trial, PUC Patient Usual Care
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measuring activities of disease and symptoms became normal and useful to assess their pain and evolution. (PCT9): “At first it was impossible, but you end up learning how to measure the pain, I learned how to grade how bad I felt”. Questionnaires were key elements that contributed to the “reflexive process” of the patients of the trial. The subjectivity of the patient was assessed using the SF-36 and HAQ questionnaires [14, 15], which allowed the patients to evaluate the state of their health and their response to the treatment received. In this phase III CT nor the doctor nor the patient knew the medication they were being administered. (PCT5): “In the surveys, those responses are a form of observing what effect the medication has on the patients”. (PCT2): “The questionnaires, the measurement, helped me to see myself”. However, this process of participative activities led the patients to re-define the perception of their illness through reflection, self-observation, and self-assessment by being more involved in the information regarding their care. (PCT7): “I decided to focus on what had happened to me and what I was thinking, and that’s how I answered the questions on the questionnaires…when I saw that I was a little better, well, it encouraged me”. Another monitoring activity was the completion of the treatment notebook at home. This activity required patients to be aware of and responsible for their health control. The patients recorded their treatment schedules, relevant issues and the progress/regressions of their disease. These exercises did activate the reflexive–interpretive process, because of the fact of observing and assessing oneself as well as writing about their experience. There was an increase in the commitment of the self-care of the patient and their ability to face different situations during their disease. (PCT3): “I had it all written down, sure, I had to write everything for the visits… had to write down everything that happened to me to be able to bring it up to the visits… that was the hardest for me…it was like going back to school in order to learn and improve”. At the beginning of the trial, the participants showed a lack of awareness about the learning and self-care process but, throughout the CT journey and due to the systematic process, they became aware of it, and put it into practice in their daily life. (PCT4): “It taught me that in the future, things would be self-controlled. You make an effort… to be more involved in the treatment and that in the very near future I would have complete responsibility”. The fact of evaluating the ordinary activities allows patients to integrate them in their daily lives and share their experience with the health professionals:
(PCT3): “It helps to think and intellectualise that you have to take care of yourself and ask for help”. (PCT4): “I found it difficult to keep records every day. At first I wanted my husband to do the writing, later I wanted to do it myself”. Working together During the course of the trial, the role played by the patient was crucial and decisive, as they performed an active, participative, responsible role and had to be engaged in the activities set by the protocol. The ritual of performing activities in a systematic manner, the visits, and the necessity of constructing channels of shared communication with the health care professionals ended up transforming the interaction between the patient and the research team. (PCT7): “I was waiting, remembering what had happened to me so I could tell it properly; it’s good to share it and know that I’m doing well… you can’t ask someone to do something you wouldn’t do yourself”. This fact does not mean that no complicity exists in the routine visit; however, the interactions differed from those established within a CT. In the routine visit, most patients had a passive role. The health professional explained and proposed actions, but the patient beliefs, attitude, and the illness process itself determined the process of the information given by the patient, and thus, influenced the management of their disease. One patient said the following about the information received at a routine visit: (PUC1): “The doctor told me several things, but I read others, and I was feeling so bad that I didn’t want to start anything new. I’d already had enough; I didn’t want to read anything else… I just kept the sheets of information that the doctors gave me”. Patients undergoing routine visits revealed also the uncertainties about access and management of information got through the Internet: (PUC5): “I had searched the Internet, and I got scared, what I had seen scared me about the treatment side effects, about everything”. In terms of the information received during routine visits, a patient explained: (PUC2): “Yes, I believe they gave me little explanation, because they probably didn’t know how I was going to respond to the treatment”. Significance of the experience: “the duties” The participants in the CT incorporated new ways of sharing space and time and grasped procedures through the systematisation of language. Thus, they set new channels of communication with specific significance.
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Working together Ac ve par cipa on Ac ve involvement
The weight of systemazaon
Construc ng channels of shared communica on
Restricted language
Significance of the experience "The du es"
reflexive/interpreta ve process
Reinterpreta on of meaning Commitment and responsibility
Reflec on, Self-observa on Self-evalua on
Interaconal Empowerment A socio- cultural change increased their control and competency over their own health
Fig. 1 Core category identified from the data analysis was “interactional empowerment”. This category represents the meaning of the experience that RA patients incorporate after participating in a CT. The process consisted of three phases or categories that occurred simultaneously: the weight of systematisation, working together; and the significance of the experience “the duties”
(PCT1): “Everything is written down. What a book to write”. (PCT5): “In the end, it became a routine”. (PCT1): “I learned to keep an order with the treatment, to take control”. The questionnaires given during the CT visits were interpreted as some work to carry out in order to moved forward and therefore, regarded as a duty: (PCT6): “It’s like a duty; you have to dedicate yourself to it full time”. The participants recognised the benefit of this experience because they had an increase in the control of their treatment and, as a consequence, they gained independence. (PCT4): “The order, the method, you have to be methodic…the frequency. It was very useful… I think it has been progressive…as time goes by”. This participatory experience is based on the reinterpretation of meanings and the use of those in social interactions. The standardised and repetitive procedures helped the patient organise the experience and internalise the information in a reflexive manner. One of the participants explained an improved relationship with his rheumatologist in a particular area: (PCT4): “My doctor asked me, and I was able to tell him how I was, so I expressed myself better”. We suggest that this exercise of reflection increased the responsibility and self-management of the disease and, on the other hand, it highlighted the importance of the treatment, its adherence and systematisation: (PCT6): “If you have control, you know what happens to you, you can control it… although I still don’t know what RA is.”
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The systematic planning, the clear information, and orientation transmitted by the professional provided an environment of control and safety: (PCT1): “Everything is really in order, good management and perfection”. (PCT8): “…went like clockwork, everything in its place, it was all organised, everything really in order”. Patients also expressed the value of being involved in the CT due to the potential positive effect of the new treatment on the care of future generations. Another contribution from the patients was to live the participation experience as a personal effort. Their commitment and responsibility provided them satisfaction due to having been part on achieving the trial objective. From an emotional point of view, they described their satisfaction on a job well done and their expectations for being part in the research development. (PCT1): “To participate, I was happy to take this forward for the sake of generations to come; this is progress. I believe in medical progress…it had already been tested in the United States… in Europe”.
Discussion The CT provides an adequate scenario to explore patients adaptations to a clinical research environment, where systematisation and measurement activities are developed for the evaluation of their own health. The principal finding of this research is identifying how “interactional empowerment” was developed through social interactions throughout the CT. In each of the visits over the 3 years, the patients and the professionals performed systematic measurements through questionnaires, visual pain scales, and disease activities together with the treatment notebook to achieve the CT objectives. As a consequence of routinely using these instruments, the patients developed a way of exploring their beliefs, attitudes, and values in the context of the questionnaires through reflexive practice. These practices increased their control and competency over their own health, for example, the patients felt more able to detect disease signs and symptoms and to obtain knowledge regarding the measures necessary when their condition worsens [16]. Similar findings were observed from the monitoring visits with the use of the information and communication technology [17]. In our study, this interactive exercise performed by patients leads us to presume that the use of tools, grasped through the social interactions during the CT, facilitated reflection, self-observation, and self-evaluation, which are elements to improve rational decisions and to participate actively in the process of assessing one’s own health and lifestyle [18, 19]. Finally, these elements can contribute to produce cultural changes in health care.
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Our theory suggests that the patients, during the CT, the patients internalised the disease process through their own learning experience. They were able to recognise through standardised reference parameters their improvement and/ or regression. Their condition was also individualised as the unique lifestyle of each participant was also considered. The experiential knowledge acquired during the CT made it possible that the patient organised the illness experience, not only through the perception of control and safety perceived in the environment, but also by the sense of active participation in one’s health through an interactive monitoring. Although studies on innovation in education for chronic diseases are a great challenge when put into practice, such studies suggest that interactive activities and participation improve the motivation of the patients. Thus, the didactic methods have changed from being predominantly vertical conferences targeting patients to a much more interactive participation [20]. Although patients and professionals may share the same motivation in CTs, as both focuses on the improvement of the patients [4], actual experience during the trial differs. For a patient that is not predisposed to receiving instruction, this experience brought organisation, systematisation, and control over disease. Moreover, the apprehension of technical language let patients to interpret their clinical manifestations, and therefore to improve the safety though continuous monitoring [5], increasing their perception of self-efficacy [21]. In contrast, the new participative interactions with the professionals through the CT activities enabled the development of educational opportunities and the recognition of their agreement and disagreement to recognise the diversity of information regarding the disease and its treatment [22]. The paradox observed in this study is that, despite of the patients not knowing the mechanisms of joint destruction at the end of the CT, the combination of the interactions and the procedures elaborated during of the CT provided a practical knowledge that improved their daily life. From the perspective of traditional medicine, one could have attempted to explain the patients what constitutes their disease and how the disease produces deterioration, but this appears to be of secondary interest for patients. The real information that an RA patient needs is that which helps them to understand their practical responses to disease. [23]. This study also identified how the interactional space constructed between patients and professionals within the trial contributes to the construction of new shared values, increasing the belief in patient autonomy. At the end of the process, the CT provided the patients improved their commitment, responsibility, and rigour through the study objectives. The patients felt that they participated along with the professionals in the improvement of their disease
and gained first-hand knowledge of the complexity of these processes. These structural mechanisms of “interactional empowerment” were developed through interactions as they are tools that can improve the resolution of problems and, as a consequence, balance the power relationships [24]. As limitations of the study, we suggest that patients included in CTs may represent a group of people with inherently participative attitudes, and therefore, the meaning of the experience may be biased towards a specific patient profile. We are also aware that the results would have been relatively different if the interviewed patients had been from other countries or other cultures. In conclusion, our results suggest that the CT is a system that organises the cognitive structure of the participants through a field of semantic and organizational meaning and of clinical interactions. During the CT, the patients internalised the disease process throughout their own experience of comprehending their own disease. They explained their participation as an experience that substantially improved their control and adaptation by a better understanding of the disease. Methodological aspects can be developed to structure the experience and offer ways of understanding and communicating the illness. This experimental model can be a possible factor of cultural change in health care needed to provide empowerment to patients. It is important to promote organizational structures that provide a climate of control and safety, where patients working together with health care professionals could participate in the improvement of their own health, through systematic and activities of measurement that progressively promote reflection, selfobservation and self-evaluation. Acknowledgements The authors thank all who participated in this study, particularly Dr Jover from San Carlos Hospital, University of Madrid, (Spain) and Rosa Muñoz Study coordinator Department of Rheumatology from Foundation Jimenez Diaz and Sandra Cano. The authors extend their appreciation to the patients who participated in this study ethics. The Department of Rheumatology Foundation Jimenez Diaz IDC funded this study. Conflict of interest The authors have no conflict of interest to declare.
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Rheumatol Int 15. Pincus T, Callahan LF, Brooks RH, Fuchs HA, Olsen NJ, Kaye JJ (1989) Self-report questionnaire scores in rheumatoid arthritis compared with traditional physical, radiographic, and laboratory measure. Ann Intern Med 110:259–266 16. Locock L, Smith L (2011) Personal benefit or benefiting others? deciding whether to take part in clinical trials. Clin Trials 8:85– 93. doi:10.1177/1740774510392257 17. Lemire M (2010) What can be expected of information and communication technologies in terms of patient empowerment in health? J Health Organ Manag 24:167–181 18. El Miedany Y, El Gaafary M, Youssef SS, Palmer D (2010) Incorporating patient reported outcome measures in clinical practice: development and validation of a questionnaire for inflammatory arthritis. Clin Exp Rheumatol 28:734–744 19. Newman ED, Lerch V, Jones JB, Stewart W (2012) Touchscreen questionnaire patient data collection in rheumatology practice: development of a highly successful system using process redesign. Arthritis Care Res (Hoboken) 64:589–596. doi:10.1002/ acr.21560 20. Faller H, Reusch A, Meng K (2011) DGRW-update: patient education. Rehabilitation (Stuttg) 50:284–291. doi:10.105 5/s-0031-1285889 21. Bandura A (1988) Self-regulation of motivation and action through goal systems. Hamilton V, Bower GH, Fridjda NH (edn) Cognitive perspectives on emotion and motivation. Kluver, Dordrecht the Netherlands, pp 37–61 22. Schildmann J, Grunke M, Kalden JR, Vollmann J (2008) Information and participation in decision-making about treatment: a qualitative study of the perceptions and preferences of patients with rheumatoid arthritis. J Med Ethics 34:775–779. doi:10.1136/ jme.2007.023705 23. van Tuyl LH, Scholte-Voshaar MM (2011) Participation of patients in medical research. Ned Tijdschr Voor Geneeskd 155:A3501 24. van Eijk-Hustings Y, van Tubergen A, Boström C et al (2012) EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis. Ann Rheum Dis 71(13–19):71. doi:10.1136/annrheumdis-2011-20018
Rheumatol Int DOI 10.1007/s00296-015-3218-0
INTERNATIONAL
ORIGINAL ARTICLE - FOOD FOR THOUGHT
Randomized clinical trials as reflexive–interpretative process in patients with rheumatoid arthritis: a qualitative study Mercedes de Jorge · Sonia Parra · Jenny de la Torre‑Aboki · Gabriel Herrero‑Beaumont
Received: 9 October 2014 / Accepted: 10 January 2015 © Springer-Verlag Berlin Heidelberg 2015
Abstract Patients in randomized clinical trials have to adapt themselves to a restricted language to capture the necessary information to determine the safety and efficacy of a new treatment. The aim of this study was to explore the experience of patients with rheumatoid arthritis after completing their participation in a biologic therapy randomized clinical trial for a period of 3 years. A qualitative approach was used. The information was collected using 15 semistructured interviews of patients with rheumatoid arthritis. Data collection was guided by the emergent analysis until no more relevant variations in the categories were found. The data were analysed using the grounded theory method. The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category “Interactional Empowerment” emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: “weight of systematisation”, “working together”, and the significance of
M. de Jorge (*) · S. Parra · G. Herrero‑Beaumont Bone and Joint Research Unit, Department of Rheumatology, IIS ‑ Fundacion Jimenez Diaz, Universidad Autonoma, Av. Reyes Catolicos 2, 28048 Madrid, Spain e-mail: [email protected] S. Parra e-mail: [email protected] G. Herrero‑Beaumont e-mail: [email protected] J. de la Torre‑Aboki Rheumatology Department, Alicante General and University Hospital, Alicante, Spain e-mail: [email protected]
the experience: “the duties”. Simultaneously these categories evolved. The clinical trial monitoring activities enabled patients to engage in a reflexive–interpretative mechanism that transformed the emotional and symbolic significance of their disease and improved the empowerment of the patient. A better communicative strategy with the health professionals, the relatives of the patients, and the community was also achieved. Keywords Rheumatoid arthritis · Clinical trial · Grounded theory · Education · Empowerment
Introduction Clinical trial (CT) is a research study designed to ascertain the safety and efficacy of medicinal products or new therapeutic interventions for a specific disease. The CT design attempts to collect all data generated by the patients through a planned, prospective, and rigorous evaluation adjusted over the entire process. The intervention method is characterised by patient and professional cooperation for the advancement of knowledge in the development of new treatments and to quantify aspects of health-related quality of life from the perspective of the patient [1, 2]. The main objective of a phase III CT is to evaluate the efficacy and safety of the experimental treatment by trying to reproduce the normal conditions of use, having considered the therapeutic options available in the studied indication. Rheumatoid arthritis (RA) is defined as a chronic autoimmune disease that produces joint swelling and pain, which substantially decreases the patient’s quality of life and alters daily life activities. These facts conditioned the dependency of the patient on a wide variety of health care services [3, 4]. The burden of chronic diseases requires
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Table 1 Background details on participants
Rheumatol Int Nine participants in a randomized clinical trial and six usual care at the rheumatology department Age 24/75 years Gender 11 female/4 males Work activity 8 active/4 retirees/2 disability/1 housewife Likert scale (pain) 6 severe pain/6 mild and 3 painless
Table 2 Interview methodologies: both groups focused on the same questions on the main aspects in the disease process Thematic axes for the elaboration of the semi-structured interview script Process of adaptation to the disease from the first symptoms, diagnosis, and successive interventions to control the disease Perception of rheumatoid arthritis in patients during routine visits to their usual care at the rheumatology department Perception of rheumatoid arthritis in patients with prior experience of participation in a clinical trial Only the intervention group answered questions related to participation in the CT
special attention because of the increase of the expenditure in health care and the need of innovation in the care of patients. Several independent studies have shown that treatment decisions driven by quantitative rather than subjective monitoring of disease activity, result in significantly improved patient outcomes [5]. Elements such as information and participation are pivotal in patient educational practices [6]. In the past 10 years, there have been advances in the development of new biological therapies and biotechnologies, oriented towards the control of RA [7]. These new treatments have shown great efficacy, substantial improvement on symptoms and acceptable safety profile [8]. In addition, they promote a greater involvement of RA patients in the decision-making process regarding their treatment [9]. CT could provide an experimental environment appropriate for studying the interaction between the patient and health professionals, through the measurement, the systematisation, and the clinical assessment needed for performing such kind of study. Moreover, through experience within this CT framework, patients have shown an improvement of self-management strategies for their chronic disease process. Therefore, the main objective of our study was to explore the significance of the experience of patients with RA who had participated in a Phase III CT during 3 years. Patients and methods Design A qualitative approach was used. Symbolic interactionism was employed as a theoretical framework to contextualise the interaction of one group of people within a sociocultural process [10, 11]. The patients were drawn from two Madrid University Hospitals (Spain). The sample required a total of 15
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patients diagnosed with RA, nine of which had participated in the same phase III clinical trial (CT group) and six patients from usual care visit at the rheumatology department without a CT experience (control group). Thus, patients of the CT group were included in the current study after finishing the CT that had lasted 3 years without treatment interruption. Sampling was sequential. To understand the scenario of care, we conducted interviews with people with a RA diagnosis of at least 3 years attending followup visits (control group). None of the patients in this group had participated, nor invited to do so, in any previous clinical trial. As analysis proceeded the emergence of variations was favoured through theoretical sampling this emergence resulted in a sample detailed in Table 1. Data collection The data collection was performed through semi-structured interviews from 2009–2011. The interviews lasted 45–60 min and were recorded by audio and transcribed verbatim. The format of interviews was that of a conversation with a structure and purpose [12]. Both groups focused on the same questions on the main aspects in the disease process. Only the intervention group answered questions related to their participation in the CT Table 2. The sample size was not predetermined, but determined with theoretical saturation. This means that no new information emerged about a category or subcategory in the process of analysing the interviews [10, 11]. The inclusion criteria for both populations were adults, 21–75 years with a diagnosis of RA for at least 3 years. Patients in the CT group must just have finished their participation in the Phase III CT that lasted 3 years without treatment interruption. The exclusion criteria were the following: patients with cognitive deterioration or communication problems; or
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patients who deny signing the informed consent form; or patients currently participating in a CT (CT group). Data analysis Grounded theory analysis involves open, axial, and selective coding, the elaboration of memos and diagrams adjusted to the constant comparison method of Strauss and Corbin [13]. The interviews were transcribed, and then read line by line to identify and name recurring concepts or ideas that were later coded. As the analysis progressed, constant comparison and theoretical sampling was used to collect more focused information, identify and validate new data or elaborate on specific concepts. The categories were developed by grouping-related concepts Table 3. The next level of coding, axial coding, added depth, and complexity to the interpretation of the data and set the stage for a final synthesis analysis. The category “Interactional Empowerment” emerged as core category, as it represented the participative experience in a clinical trial. Along the process, reflexive notes were used to ensure the internal validity of the study; there were also diagrams, theoretical sampling and constant comparison of data. The research team had the opportunity to clarify or support the analysis through a reflexive process [13]. The review of the emergent categories, the data interpretation, and the control of biases were performed by the four members of the multidisciplinary research team (two anthropologists, a rheumatologist, and a specialised nurse). The principal investigator (MJ, anthropologist) carried out the surveys. The role played by the researchers in the data collection (reflexivity) and the proposed objectives were taken into account at all times. Ethical considerations: The Ethics Committee of the Foundation Jimenez Diaz approved the study. The patients provided written informed consent prior their involvement in the study. Data protection of the patients as well as anonymity regarding the interviews and transcribed tests was guaranteed.
Results The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category “Interactional Empowerment” emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: “weight of systematisation”, “working together”, and the significance of the experience: “the duties” Fig. 1.
The weight of systematisation Patients decided to participate in this CT during the course of their disease. Their decision was conditioned by past and present experiences regarding pain, limitations, and suffering inherent to the disease and perpetuated by failures of prior treatments. Patients were concerned due to the complexity of the informed consent, the uncertainty of not knowing the study arm in which they were included, and the possible outcome of adverse events. The personal motivations of the patients to take part in a trial were the impact of the pain in their daily life and the growing disability, together with their trust in the rheumatologist and the belief in the efficacy of a new treatment. One patient explained Patient CT (PCT1): “Before, in the pharmacy, there was almost nothing for this disease; now, it’s different”. (PCT5): “I participated because, let’s see, if it rains, you have to shelter some place not get wet; I was so bad that I needed an umbrella”. (PCT2): “I need to communicate my disease as soon as possible because I don’t want to suffer”. Patients in the CT had to adapt themselves to a restricted language that focuses on capturing the necessary information to determine the safety and efficacy of the new treatment through ordered and systematic activities. In contrast, during the interactions in routine visits to their usual care centre, most of the patients described their problems related to their condition; in return the professional suggested ways of dealing with these problems. Patient at the usual care rheumatology centre (PUC1): “My doctor told me…it is a very cruel disease, but you must go on”. (PUC5): “My doctor’s opinion was essential in helping me to come to terms with…” The clinical trials tools included the physical measurement of the disease, which were used by the patients on their own or in collaboration with the professionals: “The measurement of pain” was performed using the visual analogue scale (VAS) with the professional. The participants assessed this activity as complex as they were not used to explain their pain through numerical scales: (PCT2): “It’s difficult to grade the pain; I marked what I thought, and if it was normal I would put it halfway. I calculated it bad at first; I couldn’t distinguish it, now I can”. (PCT5): “I put some percentage, more or less what I thought; I set a “barometer” for myself and I calculated it according to how I found myself”. At the beginning patients have to commit themselves to do this measurement exercise but, at the end of the process,
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Table 3 Categories and subcategories in health care scenarios: analysis constant comparison Scenario Clinical Trial
Scenario Usual Care
Motivation “A path of hope”
Routine visits to their usual care at the rheumatology department
“…to participate, I was happy to take this forward for the sake of generations to come; this is progress” (PCT1) ■ To medical progress: “I believe in medical progress…it had already been tested in the United States… and Europe” (PCT1) “I was in good hands” (PCT6) ■ Confidence: “ I had enough confidence in him (the doctor)” (PCT7) ■ To control the disease: “I thought I had nothing to lose, as long as it provided a better quality of life, I’d do anything… I noticed that they were helping and protecting me at the same time ” (PCT4) ■ To Improve: “…I participated because, let’s see…if it rains, you have to shelter some place to not get wet; I was so bad that I needed an umbrella” (PCT5)
■ Confidence: “Of course, the doctors really helped me out a lot, they helped me to believe in the possibility of a better life and to see the illness as a thing of the past” (PUC4) ■ To control the disease: “… What scared me most…not knowing what was happening to me” (PUC4) ■ To Improve: “…I really felt the support, and above all, I felt that someone else understood me, and realized what was happening to me, and what type of medication I needed to take and how long the healing process was going to be” (PUC1)
Follow-up Care Active participation
Periodic reviews with the rheumatologist and rheumatology nurse
■ Joint liability: “…To take everything strictly was to complete that which was benefitting me” (PCT6) ■ Contractual relationship (CI): “It’s like a job; you have to dedicate yourself to it full time” (PCT6)
“They ask you how you see it: if you have had difficulties, how much pain there was… they bother to ask you how and then they explain the results to you” (PUC5) “…Most of the treatments work at first, but then stop working later” (PUC3)
Interactions through Systematic actions: shared communication
Subjective experiences
■ To fill questionnaires: “The questionnaires, the measurement, helped me to see myself” (PCT2) ■ The measure: “It’s difficult to grade pain ; I marked what I thought, and if it was normal I would put it halfway … I calculated it but at first, I couldn’t distinguish it ; now I can” (PCT2) “At first it was impossible, but you end up learning how to measure the pain , I learned how to grade how bad I felt” (PCT9) ■ The book treatment: “I found it difficult to keep records every day. At first I wanted my husband to do the writing, then later I wanted to do it myself” (PCT4) ■ Systematisation of language: “ It helps to think and intellectualise that you have to take care of yourself and ask for help (PCT3) My-self – Reflection: “I decided to focus on what had happened to me and what I was thinking, and that’s how I answered the questions on the questionnaires… when I saw that I was a little better, well, it encouraged me” (PCT7) – Self-observation: “In the surveys, those responses are a form of observing what effect the medication has on the patients” (PCT5) – Self-evaluation: “At first I couldn’t, but you end up identifying the pain measurement; I was adjusting to how I felt” (PCT9) ■ Reflexive /interpretative process: “ It helps to think and intellectualise that you have to take care of yourself and ask forhelp (PCT3)
“…Another thing… the burden feels gradually bigger, e.g., walking uphill, that kills me, it leaves my legs in a bad way, and don’t mention stairs, I can’t even look at them, I don’t even want to smell them. When I’m using the subway, I’m searching for an elevator everywhere.” (PUC3) “In fact, I could not talk to anyone … I went to my room and that was because I could not stand it” (PUC2) “…because at that time I was suffering from an acute depression, I saw myself in a wheelchair” (PUC1) “So far, the only thing that the new treatments have done to me is to reduce swelling in my hands. For instance, the other day my wife, my daughter and myself went to Cadiz for a walk (one-kilometer or one and a half kilometers), and the legs got like this (and he points), all swollen…I spent the next day lying down” (PUC3) Conversational relationships ■ Explanations: “My doctor told me…it is a very cruel disease, but you must go on” (PUC1) …“my doctor’s opinion was essential in helping me to come to terms with…” (PUC5) ■ Recommendations: “They recommended me to stop working” (PCH1) “…Yes, I believe they had been a little short on explanations for that, because they probably didn’t know how I was going to respond to the treatment” (PUC2)
Quality and Safety “…went like clockwork, everything in its place, it was all organised, everything really in order” (PCT8)
“Of course, yes, the doctors helped me a lot, a lot, to have confidence, and to think that the disease was in remission” (PUC1)
Learning ■ Assessment tool: from experience
■ With education programs
“…It taught me that in future, things would be self-controlled… You make an effort … to be more involved in the treatment and that in the very near future I would have complete responsibility” (PCT4) “…it was like going back to school in order to learn and improve” (PCT3) “I learned to maintain an order with the treatment, to take the control” (PCT2)
“Yes, the nurse played us a video that I…I cried and cried and cried and I had such a bad time until I really accepted all this” (PUC4) “They suggested I should participate in the association…didn’t feel able to share” (PUC1)
PCT Patient Clinical Trial, PUC Patient Usual Care
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measuring activities of disease and symptoms became normal and useful to assess their pain and evolution. (PCT9): “At first it was impossible, but you end up learning how to measure the pain, I learned how to grade how bad I felt”. Questionnaires were key elements that contributed to the “reflexive process” of the patients of the trial. The subjectivity of the patient was assessed using the SF-36 and HAQ questionnaires [14, 15], which allowed the patients to evaluate the state of their health and their response to the treatment received. In this phase III CT nor the doctor nor the patient knew the medication they were being administered. (PCT5): “In the surveys, those responses are a form of observing what effect the medication has on the patients”. (PCT2): “The questionnaires, the measurement, helped me to see myself”. However, this process of participative activities led the patients to re-define the perception of their illness through reflection, self-observation, and self-assessment by being more involved in the information regarding their care. (PCT7): “I decided to focus on what had happened to me and what I was thinking, and that’s how I answered the questions on the questionnaires…when I saw that I was a little better, well, it encouraged me”. Another monitoring activity was the completion of the treatment notebook at home. This activity required patients to be aware of and responsible for their health control. The patients recorded their treatment schedules, relevant issues and the progress/regressions of their disease. These exercises did activate the reflexive–interpretive process, because of the fact of observing and assessing oneself as well as writing about their experience. There was an increase in the commitment of the self-care of the patient and their ability to face different situations during their disease. (PCT3): “I had it all written down, sure, I had to write everything for the visits… had to write down everything that happened to me to be able to bring it up to the visits… that was the hardest for me…it was like going back to school in order to learn and improve”. At the beginning of the trial, the participants showed a lack of awareness about the learning and self-care process but, throughout the CT journey and due to the systematic process, they became aware of it, and put it into practice in their daily life. (PCT4): “It taught me that in the future, things would be self-controlled. You make an effort… to be more involved in the treatment and that in the very near future I would have complete responsibility”. The fact of evaluating the ordinary activities allows patients to integrate them in their daily lives and share their experience with the health professionals:
(PCT3): “It helps to think and intellectualise that you have to take care of yourself and ask for help”. (PCT4): “I found it difficult to keep records every day. At first I wanted my husband to do the writing, later I wanted to do it myself”. Working together During the course of the trial, the role played by the patient was crucial and decisive, as they performed an active, participative, responsible role and had to be engaged in the activities set by the protocol. The ritual of performing activities in a systematic manner, the visits, and the necessity of constructing channels of shared communication with the health care professionals ended up transforming the interaction between the patient and the research team. (PCT7): “I was waiting, remembering what had happened to me so I could tell it properly; it’s good to share it and know that I’m doing well… you can’t ask someone to do something you wouldn’t do yourself”. This fact does not mean that no complicity exists in the routine visit; however, the interactions differed from those established within a CT. In the routine visit, most patients had a passive role. The health professional explained and proposed actions, but the patient beliefs, attitude, and the illness process itself determined the process of the information given by the patient, and thus, influenced the management of their disease. One patient said the following about the information received at a routine visit: (PUC1): “The doctor told me several things, but I read others, and I was feeling so bad that I didn’t want to start anything new. I’d already had enough; I didn’t want to read anything else… I just kept the sheets of information that the doctors gave me”. Patients undergoing routine visits revealed also the uncertainties about access and management of information got through the Internet: (PUC5): “I had searched the Internet, and I got scared, what I had seen scared me about the treatment side effects, about everything”. In terms of the information received during routine visits, a patient explained: (PUC2): “Yes, I believe they gave me little explanation, because they probably didn’t know how I was going to respond to the treatment”. Significance of the experience: “the duties” The participants in the CT incorporated new ways of sharing space and time and grasped procedures through the systematisation of language. Thus, they set new channels of communication with specific significance.
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Working together Ac ve par cipa on Ac ve involvement
The weight of systemazaon
Construc ng channels of shared communica on
Restricted language
Significance of the experience "The du es"
reflexive/interpreta ve process
Reinterpreta on of meaning Commitment and responsibility
Reflec on, Self-observa on Self-evalua on
Interaconal Empowerment A socio- cultural change increased their control and competency over their own health
Fig. 1 Core category identified from the data analysis was “interactional empowerment”. This category represents the meaning of the experience that RA patients incorporate after participating in a CT. The process consisted of three phases or categories that occurred simultaneously: the weight of systematisation, working together; and the significance of the experience “the duties”
(PCT1): “Everything is written down. What a book to write”. (PCT5): “In the end, it became a routine”. (PCT1): “I learned to keep an order with the treatment, to take control”. The questionnaires given during the CT visits were interpreted as some work to carry out in order to moved forward and therefore, regarded as a duty: (PCT6): “It’s like a duty; you have to dedicate yourself to it full time”. The participants recognised the benefit of this experience because they had an increase in the control of their treatment and, as a consequence, they gained independence. (PCT4): “The order, the method, you have to be methodic…the frequency. It was very useful… I think it has been progressive…as time goes by”. This participatory experience is based on the reinterpretation of meanings and the use of those in social interactions. The standardised and repetitive procedures helped the patient organise the experience and internalise the information in a reflexive manner. One of the participants explained an improved relationship with his rheumatologist in a particular area: (PCT4): “My doctor asked me, and I was able to tell him how I was, so I expressed myself better”. We suggest that this exercise of reflection increased the responsibility and self-management of the disease and, on the other hand, it highlighted the importance of the treatment, its adherence and systematisation: (PCT6): “If you have control, you know what happens to you, you can control it… although I still don’t know what RA is.”
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The systematic planning, the clear information, and orientation transmitted by the professional provided an environment of control and safety: (PCT1): “Everything is really in order, good management and perfection”. (PCT8): “…went like clockwork, everything in its place, it was all organised, everything really in order”. Patients also expressed the value of being involved in the CT due to the potential positive effect of the new treatment on the care of future generations. Another contribution from the patients was to live the participation experience as a personal effort. Their commitment and responsibility provided them satisfaction due to having been part on achieving the trial objective. From an emotional point of view, they described their satisfaction on a job well done and their expectations for being part in the research development. (PCT1): “To participate, I was happy to take this forward for the sake of generations to come; this is progress. I believe in medical progress…it had already been tested in the United States… in Europe”.
Discussion The CT provides an adequate scenario to explore patients adaptations to a clinical research environment, where systematisation and measurement activities are developed for the evaluation of their own health. The principal finding of this research is identifying how “interactional empowerment” was developed through social interactions throughout the CT. In each of the visits over the 3 years, the patients and the professionals performed systematic measurements through questionnaires, visual pain scales, and disease activities together with the treatment notebook to achieve the CT objectives. As a consequence of routinely using these instruments, the patients developed a way of exploring their beliefs, attitudes, and values in the context of the questionnaires through reflexive practice. These practices increased their control and competency over their own health, for example, the patients felt more able to detect disease signs and symptoms and to obtain knowledge regarding the measures necessary when their condition worsens [16]. Similar findings were observed from the monitoring visits with the use of the information and communication technology [17]. In our study, this interactive exercise performed by patients leads us to presume that the use of tools, grasped through the social interactions during the CT, facilitated reflection, self-observation, and self-evaluation, which are elements to improve rational decisions and to participate actively in the process of assessing one’s own health and lifestyle [18, 19]. Finally, these elements can contribute to produce cultural changes in health care.
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Our theory suggests that the patients, during the CT, the patients internalised the disease process through their own learning experience. They were able to recognise through standardised reference parameters their improvement and/ or regression. Their condition was also individualised as the unique lifestyle of each participant was also considered. The experiential knowledge acquired during the CT made it possible that the patient organised the illness experience, not only through the perception of control and safety perceived in the environment, but also by the sense of active participation in one’s health through an interactive monitoring. Although studies on innovation in education for chronic diseases are a great challenge when put into practice, such studies suggest that interactive activities and participation improve the motivation of the patients. Thus, the didactic methods have changed from being predominantly vertical conferences targeting patients to a much more interactive participation [20]. Although patients and professionals may share the same motivation in CTs, as both focuses on the improvement of the patients [4], actual experience during the trial differs. For a patient that is not predisposed to receiving instruction, this experience brought organisation, systematisation, and control over disease. Moreover, the apprehension of technical language let patients to interpret their clinical manifestations, and therefore to improve the safety though continuous monitoring [5], increasing their perception of self-efficacy [21]. In contrast, the new participative interactions with the professionals through the CT activities enabled the development of educational opportunities and the recognition of their agreement and disagreement to recognise the diversity of information regarding the disease and its treatment [22]. The paradox observed in this study is that, despite of the patients not knowing the mechanisms of joint destruction at the end of the CT, the combination of the interactions and the procedures elaborated during of the CT provided a practical knowledge that improved their daily life. From the perspective of traditional medicine, one could have attempted to explain the patients what constitutes their disease and how the disease produces deterioration, but this appears to be of secondary interest for patients. The real information that an RA patient needs is that which helps them to understand their practical responses to disease. [23]. This study also identified how the interactional space constructed between patients and professionals within the trial contributes to the construction of new shared values, increasing the belief in patient autonomy. At the end of the process, the CT provided the patients improved their commitment, responsibility, and rigour through the study objectives. The patients felt that they participated along with the professionals in the improvement of their disease
and gained first-hand knowledge of the complexity of these processes. These structural mechanisms of “interactional empowerment” were developed through interactions as they are tools that can improve the resolution of problems and, as a consequence, balance the power relationships [24]. As limitations of the study, we suggest that patients included in CTs may represent a group of people with inherently participative attitudes, and therefore, the meaning of the experience may be biased towards a specific patient profile. We are also aware that the results would have been relatively different if the interviewed patients had been from other countries or other cultures. In conclusion, our results suggest that the CT is a system that organises the cognitive structure of the participants through a field of semantic and organizational meaning and of clinical interactions. During the CT, the patients internalised the disease process throughout their own experience of comprehending their own disease. They explained their participation as an experience that substantially improved their control and adaptation by a better understanding of the disease. Methodological aspects can be developed to structure the experience and offer ways of understanding and communicating the illness. This experimental model can be a possible factor of cultural change in health care needed to provide empowerment to patients. It is important to promote organizational structures that provide a climate of control and safety, where patients working together with health care professionals could participate in the improvement of their own health, through systematic and activities of measurement that progressively promote reflection, selfobservation and self-evaluation. Acknowledgements The authors thank all who participated in this study, particularly Dr Jover from San Carlos Hospital, University of Madrid, (Spain) and Rosa Muñoz Study coordinator Department of Rheumatology from Foundation Jimenez Diaz and Sandra Cano. The authors extend their appreciation to the patients who participated in this study ethics. The Department of Rheumatology Foundation Jimenez Diaz IDC funded this study. Conflict of interest The authors have no conflict of interest to declare.
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