Patient involvement in basic rheumatology research at Nijmegen: a three year's responsive evaluation of added value, pitfalls and conditions for success.

BACKGROUND: Empirical evidence for effective patient-researcher collaboration in basic research is lacking. This study aims to explore good working models and impact of patient involvement in basic rheumatology research and to identify barriers and facilitators. METHOD: A responsive evaluation of a three years' participatory research project in a basic and translational laboratory research setting. Several working models for patient involvement were piloted and adapted if considered necessary. The study comprised surveys, interviews, training days, meeting reports, Q-sort exercises and field notes, and regular reflective team sessions with participant involvement. A qualitative analysis using thematic coding focused on impact, barriers and facilitators. RESULTS: Thirteen patient research partners (PRPs) and fifteen basic researchers participated. PRPs experienced basic research as fascinating though complex to understand. Their initial role was mostly listening and asking questions. After several meetings equal and more meaningful relationships emerged. Researchers' motivation increased by listening to patient stories. They learned about disease impact on daily life and to speak in understandable language. This enabled PRPs to learn about research and the pathogenesis of their disease. It inspired them to stay involved over a longer period. After three years, both parties preferred 1:1 contacts over collaboration in team meetings. A common language and respectful communication were important facilitators. Limitations were the complexity of disease processes for patients and the time commitment for researchers. Impact was reported as a sincere dialogue with multiple advantages for patients and researchers, and to a lesser extent than expected on the research process and outcomes. CONCLUSION: Patient involvement contributes to motivating young scientists in performing basic research projects. Patients and researchers valued the benefits of long-term one-on-one collaboration. These benefits outweigh the lack of direct impact on basic research goals and performance. A plain language summary of the abstract is available (as) online Additional file 1.

Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an OMERACT Initiative.

OBJECTIVE: The Contextual Factors Working Group aims to provide guidance on addressing contextual factors in rheumatology trials within OMERACT. METHODS: During the Special Interest Group session at OMERACT 2018, preliminary results were presented from a case scenario survey and semistructured interviews, including contextual factors mentioned in these. A group-based exercise sought to identify and rank important generic contextual factors. RESULTS: A total of 79 candidate factors were listed. Across the 3 groups, gender/sex, comorbidities, and the healthcare system were ranked as most important. CONCLUSION: The identified important contextual factor domains may be considered a provisional list pending further research.

Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials: A Report from the OMERACT Equity Special Interest Group.

OBJECTIVE: Despite advances integrating patient-centered outcomes into rheumatologic studies, concerns remain regarding their representativeness across diverse patient groups and how this affects equity. The Outcome Measures in Rheumatology (OMERACT) Equity Working Group aims to determine whether and how to address equity issues within the core outcome sets of domains and instruments. METHODS: We surveyed current and previous OMERACT meeting attendees and members of the Campbell and Cochrane Equity Group regarding whether to address equity issues within the OMERACT Filter 2.0 Core Outcome Sets and how to assess the appropriateness of domains, instruments, and measurement properties among diverse patients. At OMERACT 2016, results of the survey and a narrative review of differential psychosocial effects of rheumatoid arthritis (i.e., on men) were presented to stimulate discussion and develop a research agenda. RESULTS: We proposed 6 moments for which an equity lens could be added to the development, selection, or testing of patient-reported outcome measures (PROM): (1) recruitment, (2) domain selection, (3) feasibility in diverse settings, (4) instrument validity, (5) thresholds of meaning, and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking of importance of outcome domains or a patient's response to questionnaire items, and (2) conduct the same survey described above with patients representing groups experiencing health inequities.

Do not forget the professional--the value of the FIRST model for guiding the structural involvement of patients in rheumatology research.

BACKGROUND: The FIRST model describes five practical components that enable equal collaboration between patients and professionals in clinical rheumatology research: Facilitate, identify, respect, support and training. OBJECTIVE: To assess the value of this model as a framework for setting up and guiding the structural involvement of people with arthritis in health research. METHOD: The FIRST model was used as a framework during the guidance of a network of patient research partners and clinical rheumatology departments in the Netherlands. A 'monitoring and evaluation' approach was used to study the network over a period of 2 years. Data were collected using mixed methods and subjected to a directed content analysis. The FIRST components structured the data analysis. During monitoring meetings, refined and additional descriptors for each component were formulated and added if new items were found. RESULTS: The FIRST model helps to guide and foster structural partnerships between patients and professionals in health research projects. However, it should be broadened to emphasize the pivotal role of the principal investigator regarding the facilitation and support of patient research partners, to recognize the requirements of professionals for training and coaching and to capture the dynamics of collaboration, mutual learning processes and continuous reflection. CONCLUSION: FIRST is a good model to implement sustainable relationships between patients and researchers. It will benefit from further refinement by acknowledging the dynamics of collaboration and including the concept of reflection and relational empowerment. The reciprocal character of the five components, including training and support of researchers, should be incorporated.

What has been the effect on trial outcome assessments of a decade of patient participation in OMERACT?

OBJECTIVE: Since 2002, 58 patients have participated as collaborating partners in 6 Outcome Measures in Rheumatology (OMERACT) conferences. Little is known about how they engage with researchers and how they have influenced conference outcomes. METHODS: A responsive evaluation was carried out, including a thematic document analysis of conference proceedings and gray literature, participant observation, and 38 interviews with patients and professionals representing research, industry, and regulators. Interview transcripts were subjected to an inductive content analysis. RESULTS: The role of patients has evolved from a single focus group in 2002 to full integration in all parts of the conference in 2012. Longterm engagement has made a significant change in the scope and conduct of rheumatology research. It has enriched the research agenda by identifying previously neglected outcome domains such as fatigue, sleep disturbances, and flares, and it has contributed to more patient-relevant outcomes in clinical trials. Facilitating factors have been a strong commitment of the leadership, adequate selection procedure, inclusive conference design, interactive and encouraging moderation style, and self-organized support. The intensity of the program and doubts regarding the representativeness of the patient group were still seen as challenges for the future. CONCLUSION: Making patient participation an integral part of the vision and procedures of OMERACT has significantly contributed to the success of OMERACT. It has changed the perceptions and beliefs of many participants. Full use of patients' experiential knowledge before and during the conference is still challenging.

"If i wasn't this robust": patients' expectations and experiences at the Outcome Measures in Rheumatology Conference 2010.

BACKGROUND: Patients are incidentally involved in scientific conferences as collaborating partners. Little is known about how they engage with researchers. OBJECTIVE: The purpose of this study was to explore the expectations and experiences of new patients to better understand the specific features of collaborative research during conferences in its complexity. STUDY DESIGN: After a thematic literature review, we conducted fourteen interviews with eight delegates: four men and four women with three rheumatic diseases and representing five countries. They participated for the first time in the biannual conference on Outcome Measures in Rheumatology (OMERACT) in 2010. Data were subjected to a thematic content analysis. RESULTS: Before the conference, patient participants had felt privileged to be invited but felt insufficiently prepared and uncertain about what was expected from their participation. They had anticipated a learning experience and had hoped to be able to make a contribution. Most experienced the conference program as physically and mentally challenging, partially due to poor moderation or lack of individual support. They doubted their input had been beneficial. After the conference these patients also described their participation as having been a valuable, meaningful, and learning experience. Although they presumed that they had not been very productive, they expected their contribution would be more effective at future conferences. CONCLUSIONS: Patient delegates attending a scientific conference need clear information about their role prior to the event. Personalized support and a facilitative moderation style during sessions are advantageous for maximizing valuable contributions. Participation leads to personal learning curves and various benefits.