Unmet need for patient involvement in rheumatology registries and observational studies: a mixed methods study

OBJECTIVE: The contribution of patient research partners (PRPs) is well established in EULAR recommendation development. However, in observational and registry studies, PRP involvement is not well-defined and remains limited. METHODS: Based on a round table discussion during the EULAR Registries and Observational Drug Studies (RODS) meeting in 2019, a mixed methods study was undertaken, including a survey to RODS participants and EULAR PRPs and focus groups with volunteers from the survey. An inductive thematic analysis approach was applied to qualitative data and descriptive statistics to survey data. RESULTS: We retrieved 45 survey responses and ran 3 focus groups with a total of 17 participants. The notion of PRP involvement in research was positively perceived by PRPs and the wider academic rheumatology community. There is universal agreement that PRP involvement in registry research is low and inclusion in different parts of the research cycle is limited. Potential benefits of PRP involvement include: input on the research objectives based on patients’ needs, advice and support regarding recruitment and retention strategies, obtaining patient views on analysis and interpretation, and assistance in disseminating results. Researchers and PRPs highlighted that education, inclusion of PRPs with diverse backgrounds and a welcoming environment as important facilitators for PRP involvement. On the other hand, preconceptions of researchers and insufficient budget allocation have been identified as barriers. CONCLUSION: There is an unmet need to involve PRPs in registries and observational studies and to better define their required input during all research stages. This study provides suggestions for successful PRP integration.