Patient and public involvement in pragmatic trials with older adults: a multi-methods study of researchers’ experiences

Abstract

Abstract Background Patient and Public Involvement (PPI) in health research, including clinical trials, enhances research relevance and quality. However, data on PPI prevalence and characteristics in trials involving older adults remain scarce. We aimed to describe the prevalence and nature of PPI in trials with older adults and identify the main benefits and challenges associated with PPI in such trials. Methods We conducted a multi-methods study, embedded within a survey of 3,163 corresponding authors of pragmatic trials published between 2014 and 2019. We used authors’ self-reports and an electronic search filter to identify the subset involving the older adult population (≥65 years). We approached interested respondents who indicated that they had conducted PPI to participate in a semi-structured interview. Survey results were summarized using descriptive statistics, and interview transcripts were analyzed using thematic analysis. Results One hundred authors met the eligibility criteria, having completed the survey and been involved in a trial involving older adults. Most respondents were women (64.8%). PPI was reported in 46.0% of trials, primarily involving in-person discussions. Most respondents (90.7%) perceived PPI as beneficial, citing improved interventions, increased applicability of findings, higher research quality, and enhanced recruitment/retention. Challenges included communicating trial design, methods, and results (62.5%), identifying or recruiting PPI partners (50%), scheduling meetings (45.8%), and sustaining involvement (45.8%). Thematic analysis of N=8 interviews revealed five main themes related to challenges, some specific to older adults: recruitment and retention of PPI partners, importance of a good PPI chair, training for PPI partners, workload for researchers and burden for PPI partners, and procedural barriers. PPI partners influenced various research aspects, sometimes described as exceeding expectations, by influencing aims and outcomes to measure, developing interventions, refining patient-facing materials, aiding recruitment and retention, and contributing to analysis and interpretation of results. Conclusion Despite being implemented in fewer than half of the trials, PPI had a significant perceived impact. Addressing identified challenges, both general and specific to older adults, could enhance PPI uptake, as well as the quality and relevance of research.