Patient and public involvement in a randomized study: a qualitative study of participants' experiences in a Mediterranean Diet trial.

Background: Randomized clinical trials (RCTs) based on Mediterranean Diet (MedDiet) have reported that higher adherence is associated with better health outcomes. Our aim was to describe the perspectives and experiences of older adults in a MedDiet RCT for cardiovascular disease prevention.

Methods: Three focus groups on 25 participants from a MedDiet RCT, aged from 63 to 76 years old, were conducted after a conference on patient and public involvement in research at the University of Granada (Spain). Each focus group, comprising 8-10 participants, was audio-recorded, transcribed, and thematically analysed.

Results: Participants were motivated by research team commitment during follow-up, improved health status and chronic disease management, weight loss, and enhanced health literacy. Health benefits among cohabitants were highlighted by female participants. A more personalized counselling and transparency with disclosure of the results of their tests and on-going study findings were missed. Participants were willing to collaborate in the dissemination of findings. Involving patients in RCTs would align the interventions with their needs and health conditions.

Conclusion: In the context of an RCT, participants could join the research team, identifying key questions, planning study design, contributing to the intervention protocol, and helping disseminate results by selecting the best platforms for sharing findings.