Evolution of reported patient and public involvement over time in randomised controlled trials in major medical journals and in their protocols: meta-epidemiological evaluation

Abstract Objective To investigate the reporting and evolution of patient and public involvement (PPI) in randomised controlled trials published over time in major medical journals and in their trial protocols. Design Meta-epidemiological evaluation. Data source PubMed was searched for articles reporting randomised controlled trials published since 2015 in four major medical journals and their corresponding peer reviewed protocols. Eligibility criteria for selecting studies The first 10 randomised controlled trials published each year in each journal were included. Data extraction Data extraction focused on involved stakeholders, description and extent of PPI activities/processes, and recognition of PPI contributions. Published articles and protocols were assessed for consistency of the reported PPI in both. Results Of the 360 published articles reporting randomised controlled trials and 299 respective protocols, PPI was only reported in 64 (18%) articles and 56 (19%) protocols. When PPI was reported, patients and their representatives were mainly involved, with the most common PPI activity being participation in trial committees (44/64 PPI reporting articles; 39/56 protocols). PPI primarily occurred during the trial development phase, including feedback on study design, review of study materials, and assessment of feasibility. Protocols occasionally had more detailed information than the published articles, but in most cases the PPI contributions were often vague without detailed information on specific outcomes and the effect on decision making within the randomised controlled trial. Recognition of PPI contributions was more frequent in published articles (n=37; 58%) than in protocols (n=18; 32%), mainly in the acknowledgment section. Conclusion This study found limited PPI reported in randomised controlled trials published in major medical journals and in their respective protocols, underscoring the need for consistent, detailed, and transparent PPI reporting practices in clinical research. Study registration https://doi.org/10.17605/OSF.IO/4EQG2 .