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