Patient and public involvement (PPI) in randomised controlled trials (RCTs) could improve the impact of health research. PPI may be particularly relevant for RCTs on chronic conditions. We aimed to evaluate the frequency and nature of patient and public involvement in randomised controlled trials (RCTs) addressing a chronic condition, to analyse whether PPI is associated with trial characteristics and to assess the quality of PPI reporting.

We performed a methodological review. We searched PubMed in July 2021 for RCTs addressing a chronic condition in adults and published in journals from the BMJ group with a mandatory PPI statement. Our main outcome measures were number of RCTs with PPI and stages at which PPI was used; general and methodological characteristics of trials with and without PPI and quality of PPI reporting using the GRIPP2 guidelines. We involved two patient contributors in almost all stages of our review.

101 RCTs from 100 articles were included. Of these, 40 (40%) reported PPI at any stage of the research process. PPI contribution occurred mostly at the design stage of RCTs (36/40) especially for assessing the burden of the intervention (n=24) and at the conduct stage (21/40), with the elaboration of patient/public communication materials (n=14). The stages less likely to involve PPI were analysis and drafting of the manuscript. RCTs with PPI were more likely to be published in the BMJ, to have a corresponding author from the UK, to report a public funding source, to have a higher inclusion rate and to evaluate a digital intervention than non-PPI-RCTs. PPI-RCTs were associated with a less frequent use of placebo as control group. We found no significant association with the use of patient-reported or patient-important outcomes. Adherence to the reporting guidelines was poor as no RCTs adhere to the five GRIPP2 items.

Our results underline that PPI is not uncommon in RCTs on chronic conditions but rarely occurred at a decisive stage such as choice of outcomes, definition of eligibility criteria or interpretation of study findings. Yet, it seems important to enhance engagement of patients as a real partner in RCTs on chronic conditions.

Public involvement , Essais contrôlés randomisés , Revue méthodologique

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