P104: Reported Patient and Public Involvement in Randomized Controlled Trials in Major Medical Journals and their Protocols

Poster Presenter

Alice Vanneste

PhD Student
KU Leuven
Belgium

Objectives

Despite increasing emphasis and recognition of patient and public involvement (PPI), systematic data on its implementation in clinical research is lacking. This study aims to investigate the reporting and evolution of PPI in randomized controlled trials published over time.

Method

A meta-epidemiological evaluation was conducted to systematically review PPI in randomized controlled trials published since 2015 in four major medical journals. PubMed was searched for a comprehensive sample of randomized controlled trial articles and their corresponding peer-reviewed protocols.

Results

Of the 360 published randomized controlled trial articles and 299 respective protocols, PPI was only reported in 64 (18%) articles and 56 (19%) protocols. When reported, patients and their representatives were mainly involved, with the most common PPI activity being participation in trial committees (69% of PPI reporting articles). 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 impact on decision-making within the RCT. Recognition of PPI contributions was more frequent in published articles (60%) compared to protocols (32%), mainly in the acknowledgement section. Although PPI reporting increased over time, it never exceeded 30%.

Conclusion

This study revealed limited PPI reported in randomized controlled trials published in major medical journals and in their respective protocols. Our findings underscore the need for standardized PPI reporting practices to ensure consistent, detailed, and structured descriptions, ultimately enhancing the transparency and impact of PPI in clinical research.