Patient and public involvement is suboptimal in randomized controlled trials addressing a chronic condition
Résumé
To describe patient and public involvement (PPI) in randomised controlled trials (RCTs) addressing a chronic condition and to analyse whether PPI is associated with trial characteristics.< Study design and Setting: We used PubMed search to identify RCTs addressing a chronic condition and published in journals with a mandatory PPI statement. Results: Across 101 RCTs; 40 (40%) reported PPI at any stage of the research process. PPI contribution occurred mostly at the design stage of RCTs (n=36), especially for assessing the burden of the intervention (n=24), and at the conduct stage (n=21), with the elaboration of communication materials (n=14). Less than one third (13/40) of RCTs included PPI in the development or choice of outcome measures. As compared with non-PPI RCTs, PPI RCTs more frequently were published in The BMJ, had a corresponding author from the United Kingdom, reported a public funding source, had a higher inclusion rate, used usual care as a control and evaluated a digital intervention. PPI RCTs were associated with less frequent use of placebo as a control group. Conclusion: Our results underline that PPI is not uncommon in RCTs of chronic conditions but infrequently occurred at a key stage. Yet, the engagement of patients as a real partner in RCTs of chronic conditions should be enhanced.
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