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Updated: Jul 25, 2025

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Patient and public involvement is suboptimal in randomized controlled trials addressing a chronic condition
Mathilde Husson1, Agnès Dechartres2, Bruno Ramdjee1
1Département de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, Paris 75013, France.
Objectives:
To describe patient and public involvement (PPI) in randomized controlled trials (RCTs) addressing a chronic condition and to analyze 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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