Prevalence of patient and public involvement in child health randomized controlled trials and impact on research quality, loss to follow-up, and dissemination.

OBJECTIVES

Patient and public involvement (PPI) in randomized controlled trials (RCTs) is hypothesized to enhance research quality, participant enrollment and retention, and uptake of findings. However, there are few empirical data on the impact of PPI in child health RCTs. Our objective was to compare research quality, loss to follow-up, and dissemination for child health RCTs with PPI in the research process (PPI+) with trials that did not (PPI-).

STUDY DESIGN AND SETTING

In this bibliometric analysis, all child health intervention reviews in the Cochrane Library of Systematic Reviews between 2021 and 2023 were identified. One RCT from each eligible systematic review was randomly selected, generating a sample of 199 individual trials. Two independent reviewers classified trials as PPI+ or PPI- and collected data on variables of interest.

RESULTS

Only 12/199 RCTs (6%) reported PPI in the research process. Percent lost to follow-up was higher in PPI+ trials compared to PPI- trials among noncluster RCTs (15% vs. 5%; P = .03), but lower for cluster RCTs (0% vs. 2%, respectively; P = .05). Research quality was similar for PPI+ and PPI- trials (42% vs. 29%, respectively, were rated as "good/fair"; P = .34). Both academic and nonacademic measures of dissemination were modestly higher for PPI+ trials compared with PPI- trials. Specifically, PlumX Captures per year (bookmarks, favorites, readers, follows) were higher for PPI+ trials compared with PPI- trials (18.2 vs. 11.9, respectively; P = .02).

CONCLUSION

PPI was infrequent among child health RCTs. Research quality was similar for PPI+ and PPI- trials. PPI may modestly enhance dissemination of research findings. The lack of standardized reporting of PPI leads to inconsistency in describing involvement, potential misclassification of PPI in research, and prevents the definitive analysis of the impact of PPI. Improved reporting of PPI in child health RCTs is needed.

PLAIN LANGUAGE SUMMARY

Patient and public involvement (PPI) in health research refers to researchers working together with patients and other members of the public on any or all aspects of a research study. For our study, we compared research quality, loss to follow-up, and dissemination (ie, sharing of research findings) for child health randomized controlled trials (RCTs) with PPI in the research process with trials without PPI. We searched the Cochrane Library of Systematic Reviews for all child health intervention reviews published between 2021 and 2023 and randomly selected one RCT from each systematic review, creating a sample of 199 individual trials. Two reviewers classified trials as PPI+ or PPI- and collected data on variables of interest. We found that PPI in child health RCTs was uncommon (12/199, 6%), but PPI+ RCTs had similar research quality and improved dissemination compared to PPI- RCTs.