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

Patient and public involvement (PPI) in randomized controlled trials (RCTs) is hypothesized to enhance research quality, participant enrolment 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 patient and public involvement in the research process (PPI+), with trials that did not (PPI-). 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. Only 12/199 RCTs (6%) reported patient and public involvement in the research process. Percent lost to follow-up was higher in PPI+ trials compared to PPI- trials among non-cluster RCTs (15% versus 5%; p=0.03), but lower for cluster RCTs (0% versus 2%, respectively; p=0.05). Research quality was similar for PPI+ and PPI- trials (42% versus 29%, respectively were rated as 'good/fair'; p=0.34). Both academic and non-academic 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 versus 11.9, respectively; p=0.02). Patient and public involvement 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.