Prevalence of patient and public involvement in child health randomized controlled trials and impact on research quality, loss to follow-up, and dissemination
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.197 | 0.442 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.014 | 0.019 |
| Bibliometrics | 0.005 | 0.005 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.006 | 0.004 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".