Enrollment and reporting practices in pediatric general surgical randomized clinical trials: A systematic review and observational analysis.

Abstract

Pediatric surgical randomized clinical trials (RCTs) are labor-intensive and costly. This systematic review investigated patient accrual and estimates of study duration in RCTs by interrogating enrollment and registration practices. We performed a peer-review search of multiple databases from 2000 to 2016 evaluating RCTs salient to the field with inclusion mandated that a self-identified pediatric surgeon be listed as an author. Trial registries were also searched. RCTs were appraised, and predictors of success were evaluated using multivariate logistic regression, with success defined as achievement of recruitment objectives. After screening, 137 RCTs were analyzed. Mean Jadad score was 1.80 (median=2). CONSORT scores ranged between 17% and 97% (median=58%). Sixty-seven studies described sample-size determination, 49 reported projected enrollment, and 26 were successful. Among 26 registered RCTs, 15 disclosed their expected completion date, which was achieved by 8. On average, protocols underwent 3.42 iterations. 9% of trials were terminated before completion, most commonly owing to poor recruitment. Trial registration and urgent cases significantly predicted success on multivariable analysis (p<0.05). Overall quality of reporting in pediatric surgical trials is poor. Sample-size calculation and patient accrual are frequently poorly performed or underestimated, resulting in trial overrun and/or premature termination. These data may help inform subsequent study design and facilitate successful completion. Level III-Systematic Review and Observational (Case-Control) Analysis.