Critical analysis of clinical research reporting in pediatric surgery: justifying the need for a new standard

Abstract

Background/purpose: Clinical practice in surgery relies heavily on observational data in which accurate and nonbiased reporting is critical. This study aims to assess the adequacy of clinical research reporting in pediatric surgery and to develop a means to raise the standard of such reporting.

Methods: The authors analyzed all observational studies published in The Journal of Pediatric Surgery from 1997 to 2002 (n = 300). Studies were assessed for 16 baseline criteria essential for the nonbiased reporting of clinical data (details regarding surgeons, cases, interventions, and statistical methods). Seven additional criteria pertaining to comparison methods were assessed in studies using controls.

Results: Ninety-five percent of all studies were retrospective, and only 25% utilized a control group. Most studies met less than half of the essential reporting criteria (mean, 7.6 of 16 baseline criteria; 3.3 of 7 comparison criteria). Reporting deficiencies were found in all major aspects of study design and statistical analysis.

Conclusions: More rigorous reporting of clinical data in pediatric surgery could increase the clinical utility of published results. The authors have identified the fundamental elements essential to nonbiased reporting of clinical research data in surgery. Implementation of mandatory peer-review guidelines based on these principles could set a new standard for clinical reporting in surgery.