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Trial registration in pediatric surgery trials

Sana Rokhsefat1, Deanna E Morra1, Martin Offringa2

  • 1Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.

Journal of Pediatric Surgery
|November 19, 2017
PubMed

Insights

Pediatric surgical trial registration is poor, with low registration rates and incomplete data. This highlights the need for improved prospective registration to ensure transparent and reproducible research in pediatric surgery.

Area of Science:

  • Clinical Trials
  • Pediatric Surgery
  • Research Transparency

Background:

  • Prospective clinical trial registration enhances transparency and reduces selective reporting bias.
  • Previous studies indicated poor registration practices in adult surgical trials.
  • The status of pediatric surgical trial registration was previously unknown.

Purpose of the Study:

  • To determine the proportion of pediatric surgical trials published in 2014 that were prospectively registered.
  • To assess the adequacy and completeness of the registration data for these trials.

Main Methods:

  • A systematic search of MEDLINE identified prospective pediatric intervention studies published in 2014.
  • Pediatric surgical trials were selected, and their registration numbers were verified in trial registries.
  • Data completeness was assessed using the WHO minimum data set, comparing registry information with publication data.

Main Results:

  • Only 28% of the 54 analyzed pediatric surgical trials published a registration number.
  • Among registered trials, 40% were registered retrospectively, and 40% altered their primary/secondary outcomes.
  • One trial reported an incorrect registration number.

Conclusions:

  • Pediatric surgery trials published in 2014 demonstrated a low rate of prospective registration and incomplete registration data.
  • Initiatives to improve prospective trial registration are crucial for generating high-quality, transparent, and reproducible evidence in pediatric surgery.
Abstract

Keywords:
Outcome measuresPediatric surgery trialsTrial registration

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