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Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic

April V P Clyburne-Sherin1, Pravheen Thurairajah2, Mufiza Z Kapadia3

  • 1The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, SickKids Research Institute, Child Health Evaluative Sciences, 686 Bay Street, Toronto, ON, M5G 0A4, Canada. april.clyburne.sherin@gmail.com.

Trials
|September 20, 2015
PubMed

Insights

This study developed pediatric reporting guideline extensions, SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C), to improve transparency and reduce bias in pediatric clinical trials.

Area of Science:

  • Clinical Trials
  • Pediatric Research
  • Reporting Guidelines

Background:

  • Inadequate reporting of pediatric clinical trial protocols and reports is a persistent issue.
  • Existing guidelines like SPIRIT and CONSORT lack specific guidance for pediatric trials.
  • This necessitates the development of tailored reporting standards for pediatric research.

Purpose of the Study:

  • To systematically review evidence and recommendations for reporting items in pediatric trial protocols and reports.
  • To inform the development of pediatric extensions to the SPIRIT and CONSORT guidelines.
  • To improve the quality and transparency of pediatric clinical trial reporting.

Main Methods:

  • Conducted two systematic reviews searching MEDLINE, Cochrane Methodology Register, and reference lists.
  • Included publications with recommendations or empirical evidence for pediatric protocol (SPIRIT-C) or report (CONSORT-C) items.
  • Extracted study characteristics, recommendations, and evidence, synthesizing recurrent themes.

Main Results:

  • Included 366 publications for SPIRIT-C and 429 for CONSORT-C systematic reviews.
  • Identified recommendations for most original and potential reporting items for both SPIRIT-C and CONSORT-C.
  • Overarching themes included transparency, reproducibility, validity, bias, and ethics.

Conclusions:

  • These systematic reviews provide the first comprehensive evidence base for pediatric reporting guideline extensions.
  • The developed SPIRIT-C and CONSORT-C guidelines offer crucial guidance for pediatric trial reporting.
  • These extensions aim to improve reporting consistency, reduce research waste, and enhance the utility of pediatric trial documents.
Abstract

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