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Primary Outcomes Reporting in Trials (PORTal): a systematic review of inadequate reporting in pediatric randomized

Zafira Bhaloo1, Denise Adams1, Yali Liu1

  • 1CARE Program, Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton Continuing Care Center, Unit 8B, 11111 Jasper Avenue, Edmonton, Alberta T5K 0L4, Canada.

Journal of Clinical Epidemiology
|September 27, 2016
PubMed

Insights

Pediatric randomized controlled trials (RCTs) in major journals often lack clear primary outcomes and details on outcome measure validity. Further research is needed to understand if this is due to poor reporting or insufficient validation.

Area of Science:

  • Medical Research Methodology
  • Pediatric Clinical Trials

Background:

  • High-impact pediatric randomized controlled trials (RCTs) are crucial for advancing child health.
  • Assessing the quality of reporting in these trials is essential for reliable evidence synthesis.

Purpose of the Study:

  • To systematically review the reporting of primary outcomes in pediatric RCTs.
  • To evaluate the psychometric properties of outcome measures used in these trials.

Main Methods:

  • Systematic review of pediatric RCTs published in high-impact journals (2000-2010).
  • Two independent reviewers screened and extracted data from included studies.
  • Searches conducted in MEDLINE, EMBASE, and CENTRAL.

Main Results:

  • Of 206 included studies, 48.5% reported a single primary outcome, while 27% reported none.
  • 24% of studies reported multiple primary outcomes (2-20).
  • Only 33% of trials using outcome measures reported their psychometric properties.

Conclusions:

  • Pediatric RCTs in top journals demonstrate inadequate reporting of primary outcomes.
  • There is a significant deficit in reporting the psychometric properties of outcome measures in pediatric research.
  • Further investigation is required to determine if the issue lies in poor reporting or inadequate validation.
Abstract

Keywords:
Outcome measurePediatricPrimary outcomeRandomized controlled trialReportingSystematic review

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