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Quality of reporting of neonatal and infant trials in high-impact journals

Sara B DeMauro1, Annie Giaccone, Haresh Kirpalani

  • 1Department of Pediatrics, Children's Hospital of Philadelphia and the Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA. demauro@email.chop.edu

Pediatrics
|August 24, 2011
PubMed

Insights

Reporting quality for infant and neonatal randomized controlled trials (RCTs) is inconsistent, hindering validity assessment. Adhering to Consolidated Standards of Reporting Trials (CONSORT) guidelines can improve the quality of these crucial pediatric studies.

Area of Science:

  • Pediatric Research
  • Clinical Trial Methodology
  • Neonatal Medicine

Background:

  • Reporting quality of randomized controlled trials (RCTs) is crucial for assessing study validity.
  • Infant and neonatal populations require specific considerations in clinical trial design and reporting.
  • High-impact journals often publish significant pediatric research, making their reporting standards critical.

Purpose of the Study:

  • To systematically review the reporting quality of infant and neonatal RCTs published in high-impact journals.
  • To identify characteristics of RCTs that correlate with higher quality of reporting.
  • To provide recommendations for improving the reporting standards of pediatric RCTs.

Main Methods:

  • Systematic review of RCTs involving infants (<12 months) published between 2005-2009 in six leading pediatric and general medical journals.
  • Evaluation of 179 eligible RCTs using 11 quality criteria from the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
  • Nonparametric statistical methods were used to analyze the relationship between reporting quality and study characteristics.

Main Results:

  • Reporting quality varied significantly across the 179 reviewed RCTs.
  • While 99% reported participant numbers, only 50% included a flow diagram.
  • Higher reporting quality was associated with larger participant numbers, multi-center studies, and publication in general medical journals (P < .0001).

Conclusions:

  • The quality of reporting for infant and neonatal RCTs is inconsistent, particularly in pediatric-focused journals.
  • Inconsistent reporting compromises the accurate assessment of the validity of many RCT findings.
  • Adherence to CONSORT guidelines is recommended to enhance the reporting quality of pediatric RCTs.
Abstract

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