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Inconsistent outcome reporting in large neonatal trials: a systematic review

James William Harrison Webbe1, Shohaib Ali2, Susanna Sakonidou1

  • 1Section of Neonatal Medicine, Imperial College London, London, UK.

Archives of Disease in Childhood. Fetal and Neonatal Edition
|May 16, 2019
PubMed

Insights

Neonatal clinical trials show inconsistent outcome reporting, with limited parent or former patient involvement. Developing a core outcome set is recommended to improve research quality and clinical relevance.

Area of Science:

  • Neonatal research
  • Clinical trial methodology
  • Evidence-based medicine

Background:

  • Inconsistent outcome selection and reporting in clinical trials contribute to research waste.
  • The prevalence of this issue in neonatal trials is not well-documented.
  • Standardized outcome reporting is crucial for reliable research findings.

Purpose of the Study:

  • To assess outcome reporting consistency in large neonatal clinical trials.
  • To examine the use of composite outcomes in these trials.
  • To determine the extent of parent or former patient involvement in outcome selection.

Main Methods:

  • A systematic literature search was performed across major databases (CENTRAL, CINAHL, EMBASE, MEDLINE).
  • Randomized trials involving at least 100 infants per arm, published between July 2012 and July 2017, were included.
  • Outcomes, outcome measures, and parent/former patient involvement were extracted and categorized.

Main Results:

  • Seventy-six trials with 43,126 infants were analyzed, reporting 216 distinct outcomes and 889 measures.
  • Outcome reporting was highly variable; only 88% reported survival, and most outcome measures appeared in single trials.
  • Thirty-three composite outcomes were used, but no trials reported parent or former patient involvement in outcome selection.

Conclusions:

  • Inconsistent outcome reporting and lack of stakeholder involvement in neonatal trials hinder clinically meaningful research.
  • Establishing a core outcome set for neonatal trials, with multi-stakeholder input, is essential.
  • This initiative aims to enhance the quality and relevance of future neonatal research.
Abstract

Keywords:
neonatologyoutcomes researchpatient perspective

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