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Strengthening Reporting of Neonatal Trials

James Webbe1, Ami Baba2, Nancy J Butcher2,3

  • 1Neonatal Medicine, School of Public Health, Imperial College London, United Kingdom.

Pediatrics
|August 29, 2023
PubMed

Insights

This study identified exemplary reporting of neonatal trial outcomes using CONSORT-Outcomes 2022 guidelines. Emulating these examples will improve data sharing and reduce research waste in neonatal clinical trials.

Area of Science:

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

Background:

  • Variability in outcome reporting in neonatal trials hinders applicability and evidence synthesis.
  • The Neonatal Core Outcomes Set and CONSORT-Outcomes 2022 provide standardized reporting guidelines.
  • Improved outcome reporting is crucial for effective clinical decision-making and research.

Approach:

  • Reviewed 36 neonatal trials published between 2015-2020 with >100 participants per arm.
  • Assessed primary outcome reporting against CONSORT 2010 and CONSORT-Outcomes 2022 guidelines.
  • Identified and extracted verbatim examples of clear and complete outcome reporting.

Key Points:

  • Examples of good reporting were found for survival, short-term neonatal complications, and long-term developmental outcomes.
  • Reporting was categorized based on the Neonatal Core Outcome Set.
  • The identified examples serve as models for future neonatal trial publications.

Conclusions:

  • Exemplary reporting of neonatal trial outcomes has been identified.
  • These examples demonstrate adherence to CONSORT 2010 and CONSORT-Outcomes 2022 guidelines.
  • Adopting these reporting standards will enhance information dissemination and minimize research waste.
Abstract

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