Strengthening Reporting of Neonatal Trials

Webbe J 1 , Baba A 2 , Butcher NJ 2 , Rodrigues C 2 , Stallwood E 2 , Goren K 2 Show all authors , Monsour A 2 , Chang ASM 3 , Trivedi A 4 , Manley BJ 5 , McCall E 6 , Bogossian F 7 , Namba F 8 , Schmölzer GM 9 , Popat H 4 , Nguyen KA 10 , Doyle LW 11 , Jardine L 12 , Rysavy MA 13 , Konstantinidis M 14 , Muhd Helmi MA 15 , Lai NM 16 , Hay S 17 , Onland W 18 , Choo YM 1 , Gale C 1 , Soll RF 2 , Offringa M 2 , CORE OUTCOME REPORTING IN NEONATAL TRIALS (CORINT) STUDY GROUP

Affiliations 

  • 1 Neonatal Medicine, School of Public Health, Imperial College London, United Kingdom
  • 2 Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
  • 3 Quality, Safety and Risk Management (QSRM) and Department of Neonatology, KK Women's and Children's Hospital, Singapore
  • 4 The Children's Hospital at Westmead, New South Wales, Australia
  • 5 The Royal Women's Hospital, Melbourne, Australia
  • 6 School of Nursing and Midwifery, Queen's University Belfast, Northern Ireland
  • 7 University of the Sunshine Coast, Sunshine Coast, Australia
  • 8 Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Saitama, Japan
  • 9 Department of Pediatrics, University of Alberta, Edmonton, Canada
  • 10 Claude Bernard University Lyon, Lyon, France
  • 11 Department of Obstetrics and Gynaecology, The Royal Women's Hospital, University of Melbourne, Parkville, Victoria, Australia
  • 12 Department of Neonatology, Mater Mothers' Hospital, South Brisbane, Queensland, Australia
  • 13 University of Texas Health Science Centre at Houston, Houston, Texas
  • 14 Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada
  • 15 Department of Paediatrics, International Islamic University, Kuala Lumpur, Malaysia
  • 16 School of Medicine, Faculty of Health and Medical Sciences, Taylor's University, Selangor, Malaysia
  • 17 Department of Neonatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
  • 18 Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands
Pediatrics, 2023 Sep 01;152(3).
PMID: 37641894 DOI: 10.1542/peds.2022-060765

Abstract

BACKGROUND AND OBJECTIVES: There is variability in the selection and reporting of outcomes in neonatal trials with key information frequently omitted. This can impact applicability of trial findings to clinicians, families, and caregivers, and impair evidence synthesis. The Neonatal Core Outcomes Set describes outcomes agreed as clinically important that should be assessed in all neonatal trials, and Consolidated Standards of Reporting Trials (CONSORT)-Outcomes 2022 is a new, harmonized, evidence-based reporting guideline for trial outcomes. We reviewed published trials using CONSORT-Outcomes 2022 guidance to identify exemplars of neonatal core outcome reporting to strengthen description of outcomes in future trial publications.

METHODS: Neonatal trials including >100 participants per arm published between 2015 to 2020 with a primary outcome included in the Neonatal Core Outcome Set were identified. Primary outcome reporting was reviewed using CONSORT 2010 and CONSORT-Outcomes 2022 guidelines by assessors recruited from Cochrane Neonatal. Examples of clear and complete outcome reporting were identified with verbatim text extracted from trial reports.

RESULTS: Thirty-six trials were reviewed by 39 assessors. Examples of good reporting for CONSORT 2010 and CONSORT-Outcomes 2022 criteria were identified and subdivided into 3 outcome categories: "survival," "short-term neonatal complications," and "long-term developmental outcomes" depending on the core outcomes to which they relate. These examples are presented to strengthen future research reporting.

CONCLUSIONS: We have identified examples of good trial outcome reporting. These illustrate how important neonatal outcomes should be reported to meet the CONSORT 2010 and CONSORT-Outcomes 2022 guidelines. Emulating these examples will improve the transmission of information relating to outcomes and reduce associated research waste.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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