Strengthening Reporting of Neonatal Trials.

Humans Infant, Newborn Clinical Trials as Topic / standards Guidelines as Topic

Journal

Pediatrics
ISSN: 1098-4275
Titre abrégé: Pediatrics
Pays: United States
ID NLM: 0376422

Informations de publication

Date de publication:
01 09 2023
Historique:
accepted: 26 06 2023
medline: 4 9 2023
pubmed: 29 8 2023
entrez: 29 8 2023
Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1542/peds.2022-060765 PMID: 37641894
pubmed: 37641894
pii: 193774
doi: 10.1542/peds.2022-060765
pii:
doi:

Types de publication

Review Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023 by the American Academy of Pediatrics.

Auteurs

James Webbe (J)

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

Ami Baba (A)

Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.

Nancy J Butcher (NJ)

Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.

Craig Rodrigues (C)

Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.

Emma Stallwood (E)

Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.

Katherine Goren (K)

Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.

Andrea Monsour (A)

Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.

Alvin S M Chang (ASM)

Quality, Safety and Risk Management (QSRM) and Department of Neonatology, KK Women's and Children's Hospital, Singapore.
DUKE-NUS Medical School, Singapore.

Amit Trivedi (A)

The Children's Hospital at Westmead, New South Wales, Australia.

Brett J Manley (BJ)

The Royal Women's Hospital, Melbourne, Australia.

Emma McCall (E)

School of Nursing and Midwifery, Queen's University Belfast, Northern Ireland.

Fiona Bogossian (F)

University of the Sunshine Coast, Sunshine Coast, Australia.

Fumihiko Namba (F)

Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Saitama, Japan.

Georg M Schmölzer (GM)

Department of Pediatrics, University of Alberta, Edmonton, Canada.

Himanshu Popat (H)

The Children's Hospital at Westmead, New South Wales, Australia.

Kim An Nguyen (KA)

Claude Bernard University Lyon, Lyon, France.

Lex W Doyle (LW)

Department of Obstetrics and Gynaecology, The Royal Women's Hospital, University of Melbourne, Parkville, Victoria, Australia.

Luke Jardine (L)

Department of Neonatology, Mater Mothers' Hospital, South Brisbane, Queensland, Australia.
University of Queensland, Brisbane, Australia.

Matthew A Rysavy (MA)

University of Texas Health Science Centre at Houston, Houston, Texas.

Menelaos Konstantinidis (M)

Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.

Muhd Alwi Muhd Helmi (MA)

Department of Paediatrics, International Islamic University, Kuala Lumpur, Malaysia.

Nai Ming Lai (NM)

School of Medicine, Faculty of Health and Medical Sciences, Taylor's University, Selangor, Malaysia.

Susanne Hay (S)

Department of Neonatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Harvard Medical School, Boston, Massachusetts.

Wes Onland (W)

Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands.

Yao Mun Choo (YM)

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

Chris Gale (C)

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

Roger F Soll (RF)

Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.

Martin Offringa (M)

Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Division of Neonatology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Strengthening Reporting of Neonatal Trials.
questionsmedicales.fr › Personnes › Tranches d'âge › Nourrisson › Nouveau-né › Strengthening Reporting of Neonatal Trials.
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Strengthening Reporting of Neonatal Trials.
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Assurance de la qualité des soins de santé › Recommandations comme sujet › Strengthening Reporting of Neonatal Trials.