CONSORT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and impact of paediatric randomised trials

Ami Baba, Maureen Smith, Beth K Potter, An-Wen Chan, David Moher, Alene Toulany, Amanda Doherty-Kirby, Begonya Nafria Escalera, Catherine Stratton, Chris Gale, Colin Macarthur, Diane Purper-Ouakil, Edmund Juszczak, Eyal Cohen, Giorgio Reggiardo, Jennifer Preston, Jérémie F Cohen (), Julia Upton, Karel Allegaert, Katelynn Boerner, Kayur Mehta, Kim an Nguyen, Kimberly Courtney, Lisa Hartling, Menelaos Konstantinidis, Michal Odermarsky, Niina Kolehmainen, Patricia E Longmuir, Peter J Gill, Piet Leroy, Reinhard Feneberg, Ramesh Poluru, Shaun K Morris, Stefan J Friedrichsdorf, Tanya Chute Nagy, Terry P Klassen, Thierry Lacaze-Masmonteil, Wes Onland and Martin Offringa
Additional contact information
Beth K Potter: University of Ottawa [Ottawa]
David Moher: University of Ottawa [Ottawa], The Ottawa Hospital
Chris Gale: Chelsea and Westminster Hospital
Diane Purper-Ouakil: INSERM - Institut National de la Santé et de la Recherche Médicale, CHU Montpellier = Montpellier University Hospital - CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier], CESP - Centre de recherche en épidémiologie et santé des populations - UVSQ - Université de Versailles Saint-Quentin-en-Yvelines - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Paul Brousse - AP-HP. Université Paris Saclay - INSERM - Institut National de la Santé et de la Recherche Médicale - Université Paris-Saclay
Edmund Juszczak: UON - University of Nottingham, UK
Giorgio Reggiardo: UE - Union Européenne = European Union
Jennifer Preston: University of Liverpool
Jérémie F Cohen: UP13 - Université Paris 13, USPC - Université Sorbonne Paris Cité
Karel Allegaert: Erasmus MC - Erasmus University Medical Center [Rotterdam], KU Leuven - Catholic University of Leuven = Katholieke Universiteit Leuven
Kayur Mehta: JHU - Johns Hopkins University [Baltimore]
Kim an Nguyen: UCBL - Université Claude Bernard Lyon 1 - Université de Lyon, HFME - Hôpital Femme Mère Enfant [CHU - HCL] - HCL - Hospices Civils de Lyon, HCL - Hospices Civils de Lyon, LBBE - Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 - UCBL - Université Claude Bernard Lyon 1 - Université de Lyon - VAS - VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement - CNRS - Centre National de la Recherche Scientifique
Lisa Hartling: University of Alberta
Niina Kolehmainen: Newcastle University [Newcastle]
Stefan J Friedrichsdorf: UC San Francisco - University of California [San Francisco] - UC - University of California
Terry P Klassen: U of S - University of Saskatchewan [Saskatoon, Canada]
Wes Onland: Amsterdam UMC - Amsterdam University Medical Centers

Post-Print from HAL

Abstract: Paediatric randomised controlled trials (RCTs) generate critical evidence on the effects of interventions aimed at improving health outcomes in children and adolescents (aged 0-19 years). Evidence from appropriately designed, conducted, and reported RCTs is key to the evaluation and implementation of safe and effective interventions. Clear and comprehensive reporting of paediatric specific trial methods implemented in the trial and of its results facilitates a proper evaluation, including generalisability and applicability considerations and critical appraisal of trial methods and findings. The Consolidated Standards of Reporting Trials (CONSORT) 2025 statement provides general guidance for authors when reporting RCTs but contains no detail specific to paediatric trials. To overcome existing deficiencies in the reporting of paediatric clinical trials, we developed CONSORT-Children and Adolescents (CONSORT-C) 2026 as an extension of CONSORT 2025. A group writing approach was implemented and involved key partners with lived experience relevant to paediatric clinical trials, including family caregivers, trialists, child health researchers, clinicians, journal editors, and methodologists to contribute to this explanation and elaboration paper. This paper was prepared to provide explanations and good reporting examples for the 13 new CONSORT-C 2026 reporting items, paediatric considerations with good reporting examples for eight CONSORT 2025 items, and a glossary. It is recommended to use this explanation and elaboration paper as a resource together with the CONSORT-C 2026 checklist. Widespread implementation of CONSORT-C 2026 should improve reporting quality, enhance critical appraisal of key methodological aspects of paediatric RCTs, facilitate the peer review processes, and foster better understanding and interpretation of study findings by end users. Consequently, effective interventions may be translated to paediatric practice and policy decisions more efficiently, and ultimately improve patient outcomes.

Keywords: MEDLINE; Quality (philosophy); Primary care; Work (physics); Clinical trial (search for similar items in EconPapers)
Date: 2026
References: Add references at CitEc
Citations:

Published in BMJ - British Medical Journal, 2026, 392, pp.e085063-e085063. ⟨10.1136/bmj-2025-085063⟩

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-05574262

DOI: 10.1136/bmj-2025-085063

Access Statistics for this paper

More papers in Post-Print from HAL
Bibliographic data for series maintained by CCSD ().