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

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.

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Publication Details

Journal
BMJ
Published
2026-02-24
DOI
https://doi.org/10.1136/bmj-2025-085063
Citations
1
Primary Topic
Meta-analysis and systematic reviews
Type
article
Field-Weighted Citation Impact
28.09

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article

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

Reinhard Feneberg, Thierry Lacaze-Masmonteil, Emma J. Mew, Katelynn E. Boerner et al.
1 citations
BMJ
Meta-analysis and systematic reviews
28.09
article

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

Reinhard Feneberg, Thierry Lacaze-Masmonteil, Emma J. Mew, Katelynn E. Boerner, Eyal Cohen, Colin Macarthur, Jennifer Preston, Giorgio Reggiardo, Patricia E. Longmuir, Stefan J. Friedrichsdorf, Potter Bk, Julia Upton, Catherine Stratton, Jérémie F. Cohen, Edmund Juszczak, Peter J. Gill, Kimberly A. Courtney, Begonya Nafría, Tibor Nagy, Ami Baba, Wes Onland, Diane Purper-Ouakil, Amanda Doherty-Kirby, Lisa Hartling, Maureen Smith, Kayur Mehta, Chris Gale, Shaun K Morris, Kim An Nguyen, Ramesh Poluru, Piet Leroy, David Moher, Terry P Klassen, Alene Toulany, Menelaos Konstantinidis, An-Wen Chan, Martin Offringa, Karel Allegaert
article en
1 citations

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.

BMJVol. 392
Université Claude Bernard Lyon 1 (FR), Délégation Paris 5 (FR), St. Michael's Hospital (CA), European Union (BE), University of Nottingham (GB), Johns Hopkins University (US), University of Liverpool (GB), University of Ottawa (CA), University of Alberta (CA), Inserm (FR), University of California, San Francisco (US), University of Toronto (CA), Université Paris Cité (FR), Children's Hospital of Eastern Ontario (CA), Canadian Armed Forces (CA), Maastricht University Medical Centre (NL), Agricultural Research Institute of Ontario (CA), Ottawa Hospital (CA), Hospital for Sick Children (CA), Women's College Hospital (CA), Erasmus MC (NL), Universitat Internacional de Catalunya (ES), University of Saskatchewan (CA), Hôpital Femme Mère Enfant (FR), Sorbonne Paris Cité (FR), Centre Hospitalier Universitaire de Montpellier (FR), Emma Kinderziekenhuis (NL), Center for Children (US), Hospices Civils de Lyon (FR), Canadian Respiratory Research Network (CA), MinebeaMitsumi (Germany) (DE), Centre de recherche en Epidémiologie et Santé des Populations (FR), Young Adult Institute (US), Public Health Ontario (CA), Sant Joan de Déu Research Foundation (ES), Child, Adolescent and Family Mental Health (CA), Asklepios Klinik Langen (DE), Laboratoire de Biométrie et Biologie Evolutive (FR), Children’s Health Research Institute (CA), Chelsea and Westminster Hospital (GB), Skåne University Hospital (SE), SickKids Foundation (CA), Institute for Clinical Evaluative Sciences (CA), Amsterdam University Medical Centers (NL), BC Children's Hospital (CA), INCLEN Trust International (IN), Institut de Recerca Sant Joan de Déu, Ottawa Hospital Research Institute (CA), Unity Health Toronto, Newcastle University (GB), Erasmus University Rotterdam (NL), KU Leuven (BE)
Canadian Institutes of Health Research
Openalex Percentile: Top 1%
Meta-analysis and systematic reviews
28.09
DOIOpen Access PDFOpenAlex
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