CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials
Appropriately designed, conducted, and reported randomised controlled trials (RCTs) in children and adolescents inform treatment and healthcare decisions made by young people, families, researchers, clinicians, regulators, funders, policymakers, and other interest holders. To critically evaluate, interpret, and apply trial results, readers require access to a complete and transparent report of what was planned, done, and found, taking unique considerations specific to children and adolescents into account. Harmonised guidance based on evidence and consensus is needed to optimise standardised reporting and reduce research waste in paediatric RCTs. As an extension to the Consolidated Standards of Reporting Trials (CONSORT) 2025 statement, the CONSORT-Children and Adolescents (CONSORT-C) 2026 reporting guideline aims to improve the quality and completeness of reporting of paediatric RCTs that involve participants aged 0-19 years. The Enhancing the Quality of Transparency of Health Research (EQUATOR) Network’s published framework primarily informed the development of CONSORT-C 2026. A literature review was conducted to generate a list of candidate reporting items. To obtain direct input from young people and family caregivers throughout the project, a Youth Advisory Group and a Family Caregiver Advisory Group were formed. An international Delphi study with a priori consensus thresholds, consensus meeting, group writing of the explanation and elaboration paper, and pilot testing were conducted. CONSORT-C 2026 consists of a checklist with 13 new reporting items, including one youth generated and six youth endorsed items; the accompanying explanation and elaboration paper explains all items and offers examples of good reporting. CONSORT-C 2026 can be considered a minimum set of reporting items applicable to paediatric RCT reports reflecting the priorities of clinicians, researchers, young people, family caregivers, and other interest holders. Widespread implementation and uptake of CONSORT-C 2026 should optimise the usability of trial results for these populations, improve the reproducibility of trial results, and reduce research waste.
Authors
- Reinhard Feneberg
- Thierry Lacaze-Masmonteil
- Emma J. Mew (ORCID: https://orcid.org/0000-0002-5667-1394)
- Katelynn E. Boerner (ORCID: https://orcid.org/0000-0003-1652-4813)
- Eyal Cohen (ORCID: https://orcid.org/0000-0003-0112-7188)
- P. L. Leroy
- Colin Macarthur (ORCID: https://orcid.org/0000-0002-5029-0996)
- Jennifer Preston (ORCID: https://orcid.org/0000-0003-4800-234X)
- Giorgio Reggiardo (ORCID: https://orcid.org/0000-0003-4237-6797)
- Patricia E. Longmuir (ORCID: https://orcid.org/0000-0003-4827-0870)
- Stefan J. Friedrichsdorf (ORCID: https://orcid.org/0000-0001-6144-3620)
- Potter Bk
- Maï K. Nguyen (ORCID: https://orcid.org/0000-0003-1192-0980)
- Julia Upton (ORCID: https://orcid.org/0000-0001-5320-4232)
- Catherine Stratton (ORCID: https://orcid.org/0000-0002-1841-4565)
- Jérémie F. Cohen (ORCID: https://orcid.org/0000-0003-3572-8985)
- Edmund Juszczak (ORCID: https://orcid.org/0000-0001-5500-2247)
- Alène Toulany (ORCID: https://orcid.org/0000-0003-1238-7049)
- Peter J. Gill (ORCID: https://orcid.org/0000-0002-6253-1312)
- Kimberly A. Courtney
- Begonya Nafría (ORCID: https://orcid.org/0000-0002-4494-3663)
- Tibor Nagy (ORCID: https://orcid.org/0000-0002-3225-0683)
- Ami Baba
- Wes Onland
- Diane Purper-Ouakil
- An-Wen Chan
- Amanda Doherty-Kirby
- Lisa Hartling
- Chris Gale
- Ramesh Poluru
- David Moher
- Terry P. Klassen
- Maureen Smith
- Menelaos Konstantinidis
- Kayur Mehta
- Karel Allegaert
Institutions
- 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)
Publication Details
- Journal
- BMJ
- Published
- 2026-02-24
- DOI
- https://doi.org/10.1136/bmj-2025-085061
- Citations
- 4
- Primary Topic
- Meta-analysis and systematic reviews
- Type
- article
- Field-Weighted Citation Impact
- 112.35
Funders
- Canadian Institutes of Health Research