Journal Article

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

Courtney, Kimberly, Longmuir, Patricia E, Cohen, Eyal, Onland, Wes, Feneberg, Reinhard, Chute Nagy, Tanya, Klassen, Terry P, Chan, An-Wen, Odermarsky, Michal, Morris, Shaun K, Potter, Beth K, Baba, Ami, Gill, Peter J, Doherty-Kirby, Amanda, Nafria Escalera, Begonya, Juszczak, Edmund, Leroy, Piet, Poluru, Ramesh, Boerner, Katelynn, Kolehmainen, Niina, Toulany, Alene, Reggiardo, Giorgio, Nguyen, Kim An, Friedrichsdorf, Stefan J, Macarthur, Colin, Hartling, Lisa, Konstantinidis, Menelaos, Moher, David, Mehta, Kayur, Stratton, Catherine, Preston, Jennifer, Butcher, Nancy J, Purper-Ouakil, Diane, Allegaert, Karel, Gale, Chris, Cohen, Jérémie F, Upton, Julia, Lacaze-Masmonteil, Thierry, Smith, Maureen, Offringa, Martin

2026

Overview

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.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ
• Subject: Adolescents / Advisors / Business administration / Caregivers / Children & youth / Clinical trials / Design / Feedback / Humanities and Social Sciences / Pediatrics / Research Methods & Reporting / Teenagers / Writing