SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols

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, Nancy J Butcher, 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: uOttawa - Université d'Ottawa [Ontario]
An-Wen Chan: University of Toronto
David Moher: The Ottawa Hospital
Alene Toulany: University of Toronto
Catherine Stratton: University of Toronto
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 - UP11 - Université Paris-Sud - Paris 11 - 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
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], Erasmus University Rotterdam (The Netherlands, Rotterdam) - EUR, 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
Lisa Hartling: University of Alberta
Menelaos Konstantinidis: University of Toronto
Nancy J Butcher: University of Toronto
Shaun K Morris: University of Toronto
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

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Abstract: Paediatric randomised controlled trials (RCTs) are key to evaluating new and existing interventions that can improve health outcomes in newborns, infants, children, and adolescents (aged 0-19 years). Well reported RCT protocols facilitate the planning and implementation of trials that generate high quality, reproducible evidence, and strengthen the foundations of paediatric healthcare decisions and ultimately improve patient outcomes. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 statement contains a checklist of essential reporting items and an explanation and elaboration paper. However, SPIRIT 2025 does not consider important elements that are unique to paediatric RCT protocols. As a paediatric extension to SPIRIT, we developed the SPIRIT-Children and Adolescents (SPIRIT-C) 2026 checklist, which this explanation and elaboration paper accompanies. We adopted a group writing approach to prepare this explanation and elaboration paper, and involved key partners with lived experience relevant to paediatric clinical trials, including family caregivers, trialists, child health researchers, clinicians, journal editors, and methodologists. This explanation and elaboration paper presents examples, explanations, and key elements for the 17 new SPIRIT-C 2026 reporting items; paediatric considerations with good reporting examples for six SPIRIT 2025 items; and a glossary. This paper also promotes the reporting of methodological rigor, patient safety, promotes a patient oriented approach, and facilitates the generation of high quality, reproducible trial evidence that will strengthen paediatric practice and policy decisions and ultimately improve patient outcomes.

Keywords: Checklist; Protocol (science); Psychological intervention; Randomized controlled trial; Elaboration; Guideline; Key (lock); MEDLINE (search for similar items in EconPapers)
Date: 2026
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Published in BMJ - British Medical Journal, 2026, 392, pp.e085064-e085064. ⟨10.1136/bmj-2025-085064⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-05614920

DOI: 10.1136/bmj-2025-085064

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