SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols
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.
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)
- C P Gale
- 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
- Terry P. Klassen
- An-Wen Chan
- Amanda Doherty-Kirby
- Lisa Hartling
- Shaun K. Morris
- Ramesh Poluru
- David Moher
- 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-2025-085064
- Citations
- 3
- Primary Topic
- Meta-analysis and systematic reviews
- Type
- article
- Field-Weighted Citation Impact
- 84.26