SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of paediatric randomised trial protocols

Randomised controlled trial (RCT) protocols contain essential details needed to understand and evaluate the trial’s planned aims, design, data collection methods, monitoring, data analysis, and participants’ safety. However, key information is often omitted from paediatric RCT protocols, including details on dose adjustments of interventions based on age, body surface area, or weight, developmental appropriateness of trial outcome measures and processes, or strategies to minimise participants’ anxiety and pain. These deficiencies impair the planning and implementation of potentially impactful trials for children and adolescents. Appropriate guidance is needed to support harmonised, comprehensive reporting of paediatric RCT protocols involving participants aged 0-19 years. The methodological framework for developing reporting guidelines published by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network was implemented to develop a paediatric extension to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 guidelines called SPIRIT-Children and Adolescents (SPIRIT-C) 2026. A list of candidate reporting items was generated from the literature, and a Youth Advisory Group and a Family Caregiver Advisory Group contributed vital input throughout the project. An international Delphi study with a priori consensus thresholds, a consensus meeting, group writing of the explanation and elaboration paper, and pilot testing of the draft guideline were conducted. SPIRIT-C 2026 consists of a checklist with 17 new reporting items for reporting paediatric RCT protocols; four items are youth generated and six youth endorsed. These can be considered a minimum set of reporting items pertinent to paediatric RCT protocols that are relevant to various interest holders, including young people, family caregivers, researchers, paediatric trialists, ethics committees, regulators, funders, and journal editors. The accompanying explanation and elaboration paper explains all items and offers examples of good reporting. Widespread implementation and uptake of SPIRIT-C 2026 should enhance the quality and usefulness of protocols for RCTs that involve participants from birth through adolescence and ultimately foster high quality paediatric trials.

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Publication Details

Journal
BMJ
Published
2026-02-24
DOI
https://doi.org/10.1136/bmj-2025-085062
Citations
4
Primary Topic
Meta-analysis and systematic reviews
Type
article
Field-Weighted Citation Impact
112.35
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article

SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of paediatric randomised trial protocols

Reinhard Feneberg, Thierry Lacaze-Masmonteil, Emma J. Mew, Katelynn E. Boerner et al.
4 citations
BMJ
Meta-analysis and systematic reviews
112.35
article

SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of paediatric randomised trial protocols

Reinhard Feneberg, Thierry Lacaze-Masmonteil, Emma J. Mew, Katelynn E. Boerner, C P Gale, Eyal Cohen, P. L. Leroy, Colin Macarthur, Jennifer Preston, Giorgio Reggiardo, Patricia E. Longmuir, Stefan J. Friedrichsdorf, Potter Bk, Maï K. Nguyen, 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, An-Wen Chan, Amanda Doherty-Kirby, Karel Allegaert, Lisa Hartling, Shaun K. Morris, Martin Offringa, Ramesh Poluru, David Moher, Terry P. Klassen, Alene Toulany, Maureen Smith, Menelaos Konstantinidis, Kayur Mehta
article en
4 citations

Abstract

Randomised controlled trial (RCT) protocols contain essential details needed to understand and evaluate the trial’s planned aims, design, data collection methods, monitoring, data analysis, and participants’ safety. However, key information is often omitted from paediatric RCT protocols, including details on dose adjustments of interventions based on age, body surface area, or weight, developmental appropriateness of trial outcome measures and processes, or strategies to minimise participants’ anxiety and pain. These deficiencies impair the planning and implementation of potentially impactful trials for children and adolescents. Appropriate guidance is needed to support harmonised, comprehensive reporting of paediatric RCT protocols involving participants aged 0-19 years. The methodological framework for developing reporting guidelines published by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network was implemented to develop a paediatric extension to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 guidelines called SPIRIT-Children and Adolescents (SPIRIT-C) 2026. A list of candidate reporting items was generated from the literature, and a Youth Advisory Group and a Family Caregiver Advisory Group contributed vital input throughout the project. An international Delphi study with a priori consensus thresholds, a consensus meeting, group writing of the explanation and elaboration paper, and pilot testing of the draft guideline were conducted. SPIRIT-C 2026 consists of a checklist with 17 new reporting items for reporting paediatric RCT protocols; four items are youth generated and six youth endorsed. These can be considered a minimum set of reporting items pertinent to paediatric RCT protocols that are relevant to various interest holders, including young people, family caregivers, researchers, paediatric trialists, ethics committees, regulators, funders, and journal editors. The accompanying explanation and elaboration paper explains all items and offers examples of good reporting. Widespread implementation and uptake of SPIRIT-C 2026 should enhance the quality and usefulness of protocols for RCTs that involve participants from birth through adolescence and ultimately foster high quality paediatric trials.

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)
Openalex Percentile: Top 0%
Meta-analysis and systematic reviews
112.35
DOIOpen Access PDFOpenAlex
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