SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: 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: University of Ottawa [Ottawa]
An-Wen Chan: University of Toronto
David Moher: University of Ottawa [Ottawa], The Ottawa Hospital
Alene Toulany: SickKids - The Hospital for sick children [Toronto], University of Toronto
Begonya Nafria Escalera: Institut de Recerca Pediàtrica Hospital Sant Joan de Déu [Barcelona, Spain], UIC - Universitat Internacional de Catalunya [Barcelona]
Catherine Stratton: University of Toronto
Chris Gale: Chelsea and Westminster Hospital
Colin Macarthur: SickKids - The Hospital for sick children [Toronto]
Diane Purper-Ouakil: CESP - Centre de recherche en épidémiologie et santé des populations - UVSQ - Université de Versailles Saint-Quentin-en-Yvelines - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Paul Brousse - GHU AP-HP. Université Paris Saclay - INSERM - Institut National de la Santé et de la Recherche Médicale - Université Paris-Saclay, Hôpital Saint Eloi [CHU Montpellier] - CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
Edmund Juszczak: UON - University of Nottingham, UK
Eyal Cohen: SickKids - The Hospital for sick children [Toronto], University of Toronto
Jennifer Preston: University of Liverpool
Jérémie F Cohen: EPOPé [CRESS - U1153 / UMR_A 1125] - Obstetrical, Perinatal and Pediatric Epidemiology | Épidémiologie Obstétricale, Périnatale et Pédiatrique - CRESS (U1153 / UMR_A 1125) - Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques - INSERM - Institut National de la Santé et de la Recherche Médicale - UPCité - Université Paris Cité - INRAE - Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement, Département de Pédiatrie et maladies infectieuses [CHU Necker] - Hôpital Necker - Enfants Malades [AP-HP] - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
Julia Upton: SickKids - The Hospital for sick children [Toronto]
Karel Allegaert: Erasmus MC - Erasmus University Medical Center [Rotterdam], KU Leuven - Catholic University of Leuven = Katholieke Universiteit Leuven
Katelynn Boerner: UBC - University of British Columbia [Canada]
Kayur Mehta: Johns Hopkins Bloomberg School of Public Health [Baltimore] - JHU - Johns Hopkins University [Baltimore]
Kim an Nguyen: HCL - Hospices Civils de Lyon, LBBE - Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 - UCBL - Université Claude Bernard Lyon 1 - Université de Lyon - VAS - VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement - CNRS - Centre National de la Recherche Scientifique
Lisa Hartling: University of Alberta
Menelaos Konstantinidis: University of Toronto, St. Michael's Hospital
Michal Odermarsky: Skane University Hospital [Lund]
Nancy J Butcher: SickKids - The Hospital for sick children [Toronto], University of Toronto
Niina Kolehmainen: Newcastle University [Newcastle]
Patricia E Longmuir: University of Ottawa [Ottawa]
Peter J Gill: SickKids - The Hospital for sick children [Toronto]
Piet Leroy: Maastricht University [Maastricht]
Shaun K Morris: SickKids - The Hospital for sick children [Toronto], 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
Martin Offringa: SickKids - The Hospital for sick children [Toronto]

Post-Print from HAL

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 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 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 essential 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. SPIRIT-C 2026 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.

Keywords: Extension (predicate logic); MEDLINE; Clinical trial; Research design; Randomized controlled trial (search for similar items in EconPapers)
Date: 2026-04
Note: View the original document on HAL open archive server: https://hal.science/hal-05574323v1
References: Add references at CitEc
Citations:

Published in The Lancet Child & Adolescent Health, 2026, 10 (4), pp.284-296. ⟨10.1016/s2352-4642(26)00005-2⟩

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-05574323

DOI: 10.1016/s2352-4642(26)00005-2

Access Statistics for this paper

More papers in Post-Print from HAL
Bibliographic data for series maintained by CCSD ().