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

Author

Listed:
  • Ami Baba
  • Maureen Smith
  • Beth K Potter

    (uOttawa - Université d'Ottawa [Ontario])

  • An-Wen Chan

    (University of Toronto)

  • David Moher

    (The Ottawa Hospital)

  • Alene Toulany

    (University of Toronto)

  • Amanda Doherty-Kirby
  • Begonya Nafria Escalera
  • Catherine Stratton

    (University of Toronto)

  • Chris Gale

    (Chelsea and Westminster Hospital)

  • Colin Macarthur
  • Diane Purper-Ouakil

    (Hôpital Saint Eloi [CHU Montpellier] - 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 - 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 - Université Paris-Saclay)

  • Edmund Juszczak

    (UON - University of Nottingham, UK)

  • Eyal Cohen
  • Giorgio Reggiardo

    (UE - Union Européenne = European Union)

  • Jennifer Preston

    (University of Liverpool)

  • Jérémie F Cohen

    (UP13 - Université Paris 13, USPC - Université Sorbonne Paris Cité)

  • Julia Upton
  • Karel Allegaert

    (Erasmus MC - Erasmus University Medical Center [Rotterdam], KU Leuven - Catholic University of Leuven = Katholieke Universiteit Leuven)

  • Katelynn Boerner
  • Kayur Mehta

    (JHU - Johns Hopkins University [Baltimore])

  • Kim an Nguyen

    (UCBL - Université Claude Bernard Lyon 1 - Université de Lyon, HFME - Hôpital Femme Mère Enfant [CHU - HCL] - 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)

  • Kimberly Courtney
  • Lisa Hartling

    (University of Alberta)

  • Menelaos Konstantinidis

    (University of Toronto)

  • Michal Odermarsky
  • Nancy J Butcher

    (University of Toronto)

  • Niina Kolehmainen
  • Patricia E Longmuir
  • Peter J Gill
  • Piet Leroy
  • Reinhard Feneberg
  • Ramesh Poluru
  • Shaun K Morris

    (University of Toronto)

  • Stefan J Friedrichsdorf

    (UC San Francisco - University of California [San Francisco] - UC - University of California)

  • Tanya Chute Nagy
  • Terry P Klassen

    (U of S - University of Saskatchewan [Saskatoon, Canada])

  • Thierry Lacaze-Masmonteil
  • Wes Onland

    (Amsterdam UMC - Amsterdam University Medical Centers)

  • Martin Offringa

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.

Suggested Citation

  • 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, 2026. "SPIRIT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols," Post-Print hal-05614920, HAL.
    • Handle: RePEc:hal:journl:hal-05614920
    DOI: 10.1136/bmj-2025-085064
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