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Journal Article Review Ppublish 1 citation

PubMed: 42283642 DOI: 10.1016/S2352-4642(26)00005-2

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

Lancet Child Adolesc Health 10(4):284-296

Authors: 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, Martin Offringa

Affiliations

  • Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.
  • INFORM RARE Research Network, Ottawa, ON, Canada.
  • School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
  • Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.
  • School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada; Ottawa Hospital Research Institute, Ottawa, ON, Canada.
  • Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada; Department of Pediatrics, Division of Adolescent Medicine, The Hospital for Sick Children, Toronto, ON, Canada; Department of Pediatrics, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Institute of Clinical Evaluation Sciences (ICES), Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
  • SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada.
  • Institut de Recerca Sant Joan de Déu, Barcelona, Spain; Universitat Internacional de Catalunya, Immaculada, Barcelona, Spain; European Young Person's Advisory Group Network, Barcelona, Spain.
  • Division of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
  • Neonatal Medicine, School of Public Health and Centre for Paediatrics and Child Health, Imperial College London, Chelsea and Westminster Hospital Campus, London, UK.
  • University Hospital of Montpellier, Child and Adolescent Psychiatry (MPEA1), Saint Eloi Hospital, Montpellier, France; INSERM CESP U1018, Paris, France.
  • Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.
  • Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada; Edwin S.H. Leong Centre for Healthy Children, University of Toronto, ON, Canada.
  • TEDDY European Network of Excellence for Paediatric Research, Bari, Italy.
  • Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.
  • Department of General Pediatrics and Pediatric Infectious Diseases, Necker Hospital for Sick Children, Université Paris Cité, Paris, France; Center for Research in Epidemiology and Statistics, Université Paris Cité, Paris, France.
  • Division of Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada.
  • Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; Department of Hospital Pharmacy, Erasmus MC, Rotterdam, Netherlands.
  • Department of Pediatrics, Faculty of Medicine, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.
  • Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
  • Hospices Civils de Lyon, NICU Femme Mere Enfant Hospital; EMET, LBBE, University of Lyon 1, Lyon, France.
  • SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada; CHEO Research Institute, Ontario Child Health Support Unit, Ottawa, ON, Canada.
  • Alberta Research Centre for Health Evidence, Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
  • Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada; Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.
  • Children Heart Center, Skane University Hospital, Lund, Sweden.
  • Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
  • Population Health Sciences Institute, Newcastle University, Newcastle, UK; NIHR Innovation Observatory, Newcastle University, Newcastle, UK.
  • Children's Hospital of Eastern Ontario Research Institute and Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
  • Department of Pediatrics Maastricht University Medical Centre and School of Health Professions Education, Maastricht University, Maastricht, Netherlands.
  • ICON, Langen, Germany.
  • The INCLEN Trust International, New Delhi, India.
  • Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada; Division of Infectious Diseases, The Hospital for Sick Children, Toronto, ON, Canada; Department of Pediatrics, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
  • Division of Pediatric Pain, Palliative and Integrative Medicine, University of California at San Francisco, San Francisco, CA, USA.
  • SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada; Canadian PKU and Allied Disorders (CanPKU+), Toronto, ON, Canada.
  • Department of Pediatrics, College of Medicine, University of Saskatchewan, SK, Canada.
  • Maternal Infant Child and Youth Research Network (MICYRN), Vancouver, BC, Canada.
  • Department of Neonatology, Emma Children's Hospital, Amsterdam University Medical Centers, Amsterdam, Netherlands; Amsterdam Reproduction and Development, Amsterdam, Netherlands.
  • Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada; Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, ON, Canada.

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.

MeSH

Clinical Protocols, Caregivers, Adolescent, Pediatrics, Child