System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Review Ppublish 6 citations

PubMed: 42283643 DOI: 10.1016/S2352-4642(26)00004-0

CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials.

Lancet Child Adolesc Health 10(4):297-308

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

Appropriately designed, conducted, and reported randomised controlled trials (RCTs) in children and adolescents inform treatment and health-care decisions made by young people, families, researchers, clinicians, regulators, funders, policy makers, and other interest holders. To critically evaluate, interpret, and apply trial results, readers require access to a complete and transparent report of what was planned, done, and found, taking unique considerations specific to children and adolescents into account. Harmonised guidance based on evidence and consensus is needed to optimise standardised reporting and reduce research waste in paediatric RCTs. As an extension to the Consolidated Standards of Reporting Trials (CONSORT) 2025 statement, the CONSORT-Children and Adolescents (CONSORT-C) 2026 reporting guideline aims to improve the quality and completeness of reporting of paediatric RCTs that involve participants aged 0-19 years. The Enhancing the Quality of Transparency of Health Research (EQUATOR) Network's published framework primarily informed the development of CONSORT-C 2026. A literature review was conducted to generate a list of candidate reporting items. To obtain direct input from young people and family caregivers throughout the project, a Youth Advisory Group and a Family Caregiver Advisory Group were formed. An international Delphi study with a priori consensus thresholds, consensus meeting, group writing of the explanation and elaboration paper, and pilot testing were conducted. CONSORT-C 2026 consists of a checklist with 13 new reporting items, including one youth-generated and six youth-endorsed items; the accompanying explanation and elaboration paper explains all items and offers examples of good reporting. CONSORT-C 2026 can be considered a minimum set of reporting items applicable to paediatric RCT reports reflecting the priorities of clinicians, researchers, young people, family caregivers, and other interest holders. Widespread implementation and uptake of CONSORT-C 2026 should optimise the usability of trial results for these populations, improve the reproducibility of trial results, and reduce research waste.

MeSH

Caregivers, Adolescent, Research, Pediatrics, Child