{
  "abstract": "Paediatric randomised controlled trials (RCTs) generate critical evidence on the effects of interventions aimed at improving health outcomes in children and adolescents (aged 0-19 years). Evidence from appropriately designed, conducted, and reported RCTs is key to the evaluation and implementation of safe and effective interventions. Clear and comprehensive reporting of paediatric specific trial methods implemented in the trial and of its results facilitates a proper evaluation, including generalisability and applicability considerations and critical appraisal of trial methods and findings. The Consolidated Standards of Reporting Trials (CONSORT) 2025 statement provides general guidance for authors when reporting RCTs but contains no detail specific to paediatric trials. To overcome existing deficiencies in the reporting of paediatric clinical trials, we developed CONSORT-Children and Adolescents (CONSORT-C) 2026 as an extension of CONSORT 2025. A group writing approach was implemented and involved key partners with lived experience relevant to paediatric clinical trials, including family caregivers, trialists, child health researchers, clinicians, journal editors, and methodologists to contribute to this explanation and elaboration paper. This paper was prepared to provide explanations and good reporting examples for the 13 new CONSORT-C 2026 reporting items, paediatric considerations with good reporting examples for eight CONSORT 2025 items, and a glossary. It is recommended to use this explanation and elaboration paper as a resource together with the CONSORT-C 2026 checklist. Widespread implementation of CONSORT-C 2026 should improve reporting quality, enhance critical appraisal of key methodological aspects of paediatric RCTs, facilitate the peer review processes, and foster better understanding and interpretation of study findings by end users. Consequently, effective interventions may be translated to paediatric practice and policy decisions more efficiently, and ultimately improve patient outcomes.",
  "authors": [
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"
      ],
      "name": "Ami Baba"
    },
    {
      "affiliations": [
        "INFORM RARE Research Network, Ottawa, ON, Canada"
      ],
      "name": "Maureen Smith"
    },
    {
      "affiliations": [
        "School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada"
      ],
      "name": "Beth K Potter"
    },
    {
      "affiliations": [
        "Department of Medicine, Women’s College Research Institute, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "An-Wen Chan"
    },
    {
      "affiliations": [
        "School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada",
        "Ottawa Hospital Research Institute, Ottawa, ON, Canada"
      ],
      "name": "David Moher"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Alene Toulany"
    },
    {
      "affiliations": [
        "SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada"
      ],
      "name": "Amanda Doherty-Kirby"
    },
    {
      "affiliations": [
        "Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain",
        "Universitat Internacional de Catalunya, Immaculada, Barcelona, Spain",
        "European Young Person’s Advisory Group Network"
      ],
      "name": "Begonya Nafria Escalera"
    },
    {
      "affiliations": [
        "Division of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "Catherine Stratton"
    },
    {
      "affiliations": [
        "Neonatal Medicine, School of Public Health and Centre for Paediatrics and Child Health, Imperial College London, Chelsea and Westminster Hospital campus, London, UK"
      ],
      "name": "Chris Gale"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"
      ],
      "name": "Colin Macarthur"
    },
    {
      "affiliations": [
        "University Hospital of Montpellier, Child and Adolescent Psychiatry (MPEA1), Saint Eloi Hospital, Montpellier, France",
        "INSERM CESP U1018, Villejuif, France"
      ],
      "name": "Diane Purper-Ouakil"
    },
    {
      "affiliations": [
        "Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK"
      ],
      "name": "Edmund Juszczak"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Eyal Cohen"
    },
    {
      "affiliations": [
        "TEDDY European Network of Excellence for Paediatric Research, Bari, Italy"
      ],
      "name": "Giorgio Reggiardo"
    },
    {
      "affiliations": [
        "Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK"
      ],
      "name": "Jennifer Preston"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Jérémie F Cohen"
    },
    {
      "affiliations": [
        "Division of Immunology and Allergy, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada"
      ],
      "name": "Julia Upton"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Karel Allegaert"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Faculty of Medicine, BC Children’s Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada"
      ],
      "name": "Katelynn Boerner"
    },
    {
      "affiliations": [
        "Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA"
      ],
      "name": "Kayur Mehta"
    },
    {
      "affiliations": [
        "Hospices Civils de Lyon, NICU Femme Mere Enfant Hospital",
        "EMET, LBBE, University of Lyon 1, Lyon, France"
      ],
      "name": "Kim An Nguyen"
    },
    {
      "affiliations": [
        "SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada",
        "CHEO Research Institute, Ontario Child Health Support Unit, Ottawa, ON, Canada"
      ],
      "name": "Kimberly Courtney"
    },
    {
      "affiliations": [
        "Alberta Research Centre for Health Evidence, Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada"
      ],
      "name": "Lisa Hartling"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Menelaos Konstantinidis"
    },
    {
      "affiliations": [
        "Children Heart Center, Skane University Hospital, Lund, Sweden"
      ],
      "name": "Michal Odermarsky"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada",
        "Department of Psychiatry, University of Toronto, Toronto, ON, Canada"
      ],
      "name": "Nancy J Butcher"
    },
    {
      "affiliations": [
        "Population Health Sciences Institute, Newcastle University, Newcastle, UK",
        "NIHR Innovation Observatory, Newcastle University, Newcastle, UK"
      ],
      "name": "Niina Kolehmainen"
    },
    {
      "affiliations": [
        "Children’s Hospital of Eastern Ontario Research Institute and Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada"
      ],
      "name": "Patricia E Longmuir"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"
      ],
      "name": "Peter J Gill"
    },
    {
      "affiliations": [
        "Department of Pediatrics Maastricht University Medical Centre and School of Health Professions Education",
        "Maastricht University, Netherlands"
      ],
      "name": "Piet Leroy"
    },
    {
      "affiliations": [
        "ICON, Langen, Germany"
      ],
      "name": "Reinhard Feneberg"
    },
    {
      "affiliations": [
        "The INCLEN Trust International, New Delhi, India"
      ],
      "name": "Ramesh Poluru"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Shaun K Morris"
    },
    {
      "affiliations": [
        "Division of Pediatric Pain, Palliative and Integrative Medicine, University of California at San Francisco, San Francisco, CA, USA"
      ],
      "name": "Stefan J Friedrichsdorf"
    },
    {
      "affiliations": [
        "SPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada",
        "Canadian PKU and Allied Disorders (CanPKU+), Toronto, ON, Canada"
      ],
      "name": "Tanya Chute Nagy"
    },
    {
      "affiliations": [
        "Department of Pediatrics, College of Medicine, University of Saskatchewan, SK, Canada"
      ],
      "name": "Terry P Klassen"
    },
    {
      "affiliations": [
        "Maternal Infant Child and Youth Research Network (MICYRN), Vancouver, BC, Canada"
      ],
      "name": "Thierry Lacaze-Masmonteil"
    },
    {
      "affiliations": [
        "Department of Neonatology, Emma Children’s Hospital, Amsterdam University Medical Centers, Amsterdam, Netherlands",
        "Amsterdam Reproduction and Development, Amsterdam, Netherlands"
      ],
      "name": "Wes Onland"
    },
    {
      "affiliations": [
        "Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"
      ],
      "name": "Martin Offringa"
    }
  ],
  "title": "CONSORT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and impact of paediatric randomised trials",
  "uid": "6b18e274-7e9c-55b1-9722-16670edae8cd"
}