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

Ami Baba1, Maureen Smith2, Beth K Potter3

  • 1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.

The Lancet. Child & Adolescent Health
|June 12, 2026
PubMed

Insights

New CONSORT-Children and Adolescents (CONSORT-C) 2026 guidelines improve reporting for paediatric randomized controlled trials (RCTs). This ensures better use of research findings for children and adolescents, reducing waste.

Area of Science:

  • * Clinical Trials Methodology
  • * Pediatric Research
  • * Health Research Reporting Standards

Background:

  • * High-quality randomized controlled trials (RCTs) in children and adolescents are crucial for informing healthcare decisions.
  • * Current reporting practices often lack completeness and transparency, hindering critical evaluation of pediatric RCTs.
  • * Standardized, evidence-based reporting guidelines are needed to reduce research waste in pediatric RCTs.

Purpose of the Study:

  • * To introduce the CONSORT-Children and Adolescents (CONSORT-C) 2026 reporting guideline.
  • * To enhance the quality and completeness of reporting for pediatric RCTs involving participants aged 0-19 years.
  • * To provide a minimum set of reporting items reflecting the priorities of all stakeholders.

Main Methods:

  • * Development informed by the EQUATOR Network framework.
  • * Literature review to identify candidate reporting items.
  • * Input from a Youth Advisory Group and a Family Caregiver Advisory Group.
  • * International Delphi study, consensus meeting, and pilot testing.

Main Results:

  • * CONSORT-C 2026 includes a checklist with 13 new reporting items.
  • * One item is youth-generated, and six are youth-endorsed.
  • * An accompanying explanation and elaboration paper provides detailed guidance and examples.

Conclusions:

  • * CONSORT-C 2026 offers a minimum standard for reporting pediatric RCTs.
  • * Implementation aims to optimize the usability and reproducibility of trial results.
  • * Adoption of CONSORT-C 2026 is expected to reduce research waste and improve evidence-based practice for young people.

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