CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials
File(s)
Accepted version
Author(s)
Type
Journal Article
Abstract
Appropriately designed, conducted, and reported randomised controlled trials (RCTs) in children and adolescents inform treatment and healthcare decisions made by young people, families, researchers, clinicians, regulators, funders, policymakers, 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.
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.
Date Issued
2026-02-24
Date Acceptance
2025-11-17
Citation
The BMJ, 2026, 392
ISSN
0959-8146
Publisher
BMJ Publishing Group
Journal / Book Title
The BMJ
Volume
392
Copyright Statement
Copyright © 2026, The Author(s). Published by BMJ Publishing Group Ltd. This is the author’s accepted manuscript made available under a CC-BY licence in accordance with Imperial’s Research Publications Open Access policy (www.imperial.ac.uk/oa-policy)
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/41734966
Publication Status
Published
Coverage Spatial
England
Article Number
e085061
Date Publish Online
2026-02-24