TY - JOUR
T1 - CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement
T2 - enhancing the reporting and impact of paediatric randomised trials
AU - Baba, Ami
AU - Smith, Maureen
AU - Potter, Beth K.
AU - Chan, An-Wen
AU - Moher, David
AU - Toulany, Alene
AU - Doherty-Kirby, Amanda
AU - Escalera, Begonya Nafria
AU - Stratton, Catherine
AU - Gale, Chris
AU - Macarthur, Colin
AU - Purper-Ouakil, Diane
AU - Juszczak, Edmund
AU - Cohen, Eyal
AU - Reggiardo, Giorgio
AU - Preston, Jennifer
AU - Cohen, Jeremie F.
AU - Upton, Julia
AU - Allegaert, Karel
AU - Boerner, Katelynn
AU - Mehta, Kayur
AU - Nguyen, Kim An
AU - Courtney, Kimberly
AU - Hartling, Lisa
AU - Konstantinidis, Menelaos
AU - Odermarsky, Michal
AU - Butcher, Nancy J.
AU - Kolehmainen, Niina
AU - Longmuir, Patricia E.
AU - Gill, Peterj
AU - Leroy, Piet
AU - Feneberg, Reinhard
AU - Poluru, Ramesh
AU - Morris, Shaun K.
AU - Friedrichsdorf, Stefan J.
AU - Nagy, Tanya Chute
AU - Klassen, Terry P.
AU - Lacaze-Masmonteil, Thierry
AU - Onland, Wes
AU - Offringa, Martin
PY - 2026/4/1
Y1 - 2026/4/1
N2 - 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 trans parent 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.
AB - 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 trans parent 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.
KW - CLINICAL-TRIALS
KW - HEALTH RESEARCH
KW - GUIDELINES
KW - CHALLENGES
KW - OUTCOMES
U2 - 10.1016/S2352-4642(26)00004-0
DO - 10.1016/S2352-4642(26)00004-0
M3 - Article
SN - 2352-4642
VL - 10
SP - 297
EP - 308
JO - Lancet child & adolescent health
JF - Lancet child & adolescent health
IS - 4
ER -