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CONSORT-Children and Adolescents (CONSORT-C) 2026 Extension Statement : Enhancing the Reporting and Impact of Pediatric Randomized Trials

Baba, Ami ; Smith, Maureen ; Potter, Beth K ; Chan, An-Wen ; Moher, David ; Toulany, Alene ; Doherty-Kirby, Amanda ; Nafria Escalera, Begonya ; Stratton, Catherine and Gale, Chris , et al. (2026) In JAMA Pediatrics
Abstract

IMPORTANCE: Randomized controlled trials (RCTs) in children and adolescents provide evidence for patients, families, researchers, clinicians, regulators, funders, policymakers, and other interest holders to inform decisions about health care interventions and improve outcomes for young patients and their families. 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. Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs.

OBJECTIVE: To develop a pediatric reporting... (More)

IMPORTANCE: Randomized controlled trials (RCTs) in children and adolescents provide evidence for patients, families, researchers, clinicians, regulators, funders, policymakers, and other interest holders to inform decisions about health care interventions and improve outcomes for young patients and their families. 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. Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs.

OBJECTIVE: To develop a pediatric reporting guideline extension to the Consolidated Standards of Reporting Trials (CONSORT) 2025 guideline, CONSORT-Children and Adolescents (CONSORT-C) 2026, that supports comprehensive reporting and enhances the transparency, reproducibility, accuracy, and utility of published pediatric RCT reports.

EVIDENCE REVIEW: 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.

MAIN OUTCOMES AND MEASURES: Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs. As an extension to the CONSORT 2025 statement, the CONSORT-C 2026 reporting guideline aims to improve the quality and completeness of reporting of pediatric RCTs that involve participants aged 0 to 19 years.

FINDINGS: The new CONSORT-C 2026 guideline is an extension to the updated CONSORT 2025 statement and adds reporting items applicable to pediatric RCT reports involving children and adolescents aged 0 to 19 years. Developed in partnership with young people (aged 10-24 years) and family caregivers, CONSORT-C 2026 comprises 13 new items recommended to be reported in pediatric RCT reports in addition to the CONSORT 2025 items. The 13 new reporting items include 1 youth-generated and 6 youth-endorsed items. CONSORT-C 2026 can be considered a minimum set of reporting items applicable to pediatric RCT reports reflecting the priorities of clinicians, researchers, young people, family caregivers, and other interest holders.

CONCLUSIONS AND RELEVANCE: Widespread implementation and uptake of CONSORT-C 2026 should optimize the usability of trial results for these populations, improve the reproducibility of trial results, and reduce research waste.

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publishing date
type
Contribution to journal
publication status
epub
in
JAMA Pediatrics
publisher
American Medical Association
external identifiers
  • pmid:41734893
ISSN
2168-6211
DOI
10.1001/jamapediatrics.2026.0104
language
English
LU publication?
no
id
6adb6633-0b30-4dbd-86d2-b292d62c77b5
date added to LUP
2026-02-25 21:10:18
date last changed
2026-02-26 07:52:17
@article{6adb6633-0b30-4dbd-86d2-b292d62c77b5,
  abstract     = {{<p>IMPORTANCE: Randomized controlled trials (RCTs) in children and adolescents provide evidence for patients, families, researchers, clinicians, regulators, funders, policymakers, and other interest holders to inform decisions about health care interventions and improve outcomes for young patients and their families. 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. Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs.</p><p>OBJECTIVE: To develop a pediatric reporting guideline extension to the Consolidated Standards of Reporting Trials (CONSORT) 2025 guideline, CONSORT-Children and Adolescents (CONSORT-C) 2026, that supports comprehensive reporting and enhances the transparency, reproducibility, accuracy, and utility of published pediatric RCT reports.</p><p>EVIDENCE REVIEW: 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.</p><p>MAIN OUTCOMES AND MEASURES: Harmonized guidance based on evidence and consensus is needed to optimize standardized reporting and reduce research waste in pediatric RCTs. As an extension to the CONSORT 2025 statement, the CONSORT-C 2026 reporting guideline aims to improve the quality and completeness of reporting of pediatric RCTs that involve participants aged 0 to 19 years.</p><p>FINDINGS: The new CONSORT-C 2026 guideline is an extension to the updated CONSORT 2025 statement and adds reporting items applicable to pediatric RCT reports involving children and adolescents aged 0 to 19 years. Developed in partnership with young people (aged 10-24 years) and family caregivers, CONSORT-C 2026 comprises 13 new items recommended to be reported in pediatric RCT reports in addition to the CONSORT 2025 items. The 13 new reporting items include 1 youth-generated and 6 youth-endorsed items. CONSORT-C 2026 can be considered a minimum set of reporting items applicable to pediatric RCT reports reflecting the priorities of clinicians, researchers, young people, family caregivers, and other interest holders.</p><p>CONCLUSIONS AND RELEVANCE: Widespread implementation and uptake of CONSORT-C 2026 should optimize the usability of trial results for these populations, improve the reproducibility of trial results, and reduce research waste.</p>}},
  author       = {{Baba, Ami and Smith, Maureen and Potter, Beth K and Chan, An-Wen and Moher, David and Toulany, Alene and Doherty-Kirby, Amanda and Nafria Escalera, Begonya and Stratton, Catherine and Gale, Chris and Macarthur, Colin and Purper-Ouakil, Diane and Juszczak, Edmund and Cohen, Eyal and Reggiardo, Giorgio and Preston, Jennifer and Cohen, Jérémie F and Upton, Julia and Allegaert, Karel and Boerner, Katelynn and Mehta, Kayur and Nguyen, Kim An and Courtney, Kimberly and Hartling, Lisa and Konstantinidis, Menelaos and Odermarsky, Michal and Butcher, Nancy J and Kolehmainen, Niina and Longmuir, Patricia E and Gill, Peter J and Leroy, Piet and Feneberg, Reinhard and Poluru, Ramesh and Morris, Shaun K and Friedrichsdorf, Stefan J and Chute Nagy, Tanya and Klassen, Terry P and Lacaze-Masmonteil, Thierry and Onland, Wes and Offringa, Martin}},
  issn         = {{2168-6211}},
  language     = {{eng}},
  month        = {{02}},
  publisher    = {{American Medical Association}},
  series       = {{JAMA Pediatrics}},
  title        = {{CONSORT-Children and Adolescents (CONSORT-C) 2026 Extension Statement : Enhancing the Reporting and Impact of Pediatric Randomized Trials}},
  url          = {{http://dx.doi.org/10.1001/jamapediatrics.2026.0104}},
  doi          = {{10.1001/jamapediatrics.2026.0104}},
  year         = {{2026}},
}