The BMJ has teamed up with leading paediatric journals, JAMA Pediatrics and The Lancet Child & Adolescent Health, to co-publish two papers that will enhance trial conduct and reporting to improve the health of young patients and their families.
The papers provide essential checklist items for researchers to include in clinical trial protocols and reports aimed at enhancing the usefulness, and impact of paediatric randomised controlled trials (RCTs).
For example, what is the rationale for undertaking the trial in children/adolescents and how will participants' consent be obtained and their confidentiality respected? How will age or development-related differences in treatment effects be addressed, and what impact will trial participation have on the child/adolescent's daily life?
The paper authors say this new guidance will strengthen the quality and safety of the paediatric evidence base, improve health outcomes of children and adolescents, and reduce research and resource waste.
The first paper describes the new CONSORT-Children and Adolescents (CONSORT-C) 2026 guideline. Developed in partnership with young people, family caregivers, and other paediatric trial interest holders including paediatric trialists and journal editors, it comprises 13 new items recommended to be reported in addition to the CONSORT 2025 items in paediatric RCT reports involving children and adolescents aged 0-19 years.
"CONSORT-C 2026 intends to facilitate comprehensive reporting, enhancing the transparency, reproducibility, accuracy, and utility of published paediatric RCT reports," say the authors.
The second paper describes the new SPIRIT-Children and Adolescents (SPIRIT-C) 2026 guideline, which details key reporting items applicable to paediatric RCT protocols involving children and adolescents aged 0-19 years. Developed in partnership with young people, family caregivers, and the other paediatric trial interest holders, it consists of a checklist of 17 new items recommended to be reported in addition to the SPIRIT 2025 items in paediatric RCT protocols. All relevant items are aligned with those in CONSORT-C 2026.
"Inclusion of these SPIRIT-C 2026 items supports comprehensive, meaningful, relevant, and transparent reporting, which can improve both the quality and usefulness of paediatric RCT protocols," say the authors.
Two accompanying papers, explaining and elaborating on these new recommendations, are also published by The BMJ today.
Public links to papers:
Enhancing the reporting and impact of paediatric randomised trials: CONSORT-Children and Adolescents (CONSORT-C) 2026 extension
https://www.bmj.com/content/392/bmj-2025-085061
Enhancing the reporting and usefulness of paediatric randomised trial protocols: SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension
https://www.bmj.com/content/392/bmj-2025-085062
CONSORT-C 2026 Explanation and Elaboration: Recommendations for enhancing the reporting and impact of paediatric randomised trials
https://www.bmj.com/content/392/bmj-2025-085063
SPIRIT-C 2026 Explanation and Elaboration: Recommendations for enhancing the reporting and usefulness of paediatric randomised trial protocols
https://www.bmj.com/content/392/bmj-2025-085064
