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SPIRIT-C and CONSORT-C: new reporting guidelines for randomized trials involving children and adolescents

Published on 27 February 2026
Modified on 27 February 2026

SPIRIT-C and CONSORT-C: new reporting guidelines for randomized trials involving children and adolescents

A researcher from the OPPaLE team (Prof Jérémie Cohen) has contributed to the development of SPIRIT-C and CONSORT-C, new reporting guidelines designed to strengthen the conduct and reporting of paediatric randomised controlled trials (RCTs).

Published today in The BMJ, this suite of papers provides checklist items for researchers to include in trial protocols and reports, with the goal of improving the usefulness, transparency, and impact of research that informs the care of children, adolescents, and their families.

Paediatric trials raise specific methodological and ethical considerations that may not be adequately addressed by existing guidance that is mainly focused on adult research. For example: What is the rationale for undertaking the trial in children and/or adolescents? How will consent be obtained in an age-appropriate way? How will researchers account for age- or development-related differences in treatment effects? And what impact might participation have on the child’s or adolescent’s daily life, including school and family routines?

The first paper introduces CONSORT-Children and Adolescents (CONSORT-C) 2026, an extension of the CONSORT reporting guideline for RCTs. Developed in partnership with young people, family caregivers, and other paediatric trial stakeholders, CONSORT-C recommends 13 new items to be reported in addition to the CONSORT 2025 items.

The second paper presents SPIRIT-Children and Adolescents (SPIRIT-C) 2026, an extension of the SPIRIT guideline for trial protocols. SPIRIT-C outlines key reporting items specifically applicable to paediatric RCT protocols involving children and adolescents. It includes a checklist of 17 new items recommended to be reported in addition to the SPIRIT 2025 items.

Two accompanying “Explanation and Elaboration” papers provide the rationale for each new item and practical examples of good reporting, for a total of four papers published today by The BMJ.

Together, SPIRIT-C and CONSORT-C provide a framework for designing, conducting, and reporting paediatric trials in a way that better reflects the realities of childhood and adolescence, helping ensure that evidence used to guide care is rigorous, relevant, and trustworthy.

 

Links to papers:

By Jérémie Cohen

jeremie.cohen@inserm.fr

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