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.
Baba et al. (Tue,) studied this question.