<2> CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials
<3> Introduction
The importance of randomised controlled trials (RCTs) in children and adolescents cannot be overstated. These trials provide crucial evidence for patients, families, researchers, clinicians, regulators, funders, policymakers, and other stakeholders to inform decisions about healthcare interventions and improve outcomes for young patients and their families. To address the unique needs of paediatric RCTs, the CONSORT-Children and Adolescents (CONSORT-C) 2026 guideline has been developed as an extension to the updated Consolidated Standards Of Reporting Trials (CONSORT) 2025 statement.
<3> Background
Paediatric RCTs are essential for understanding the safety and efficacy of healthcare interventions in children and adolescents. However, the existing CONSORT 2025 statement does not provide specific guidance on reporting items applicable to paediatric RCTs. The CONSORT-C 2026 guideline aims to address this gap by providing 13 new items recommended to be reported in paediatric RCT reports, in addition to the CONSORT 2025 items.
<3> Development of CONSORT-C 2026