Extension Statement for CONSORT-C: Improving Reporting Standards and Influence in Pediatric and Adolescent Research

Category	Detail
Condition	Randomized controlled trials (RCTs) in pediatric and adolescent populations
Key Mechanisms	Development of CONSORT-C 2026 extension to improve reporting quality and transparency specific to pediatric RCTs
Target Population	Newborns, infants, children, and adolescents aged 0-19 years
Care Setting	Clinical research settings conducting pediatric and adolescent RCTs

Pediatric RCTs are underrepresented and often suffer from suboptimal reporting, limiting evidence quality.
CONSORT-C 2026 provides harmonized, evidence-based reporting guidance tailored to the unique needs of pediatric trials.
Young people and family caregivers were actively involved in the development process to ensure relevance and applicability.

Not applicable—focus is on reporting standards for pediatric RCTs rather than diagnosis.

Use CONSORT-C 2026 checklist to ensure comprehensive and transparent reporting of pediatric RCTs.
Report critical trial elements including consent/assent processes, comparator interventions, randomization, blinding, pain and harms prevention, missing data sources, and age-appropriate outcomes.

Monitor adherence to CONSORT-C 2026 guidelines to improve reporting quality and reduce research waste.

Poor reporting in pediatric RCTs risks misinterpretation, limits critical appraisal, and impedes evidence-based pediatric care.

Newborns, infants, children, and adolescents aged 0-19 years involved in RCTs

Not applicable—article focuses on reporting standards rather than treatment data.

Involve pediatric patients and family caregivers in trial design and reporting to enhance relevance and clarity.
Adopt age-appropriate trial interventions and formulations considering biological and developmental differences.
Ensure transparent reporting of consent and assent processes respecting jurisdictional variations.
Report trial procedures addressing pain and harms prevention specific to pediatric populations.
Use international consensus-based guidelines (CONSORT-C 2026) to standardize pediatric RCT reporting.

Clinical Scorecard: Extension Statement for CONSORT-C: Improving Reporting Standards and Influence in Pediatric and Adolescent Research