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Transparent Reporting of Pediatric Clinical Trial Interventions: TIDieR-Children and Adolescents

Katherine Goren1, Veronica Ka Wai Lai1, Ami Baba1

  • 1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.

Pediatrics
|October 14, 2025
PubMed

Insights

This study introduces the TIDieR-Child & Adolescent Health (TIDieR-C) checklist to improve reporting of pediatric interventions in randomized controlled trials (RCTs). The checklist ensures comprehensive details for better understanding and replication of effective treatments for children and adolescents.

Area of Science:

  • Clinical Trials Methodology
  • Pediatric Health Research
  • Intervention Science

Background:

  • Pediatric randomized controlled trials (RCTs) are crucial for guiding interventions in children and adolescents.
  • Effective implementation of interventions requires detailed reporting of their elements, infrastructure, and delivery in RCTs.
  • Existing reporting frameworks need adaptation for the unique aspects of pediatric trial interventions.

Purpose of the Study:

  • To develop comprehensive guidance for reporting trial interventions in pediatric RCT protocols and reports.
  • To create a checklist (TIDieR-C) addressing pediatric-specific considerations for intervention reporting.
  • To enhance the understanding, replicability, and implementation fidelity of pediatric interventions.

Main Methods:

  • Utilized the 12-item Template for the Intervention Description and Replication (TIDieR) framework.
  • Identified pediatric considerations (PCs) from 50 pediatric RCT reports and expert input.
  • Conducted an expert panel meeting and a Family Caregiver Workshop for consensus on PCs and reporting examples.

Main Results:

  • Developed the TIDieR-Child & Adolescent Health (TIDieR-C) checklist with 13 consensus-based pediatric considerations.
  • PCs cover age-appropriateness, medication palatability adjustments, acceptability, and pediatric-specific dosing.
  • Consensus was achieved on reporting exemplars to accompany the checklist.

Conclusions:

  • The TIDieR-C checklist provides a minimum set of considerations for reporting pediatric trial interventions.
  • It can be used alongside pediatric extensions of SPIRIT and CONSORT guidelines.
  • Adoption of TIDieR-C is expected to improve the reporting and appraisal of interventions in pediatric research.

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