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SPIRIT-Children and Adolescents (SPIRIT-C) 2026 Extension Statement: Enhancing the Reporting and Usefulness of

Ami Baba1, Maureen Smith2, Beth K Potter3

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

JAMA Pediatrics
|February 24, 2026
PubMed

Insights

New reporting guidelines, SPIRIT-C 2026, improve pediatric randomized controlled trial (RCT) protocols by adding 17 essential items. This enhances clarity and usefulness for trials involving children and adolescents.

Area of Science:

  • Clinical Trials
  • Pediatric Research
  • Reporting Guidelines

Background:

  • Pediatric randomized controlled trial (RCT) protocols often lack crucial details, hindering trial planning and implementation.
  • Key omissions include dose adjustments, developmental appropriateness of measures, and strategies for managing participant anxiety and pain.
  • There is a need for harmonized guidance for comprehensive reporting of pediatric RCT protocols.

Purpose of the Study:

  • To develop SPIRIT-C 2026, a pediatric reporting guideline extension to SPIRIT 2025.
  • To support comprehensive and transparent reporting of pediatric RCT protocols for children and adolescents aged 0 to 19 years.

Main Methods:

  • Development followed the EQUATOR Network's framework for reporting guidelines.
  • Included literature review, input from Youth and Family Caregiver Advisory Groups, an international Delphi study, a consensus meeting, and pilot testing.
  • Utilized a methodological framework for developing reporting guidelines.

Main Results:

  • SPIRIT-C 2026 introduces 17 new reporting items for pediatric RCT protocols, including 4 youth-generated and 6 youth-endorsed items.
  • These items are aligned with the Consolidated Standards of Reporting Trials-Children and Adolescents 2026 guideline for completed trials.
  • The guideline provides a minimum set of reporting items relevant to all stakeholders.

Conclusions:

  • SPIRIT-C 2026 enhances the quality and usefulness of pediatric RCT protocols through comprehensive and transparent reporting.
  • Implementation of SPIRIT-C 2026 is expected to foster higher-quality pediatric trials.
  • Improved protocols support better understanding and evaluation of trial aims, design, data collection, monitoring, analysis, and participant safety.
Abstract

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