Journal-based CME Course: SPIRITñChildren and Adolescents (SPIRIT-C) 2026 Extension Statement – Enhancing the Reporting and Usefulness of Pediatric Randomized Trial Protocols

Activity ID

14863

Expires

February 24, 2029

Format Type

Journal-based

CME Credit

1

Fee

$30

CME Provider: JAMA Pediatrics

Description of CME Course

Importance  Key information is often omitted from pediatric randomized controlled trial (RCT) protocols, including details on dose adjustments of interventions based on age, body surface area, or weight; developmental appropriateness of trial outcome measures and processes; or strategies to minimize participants’ anxiety and pain. These deficiencies impair the planning and implementation of potentially impactful trials for children and adolescents. Appropriate guidance is needed to support harmonized, comprehensive reporting of pediatric RCT protocols involving participants aged 0 to 19 years. Developed in partnership with young people (aged 10-24 years) and family caregivers, the Standard Protocol Items: Recommendations for Interventional Trials–Children and Adolescents (SPIRIT-C) 2026 consists of 17 new items recommended to be reported in addition to the SPIRIT 2025 items in pediatric RCT protocols.

Objective  To develop a pediatric reporting guideline extension to the SPIRIT 2025 guideline, SPIRIT-C 2026, that supports comprehensive and transparent reporting of pediatric RCT protocols.

Evidence Review  The methodological framework for developing reporting guidelines published by the EQUATOR Network was implemented to develop a pediatric extension to the SPIRIT 2025 guidelines called SPIRIT-C 2026. A list of candidate reporting items was generated from the literature, and a Youth Advisory Group and a Family Caregiver Advisory Group contributed vital input throughout the project. An international Delphi study with a priori consensus thresholds, a consensus meeting, group writing of the explanation and elaboration paper, and pilot testing of the draft guideline were conducted.

Main Outcomes and Measures  SPIRIT-C 2026 details key reporting items applicable to pediatric RCT protocols involving children and adolescents aged 0 to 19 years. All relevant items are aligned with those in Consolidated Standards of Reporting Trials–Children and Adolescents 2026, a new reporting guideline for completed pediatric RCTs.

Findings  SPIRIT-C 2026 consists of a checklist with 17 new reporting items for reporting pediatric RCT protocols; 4 items are youth generated and 6 youth endorsed. These can be considered a minimum set of reporting items pertinent to pediatric RCT protocols that are relevant to various interest holders, including young people, family caregivers, researchers, pediatric trialists, ethics committees, regulators, funders, and journal editors. Widespread implementation and uptake of SPIRIT-C 2026 should enhance the quality and usefulness of protocols for RCTs that involve participants from birth through adolescence and ultimately foster high-quality pediatric trials.

Conclusions and Relevance  Inclusion of these SPIRIT-C 2026 items supports comprehensive, meaningful, relevant, and transparent reporting, which can improve both the quality and usefulness of pediatric RCT protocols. RCT protocols contain essential details needed to understand and evaluate the trial’s planned aims, design, data collection methods, monitoring, data analysis, and participants’ safety.

Disclaimers

1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.

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