Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

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

Baba, Ami ; Smith, Maureen ; Potter, Beth K ; Chan, An-Wen ; Moher, David ; Toulany, Alene ; Doherty-Kirby, Amanda ; Nafria Escalera, Begonya ; Stratton, Catherine and Gale, Chris , et al. (2026) In JAMA Pediatrics
Abstract

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... (More)

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.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
publishing date
type
Contribution to journal
publication status
epub
subject
in
JAMA Pediatrics
publisher
American Medical Association
external identifiers
  • pmid:41734892
ISSN
2168-6211
DOI
10.1001/jamapediatrics.2026.0113
language
English
LU publication?
no
id
31e70dd1-fda0-4379-9c2c-e0c246e8ae2e
date added to LUP
2026-02-25 21:09:11
date last changed
2026-02-26 10:22:49
@article{31e70dd1-fda0-4379-9c2c-e0c246e8ae2e,
  abstract     = {{<p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p>}},
  author       = {{Baba, Ami and Smith, Maureen and Potter, Beth K and Chan, An-Wen and Moher, David and Toulany, Alene and Doherty-Kirby, Amanda and Nafria Escalera, Begonya and Stratton, Catherine and Gale, Chris and Macarthur, Colin and Purper-Ouakil, Diane and Juszczak, Edmund and Cohen, Eyal and Reggiardo, Giorgio and Preston, Jennifer and Cohen, Jérémie F and Upton, Julia and Allegaert, Karel and Boerner, Katelynn and Mehta, Kayur and Nguyen, Kim An and Courtney, Kimberly and Hartling, Lisa and Konstantinidis, Menelaos and Odermarsky, Michal and Butcher, Nancy J and Kolehmainen, Niina and Longmuir, Patricia E and Gill, Peter J and Leroy, Piet and Feneberg, Reinhard and Poluru, Ramesh and Morris, Shaun K and Friedrichsdorf, Stefan J and Chute Nagy, Tanya and Klassen, Terry P and Lacaze-Masmonteil, Thierry and Onland, Wes and Offringa, Martin}},
  issn         = {{2168-6211}},
  language     = {{eng}},
  month        = {{02}},
  publisher    = {{American Medical Association}},
  series       = {{JAMA Pediatrics}},
  title        = {{SPIRIT-Children and Adolescents (SPIRIT-C) 2026 Extension Statement : Enhancing the Reporting and Usefulness of Pediatric Randomized Trial Protocols}},
  url          = {{http://dx.doi.org/10.1001/jamapediatrics.2026.0113}},
  doi          = {{10.1001/jamapediatrics.2026.0113}},
  year         = {{2026}},
}