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

Pediatric randomized controlled trials (RCTs) inform decisions concerning the choice of interventions in children and adolescents. To enable the implementation of effective interventions, RCT reports need to provide adequate details on the elements, infrastructure, and delivery of these interventions. Using the 12-item Template for the Intervention Description and Replication (TIDieR) framework, an international team developed guidance for comprehensive reporting of trial interventions in pediatric RCT protocols and reports. We (1) identified initial pediatric considerations (PCs) and examples of good reporting using 50 recent pediatric RCT reports, (2) held an expert panel meeting, (3) conducted a Family Caregiver Workshop to discuss and get input on PCs, (4) compiled PCs and examples of good reporting, and (5) achieved consensus on final PCs and examples. Thirteen PCs reached consensus; they address how trial intervention materials were appropriate for the age and developmental stage of trial participants, which adjustments to enhance palatability of medications and acceptability of interventions were implemented, and how pediatric-specific dosing was determined. Consensus was also reached on accompanying good reporting exemplars. Presenting a minimum set of considerations pertinent to pediatric trial interventions, the TIDieR-Child & Adolescent Health (TIDieR-C) checklist can help trial authors and evidence end users comprehensively report and appraise tested interventions. It can be used with the pediatric-specific extensions of the Standard Protocol Items for Randomized Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT): SPIRIT-Children & Adolescents and CONSORT-Children & Adolescents. Uptake of this guidance may lead to improved understanding, replicability, and implementation fidelity of effective trial interventions.

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Publication Details

Journal
PEDIATRICS
Published
2025-10-15
DOI
https://doi.org/10.1542/peds.2025-072867
Citations
8
Primary Topic
Pharmaceutical studies and practices
Type
article
Field-Weighted Citation Impact
27.95
Controls
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article

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

Maureen Smith, Lisa Hartling, Martin Offringa, Katherine Goren et al.
8 citations
PEDIATRICS
Pharmaceutical studies and practices
27.95
article

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

Maureen Smith, Lisa Hartling, Martin Offringa, Katherine Goren, Michal Odermarsky, Giorgio Reggiardo, Patricia E. Longmuir, Julia Upton, Catherine Stratton, Edmund Juszczak, Peter J. Gill, Kim An Nguyen, Veronica Ka Wai Lai, Christine MacArthur, Nancy J. Butcher, Kayur Mehta, Amit P. Trivedi, Ricardo M. Fernandes, Ami Baba, Karel Allegaert, Ramesh Poluru, Tammy Hoffmann, Peter Szatmari, David Metz, Diane Purper-Ouakil
article en
8 citations

Abstract

Pediatric randomized controlled trials (RCTs) inform decisions concerning the choice of interventions in children and adolescents. To enable the implementation of effective interventions, RCT reports need to provide adequate details on the elements, infrastructure, and delivery of these interventions. Using the 12-item Template for the Intervention Description and Replication (TIDieR) framework, an international team developed guidance for comprehensive reporting of trial interventions in pediatric RCT protocols and reports. We (1) identified initial pediatric considerations (PCs) and examples of good reporting using 50 recent pediatric RCT reports, (2) held an expert panel meeting, (3) conducted a Family Caregiver Workshop to discuss and get input on PCs, (4) compiled PCs and examples of good reporting, and (5) achieved consensus on final PCs and examples. Thirteen PCs reached consensus; they address how trial intervention materials were appropriate for the age and developmental stage of trial participants, which adjustments to enhance palatability of medications and acceptability of interventions were implemented, and how pediatric-specific dosing was determined. Consensus was also reached on accompanying good reporting exemplars. Presenting a minimum set of considerations pertinent to pediatric trial interventions, the TIDieR-Child & Adolescent Health (TIDieR-C) checklist can help trial authors and evidence end users comprehensively report and appraise tested interventions. It can be used with the pediatric-specific extensions of the Standard Protocol Items for Randomized Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT): SPIRIT-Children & Adolescents and CONSORT-Children & Adolescents. Uptake of this guidance may lead to improved understanding, replicability, and implementation fidelity of effective trial interventions.

PEDIATRICSVol. 156(5)
Université Claude Bernard Lyon 1 (FR), Bond University (AU), St. Michael's Hospital (CA), Centre for Addiction and Mental Health (CA), University of Lisbon (PT), University of Nottingham (GB), Johns Hopkins University (US), University of Alberta (CA), University of Toronto (CA), Children's Hospital of Eastern Ontario (CA), Hospital for Sick Children (CA), Children's Hospital at Westmead (AU), Hôpital Femme Mère Enfant (FR), Monash Children’s Hospital (AU), Canadian Respiratory Research Network (CA), European Centre for Training and Research in Earthquake Engineering (IT), Skåne University Hospital (SE), SickKids Foundation (CA), Hôpital Saint Eloi (FR), Institute for Clinical Evaluative Sciences (CA), St Michael's Hospital (GB), Impact (CA), INCLEN Trust International (IN), KU Leuven (BE)
Openalex Percentile: Top 0%
Pharmaceutical studies and practices
27.95
DOISourceOpenAlex
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