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

Goren, Katherine ; Lai, Veronica Ka Wai ; Baba, Ami ; Smith, Maureen ; Allegaert, Karel ; Butcher, Nancy J ; Fernandes, Ricardo ; Gill, Peter J ; Hartling, Lisa and Juszczak, Edmund , et al. (2025) In Pediatrics 156(5). p.1-20
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... (More)

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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publishing date
type
Contribution to journal
publication status
published
in
Pediatrics
volume
156
issue
5
article number
e2025072867
pages
1 - 20
publisher
American Academy of Pediatrics
external identifiers
  • pmid:41087014
ISSN
1098-4275
DOI
10.1542/peds.2025-072867
language
English
LU publication?
no
additional info
Copyright © 2025 by the American Academy of Pediatrics.
id
8e4ab258-3f14-473c-9b05-abecb1d98873
date added to LUP
2025-10-15 16:14:21
date last changed
2025-10-17 10:32:01
@article{8e4ab258-3f14-473c-9b05-abecb1d98873,
  abstract     = {{<p>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 &amp; 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 &amp; Adolescents and CONSORT-Children &amp; Adolescents. Uptake of this guidance may lead to improved understanding, replicability, and implementation fidelity of effective trial interventions.</p>}},
  author       = {{Goren, Katherine and Lai, Veronica Ka Wai and Baba, Ami and Smith, Maureen and Allegaert, Karel and Butcher, Nancy J and Fernandes, Ricardo and Gill, Peter J and Hartling, Lisa and Juszczak, Edmund and Longmuir, Patricia E and Macarthur, Colin and Mehta, Kayur and Metz, David and Nguyen, Kim An and Odermarsky, Michal and Poluru, Ramesh and Purper-Ouakil, Diane and Reggiardo, Giorgio and Stratton, Catherine and Szatmari, Peter and Trivedi, Amit and Upton, Julia and Hoffmann, Tammy and Offringa, Martin}},
  issn         = {{1098-4275}},
  language     = {{eng}},
  month        = {{10}},
  number       = {{5}},
  pages        = {{1--20}},
  publisher    = {{American Academy of Pediatrics}},
  series       = {{Pediatrics}},
  title        = {{Transparent Reporting of Pediatric Clinical Trial Interventions : TIDieR-Children and Adolescents}},
  url          = {{http://dx.doi.org/10.1542/peds.2025-072867}},
  doi          = {{10.1542/peds.2025-072867}},
  volume       = {{156}},
  year         = {{2025}},
}