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Record W4415174662 · doi:10.1542/peds.2025-072867

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

2025· article· en· W4415174662 on OpenAlexaff
Katherine Goren, Veronica Ka Wai Lai, Ami Baba, Maureen Smith, Karel Allegaert, Nancy J. Butcher, Ricardo M. Fernandes, Peter J. Gill, Lisa Hartling, Edmund Juszczak, Patricia E. Longmuir, Kayur Mehta, David Metz, Kim An Nguyen, Michal Odermarsky, Ramesh Poluru, Diane Purper-Ouakil, Giorgio Reggiardo, Catherine Stratton, Peter Szatmari, Amit Trivedi, Julia Upton, Tammy Hoffmann, Martin Offringa

Bibliographic record

VenuePEDIATRICS · 2025
Typearticle
Languageen
FieldMedicine
TopicPharmaceutical studies and practices
Canadian institutionsHospital for Sick ChildrenCentre for Addiction and Mental HealthSt. Michael's HospitalUniversity of AlbertaSickKids FoundationUniversity of TorontoChildren's Hospital of Eastern OntarioInstitute for Clinical Evaluative SciencesImpactCanadian Respiratory Research Network
Fundersnot available
KeywordsRandomized controlled trialPsychological interventionProtocol (science)Intervention (counseling)ChecklistFidelityClinical trial

Abstract

fetched live from OpenAlex

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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.747
metaresearch head score (Gemma)0.872
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Reporting · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: none
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.253
Threshold uncertainty score0.312

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.7470.872
Meta-epidemiology (narrow)0.0040.007
Meta-epidemiology (broad)0.0070.014
Bibliometrics0.0190.016
Science and technology studies0.0050.008
Scholarly communication0.0150.015
Open science0.0070.018
Research integrity0.0100.013
Insufficient payload (model declined to judge)0.0180.012

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.252
GPT teacher head0.512
Teacher spread0.260 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designTheoretical or conceptual
DomainReporting
GenreMethods

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations9
Published2025
Admission routes1
Has abstractyes

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