Reporting of Clinical Trial Interventions Published in Leading Otolaryngology-Head and Neck Surgery Journals.
Consolidated Standards for Reporting Trials guidelines
Template for Intervention Description and Replication checklist
clinical trials
evidence-based medicine
reporting guidelines
Journal
The Laryngoscope
ISSN: 1531-4995
Titre abrégé: Laryngoscope
Pays: United States
ID NLM: 8607378
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
12
09
2019
revised:
16
10
2019
accepted:
24
10
2019
pubmed:
21
11
2019
medline:
15
12
2020
entrez:
21
11
2019
Statut:
ppublish
Résumé
Randomized controlled trials (RCTs) play a crucial role in advancing patient care within otolaryngology-head and neck surgery (OTL-HNS), yet studies have shown the reporting of these trials needs improvement. Here, we evaluate the completeness of intervention reporting of RCTs in OTL-HNS and evaluate whether the publication of the Template for Intervention Description and Replication (TIDieR) checklist has influenced intervention reporting. Retrospective Cross-Sectional Analysis. We searched PubMed for RCTs published in top OTL-HNS journals in two cohorts, one before the release of the TIDieR and one afterward. A sample of 300 RCTs was randomly selected and screened for inclusion. Once the dataset was finalized, we extracted trial characteristics and assessed each trial's adherence to the TIDieR checklist. We then used descriptive characteristics, a generalized estimated equation, time-series analysis, and a two-sample t test to analyze our data. After screening was completed, 173 RCTs were included in our analysis. Of these RCTs, 103 (59.5%) showed <60% adherence to the TIDieR checklist. We found a slight increase in adherence to TIDieR items after the checklist was released, although this was not statistically significant (P = .91). In addition, we found that trials with a crossover study design or multiple interventions and those that provided a Consolidated Standards for Reporting Trials statement were associated with greater adherence to the TIDieR checklist. The majority of OTL-HNS RCTs included in our analysis showed suboptimal reporting factors related to the TIDieR checklist. Requiring a TIDieR statement and automating the journal requirements process for all OTL-HNS clinical trials would be a worthwhile, efficient approach to improving research quality and ultimately patient care within OTL-HNS. NA Laryngoscope, 130:E507-E514, 2020.
Types de publication
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
E507-E514Informations de copyright
© 2019 The American Laryngological, Rhinological and Otological Society, Inc.
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