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Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications

INTRODUCTION: Non-pharmacological invasive interventions in cardiology are complex and often inadequately reported. Template for Intervention Description and Replication (TIDieR) checklist and guide were developed to aid reporting and assessment of non-pharmacological interventions. The aim of our s...

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Autores principales: Lišnić, Viktoria, Ashraf, Hishaam, Viđak, Marin, Marušić, Ana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10597631/
https://www.ncbi.nlm.nih.gov/pubmed/37881632
http://dx.doi.org/10.3389/fmed.2023.1276847
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author Lišnić, Viktoria
Ashraf, Hishaam
Viđak, Marin
Marušić, Ana
author_facet Lišnić, Viktoria
Ashraf, Hishaam
Viđak, Marin
Marušić, Ana
author_sort Lišnić, Viktoria
collection PubMed
description INTRODUCTION: Non-pharmacological invasive interventions in cardiology are complex and often inadequately reported. Template for Intervention Description and Replication (TIDieR) checklist and guide were developed to aid reporting and assessment of non-pharmacological interventions. The aim of our study was to assess the completeness of describing invasive cardiology interventions in clinical trials at the level of trial registration and corresponding journal article publication. METHODOLOGY: We searched for clinical trials in invasive cardiology registered in Clinicaltrials.gov and corresponding journal publications. We used the 10-item TIDieR checklist for registries and 12-item checklist for journal publications. RESULTS: Out of 7,017 registry items retrieved by our search, 301 items were included in the analysis. The search for corresponding published articles yielded 192 journal publications. The majority of trials were funded by the industry and were medical device trials. The median number of reported TIDieR items was 4.5 (95% CI 4.49–4.51) out of 10, and while the corresponding journal articles reported 6.5 (95% CI 6.0–6.5) out of 12 TIDieR items. CONCLUSION: Registration and reporting of invasive cardiology trials is often incomplete and adequate detailed description of the interventions is not provided. TIDieR checklist is an important tool which should be used to ensure rigorous reporting of non-pharmacological interventions in cardiology.
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spelling pubmed-105976312023-10-25 Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications Lišnić, Viktoria Ashraf, Hishaam Viđak, Marin Marušić, Ana Front Med (Lausanne) Medicine INTRODUCTION: Non-pharmacological invasive interventions in cardiology are complex and often inadequately reported. Template for Intervention Description and Replication (TIDieR) checklist and guide were developed to aid reporting and assessment of non-pharmacological interventions. The aim of our study was to assess the completeness of describing invasive cardiology interventions in clinical trials at the level of trial registration and corresponding journal article publication. METHODOLOGY: We searched for clinical trials in invasive cardiology registered in Clinicaltrials.gov and corresponding journal publications. We used the 10-item TIDieR checklist for registries and 12-item checklist for journal publications. RESULTS: Out of 7,017 registry items retrieved by our search, 301 items were included in the analysis. The search for corresponding published articles yielded 192 journal publications. The majority of trials were funded by the industry and were medical device trials. The median number of reported TIDieR items was 4.5 (95% CI 4.49–4.51) out of 10, and while the corresponding journal articles reported 6.5 (95% CI 6.0–6.5) out of 12 TIDieR items. CONCLUSION: Registration and reporting of invasive cardiology trials is often incomplete and adequate detailed description of the interventions is not provided. TIDieR checklist is an important tool which should be used to ensure rigorous reporting of non-pharmacological interventions in cardiology. Frontiers Media S.A. 2023-10-10 /pmc/articles/PMC10597631/ /pubmed/37881632 http://dx.doi.org/10.3389/fmed.2023.1276847 Text en Copyright © 2023 Lišnić, Ashraf, Viđak and Marušić. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Lišnić, Viktoria
Ashraf, Hishaam
Viđak, Marin
Marušić, Ana
Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications
title Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications
title_full Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications
title_fullStr Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications
title_full_unstemmed Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications
title_short Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications
title_sort completeness of intervention description in invasive cardiology trials: an observational study of clinicaltrials.gov registry and corresponding publications
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10597631/
https://www.ncbi.nlm.nih.gov/pubmed/37881632
http://dx.doi.org/10.3389/fmed.2023.1276847
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