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

Viktoria Lišnić; Hishaam Ashraf; Marin Viđak; Ana Marušić

doi:10.3389/fmed.2023.1276847

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

Front Med (Lausanne). 2023 Oct 10:10:1276847. doi: 10.3389/fmed.2023.1276847. eCollection 2023.

Authors

Viktoria Lišnić¹, Hishaam Ashraf², Marin Viđak^{3

4}, Ana Marušić³

Affiliations

¹ Department of Cardiology, University Hospital of Split, Split, Croatia.
² Wirral University Teaching Hospital, Wirral, United Kingdom.
³ Department of Research in Biomedicine and Health, Center for Evidence-Based Medicine, University of Split School of Medicine, Split, Croatia.
⁴ Department of Cardiology, Dubrava University Hospital, Zagreb, Croatia.

Abstract

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.

Keywords: ClinicalTrials.gov; TIDieR checklist; cardiology; non-pharmaceutic interventions; quality of reporting.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. Croatian Science Foundation under grant agreement no. IP-2019-04-4882 (Professionalism in Health: Decision making in practice and research, ProDeM). The funder had no role in the design of this study, its execution, analyses, interpretation of the data, or decision to submit results.