Background Randomised controlled trials (RCTs) provide the highest-level of evidence among primary research in cardiovascular medicine. Yet, even the best trial may be less useful if it fails to provide an accurate means of reproducibility. Unfortunately, discrepancies in the standards of trial reporting have been persistent in previous trials. The Template for Intervention Description and Replication (TIDieR) checklist aims to improve research efficacy by setting standards for quality intervention reporting and reproducibility. The goal of this study was to assess adherence to the TIDieR checklist among RCTs published in cardiovascular health journals. We also compared the quality of intervention reporting before and after the publication of TIDieR.
Methods This cross-sectional, methodological study analysed 101 trials published within high-impact cardiology journals. Our primary objective was to assess overall adherence to the TIDieR checklist. Our secondary objective was to use an interrupted time-series analysis to determine if intervention reporting increased following the publication of TIDieR in March 2014. Additionally, we used generalised estimating equations to identify trial characteristics associated with intervention reporting.
Results Trials in our sample reported 8.6/12 TIDieR checklist items, on average. The most under-reported items were those for describing the expertise of the interventionists and for describing the location of the intervention.
Conclusion Improved outcome reporting and intervention reproducibility among RCTs are greatly needed in cardiovascular medicine. Clinicians and researchers should advocate for the ethical publication of complete, translatable and replicable clinical research results.
- statistics & research methods
- clinical trials
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Contributors All authors contributed equally to the production of this article.
Funding This study was funded through the 2019 Presidential Research Fellowship Mentor–Mentee Program at Oklahoma State University Center for Health Sciences. MV is supported by the Oklahoma Center for the Advancement of Science and Technology and the US Department of Health and Human Services Office of Research Integrity.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This cross-sectional study of published cardiology trials does not meet the regulatory definition of human subject research per the US Code of Federal Regulations and did not require the oversight of an institutional review board.
Provenance and peer review Not commissioned; externally peer reviewed.
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