William Palmer 1 , Ochije Okonya 2 , Samuel Jellison 2 , Jarryd Horn 2 , Zachery Harter 3 , Matt Wilkett 4 , Matt Vassar 2 Show Affiliations »
Abstract
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. © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.
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. © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.
Keywords:
cardiology; clinical trials; statistics & research methods
Year: 2020
PMID： 32139513 DOI： 10.1136/bmjebm-2019-111309
Source DB: PubMed Journal: BMJ Evid Based Med ISSN： 2515-446X