Baasan, O.; Freihat, O.; Nagy, D.U.; Lohner, S. Change over Five Years in Important Measures of Methodological Quality and Reporting in Randomized Cardiovascular Clinical Trials. J. Cardiovasc. Dev. Dis.2024, 11, 2.
Baasan, O.; Freihat, O.; Nagy, D.U.; Lohner, S. Change over Five Years in Important Measures of Methodological Quality and Reporting in Randomized Cardiovascular Clinical Trials. J. Cardiovasc. Dev. Dis. 2024, 11, 2.
Baasan, O.; Freihat, O.; Nagy, D.U.; Lohner, S. Change over Five Years in Important Measures of Methodological Quality and Reporting in Randomized Cardiovascular Clinical Trials. J. Cardiovasc. Dev. Dis.2024, 11, 2.
Baasan, O.; Freihat, O.; Nagy, D.U.; Lohner, S. Change over Five Years in Important Measures of Methodological Quality and Reporting in Randomized Cardiovascular Clinical Trials. J. Cardiovasc. Dev. Dis. 2024, 11, 2.
Abstract
Objectives: The aim of our current study was to analyze whether the use of important measures of methodological quality and reporting of randomized clinical trials published in the field of cardiovascular disease research have changed over time. Further aim was to investigate whether there was an improvement over time in the ability of these trials to provide a good estimate of the true intervention effect. Methods We conducted two searches in the Cochrane Central Register of Controlled Trials (CENTAL) database to identify cardiovascular clinical research trials published in either 2012 or 2017. Randomized clinical trials (RCTs) trials in cardiovascular disease research with adult participants were eligible to be included. We randomly selected 250 RCTs for both publication year 2012 and 2017. Trial characteristics, data on measures of methodological quality and reporting were extracted and risk of bias for each trial was assessed. Results As compared to 2012 in 2017 there were significant improvements in the reporting of the presence of a data monitoring committee (42.0% in 2017 compared to 34.4% in 2012), and a positive tendency of registering cardiovascular disease research RCTs in clinical trial registries (83.6% in 2017 compared to 72.0% in 2012). On the other hand, we also observed that significantly fewer RCTs reported sample size calculation (60.4% in 2017 compared to 98.4% in 2012) in 2017 as compared to 2012. RCTs in 2017 were more likely to have low overall risk of bias ( RoB ) than in 2012 (29.2% in 2017compared to 21.2% in 2012). Conclusion: As compared to 2012 in 2017 there were significant improvement in some, but not all the important measures of methodological quality. Although more trials in the field of cardiovascular disease research had a lower overall RoB in 2017, the improvement over time was not consistently perceived in all RoB domains.
Keywords
cardiovascular disease; randomized clinical trials; risk of bias; trial registration; data monitoring committee
Subject
Public Health and Healthcare, Other
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
