Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

Odgerel Baasan; Omar Freihat; David U Nagy; Szimonetta Lohner

doi:10.3389/fcvm.2022.830070

Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

Front Cardiovasc Med. 2022 Mar 17:9:830070. doi: 10.3389/fcvm.2022.830070. eCollection 2022.

Authors

Odgerel Baasan^{1

2}, Omar Freihat¹, David U Nagy^{2

3}, Szimonetta Lohner^{2

4}

Affiliations

¹ Doctoral School of Health Sciences, University of Pécs, Pécs, Hungary.
² Cochrane Hungary, Clinical Centre of the University of Pécs, Medical School, University of Pécs, Pécs, Hungary.
³ Institute of Geobotany/Plant Ecology, Martin-Luther-University, Halle, Germany.
⁴ Department of Public Health Medicine, Medical School, University of Pécs, Pécs, Hungary.

Abstract

Background: All randomized-controlled trials (RCTs) are required to follow high methodological standards. In this study, we aimed to assess the methodological quality of published cardiovascular clinical research trials in a representative sample of RCTs published in 2017.

Methods: Cochrane Central Register of Controlled Trials was used to identify cardiovascular clinical research trials with adult participants published in 2017. Overall, 250 (10%) RCTs were randomly selected from a total of 2,419 studies. Data on general trial characteristics were extracted and the risk of bias (RoB) was determined.

Results: Overall, 86% of RCTs have reported at least one statistically significant result, with the primary outcome significant in 69%, treatment favored in 55%, and adverse events reported in 68%. Less than one-third (29%) of trials were overall low RoB, while the other two-thirds were rated unclear (40%) or with high RoB (31%). Sequence generation, allocation concealment, and selective reporting were the domains most often rated with high RoB. Drug trials were more likely to have low RoB than non-drug trials. Significant differences were found in RoB for the allocation concealment and blinding of participants and personnel between industry-funded and non-industry-funded trials, with industry-funded trials more often rated at low RoB.

Conclusion: Almost two-thirds of RCTs in the field of cardiovascular disease (CVD) research, were at high or unclear RoB, indicating a need for more rigorous trial planning and conduct. Prospective trial registration is a factor predicting a lower risk of bias.

Keywords: cardiovascular diseases; data monitoring committee; funding source; randomized controlled trials; risk of bias; trial registration.