ASSESSMENT OF METHODOLOGICAL QUALITY IN RANDOMIZED CARDIOVASCULAR CLINICAL TRIALS

Abstract

As in all clinical fields, clinical trials are essential in cardiology in order to pro-vide the information needed to answer questions that arise in clinical practice. However, inappropriate design and conduct of clinical trials will result in distort-ed information that will affect medical decision-making and, in extreme cases, may lead to patients not receiving the most appropriate treatment Methods Cochrane Central Register of Controlled Trials was used to identify cardiovascular clinical research trials with adult participants published in 2017 and 2012. .We included the first 250 (about 10%) eligible RCTs for both year 2012 and 2017. Trial characteristics, data on measures of methodological quality, and re-porting were extracted and the 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; p < 0.001), and a positive change in registering randomized cardiovascular disease research in clinical trial registries (78.4% in 2017 compared to 68.9% in 2012; p = 0.03). We also observed that significantly more RCTs reported sample size calculation (60.4% in 2017 compared to 49.6% in 2012; p < 0.01) in 2017 as compared to 2012. RCTs in 2017 were more likely to have a low overall risk of bias (RoB) than in 2012 (29.2% in 2017 compared to 21.2% in 2012; p < 0.01). However, fewer 2017 RCTs were rated low (50.8% compared to 65.6%; p < 0.001) risk for blinding of participants and personnel, for blinding of outcome assessors (82.4% compared to 90.8%; p < 0.001), and selective outcome reporting (62.8% compared to 80.0%; <0.001). Conclusions: As compared to 2012, in 2017 there were significant improve-ments 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.