The Effect of Cardiac Resynchronization Therapy on Outcomes in Women: A Substudy of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial

Sex, Race, and Age Differences of Cardiovascular Outcomes in Cardiac Resynchronization Therapy RCTs: A Systematic Review and Meta-analysis

“…Elanchenny 27 publications. Three studies showed "some concerns" [24][25][26] overall, while one study showed "low" risk of bias. 27 The RobVis 22 summary plot to visualize the risk of bias domains for the four studies is shown (Supplementary Figure S1), wherein bias due to deviations from the intended intervention was most concerning, as various stakeholders could not be blinded to implant procedure and/or study methodology.…”

“…Nineteen studies were identified for potential data extraction, of which six studies were included (Figure 1). 15,[24][25][26][27][28] Of those six studies, only four 24,[26][27][28] were eligible for meta-analyses, while the other two 15,25 underwent secondary exclusion but have been reported in the results. Thirteen of the 19 studies (original trials or secondary analyses) eligible for data extraction were excluded as they provided insufficient data to calculate event rates in our analyses (Supplementary Tables S2 and S3).…”

Sex, Race, and Age Differences in Cardiovascular Outcomes in Implantable Cardioverter–Defibrillator Randomized Controlled Trials: A Systematic Review and Meta-analysis

“…Of 25 publications reporting on ICD therapy, there were 11 distinct RCTs; sex- and race-based clinical outcome data were only available from 5 of these ICD RCTs. 12 , 13 , 14 , 15 , 16 ( Fig. 1 ).…”

“…Using RoB2 to assess the methodological quality, 4 studies 12 , 13 , 15 , 16 showed “some concerns” overall, and one study 14 showed “high” bias. Most risk of bias was related to deviations from the intended intervention, in cases in which personnel or patients could not be blinded to certain variables due to the nature of device 14 , 17 implantations.…”

“…After 2976 duplicates were removed, 3896 citations were eligible for abstract screening from which 175 were eligible for further full-text review. Of 25 publications reporting on ICD therapy, there were 11 distinct RCTs from which sex and race-based clinical outcomes data were only available from five ICD RCTs [12][13][14][15][16] (Figure 1).…”