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. 2017 Jul 4;17(9):1–106.

Table 2:

Risk-of-Bias Assessment for the Effectiveness of the LAAC Device Versus Novel Oral Anticoagulants With Warfarin as a Common Comparator

Study, Yeara Selection Biasb Performance Biasc Detection Biasd Attrition Biase Reporting Biasf Sum Bias
Stroke Mortality Hem. Stroke Isch. Stroke
RELY, 200915 Low Low Low Low Low Low Low Low Low
ARISTOTL E, 201116 Low Low Low Low Low Low Unclear Low Low
ROCKET AF, 201117 Low Low Low Low Low Low Low Low Low
J ROCKET AF, 201218 Low Low Low Low Low Low Low Low Low
ENGAGE AF, 201319 Low Low Low Low Low Low Low Low Low
PREVAIL, 201420 Low Unclear Unclear Unclear Unclear Low Low Low Unclear
PROTECT AF, 201421 Low Unclear Unclear Unclear Unclear Low Low Low Unclear
a

All studies were double-blinded randomized controlled trials except for PREVAIL and PROTECT AF, which were randomized but not double-blinded.

b

Selection bias refers to bias with regard to random sequence generation and allocation concealment.

c

Performance bias refers bias with regard to the blinding of participants and study personnel.

d

Detection bias refers to bias with regard to the blinding of outcome assessment.

e

Attrition bias refers to incomplete outcome data.

f

Reporting bias refers to selective reporting.