We performed a sensitivity analysis to determine the robustness of
effect estimates against within-study bias risk. Sensitivity analyses
were conducted by excluding sequentially one study and adding subgroups:
(1) studies with a short versus long follow-up (≥4 weeks versus
<4 weeks), (2) ischemic stroke versus intracranial hemorrhage,
(3) sample size (n≥4000 versus n<4000), and (4) type of coronary
artery disease (stable versus acute coronary syndrome). Six variables
were included for assessment of bias risk: adequate sequence generation,
allocation concealment, blinding to treatment arm, blinded treatment
assessment, intention-to-treat analysis, and incomplete outcome
data assessment. Trials without blinded outcome assessment or blinding
to treatment arm were assumed as studies with high bias risk. In
addition, numbers needed to treat were computed using the inverse
of underlying risk as indicated by the control event rate. Small study
bias or reporting bias was appraised by graphic inspection of funnel
plots. Unadjusted P values are reported throughout, with hypothesis
testing set at the 2-tailed significance level of 0.05. Variables are reported
as number or percentage as appropriate.
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