Table 1. A summary of the RCTs bias using the Cochrane assessment tool.
RCT=Randomized Controlled Trial
COCHRANE APPRAISAL | Random Sequence Generation - Selection bias | Allocation of concealment - Selection bias | Blinding of both participants and evaluators - Performance bias | Blinding of assessment during outcome collection - Detection bias | Incomplete outcome data - Attrition bias | Selective reporting - Reporting bias | Other bias / Comments |
Wanner et al. 2016 [14] EMPA-REG | LOW RISK | HIGH RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | Small sample size to generalise to the broader population |
Neal et al. 2017 [10] CANVAS | LOW RISK | LOW RISK | HIGH RISK | LOW RISK | LOW RISK | LOW RISK | Few clinical events, small proportion of participants to generalise |
Wiviott et al. 2018 [7] DECLARE TIMI-58 | LOW RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | Premature discontinuation of thousands of patients from each study group - statistical data possibly affected |
Perkovic et al. 2019 [15] CREDENCE | LOW RISK | LOW RISK | LOW RISK | LOW RISK | HIGH RISK | LOW RISK | Trial stopped early - potential limited power |
Phrommintikul et al. 2019 [16] | LOW RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | Small sample size |
Bonora et al. 2019 [17] | LOW RISK | LOW RISK | LOW RISK | LOW RISK | UNCLEAR | LOW RISK | Small sample size |
Petrie et al. 2020 [18] DAPA-HF | LOW RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | N/A |
Fuchigami et al. 2020 [19] | LOW RISK | LOW RISK | LOW RISK | HIGH RISK | LOW RISK | LOW RISK | Small sample size, poor genetic diversity (all Japanese), short follow up |
Packer et al. 2020 [20] EMPEROR-REDUCED | LOW RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | LOW RISK | N/A |
Cannon et al. 2020 [21] VERTIS-CV | LOW RISK | LOW RISK | LOW RISK | HIGH RISK | LOW RISK | LOW RISK | N/A |