Was true randomization used for assigning participants to treatment groups? |
Y |
Y |
Y |
Was allocation to treatment groups concealed? |
Y |
Y |
Y |
Were treatment groups similar at the baseline? |
Y |
Y |
Y |
Were participants blind to treatment assignment? |
NA |
NA |
NA |
Were those delivering treatment blind to treatment assignment? |
NA |
NA |
NA |
Were outcomes assessors blind to treatment assignment? |
NA |
NA |
NA |
Were treatment groups treated identically other than the intervention of interest? |
Y |
Y |
Y |
Was follow up complete and if not, were differences between groups in terms of their follow up adequately described and analyzed? |
Y |
Y |
Y |
Were participants analyzed in the groups to which they were randomized? |
Y |
Y |
Y |
Were outcomes measured in the same way for treatment groups? |
Y |
Y |
Y |
Were outcomes measured in a reliable way? |
Y |
Y |
Y |
Was appropriate statistical analysis used? |
Y |
Y |
Y |
Was the trial design appropriate, and any deviations from the standard RCT design (individual randomization, parallel groups) accounted for in the conduct and analysis of the trial? |
Y |
Y |
Y |
Bias risk (%) |
90% |
90% |
90% |