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