Table 4.
Study identification | |||||||
---|---|---|---|---|---|---|---|
Criteria | [47] | [42] | [39] | [45] | [53] | [44] | [46] |
1. Was true randomisation used for assignment of participants to treatment groups? | Y | Y | Y | Y | ? | Y | Y |
2. Was allocation to treatment groups concealed? | Y | Y | Y | Y | N | ? | Y |
3. Were treatment groups similar at the baseline? | N | Y | N | Y | Y | Y | Y |
4. Were participants blind to treatment assignment? | N | N | N | N | N | ? | Y |
5. Were those delivering treatment blind to treatment assignment? | N | N | N | N | N | N | Y |
6. Were outcomes assessors blind to treatment assignment? | Y | Y | Y | Y | N | N | Y |
7. Were treatment groups treated identically other than the intervention of interest? | Y | Y | Y | Y | Y | Y | Y |
8. Was follow-up complete and if not, were differences between groups in terms of their follow up adequately described and analysed? | Y | Y | Y | Y | Y | Y | Y |
9. Were participants analysed in the groups to which they were randomised? | Y | Y | Y | Y | Y | Y | Y |
10. Were outcomes measured in the same way for treatment groups? | Y | Y | Y | Y | Y | Y | Y |
11. Were outcomes measured in a reliable way? | Y | Y | Y | Y | Y | Y | Y |
12. Was appropriate statistical analysis used? | Y | Y | Y | Y | N | Y | Y |
13. 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? | Y | Y | Y | Y | N | Y | Y |
Total score | 76.9% | 76.9% | 69.2% | 92.3% | 46.2% | 69.2% | 100.0% |
Y yes, N no, ? unclear, N/A not applicable