Yes | No | Unclear | Comments | |
---|---|---|---|---|
1. Was the randomisation procedure adequate? | ☐ | ☐ | ☐ | |
2. Was the treatment allocation adequately concealed? | ☐ | ☐ | ☐ | |
3. Were participants blinded to the intervention? | ☐ | ☐ | ☐ | |
4. Were physicians blinded to the intervention? | ☐ | ☐ | ☐ | |
5. Were outcome assessors blinded to the intervention? | ☐ | ☐ | ☐ | |
6. Incomplete outcome data: Is the attrition rate <15 %? | ☐ | ☐ | ☐ | |
7. Are all pre-specified outcomes of interest reported in the pre-specified way? | ☐ | ☐ | ☐ | |
8. Was intention-to-treat analysis used? | ☐ | ☐ | ☐ | |
9. Were the treatment and control group similar at baseline? | ☐ | ☐ | ☐ |