| Bias domain (item no.) |
Source of bias |
Possible answers |
| Selection (1) |
Was the method of randomisation adequate? |
Yes/no/unsure |
| Selection (2) |
Was the treatment allocation concealed? |
Yes/no/unsure |
| Selection (3) |
Were the groups similar at baseline regarding the most important prognostic indicators? |
Yes/no/unsure |
| Performance (4) |
Was the participant blinded to the intervention? |
Yes/no/unsure |
| Performance (5) |
Was the care provider blinded to the intervention? |
Yes/no/unsure |
| Performance (6) |
Were co‐interventions avoided or similar? |
Yes/no/unsure |
| Performance (7) |
Was the compliance acceptable in all groups? |
Yes/no/unsure |
| Detection (8) |
Was the outcome assessor blinded to the intervention? |
Yes/no/unsure |
| Detection (9) |
Was the timing of the outcome assessment similar in all groups? |
Yes/no/unsure |
| Attrition (10) |
Was the drop‐out rate described and acceptable? |
Yes/no/unsure |
| Attrition (11) |
Were all randomised participants analysed in the group to which they were allocated? |
Yes/no/unsure |
| Reporting (12) |
Are reports of the study free of suggestion of selective outcome reporting? |
Yes/no/unsure |
| Other (13) |
Are other sources of potential bias unlikely? |
Yes/no/unsure |
