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