Appendix 1

Sources of risk of bias

ItemJudgement
(A) Sequence generation
1. Was the method of randomisation adequate?Yes/no/unsure
(B) Allocation concealment
2. Was the treatment allocation concealed?Yes/no/unsure
(C) Blinding of participants, personnel and outcome
Was knowledge of the allocated interventions adequately prevented during the study?
3. Was the patient blinded to the intervention?Yes/no/unsure
4. Was the care provider blinded to the intervention?Yes/no/unsure
5. Was the outcome assessor blinded to the intervention?Yes/no/unsure
(D) Incomplete outcome data
Were incomplete outcome data adequately addressed?
6. Was the drop-out rate described and acceptable?Yes/no/unsure
7. Were all randomly assigned participants analysed in the group to which they were allocated?Yes/no/unsure
(E) Other sources of potential bias
8. Were the groups similar at baseline regarding the most important prognostic indicators?Yes/no/unsure
9. Were co-interventions avoided or similar?Yes/no/unsure
10. Was the compliance acceptable in all groups?Yes/no/unsure
11. Was the timing of the outcome assessment similar in all groups?Yes/no/unsure