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. 2013 Dec 12;2013(12):CD008742. doi: 10.1002/14651858.CD008742.pub2

1. Criteria for assessing risk of bias in randomised clinical trials.

Item Judgement
1. Was the method of randomisation adequate? Yes/No/Unsure
2. Was the treatment allocation concealed? Yes/No/Unsure
Was knowledge of the allocated interventions adequately prevented during the study?
3. Was the participant blinded to the intervention?
4. Was the care provider blinded to the intervention?
5. Was the outcome assessor blinded to the intervention?
Yes/No/Unsure
Yes/No/Unsure
Yes/No/Unsure
Were incomplete outcome data adequately addressed?
6. Was the dropout rate described and acceptable?
7. Were all randomly assigned participants analysed in the group to which they were allocated?
 
Yes/No/Unsure
Yes/No/Unsure 
8. Are reports of the study free of suggestion of selective outcome reporting? Yes/No/Unsure 
Other sources of potential bias:
9.  Were the groups similar at baseline regarding the most important prognostic indicators?
10. Were co‐interventions avoided or similar?
11. Was compliance acceptable in all groups?
12. Was the timing of the outcome assessment similar in all groups?
 
Yes/No/Unsure
Yes/No/Unsure
Yes/No/Unsure
Yes/No/Unsure

Risk of bias was assessed using the 12 criteria above (Furlan 2009). The criteria for a judgement of 'Yes' are outlined in Appendix 2.