Methodological quality assessment
| Sources of risk of bias | |
|---|---|
| Item | |
| A | 1. Was the method of randomisation adequate? |
| B | 2. Was the treatment allocation concealed? |
| C | Was knowledge of the allocated interventions adequately prevented during the study? 3. Was the patient blinded to the intervention? 4. Was the care provider blinded to the intervention? 5. Was the outcome assessor blinded to the intervention? |
| D | Were incomplete outcome data adequately addressed? 6. Was the drop-out rate described and acceptable? 7. Were all randomised participants analysed in the group to which they were allocated? |
| E | 8. Are reports of the study free of suggestion of selective outcome reporting? |
| F | Other sources of potential bias: 9. Were the groups similar at baseline regarding the most important prognostic indicators? 10. Were cointerventions avoided or similar? 11. Was the compliance acceptable in all groups? 12. Was the timing of the outcome assessment similar in all groups? |