Domain | Description | Judgment | |
Random sequence generation | Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups | Was the allocation sequence adequately generated? Low risk/High risk/Unclear |
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Allocation concealment | Describe the method used to conceal the allocation sequence in sufficient detail to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment | Was allocation adequately concealed? Low risk/High risk/Unclear |
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Blinding | Describe all measures used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective Assess blinding for each outcome |
Was knowledge of the allocated intervention adequately prevented during the study? Low risk/High risk/Unclear |
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Incomplete outcome data | Describe the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re‐inclusions in analyses performed by the review authors | Were incomplete outcome data adequately addressed? Low risk/High risk/Unclear |
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Selective reporting | State how the possibility of selective outcome reporting was examined by the review authors, and what was found | Are reports of the study free of suggestion of selective outcome reporting? Low risk/High risk/Unclear |
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Other bias | Selection bias (differences in comparison groups) | |
Was the study apparently free of other problems that could put it at a high risk of bias? Low risk/High risk/Unclear |
Performance bias (differences in the care provided other than the experimental intervention) | |||
Attrition bias (differences in withdrawals, loss to follow‐up, or protocol deviations) | |||
Detection bias (differences in outcome assessment between groups) | |||
Other | |