Paper title | ||
Paper authors | ||
Reviewer | ||
Domain | Support for judgement | Review authors' judgement |
Selection bias | Insert description, preferably a direct quote from report or correspondence, and add comment | One of : "Low risk", "High risk", "Unclear risk" |
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 | Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence |
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 | Selection bias (biased allocation to interventions) due to inadequate concealment of allocations before assignment |
Performance bias | ||
Blinding of participants and personnel Assessments should be made for each main outcome (or class of outcomes) |
Describe all measures used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information related to whether intended blinding was effective | Performance bias due to knowledge of allocated interventions by participants and personnel during the study |
Detection bias | ||
Blinding of outcome assessmentAssessments should be made for each main outcome (or class of outcomes) | Describe all measures used, if any, to blind outcome assessors from knowledge of which intervention a participant received. Provide any information related to whether intended blinding was effective | Detection bias due to knowledge of allocated interventions by outcome assessors |
Attrition bias | ||
Incomplete outcome dataAssessments should be made for each main outcome (or class of outcomes) | Describe completeness of outcome data for each main outcome, including attrition and exclusions from analysis. State whether attrition and exclusions were reported, numbers in each intervention group (compared with total randomised participants), reasons for attrition/exclusions when reported and any re‐inclusions in analyses performed by review authors | Attrition bias due to amount, nature or handling of incomplete outcome data |
Reporting bias | ||
Selective reporting | State how the possibility of selective outcome reporting was examined by the review authors, and what they found | Reporting bias due to selective outcome reporting |
Other bias | ||
Other sources of bias | State any important concerns about bias not addressed in other domains of the tool If particular questions/entries were pre‐specified in the review protocol, responses should be provided for each question/entry |
Bias due to problems not covered elsewhere in the table |