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. 2020 Apr 14;2020(4):CD010599. doi: 10.1002/14651858.CD010599.pub2
Potential bias Authors' judgement
Random sequence generation (selection bias)
 
High – not randomized or quasi‐randomized
Unclear – randomized stated, but method not reported
Low – described method of randomization
Allocation concealment (selection bias) High – not concealed, open‐label trial for individually randomized or method of concealment not adequate
Unclear – details of method not reported or insufficient details
Low – central allocation, sequentially numbered opaque sealed envelopes
Blinding (performance bias and detection bias)
 
High – personnel, participants, or outcome assessors not blinded
Unclear – no details or insufficient details reported
Low – personnel, participants, and outcome assessors blinded
Incomplete outcome data (attrition bias) High – losses to follow‐up not evenly distributed across intervention and control group, high attrition rate (≥ 20% for the main outcome)
Unclear – no details reported, insufficient details reported
Low – no losses to follow‐up, losses < 20% and evenly distributed across groups, intention‐to‐treat analysis used
Note: for cluster randomized controlled trials, the loss relates to the clusters
Selective reporting (reporting bias) High – did not fully report measured or relevant outcomes
Unclear – insufficient information reported to judge
Low – all expected outcomes were reported 
Other bias Low – no obvious other source of bias of concern to review authors
High – major source of bias such as unexplained differences in baseline characteristics