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 |