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. 2021 Jun 24;17(2):e1154. doi: 10.1002/cl2.1154
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned (1:1) to the intervention or TAU groups using computer‐based adaptive randomisation procedures at the study centre.
Allocation concealment (selection bias) Low risk Treatment allocation for each participant was sent to the interviewer's laptop at the end of the baseline interview by the central data centre for the study.
Blinding of participants and personnel (performance bias) High risk Due to the nature of the intervention, blinding of participants and personnel was not possible.
Blinding of outcome assessment (detection bias) High risk Personnel who conducted outcome assessments were not blinded to study assignment.
Incomplete outcome data (attrition bias) Low risk Attrition rates were within the anticipated levels and were accounted for in the sample size calculations. Multiple amputations with more than 20 models were performed to account for missing data when appropriate.
Selective reporting (reporting bias) Low risk No evidence of selective outcome reporting was detected.
Other bias Low risk No evidence for other biases was detected.