3. Risk of bias ACTG‐A5164, 2009.
Bias | Authors' judgement | Support for judgement |
Random sequence generation | Low | Random sequence was generated by central computer using permuted blocks within strata. Neither block size nor treatment assignments to other sites were public. |
Allocation concealment | Unclear | No details provided in protocol or included study. |
Blinding of participants and personnel | High | Protocol stated that for arm B (deferred ART), no study‐provided drugs were to be provided initially hence blinding of participants and personnel was not possible. |
Blinding of outcome assessment | Low | Primary outcome was a composite endpoint of survival and viral load. Detection bias was unlikely. |
Incomplete outcome data | Low | Equal numbers withdrew without primary endpoint data in each study arm. Details provided for these participants. |
Selective reporting | Low | Reported outcomes were consistent with protocol. |