[Summary text]
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
“Eligible participants were assigned to one of the three study weeks with simple randomization. Each site prepared separate randomization list. The random order of assignment was determined in advance by lots method.”
"Randomization was performed with the use of a computer-generated, per-block, random-numbers list in a 1:1 ratio and was stratified according to study site and CD4+ T-cell count at enrollment (≤50 or 51 to 200 per cubic millimeter)."
Unclear risk of bias – did not specify randomization method.
“Prior to initiating the trial, study subject numbers were randomly assigned 1:1 to early vs. delayed treatment groups by a computer algorithm…”
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Allocation not concealed
Not concealed
Not concealed
Probably low risk (“sealed envelopes”)
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Not blinded
Not blinded
Not blinded
Not blinded
Detection bias due to knowledge of the allocated interventions by outcome assessors
Not blinded
Not blinded
“An independent reviewer who was unaware of the study-group assignments assessed new AIDS-defining events on the basis of standardized definitions of the AIDS Clinical Trials Group. The cause of death was reviewed by the study team member who was unaware of study-group assignments. A reviewer who was unaware of the study-group assignments confirmed tuberculosis associated IRIS cases on the basis of at least one major or two minor clinical criteria."
Not blinded
Attrition bias due to amount, nature or handling of incomplete outcome data
2011 and 2012 presentations of same trial varied in numbers enrolled by arm
No apparent bias
No apparent bias
No apparent bias
Reporting bias due to selective outcome reporting
Unclear -- trial protocol not available
Consistent with trial protocol
Consistent with trial protocol
Unclear -- trial protocol not available
Bias due to problems not covered elsewhere in the table
None detected
No apparent bias
No apparent bias
No apparent bias
Forest plot of comparison: 1 Earlier ART (≤2 wks) vs. delayed ART (≥8 wks and within 6 mos of combined HIV/TB therapy), outcome: 1.1 All-cause mortality.
Forest plot of comparison: 1 Earlier ART (≤2 wks) vs. delayed ART (≥8 wks and within 6 mos of combined HIV/TB therapy), outcome: 1.2 Grade 3 or 4 non-IRIS adverse event.
Forest plot of comparison: 1 Earlier ART (≤2 wks) vs. delayed ART (≥8 wks and within 6 mos of combined HIV/TB therapy), outcome: 1.3 AIDS-defining illness.
Forest plot of comparison: 1 Earlier ART (≤2 wks) vs. delayed ART (≥8 wks and within 6 mos of combined HIV/TB therapy), outcome: 1.4 Incident IRIS.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.