Theron 2014a.

Study characteristics
Methods	Pragmatic, randomized, parallel‐group, multi‐centre trial, Eligible participants were randomly assigned to undergo either Xpert MTB/RIF or smear microscopy
Participants	Eligible participants had one or more symptoms of tuberculosis according to WHO criteria, able to spontaneously expectorate two sputum samples, had not received anti‐tuberculosis treatment within the previous 60 days, gave informed consent, 18 years old and older Female: 43% HIV infection: 60% Setting: five peri‐urban primary healthcare tuberculosis clinics, with attached or close‐by treatment facilities and microscopy laboratories Countries: South Africa, Tanzania, Zambia, Zimbabwe Sample size: 758 participants randomized to microscopy, 744 to Xpert
Interventions	Intervention group received Xpert MTB/RIF sputum testing, and control group smear microscopy sputum testing
Outcomes	Primary outcome: tuberculosis‐related morbidity (graded using tuberculosis score and Karnofsky performance score) Secondary outcomes: Feasibility of point‐of‐care Xpert MTB/RIF testing (accuracy, failure rates, operator protocol adherence, and user appraisals); Time to diagnosis (overall, and at days 1, 2, 3, 14, 28, and 56); Time to anti‐tuberculosis treatment initiation (overall, and at days 1, 2, 3, 14, 28, and 56); Proportion of culture‐positive participants not started on anti‐tuberculosis treatment (dropouts), or lost to follow‐up (culture‐positive participants started on treatment who were not retained in the study)
Notes	Target condition: tuberculosis case definition: culture positive participants
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization schedule generated prior to the study, using computer‐generated allocation list
Allocation concealment (selection bias)	Low risk	A nurse at each site, blinded to the lists, contacted the data manager by telephone to obtain assignment once an eligible participant was identified
Baseline characteristics similar (selection bias)	Low risk	Selection bias was not detected
Blinding of participants and personnel (performance bias) All outcomes	High risk	Central laboratory personnel were blinded, however clinicians could not be blinded
Protection against contamination (performance bias)	Low risk	Participants were assigned to intervention based on computer‐generated allocation list by the data manager
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The study was not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Similar proportions of loss to follow‐up were observed in both groups
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes in the methods sections were reported
Other bias	Low risk	Not detected