Churchyard 2015.

Study characteristics
Methods	Two‐arm, parallel, cluster‐randomized trial. A cluster was defined as a laboratory and two primary care clinics, served by but not co‐located with that laboratory.
Participants	Participants had suspected tuberculosis: a systematic sample of adults giving sputum for tuberculosis investigation; 18 years old and older Female: 62% overall HIV: 62% overall, 33% of whom had ever been on antiretroviral therapy Setting: primary healthcare clinics and laboratories in medium‐burden districts in four provinces Country: South Africa Sample size: 4658 participants in total, 10 clusters in each arm
Interventions	In the Xpert group, participants had one spot sputum specimen collected for Xpert MTB/RIF testing at the associated laboratory. In the microscopy group, participants had two sputum specimens collected for fluorescence microscopy.
Outcomes	Primary outcome: mortality, measured 6 months after enrolment Secondary outcomes: proportion with a positive index test result; in participants with a positive result, initial loss to follow‐up, defined as the proportion not started on tuberculosis treatment within 28 days of enrolment; proportion of the overall cohort starting tuberculosis treatment by 6 months from enrolment
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization sequence was generated by a statistician using Stata statistical software
Allocation concealment (selection bias)	Low risk	Randomization was by laboratory, at the outset
Baseline characteristics similar (selection bias)	Unclear risk	Differences between groups reported, but these were adjusted for in the analysis
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and clinicians were not blinded. It is not possible to blind in pragmatic settings.
Protection against contamination (performance bias)	Low risk	randomization by cluster
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Deaths were recorded through participants' nominated contacts, clinic staff, and by accessing the department of home affairs vital statistics using South African's identification numbers. In case of ascertainment conflict, an endpoint small committee assigned vital status, but for small number of participants
Incomplete outcome data (attrition bias) All outcomes	Low risk	The proportion of loss to follow‐up was similar in both arms.
Selective reporting (reporting bias)	Low risk	All outcomes were reported
Other bias	Low risk	Not detected