Durovni 2014.

Study characteristics
Methods	Stepped‐wedge cluster‐randomized trial. All 14 laboratories started with smear microscopy. Two laboratories then switched overnight to the Xpert arm every month, so that by the eighth and final month of the trial, all clusters were in the Xpert arm. The unit of comparisons were laboratories and the clinics that used their services.
Participants	Participants who had sputum samples sent to the study laboratories for the diagnosis of pulmonary tuberculosis between February and October 2012 All age groups Female: 35.6% Xpert, 35.9% smear microscopy HIV infection: 7.4% Xpert, 9.8% smear Settings: primary healthcare facilities that used the laboratories in the study Country: Brazil, the study was conducted in the cities of Manaus (three laboratories) and Rio de Janeiro (eleven laboratories) Sample size: 2610 Xpert, 2050 smear microscopy, 14 clusters
Interventions	The diagnostic test for pulmonary tuberculosis was: Intervention: Xpert Comparison arm: sputum smears
Outcomes	Primary outcome notification rate of laboratory confirmed pulmonary tuberculosis by clinics relying on study laboratories’ services time to treatment initiation, estimated by the notification date minus the laboratory result date Secondary outcomes notification rates: for pulmonary tuberculosis, despite a negative test result, pulmonary tuberculosis without any laboratory result reported, overall pulmonary tuberculosis, irrespective of laboratory test result. the rate of Xpert tests positive for rifampicin resistance proportion of participants with a rifampicin‐resistant Xpert result confirmed by conventional DST (PPV)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stepped‐wedge trial design: randomization of the order in which the intervention was implemented in the laboratories was stratified by case load and estimated HIV prevalence. No detailed information was given on how the sequence was generated.
Allocation concealment (selection bias)	Unclear risk	Allocation was not concealed, but the staff were blinded to the order of entry into the intervention
Baseline characteristics similar (selection bias)	Low risk	Baseline characteristics were similar in the two groups
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and clinicians were not blinded to the intervention itself.
Protection against contamination (performance bias)	Low risk	Laboratories and clinics serving laboratories were randomized in a stepped‐wedge design; Xpert MTB/RIF replaced smear microscopy; no risk of contamination
Blinding of outcome assessment (detection bias) All outcomes	Low risk	It was not clear who assessed the outcomes, and whether there was a difference in how the outcome was assessed between the baseline and intervention periods
Incomplete outcome data (attrition bias) All outcomes	Low risk	The proportion lost to follow‐up were disclosed and analysed. 41% of notifications could not be linked to any test, but the proportion was similar in the two arms.
Selective reporting (reporting bias)	Unclear risk	Some outcomes were not prespecified.
Other bias	Low risk	Not detected