Calligaro 2015.

Study characteristics
Methods	Individual randomized controlled trial in ICUs in four hospitals.
Participants	Participants: people who were mechanically ventilated, and suspected of having tuberculosis, 18 years old and older, admitted between 1 Aug 2010 and 31 July 2013. with no tuberculosis treatment in the previous 60 days Female: 40% in the Xpert arm, 41% in the smear microscopy arm HIV infection: 27% Xpert, 32% smear Settings: intensive care units (ICUs) in four tertiary and secondary hospitals in Cape Town Country: South Africa Sample size: 317 participants in total
Interventions	Smear and culture (control), or Xpert MTB/RIF and culture (intervention) of tracheal aspirate samples
Outcomes	Primary outcome: proportion of culture‐positive participants started on anti‐tuberculous treatment in each trial group 48 hrs after enrolment Secondary outcomes time to bacteriological diagnosis, time to treatment initiation, the proportion of culture‐positive participants started on antituberculous treatment by the end of the study, proportion of participants given empirical anti‐tuberculous treatment, mortality.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Use of block size of 10, by computer‐generated allocation list
Allocation concealment (selection bias)	Low risk	Allocation list was kept centrally by the data manager, a nurse contacted the data manager each time an eligible participant was identified
Baseline characteristics similar (selection bias)	Low risk	No substantial differences observed
Blinding of participants and personnel (performance bias) All outcomes	High risk	Laboratory staff were blinded to clinical and microbiological details of the participants. Participants and clinicians were not blinded to the test used.
Protection against contamination (performance bias)	Low risk	Allocation and assignment of the group was done centrally, by a data manager, after a nurse called following availability of eligible participants. No risk of contamination
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Assessment of the outcome was done using study staff who were not blinded, but the outcome was clear.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The proportions of loss to follow‐up were 29% in smear, and 8% in the Xpert MTB/RIF groups.
Selective reporting (reporting bias)	Low risk	All outcomes in the methods section were reported
Other bias	Low risk	not detected