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. 2021 May 6;2021(5):CD012972. doi: 10.1002/14651858.CD012972.pub2

Schmidt 2017.

Study characteristics
Methods Before and after evaluation cohort to evaluate impact of roll‐out of Xpert MTB/RIF on detection and treatment of adults with pulmonary tuberculosis
Participants 18 years old and above
Adults suspected of pulmonary tuberculosis
Female: 45.9% before, 44.1% after
HIV infection was not reported
Setting: primary health care in the Cape Winelands East in Weastern Cape. The Cape Winelands is a semi‐rural area with a very high estimated total tuberculosis case notification rate of 1400 per 100,000 population
Country: South Africa
Sample size: 15,629 before; 10,741 after
Interventions Data were collected from the electronic NHLS database, which records all microbiological tests for tuberculosis in the region, including the type of test (sputum smear microscopy, Xpert MTB/RIF, or liquid culture), and the result of each test. Unique individuals tested for pulmonary tuberculosis were identified by unique laboratory identifiers. Data from the two periods were compared for the proportion of participants investigated for tuberculosis who tested positive by sputum smear microscopy, liquid culture, or Xpert MTB/RIF, and the proportion of sputum smear microscopy, liquid culture, or Xpert MRB/RIF tests that were positive.
Outcomes Primary outcome: tuberculosis detection
Secondary outcome:
  • median time to diagnosis

  • median time to treatment

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk A before‐after study, no randomization was done
Allocation concealment (selection bias) High risk A before‐after study, where allocation of intervention was not concealed; allocation was determined by calender period
Baseline characteristics similar (selection bias) Low risk No substantial differences observed
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding was done
Protection against contamination (performance bias) Low risk Data were extracted by specific test used, based on the unique laboratory identifier
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Data were available prior to the evaluation; outcome assessor unlikely to be blinded in routine care
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing data were similar before and after intervention, and not statistically different
Selective reporting (reporting bias) Low risk All outcomes stated in the methods were reported
Other bias High risk Risk of confounding due to before‐after design