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. 2019 Jun 7;2019(6):CD009593. doi: 10.1002/14651858.CD009593.pub4

Rice 2017

Study characteristics
Patient sampling Cross‐sectional design consecutive enrolment, retrospective data collection
Patient characteristics and setting Presenting signs and symptoms: signs and symptoms of pulmonary TB
Age: median 50 years (IQR 35 to 60)
Sex, female: not reported
HIV infection: not reported
History of TB: not reported
Sample size: 751
Clinical setting: outpatient
Laboratory level: central
Country: USA
World Bank Income Classification: high income
High TB burden country: no
High MDR‐TB burden country: no
High TB/HIV burden country: no
Prevalence of TB cases in the study: 18.2%
Index tests Index: Xpert MTB/RIF
Target condition and reference standard(s) Target condition: pulmonary TB
Reference standard for pulmonary TB: Middlebrook solid, MGIT 960
Target condition: rifampicin resistance
Reference standard for rifampicin resistance: MGIT 960
Flow and timing  
Comparative  
Notes Participants were also tested with Xpert if the test result would alter case management or TB control activities
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes
Was a case‐control design avoided? Yes
Did the study avoid inappropriate exclusions? Yes
Low Low
DOMAIN 2: Index Test Xpert MTB/RIF
Were the index test results interpreted without knowledge of the results of the reference standard? Yes
If a threshold was used, was it pre‐specified? Yes
Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes
Were the reference standard results for TB detection interpreted without knowledge of the results of the index test? Unclear
Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test? Yes
Unclear Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes
Did all patients receive the same reference standard? Yes
Were all patients included in the analysis? Yes
Low