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. 2019 Oct 21;2019(10):CD011420. doi: 10.1002/14651858.CD011420.pub3

Juma 2017.

Study characteristics
Patient sampling Cross‐sectional, prospective and consecutive enrolment
Patient characteristics and setting Presenting signs and symptoms: HIV‐infected and HIV‐uninfected adults (aged above 14 years) suspected of extrapulmonary tuberculosis.
 Age: 43 (SD: 14.8)
 Sex, female: 46%
 HIV infection: 68%
 Median CD4 cell count per µL: not stated
History of tuberculosis: 6%
 Sample size: 99 (67 with HIV included)
 Clinical setting: inpatients
 Country: Kenya
 Tuberculosis incidence rate: 319 per 100,000
 Number (proportion) of tuberculosis cases in the study: 29 (33%)
Index tests LF‐LAM
Target condition and reference standard(s) Target: extrapulmonary tuberculosis, any site
Reference standard: any of mycobacterial culture (solid and liquid) or nucleic acid amplification test. No sputum specimens tested
Flow and timing All patients were included in the analysis
Comparative  
Notes The study excluded participants with suspected pulmonary tuberculosis and the reference standard was restricted to extrapulmonary specimens
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? No    
    High Low
DOMAIN 2: Index Test All tests
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    
    High High
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? No    
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes    
    High 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? No    
Were all patients included in the analysis? Yes    
    Low