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

Bjerrum 2015.

Study characteristics
Patient sampling Cross‐sectional, prospective and consecutive enrolment
Patient characteristics and setting Presenting signs and symptoms: HIV‐infected adults included irrespective of symptoms. A positive WHO symptom screen was reported for 91% of participants.
Age: mean 39 (SD10)
Sex, female: 64%
HIV infection: 100%
Median CD4 cell count per µL: 127 (IQR 35 to 256)
History of tuberculosis: 6%
Sample size: 469
Clinical setting: outpatient and inpatients
Country: Ghana
Tuberculosis incidence rate: 152 per 100,000
Number (proportion) of tuberculosis cases in the study: 55 (12%)
Index tests LF‐LAM
Target condition and reference standard(s) Target condition: pulmonary tuberculosis
Reference standard: any of sputum mycobacterial culture (solid and liquid) or nucleic acid amplification test; no extrapulmonary specimens tested
Flow and timing All patients were included in the analysis
Comparative  
Notes The study authors did not attempt sputum induction and excluded individuals without some respiratory specimen available. There was no attempt to identify extrapulmonary tuberculosis.
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    
    Low Low
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? Yes    
Were all patients included in the analysis? Yes    
    Low