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%) |
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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 |
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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 |