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

Ali 2017

Study characteristics
Patient sampling Cross‐sectional design, unclear manner of enrolment, retrospective data collection
Patient characteristics and setting Presenting signs and symptoms: people with pulmonary TB, recently found to have smear‐positive sputum
Age:
≤ 15 years 1 (0.8% ) 16 to 30 81 (64.3%) 31 to 45 23 (18.2%) 46 to 60 15 (11.9%) ≥ 60 6 (4.8%)
Sex, female: 33%
HIV infection: not reported
History of TB: 57%
Sample size: 126
Clinical setting: laboratory‐based
Laboratory level: central
Country: Sudan
World Bank Income Classification: middle income
High TB burden country: no
High MDR‐TB burden country: no
High TB/HIV burden country: no
Index tests Index: Xpert MTB/RIF
Target condition and reference standard(s) Target condition: rifampicin resistance
Reference standard for rifampicin resistance: LJ
Flow and timing  
Comparative  
Notes Participants were recruited from random geographical clusters during a one‐year period
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear
Was a case‐control design avoided? Yes
Did the study avoid inappropriate exclusions? No
High Unclear
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? Unclear
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