Vadwai 2011.
Study characteristics | |||
Patient Sampling | Cross‐sectional, consecutive, prospective | ||
Patient characteristics and setting | Presenting signs and symptoms: TBM symptoms included irritability, restlessness, neck stiffness, headache persistent for 2 to 3 weeks, vomiting, seizures, and changes in mental condition or behaviour. LNTB symptoms included enlargement of lymph nodes and mass formation in the neck Age, months: median (IQR) 66 (12 to 168) Sex, female: not reported HIV infection: 3% Sample size included for analysis: 14: 5 LNTB; 9 TBM Clinical setting: inpatient Laboratory level where index test was performed: central Country: India World Bank income classification: middle income High TB burden country: yes High TB/HIV burden country: yes High MDR‐TB burden country: yes Prevalence of tuberculosis cases in the study: 20% LNTB and TBM | ||
Index tests | Xpert MTB/RIF | ||
Target condition and reference standard(s) | Lymph node TB and tuberculous meningitis Solid and liquid culture (LJ and MGIT) |
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Flow and timing | Index and reference tests were collected within pre‐specified time period | ||
Comparative | |||
Notes | |||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | Low risk | ||
Are there concerns that the included patients and setting do not match the review question? | High | ||
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 | ||
Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 2: Index Test (Xpert Ultra) | |||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
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 | ||
Could the patient flow have introduced bias? | Low risk |