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. 2020 Aug 27;2020(8):CD013359. doi: 10.1002/14651858.CD013359.pub2

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)
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