Hasan 2017.
Study characteristics | |||
Patient Sampling | Cross‐sectional, convenience, prospective | ||
Patient characteristics and setting | Presenting signs and symptoms: children younger than 15 years based on clinical symptoms, chest radiography, and Kenneth Jones score ≥ 5 Age, months: median (IQR) 82 (24 to 108) Sex, female: 22% HIV infection: 0% Sample size included for analysis: 50 Clinical setting: inpatient and outpatient Laboratory level where index test was performed: intermediate Country: Pakistan World Bank income classification: middle income High TB burden country: yes High TB/HIV burden country: no High MDR‐TB burden country: yes Prevalence of tuberculosis cases in the study: 18% | ||
Index tests | Xpert MTB/RIF | ||
Target condition and reference standard(s) | Pulmonary tuberculosis MGIT; composite reference standard; clinical reference standard |
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Flow and timing | Index and reference tests were collected within pre‐specified time period | ||
Comparative | |||
Notes | The index test was performed on stool; no stool processing method for Xpert has been established; centrifugation was used in this study | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | No | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | High risk | ||
Are there concerns that the included patients and setting do not match the review question? | Low concern | ||
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? | Unclear | ||
DOMAIN 2: Index Test (Xpert Ultra) | |||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Unclear | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
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 |