Boum 2016
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, unknown manner of enrolment, prospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: presumed pulmonary TB with cough for 2 weeks and at least 1 additional TB symptom (fever, weight loss, or night sweats) Age: 18 years and older, median 35 years (IQR 29 to 43) for HIV‐positive participants; median 46 years (IQR 30 to 60) for HIV‐negative participants Sex, female: 50% HIV infection: 70% History of TB: 12% Sample size: 887 Clinical setting: both outpatient and inpatient Laboratory level: biosafety level 3 laboratory of Epicentre/Médecins sans Frontières Mbarara Research Centre Country: Uganda World Bank Income Classification: low income High TB burden country: no High MDR‐TB burden country: no High TB/HIV burden country: yes Prevalence of TB cases in the study: 23.8% |
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| Index tests | Index: Xpert MTB/RIF | ||
| Target condition and reference standard(s) | Target condition: pulmonary TB Reference standard for pulmonary TB: MGIT 960 |
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| Flow and timing | Could not account for all patients | ||
| 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? | Unclear | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Unclear | Low | ||
| 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? | Yes | ||
| Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test? | |||
| Low | 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? | No | ||
| High | |||