Chaisson 2014
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, consecutive enrolment, prospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: presumed pulmonary TB Age: adults, median 54 years (IQR 43 to 60) Sex, female: 23% HIV infection: 30% History of TB: not reported Sample size: 142 Clinical setting: inpatient Laboratory level: central Country: USA World Bank Income Classification: high income High TB burden country: no High MDR‐TB burden country: no High TB/HIV burden country: no Prevalence of TB cases in the study: 6.3% |
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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: 7H11 and BacT/Alert MP |
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| Flow and timing | 59 participants (25% of eligible patients) were not tested, 46 owing to insufficient quantity and 13 for the following reasons: 6 samples rejected for culture because > 3 days had elapsed since collection, 4 samples that were not tested for reasons that were not documented, 2 specimens that arrived when the Xpert machine was not operating because it was undergoing routine maintenance, and 1 specimen that was not 1 of the first 2 samples collected | ||
| 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 | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Low | 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 | ||
| 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? | No | ||
| Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test? | |||
| High | 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 | ||
| Unclear | |||