Barnard 2015
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, consecutive enrolment, retrospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: presumed pulmonary TB defined as 2 of the following: HIV infection, persistent cough lasting > 3 weeks, haemoptysis, weight loss > 4 kg, intermittent fever > 3 weeks or drenching night sweats > 2 weeks. In addition, at least 1 of the following radiological criteria had to be present: cavitation, diffuse infiltrates, hilar or mediastinal adenopathy, primarily smear‐negative Age: 44 years (SD 16) Sex, female: 52% HIV infection: not reported History of TB: yes, % not reported Sample size: 112 Clinical setting: not reported Laboratory level: central Country: South Africa World Bank Income Classification: middle income High TB burden country: yes High MDR‐TB burden country: yes High TB/HIV burden country: yes Prevalence of TB cases in the study: 34.8% |
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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 Target condition: rifampicin resistance Reference standard for rifampicin resistance: MTBDRplus |
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| Flow and timing | 72 participants were excluded due to incomplete data | ||
| 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? | No | ||
| High | Unclear | ||
| 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? | Unclear | ||
| Unclear | 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 | |||