Carriquiry 2012
| Study characteristics | |||
| Patient sampling | Cross‐sectional design, consecutive enrolment, prospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: cough for > 10 days with abnormal chest x‐ray and at least 1 of the following symptoms: fever, fatigue, night sweats, haemoptysis, chest pain, or weight loss Age: 18 years or older, median 35 years (IQR 29 to 42) Sex, female: 27.5% HIV infection: 100% History of TB: 25% Sample size: 131 Clinical setting: both inpatient and outpatient Laboratory level: central Country: Peru World Bank Income Classification: middle income High TB burden country: no High MDR‐TB burden country: yes High TB/HIV burden country: no TB incidence rate: 101 per 100,000 MDR‐TB prevalence: percentage MDR‐TB among new TB cases = 5.3% (Source: nationwide survey 2006) and among retreatment cases = 24% (Source: nationwide survey 2006) Prevalence of TB cases in the study: 34.4% |
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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: LJ culture and MGIT 960 Target condition: rifampicin resistance Reference standard for rifampicin resistance: proportion method on LJ media |
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| Flow and timing | |||
| 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 | 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? | Yes | ||
| 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? | Yes | ||
| Low | |||