Calligaro 2017
| Study characteristics | |||
| Patient sampling | Randomized trial, consecutive enrolment, prospective data collection | ||
| Patient characteristics and setting | Presenting signs and symptoms: HIV‐positive patients with at least one TB symptom according to predefined WHO criteria and HIV‐positive patients irrespective of symptoms (in line with the WHO recommendation to screen all HIV‐positive individuals for TB) Age: 18 years or older, median 38 (IQR 32 to 47) Sex, female: 55% HIV infection: 58% History of TB: yes, per cent not reported Sample size: 403 Clinical setting: outpatient Laboratory level: in South Africa, diagnostic tests were done at the point‐of‐contact at the mobile van, whereas in Zimbabwe, screened and eligible participants were transported to Mabvuku Clinic and the investigations were done there Country: Zimbabwe, South Africa World Bank Income Classification: low and 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: 10.4% |
||
| Index tests | Index: Xpert MTB/RIF | ||
| Target condition and reference standard(s) | Target condition: pulmonary TB Reference standard for pulmonary TB: MGIT 960 |
||
| 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? | |||
| 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 | |||