Peter 2016.
| Study characteristics | |||
| Patient sampling | Randomized controlled trial, consecutive prospective enrolment | ||
| Patient characteristics and setting | Presenting signs and symptoms: HIV‐infected adults suspected of tuberculosis; Presenting with any of cough, night sweats, fever, or weight loss; or Illness that necessitate admission Age: median 37 (IQR 30 to 44) Sex, female: 50% HIV infection: 100% Median CD4 cell count per µL: 81 (IQR 26 to 198) History of tuberculosis: 27% Sample size: 1172 Clinical setting: inpatient Country: South Africa, Zimbabwe, Zambia Tuberculosis incidence rate: 567 per 100,000 (South Africa); 221 per 100,000 (Zimbabwe); 361 per 100,000 (Zambia) Number (proportion) of tuberculosis cases in the study: 342 (29%) |
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| Index tests | LF‐LAM | ||
| Target condition and reference standard(s) | Target condition: pulmonary tuberculosis, extrapulmonary tuberculosis, mycobacteraemia Reference standard: any of mycobacterial culture (solid and liquid) or nucleic acid amplification test; extrapulmonary specimens collected for those participants where treating clinicians found it indicated |
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| Flow and timing | All patients were included in the analysis | ||
| Comparative | |||
| Notes | Health providers selected the sites for testing based on their own clinical suspicion. High concern of applicability because of a lack of study directed extrapulmonary testing. Not all participants received the same reference standard as tuberculosis diagnostics performed at the discretion of the clinician and varied across sites. | ||
| 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 All tests | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | No | ||
| 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? | No | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
| High | High | ||
| 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? | No | ||
| Were all patients included in the analysis? | Yes | ||
| High | |||