Pandie 2016.
| Study characteristics | |||
| Patient sampling | Cross‐sectional, prospective and consecutive enrolment | ||
| Patient characteristics and setting | Presenting signs and symptoms: HIV‐infected and HIV‐uninfected adults suspected of pericardial tuberculosis. Presented with pericardial effusion
Age: median 34 (IQR 29‐42)
Sex, female: 38%
HIV infection: 74%
Median CD4 cell count per µL: 139 (IQR 81 to 249) History of tuberculosis: not stated Sample size: 102 Clinical setting: inpatients Country: South Africa Tuberculosis incidence rate: 567 per 100,000 Number (proportion) of tuberculosis cases in the study: 74 (49%) |
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| Index tests | LF‐LAM | ||
| Target condition and reference standard(s) | Target condition: extrapulmonary tuberculosis (pericardial tuberculosis) and pulmonary tuberculosis Reference standard: mycobacterial culture (liquid). There was no protocol to ensure a minimum standard of sputum sampling and testing |
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| Flow and timing | Not all patients were included in the analysis | ||
| Comparative | |||
| Notes | The study authors excluded participants with disseminated tuberculosis if not having pericardial effusion, and excluded patients with pulmonary tuberculosis if no sign of pericardial effusion. Not all patients received the same reference standard. For some patients sputum induction was attempted and sputum examined for mycobacteria. Not all participants were included in the analysis and it is unclear who was excluded. The true negative values reported conflicts and provides uncertainty about the specificity reported. | ||
| 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 | Low | ||
| DOMAIN 2: Index Test All tests | |||
| 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? | 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? | No | ||
| High | |||