Aggerbeck 2018.
| Study characteristics | |||
| Patient Sampling | Prospective, cohort, consecutive | ||
| Patient characteristics and setting | Enrolment criteria: children with signs of TB, symptoms of TB, or close contact to a sputum smear TB‐positive case Age: < 5 years Sex: 51% female overall (not reported for the < 5‐year subgroup) HIV infection: 25% overall (not reported for the < 5‐year subgroup) Sample size included for analysis: 235 Setting: outpatient Country: South Africa World Bank Income Classification: upper middle High TB burden country: yes High TB/HIV burden country: yes Prevalence of TB cases in the study: composite reference standard 8.1%, microbiological reference standard 1.4% |
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| Index tests | Children with 1 of following symptoms concerning for TB: fever, cough, decreased playfulness, or night sweats | ||
| Target condition and reference standard(s) | Active TB not specified as pulmonary Microbiological reference standard and composite reference standard (includes those diagnosed by clinical symptoms) |
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| Flow and timing | Timing between index test and reference standard not reported. No missing data reported for the index tests or reference standards. |
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| 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 | ||
| Could the selection of patients have introduced bias? | Low risk | ||
| Are there concerns that the included patients and setting do not match the review question? | Low concern | ||
| 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 | ||
| Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | Yes | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear risk | ||
| Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
| DOMAIN 4: Flow and Timing | |||
| Was there an appropriate interval between index test and reference standard? | Unclear | ||
| Did all patients receive the same reference standard? | Yes | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | Low risk | ||