Skip to main content
. 2021 Jun 28;2021(6):CD013693. doi: 10.1002/14651858.CD013693.pub2

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%
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)
Flow and timing Timing between index test and reference standard not reported.
No missing data reported for the index tests or reference standards.
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