Tuberculosis Paediatrics
Conditions
Interventions
Chest x ray classification
Sponsors
Thrasher Research Fund
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children with signs and symptoms suggestive of PTB aged 0-14 years presenting to study sites; AND 2. Children who have undergone a digital PA/AP CXR examination as part of diagnostic workup; AND 3. Informed consent and assent (in children over 7 yrs)
Exclusion criteria
Exclusion criteria: 1. Children who are diagnosed positive for extrapulmonary TB (e.g. tuberculous meningitis) without any evidence of PTB, OR 2. Children who are currently on treatment for TB or those who have taken any treatment for TB in the 6-months prior to study site visit. In exceptions, children who have received less than three daily doses given since treatment initiation before the study site visit can be considered eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of AI in detecting confirmed and unconfirmed paediatric PTB cases (composite reference standard)* ;Difference in AUROC of readers with and without AI in classifying a CXR as consistent with PTB or not using radiological reference standard as reference standard.;Sensitivity and specificity of AI in detecting confirmed and unconfirmed paediatric PTB cases (composite reference standard)* | — |
Secondary
| Measure | Time frame |
|---|---|
| •Sensitivity and specificity of AI in in correctly identifying PTB cases using microbiological reference standard. •AUROC of AI using microbiological and composite reference standard. •Sensitivity, Specificity and AUROC of AI stratified by subgroups - age (0-9 years, 10-14 years), sex, severity of PTB (non-severe versus severe), and by study site. •Sensitivity, specificity and AUROC of AI versus radiological reference standard; overall and by subgroups. •Agreement statistics# between radiological reference standard and AI;•Sensitivity and specificity of AI in in correctly identifying PTB cases using microbiological reference standard. •AUROC of AI using microbiological and composite reference standard. •Sensitivity, Specificity and AUROC of AI stratified by subgroups - age (0-9 years, 10-14 years), sex, severity of PTB (non-severe versus severe), and by study site. •Sensitivity, specificity and AUROC of AI versus radiological reference standard; overall and by subgroups. •Agreement statistics# between radiological reference standard and AI;•Difference in sensitivity and specificity of readers with and without AI in correctly classifying CXRs into those which are consistent with PTB or not radiological reference standard as the reference standard. •Difference in accuracy of readers with and without AI based on WHO-TDA elements. •AUROC, sensitivity and specificity of readers in detecting radiological findings relevant for paediatric PTB . •Accuracy, AUROC, sensitivity and specificity stratified by subgroups, including type and experience of readers, and severity of disease (severe/non-severe), confirmed/unconfirmed PTB. | — |
Countries
Pakistan, South Africa
Contacts
Public ContactCynthia ;Atiqa Baard;Ambareen
Project Manager;Professor of Microbiology
Outcome results
None listed