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| ID | Type | Description | Link |
|---|---|---|---|
| INV-072724 | Other Grant/Funding Number | Bill & Melinda Gates Foundation |
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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This study plans to conduct clinical validation of the model in real clinical settings, comparing it with primary care physicians and specialist physicians to ensure the model's practicality. Through continuous optimization and practice, the study aims to use AI-assisted heart sound auscultation to empower the auscultation capabilities of primary care obstetricians, pediatricians, and non-cardiovascular specialists nationwide. This will not only reduce the missed diagnosis rate and improve the detection rate of existing CHD screenings, but also expand the coverage of current CHD screening networks, incorporating newborns, infants, preschool children, children, and adolescents aged 0-18 years into the screening scope. The study aims to establish a new benchmark in child health management by providing feasible and cost-effective child health management solutions for other developing countries, contributing to global efforts for the health of children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary care physicians | Active Comparator |
| |
| AI + Primary care physicians | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary care physicians | Diagnostic Test | For participants in Group A, a nonblinded independent staff member will first collect medical history, followed by sequential auscultation and CHD assessment by a specialist physician and a primary care physician, with an echocardiogram performed last. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Auscultation in CHD Detection: AI model & Experienced Cardiologists' Independent Auscultatio | From enrollment to the end of treatment at 6 months | |
| Specificity of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Healthcare Physicians' Auscultation & AI model & Experienced Cardiologists' Independent Auscultation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates of CHD in children across different regions of Qinghai Province | From enrollment to the end of treatment at 6 months |
Inclusion Criteria (Schools):
Exclusion Criteria (Schools):
Inclusion Criteria (Individuals):
Exclusion Criteria (Individuals):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qinghai Provincial Women and Children's Hospital | Xining | Qinghai | 810007 | China |
IPD may not be shared or may be unavailable for sharing due to several reasons. Firstly, confidentiality is of utmost importance. IPD contains sensitive personal information, and sharing such data could potentially compromise the privacy of participants, thereby restricting the sharing of such detailed information. Secondly, the data is protected by intellectual property rights. This may limit its sharing without proper agreements or permissions. Thirdly, IPD is large in volume and complex in nature, requiring substantial resources for storage, transmission, and analysis. Detailed discussions and plans need to be formulated to ensure the integrity and security of the data during the sharing process.
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| AI + Primary care physicians | Diagnostic Test | For participants in Group B, after medical history collection, both a specialist physician and a primary care physician will perform auscultation and CHD assessment. Subsequently, the primary care physician will use an electronic stethoscope to collect heart sound data according to the protocol and upload the recordings to a cloud platform. The AI model will analyze the data on the cloud platform and provide a diagnostic result within 5-10 seconds for the primary care physician's reference. The primary care physician may reassess the findings based on the AI model's feedback, and the participant will then undergo an echocardiogram. |
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| From enrollment to the end of treatment at 6 months |
| Accuracy of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Care Physicians' Auscultation & AI model & Experienced Cardiologists' Independent Auscultation | From enrollment to the end of treatment at 6 months |
| The rate of diagnostic revisions by physicians, the proportions of correct and incorrect changes | From enrollment to the end of treatment at 6 months |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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