Efficacy Comparison Between Independent Auscultation by Primary Care Physicians and AI-Assisted Auscultation in Large-scale Screening for Congenital Heart Disease: A Cluster Randomized Controlled Trial in China

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.

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.