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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28,833
- 试验地点
- 1
- 主要终点
- Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The school is of the type: kindergarten, primary school, junior high school, or senior high school.
- •The school has medical screening facilities and conditions that can support AI-assisted screening.
- •The area where the school is located has at least one primary healthcare institution willing to participate in this trial.
- •The school's management and teaching staff are willing to participate in the study and can cooperate to complete the related screening and data collection work.
排除标准
- •More than half of the students in the school refuse to participate in the trial.
- •Schools that are unable to complete the study due to severe limitations in geographical location and transportation conditions.
- •Schools lacking medical screening facilities and conditions necessary for the implementation of screening.
- •Areas where there are no primary healthcare institutions willing to participate in this trial.
- •Schools whose management and teaching staff refuse to participate in the study or are unable to cooperate in completing the related screening and data collection work.
- •Inclusion Criteria (Individuals):
- •Children aged between 0 and 18 years, regardless of gender.
- •Children who agree to undergo echocardiography to determine the presence of congenital heart disease.
- •Individuals who voluntarily participate in this study and sign the informed consent form.
- •Exclusion Criteria (Individuals):
- •Individuals over the age of
- •Children who are unable to complete echocardiography or do not cooperate with auscultation.
- •Participants who are unable to provide informed consent or are unwilling to comply with the study requirements to provide medical data for further analysis and research.
- •Participants who have received interventional or surgical treatment for CHD.
研究组 & 干预措施
Primary care physicians
干预措施: Primary care physicians (Diagnostic Test)
AI + Primary care physicians
干预措施: AI + Primary care physicians (Diagnostic Test)
结局指标
主要结局
Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians
时间窗: From enrollment to the end of treatment at 6 months
次要结局
- The rate of diagnostic revisions by physicians, the proportions of correct and incorrect changes(From enrollment to the end of treatment at 6 months)
- Sensitivity, specificity, accuracy, and false negatives of auscultation in CHD detection: Primary Care Physicians/Experienced Cardiologists' Independent Auscultation & AI Model(From enrollment to the end of treatment at 6 months)
- Specificity, accuracy, and false negatives of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Healthcare Physicians' 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)
- Sensitivity, specificity, accuracy, and false negatives of auscultation in CHD detection: Primary Care Physicians/Experienced Cardiologists' Independent Auscultation & AI Model(From enrollment to the end of treatment at 6 months)
- Sensitivity, specificity, accuracy, and false negatives of Auscultation in CHD Detection: Specialist Physicians' Independent Auscultation & AI-assisted Primary Healthcare Physicians' Auscultation(From enrollment to the end of treatment at 6 months)
研究者
Kun Sun
Professor of Department of Pediatric Cardiology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine