Autonomous Artificial Intelligence Versus AI Assisted Human Optical Diagnosis of Colorectal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Accuracy of optical diagnosis, for polyps 1-5mm, compared with an agreed upon CADx-assisted diagnosis
研究概览
简要总结
Computer-aided image-enhanced endoscopy can predict the nature of colorectal polyps with over 90% accuracy. This technology uses artificial intelligence (AI) to analyze video recordings of polyps, learning to make diagnoses in real-time. This means that doctors can get immediate predictions about small polyps during the procedure, reducing the need for separate pathology exams and saving costs, ultimately improving patient care.
Human and AI interactions are complex and a framework to reap synergistic effects CADx systems when used by humans to harness optimal performance needs to be established. AI solutions in medicine are usually developed to be used as assistive devices, however, then they rely on humans to correct AI errors. Optical polyp diagnosis is a complex task. Non experts usually achieve diagnostic accuracy in 70-80%. CADx systems have a similar diagnostic accuracy when used autonomously. Clinical evaluation of CADx systems showed that CADx assisted OD performs equally to the operator performance when using non CADx assisted OD. To harness a benefit of clinical CADx implementation we would have to find a way that synergies between human and CADx come into play to eliminate cases in which CADx assisted and/ or human OD results in low diagnostic accuracy and also addresses the problem of serrated polyp recognition.
详细描述
Our study hypothesis is that for CADx implementation, instead of using the high/low confidence framework, identifying cases with suboptimal diagnostic accuracy could be facilitated through identifying cases in which CADx and endoscopist disagreed in their diagnosis. Eliminating such cases might separate out cases with low accuracy when using CADx assisted OD. Since endoscopists have a high sensitivity but low specificity for serrated polyp OD, this framework will also allow us to implement a strategy to adequately manage serrated polyps found in the cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for full colonoscopy.
排除标准
- •Known inflammatory bowel disease
- •Active colitis
- •coagulopathy
- •familial polyposis syndrome
- •poor general health, defined as an American Society of Anesthesiologists class >3
- •emergency colonoscopy
结局指标
主要结局
Accuracy of optical diagnosis, for polyps 1-5mm, compared with an agreed upon CADx-assisted diagnosis
时间窗: up to 100 weeks
Accuracy of optical diagnosis, for polyps 1-5mm, compared with an agreed upon CADx-assisted diagnosis , when histopathology results are used as the reference
次要结局
- Accuracy of optical diagnosis, for polyps 1-10mm, compared with an agreed upon CADx-assisted diagnosis(up to 100 weeks)
- Test characteristics, including recall, specificity, positive and negative predictive values (PPV/NPV), and particularly the NPV of rectosigmoid neoplastic polyps.(up to 100 weeks)
- Agreement of surveillance interval recommendations of AI-A and AI-H compared with the pathology-based recommendations(up to 100 weeks)
- Proportion of patients for whom an immediate surveillance recommendation can be directly provided for each approach, and how often histopathology-based polyp examination would have been avoided.(up to 100 weeks)
- Variability of OD (AI-A and AI-H) across participating endoscopists.(up to 100 weeks)
- Cost-effectiveness of OD ((AI-A and AI-H)(up to 100 weeks)
研究者
Daniel Von Renteln
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)