Clinical Performance of the DOACT Algorithm Versus AI-Based Decision Models in Oral Anticoagulant Therapy for Vascular Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Accuracy of the DOACT Algorithm in Guiding Oral Anticoagulant Therapy
研究概览
简要总结
Study using a decision algorithm for the application of an oral anticoagulant calculator in vascular diseases, aimed at validating a clinical decision-support tool for conditions such as deep vein thrombosis, superficial thrombophlebitis, and pulmonary thromboembolism.
详细描述
Cross-sectional, three-arm comparative validation study evaluating the accuracy and clinical utility of the DOACT algorithm versus standard clinical decision-making and large language model (LLM)-based decision tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Single-blind. Investigator was blinded to the intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physicians with residency training in Vascular Surgery or official Board Certification in Vascular Surgery.
- •Currently practicing clinical and/or surgical vascular care in Brazil.
- •Completed the informed consent process (TCLE) and voluntarily agreed to participate.
排除标准
- •Physicians without formal Vascular Surgery residency and without Board Certification.
- •Physicians not performing vascular clinical or surgical care (e.g., exclusively administrative, academic, or non-assistance roles).
- •Less than 1 year of professional experience after medical school graduation.
- •Did not sign or did not fully complete the TCLE.
- •Large Language Models (LLMs)
- •Inclusion Criteria
- •Free-access LLMs available to the public at the time of data collection.
- •All responses generated using the same standardized prompt.
- •Capable of producing complete, text-based clinical answers relevant to vascular surgery decision-making.
- •Exclusion Criteria
- •Paid or subscription-based LLMs.
- •LLMs requiring institutional licenses, restricted access, or proprietary tokens.
- •Models unable to generate full responses to the standardized prompt.
结局指标
主要结局
Accuracy of the DOACT Algorithm in Guiding Oral Anticoagulant Therapy
时间窗: Day 1
Accuracy of anticoagulation recommendations Description: Proportion of correct responses generated by the four evaluated LLMs, vascular surgeons, and non-vascular physicians, with and without access to the DOACT algorithm, using standardized clinical vignettes.
Accuracy of anticoagulation recommendations
时间窗: Day 1
Proportion of correct responses generated by LLMs, vascular surgeons, and non-vascular physicians with and without access to the DOACT algorithm. All LLM outputs will be generated using the same standardized prompt, following methodological guidance recommended by IBM for evaluating large language models.
次要结局
未报告次要终点
研究者
ITALO EUGENIO SOUZA GADELHA DE ABREU
Principal Investigator
Science Valley Research Institute