Physician Diagnosis of Neurologic Cases Assisted by Large Language Models: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Top-1 diagnostic accuracy
研究概览
简要总结
This study is a prospective randomized controlled trial that aims to evaluate whether large language model (LLM) assistance improves physicians' diagnostic performance compared with conventional assistance.
详细描述
The study population consists of licensed physicians who have completed at least two years of neurology training. Participants are randomly assigned in a 1:1 ratio to the LLM assistance group or the conventional assistance group. In the LLM assistance group, physicians are assisted by an in-house LLM and are allowed to use conventional resources (e.g., search engines, UpToDate, or clinical guidelines) before submitting a final diagnosis. Access to any other LLMs is not permitted. In the conventional assistance group, physicians use only conventional resources and do not have access to the in-house LLM or any other LLMs at any point during the study. The primary outcome is top-1 diagnostic accuracy. Secondary outcomes include top-3 diagnostic accuracy, the time required to complete each case, and physicians' diagnostic confidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Licensed physicians who have completed at least two years of neurology training.
- •Willing to participate in the study and able to provide written informed consent.
排除标准
- •Physicians who have previously participated in the development of the in-house LLM or the construction of datasets used in this study.
- •Physicians who were involved in the clinical care of patients whose cases were used to construct the case dataset for this study.
- •Physicians who are known to have previously reviewed or been exposed to the specific cases used in this study.
研究组 & 干预措施
LLM assistance group
Physicians are assisted by an in-house LLM and are allowed to use conventional resources. Access to any other LLMs is not permitted.
干预措施: LLM assistance (Other)
Conventional assistance group
Physicians use only conventional resources and do not have access to the in-house LLM or any other LLMs at any point during the study.
结局指标
主要结局
Top-1 diagnostic accuracy
时间窗: Baseline
Top-1 diagnosis is considered correct if the physician's final top-ranked diagnosis matches the reference diagnosis or a clinically similar diagnosis judged as equivalent by neurologists.
次要结局
- Top-3 diagnostic accuracy(Baseline)
- Time spent on diagnosis(Baseline)
- Diagnostic confidence(Baseline)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University