用大模型安全高效预筛肝病患者,提升临床试验招募效率。
Enhancing Hepatopathy Clinical Trial Efficiency: A Secure, Large Language Model-Powered Pre-Screening Pipeline
- 拆解复杂入组标准为多步问题,结合专家思维与协作策略问答病历。
- 精度达0.921,每任务仅需0.44秒,肝癌与肝硬化试验表现良好。
- 兼顾隐私保护与低资源环境适用性,适合临床落地推广。
背景:肝细胞癌和肝硬化等复杂肝病的受试者招募常需解读语义复杂的入组标准。传统人工筛选耗时且易出错。尽管人工智能预筛具潜力,但在准确性、效率和数据隐私方面仍存挑战。方法:我们构建了一种新型患者预筛流程,融合临床经验指导大语言模型的精准、安全与高效应用。该流程将复杂标准拆解为一系列复合问题,并采用两种策略基于电子病历进行语义问答:(1)路径A,模拟专家思维链;(2)路径B,基于预设立场的智能体协作。在问题与标准两个层级上评估精度、耗时与反事实推理三重指标。结果:流程在标准层级精度达0.921,每任务耗时0.44秒。路径B在复杂推理中表现更优,路径A在精确数据提取与更快处理速度方面占优,两者精度相当。在肝细胞癌(0.878)与肝硬化(0.843)试验中均表现良好。结论:该数据安全、高效且高精度的预筛流程,为肝病临床试验提供了有力支持,具备优化招募流程的潜力,且适应资源受限场景,具有临床实用价值。
原文摘要 · Abstract (English)
Background: Recruitment for cohorts involving complex liver diseases, such as hepatocellular carcinoma and liver cirrhosis, often requires interpreting semantically complex criteria. Traditional manual screening methods are time-consuming and prone to errors. While AI-powered pre-screening offers potential solutions, challenges remain regarding accuracy, efficiency, and data privacy. Methods: We developed a novel patient pre-screening pipeline that leverages clinical expertise to guide the precise, safe, and efficient application of large language models. The pipeline breaks down complex criteria into a series of composite questions and then employs two strategies to perform semantic question-answering through electronic health records - (1) Pathway A, Anthropomorphized Experts' Chain of Thought strategy, and (2) Pathway B, Preset Stances within an Agent Collaboration strategy, particularly in managing complex clinical reasoning scenarios. The pipeline is evaluated on three key metrics-precision, time consumption, and counterfactual inference - at both the question and criterion levels. Results: Our pipeline achieved high precision (0.921, in criteria level) and efficiency (0.44s per task). Pathway B excelled in complex reasoning, while Pathway A was effective in precise data extraction with faster processing times. Both pathways achieved comparable precision. The pipeline showed promising results in hepatocellular carcinoma (0.878) and cirrhosis trials (0.843). Conclusions: This data-secure and time-efficient pipeline shows high precision in hepatopathy trials, providing promising solutions for streamlining clinical trial workflows. Its efficiency and adaptability make it suitable for improving patient recruitment. And its capability to function in resource-constrained environments further enhances its utility in clinical settings.
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