Development and Multicenter Validation of a Privacy-Preserving OCR-LLM Pipeline for Four-Subtype Coronary Syndrome Classification Using Admission HPI Across Heterogeneous EHR Systems
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Overall classification accuracy
研究概览
简要总结
This study develops and validates a privacy-preserving OCR-LLM pipeline that converts admission history of present illness (HPI) records into structured coronary syndrome subtypes (STEMI, NSTEMI, unstable angina, and chronic coronary syndrome). The system first extracts text from de-identified HPI images using locally deployed OCR, then applies large language models with a fixed diagnostic prompt to generate subtype classification and evidence. Performance is evaluated in an internal validation cohort and multiple external datasets covering heterogeneous EHR templates, emergency department cases, and an English dataset from MIMIC-IV. A clinician usability study assesses changes in diagnostic accuracy and time with and without tool assistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospital encounters with admission HPI documenting sym
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- •evant to coronary syndrome subtyping.
- •Cases with sufficient documentation to assign one of four target subtypes (STEMI, NSTEMI, UA, CCS) by adjudication.
排除标准
- •Unclear subtype or incomplete/uncertain time information preventing gold standard assignment.
- •Non-CHD primary reason for admission after screening (for MIMIC-IV cohort).
研究组 & 干预措施
Internal Development and Validation Cohort
Retrospective cohort used for model development and internal validation. Inputs are de-identified admission HPI records (image or text) from the AIM-CHD dataset. Expert adjudication provides the reference standard labels for 4-class coronary syndrome subtyping (STEMI, NSTEMI, unstable angina, chronic coronary syndrome).
干预措施: OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM) (Device)
Internal Development and Validation Cohort
Retrospective cohort used for model development and internal validation. Inputs are de-identified admission HPI records (image or text) from the AIM-CHD dataset. Expert adjudication provides the reference standard labels for 4-class coronary syndrome subtyping (STEMI, NSTEMI, unstable angina, chronic coronary syndrome).
干预措施: Manual Clinical Data Review (Device)
Multicenter External Validation Cohort
Retrospective multicenter cohort used for external validation across heterogeneous EHR templates and documentation styles. De-identified admission HPI records are processed through the same OCR-LLM pipeline, and predictions are compared with expert adjudicated reference labels to assess generalizability.
干预措施: OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM) (Device)
Multicenter External Validation Cohort
Retrospective multicenter cohort used for external validation across heterogeneous EHR templates and documentation styles. De-identified admission HPI records are processed through the same OCR-LLM pipeline, and predictions are compared with expert adjudicated reference labels to assess generalizability.
干预措施: Manual Clinical Data Review (Device)
Emergency Department External Validation Cohort
Retrospective cohort representing real-world emergency department workflow. De-identified ED admission HPI records are used to evaluate model performance under time-sensitive, information-limited conditions and assess robustness to ED documentation variability.
干预措施: OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM) (Device)
Emergency Department External Validation Cohort
Retrospective cohort representing real-world emergency department workflow. De-identified ED admission HPI records are used to evaluate model performance under time-sensitive, information-limited conditions and assess robustness to ED documentation variability.
干预措施: Manual Clinical Data Review (Device)
English EHR External Validation Cohort
Retrospective cohort derived from the public de-identified MIMIC-IV database. English admission notes/HPI text are used to evaluate cross-language transportability and performance of the same classification prompts and post-processing rules against reference labels derived by adjudication/structured diagnosis mapping (as prespecified in the protocol).
干预措施: OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM) (Device)
English EHR External Validation Cohort
Retrospective cohort derived from the public de-identified MIMIC-IV database. English admission notes/HPI text are used to evaluate cross-language transportability and performance of the same classification prompts and post-processing rules against reference labels derived by adjudication/structured diagnosis mapping (as prespecified in the protocol).
干预措施: Manual Clinical Data Review (Device)
Clinician Usability Cohort
Prospective usability evaluation cohort. Physicians complete a structured coronary syndrome subtyping task using admission HPI cases. Outcomes include diagnostic accuracy and time to completion; within-participant comparisons may be performed between unassisted and tool-assisted conditions as prespecified.
干预措施: OCR-Prompt-LLM Information Extraction and Classification Workflow (OCR-Prompt-LLM) (Device)
Clinician Usability Cohort
Prospective usability evaluation cohort. Physicians complete a structured coronary syndrome subtyping task using admission HPI cases. Outcomes include diagnostic accuracy and time to completion; within-participant comparisons may be performed between unassisted and tool-assisted conditions as prespecified.
干预措施: Manual Clinical Data Review (Device)
结局指标
主要结局
Overall classification accuracy
时间窗: 1 month
Time Frame: Up to completion of dataset evaluation (internal + external cohorts) Description: Proportion of cases with correct subtype (STEMI/NSTEMI/UA/CCS) compared with expert-adjudicated gold standard.
次要结局
未报告次要终点