Clinical Validation of a Pre-trained and Fine-tuned Model for Analyzing Time-Series Electronic Health Records in Critical Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,800
- 试验地点
- 1
- 主要终点
- In-hospital Mortality
研究概览
简要总结
The goal of this observational study is to validate the generalization capability and predictive performance of the "Time-Series Electronic Health Record Foundation Model (EHR Foundation Model)", which was pre-trained on a large-scale critical care dataset, within the real-world clinical environment of the Intensive Care Unit (ICU) at Peking University People's Hospital. The main question it aims to answer is:
· Based on the "pre-training + fine-tuning" paradigm, whether the EHR foundation model can effectively provide accurate and dynamic prognostic support information in real-world clinical scenarios.
Participants who agree to take part in the research, in addition to completing the signed informed consent form, if the patient's hospital stay is too short, will be obtained information on prognostic outcomes (e.g., 28-day mortality) through telephone follow-up.
详细描述
The clinical validation design combines a retrospective cohort study with a prospective cohort study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years, no gender restriction;
- •ICU length of stay ≥ 24 hours (to ensure sufficient time-series monitoring data for model generation);
- •Complete electronic health record data, including baseline demographic characteristics and at least one complete laboratory test record after ICU admission.
排除标准
- •Patients who are transferred out or die within 24 hours of ICU admission;
- •Duplicate admission records for non-initial ICU admissions (only the initial ICU admission record is retained to ensure independence);
- •Severe deficiency in core data (e.g., absence of major vital sign recordings or > 50% missing key laboratory test results);
- •Patients with abandonment of treatment or discharge against medical advice, leading to inability to ascertain the definitive clinical outcome.
研究组 & 干预措施
Survivor group
Patients confirmed to have survived beyond 28 days (outcome obtained from hospital records or telephone follow-up).
Non-survivor group
Patients confirmed to have died within 28 days (outcome obtained from hospital records or telephone follow-up).
结局指标
主要结局
In-hospital Mortality
时间窗: The endpoints are patient discharge or death. For prognostic outcomes (e.g., 28-day mortality), if the patient's hospital stay is insufficient, the outcome will be obtained through telephone follow-up.
Death events occurring during the patient's current hospitalization.
次要结局
未报告次要终点
研究者
Zhao Huiying
Chief Physician
Peking University People's Hospital