数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:
|
通过病历系统对纳入患者的姓名、年龄、性别、吸烟史、饮酒史、常住地、医保类型等个人基本信息进行采集,对患者个人隐私信息(如姓名、住院病历号、身份证号等)进行脱敏处理;根据住院病历系统中入院记录、病程记录、出院记录、医嘱信息等采集患者相关疾病信息,住院情况包括入院病情、入院方式、住院科室、发病节气、住院时间、西医诊断、中医诊断、治疗结局等,纳入患者的生命体征(平均动脉压、呼吸频率、脉搏)、实验室检查(肝功能、肾功能、C反应蛋白)和功能检查资料(左室射血分数、心室壁厚度和心电图等)信息,完成的病例报告表由监查员审查后收回,交于课题组进行数据处理。病例报告表的数据采用双人双份录入,经核查确认无误后锁定数据库。
|
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:
|
The patients' personal basic information, such as name, age, gender, smoking history, drinking history, permanent residence, medical insurance type, etc. were collected through the medical record system, and the patients' personal privacy information (such as name, hospital medical record number, ID number, etc.) was desensitized. Collect relevant disease information of patients according to admission records, course records, discharge records, and doctor's order information in the inpatient medical record system. Hospitalization conditions include admission condition, admission method, inpatient departments, solar terms, length of stay, Western medicine diagnosis, traditional Chinese medicine diagnosis, treatment outcome, etc. The patient's vital signs (mean arterial pressure, respiratory rate, pulse), laboratory tests (liver function, kidney function, C-reactive protein) and functional test data (left ventricular ejection fraction, ventricular wall thickness, electrocardiogram, etc.) were included. The completed case report form was reviewed by the monitor and returned to the research group for data processing. The data of the case report form shall be entered in two copies by two persons, and the database shall be locked after verification and confirmation.
|