国际数据标准模型及其应用于国内临床数据标准转换的研究  

Research on International Data Standard Model and its Application to Domestic Clinical Data Standard Conversion

作　　者：黄嘉俊 叶正强[2] HUANG Jiajun;YE Zhengqiang(Information Department,Shanghai Changning Maternity&Infant Health Hospital;Information Department,Eye&ENT Hospital of Fudan University,Shanghai 200050,China)

机构地区：[1]上海市长宁区妇幼保健院信息科,上海200050 [2]复旦大学附属眼耳鼻喉科医院信息中心,上海200050

出　　处：《微型电脑应用》2024年第10期203-207,212,共6页Microcomputer Applications

摘　　要：规范化数据采集、统一数据标准是提高临床研究质量的核心要素,尤其对于全球多中心研究,在统一数据标准的前提下,才能实现不同医疗机构、不同地区、不同疾病领域的临床数据互联互通、共享利用。通过对临床数据交换标准协会(CDISC)临床数据获取标准协调(CDASH)和观察性医疗结果合作组织(OMOP)通用数据模型(CDM)这2项成熟的国际数据标准模型进行综述,并结合中文语义环境和临床研究应用场景,总结如何从医疗机构院内源数据到OMOP CDM和CDISC CDASH进行数据标准转换,以探讨其在国内临床研究的适用性。Standardized data collection and unified data standards are the core elements of improve the quality of clinical re-search,especially for global multi center-research.Under the premise of unified data standards,the interconnection,sharing and utilization of clinical data resources can be realized among different medical institutions,regions and disease fields.This pa-per summarizes the two international data standard models,i.e.,CDISC CDASH and OMOP CDM,and combines Chinese se-mantic characteristics and clinical research application scenarios,summarizes the conversion of data standards from the source data of medical institutions to OMOP CDM and CDISC CDASH in order to explore its applicability in clinical research.

关 键 词：临床数据交换标准协会临床数据获取标准协调 观察性医疗结果合作组织 通用数据模型 临床研究 数据标准 

分 类 号：TP311.13[自动化与计算机技术—计算机软件与理论]