多中心回顾性电子病历数据使用全流程操作规程  

The full process operating procedure for the using of multi-center retrospective electronic medical record data

作　　者：钟雪[1] 钱东方 张子轩 谭斯元 刘建峰 崔学艳[3] 聂瑞芳 李婷[5] 王倩 郭其 刘秋爽 梁艳[9] 黄琳[1] 李理总 封宇飞 ZHONG Xue;QIAN Dongfang;ZHANG Zixuan;TAN Siyuan;LIU Jianfeng;CUI Xueyan;NIE Ruifang;LI Ting;WANG Qian;GUO Qi;LIU Qiushuang;LIANG Yan;HUANG Lin;LI Lizong;FENG Yufei(Dept.of Pharmacy,Peking University People’s Hospital,Beijing 100044,China;Beijing North Medical Health Economic Research Center,Beijing 100021,China;Dept.of Pharmacy,Shandong Provincial Qianfoshan Hospital,Jinan 250014,China;Dept.of Pharmacy,Shandong Provincial Hospital,Jinan 250021,China;Dept.of Pharmacy,Beijing Hospital,Beijing 100730,China;Dept.of Pharmacy,Jinan Central Hospital,Jinan 250013,China;Dept.of Pharmacy,Yantai Affiliated Hospital of Binzhou Medical University,Shandong Yantai 256699,China;Dept.of Pharmacy,The 2nd Affiliated Hospital of Harbin Medical University,Harbin 150086,China;Dept.of Pharmacy,Medical Supplies Center of PLA General Hospital,Beijing 100853,China)

机构地区：[1]北京大学人民医院药学部,北京100044 [2]北京北方医药健康经济研究中心,北京100021 [3]山东省千佛山医院药学部,济南250014 [4]山东省立医院药学部,济南250021 [5]北京医院药学部,北京100730 [6]济南市中心医院药学部,济南250013 [7]滨州医学院烟台附属医院药学部,山东烟台256699 [8]哈尔滨医科大学附属第二医院药学部,哈尔滨150086 [9]解放军总医院医疗保障中心药剂科,北京100853

出　　处：《中国药房》2022年第19期2314-2320,共7页China Pharmacy

基　　金：中国药品监督管理研究会立项课题(No.药监研[2021]043号)。

摘　　要：随着医疗信息化的逐步完善与医疗健康大数据的蓬勃发展,真实世界研究的探索和实践日益成熟,真实世界数据已成为药品上市后再评价的重要证据来源。电子病历数据作为重要的高质量真实世界医疗数据,更是开展药品上市后再评价研究不可或缺的数据源。现有真实世界研究的指南和规范多从前瞻性研究角度设计,并未提出回顾性研究实施中的具体措施和方法,尤其是针对使用常规收集的电子病历数据技术层面的操作建议。本文结合现有指南和规范制订的操作流程框架,创新性地添加了针对回顾性电子病历数据的数据验证、数据合库、数据核查及贯穿始终的质量控制和数据管理与储存等操作规程,并以药品上市后安全性评价为例,描述利用电子病历数据开展多中心回顾性真实世界研究涉及的数据分析方法及要点,最终建立了适用于多中心回顾性电子病历数据使用的全流程操作规程。With the gradual improvement of medical informatization and the vigorous development of medical and health big data,the exploration and practice of real-world research are becoming more and more mature,and real-world data have become an important source of evidence for post marketing re-evaluation of drugs.As an important high-quality real-world medical data,electronic medical record data is an indispensable data source for post marketing re-evaluation of drugs.Most of the existing guidelines and norms of real-world research are designed from the perspective of prospective research,and do not propose specific measures and methods in the implementation of retrospective research,especially for the operation suggestions on the technical level of using conventionally collected electronic medical record data.In combination with the operational process framework formulated by the existing guidelines and norms,this paper creatively adds the operating procedures for data validation,data integration,data verification,and throughout quality control,data management and storage of retrospective electronic medical record data,and describes the data analysis methods and key points involved in carrying out multi-center retrospective real-world research using electronic medical record data,taking the post marketing safety research of drugs as an example.Finally,the full process operation procedure applicable to the use of multi-center retrospective electronic medical record data is established.

关 键 词：真实世界数据 电子病历 回顾性研究 数据治理 多中心研究 操作规程 

分 类 号：R951[医药卫生—药学]