Preliminary assessment of the data appropriateness of electronic health records for real-world studies:A survey of hospitals in a developing region in China  

作　　者：Yuelin Yu Lin Zhuo Ruogu Meng Wanqian Guo Yuanyuan Chen Yunjing Zhang Ying Chen Hongjing Shi Zhi Lin Siyan Zhan Shengfeng Wang 

机构地区：[1]Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100191,China [2]Research Center of Clinical Epidemiology,Peking University Third Hospital,Beijing 100191,China [3]National Institute of Health Data Science,Peking University,Beijing 100191,China [4]Health Science Center,Peking University,Beijing 100191,China

出　　处：《Chinese Medical Journal》2024年第9期1130-1131,共2页中华医学杂志（英文版）

基　　金：supported by grants from the National Natural Science Foundation of China(Nos.82173616 and 82003536);Peking University Medicine Fund of Fostering Young Scholars’Scientific&Technological Innovation(No.BMU2022PYB035);Fundamental Research Funds for the Central University,Key Clinical Projects of Peking University Third Hospital(No.BYSYZD2021030);Institute of Cultural Heritage and Innovation,Fuzhou Branch,Peking University(No.FZICIPKU20200010)

摘　　要：To the Editor:Assessment of data appropriateness is a process to answer whether electronic health records(EHRs)from routine healthcare practices couldt intended study purposes,for example,available to be proceeded,with enough individual records,with relevant information able to be extracted from records,etc.[1-3]This has been increasingly underscored as a prerequisite when using EHRs(one important type of real-world data[RWD])for scientic purposes.[4-6]Although controversies remain on the denitions,types and assessment methods of the dimensions of RWD appropriateness,the latest ofcial guidelines(i.e.,from the U.S.Food and Drug Administration[FDA][4]and China National Medical Products Administration[NMPA][6])suggest that the assessment start from a preliminary stage on variable existence,and subsequently deepen into the issue of data value(such as missing value,outliers,etc.),as the preliminary assessment is the foundation of the overall RWD appropriateness.[7]Little is known about the appropriateness of EHRs in developing regions,which feature high visit volumes and a great number of hospitals.Therefore,this study aimed to preliminarily investigate RWD appropriateness from hospitals in developing regions from the perspective of core variables’comparison.

关 键 词：ELECTRONIC dimensions RECORDS 

分 类 号：R197.3[医药卫生—卫生事业管理]