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,wit...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.展开更多
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)+1 种基金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)
文摘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.
