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中国循证儿科杂志

中国循证儿科杂志 ›› 2022, Vol. 17 ›› Issue (2): 116-121.

• 论著 • 上一篇    下一篇

基于电子病例报告表在医院医疗信息平台自动抓取儿童肺炎真实世界数据的方法学探讨

王颖雯1,2,9,苏玲1,9,桂永浩3,张崇凡1,2,陆权3,洪建国3,沈兵4,冯瑞5,方金武6,王伟炳6,顾莺1,董晓艳7,王莹3,陆国平1,俞蕙1,叶颖子1,3,汤粱峰1,葛小玲1,黄敏8,余松轩4,徐虹1,7,张晓波1,3   

  1. 1 复旦大学附属儿科医院上海，201102；2 复旦大学GRADE中心上海，201102； 3 上海市儿科临床质量控制中心上海，201102；4 上海市申康医院发展中心上海，200041；5 复旦大学计算机科学技术学院上海，200433；6 复旦大学公共卫生学院上海，200032；7 上海交通大学医学院附属上海市儿童医院上海，200062；8 上海市市级医院儿内科联盟上海，201102；9 共同第一作者
  • 收稿日期:2022-03-10 修回日期:2022-03-28 出版日期:2022-04-25 发布日期:2022-04-25
  • 通讯作者: 张晓波,徐虹

Methodological discussion on automatically capturing real-world data on pediatric pneumonia from electronic case reports form based on the hospital medical information platform

WANG Yingwen1,2,9, SU Ling1,9, GUI Yonghao3, ZHANG Chongfan1,2, LU Quan3, HONG Jianguo3, SHEN Bing4, FENG Rui5, FANG Jinwu6, WANG Weibing6, GU Ying1, DONG Xiaoyan7, WANG Ying3, LU Guoping1, YU Hui1, YE Yingzi1,3, TANG Liangfeng1, GE Xiaoling1, HUANG Min8, YU Songxuan4, XU Hong1,7, ZHANG Xiaobo1,3   

  1. 1 Children's Hospital of Fudan University, Shanhgai, 201102 China; 2 GRADE Center of Fudan University, Shanghai, 201102 China; 3 Shanghai Medical Quality Control Center for Pediatrics, Shanghai, 201102 China; 4 Shanghai Hospital Development Center, Shanghai, 200041 China; 5 School of Computer Science Fudan University, Shanghai, 200433 China; 6 School of Public Health Fudan University, Shanghai, 200032 China；7 Shanghai Children's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200062 China; 8 Shanghai Federation of Pediatric Internal Medicine, Shanhgai, 201102 China; 9 Co-first author
  • Received:2022-03-10 Revised:2022-03-28 Online:2022-04-25 Published:2022-04-25
  • Contact: ZHANG Xiaobo,email：zhangxiaobo030@163.com；XU Hong,email：hxu@shmu.edu.cn

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摘要： 背景：在医院医疗信息中自动抓取真实世界数据用于临床研究和管理备受关注。目的：构建电子病例报告表（eCRF）数据采集平台，实现真实世界数据服务于临床研究和疾病管理。设计：数据建模。方法：系统文献检索和提取儿童肺炎变量形成变量池，审核专家根据变量池确定核心变量，开发临床数据交换标准协会eCRF表单。验证和修正变量后，构建和完善平台数据中采集测试模型，测试数据采集能力，并行测试数据采集时效性和系统安全性分析。主要结局指标：儿童肺炎采集数据的应答率。结果：审核专家选择了7部指南、4部诊疗建议、10部专家共识和9部经典专著作为变量的来源，确定了18个域及其335个可自动采集的儿童肺炎变量，经5轮测试评估和改进修正结果。人口学信息模块（8个变量）第1~5轮均100%达标。结构化信息模块（175个变量）第1轮89.7%达标，第2~5轮均100%达标。文本数据模块（152个变量）第1轮50.0%达标，未达标变量数21个，未出现变量数70个；第5轮90.1%达标，未达标变量数7个，未出现变量数8个。总体达标率为95.5%（320/335）。检测变量均能够在数据产生的24 h内实现自动采集，均可实现数据的核查和锁定功能。结论：构建的儿童肺炎eCRF数据采集平台可以实现在医院医疗信息中自动抓取真实世界数据，服务于临床研究和疾病管理。

关键词: 临床数据交换标准协会, 临床数据获取协调标准, 病例报告表, 数据采集平台, 肺炎, 儿科

Abstract: Background：Automatic capture of real-world data from hospital medical information system for clinical research and management has always been paid much attention. Objective：To construct an electronic case report form (eCRF) data collecting platform, and to apply the real-world data to clinical research and disease management. Design：Data modeling. Methods：Variables for pediatric pneumonia were extracted from the literature sought by a systematic search in databases to form a variable pool. Experts for reviewing were required to identify core variables from the pool for the development of eCRF following the rule of Clinical Data Interchange Standards Consortium (CDISC). After variable verification and correction, data collection test model was built and improved by testing the data collection ability, and the timeliness and system security were analyzed in parallel. Main outcome measures：Response rate of eCRF for pediatric pneumonia data. Results：Based on the selected 7 guidelines, 4 articles on diagnosis and treatment recommendations, 10 papers of expert consensus and 9 classic monographs as the original source of variables, experts for reviewing identified 18 domains and 335 pediatric pneumonia variables for automatic collection. The results were refined after 5 rounds of testing and evaluation. The module of demographic information (8 variables) was 100% up to the standard in round 1 to 5. The module of structured information (175 variables) was 89.7% up to the standard in the first round, and 100% in the second to fifth rounds. The module of text data (152 variables) was 50.0% up to the standard in round 1 with 21 variables failing to meet the standard and 70 variables failing to be captured and in round 5, the rate was 90.1%, and the number of variables failing to meet the standard and to appear decreased to 7 and 8, respectively. The overall compliance rate was 95.5%(320/335). The detected variables could be automatically collected within 24 hours of data generation. Data verification and locking could also be done at the same time. Conclusion：The eCRF data collection platform can automatically capture realworld data from hospital medical information system to facilitate clinical research and disease management.

Key words: Clinical data interchange standards consortium, Clinical data acquisition standards harmonization, Case report form, Data collected platform, Pneumonia, Peidatric