设计并开发一个针对特定疾病的临床数据库系统，以提高中国医院数据的可用性。
Design and development of a disease-specific clinical database system to increase the availability of hospital data in China.
作者信息
Liu Mimi, Luo Jinni, Li Lin, Pan Xuemei, Tan Shuyan, Ji Weidong, Zhang Hongzheng, Tang Shengsheng, Liu Jingjing, Wu Bin, Chen Zebin, Wu Xiaoying, Zhou Yi
机构信息
Zhongshan School of Medicine, Sun Yat-Sen University, Guangzhou, Guangdong China.
Gastroenterology Department, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong China.
出版信息
Health Inf Sci Syst. 2023 Jan 30;11(1):11. doi: 10.1007/s13755-023-00211-4. eCollection 2023 Dec.
PURPOSE
In order to meet restrictions and difficulties in the development of hospital medical informatization and clinical databases in China, in this study, a disease-specific clinical database system (DSCDS) was designed and built. It provides support for the full utilization of real world medical big data in clinical research and medical services for specific diseases.
METHODS
The development of DSCDS involved (1) requirements analysis on precision medicine, medical big data, and clinical research; (2) design schematics and basic architecture; (3) standard datasets of specific diseases consisting of common data elements (CDEs); (4) collection and aggregation of specific disease data scattered in various medical business systems of the hospital; (5) governance and quality improvement of specific disease data; (6) data storage and computing; and (7) design of data application modules.
RESULTS
A DSCDS for liver cirrhosis was created in the gastrointestinal department of a 3A grade hospital in China and had more than nine data application modules. Based on this DSCDS, a series of clinical studies are being carried out, such as retrospective or prospective cohorts, prognostic studies using multimodal data, and follow-up studies.
CONCLUSION
The development of the DSCDS for liver cirrhosis in this paper provides experience and reference for the design and development of DSCDSs for other specific diseases in China; it can even expand to the development of DSCDSs in other countries if they have the demand for DSCDS and the same or better medical informatization foundation. DSCDS has more accurate, standard, comprehensive, multimodal and usable data of specific diseases than the general clinical database system and clinical data repository (CDR) and provides a credible data foundation for medical research, clinical decision-making and improving the medical service quality of specific diseases.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s13755-023-00211-4.
目的
为应对我国医院医疗信息化和临床数据库发展中的限制与困难，本研究设计并构建了一种疾病特异性临床数据库系统（DSCDS）。它为特定疾病的临床研究和医疗服务中充分利用真实世界医学大数据提供支持。
方法
DSCDS的开发涉及：（1）对精准医学、医学大数据和临床研究的需求分析；（2）设计示意图和基本架构；（3）由通用数据元素（CDE）组成的特定疾病标准数据集；（4）收集和汇总分散在医院各个医疗业务系统中的特定疾病数据；（5）特定疾病数据的治理和质量改进；（6）数据存储和计算；以及（7）数据应用模块的设计。
结果
在中国一家三甲医院的胃肠科创建了一个肝硬化的DSCDS，拥有九个以上的数据应用模块。基于此DSCDS，正在开展一系列临床研究，如回顾性或前瞻性队列研究、使用多模态数据的预后研究以及随访研究。
结论
本文中肝硬化DSCDS的开发为我国其他特定疾病DSCDS的设计和开发提供了经验和参考；如果其他国家有对DSCDS的需求且有相同或更好的医疗信息化基础，甚至可以扩展到其他国家DSCDS的开发。DSCDS比一般临床数据库系统和临床数据仓库（CDR）拥有更准确、标准、全面、多模态且可用的特定疾病数据，并为医学研究、临床决策和提高特定疾病的医疗服务质量提供了可信的数据基础。
补充信息
在线版本包含可在10.1007/s13755-023-00211-4获取的补充材料。
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