真实世界数据采集、治理与管理的一体化解决工具研究

Research on Integrated Solution Tools for Real-World Data Collection,Governance and Management

随着网络信息技术的提高,医疗卫生相关数据的电子化已达到较高水平。在传统的研究方式中,通常需要耗费大量的人工和时间成本对相关信息进行整理和提取。而应用自然语言处理技术对诊疗文本进行数据的自动化提取,可明显提高研究效率,降低研究成本。基于真实世界数据的产生和应用场景,以及满足监管部门的法规要求,本研究构建了一个用于真实世界数据采集、治理和管理的一体化解决工具,即电子源数据记录(eSource record,ESR)工具,功能设计主要包含源数据采集、数据提取和治理以及电子数据采集系统对接三部分。为了验证解决方案的可行性,2021年6月,本研究采用ESR工具,在海南博鳌乐城国际医疗旅游先行区一家医疗机构的医疗美容科进行了试点研究,对其真实世界研究的源数据进行了采集管理。

With the advancement of information technology,the digitalization of medical and health-related data has reached a high level.Traditional research methods are typically labor intensive and time consuming to sort and extract this information.The use of natural language processing technology to automatically extract data from medical texts has markedly improved research efficiency and reduced research costs.Based on the generation and application scenarios of real-world data,as well as the requirements of regulatory authorities,this study constructed an integrated solution tool,namely the electronic source data record(eSource record,ESR),for real-world data collection,governance,and management.The functional design of ESR mainly includes three parts:source data collection,data extraction and management,and integration with the electronic data collection system.In June 2021,we conducted a pilot study at a cosmetic dermatology department of a medical institution in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan.To verify the feasibility of ESR,we used it to conduct source data collection for a real-world study.