Department of Biostatistics, Peking University First Hospital, Beijing, Beijing, China.
Department of Biostatistics, Peking University First Hospital, Beijing, Beijing, China
BMJ Open. 2020 Dec 29;10(12):e038375. doi: 10.1136/bmjopen-2020-038375.
To investigate the gap between real-world data and clinical research initiated by doctors in China, explore the potential reasons for this gap and collect different stakeholders' suggestions.
This qualitative study involved three types of hospital personnel based on three interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.
Six tertiary hospitals (three general hospitals and three specialised hospitals) in Beijing, China, were included.
In total, 42 doctors from 12 departments, 5 information technology managers and 4 clinical managers were interviewed through stratified purposive sampling.
Electronic medical record data cannot be directly downloaded into clinical research files, which is a major problem in China. The lack of data interoperability, unstructured electronic medical record data and concerns regarding data security create a gap between real-world data and research data. Updating hospital information systems, promoting data standards and establishing an independent clinical research platform may be feasible suggestions for solving the current problems.
Determining the causes of gaps and targeted solutions could contribute to the development of clinical research in China. This research suggests that updating the hospital information system, promoting data standards and establishing a clinical research platform could promote the use of real-world data in the future.
调查中国医生发起的真实世界数据与临床研究之间的差距，探讨产生这种差距的潜在原因，并收集不同利益相关者的建议。
本定性研究基于三个访谈大纲，涉及三类医院人员。采用建构主义扎根理论分析流程进行数据分析。
中国北京的 6 家三级医院（3 家综合医院和 3 家专科医院）。
通过分层目的抽样，共对来自 12 个科室的 42 名医生、5 名信息技术经理和 4 名临床经理进行了访谈。
电子病历数据无法直接下载到临床研究文件中，这是中国的一个主要问题。数据互操作性缺乏、电子病历数据非结构化以及对数据安全的担忧导致了真实世界数据和研究数据之间的差距。更新医院信息系统、推广数据标准和建立独立的临床研究平台可能是解决当前问题的可行建议。
确定差距的原因和针对性的解决方案有助于促进中国的临床研究发展。本研究表明，更新医院信息系统、推广数据标准和建立临床研究平台可能有助于未来更多地使用真实世界数据。
