真实世界数据的真实性及其影响因素探讨

Validity of Real-World Data and the Risk Factors

真实世界数据是产生真实世界证据的源头,其真实性是对数据资料最基本的要求。真实世界数据具有来源广泛、数据量大、内容丰富、种类繁多、分散性强、异质性高等特点。从数据来源和数据统计分析两方面分析可能导致真实世界数据偏差的原因,提出从病历质量、患者引导、研究人员培训、优化系统、规范数据分析等方面提高真实世界数据的真实性。

As the basis of conducting real-word studies,the validity of real-world data(RWD)should be highly valued.RWD was characterized by the universality of sources,the abundant of data,the richness of content,and the diversity of types,and was highly dispersed and heterogenized.The risk factors that might lead to bias of RWD were analyzed from the aspects of data source and data statistical analysis.To improve the RWD validity,the quality of medical records should be improved;patients'education and researchers'training are needed;the system should be perfected and the data analysis should be standardized.