真实世界临床数据管理标准操作规程研究:以梅毒临床数据为例

Standard operation procedure of real-world data management:syphilis data as an example

医院数据是真实世界数据的主要来源之一, 不科学、不规范的数据管理极大地妨碍了真实世界证据的可靠性。基于临床数据应用于科学研究时发现的问题, 本研究制定面向真实世界的数据管理标准操作规程(standard operation procedure, SOP), 从内容与逻辑一致性、完整性和规范性方面对数据整理进行标准化, 并以某三级甲等医院的梅毒临床数据为例, 对其进行验证。自某院医院信息系统基础信息库、诊断库、检验信息库和治疗信息库导出2008年1月1日至2018年1月1日皮肤科就诊的梅毒患者的临床数据, 共提取相关信息71 705条。SOP分析显示:完全重复6 816条;姓名、就诊ID号、身份证号码、年龄及性别存在内容或逻辑不一致的条目分别为152条、360条、88条、107条及457条;婚姻、民族、性别、生日和身份证号码项目缺失条目较多, 分别为1 711条、1 077条、457条、496条和355条。规范化情况总体较好, 其中职业项目填写不规范为1 884条。利用规范整理后的数据可有效统计梅毒不同分期的患者比例和诊疗费用, 表明本研究提出的面向真实世界的临床数据管理与分析SOP, 可用于建设基于医疗实践数据、以科学研究为导向的临床-科研型双功能数据库。

Clinical data is one of the key sources of real-world data,while the reliability of such data is often hindered by unscientific and irregular data management.Based on various problems found in the application of clinical data to scientific research,this study formulated a standard operation procedure(SOP)for real-world data management,and organized the data in terms of content and logic consistency,completeness and standardization.The clinical data of syphilis at a tertiary hospital were used as an example for verification.The clinical data of syphilis patients in the dermatology department from January 1,2008 to January 1,2018 were derived from the basic information database,diagnosis database,laboratory information database,and treatment information database of its hospital information system,and a total of 71705 pieces of relevant information were extracted.SOP analysis showed that 6816 articles were completely repeated.There were content or logical inconsistencies in name,medical identification number,resident ID number,age and gender,being 152,360,88,107 and 457 respectively.There were many missing entries for marital status,ethnicity,gender,birthday,and ID number,being 1711,1077,457,496 and 355 respectively.The standardization situation was generally good,and the number of irregularities in filling out occupational items was 1884.The standardized and collated data could effectively count the proportion of patients in different stages of syphilis and the cost of diagnosis and treatment,indicating that the real-world data management and analysis SOP proposed in this study could be used to build a clinical-research oriented dual-functional database based on medical practice data.