摘要
目的:探讨中医药研究领域将病例报告表数据转化为数据表格模型(SDTM)标准数据格式的方法。方法:目前常用单纯SDTM方法、数据提交SDTM方法和数据库SDTM方法实现SDTM标准,本文通过比较分析这3种方法的优缺点,介绍了中国中医科学院临床评价中心实现中医临床研究数据SDTM标准化的具体经验。结果:单纯SDTM方法最大化的使用SDTM标准,但需要改变原有的工作流程和软件系统,时间成本和花费较大;数据提交SDTM方法最小化的使用SDTM标准,花费最小,但不能保证数据质量和溯源性;数据库SDTM方法通过在数据录入之前预先在原有不兼容SDTM标准的系统内设立SDTM转化程序,生成SDTM标准的数据库。结论:数据库SDTM方法是适合中医药临床研究的一种较为实用的方法。
This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form （CRF） to Study Data Tabulation Model （SDTM） database format in clinical research of traditional Chinese medicine （TCM）. Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.
出处
《世界科学技术-中医药现代化》
2015年第2期301-305,共5页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家中医药管理局行业专项(200907001-6):临床研究支撑技术与临床科研一体化网络的研究
负责人:刘保延
科学技术部国家"十二五"科技支撑计划项目(2012BAI24B02):针灸临床疗效评价共性技术与数据管理方法研究
负责人:刘保延
关键词
临床研究
研究数据表格模型
数据提交
方法
Clinical research
Study Data Tabulation Model
data submission
method
