摘要
目的:本文以失眠辨证论治的随机对照临床疗效评价研究为例,探讨数据管理的设计方法、实施过程及其规范执行,对提高研究质量及证据级别的意义。方法:以"中医药辨证论治治疗原发性失眠的有效核心处方发现研究"的临床试验为例,介绍其实现数据管理设计、实施的具体方法、流程、关键环节和效果,并与文献研究结果比较其意义。结果:1设计并实现了临床试验研究方案中的数据管理设计、数据管理计划及数据管理流程;2设计了临床病例报告表、数据字典、数据验证计划、医学审核计划;3设计并建设了基本符合临床数据交换标准协会数据提交标准的数据库;4设计并规范了数据录入及数据过程管理;5设计并形成了临床研究数据管理标准操作规程、数据管理报告、数据审核决议、统计分析计划人群。结论:目前中医药治疗失眠临床研究中规范的数据管理应用情况较差;而数据管理设计是临床研究计划内关于研究方法与步骤的重要环节,应根据研究目的和内容,结合统计学要求,针对研究全过程,认真考虑研究中的关键环节和问题,进行科学客观的设计,合理安排各种试验因素,严格控制可能出现的误差,用最少的人力、物力和时间,最大限度地获得丰富而可靠的数据,其中贯穿研究始终的临床研究数据管理标准操作规程制定,辅助临床研究数据管理全程的数据管理系统的使用,较高水平的临床研究数据管理的团队及参研人员的分工、协调与合作是设计、实施优质高效数据管理的关键。
This study discussed the design approach and the process of data management and the significance of its normative implementation for promoting the quality and the level of evidence. The study took the RCTs of insomnia as an example in line with its treatment based on syndrome differentiation. We introduced the realization of the method, process, key points and the effect of the design approach and implement actions of data management and its significance compared with the results of literature studies, giving the instance of the discovery on the effective core prescription of TCM syndrome differentiation and treatment for primary insomnia research. The results were as follows： We designed and realized the design of data management in the clinical trial research programs, data management plans and a data management process; and designed the case report form, data dictionary, data validation plan and medical audit plan; designed and constructed the database in accord with the Clinical Data Interchange Standards Consortium for the data submitted standards; designed the specification and the management of data entry and data process; and designed the formation of the clinical research data management standard operating procedures, data management report, data audit resolution and statistical analysis plan population. In conclusion, the standardized application of data management was undesirable for current clinical researches for the treatment of insomnia with Chinese medicine. However, the design of data management was critical for the clinical research planning the methods and protocols of researches. Based on the end and contents of the study, critical problems and links in the research should be considered in the whole process in regard to statistical commands. Studies need scientificaly and objectively designing and varieties of factors reasonably arranging to minimize the possible errors and human and material resources and duration and to maximize its volumes of sound data, among which the formulation of sta
作者
吴东宁
何丽云
文天才
艾艳柯
王鑫
吕晓颖
Wu Dongning He Liyun Wen Tiancai Ai Yanke Wang Xin Lu Xiaoying(Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China)
出处
《世界科学技术-中医药现代化》
2016年第9期1614-1620,共7页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家自然科学基金委面上项目(81072920):中药新药有效核心处方发现的随机对照盲法设计方法研究
负责人:何丽云
关键词
失眠
数据管理
设计方法
数据库
电子数据采集系统
Insomnia
data management
design method
database
electronic data acquisition system
