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临床数据库研究的障碍与方法:加利福尼亚大学旧金山分校的经验

Obstacles and approaches to clinical database research: experience at the University of California, San Francisco.

作者信息

Newman T B, Brown A, Easterling M J

机构信息

Department of Laboratory Medicine, University of California, San Francisco.

出版信息

Proc Annu Symp Comput Appl Med Care. 1994:568-72.

Abstract

With increasing availability of clinical data in machine-readable form, and decreasing cost of storing and manipulating that data, retrospective research using clinical databases has become more feasible. Nonetheless, much of the potential for clinical research using these data remains unrealized. Obstacles to clinical database research include difficulty accessing data, difficulty using retrospective data to draw valid inferences about medical tests and treatments, and a shortage of investigators trained and interested in using a clinical database to answer their questions. At the University of California, San Francisco, we have developed a Clinical Database Research Program (CDRP) to try to overcome these obstacles. The CDRP maintains a relational database of patient data obtained from diverse sources and a small staff dedicated to providing such data to researchers. The CDRP staff also provides support for design and analysis of studies using the database--the development of methods for such studies is our primary research interest. Finally, to increase the number of investigators using the database for research, we are integrating training in clinical epidemiology and clinical research methods into residency and fellowship training, and offering an elective in clinical database research for trainees who wish to undertake a specific project.

摘要

随着以机器可读形式存在的临床数据越来越多,以及存储和处理这些数据的成本不断降低,利用临床数据库进行回顾性研究变得更加可行。尽管如此,利用这些数据进行临床研究的许多潜力仍未实现。临床数据库研究面临的障碍包括获取数据困难、利用回顾性数据对医学检查和治疗得出有效推论困难,以及缺乏受过使用临床数据库回答问题培训且对此感兴趣的研究人员。在加利福尼亚大学旧金山分校,我们开发了一个临床数据库研究项目(CDRP)来试图克服这些障碍。CDRP维护着一个从不同来源获取的患者数据关系数据库,并有一小批工作人员专门负责向研究人员提供此类数据。CDRP的工作人员还为使用该数据库的研究设计和分析提供支持——此类研究方法的开发是我们的主要研究兴趣所在。最后,为了增加使用该数据库进行研究的研究人员数量,我们正在将临床流行病学和临床研究方法的培训纳入住院医师和专科培训,并为希望开展特定项目的学员提供临床数据库研究选修课。

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