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注册数据在临床研究中的机遇与挑战。

Opportunities and pitfalls of registry data for clinical research.

机构信息

Department of Epidemiology, University of Washington, Box 357236, Seattle, WA 98195, USA.

出版信息

Paediatr Respir Rev. 2013 Sep;14(3):141-5. doi: 10.1016/j.prrv.2013.04.004. Epub 2013 May 24.

Abstract

The use of disease registries for clinical epidemiological studies has become increasingly common and has led to advancements in the understanding of many disease processes. The availability of demographic and disease characteristic data on large patient populations, coupled with the minimal cost and relative speed of conducting retrospective investigations, provide an attractive alternative to original data collection. However, limitations inherent to the data collection process can result in the loss of generalizability and introduce bias, leading to erroneous or invalid results. Recognition and identification of these limitations will be unique to each investigation and to the registry being used. The purpose of this article is to highlight the opportunities that registries provide for researchers while presenting potential pitfalls in their use. We conclude with a discussion of a practical approach when considering registry data for clinical research.

摘要

疾病登记处被广泛应用于临床流行病学研究,使人们对多种疾病的发病机制有了更深入的了解。这种方法利用大量患者的人口统计学和疾病特征数据,成本低、速度快,能够进行回顾性研究,为原始数据收集提供了一种有吸引力的替代方法。然而,数据收集过程中固有的局限性可能导致普遍性的丧失,并引入偏差,从而导致错误或无效的结果。这些局限性的识别和确定对于每个研究和使用的登记处都是独特的。本文的目的是强调登记处为研究人员提供的机会,同时也指出其使用过程中的潜在陷阱。最后,我们将讨论在考虑将登记处数据用于临床研究时的一种实用方法。

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