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临床研究中的个案研究。

Individual case studies in clinical research.

作者信息

Charlton B G, Walston F

机构信息

Department of Psychology, University of Newcastle upon Tyne, UK.

出版信息

J Eval Clin Pract. 1998 May;4(2):147-55. doi: 10.1046/j.1365-2753.1998.00011.x.

DOI:10.1046/j.1365-2753.1998.00011.x
PMID:9839641
Abstract

Case studies have acquired an unmerited reputation as being anecdotal, unscientific and intrinsically inferior to group studies. The subsequent disregarding of individual patients as the focus of investigation has led to the neglect of an extremely useful clinical research method, and has probably impaired the pace of therapeutic innovation. The purpose of this paper is to clarify the scope and nature of case studies and promote their rehabilitation. Case studies can, in principle, be used to test any theory that has implications for individual patients. There are two crucial methodological stages. The first is to identify scientifically plausible general theories and derive from them specific hypotheses or models of sufficient precision to have implications for individual cases. The second is to test these hypothetical models against 'pure' cases, selected so as to exclude interfering variables. There are two main types of case study--those made by serendipity (unplanned case observations which challenge an implicit theoretical framework); and formal case studies (designed prospectively to collect pure cases to test a prior hypothesis). The difference between serendipity and planned case studies roughly corresponds to the difference between surveillance and screening. A worked-example of a formal case study is described here in order to illustrate the method. Individual case studies deserve fresh consideration by researchers, since they are a clinician-friendly method with a unique potential for incorporation into routine practice.

摘要

案例研究背负了不应有的名声,被认为是轶事性的、不科学的,本质上不如群组研究。随后,将个体患者排除在研究重点之外,导致一种极为有用的临床研究方法被忽视,还可能减缓了治疗创新的步伐。本文旨在阐明案例研究的范围和性质,并推动其复兴。原则上,案例研究可用于检验任何对个体患者有影响的理论。有两个关键的方法学阶段。第一个阶段是科学地确定合理的一般理论,并从中推导出足够精确的具体假设或模型,以便对个体病例产生影响。第二个阶段是针对“纯粹”的病例检验这些假设模型,这些病例的选择要排除干扰变量。案例研究主要有两种类型——偶然发现的案例(意外的病例观察对隐含的理论框架构成挑战)和正式的案例研究(前瞻性设计以收集纯粹病例来检验先前的假设)。偶然发现与计划好的案例研究之间的差异大致对应于监测与筛查之间的差异。这里描述了一个正式案例研究的实例,以说明该方法。个体案例研究值得研究者重新审视,因为它们是一种对临床医生友好的方法,具有融入常规实践的独特潜力。

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