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评估检测性能需要多少患者?

How many patients are necessary to assess test performance?

作者信息

Arkin C F, Wachtel M S

机构信息

Department of Pathology, New England Deaconess Hospital, Boston, Mass. 02115.

出版信息

JAMA. 1990 Jan 12;263(2):275-8.

PMID:2403604
Abstract

Test performance characteristics are important in assessing the clinical usefulness of laboratory tests and serve as a basis for comparing one test to another. Statistical comparisons of performance characteristics are meaningful only when they can detect medically important differences; that is, when they provide adequate statistical power. This requires choosing the appropriate sample size in determining the performance characteristics of interest. Using standard formulas, we designed tables that provide such sample size requirements. Example problems of sample size determination in laboratory test comparisons are given. Used appropriately, this approach should result in better studies of laboratory tests and fewer meaningless negative studies.

摘要

检验性能特征在评估实验室检验的临床实用性方面很重要,并作为比较一项检验与另一项检验的基础。只有当性能特征的统计比较能够检测出医学上的重要差异时,即当它们提供足够的统计效力时,这些比较才有意义。这就要求在确定感兴趣的性能特征时选择合适的样本量。我们使用标准公式设计了表格,这些表格给出了此类样本量要求。文中给出了实验室检验比较中样本量确定的示例问题。如果使用得当,这种方法应能带来对实验室检验更好的研究,并减少无意义的阴性研究。

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