An exact test for comparing two predictive values in small-size clinical trials
An exact test for comparing two predictive values in small-size clinical trials
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DOI：
10.1002/pst.1968
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发表时间：
2019-10-23
影响因子：
1.5
通讯作者：
Yamamoto, Kouji
中科院分区：
文献类型：
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作者：
Takahashi, Kanae;Yamamoto, Kouji
阳性和阴性预测值描述了诊断测试的性能。有几种方法可以检验配对设计中预测值的相等性。然而，这些方法都是建立在大样本理论基础上的，由于第一类错误率的膨胀，它们可能不适合小样本临床试验。在这项研究中，我们提出了一个精确的测试，以严格控制1型错误率进行小规模的临床试验，调查配对设计中的预测值的平等。此外，我们进行模拟研究，以评估性能的精确测试和现有的方法在小规模的临床试验。所提出的检验可以计算精确的P值，并且作为模拟的结果，所提出的检验的经验类型1错误率不超过显著性水平，无论设置如何，所提出的检验的经验功效与基于大样本理论的其他方法没有太大差异。因此，它被认为是有用的，当类型1的错误率需要严格控制建议的精确测试。
Positive and negative predictive values describe the performance of a diagnostic test. There are several methods to test the equality of predictive values in paired designs. However, these methods were premised on large sample theory, and they may not be suitable for small-size clinical trials because of inflation of the type 1 error rate. In this study, we propose an exact test to control the type 1 error rate strictly for conducting a small-size clinical trial that investigates the equality of predictive values in paired designs. In addition, we execute simulation studies to evaluate the performance of the proposed exact test and existing methods in small-size clinical trials. The proposed test can calculate the exact P value, and as a result of simulations, the empirical type 1 error rate for the proposed test did not exceed the significance level regardless of the setting, and the empirical power for the proposed test is not much different from the other methods based on large-sample theory. Therefore, it is considered that the proposed exact test is useful when the type 1 error rate needs to be controlled strictly.