A non-inferiority test and sample size determination for comparing two predictive values of diagnostic tests

A non-inferiority test and sample size determination for comparing two predictive values of diagnostic tests
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用于比较诊断测试的两个预测值的非劣效性检验和样本量确定

DOI:
10.1080/23737484.2020.1719559
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发表时间:
2020
期刊:
Communications in Statistics: Case Studies, Data Analysis and Applications
影响因子:
--
通讯作者:
K.
K.
中科院分区:
--
文献类型:
--
作者:
Takahashi;K. and Yamamoto;K.

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阳性和阴性预测值描述了诊断测试应用于一组个体时的临床表现。由于检查的简单性和测试的侵入性,在某些情况下测试预测值的非劣效性可能就足够了,但尚未提出预测值的非劣效性测试。在本研究中,我们提出了一种非劣效性检验,该检验研究配对设计中预测值的非劣效性,以及计算样本量的公式以执行两个预测值的非劣效性检验。模拟研究表明,所提出的非劣效性检验可用于比较临床试验中的两个预测值。
Positive and negative predictive values describe the clinical performance of the diagnostic test when it is applied to a cohort of individuals. Testing non-inferiority of predictive values may be adequate in some cases due to the simplicity of the examination and the invasiveness of the test, but no non-inferiority test for predictive values has been proposed yet. In this study, we propose a non-inferiority test that investigates the non-inferiority of predictive values in paired designs, and formulae for the calculation of sample size to execute the non-inferiority test of two predictive values. Simulation studies showed that the proposed non-inferiority test is useful for comparing two predictive values in clinical trials.
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