On the non-inferiority of a, diagnostic test based on paired observations
On the non-inferiority of a, diagnostic test based on paired observations
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DOI：
10.1002/sim.1569
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发表时间：
2003-10-15
影响因子：
2
通讯作者：
Genant, HK
中科院分区：
文献类型：
--
作者：
Lu, Y;Jin, H;Genant, HK
诊断试验相对于标准或最佳试验的非劣效性是医学研究中的常见问题。我们通常希望确定新的诊断测试是否与标准参考测试一样好。有时，我们感兴趣的是一个廉价的测试，可能有一个可接受的低灵敏度或特异性。虽然假设检验程序和样本量公式的等效性的敏感性或特异性单独提出，很少有研究讨论了同时比较两个参数。在本文中，我们提出了三种不同的测试程序和样本量公式，同时比较的灵敏度和特异性的基础上配对观察和已知的疾病状态。这些统计程序，然后用来比较两个分类规则，确定妇女为未来骨质疏松性骨折。仿真实验表明，新的测试和样本量公式给出了适当的I型和II型错误率。我们的方法和方法的吕和坎伯兰之间的差异进行了讨论。版权所有（C）2003约翰威利父子有限公司。
Non-inferiority of a diagnostic test to the standard or the optimum test is a common issue in medical research. Often we want to determine if a new diagnostic test is as good as the standard reference test. Sometimes we are interested in an inexpensive test that may have an acceptably inferior sensitivity or specificity. While hypothesis testing procedures and sample size formulae for the equivalence of sensitivity or specificity alone have been proposed, very few studies have discussed simultaneous comparisons of both parameters. In this paper, we present three different testing procedures and sample size formulae for simultaneous comparison of sensitivity and specificity based on paired observations and with known disease status. These statistical procedures are then used to compare two classification rules that identify women for future osteoporotic fracture. Simulation experiments demonstrate that the new tests and sample size formulae give the appropriate type I and II error rates. Differences between our approach and the approach of Lui and Cumberland are discussed. Copyright (C) 2003 John Wiley Sons, Ltd.