Lu Ying, Jin Hua, Genant Harry K
Department of Radiology, Box 0629, University of California, San Francisco, San Francisco, CA 94143-0629, USA.
Stat Med. 2003 Oct 15;22(19):3029-44. doi: 10.1002/sim.1569.
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.
在医学研究中，诊断试验相对于标准或最佳试验的非劣效性是一个常见问题。我们常常想确定一种新的诊断试验是否与标准参考试验一样好。有时我们会对一种成本较低但敏感性或特异性稍差但仍可接受的试验感兴趣。虽然已经提出了仅针对敏感性或特异性等效性的假设检验程序和样本量公式，但很少有研究讨论这两个参数的同时比较。在本文中，我们提出了三种不同的检验程序和样本量公式，用于基于配对观察和已知疾病状态同时比较敏感性和特异性。然后，这些统计程序被用于比较两种用于识别未来骨质疏松性骨折女性的分类规则。模拟实验表明，新的检验方法和样本量公式给出了合适的I型和II型错误率。我们还讨论了我们的方法与Lui和Cumberland方法之间的差异。
