Department of Environmental and Occupational Health, Epidemiology and Biostatistics Program, School of Community Health Sciences, University of Nevada Las Vegas, Las Vegas, NV, USA.
Stat Methods Med Res. 2018 Jul;27(7):2132-2141. doi: 10.1177/0962280216676854. Epub 2016 Nov 16.
In an agreement test between two raters with binary endpoints, existing methods for sample size calculation are always based on asymptotic approaches that use limiting distributions of a test statistic under null and alternative hypotheses. These calculated sample sizes may be not reliable due to the unsatisfactory type I error control of asymptotic approaches. We propose a new sample size calculation based on exact approaches which control for the type I error rate. The two exact approaches are considered: one approach based on maximization and the other based on estimation and maximization. We found that the latter approach is generally more powerful than the one based on maximization. Therefore, we present the sample size calculation based on estimation and maximization. A real example from a clinical trial to diagnose low back pain of patients is used to illustrate the two exact testing procedures and sample size determination.
在两位评分者之间的二项终点协议测试中，现有的样本量计算方法始终基于渐近方法，这些方法使用在零假设和备择假设下检验统计量的极限分布。由于渐近方法不能令人满意地控制Ⅰ类错误，因此这些计算出的样本量可能不可靠。我们提出了一种新的基于精确方法的样本量计算方法，该方法可以控制Ⅰ类错误率。这两种精确方法分别是：一种基于最大化的方法，另一种基于估计和最大化的方法。我们发现后者方法通常比基于最大化的方法更有效。因此，我们提出了基于估计和最大化的样本量计算方法。使用临床试验中诊断患者腰痛的实际示例来说明这两种精确检验程序和样本量确定。
