比较正常百分位数差异、非劣效性和等效性检验的替代方法。
Comparison of alternative approaches for difference, noninferiority, and equivalence testing of normal percentiles.
机构信息
Department of Management Science, National Chiao Tung University, Hsinchu, Taiwan, 30010, Republic of China.
出版信息
BMC Med Res Methodol. 2020 Mar 13;20(1):59. doi: 10.1186/s12874-020-00933-z.
BACKGROUND
Percentiles are widely used in scientific research for determining the comparative magnitude and reference limit of quantitative measurements. The investigations for point and interval estimation of normal percentiles are well documented in the literature. However, the corresponding statistical tests of hypothesis have received relatively little attention.
METHODS
To facilitate data analysis and design planning of percentile study, this paper aims to present hypothesis testing procedures and associated power functions for assessing the difference, noninferiority, and equivalence of normal percentiles.
RESULTS
Numerical illustrations about drug dissolution are provided to demonstrate the usefulness of the suggested exact approaches and the deficiency of approximate methods.
CONCLUSIONS
The exact approaches are superior to the approximate methods on the basis of control of Type I errors. Computer algorithms are constructed to implement the recommended test procedures and sample size calculations for percentile analysis.
背景
百分位数在科学研究中被广泛用于确定定量测量的比较幅度和参考限值。正态百分位数的点估计和区间估计的研究在文献中已有详细记载。然而，相应的假设统计检验相对较少受到关注。
方法
为了便于百分位研究的数据分析和设计规划，本文旨在提出假设检验程序和相关功效函数，以评估正态百分位数的差异、非劣效性和等效性。
结果
提供了关于药物溶解的数值说明，以展示所建议的精确方法的有用性和近似方法的不足。
结论
基于对 I 类错误的控制，精确方法优于近似方法。构建了计算机算法来实现推荐的百分位分析的检验程序和样本量计算。
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