Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method
Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method
复制标题
用于评估 Bland-Altman 方法两种测量方法之间一致性的样本量
DOI：
10.1515/ijb-2015-0039
复制
发表时间：
2016-11-01
影响因子：
1.2
通讯作者：
Ji, Mu-Huo
中科院分区：
文献类型：
--
作者：
Lu, Meng-Jie;Zhong, Wei-Hua;Ji, Mu-Huo
Bland-Altman 方法已广泛用于评估两种测量方法之间的一致性。然而，关于样本量估计仍然没有解决。我们提出了一种用于 Bland-Altman 一致性评估的样本量估计新方法。根据 Bland-Altman 方法，一致性结论是根据 LOA（一致性限度）的置信区间宽度与预定义的临床一致性限度进行比较得出的。根据统计推断理论，推导出样本量估计的公式，该公式取决于预先确定的α、β水平、两次测量之间的差异的平均值和标准差以及预先确定的限值。利用这种新方法，计算方法比较研究中经常出现的不同参数设置下的样本量，并使用蒙特卡罗模拟来获得相应的功效。蒙特卡罗仿真结果表明，所获得的功率与预定功率水平相符，验证了该方法的正确性。样本量估计方法可以应用于 Bland-Altman 方法来评估两种测量方法之间的一致性。
The Bland-Altman method has been widely used for assessing agreement between two methods of measurement. However, it remains unsolved about sample size estimation. We propose a new method of sample size estimation for Bland-Altman agreement assessment. According to the Bland-Altman method, the conclusion on agreement is made based on the width of the confidence interval for LOAs (limits of agreement) in comparison to predefined clinical agreement limit. Under the theory of statistical inference, the formulae of sample size estimation are derived, which depended on the pre-determined level of alpha, beta, the mean and the standard deviation of differences between two measurements, and the predefined limits. With this new method, the sample sizes are calculated under different parameter settings which occur frequently in method comparison studies, and Monte-Carlo simulation is used to obtain the corresponding powers. The results of Monte-Carlo simulation showed that the achieved powers could coincide with the pre-determined level of powers, thus validating the correctness of the method. The method of sample size estimation can be applied in the Bland-Altman method to assess agreement between two methods of measurement.