Before new clinical measurement methods are implemented in clinical practice, it must be confirmed whether their results are equivalent to those of existing methods. The agreement of the trend between these methods is evaluated using the four-quadrant plot, which describes the trend of change in each difference of the two measurement methods' values in sequential time points, and the plot's concordance rate, which is calculated using the sum of data points in the four-quadrant plot that agree with this trend divided by the number of all accepted data points. However, the conventional concordance rate does not consider the covariance between the data on individual subjects, which may affect its proper evaluation. Therefore, we proposed a new concordance rate calculated by each individual according to the number of agreement. Moreover, this proposed method can set a parameter that the minimum concordant number between two measurement techniques. The parameter can provide a more detailed interpretation of the degree of agreement. A numerical simulation conducted with several factors indicated that the proposed method resulted in a more accurate evaluation. We also showed a real data and compared the proposed method with the conventional approach. Then, we concluded the discussion with the implementation in clinical studies.
翻译:在临床实践中实施新的临床测量方法之前,必须确认这些方法的结果是否等同于现有方法的结果;评估这些方法之间趋势的一致时,要使用四象方图进行评估,其中说明两种测量方法在先后时间点上数值的每一种差异的变化趋势,以及该图的一致率,该图的一致率是使用四象方图中的数据点和与该趋势一致的四象图中的数据点和所有公认数据点数之和计算得出的;然而,常规一致率并不考虑个别主题数据之间的差异,这可能影响对数据的适当评估;因此,我们建议由每个人根据协议数计算出新的一致率;此外,这一拟议方法可以设定一种参数,使两种测量技术之间的最低一致数成为参数;该参数可以更详细地解释同意度;用数字模拟用若干因素表明,拟议的方法最终进行了更准确的评估;我们还展示了真实的数据,并将拟议方法与常规方法作了比较。然后,我们结束了与临床研究的执行的讨论。