Barnhart Huiman X, Lokhnygina Yuliya, Kosinski Andrzej S, Haber Michael
Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University, Durham, North Carolina 27715, USA.
J Biopharm Stat. 2007;17(4):721-38. doi: 10.1080/10543400701329497.
In method comparison and reliability studies, it is often important to assess agreement between multiple measurements made by different methods, devices, laboratories, observers, or instruments. For continuous data, the concordance correlation coefficient (CCC) is a popular index for assessing agreement between multiple methods on the same subject where none of the methods is treated as reference. Barnhart et al. (2007) proposed coefficient of individual agreement (CIA) to assess individual agreement between multiple methods for situations with and without a reference method extending the concept of individual bioe-quivalence from the FDA 2001 guidelines. In this paper, we propose a new CCC for assessing agreement between multiple methods where one of the methods is treated as reference. We compare the properties of the CCC and CIA and their dependency on the relative magnitude of between-subject variability and within-subject variability. The relationship between CCC and CIA as well as the impact of between-subject variability are presented algebraically and graphically. Several examples are presented to explain the interpretation of the CCC and CIA values.
在方法比较和可靠性研究中,评估不同方法、设备、实验室、观察者或仪器所进行的多次测量之间的一致性通常很重要。对于连续数据,一致性相关系数(CCC)是评估同一受试者多种方法之间一致性的常用指标,其中没有一种方法被视为参考方法。Barnhart等人(2007年)提出了个体一致性系数(CIA),以评估有无参考方法情况下多种方法之间的个体一致性,扩展了美国食品药品监督管理局2001年指南中个体生物等效性的概念。在本文中,我们提出了一种新的CCC,用于评估将其中一种方法视为参考方法时多种方法之间的一致性。我们比较了CCC和CIA的性质及其对受试者间变异性和受试者内变异性相对大小的依赖性。以代数和图形方式展示了CCC与CIA之间的关系以及受试者间变异性的影响。给出了几个例子来解释CCC和CIA值的含义。