Estimating the reliability of repeatedly measured endpoints based on linear mixed-effects models. A tutorial

• Published in: Pharmaceutical statistics : the journal of the pharmaceutical industry Vol. 15; no. 6; pp. 486 - 493
• Main Authors: Van der Elst, Wim, Molenberghs, Geert, Hilgers, Ralf-Dieter, Verbeke, Geert, Heussen, Nicole
• Format: Journal Article
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 01.11.2016; Wiley Subscription Services, Inc
• Subjects: Confidence Intervals; Endpoint Determination; Humans; intra-class correlation; Linear Models; Models, Statistical; Outcome Assessment (Health Care) - methods; Reproducibility of Results; Research Design; test-retest reliability; within-cluster correlation; within-cluster correlation; intra-class correlation; test-retest reliability
• ISSN: 1539-1604; 1539-1612; 1539-1612
• DOI: 10.1002/pst.1787

There are various settings in which researchers are interested in the assessment of the correlation between repeated measurements that are taken within the same subject (i.e., reliability). For example, the same rating scale may be used to assess the symptom severity of the same patients by multiple physicians, or the same outcome may be measured repeatedly over time in the same patients. Reliability can be estimated in various ways, for example, using the classical Pearson correlation or the intra‐class correlation in clustered data. However, contemporary data often have a complex structure that goes well beyond the restrictive assumptions that are needed with the more conventional methods to estimate reliability. In the current paper, we propose a general and flexible modeling approach that allows for the derivation of reliability estimates, standard errors, and confidence intervals – appropriately taking hierarchies and covariates in the data into account. Our methodology is developed for continuous outcomes together with covariates of an arbitrary type. The methodology is illustrated in a case study, and a Web Appendix is provided which details the computations using the R package CorrMixed and the SAS software. Copyright © 2016 John Wiley & Sons, Ltd.