Applying linear mixed models to estimate reliability in clinical trial data with repeated measurements.
Repeated measures are exploited to study reliability in the context of psychiatric health sciences. It is shown how test-retest reliability can be derived using linear mixed models when the scale is continuous or quasi-continuous. The advantage of this approach is that the full modeling power of mixed models can be used. Repeated measures with a different mean structure can be used to usefully study reliability, correction for covariate effects is possible, and a complicated variance-covariance structure between measurements is allowed. In case the variance structure reduces to a random intercept (compound symmetry), classical methods are recovered. With more complex variance structures (e.g., including random slopes of time and/or serial correlation), time-dependent reliability functions are obtained. The methodology is motivated by and applied to data from five double-blind randomized clinical trials comparing the effects of risperidone to conventional antipsychotic agents for the treatment of chronic schizophrenia. Model assumptions are investigated through residual plots and by investigating the effect of influential observations.
Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium. tvangene@prdbe.jnj.com
Tony
T
Vangeneugden
Annouschka
A
Laenen
Helena
H
Geys
Didier
D
Renard
Geert
G
Molenberghs
D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D016014:Linear Models; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D018967:Risperidone / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy
D014150:Antipsychotic Agents; D018967:Risperidone