Random Intercept Logistic Models Research Articles

A maximin criterion for the logistic random intercept model with covariates

A maximin criterion is used to find optimal designs for the logistic random intercept model with dichotomous independent variables. The dichotomous independent variables can be subdivided into variables for which the distribution is specified prior to data sampling, called variates, and into variables for which the distribution is not specified prior to data sampling, but is obtained from data sampling, called covariates. The proposed maximin criterion maximizes the smallest possible relative efficiency not only with respect to all possible values of the model parameters, but also with respect to the joint distribution of the covariates. We have shown that, under certain conditions, the maximin design is balanced with respect to the joint distribution of the variates. The proposed method will be used to plan a (stratified) clinical trial where variates and covariates are involved.

Deviations from the population-averaged versus cluster-specific relationship for clustered binary data.

There has been much debate about the relative merits of mixed effects and population-averaged logistic models. We present a different perspective on this issue by noting that the investigation of the relationship between these models for a given dataset offers a type of sensitivity analysis that may reveal problems with assumptions of the mixed effects and/or population-averaged models for clustered binary response data in general and longitudinal binary outcomes in particular. We present several datasets in which the following violations of assumptions are associated with departures from the expected theoretical relationship between these two models: 1) negative intra-cluster correlations; 2) confounding of the response-covariate relationship by cluster effects; and 3) confounding of autoregressive relationships by the link between baseline outcomes and subject effects. Under each of these conditions, the expected theoretical attenuation of the population-averaged odds ratio relative to the cluster-specific odds ratio does not necessarily occur. In all cases, the naive fitting of a random intercept logistic model appears to lead to bias. In response, the random intercept model is modified to accommodate negative intra-cluster correlations, confounding due to clusters, or baseline correlations with random effects. Comparisons are made with GEE estimation of population-averaged models and conditional likelihood estimation of cluster-specific models. Several examples, including a cross-over trial, a multicentre nonrandomized treatment study, and a longitudinal observational study are used to illustrate these modifications.

Accommodating negative intracluster correlation with a mixed effects logistic model for bivariate binary data

We extend the random intercept logistic model to accommodate negative intracluster correlations for bivariate binary response data. This approach assumes a single random effect per cluster but entails separate affine transformations of this random effect for the two responses of the pair. We show this approach works for two data sets and a simulation whereas other mixed effects approaches fail. The two data sets are from a crossover trial and a developmental toxicity study of the effects of chemical exposure on malformation risk among rat pups. Comparisons are made with the conditional likelihood approach and with generalized estimating equations estimation of the population-averaged logit model. Simulations show the conditional likelihood approach does not perform well for moderate to strong negative correlations as a positive intracluster correlation is assumed. The proposed mixed effects approach appears to be slightly more conservative than the population-averaged approach with respect to coverage of confidence intervals. Nonetheless, the statistical literature suggests that mixed effects models provide information in addition to that provided by population-averaged models under scientific contexts such as crossover trials. Extensions to trivariate and higher-dimensional responses also are addressed. However, such extensions require certain constraints on the correlation structure.