Bayesian Multivariate Logistic Regression for Superiority and Inferiority Decision-Making under Observable Treatment Heterogeneity.

The effects of treatments may differ between persons with different characteristics. Addressing such treatment heterogeneity is crucial to investigate whether patients with specific characteristics are likely to benefit from a new treatment. The current paper presents a novel Bayesian method for superiority decision-making in the context of randomized controlled trials with multivariate binary responses and heterogeneous treatment effects.

Bayesian multilevel multivariate logistic regression for superiority decision-making under observable treatment heterogeneity.

Background: In medical, social, and behavioral research we often encounter datasets with a multilevel structure and multiple correlated dependent variables. These data are frequently collected from a study population that distinguishes several subpopulations with different (i.e.

Decision-making with multiple correlated binary outcomes in clinical trials.

Clinical trials often evaluate multiple outcome variables to form a comprehensive picture of the effects of a new treatment. The resulting multidimensional insight contributes to clinically relevant and efficient decision-making about treatment superiority. Common statistical procedures to make these superiority decisions with multiple outcomes have two important shortcomings, however: (1) Outcome variables are often modeled individually, and consequently fail to consider the relation between outcomes; and (2) superiority is often defined as a relevant difference on a single, on any, or on all outcome(s); and lacks a compensatory mechanism that allows large positive effects on one or multiple outcome(s) to outweigh small negative effects on other outcomes.

Potential impact of maternal vaccination on life-threatening respiratory syncytial virus infection during infancy.

Background: Respiratory syncytial virus (RSV) infection is an important cause of infant mortality. Here, we estimated the potential impact of maternal vaccination against RSV on life-threatening RSV infection in infants.

Methods: We developed a mathematical model for maternal vaccine-induced antibody dynamics and used characteristics of a maternal RSV vaccine currently in phase 3 of clinical development.