Abstract The before-and-after study with multiple unaffected control groups is widely applied to study treatment effects. The current methods usually assume that the control groups’ differences between the before and after periods, i.e. the group time effects, follow a normal distribution....

Abstract We address several questions relating to the use of standard regression and Structural Nested Mean Model (SNMM) approach (e. g., Ten Have et al. 2007) to analyze post-randomization effect modifiers of the intent-to-treat effect of a randomized intervention on a subsequent outcome,...

Abstract An instrumental variable can be used to test the causal null hypothesis that an exposure has no causal effect on the outcome, by assessing the association between the instrumental variable and the outcome. Under additional assumptions, an instrumental variable can be used to estimate...

In assessing the mechanism of treatment efficacy in randomized clinical trials, investigators often perform mediation analyses by analyzing if the significant intent-to-treat treatment effect on outcome occurs through or around a third intermediate or mediating variable: indirect and direct...