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Mediation analyses play important roles in making causal inference inbiomedical research to examine causal pathways that may be mediated by one ormore intermediate variables (i.e., mediators). Although mediation frameworkshave been well established such as counterfactual-outcomes (i.e.,potential-outcomes) models and traditional linear mediation models, littleeffort has been devoted to dealing with mediators with zero-inflated structuresdue to challenges associated with excessive zeros. We develop a novel mediationmodeling approach to address zero-inflated mediators containing true zeros andfalse zeros. The new approach can decompose the total mediation effect into twocomponents induced by zero-inflated structures: the first component isattributable to the change in the mediator on its numerical scale which is asum of two causal pathways and the second component is attributable only to itsbinary change from zero to a non-zero status. An extensive simulation study isconducted to assess the performance and it shows that the proposed approachoutperforms existing standard causal mediation analysis approaches. We alsoshowcase the application of the proposed approach to a real study in comparisonwith a standard causal mediation analysis approach.

A Novel Causal Mediation Analysis Approach for Zero-Inflated Mediators