

dose) as well as health service interventions that may require multiple sessions, visits, or interactions.

The frequency, format, and intensity of the exposure is another important consideration for the measurement of exposure in CER studies, which is applicable to medications (e.g. Other important factors to consider when defining exposure are the timeframe (induction and latent periods), changes in exposure status or exposure to other therapies, and consistency and accuracy of exposure measurement. When possible, an operational definition of exposure that has evidence of validity with estimates of sensitivity, specificity, and positive predictive value should be used. For interventions that target health and well-being, the physiological or psychological basis for the mechanism of action, whether known or hypothesized, should guide the development of the exposure definition. First, it is helpful to lay out a theoretical link between the exposure and the event/outcome of interest that draws from the study's conceptual framework. In this chapter, we discuss potential exposure measurement approaches for observational comparative effectiveness research (CER). Characterization of exposure is a central issue in the analysis of observational data however, no “one size fits all” solution exists for exposure measurement.
