Prospective Cohort Survey: Testing Population-Level Predictions 

Using a prospective cohort survey to test population-level predictions generated by Projects 1-3

Project 4’s (Project Director: Dr. Joanna Cohen) specific aims are to test population-level predictions that arise from Project 1-3’s controlled studies of product toxicity, user behavior and product abuse liability using a prospective cohort survey that includes current exclusive ECIG users and current dual users of ECIGs and tobacco cigarettes. Specifically, the study will assess the population-level effects of three potential regulatory actions: (1) limits on liquid nicotine concentration, (2) constraints on nicotine flux and (3) reduction in flavor availability.

Project 4 addresses the scientific domain of impact analysis and its instruments are informed by the Contextual Knowledge Core that will help determine how to assess self-report accurately and assess dependence reliably among ECIG users.

Overall, results will reveal the extent to which observations made under controlled conditions yield valid population-level predictions. Thus, this project is part of a center with an integrative theme of impact analysis that draws on the team’s expertise in evaluating population-level effects of tobacco regulation and will provide FDA a set of tools that can be used to guide regulation development so that, by the time a regulation goes into effect, validated methods have been used to test it, refine it and generate data that show its health-promoting effects are maximized and unintended consequences are minimized.