Design and methods of the Population Assessment of Tobacco and Health (PATH) Study

Introduction:
This text describes the methods and design of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal cohort study of adults and youth in the USA. The study aims to inform the regulatory mission of the Food and Drug Administration's (FDA) Center for Tobacco Products by collecting data on tobacco use patterns, risk perceptions, and health outcomes over time. The PATH Study's design allows for the assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse behaviors, and transitions between products, as well as factors associated with these use patterns.

Key Points:

* The PATH Study is a nationally representative, longitudinal cohort study of 45,971 adults and youth in the USA.
* The study uses Audio Computer-Assisted Self-Interviewing and Computer-Assisted Personal Interviewing to collect information on tobacco use patterns, risk perceptions, and health outcomes.
* The PATH Study's design allows for the assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse behaviors, and transitions between products, as well as factors associated with these use patterns.
* The study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use.
* The PATH Study's conceptual framework is based on the Host, Agent, Vector, Environment (HAVE) model, which illustrates the transmission of infectious agents and has been validated in assessing the impact of tobacco control policy interventions.
* The HAVE model assumes that host, agent, vector, and environmental factors interact to influence a variety of behavioral and health outcomes.
* The PATH Study is a research study that assesses within-person changes and between-person differences in a large national cohort of participants aged 12 years and older over time.
* The PATH Study complements and is complemented by national cross-sectional surveillance studies, such as the Tobacco Use Supplement to the Current Population Survey, the NSDUH, the National Health Interview Survey, the National Youth Tobacco Survey, and the MTF.

Main Message:
The PATH Study is a comprehensive, longitudinal study that will provide valuable data to inform the regulatory mission of the FDA's Center for Tobacco Products. The study's design and methods allow for the assessment of patterns of use of a spectrum of tobacco products and the factors associated with these use patterns. The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform tobacco control policies and efforts to reduce the Nation's burden of tobacco-related death and disease.

Hyland, Andrew, Bridget K Ambrose, Kevin P Conway, Nicolette Borek, Elizabeth Lambert, Charles Carusi, Kristie Taylor, et al. “Design and Methods of the Population Assessment of Tobacco and Health (PATH) Study.” Tobacco Control 26, no. 4 (July 2017): 371–78. https://doi.org/10.1136/tobaccocontrol-2016-052934.