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Background This paper describes the methods and conceptual framework for Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study data collection. The National Institutes of Health, through the National Institute on Drug Abuse, is partnering with the Food and Drug Administration9s (FDA) Center for Tobacco Products to conduct the PATH Study under a contract with Westat. Methods The PATH Study is a nationally representative, longitudinal cohort study of 45 971 adults and youth in the USA, aged 12 years and older. Wave 1 was conducted from 12 September 2013 to 15 December 2014 using Audio Computer-Assisted Self-Interviewing to collect information on tobacco-use patterns, risk perceptions and attitudes towards current and newly emerging tobacco products, tobacco initiation, cessation, relapse behaviours and health outcomes. The PATH Study9s design allows for the longitudinal assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse and transitions between products, as well as factors associated with use patterns. Additionally, the PATH Study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use. Conclusions The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform FDA9s regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation9s burden of tobacco-related death and disease.

Although non-cigarette tobacco product use is increasing among U.S. adults, their associations with substance use and mental health problems are unclear. This study examined co-occurrence of tobacco use, substance use, and mental health problems, and its moderation by gender, among 32,202U.S. adults from Wave 1 (2013-2014) of the nationally representative longitudinal Population Assessment of Tobacco and Health (PATH) Study.Participants self-reported current cigarette, e-cigarette, traditional cigar, cigarillo, filtered cigar, hookah, smokeless tobacco and other tobacco product use; past year alcohol, marijuana, and other drug use; and past year substance use, internalizing and externalizing problems.Compared to non-current tobacco users, current users were more likely to report alcohol or drug use (adjusted odds ratio (AOR)=2.6; 95% confidence interval (CI): 2.3, 2.9), with the strongest associations observed for cigarillo and hookah users. Across all tobacco product groups, users were more likely to report internalizing (AOR=1.9; 95% CI: 1.7, 2.1), externalizing (AOR=1.6; 95% CI: 1.5, 1.8), and substance use (AOR=3.4; 95% CI: 2.9, 4.1) problems than non-users. Gender moderated many of these associations and, of these, all non-cigarette tobacco product associations were stronger among females.This nationally representative study of U.S. adults is the first to comprehensively document tobacco use, substance use, and mental health comorbidities across the range of currently available tobacco products, while also demonstrating that female tobacco users are at increased risk for substance use and mental health problems. These findings may point to gender differences in vulnerability and suggest that interventions incorporate gender-specific approaches.

Exposure is often cited as an explanation for campaign success or failure. A lack of validation evidence for typical exposure measures, however, suggests the possibility of either misdirected measurement or incomplete conceptualization of the idea. If whether people engage campaign content in a basic, rudimentary manner is what matters when we talk about exposure, a recognition-based task should provide a useful measure of exposure, or what we might call encoded exposure, that we can validate. Data from two independent sources, the National Survey of Parents and Youth (NSPY) and purchase data from a national antidrug campaign, offer such validation. Both youth and their parents were much more likely to recognize actual campaign advertisements than to claim recognition of bogus advertisements. Also, gross rating points (GRPs) for a campaign advertisement correlated strikingly with average encoded exposure for an advertisement among both youth (r = 0:82) and their parents (r = 0:53).