RT Journal Article SR Electronic T1 Design and methods of the Population Assessment of Tobacco and Health (PATH) Study JF Tobacco Control JO Tob Control FD BMJ Publishing Group Ltd SP 371 OP 378 DO 10.1136/tobaccocontrol-2016-052934 VO 26 IS 4 A1 Andrew Hyland A1 Bridget K Ambrose A1 Kevin P Conway A1 Nicolette Borek A1 Elizabeth Lambert A1 Charles Carusi A1 Kristie Taylor A1 Scott Crosse A1 Geoffrey T Fong A1 K Michael Cummings A1 David Abrams A1 John P Pierce A1 James Sargent A1 Karen Messer A1 Maansi Bansal-Travers A1 Ray Niaura A1 Donna Vallone A1 David Hammond A1 Nahla Hilmi A1 Jonathan Kwan A1 Andrea Piesse A1 Graham Kalton A1 Sharon Lohr A1 Nick Pharris-Ciurej A1 Victoria Castleman A1 Victoria R Green A1 Greta Tessman A1 Annette Kaufman A1 Charles Lawrence A1 Dana M van Bemmel A1 Heather L Kimmel A1 Ben Blount A1 Ling Yang A1 Barbara O'Brien A1 Cindy Tworek A1 Derek Alberding A1 Lynn C Hull A1 Yu-Ching Cheng A1 David Maklan A1 Cathy L Backinger A1 Wilson M Compton YR 2017 UL http://tobaccocontrol.bmj.com/content/26/4/371.abstract AB 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 Administration's (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 Study's 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 FDA's regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation's burden of tobacco-related death and disease.