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How does regulation affect tobacco users?

Using the PATH Study to see how regulating tobacco products affects behavior and health

On September 19, 2011, the National Institutes of Health (NIH) and Food and Drug Administration (FDA) initiated a prospective, longitudinal cohort study to assess tobacco use behaviors and health across the nation.

The Population Assessment of Tobacco and Health (PATH) Study is designed to support FDA efforts to regulate tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act for purposes of protecting the public health. To fulfill this mandate, FDA requires a solid evidence base to inform its regulatory activities.

  • Westat leads a team of preeminent research organizations with expertise in tobacco use behaviors and health to support NIH and FDA on the PATH Study.
  • We developed the research and sample design, questionnaires, survey methods, and biospecimen collection protocols to support study objectives.
  • Westat’s procedures for the study serve to identify, sample, enroll into the study, and annually collect interview data and biospecimens from a national representative sample of nearly 49,000 adults and youths (including users and non-users of tobacco products). They have been in place since the start of data collection in September 2013.
  • We support NIH and FDA in activities to analyze behavioral and biospecimen data and to conduct special studies with study partners.
  • For each data collection wave, Westat supports NIDA and FDA in developing and making available to researchers and the public a variety of restricted-use and public-use data files to enable widespread analysis and dissemination of PATH Study-based information.
  • The PATH Study developed customized survey management, GIS-based tracking, and instrument design, data processing, and data analysis tools and systems.
  • It also uses Blaise, a comprehensive commercial, off-the-shelf (COTS) survey processing system with state-of-the-art audio computer-assisted self-interviewing (ACASI), computer-assisted personal interviewing (CAPI), computer-assisted telephone interviewing (CATI), computer-assisted web interviewing (CAWI), and other self-response capabilities across a wide variety of platforms (smartphone, tablet, desktop).
  • Having recently completed the fourth longitudinal wave, Westat continues in its efforts to meet NIH’s and FDA’s research needs in the context of rapidly evolving tobacco regulatory science and tobacco regulatory actions.
  • In January 2016, NIDA awarded Westat the contract to continue supporting the PATH Study through 2024, covering design, data collection, and analysis for Wave 4 to Wave 7.
  • In the long term, by measuring the behavioral and health effects associated with tobacco product regulations, the PATH Study will provide a wealth of previously unavailable empirical evidence for developing, implementing, and assessing the regulations.

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