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How does regulation affect tobacco users?

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

Challenge

In an effort to protect the nation’s health from the harmful effects of tobacco products, the 2009 Family Smoking Prevention and Tobacco Control Act authorized the Food and Drug Administration (FDA) to regulate the manufacturing, marketing, and distribution of these products. This task would require the Center for Tobacco Products (CTP) at FDA to amass a solid evidence base to inform its regulatory activities. A longitudinal cohort study was considered to be the best way to provide that evidence, and in September 2011, the National Institutes of Health (NIH) and CTP initiated the Population Assessment of Tobacco and Health (PATH) Study.

The study’s goal is to assess tobacco use behavior, attitudes, and beliefs, and tobacco-related health outcomes across the nation using interview data and biospecimen data. With these measurements, the study provides the evidence-based information required to develop, implement, and evaluate tobacco regulations. What was needed was a dynamic research company—long experienced in longitudinal, large-scale surveys, expert in tobacco regulatory science, interviewing techniques and use of technologies, equity-driven, and possessing a reputation for staff continuity and flexibility—to develop and implement the study. The National Institute on Drug Abuse (NIDA) and CTP tapped Westat for the job. The PATH Study is the premier national tobacco study and Westat has conducted it from its inception in 2011 to the present day.

Solution

In collaboration with NIDA and CTP, we set to work applying our tobacco regulatory science knowledge to the construction of the overall study design, the sampling and weighting procedures, the development of questionnaires, and the design of biological specimen collection protocols. We also designed and developed the PATH Study’s complex systems for survey processing and management, GIS-based tracking, automated instrument design and testing, data processing, and analysis.

Next, we enrolled a nationally representative sample of tobacco users and nonusers—approximately 34,000 adults and 15,000 youth aged 12-17. Most participants have stayed with the study since the beginning. As needed, we replenish the sample.

We use the gold standard system for survey interviewing—Blaise. This powerful system offers 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 interviewing capabilities across a variety of platforms.

To gather the data, we rigorously train our field data collectors, help desk staff, phlebotomists, and others who interact with the participants in person-to-person communication, interviewing techniques, the collection of biospecimens, and the goals and importance of the study.

For each annual survey, we revamp the questionnaire to reflect NIDA’s and CTP’s current needs for scientific data, the changing tobacco product marketplace, and shifts in the public’s use and perceptions of the products. The questionnaires include granular questions about behavior, attitudes, and beliefs around 12 distinct tobacco products. Questions not only focus on tobacco use behavior but also on substance use and abuse, mental health issues, health and medical care, and social factors.

Blood and urine samples are collected from study participants to assess exposure to tobacco products and potential harms. Westat coordinates the shipping of specimens to the Centers for Disease Control and Prevention (CDC) and other laboratories for analysis; processes and conducts quality control reviews of the biomarker data from laboratory analysis; and produces technical documentation. We also manage the PATH Study Biospecimen Access Program, which allows the research community to use these biospecimens for their own studies.

Westat’s efforts on the PATH Study include collaborating with NIDA and CTP to examine health inequities related to tobacco use—a topic we presented on with other researchers at the 2023 Society for Research on Nicotine and Tobacco’s conference.

For each longitudinal survey wave, Westat produces a vast number of data files for use by NIDA, CTP, and the Westat team, as well as restricted- and public-use files for the external research community. These data files include questionnaire and biomarker data, along with extensive technical and methodological documentation.

In collaboration with NIDA and CTP staff, Westat develops special analyses, reports, and peer-reviewed publications in leading medical, health, and social science journals. Currently, we have jointly produced more than 100 such publications; PATH Study data has resulted in more than 700 additional publications by outside researchers and hundreds of presentations at scientific meetings.

Our research is enhanced by the preeminent research, clinical, and academic partners we lead who contribute to the study’s design, publications, and other scientific output. They include Roswell Park Comprehensive Cancer Center, Dartmouth University, Medical University of South Carolina, New York University, Rutgers University, University of California at San Diego, University of Minnesota, and University of Waterloo.

We have collected PATH Study data continuously since 2013 with the exception of a 3-month pause when the COVID-19 pandemic halted in-person interviews in 2020. By pivoting to alternate interviewing modalities, a repurposed, self-administered questionnaire, and a different way of collecting biospecimens, we were able to complete that year’s survey on time—making the PATH Study the only nationally representative tobacco study to collect data on adults in 2020.

Results

The PATH Study is providing a wealth of evidence to further NIDA’s and CTP’s understanding of tobacco use behaviors and how use affects health over time. This intelligence informs CTP’s regulatory decisions and actions regarding the manufacture, distribution, and marketing of tobacco products in an effort to reduce the public health burden of tobacco use on Americans and create a healthier future for our society.

Westat’s role in the PATH Study enables NIDA and CTP to provide more data about tobacco use at a greater level of detail than any other tobacco study.

Charles Carusi, Project Director

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