April 20, 2017
5 min read

PATH study will improve understanding of tobacco use, associations with health outcomes

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More than one in four adults and nearly one in 10 young adults in the United States report some form of tobacco use.

The majority say they use multiple tobacco products, with traditional and electronic cigarettes being the most common combination among both age groups, according to study findings published in The New England Journal of Medicine.

Andrew Hyland

“Although [there has been progress], there is still a huge public health problem. Cigarette smoking continues to be the number one preventable cause of death in the United States,” Andrew Hyland, PhD, chair of the department of health behavior at Roswell Park Cancer Institute, told HemOnc Today. “We still have 36 million cigarette smokers in the United States and 480,000 deaths per year associated with cigarette smoking.”

In 2011, the NIH’s National Institute on Drug Abuse and the FDA’s Center for Tobacco Products initiated the Population Assessment of Tobacco and Health (PATH) study as a joint effort to assess tobacco use trends in the United States.

Roswell Park Cancer Institute serves as the scientific lead on the study. Other study collaborators are Westat, the Truth Initiative, UC San Diego, University of Waterloo in Ontario, Geisel School of Medicine at Dartmouth, Medical University of South Carolina, Rutgers University and University of Minnesota.

Researchers gathered baseline data between September 2013 and December 2014 for 32,320 adults and 13,651 young adults aged 12 to 17 years. Study participants reported their use of 12 types of tobacco products, including cigarettes, e-cigarettes, cigars, pipe tobacco, hookah, smokeless tobacco and snus. More than one-quarter (27.6%) of adults reported current use of tobacco. Also, 8.9% of young adults reported some form of tobacco use within the previous 30 days, and 1.6% indicated they used tobacco daily.

HemOnc Today spoke with Hyland, principal investigator of the PATH study, and Karin A. Kasza, MA, senior research specialist in the department of health behavior at Roswell Park Cancer Institute, about the preliminary findings and how they hope this research will inform future efforts to further reduce tobacco use in the United States.

Question: What prompted you to conduct this study?

Hyland: The PATH study is an initiative funded by the FDA as a federal effort, and we collaborated with a group of organizations to put a proposal together. We won the contract, so this is our involvement. It is an opportunity to get work done that we believe is important. In terms of what motivated the FDA to implement this project, it comes down to the 2009 law passed by Congress that created the Center for Tobacco Products. This is a new center within FDA that is charged with regulating tobacco products, such as aspects of marketing and product design. This is a new concept for FDA, especially when looking at this from the standpoint of safety and cigarettes and not normally thinking of the two in the same breath. Tobacco products are not used to treat a condition, so a new public health standard was created for the Center for Tobacco Products. As part of the mission of the center, they need scientific data. Through the PATH study, we will create an anchor for scientific information to be obtained about the latest trends in tobacco use and, ultimately, how these tobacco use patterns are associated with outcomes in health.


Q: What makes this study unique?

Hyland: There are other national surveillance systems for tobacco use, and they are fantastic systems that we have had in place for a long time. The PATH study unique because it is longitudinal, so we are tracking the same people over time. This is a powerful and rigorous design. Another distinguishing feature is that, in addition to detailed questions about tobacco use, biospecimens also will be obtained. Many of the participants give blood and urine samples, which allows for a more rigorous assessment of those changes over time. For example, when looking at indicators of exposure to tobacco products, we can go on self-report. There is validity to this, but people may not always recall everything accurately, so bringing in biospecimens helps with a more accurate measure. A third distinguishing feature is the array of tobacco products assessed. Our existing tobacco surveillance systems look at cigarettes, cigars and smokeless tobacco, but in today’s world, a lot of this is changing. There are a lot more products available, such as e-cigarettes and different types of smokeless tobacco — including hookah or water pipe — that are not assessed in most other studies. The PATH study tries to assess a complete picture of all available tobacco products. Lastly, this is a very large sample size, which allows us to identify patterns and changes within subgroups. We are making rigorous efforts to try to accelerate the speed of the delivery of the data. We recognize that it is a resource to the larger clinical community, and the large sample size will help facilitate many additional secondary analyses.

Q: What have baseline data shown thus far?

Kasza: We are seeing a lot of use of noncigarette products — such as e-cigarettes, cigars and water-pipe smoking, particularly among young adults — but cigarette use remains most prevalent among both young adults and adults. Also, about 40% of tobacco users are using more than one type of tobacco product. This is true for young adults and adults.

Q: Were you surprised to see how many Americans continue to use tobacco?

Hyland: There actually was a lot of good news in the tobacco use trend. For example, cigarette smoking rates are the lowest they have ever been. Per-capita cigarette consumption nationwide is as low as it has been in 100 years. This is the good news. The bad news is that it has been more than 50 years since the first Surgeon General’s report came out saying that cigarette smoking is a cause of lung cancer.


Q: How can this research inform future efforts to try to reduce tobacco use?

Hyland: The Center for Tobacco Products is a regulatory agency that needs data to consider and implement recommendations. These data are an anchor point. With this particular study, we are looking at the baseline cross-sectional data, which is all that we have now. In the future, we will have longitudinal data. The data system that we have for the PATH study is a fantastic data system and resource. There are a lot of other resources and systems that will feed into the regulatory decision-making, but the PATH study is an anchor for regulatory thinking within the Center for Tobacco Products. Some people think e-cigarettes will lead to a gateway for cigarette smoking, whereas others believe it is a gateway out of cigarette smoking for those who have tried to quit and were not able to. The PATH study data can help explore these behavioral patterns and try to understand who may progress on from e-cigarette smoking to cigarette smoking. Over time, the PATH study will help to work toward policies and regulations to help maximize a public health benefit. We will have the data to look at trends and see what is driving these trends.

Q: What is next for the PATH study?

Hyland : Data collection efforts are ongoing. Efforts are underway to make the PATH study data available to the scientific community as quickly as possible. Through comparison with the baseline data, future waves of data will help scientists understand how tobacco use behaviors change within individuals over time and what factors are responsible for those changes, as well as to see if use of various products is associated with changes in harmful exposures and, ultimately, health outcomes. – by Jennifer Southall


Kasza KA, et al. N Engl J Med. 2017;doi:10.1056/NEJMsa1607538.

For more information:

Andrew Hyland, PhD, and Karin A. Kasza, MA, both can be reached at Roswell Park Cancer Institute, Elm and Carlton streets, Buffalo, NY 14263;email: andrew.hyland@roswellpark.org.

Disclosure: Hyland and Kasza report no relevant financial disclosures.