Population Assessment of Tobacco and Health (PATH) Study Wave 1 and Wave 4 Biomarker Cores and Available Biomarker...

The Population Assessment of Tobacco and Heath (PATH) Study is a nationally representative longitudinal cohort study on U.S. tobacco use and its effects on health. It is unique among longitudinal studies of tobacco in that it collects biospecimens from representative subsamples of participants, the biomarker cores, which allows for analyses of biomarkers related to tobacco use at the population level.

We summarize the formation of the Wave (W)1 and W4 Biomarker Cores, the subsequent expansion of the W1 Biomarker Core, the creation of weights to make appropriate cross-sectional and longitudinal inferences regarding the target populations, and the available biomarker data. Our analyses will illustrate the effect of the expansion of the W1 Biomarker Core and provide an example of various analyses that researchers can perform.

We demonstrate the utility of the W1 and W4 Biomarker Cores for tobacco regulatory science research and show how the expanded W1 Biomarker Core represents the PATH Study adult target population at W1. For example, our results show that for individuals who use ENDS exclusively, urinary cotinine, a biomarker of nicotine exposure, increased substantially between 2014 and 2022, which corroborates recent tobacco use literature on the ability of recent-generation ENDS to deliver nicotine levels similar to combusted cigarette use.

In this paper, we provide the tools necessary to understand and use PATH Study biomarker data for regulatory science investigations such as identifying toxicants in tobacco products and determining where tobacco products fall on the continuum of risk compared to combusted tobacco.