2020 design and methods of the Population Assessment of Tobacco and Health (PATH) study during the COVID-19 pandemic.

The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative, longitudinal study of the US population on tobacco use and its effects on health, collecting data annually since 2013. The COVID-19 pandemic interrupted in-person survey data collections around the world. In the USA, this included a PATH Study data collection focused on youth (13-17) and young adults (18-19) as well as other US surveys on tobacco use. Given that it was necessary to pause data collection and considering that tobacco-use behaviours could be expected to change along with pandemic-related changes in the social environment, the original design for the 2020 PATH Study data collection for youth and young adults was modified. Also, the PATH Study Adult Telephone Survey was developed to address the need for adult tobacco use monitoring in this unprecedented time. This article describes the modifications made to the 2020 PATH Study design and protocol to provide nationally representative data for youth and adults after the onset of the COVID-19 pandemic as well as the implications of these modifications for researchers.

Respiratory symptoms and outcomes among cigar smokers: findings from the Population Assessment of Tobacco and Health (PATH) study waves 2-5 (2014-2019).

BACKGROUND: The mechanisms by which cigarette smoking increases the risk of respiratory disease have been studied. However, less is known about risks of respiratory symptoms and outcomes associated with smoking cigars, and risks by cigar types have not been previously explored. The aim of this study was to examine associations between cigar use, including traditional cigars, cigarillos, filtered cigars, and dual cigar and cigarette use, and functionally important respiratory symptoms (FIRS), lifetime asthma diagnosis, uncontrolled asthma, and new cases of FIRS. METHODS: Data from Waves 2-5 (2014-19) of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal study, were analyzed in two ways. For cross-sectional analysis, the analytic sample included adults 18 and older at each wave, resulting in 44,040 observations. Separately, longitudinal analyses were assessed among adults 18 and older at Wave 2, resulting in 7,930 individuals. Both analyses excluded adults with chronic obstructive pulmonary disease (COPD) or non-asthma respiratory disease. RESULTS: Current established cigarillo smokers had higher odds of having FIRS (Adjusted odds ratio (AOR): 1.72; 95% CI: 1.08, 2.74) compared to never smokers of cigarillos and cigarettes, after adjusting for covariates. Current established filtered cigar smokers had higher odds of asthma diagnosis (AOR: 1.35; 95% CI: 1.10, 1.66) while current established dual smokers of filtered cigars and cigarettes had higher odds of uncontrolled asthma (AOR: 5.13; 95% CI: 1.75, 15.02) compared to never smokers of filtered cigars or cigarettes. Both current established cigar smokers and current established dual smokers of cigarettes and cigars had higher odds of new FIRS compared to never cigar or cigarette smokers (AORs: 1.62; 95% CI: 1.02, 2.60 for exclusive cigars and 2.55; 95% CI 1.57, 4.14 for dual smokers). CONCLUSIONS: This study provides evidence that cigar smokers or dual smokers of cigars and cigarettes have greater odds of FIRS, asthma, and uncontrolled asthma and that new incidence of FIRS is higher among any cigar smokers compared to never cigar or cigarette smokers. Understanding health impacts associated with cigar use provides information for supporting policy development, as well as for designing clinical interventions focused on smoking cessation for cigars.

Relationship Between Tobacco Product Use and Health-Related Quality of Life Among Individuals With COPD in Waves 1-5 (2013-2019) of the Population Assessment of Tobacco and Health Study.

Introduction: We examined the association between tobacco product use and health-related quality of life (HRQoL) among individuals with chronic obstructive pulmonary disease (COPD) in Waves 1-5 of the Population Assessment of Tobacco and Health (PATH) Study. Methods: Adults ≥40 years with an ever COPD diagnosis were included in cross-sectional (Wave 5) and longitudinal (Waves 1 to 5) analyses. Tobacco use included 13 mutually exclusive categories of past 30-day (P30D) single use and polyuse with P30D exclusive cigarette use and ≥5-year cigarette cessation as reference groups. Multivariable linear regression and generalized estimating equations (GEE) were used to examine the association between tobacco use and HRQoL as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 questionnaire. Results: Of 1670 adults, 79.4% ever used cigarettes; mean (standard error [SE]) pack years was 30.9 (1.1). In cross-sectional analysis, P30D exclusive cigarette use, and e-cigarette/cigarette dual use were associated with worse HRQoL compared to ≥5-year cigarette cessation. Compared to P30D exclusive cigarette use, never tobacco use and ≥5-year cigarette cessation were associated with better HRQoL, while e-cigarette/cigarette dual use had worse HRQoL. Longitudinally (n=686), e-cigarette/cigarette dual use was associated with worsening HRQoL compared to both reference groups. Only never tobacco use was associated with higher HRQoL over time compared to P30D exclusive cigarette use. Conclusions: E-cigarette/cigarette dual use was associated with worse HRQoL compared to ≥5-year cigarette cessation and exclusive cigarette use. Never use and ≥5-year cigarette cessation were the only categories associated with higher HRQoL compared to exclusive cigarette use. Findings highlight the importance of complete smoking cessation for individuals with COPD.

Changes in Tobacco Dependence and Association With Onset and Progression of Use by Product Type From Waves 1 to 3 of the Population Assessment of Tobacco and Health (PATH) Study.

INTRODUCTION: This study examined trajectories of tobacco dependence (TD) in relationship to changes in tobacco product use, and explored the effects of product-specific adding, switching, or discontinued use on dependence over time. AIMS AND METHODS: Data were analyzed from the first three waves from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal study of adults and youth in the United States. Data included 9556 wave 1 (2013-2014) adult current established tobacco users aged 18 or older who completed all three interviews and had established use at ≥2 assessments. Mutually exclusive groups included: users of cigarettes only, e-cigarettes only, cigars only, hookah only, any smokeless only, cigarette + e-cigarette dual users, and other multiple product users. A validated 16-item scale assessed TD across product users. RESULTS: People who used e-cigarettes exclusively at wave 1 had small increases in TD through wave 3. Wave 1 multiple product users' TD decreased across waves. TD for all other wave 1 user groups remained about the same. For wave 1 cigarette only smokers, switching to another product was associated with lower levels of TD than smokers whose use stayed the same. Movement to no established use of any tobacco product was consistently associated with lower TD for all product users. CONCLUSIONS: Except for wave 1 e-cigarette only users (who experienced small increases in TD), TD among U.S. tobacco product users was stable over time, with daily users less likely to vary from baseline. IMPLICATIONS: The level of TD among most U.S. tobacco users was stable over the first three waves of the PATH Study and trends in levels of TD were predominantly unrelated to changes in patterns of continued product use. Stable levels of TD suggest a population at persistent risk of health impacts from tobacco. Wave 1 e-cigarette users experienced small increases in levels of TD over time, perhaps due to increases in quantity or frequency of their e-cigarette use or increasing efficiency of nicotine delivery over time.

Patterns of Premium and Nonpremium Cigar Use in the United States: Findings from Wave 6 (2021) of the Population Assessment of Tobacco and Health Study.

INTRODUCTION: Understanding the characteristics of premium cigar use patterns is essential for minimizing public health harms. Typically, premium cigars are handmade, larger, more expensive, and without the characterizing flavors that are present in other cigar types: Nonpremium traditional cigars, cigarillos, and filtered cigars. AIMS AND METHODS: Self-reported brand and price data were used from Wave 6 of the Population Assessment of Tobacco and Health (PATH) Study to define and estimate premium versus nonpremium cigar use among U.S. adults, as well as to explore cigar smoking patterns, purchasing behavior, and reasons for use by cigar type. RESULTS: In 2021, 0.9% (95% CI = 0.7-1.0) of adults were premium cigar users, compared to 0.4% of nonpremium traditional cigar users (95% CI = 0.3-0.5), 1.1% of cigarillo users (95% CI = 1.0-1.2), and 0.6% filtered cigar users (95% CI = 0.5-0.7). Premium cigar users were overwhelmingly male (97.7%), and 35.8% were aged ≥55 years. The average premium cigar price/stick was $8.67, $5.50-7.00 more than other cigar types. Compared to other cigar types, significantly fewer premium cigar users had a regular brand with a flavor other than tobacco (~15% vs. 38%-53%). Though flavors remained the top reason for premium cigar use, they were less likely to endorse flavors as a reason for use than other cigar users (~40% vs. 68-74%). Premium cigar users had a lower prevalence (aRR: 0.37, 95% CI = 0.25-0.55) of dual use of cigars and cigarettes. CONCLUSIONS: Although <1% of U.S. adults use premium cigars, their use and purchasing characteristics continue to differ from other cigar types, highlighting the importance of capturing data specific to premium cigar use. IMPLICATIONS: This manuscript extends previous research from the National Academies of Science, Engineering, and Medicine report, "Premium cigars: Patterns of use, marketing, and health effects" by utilizing the most recent PATH Study data (Wave 6) to examine patterns of cigar use, including purchasing behavior and reasons for use, by cigar type (eg, premium traditional cigars, nonpremium traditional cigars, cigarillos, and filtered cigars). The findings support continued research on patterns of premium cigar use, which differ from use patterns of other cigar types.

Update to the design and methods of the PATH Study, Wave 4 (2016-2017).

The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative study of the US population on tobacco use and its effects on health, with four waves of data collection between 2013 and 2017. Prior work described the methods of the first three waves. In this paper, we describe the methods of Wave 4, during which a replenishment sample was added to the ongoing cohort. We describe the design and estimation methods of the continuing Wave 1 cohort (with four waves of data) and the Wave 4 cohort (the new cohort created at Wave 4). We provide survey quality metrics, including response rates for both cohorts and a panel conditioning analysis, and guidance on understanding the target populations for both cohorts.

Association between tobacco product use and asthma among US adults from the Population Assessment of Tobacco and Health (PATH) Study waves 2-4.

BACKGROUND: Research on cigarettes and adult asthma offers mixed findings, perhaps due to overlap with chronic obstructive pulmonary disease (COPD) and inadequate adjustment for other smoke exposures. Associations between other tobacco products, including e-cigarettes, and asthma are also understudied. RESEARCH QUESTION: Using Population Assessment of Tobacco and Health Study waves 2-4 (2014/2015-2016/2017) data, we assessed the relation between tobacco product use and asthma in persons unlikely to have COPD. STUDY DESIGN AND METHODS: Prospective study of 10 267 adults aged 18-39 years without COPD diagnoses. Past-month tobacco use at wave 2 was modelled first as combustible versus non-combustible use and second as specific product categories (former, cigarettes, e-cigarettes, cigars, hookah, smokeless tobacco). Outcomes included lifetime asthma prevalence at wave 2, incidence (waves 3 and 4) and Asthma Control Test score (lower=worse). Multivariable regressions adjusted for predictors of asthma, including other smoke exposures: cigarette pack-years, secondhand smoke and marijuana use. Sensitivity analyses examined findings when persons >39 years and those with both COPD and asthma were added, and when smoke exposure adjustments were removed. RESULTS: No product, including cigarettes and e-cigarettes, was associated with prevalence or incidence of asthma. Among people with asthma at wave 2, combustible tobacco (beta=-0.86, 95% CI (-1.32 to -0.39)) and cigarettes (beta=-1.14, 95% CI (-1.66 to -0.62)) were associated with worse asthma control. No tobacco product was associated with asthma control over time. In sensitivity analyses, tobacco use became associated with incident asthma as adults >39 years and those with asthma+COPD were added, and as adjustments for other smoke exposures were omitted. INTERPRETATION: Although cigarette use was associated with worse asthma control, there were no longitudinal associations between combustible tobacco or e-cigarette use and new onset or worsening asthma in these preliminary analyses. Research on tobacco and asthma should exclude COPD and adjust for smoking history and other smoke exposures.

RETRACTED: Changes in Tobacco Dependence and Association With Onset and Progression of Use by Product Type From Wave 1 to Wave 3 of the Population Assessment of Tobacco and Health (PATH) Study.

INTRODUCTION: This study examined trajectories of tobacco dependence (TD) in relation to changes in tobacco product use and explored the effects of product-specific adding, switching, or discontinued use on dependence over time. AIMS AND METHODS: Data were analyzed from the first three waves of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal study of adults and youth in the United States. Data included 9556 Wave 1 (2013/2014) adult current established tobacco users who completed all three interviews and had established use at ≥2 assessments. Groups included cigarettes-only users, e-cigarettes-only users, cigars-only users, hookah-only users, any smokeless-only users, cigarette + e-cigarette dual users, and multiple product users. A validated 16-item scale assessed TD across product users. RESULTS: Wave 1 e-cigarette-only users' who maintained exclusive e-cigarette use increased levels of TD through Wave 3 as did those who added or switched to another product. Wave 1 multiple product users' TD decreased across waves. TD for all other Wave 1 user groups remained about the same. For Wave 1 cigarette-only smokers, switching to another product or moving to a pattern of no established use was associated with lower levels of TD than smokers whose use stayed the same. Movement to no established use of any tobacco product was consistently associated with lower TD for all other product users. CONCLUSIONS: Except for Wave 1 e-cigarette-only users, TD among US tobacco product users was stable over time, with daily users less likely to vary from baseline. IMPLICATIONS: The level of TD among most US tobacco users was stable over the first three waves of the PATH Study and trends in levels of TD were predominantly unrelated to changes in patterns of continued product use. Stable levels of TD suggest a population at persistent risk of health impacts from tobacco. Wave 1 e-cigarette users, including those maintaining exclusive e-cigarette use, experienced increasing levels of TD over time, perhaps because of increases in quantity or frequency of their e-cigarette product use or increasing efficiency of nicotine delivery over time.

Association of tobacco product use with chronic obstructive pulmonary disease (COPD) prevalence and incidence in Waves 1 through 5 (2013-2019) of the Population Assessment of Tobacco and Health (PATH) Study.

BACKGROUND: We examined the association of non-cigarette tobacco use on chronic obstructive pulmonary disease (COPD) risk in the Population Assessment of Tobacco and Health (PATH) Study. METHODS: There were 13,752 participants ≥ 40 years with Wave 1 (W1) data for prevalence analyses, including 6945 adults without COPD for incidence analyses; W1-5 (2013-2019) data were analyzed. W1 tobacco use was modeled as 12 mutually-exclusive categories of past 30-day (P30D) single and polyuse, with two reference categories (current exclusive cigarette and never tobacco). Prevalence and incidence ratios of self-reported physician-diagnosed COPD were estimated using weighted multivariable Poisson regression. RESULTS: W1 mean (SE) age was 58.1(0.1) years; mean cigarette pack-years was similar for all categories involving cigarettes and exclusive use of e-cigarettes (all > 20), greater than exclusive cigar users (< 10); and COPD prevalence was 7.7%. Compared to P30D cigarette use, never tobacco, former tobacco, and cigar use were associated with lower COPD prevalence (RR = 0.33, (95% confidence interval-CI) [0.26, 0.42]; RR = 0.57, CI [0.47, 0.70]; RR = 0.46, CI [0.28, 0.76], respectively); compared to never tobacco use, all categories except cigar and smokeless tobacco use were associated with higher COPD prevalence (RR former = 1.72, CI [1.33, 2.23]; RR cigarette = 3.00, CI [2.37, 3.80]; RR e-cigarette = 2.22, CI [1.44, 3.42]; RR cigarette + e-cigarette = 3.10, CI [2.39, 4.02]; RR polycombusted = 3.37, CI [2.44, 4.65]; RR polycombusted plus noncombusted = 2.75, CI]1.99, 3.81]). COPD incidence from W2-5 was 5.8%. Never and former tobacco users had lower COPD risk compared to current cigarette smokers (RR = 0.52, CI [0.35, 0.77]; RR = 0.47, CI [0.32, 0.70], respectively). Compared to never use, cigarette, smokeless, cigarette plus e-cigarette, and polycombusted tobacco use were associated with higher COPD incidence (RR = 1.92, CI [1.29, 2.86]; RR = 2.08, CI [1.07, 4.03]; RR = 1.99, CI [1.29, 3.07]; RR = 2.59, CI [1.60, 4.21], respectively); exclusive use of e-cigarettes was not (RR = 1.36, CI [0.55, 3.39]). CONCLUSIONS: E-cigarettes and all use categories involving cigarettes were associated with higher COPD prevalence compared to never use, reflecting, in part, the high burden of cigarette exposure in these groups. Cigarette-but not exclusive e-cigarette-use was also strongly associated with higher COPD incidence. Compared to cigarette use, only quitting tobacco was protective against COPD development.

Correlates of tobacco product initiation among youth and young adults between waves 1-4 of the population assessment of tobacco and Health (PATH) study (2013-2018).

INTRODUCTION: While risk factors for cigarette smoking among youth and young adults are well-documented, less is known about the correlates of initiation of other tobacco products. This study aims to provide estimates and correlates of initiation among U.S. youth and young adults. METHODS: Data on youth aged 12-17 (n = 10,072) and young adults aged 18-24 (N = 5,727) who provided information on cigarettes, electronic nicotine delivery systems (ENDS), cigars, pipe, hookah and smokeless tobacco use in Wave 1 (W1: 2013-2014)-Wave 4 (W4: 2016-2018) of the nationally-representative PATH Study were used to calculate ever use initiation and correlates of initiation by W4. RESULTS: Nearly 6 million youth and 2.5 million young adults used tobacco for the first time between W1-W4. Approximately one quarter of youth and young adult ENDS never users initiated ENDS between W1-W4 of the PATH Study. Among youth, use of other tobacco products, ever substance use, and high externalizing problems were associated with initiation of most products. Among young adults, use of other tobacco products and ever substance use were associated with initiation of most products. In both youth and young adults, Hispanics were more likely to initiate hookah use than their non-Hispanic White counterparts. While male sex was a risk factor for most tobacco product initiation across both age groups, it was not associated with hookah initiation. CONCLUSIONS: Cigarette and non-cigarette products shared many correlates of initiation, although there are noteworthy demographic differences. Findings can help tailor product specific interventions to reach populations at risk during preliminary stages of use.

Tobacco Use and Respiratory Symptoms Among Adults: Findings From the Longitudinal Population Assessment of Tobacco and Health (PATH) Study 2014-2016.

INTRODUCTION: We examined the relationship between current tobacco use and functionally important respiratory symptoms. METHODS: Longitudinal cohort study of 16 295 US adults without COPD in Waves 2-3 (W2-3, 2014-2016) of the Population Assessment of Tobacco and Health Study. Exposure-Ten mutually exclusive categories of tobacco use including single product, multiple product, former, and never use (reference). Outcome-Seven questions assessing wheezing/cough were summed to create a respiratory symptom index; cutoffs of ≥2 and ≥3 were associated with functional limitations and poorer health. Multivariable regressions examined both cutoffs cross-sectionally and change over approximately 12 months, adjusting for confounders. RESULTS: All tobacco use categories featuring cigarettes (>2/3's of users) were associated with higher risk (vs. never users) for functionally important respiratory symptoms at W2, for example, at symptom severity ≥ 3, risk ratio for exclusive cigarette use was 2.34 [95% CI, 1.92, 2.85] and for worsening symptoms at W3 was 2.80 [2.08, 3.76]. There was largely no increased symptom risk for exclusive use of cigars, smokeless tobacco, hookah, or e-cigarettes (adjustment for pack-years and marijuana attenuated the cross-sectional e-cigarette association from 1.53(95% CI 0.98, 2.40) to 1.05 (0.67, 1.63); RRs for these products were also significantly lower compared to exclusive use of cigarettes. The longitudinal e-cigarette-respiratory symptom association was sensitive to the respiratory index cutoff level; exclusive e-cigarette use was associated with worsening symptoms at an index cutoff ≥ 2 (RR = 1.63 [1.02, 2.59]) and with symptom improvement at an index cutoff of ≥ 3 (RR = 1.64 [1.04, 2.58]). CONCLUSIONS: Past and current cigarette smoking drove functionally important respiratory symptoms, while exclusive use of other tobacco products was largely not associated. However, the relationship between e-cigarette use and symptoms was sensitive to adjustment for pack-years and symptom severity. IMPLICATIONS: How noncigarette tobacco products affect respiratory symptoms is not clear; some studies implicate e-cigarettes. We examined functionally important respiratory symptoms (wheezing/nighttime cough) among US adults without COPD. The majority of adult tobacco users smoke cigarettes and have higher risk of respiratory symptoms and worsening of symptoms, regardless of other products used with them. Exclusive use of other tobacco products (e-cigarettes, cigars, smokeless, hookah) was largely not associated with functionally important respiratory symptoms and risks associated with their use was significantly lower than for cigarettes. The association for e-cigarettes was greatly attenuated by adjustment for cigarette pack-years and sensitive to how symptoms were defined.

Tobacco Product Use and Functionally Important Respiratory Symptoms Among US Adolescents/Young Adults.

OBJECTIVE: The relation between respiratory symptoms and the range of tobacco product use among US adolescents/young adults is not yet clear. This cross-sectional analysis examines tobacco product use and respiratory symptoms in a nationally representative sample of 21,057 adolescents/young adults aged 12-24 years from Wave 4 (2016-17) of the Population Assessment of Tobacco and Health Study. METHODS: Presence of functionally important respiratory symptoms was defined by questions regarding wheezing and nighttime cough at a cutoff score associated with poorer functional health status. Past-30-day tobacco use was analyzed 2 ways: never-tobacco users (reference) versus combustible users, noncombustible-only users, and former users; or frequency of use of cigarettes and/or e-cigarettes. Weighted Poisson regression adjusted for past-30-day marijuana use, secondhand smoke exposure, and asthma. RESULTS: Functionally important respiratory symptoms were present in 10.0% overall: 13.8% of combustible users, 9.0% of noncombustible users, 8.2% of noncurrent users and 9.7% of never users. Functionally important respiratory symptoms were associated with combustible tobacco use (relative risk [RR] = 1.52[95% CI 1.29, 1.80]), marijuana use (RR = 1.54[1.34, 1.77]) and secondhand smoke exposure (RR = 1.04[1.03, 1.05]). Higher cigarette smoking frequency was also associated with functionally important respiratory symptoms for frequency categories >14 days/month (eg, RR = 1.93[1.50, 2.49] for 15-29 days/month). Frequency of e-cigarette use was not associated with functionally important respiratory symptoms. CONCLUSIONS: During 2016-17, smoking cigarettes, marijuana use, and secondhand smoke exposure were cross-sectionally associated with functionally important respiratory symptoms in adolescents/young adults. Risk increased with increased frequency of cigarette use but not e-cigarette use. Given changes to contemporary e-cigarettes and use, findings may not generalize to newer products.

Smokeless Tobacco Use and Prevalence of Cardiovascular Disease Among Males in the Population Assessment of Tobacco and Health (PATH) Study, Waves 1-4.

The purpose of this period prevalence study is to compare the prevalence of cardiovascular disease (CVD) in current/former established smokeless tobacco (SLT) users (ever SLT users who have used the product fairly regularly) to those who were: 1) never established cigarette smokers and SLT users, and 2) current/former established exclusive cigarette smokers (have smoked at least a 100 or more cigarettes in lifetime) only, adjusting for known risk factors for CVD. Analyses included 4,703 men ≥ 40 years of age who participated in the Population Assessment of Tobacco and Health (PATH) Study, Waves: 1-4, conducted between 2013 and 2017. Current users were those using SLT products daily or on some days, whereas former users had not used SLT and/or cigarettes in the past 12 months. CVD prevalence was defined as a self-reported diagnosis of congestive heart failure, stroke, or myocardial infarction. Among current/former established SLT users, years of use defined exposure history, while pack-years defined exposure history for smokers. Adjusted odds ratios (AOR) and 95% confidence intervals (CI) were reported with trend tests to examine dose-response associations. Current/former established exclusive SLT users were not significantly more likely to have had any CVD compared to never established cigarette and SLT users (OR = 1.7 [0.8-3.7]), or current/former established exclusive cigarette smokers (OR = 0.9 [0.5-1.8]). Current/former established exclusive cigarette smokers were more likely to have had any CVD compared to those who were never established cigarette and SLT users (OR = 1.6 [1.1-2.3]).

Validation of the Wave 1 and Wave 2 Population Assessment of Tobacco and Health (PATH) Study Indicators of Tobacco Dependence Using Biomarkers of Nicotine Exposure Across Tobacco Products.

INTRODUCTION: This study examined the predictive relationships between biomarkers of nicotine exposure and 16-item self-reported level of tobacco dependence (TD) and subsequent tobacco use outcomes. AIMS AND METHODS: The Population Assessment of Tobacco and Health (PATH) Study surveyed adult current established tobacco users who provided urine biospecimens at Wave 1 (September 2013-December 2014) and completed the Wave 2 (October 2014-October 2015) interview (n = 6872). Mutually exclusive user groups at Wave 1 included: Cigarette Only, E-cigarette Only, Cigar Only, Hookah Only, Smokeless Tobacco Only, Cigarette Plus E-cigarette, multiple tobacco product users who smoked cigarettes, and multiple tobacco product users who did not smoke cigarettes. Total Nicotine Equivalents (TNE-2) and TD were measured at Wave 1. Approximate one-year outcomes included frequency/quantity used, quitting, and adding/switching to different tobacco products. RESULTS: For Cigarette Only smokers and multiple tobacco product users who smoked cigarettes, higher TD and TNE-2 were associated with: a tendency to smoke more, smoking more frequently over time, decreased likelihood of switching away from cigarettes, and decreased probability of quitting after one year. For other product user groups, Wave 1 TD and/or TNE-2 were less consistently related to changes in quantity and frequency of product use, or for adding or switching products, but higher TNE-2 was more consistently predictive of decreased probability of quitting. CONCLUSIONS: Self-reported TD and nicotine exposure assess common and independent aspects of dependence in relation to tobacco use behaviors for cigarette smokers. For other product user groups, nicotine exposure is a more consistent predictor of quitting than self-reported TD. IMPLICATIONS: This study suggests that smoking cigarettes leads to the most coherent pattern of associations consistent with a syndrome of TD. Because cigarettes continue to be prevalent and harmful, efforts to decrease their use may be accelerated via conventional means (eg, smoking cessation interventions and treatments), but also perhaps by decreasing their dependence potential. The implications for noncombustible tobacco products are less clear as the stability of tobacco use patterns that include products such as e-cigarettes continue to evolve. TD, nicotine exposure measures, and consumption could be used in studies that attempt to understand and predict product-specific tobacco use behavioral outcomes.

Validation of an Index for Functionally Important Respiratory Symptoms among Adults in the Nationally Representative Population Assessment of Tobacco and Health Study, 2014-2016.

The purpose of this study is to validate the seven-item wheezing module from the International Study of Asthma and Allergies in Children (ISAAC) in the nationally representative Population Assessment of Tobacco and Health Study. Adult participants with complete Wave 2-3 data were selected, including those with asthma but excluding those with COPD and other respiratory diseases (n = 16,295). We created a nine-point respiratory symptom index from the ISAAC questions, assessed the reliability of the index, and examined associations with self-reported asthma diagnosis. Threshold values were assessed for association with functional outcomes. The weighted prevalence for one or more respiratory symptom was 18.0% (SE = 0.5) for adults without asthma, 70.1% (SE = 1.3) for those with lifetime asthma, 75.7% (SE = 3.7) for adults with past-year asthma not on medications, and 92.6% (SE = 1.6) for those on medications. Cronbach's alpha for the respiratory symptom index was 0.86. Index scores of ≥2 or ≥3 yielded functionally important respiratory symptom prevalence of 7-10%, adequate sensitivity and specificity for identifying asthma, and consistent independent associations with all functional outcomes and tobacco use variables. Respiratory symptom index scores of ≥2 or ≥3 are indicative of functionally important respiratory symptoms and could be used to assess the relationship between tobacco use and respiratory health.

Biomarkers of Inflammation and Oxidative Stress among Adult Former Smoker, Current E-Cigarette Users-Results from Wave 1 PATH Study.

BACKGROUND: Former smokers who currently use e-cigarettes have lower concentrations of biomarkers of tobacco toxicant exposure than current smokers. It is unclear whether tobacco toxicant exposure reductions may lead to health risk reductions. METHODS: We compared inflammatory biomarkers (high-sensitivity C-reactive protein, IL6, fibrinogen, soluble intercellular adhesion molecule-1) and an oxidative stress marker (F2-isoprostane) among 3,712 adult participants in Wave 1 (2013-2014) of the Population Assessment of Tobacco and Health Study by tobacco user groups: dual users of cigarettes and e-cigarettes; former smokers who currently use e-cigarettes-only; current cigarette-only smokers; former smokers who do not currently use any tobacco; and never tobacco users. We calculated geometric means (GM) and estimated adjusted GM ratios (GMR). RESULTS: Dual users experienced greater concentration of F2-isoprostane than current cigarette-only smokers [GMR 1.09 (95% confidence interval, CI, 1.03-1.15)]. Biomarkers were similar between former smokers who currently use e-cigarettes and both former smokers who do not use any tobacco and never tobacco users, but among these groups most biomarkers were lower than those of current cigarette-only smokers. The concentration of F2-isoprostane decreased by time since smoking cessation among both exclusive e-cigarette users (P trend = 0.03) and former smokers who do not currently use any tobacco (P trend = 0.0001). CONCLUSIONS: Dual users have greater concentration of F2-isoprostane than smokers. Exclusive e-cigarette users have biomarker concentrations that are similar to those of former smokers who do not currently use tobacco, and lower than those of exclusive cigarette smokers. IMPACT: This study contributes to an understanding of the health effects of e-cigarettes.

Cardiovascular Risk Factor and Disease Measures from the Population Assessment of Tobacco and Health (PATH) Study.

BACKGROUND: Cardiovascular disease is a key health condition associated with tobacco use; however, clinical measures are not typically possible in population-based studies. In this paper, we assess the reliability and validity of self-reported cardiovascular risk factors and diseases in a large nationally representative study of tobacco use and health outcomes. METHODS: This paper analyzes self-reported cardiovascular risk factors and disease among adults age 40 years and older based on U.S. nationally representative data from the Population Assessment of Tobacco and Health (PATH) Study. Prevalence of cardiovascular risk factors (self-reported high blood pressure, high cholesterol, diabetes and family history of premature heart disease, BMI ≥ 35, and tobacco use) and cardiovascular disease (self-reported heart attack, stroke and/or congestive heart failure (CHF)) were considered along with ratings of physical functioning, fatigue, and general health. RESULTS: Self-reported cardiovascular disease was found to be associated with functional health measures (walking up a flight of stairs) and general ratings of health. Prospective analyses found strong correlations between sequential data collection waves for history of hypertension, elevated cholesterol and CHF, while more modest correlations were noted for stroke and heart attack. The overall prevalence of cardiovascular disease and hypertension was comparable to those from the National Health and Nutrition Examination Survey (NHANES). CONCLUSIONS: These analyses suggest reliability and concurrent validity regarding self-reported cardiovascular risk factors and disease assessed in the PATH Study.

Longitudinal Uses of the Population Assessment of Tobacco and Health Study.

OBJECTIVES: The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative study of the US population on tobacco use and its effects on health, with 3 waves of data collection between 2013 and 2016. Prior work described the methods of the first wave. In this paper, we describe the methods of the subsequent 2 waves and provide recommendations for how to conduct longitudinal analyses of PATH Study data. METHODS: We use standard survey quality metrics to evaluate the results of the follow-up waves of the PATH Study. The recommendations and examples of longitudinal and cross-sectional analyses of PATH Study data follow a design-based statistical inference framework. RESULTS: The quality metrics indicate that the PATH Study sample of approximately 40,000 continuing respondents remains representative of its target population. Depending on the intended analysis, different survey weights may be appropriate. CONCLUSION: The PATH Study data are a valuable resource for regulatory scientists interested in longitudinal analysis of tobacco use and its effects on health. The availability of multiple sets of specialized survey weights enables researchers to target a wide range of tobacco-related analytic questions.

Predictive validity of the adult tobacco dependence index: Findings from waves 1 and 2 of the Population Assessment of Tobacco and Health (PATH) study.

BACKGROUND AND AIMS: Building on published work1 establishing concurrent validity of a self-report tobacco dependence (TD) index among users of different tobacco products in Wave 1 (W1) of the Population Assessment of Tobacco and Health (PATH) Study, the current study examines prospective relationships with tobacco use behaviors to establish predictive validity of the TD index. Hypotheses suggested high levels of W1 TD would be associated with persistent tobacco use at Wave 2 (W2). PARTICIPANTS: A U.S. nationally representative sample of 32,320 adult W1 and W2 interviews focused on 11,615 W1 adults who were current established tobacco users and completed the W2 interview. FINDINGS: Higher TD scores and greater changes in TD scores were associated with greater quantity and frequency of tobacco use at the W2 interview for Cigarette Only (n = 7068), Smokeless (smokeless or snus pouches) Only (n = 772), Cigarette plus E-Cigarette (n = 592), and Multiple Products (n = 1866) users, although not significantly so for E-Cigarette Only (n = 367), Cigar Only (traditional, cigarillo, or filtered) (n = 584), or Hookah Only (n = 366) users. Higher TD was associated with decreased odds of successful quitting for Cigarette and Multiple Product users. Higher TD was associated with increased odds of a quit attempt for those in the Hookah and Multiple Products user groups and was not associated with quit attempts or deceased odds of quit success among exclusive E-Cigarette, Cigar, Smokeless and Cigarette plus E-Cigarette users. CONCLUSION: Support for the predictive validity of the PATH Study measures of adult TD will enable regulatory investigations of TD across several tobacco products.