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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.

PDF - 94K, Detailed mixed models analysis of self-reported and biomarker data.

Epidemiological data suggest robust associations of high vegetable intake with decreased risks of bladder cancer incidence and mortality, but translational prevention studies have yet to be conducted. We designed and tested a novel intervention to increase vegetable intake in patients with noninvasive bladder cancer. We randomized 48 patients aged 50 to 80 years with biopsy-proven noninvasive (Ta, T1, or carcinoma in situ) urothelial cell carcinoma to telephone- and Skype-based dietary counseling or a control condition that provided print materials only. The intervention behavioral goals promoted seven daily vegetable servings, with at least two of these as cruciferous vegetables. Outcome variables were self-reported diet and plasma carotenoid and 24-hour urinary isothiocyanate (ITC) concentrations. We used two-sample t tests to assess between-group differences at 6-month follow-up. After 6 months, intervention patients had higher daily intakes of vegetable juice (P = 0.02), total vegetables (P = 0.02), and cruciferous vegetables (P = 0.07); lower daily intakes of energy (P = 0.007), fat (P = 0.002) and energy from fat (P = 0.06); and higher plasma α-carotene concentrations (P = 0.03). Self-reported cruciferous vegetable intake correlated with urinary ITC concentrations at baseline (P < 0.001) and at 6 months (P = 0.03). Although urinary ITC concentrations increased in the intervention group and decreased in the control group, these changes did not attain between-group significance (P = 0.32). In patients with noninvasive bladder cancer, our novel intervention induced diet changes associated with protective effects against bladder cancer. These data show the feasibility of implementing therapeutic dietary modifications to prevent recurrent and progressive bladder cancer. Cancer Prev Res; 6(9); 971–8. ©2013 AACR.

Supplementary Table 1 from Low to Moderate Alcohol Intake Is Not Associated with Increased Mortality after Breast Cancer

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.

ObjectivesTo estimate the effect of menthol use and transitions in use (switching to or from menthol) on short-term and long-term cessation from cigarette smoking and whether this differed across demographic groups (age, sex, race).MethodsWe compared the probability of 30+ day and 12-month abstinence from cigarette smoking by menthol use status using two cohorts of US adult cigarette smokers who attempted to quit smoking in the Population Assessment of Tobacco and Health (wave 1 to wave 3 and wave 2 to wave 4; n=5759), inverse probability of treatment weighting and adjusted risk ratios (aRRs).ResultsUsing menthol (vs non-menthol) prior to a quit attempt decreased the probability of 30+ day abstinence by 28% (aRR=0.78; 95% CI 0.67 to 0.91) and the probability of 12-month abstinence by 53% (aRR=0.65; 95% CI 0.47 to 0.88). Additionally, switching from menthol (vs maintaining menthol use) increased the probability of 30+ day abstinence by 58% (aRR=1.58; 95% CI 1.00 to 2.50) and the probability of 12-month abstinence by 97% (aRR=1.86; 95% CI 0.92 to 3.74). Switching to menthol (vs maintaining non-menthol use) was associated with a lower probability of 30+ day (aRR=0.70; 95% CI 0.42 to 1.16) and 12-month abstinence (aRR=0.64; 95% CI 0.30 to 1.36), but these associations were imprecise. The effects of menthol use on impaired quitting were slightly larger for non-Hispanic Black smokers, but not different for other demographic groups.ConclusionThese results demonstrate that menthol impaired menthol smokers’ attempts to quit smoking but switching from menthol improved success. This suggests that removing menthol may improve menthol smokers’ success during quit attempts.

Breast cancer survivors often have a reduced digestive capacity to digest whole grains due to cancer treatment. The purpose of this study was to investigate the independent and joint associations of whole grain and refined grain consumption with total mortality among breast cancer survivors. We studied a cohort of 3081 female breast cancer survivors who provided demographic, dietary, and lifestyle data at baseline, year 1 and year 4. Mortality was assessed via semi-annual telephone interviews and confirmed by the National Death Index (NDI) and death certificates. We assessed the associations of whole grain and refined grain with incident of mortalities using Cox proportional hazards models. Increased whole grain consumption was marginally associated with an increased risk of total mortality (p = 0.07) but was not significantly associated with breast cancer-specific mortality (p = 0.55). An increased intake of refined grains was associated with an increased risk of both total (HR = 1.74; 95% CI,1.17 to 2.59) and breast cancer-specific mortality (HR = 1.16; 95% CI, 1.08 to 1.26). Furthermore, we examined the joint associations of whole grain and refined grain with total mortality. Among those with a high consumption of refined grain, those with high consumption of whole grain had a higher risk of total mortality (HR = 1.52, 95% CI, 1.07 to 2.14) than those with a low consumption of whole grain. Increased consumption of whole grains may exacerbate the adverse associations of refined grain with mortality among breast cancer survivors. Our findings indicate the need to revisit current dietary guidelines for breast cancer survivors regarding whole grain intake.

ImportanceMenthol may make cigarette smoke less aversive and could lead youth to smoke more frequently and become more dependent on nicotine.ObjectiveTo assess the association of menthol use with cigarette smoking frequency and nicotine dependence (ND) among youth cigarettes users.Design, setting, and participantsThis cohort study used a pooled sample of cohorts of US youth (aged 12-17 years at their baseline and follow-up interviews) in the Population Assessment of Tobacco and Health Study (September 2013 to November 2019). Household interviews were conducted using audio computer-assisted self-interviews. US youth who were past-30-day cigarette smokers at any of wave 2 through wave 5, completed the preceding survey (eg, wave 2 past-30-day cigarette smokers completed wave 1), and indicated whether they used menthol cigarettes were eligible. The association of menthol use with smoking frequency and ND was estimated using inverse probability of treatment weighting adjusted mean differences (aMDs), adjusted risk ratios (aRRs), and corresponding 95% CIs. Data were analyzed from December 2021 to March 2022.ExposuresMenthol use and transitions in use (switching to or from menthol cigarettes).Main outcomes and measuresMain outcomes were the number of days smoked in the past 30 days, the risk of frequent smoking (smoking ≥20 days in the past 30 days), and symptoms of ND.ResultsThere were a total of 1492 observations among 1096 US youth cigarette smokers, of whom 49.4% were female, 67.2% were non-Hispanic White, and 28.7% were aged 12 to 14 years at their baseline survey (all percentages are weighted). Among those who switched from not smoking to smoking (61% of the sample), menthol use was associated with smoking on 3.1 additional days (aMD; 95% CI, 1.9 to 4.2 days), 59% higher risk of being a frequent smoker (aRR, 1.59; 95% CI, 1.23 to 2.06), and 10% higher ND scores (aMD, 1.09; 95% CI, 1.02 to 1.17). Switching from smoking menthol to smoking nonmenthol (vs maintaining menthol use) was associated with smoking on 3.6 fewer days (aMD; 95% CI, -6.3 to -0.9 days) and 47% lower risk of being a frequent smoker (aRR, 0.68; 95% CI, 0.50 to 0.92).Conclusions and relevanceThese findings suggest that the addition of menthol to cigarettes is associated with increased smoking frequency and ND among US youth.

ImportanceThe inclusion of graphic warning labels (GWLs) on cigarette packs is recommended for tobacco control but has not yet been implemented in the US. It is unknown whether and to what extent the inclusion of GWLs on cigarette packs affects smokers' willingness to display the packs in public.ObjectiveTo determine whether the inclusion of GWLs on cigarette packs affects pack-hiding behavior among smokers in social settings.Design, setting, and participantsThis community-based randomized clinical trial assessed smokers' real-world experience of using cigarettes repackaged to include GWLs (GWL packs) compared with standard US packs and blank packs over a 3-month intervention period with 12 months of follow-up between September 6, 2016, and December 3, 2019. The study included 357 participants aged 21 to 65 years from San Diego County, California, who smoked 5 or more cigarettes per day, were not actively planning to quit smoking, were not pregnant, and had no unstable medical conditions. Participants purchased and received cigarette packs through the study website.InterventionsDuring the 1-month run-in period, participants received their usual US cigarette packs. During the 3-month intervention period, participants were randomized to receive GWL packs (study-manufactured packs with 3 rotating images under license from the Commonwealth of Australia; GWL pack group), blank packs (study-manufactured packs devoid of industry marketing imagery; blank pack group), or standard US packs (US pack group).Main outcomes and measuresPack hiding was queried daily (with participants reporting behavior within the last 4 hours) and weekly via interactive text messages during the 1-month run-in and intervention periods. Self-reported smoking behavior was biochemically validated.ResultsAmong 357 enrolled participants, the mean (SD) age was 39.3 (11.8) years; 195 participants (54.6%) were female, 40 (11.2%) were Hispanic, 243 (68.1%) were non-Hispanic White, and 74 (20.7%) were of other non-Hispanic races (including American Indian or Alaska Native, Asian or Pacific Islander, Black or African American, or multiracial). A total of 18 987 cigarette packs were purchased and delivered during the run-in and intervention periods. Daily querying showed that the inclusion of GWLs on cigarette packs increased the percentage of smokers who hid their packs at least some of the time from 41.3% (95% CI, 39.6%-43.0%) during the run-in period to 57.1% (95% CI, 55.9%-58.1%) by the end of the intervention period. In the postintervention period, returning to standard US packs reduced pack-hiding behavior to the levels observed during the run-in period. Pack hiding remained at run-in levels for both the blank pack group (35.2%; 95% CI, 33.6%-36.8%) and the US pack group (41.4%; 95% CI, 39.7%-43.1%]) throughout the study. Although even participants in the GWL group with the lowest prestudy tendency to conceal score (ie, 1) had a mean (SE) probability of pack hiding during the intervention of 0.84 (0.02), this group's probability of pack hiding decreased to a mean (SE) of 0.43 (0.03) after intervention. When social reactions to packs were queried at the end of the study, the modal response from participants in the GWL pack group was observers' aversive reactions to the packs, whereas the modal response from participants in the blank pack group was observers' positive interest in the study. Neither smoking prevalence nor consumption differed by group at any point in the study.Conclusions and relevanceIn this randomized clinical trial, receiving cigarettes in GWL packs vs blank packs increased pack-hiding behavior in social settings, which may be associated with aversive reactions from observers. However, 12-month smoking behavior did not change.Trial registrationClinicalTrials.gov Identifier: NCT02676193.

IntroductionWhile 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.MethodsData 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.ResultsNearly 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.ConclusionsCigarette 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.

OBJECTIVES:To identify how the 2017 rapid surge in sales of JUUL e-cigarettes affected usage among US youth and young adults.METHODS:Annual surveys in the Population Assessment of Tobacco and Health Study assess tobacco use by product and brand among the US population. We identified 2 cohorts aged 14 to 34 years, 1 with baseline survey in 2014 before the rapid surge of JUUL and the other in 2017 as the surge in JUUL sales was occurring. For 5 age groups, we compared 2-year incidence of first tobacco use and of new-onset daily tobacco use by product, and report levels of dependence.RESULTS:Sociodemographic variables and rates of experimentation with any tobacco product were similar between cohorts. Among baseline nondaily tobacco users, only those aged 14 to 17 years had an increase in the 2-year incidence of new daily tobacco use (2014 cohort = 4.8%, 95% confidence interval 4.3, 5.5 vs 2017 cohort = 6.3%, 95% confidence interval 5.8–7.0) to rates approaching those in the 1990s. In 2019, three-quarters of new daily tobacco users aged 14 to 17 vaped daily and had e-cigarette dependence scores similar to daily cigarette smokers and older adult e-cigarette vapers. We estimate that about 600 000 Americans aged CONCLUSIONS:The surge in US JUUL sales was associated with a sharp rise in daily e-cigarette vaping and daily tobacco use among US youth, not young adults.

Insomnia is prevalent in up to 40% of breast cancer survivors. Few studies have examined pessimism and dietary factors as risk factors for insomnia among breast cancer survivors. We leveraged a cohort of 2944 breast cancer survivors who enrolled in the Women’s Healthy Eating and Living study; these survivors provided dietary, insomnia, mental health, demographic, and lifestyle information at baseline and at 1- and 4-year follow-up assessments. Insomnia symptoms were assessed using the Women’s Health Initiative (WHI)-Insomnia Rating Scale, and pessimism was assessed using the Life Orientation Test Revised (LOT-R). Total calorie intake and acid-producing diets were assessed using 24 h dietary recalls. Multivariable-adjusted generalized estimating equation (GEE) models were used to test the independent and joint effects of psychological and dietary factors on insomnia. In the multivariable model, women in the third tertile of pessimism had greater odds (OR = 1.57 95% CI [1.37–1.79]) of insomnia when compared to women in the lowest tertile. Total calorie intake and acid-producing diets were each independently and significantly associated with insomnia symptoms. Further, pessimism and calorie intake/acid-producing diets were jointly associated with insomnia. For instance, women with pessimism scores in tertile 3 and total calorie intakes < median reported 2 times the odds (OR = 2.09; 95% CI [1.51–3.47]) of insomnia compared to women with pessimism score in tertile 1 and calorie intakes < median. Our results highlight the need for patient care regarding mental health, and recommendations of healthy dietary intakes for breast cancer survivors.

Electronic cigarettes (e-cigarettes) are the preferred smoking-cessation aid in the United States; however, there is little evidence regarding long-term effectiveness among those who use them. We used the Population Assessment of Tobacco and Health Study to compare long-term abstinence between matched US smokers who tried to quit with and without use of e-cigarettes as a cessation aid. We identified a nationally representative cohort of 2,535 adult US smokers in 2014–2015 (baseline assessment), who, in 2015–2016 (exposure assessment), reported a past-year attempt to quit and the cessation aids used, and reported smoking status in 2016–2017 (outcome assessment; self-reported ≥12 months continuous abstinence). We used propensity-score methods to match each e-cigarette user with similar nonusers. Among US smokers who used e-cigarettes to help quit, 12.9% (95% confidence interval (CI): 9.1%, 16.7%) successfully attained long-term abstinence. However, there was no difference compared with matched non–e-cigarette users (cigarette abstinence difference: 2%; 95% CI: −3%, 7%). Furthermore, fewer e-cigarette users were abstinent from nicotine products in the long term (nicotine abstinence difference: −4%; 95% CI: −7%, −1%); approximately two-thirds of e-cigarette users who successfully quit smoking continued to use e-cigarettes. These results suggest e-cigarettes may not be an effective cessation aid for adult smokers and, instead, may contribute to continuing nicotine dependence.

Objectives To make projections of cigarette consumption that incorporate state-specific trends in smoking behaviors, assess the potential for states to reach an ideal target, and identify State-specific targets for cigarette consumption. Methods We used 70 years (1950–2020) of annual state-specific estimates of per capita cigarette consumption (expressed as packs per capita or “ppc”) from the Tax Burden on Tobacco reports (N = 3550). We summarized trends within each state by linear regression models and the variation in rates across states by the Gini coefficient. Autoregressive Integrated Moving Average (ARIMA) models were used to make state-specific forecasts of ppc from 2021 through 2035. Results Since 1980, the average rate of decline in US per capita cigarette consumption was 3.3% per year, but rates of decline varied considerably across US states (SD = 1.1% per year). The Gini coefficient showed growing inequity in cigarette consumption across US states. After reaching its lowest level in 1984 (Gini = 0.09), the Gini coefficient began increasing by 2.8% (95% CI: 2.5%, 3.1%) per year from 1985 to 2020 and is projected to continue to increase by 48.1% (95% PI = 35.3%, 64.2%) from 2020 to 2035 (Gini = 0.35; 95% PI: 0.32, 0.39). Forecasts from ARIMA models suggested that only 12 states have a realistic chance (≥50%) of reaching very low levels of per capita cigarette consumption (≤13 ppc) by 2035, but that all US states have opportunity to make some progress. Conclusion While ideal targets may be out of reach for most US states within the next decade, every US state has the potential to lower its per capita cigarette consumption, and our identification of more realistic targets may provide a helpful incentive.

Key Points Question Is switching to e-cigarettes associated with prevention of relapse to cigarette smoking? Findings In this cohort study of a representative sample of US adults, 9.4% of respondents who smoked cigarettes became recent former smokers 1 year later. Switching to any tobacco product including e-cigarettes was associated with an 8.5% increase in relapse to smoking over the next year; this increase in relapse was similar to that seen in individuals who switched to other tobacco products. Meaning Switching to e-cigarettes is not associated with relapse prevention for cigarette smoking in US adults., This cohort study examines the relapse rates for adults who switched from smoking cigarettes to e-cigarettes or other tobacco products vs those who remained tobacco free., Importance Although e-cigarettes are not approved as a cessation device, many who smoke believe that e-cigarettes will help them quit cigarette smoking successfully. Objective To assess whether people who recently quit smoking and who had switched to e-cigarettes or another tobacco product were less likely to relapse to cigarette smoking compared with those who remained tobacco free. Design, Setting, and Participants This cohort study analyzed a nationally representative sample of US households that participated in 4 waves of the Population Assessment of Tobacco and Health Study (conducted 2013 through 2017), combining 2 independent cohorts each with 3 annual surveys. Eligible participants were individuals who smoked at baseline, had recently quit at the first follow-up, and completed the second follow-up survey. Exposures Use of e-cigarettes or alternate tobacco products at follow-up 1 after recently quitting smoking. Main Outcomes and Measures Weighted percentage of participants with over 12 months abstinence by follow-up 2. Results Of a total of 13 604 participants who smoked cigarettes at baseline, 9.4% (95% CI, 8.7%-10.0%) recently had quit smoking (mean age, 41.9; 95% CI, 39.7-46.6 years; 641 [43.2%] women) Of these, 22.8% (95% CI, 19.7%-26.0%) had switched to e-cigarettes, with 17.6% (95% CI, 14.8%-20.5%) using them daily. A total of 37.1% (95% CI, 33.7%-40.4%) used a noncigarette tobacco product and 62.9% (95% CI, 59.6%-66.3%) were tobacco free. Rates of switching to e-cigarettes were highest for those who were in the top tertile of tobacco dependence (31.3%; 95% CI, 25.0%-37.7%), were non-Hispanic White (26.4%; 95% CI, 22.3%-30.4%), and had higher incomes (annual income ≥$35 000, 27.5%; 95% CI, 22.5%-32.4% vs

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.

Key Points Question Can graphic warning labels on cigarette packs affect cognitions and smoking behavior among US daily smokers who are not ready to quit smoking? Findings This randomized clinical trial found that graphic warning labels decreased positive perceptions of cigarettes associated with branded cigarette packs but without clearly increasing health concerns. They also increased quitting cognitions but did not affect either cigarette cessation or consumption levels. Meaning Placing graphic warning labels on US cigarette packs did not have an effect on smoking behavior; however, these findings suggest that they may enhance other tobacco control strategies to reduce cigarette smoking., This randomized clinical trial examines whether graphic warning labels on cigarette packs can affect US smokers’ perceptions about their cigarettes or health consequences and changes in smoking behavior., Importance The US Food and Drug Administration’s implementation of graphic warning labels (GWLs) on cigarette packs is under challenge in US courts. Objective To determine whether GWLs can affect US smokers’ perceptions about their cigarettes or health consequences and changes in smoking behavior. Design, Setting, and Participants This study was a randomized clinical trial of the effect of a 3-month, real-world experience of cigarettes with GWL packaging. Community recruitment was done from September 2016 through December 2019 of daily smokers from San Diego, California, aged 21 to 65 years, who were not ready to quit. Participants were randomized to purchase and receive cigarettes in 1 of 3 pack designs: GWL, blank, or standard US pack. Data analysis was performed from July 2020 to February 2021. Interventions The study manufactured GWL cigarette packs (3 versions with Australian-licensed images) and packs devoid of marketing. For 3 months, participants purchased GWL, blank, or standard US pack cigarettes that were delivered to their home. Main Outcomes and Measures Smoking-related cognitions and behavior were queried by daily and weekly interactive text messages. Smoking behavior was self-reported before and after the intervention by 96% of randomized participants and was biochemically validated on a subsample. Results The study sample included 357 participants (195 women [54.6%]; mean [SD] age, 39.5 [11.9] years); 116 were randomized to the standard US pack group, 118 were randomized to the GWL pack group, and 125 were randomized to the blank pack group. Over the 3 months, participants who received the GWL packs had reduced positive perceptions of recent cigarettes smoked compared with participants who received the branded US pack (mean difference, −0.46 SD; 95% CI, −0.73 SD to −0.20 SD; P

ObjectiveTo assess the effectiveness of e-cigarettes in smoking cessation in the USA from 2017 to 2019, given the 2017 increase in high nicotine e-cigarette sales.MethodsIn 2017, the PATH Cohort Study included data on 3578 previous year smokers with a recent quit attempt and 1323 recent former smokers. Respondents reported e-cigarettes or other products used to quit cigarettes and many covariates associated with e-cigarette use. Study outcomes were 12+ months of cigarette abstinence and tobacco abstinence in 2019. We report weighted unadjusted estimates and use propensity score matched analyses with 1500 bootstrap samples to estimate adjusted risk differences (aRD).ResultsIn 2017, 12.6% (95% CI 11.3% to 13.9%) of recent quit attempters used e-cigarettes to help with their quit attempt, a decline from previous years. Cigarette abstinence for e-cigarette users (9.9%, 95% CI 6.6% to 13.2%) was lower than for no product use (18.6%, 95% CI 16.0% to 21.2%), and the aRD for e-cigarettes versus pharmaceutical aids was −7.3% (95% CI −14.4 to –0.4) and for e-cigarettes versus any other method was −7.7% (95% CI −12.2 to –3.2). Only 2.2% (95% CI 0.0% to 4.4%) of recent former smokers switched to a high nicotine e-cigarette. Subjects who switched to e-cigarettes appeared to have a higher relapse rate than those who did not switch to e-cigarettes or other tobacco, although the difference was not statistically significant.ConclusionsSales increases in high nicotine e-cigarettes in 2017 did not translate to more smokers using these e-cigarettes to quit smoking. On average, using e-cigarettes for cessation in 2017 did not improve successful quitting or prevent relapse.

The purpose of this study was to examine the independent and joint associations of acid-producing diets and depressive symptoms with physical health among breast cancer survivors. We studied a cohort of 2944 early stage breast cancer survivors who provided dietary, physical health, demographic, and lifestyle information at baseline, year 1, and year 4. We assessed the intakes of acid-producing diets via two commonly used dietary acid load scores: potential renal acid load (PRAL) and net endogenous acid production (NEAP). Physical health was measured using the Rand 36-Item Short Form Health Survey (SF-36), consisting of physical functioning, role limitation due to physical function, bodily pain, general health, and overall physical health subscales. Increased dietary acid load and depression were each independently and significantly associated with reduced physical health subscales and overall physical health. Further, dietary acid load and depression were jointly associated with worse physical health. For instance, depressed women with dietary acid load higher than median reported 2.75 times the risk (odds ratio = 2.75, 95% confidence interval: 2.18–3.47) of reduced physical function and 3.10 times the risk of poor physical health (odds ratio = 3.10, 95% confidence interval: 2.53–3.80) compared to non-depressed women with dietary acid load lower than median. Our results highlight the need of controlling acid-producing diets and the access of mental care for breast cancer survivors.

PURPOSE: We provide a US national assessment of youth perceptions of the harm and addictiveness of six separate tobacco products, identifying a continuum of perceived harm associated with a range of products in relation to patterns of current use, former use, and susceptibility to use tobacco products. METHODS: We evaluated youth respondents (N = 13,651) ages 12–17 from Wave 1 (2013–2014) of the Population Assessment of Tobacco and Health (PATH) Study. Analyses (2015–2016) focused on refining measures of perceived harm for each product and delineating youth characteristics (demographic, tobacco use status) associated with beliefs about the harmfulness and addictiveness of tobacco products. RESULTS: Cigars, hookah and e-cigarettes were each perceived as having significantly lower harm (p's < 0.05) than smokeless products, with the lowest ratings of harmfulness and addictiveness observed for hookah and e-cigarettes (p's < 0.001). Incrementally lower levels of harm and addictiveness perceptions were observed among youth at increasing risk for tobacco use (p's < 0.05). CONCLUSIONS: Among U.S. youth, lower perceptions of harm and addictiveness of tobacco products were associated with susceptibility to use tobacco and patterns of tobacco product use. Future longitudinal assessments from the PATH Study can provide key information on youth development of perceptions of harm and addictiveness and influences on patterns of tobacco use.

Background: Smoking is a known risk factor for various types of cancer, and breast cancer patients who smoke are known to have higher breast cancer mortality. However, few studies have found an association between smoking and breast cancer incidence or tumor biology. The Athena Breast Health Network distributes an intake questionnaire at the UCSF and UCSD breast care centers which can be used to investigate links between tobacco exposure and the characteristics of incident breast cancer. Methods: Intake questionnaires were distributed to all new patients at the UCSF and UCSD breast care centers from December 2012 to May 2018. Patients who completed the questionnaire with a known diagnosis of breast cancer were compared to those without in a case-control study. Breast cancer diagnoses were determined by ICD9 diagnosis codes from the patients' medical records. The association of smoking and breast cancer prevalence and biology was analyzed using generalized linear models and Fisher tests in R. Results: Of the 7727 patients who completed the Athena intake questionnaire at UCSF and UCSD, 5499 consented to have their data used for research. A first analysis was conducted on 4175 UCSF patients alone: 2186 of the UCSF patients who had completed the questionnaire had a documented breast cancer diagnosis, vs 1989 with no known diagnosis at the time of this analysis. 1096 of the 4175 UCSF patients reported having ever smoked, including 73 who had accrued 30 or more pack years. Complete pathology data was available for 1120 cancer patients. Controlling for age, more patients with invasive breast cancer reported having ever smoked, with an odd's ratio (OR) of 2.32 (p = .0043). By including DCIS, the OR drops slightly to 2.26 (p = .0058). Taking alcohol consumption into account as a confounder lowered the OR to 2.19 (p = .0454). Overall, the risk of breast cancer increases with each additional pack year (OR = 1.08, p = .0211), independent of age. There are no significant differences in tumor biology for any smoking group. Conclusions: A history of smoking is associated with an increased risk of developing breast cancer and is directly related to cumulative pack years exposure. This association should be further validated in cohort studies. Citation Format: Dreher N, Layton TM, Parker BA, Shibley WP, Acerbi I, Wallace AM, Blair S, Pierce JP, Glantz S, Guydish J, Hiatt R, van 't Veer L, Esserman L, Athena Breast Health Network Investigators and Advocate Partners. Tobacco exposure and breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P4-10-03.

IntroductionGraphic warning labels on cigarette packaging are mandated in 118 countries and are under consideration in the USA. We propose an appeal–aversion assessment tool to help regulators choose among graphic packaging options.MethodsAfter familiarisation with different cigarette packaging, adult daily smokers (n=338) from San Diego, California, USA completed a discrete choice appeal–aversion purchasing task and provided information on nicotine dependence and sociodemographics (2017–2019). The conjoint analysis estimated the importance and price utility for product attributes (ie, packaging, price, tobacco origin and quitline number). The price premiums that smokers would be willing to pay to avoid purchasing graphic packaging were calculated.ResultsAmong purchase determinants, the price was the most important attribute (65.5%), followed by packaging design (27.1%). Compared with blank packaging without marketing, branded industry packs had appeal valuations (US$0.54; 95% CI: US$0.44 to US$0.65), whereas graphic warning packs had aversion valuations that varied with the salience of the image (blindness=−US$2.53, 95% CI: −US$2.76 to −US$2.31; teeth damage=−US$2.90, 95% CI: −US$3.17 to −US$2.63; and gangrenous foot=−US$3.70, 95% CI: −US$4.01 to −US$3.39). The aversion was such that 46.2% of participants were willing to pay a 50+% premium over their current cigarette price to have their branded packs rather than a graphic pack. These appeal–aversion valuations were moderated by sex, income and nicotine dependence (pConclusionsSmokers indicated a willingness to pay substantial premiums to avoid purchasing graphic packaging. Results suggest that mandating graphic warnings on US cigarette packs would induce price aversion and may deter cigarette purchasing. Price valuations from this appeal–aversion tool could be useful for regulators to differentiate between graphic warning labels.

Seasons can affect human inflammatory status and the occurrence of diseases, and foods may also have differential impacts on inflammation across seasons, however, few studies have investigated whether there are independent and joint impacts of seasons and red meat, fruit and vegetable intakes on inflammation in breast cancer survivors. We conducted a cross-sectional study by leveraging a large cohort, the Women’s Healthy Eating and Living (WHEL) study. The WHEL study comprised primarily early stage breast cancer survivors and collected blood samples, dietary intake, demographic, and health status information at baseline. We selected 2919 participants who provided baseline dietary information and had measurement of C-reactive protein (CRP), a general marker of inflammation. In our multivariable-adjusted analyses, we found that red meat intakes were positively associated, while fruit and vegetable intakes were inversely associated with CRP, blood collected in the winter season was associated with lower CRP when compared to summer, and increased smoking intensity and body mass index (BMI) as well as having cardio-metabolic conditions (such as heart disease or diabetes) were positively associated with CRP. Furthermore, we examined the joint associations of food intakes and the season of blood draw with CRP in different subgroups. We found that moderate intakes of red meat were associated with a reduction of CRP in winter but not in other seasons, increased intakes of fruit and vegetables were associated with reduced inflammation in most seasons except winter. These associations were observed in most subgroups except past smokers with pack-years ≥ 15, in whom we observed no benefit of red meat intakes in winter. Our study provides valuable evidence for considering seasonal impacts on inflammation and seasonal food impacts in different subgroups among breast cancer survivors. The results of our study are in line with one of the emphases of the current NIH 2020–2030 nutrition strategy plan—namely, pay attention to what, when, and who should eat.

Background California Proposition 56 increased cigarette excise tax by $2 per pack with equivalent increases on non-cigarette tobacco products. We estimated the changes in cigarette price, cigarette use, and non-cigarette use following the implementation of Proposition 56 in California in 2017. Methods Seven waves of Tobacco Use Supplements to the Current Population Survey (TUS-CPS) 2011–2019 data were used to obtain state-level aggregate self-reported outcomes, including cigarette price per pack, current and daily cigarette use, cigarette consumption per day, and current and daily use of non-cigarette tobacco products (hookah, pipe, cigar, and smokeless tobacco). A modified version of a synthetic control method was used to create a “synthetic” California that best resembled pre-policy sociodemographic characteristics and outcome trends in California while correcting time-invariant pre-policy differences. Various sensitivity analyses were also conducted. Results The implementation of Proposition 56 was associated with an increase in self-reported cigarette price per pack in California ($1.844, 95%CI: $0.153, $3.534; p = 0.032). No evidence suggested that Proposition 56 was associated with the changes in the prevalence of current or daily cigarette use, cigarette consumption per day, or the prevalence of current or daily use of non-cigarette tobacco products. Conclusion Most of the cigarette tax increase following Proposition 56 in California was passed on to consumers. There is a lack of evidence that the implementation of Proposition 56 was associated with the changes in the use of cigarettes and other tobacco products such as hookah, pipe, cigar, and smokeless tobacco.

Cancer survivors are at accelerated risk of aging and more susceptible to unhealthy diets and lifestyles than people without cancers. However, current dietary guidelines for cancer survivors not quite different from that for general healthy population. Further, these guidelines are not specific for cancer survivors who are past smokers. Acid-producing diet can accelerate aging and stimulate cancer development if acid-base balance is not regulated properly. Cancer survivors and past smokers have reduced capacities to adjust acid-base balance. Thus, we conducted prospective cohort analyses among 2950 early-stage breast cancer survivors who enrolled in the Women’s Healthy Eating and Living study and provided dietary information through 24-hour recalls at baseline and during follow-up. We assessed dietary acid load using two common dietary acid load scores, potential renal acid load (PRAL) score, and net endogenous acid production (NEAP) score. We assessed past smoking intensity by pack-years of smoking. After an average of 7.3 years of follow-up, there were 295 total death, and 249 breast cancer-specific death. Increased PRAL and NEAP scores were positively associated with total mortality and breast cancer-specific mortality (p for trend

Introduction This study compared tobacco use and cessation for African Americans (AA), Asians/Pacific Islanders (API), Hispanics/Latinos (H/L), American Indian/Alaskan Natives (AI/AN), and non-Hispanic Whites (NHW) in the United States to California (CA), the state with the longest continually funded tobacco control program. The purpose of this study was to identify tobacco use disparities across racial/ethnic groups across time. Methods Cigarette use prevalence (uptake and current use), consumption (mean number of cigarettes smoked per day [CPD]), and quit ratios were calculated across survey years, and trends were examined within each race/ethnic group and comparing between CA and the United States, utilizing the 1992–2019 Tobacco Use Supplements to the Current Population Survey. Results Prevalence decreased for all race/ethnic groups. Current use among CA NHW showed significant decline compared with US counterparts, whereas US H/L showed greater decline than CA counterparts. CPD decreased by approximately 30% across race/ethnic groups, with CA groups having lower numbers. The greatest decrease occurred among AA in CA (average 10.3 CPD [95% confidence interval (CI): 10.3, 12.6] in 1992/1993 to 3 CPD [95% CI: 2.4, 3.7] in 2018/2019). Quit ratios increased from 1992/1993 to 2018/2019 for CA H/L 52.4% (95% CI: 49.8, 53.0) to 59.3 (95% CI: 55.8, 62.5) and CA NHWs 61.5% (95% CI: 60.7, 61.9) to 63.8% (95% CI: 63.9, 66.9). Conclusions Although overall prevalence decreased over time for each racial/ethnic group, declines in CA outpaced the United States only for NHWs. Reductions in CPD were encouraging but the quit ratio points to the need to increase tobacco control efforts toward cessation. Implications The successes in reduced cigarette use uptake and prevalence across time for both California and the rest of the United States were observed largely among non-Hispanic White populations. Although reductions in the number of cigarettes smoked per day are a notable success, particularly among the Californian African Americans, efforts to support quitting across racial/ethnic groups, especially marginalized groups, need to be prioritized.

Background The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers. Method To investigate the “real-world” impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up. Results The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables. Conclusions This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior., Highlights • The efficacy of Graphic Warning Labels (GWLs) on Cigarette Packs has been disputed in US courts. • This trial randomly assigned US smokers to receive cigarettes in one of three study pack groups. • Study packs were:1-Blank Pack devoid of tobacco imagery; 2-GWL Pack; 3- Standard US pack. • We assessed smoking cognitions and behavior pre-randomization and during the intervention. • Smoking behavior is validated by saliva cotinine.

Reducing tobacco use is an important public health objective. It is the largest preventable cause of death and disease, yet inequalities remain. This study examines combined educational and racial/ethnic disparities in the United States related to cigarette smoking for the three largest racial/ethnic groups (African Americans, Hispanics/Latinos, and non-Hispanic Whites). Data included nine Tobacco Use Supplements to the Current Population Surveys (TUS-CPS) conducted in the United States from 1992/1993-2018 for four smoking metrics: ever smoking rates, current smoking rates, consumption (cigarettes per day), and quit ratios. Across all TUS-CPS samples, there were 9.5% African Americans, 8.8% Hispanics/Latinos, and 81.8% non-Hispanic Whites who completed surveys. Findings revealed that lower educational attainment was associated with increased ever and current smoking prevalence over time across all racial/ethnic groups, and education-level disparities within each race/ethnicity widened over time. Disparities in ever and current smoking rates between the lowest and highest categories of educational attainment (less than a high school education vs. completion of college) were larger for African Americans and non-Hispanic Whites than Hispanics/Latinos. Non-Hispanic Whites had the highest cigarette consumption across all education levels over time. College graduates had the highest quit ratios for all racial/ethnic groups from 1992 to 2018, with quit ratios significantly increasing for Hispanics/Latinos and non-Hispanic Whites, but not African Americans. In conclusion, educational disparities in smoking have worsened over time, especially among African Americans and Hispanics/Latinos. Targeted tobacco control efforts could help reduce these disparities to meet public health objectives, although racial/ethnic disparities may persist regardless of educational attainment.

The incidence of depression is two-to-three times higher in cancer survivors than the general population. Acid-producing diets may play important roles in the development of depression. Cancer survivors are more susceptible to acid-producing diets, yet few prospective studies have investigated the association of acid-producing diets with depression among breast cancer survivors. We leveraged a large cohort of 2975 early stage breast cancer survivors, which collected detailed dietary data via 24-h recalls. Potential renal acid load (PRAL) and net endogenous acid production (NEAP), two commonly used dietary acid load scores, were used to estimate acid-producing diets. Intakes of PRAL and NEAP were assessed at baseline and years one and four. Increased PRAL and NEAP were each independently associated with increased depression in the longitudinal analyses, after adjusting for covariates. The magnitude of the associations was stronger for PRAL than NEAP. Women with the highest quartile intakes of PRAL had 1.34 (95% CI 1.11&ndash, 1.62) times the risk of depression compared to women with the lowest quartile. Furthermore, we also observed a joint impact of PRAL and younger age on depression, as well as a joint impact of PRAL and physical activity on depression. Decreasing the consumption of acid-producing diets may be a novel and practical strategy for reducing depressive symptoms among breast cancer survivors, especially those who are younger and have a sedentary lifestyle.

The objective of this study is to assess the impact of the California 1995 Smoke-Free Workplace Act (SFWA) on cigarette smoking prevalence in the population. We used survey responses related to cigarette smoking from the Behavioral Risk Factor Surveillance System (BRFSS) from 1990 to 2000. We utilize a synthetic control method which creates a weighted combination of control states to produce a single 'synthetic' control group to best approximate the counterfactual trend in California in the absence of the SFWA. Variables known to be associated with smoking were included to weight each state in the pre-intervention period as medians by state and included: distribution of race/ethnicity (White, Black, Asian, Hispanic), sex (Male/Female), marital status (married/unmarried), high school education (yes/no) and employment status (yes/no). We find evidence that there was a small decrease in population smoking prevalence in California in the year immediately following the SFWA, but this effect was not sustained beyond 1995. We hypothesize that one potential explanation for the lack of prolonged impact on population smoking prevalence is that there are sustained effects from the passage of 1989 California Proposition 99, which enacted an excise tax on tobacco products. Understanding how workplace smoking ban legislation affects population smoking behaviors is necessary to better inform policy development in other states and counties and to improve existing policies. Future work should consider the impact of smoking legislation impacts subgroups of the population by socioeconomic status, occupation or race/ethnicity.

Introduction Cigarette advertising is a causal agent of smoking uptake among young people. Although prior research links ad receptivity to tobacco product interest and use, little is known regarding the specific advertising tactics associated with increased product appeal among young people. Methods A national sample of 13–20 year-olds (N = 3688, youth) and 21–24 year-olds (N = 1556, young adults) in the US participated in an online survey in 2017 (mean age 18.1 years). The majority (72.0%) of youth and nearly half (44.8%) of young adults were never smokers. Participants were shown a cigarette ad, randomly assigned from a pool of 50 advertisements, and reported how much they liked the ad, and were curious about and interested in using the advertised product. All 50 advertisements were content analyzed for a variety of features. Data from the survey and content analysis were merged and mixed effects analyses used to identify the features associated with increased liking, curiosity, and interest in using, referred to collectively as product appeal. Results Presence of a sweepstakes offer was associated with increased liking, curiosity and interest among youth and curiosity and interest among young adults. Outdoors settings, flora imagery, natural descriptors, and environmental themes were associated with increased appeal. Price reductions (eg, coupons) were associated with decreased appeal among youth. Conclusions This study identified several advertising tactics associated with increased appeal among youth and young adults. If additional research confirms these findings, the U.S. Food and Drug Association should consider restricting use of these tactics in tobacco advertising. Implications This study's findings provide insight into features of cigarette ads that appeal to youth and young adults. Overall, the presence of sweepstakes appealed to youth and young adults and outdoors and environmental themes were particularly appealing to young adults. Such tactics could serve to further brand engagement, improve brand image and lead to initiation or escalation of use. If confirmatory studies further demonstrate the effects of the tactics identified in this study on youth product appeal, U.S. Food and Drug Administration should consider using its authority to restrict the use of youth-appealing tactics.

Current dietary guidelines do not consider cancer survivors&rsquo, and past smokers&rsquo, low capacity to regulate their acid&ndash, base balance. People with a low capacity to regulate their acid&ndash, base balance are more susceptible to acid-producing diets. We studied a cohort of 2950 early stage breast cancer survivors who provided dietary information at baseline and during follow-up. We assessed the intakes of acid-producing diets via two commonly used dietary acid load scores: potential renal acid load (PRAL) and net endogenous acid production (NEAP). We assessed past smoking intensity by pack-years of smoking. After an average of 7.3 years of follow-up, there were 295 total deaths, 249 breast cancer-specific deaths, and 490 cases of recurrent breast cancer. Increased intakes of dietary acid load and pack-years of smoking were each independently and jointly associated with increased total mortality and breast cancer-specific mortality, tests for trends and overall associations were statistically significant for NEAP and marginally significant for PRAL. Compared to women in the lowest tertile of NEAP and pack-year of smoking = 0, women in the highest tertile of NEAP and pack-years of smoking &gt, 15 had the greatest increased risk of total mortality (HR = 3.23, 95%CI 1.99&ndash, 5.26). Further, dietary acid scores were associated with increased breast cancer recurrence among women with pack-years of smoking &gt, 0 but not in those with pack-years of smoking = 0 (p values for interactions &lt, 0.05). Our study provides valuable evidence for adding dietary acid load scores to dietary guidelines for breast cancer survivors and developing specific guidelines for past smokers among these survivors.

Objective We explored the association of smoking and GBS colonization among women delivering neonates 35 weeks+. Design Retrospective chart review Setting A large tertiary care inner-city hospital in the southern United States Population/Sample 803 women pregnant women of term or near term neonates Methods The electronic health records of a convenience sample. Main Outcome Measures The outcome variable of interest was maternal GBS colonization. The primary independent variable of interest was tobacco smoking during pregnancy. Results The prevalence of maternal GBS colonization was 32% among the study population. In the univariate analyses, factors associated with maternal GBS colonization were tobacco smoking during pregnancy (P of trend

BackgroundMore smokers report using e-cigarettes to help them quit than FDA-approved pharmacotherapy.ObjectiveTo assess the association of e-cigarettes with future abstinence from cigarette and tobacco use.DesignCohort study of US sample, with annual follow-up.ParticipantsUS adult (ages 18+) daily cigarette smokers identified at Wave 1 (W1; 2013-14) of the PATH Study, who reported a quit attempt before W2 and completed W3 (n = 2443).ExposuresUse of e-cigarettes, pharmacotherapy (including nicotine replacement therapy), or no product for last quit attempt (LQA), and current daily e-cigarette use at W2.AnalysisPropensity score matching (PSM) of groups using different methods to quit.Outcome measures12+ months abstinence at W3 from cigarettes and from all tobacco (including e-cigarettes). 30+ days abstinence at W3 was a secondary outcome.ResultsAmong daily smokers with an LQA, 23.5% used e-cigarettes, 19.3% used pharmacotherapy only (including NRT) and 57.2% used no product. Cigarette abstinence for 12+ months at W3 was ~10% in each group. Half of the cigarette abstainers in the e-cigarette group were using e-cigarettes at W3. Different methods to help quitting had statistically comparable 12+ month cigarette abstinence at W3 (e-cigarettes vs no product: Risk Difference (RD) = 0.01, 95% CI: -0.04 to 0.06; e-cigarettes vs pharmacotherapy: RD = 0.02, 95% CI:-0.04 to 0.09). Likewise, daily e-cigarette users at W2 did not show a cessation benefit over comparable no-e-cigarette users and this finding was robust to sensitivity analyses. Abstinence for 30+ days at W3 was also similar across products.LimitationsThe frequency of e-cigarette use during the LQA was not assessed, nor was it possible to assess continuous abstinence from the LQA.ConclusionAmong US daily smokers who quit cigarettes in 2014-15, use of e-cigarettes in that attempt compared to approved cessation aids or no products showed similar abstinence rates 1-2 years later.

IMPORTANCE: Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. OBJECTIVE: To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: The Men’s Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those

Background and hypothesisThe role of smoking as a risk factor for group B streptococcal (GBS) colonization in women during pregnancy has not been previously adequately explored. We hypothesized that women of term or near term neonates who smoked during pregnancy were more likely to have GBS colonization than their non-smoking counterparts.MethodsThe electronic health records (EHRs) of a convenience sample of women delivering in an inner-city university tertiary care center were reviewed. The outcome variable of interest was maternal GBS colonization during pregnancy. The primary independent variable of interest was tobacco smoking during pregnancy, determined from the EHRs by the number of cigarettes smoked during gestation. Descriptive statistics were conducted and categorical data were compared by the Fischer's exact test. Multiple logistic regression analysis was further conducted to determine the independent impact of tobacco smoke exposure on GBS colonization.ResultsThe prevalence of maternal GBS colonization was 35% among the study population. In the univariate analyses, factors associated with maternal GBS colonization were tobacco smoking during pregnancy (P of trend ConclusionThe prevalence of GBS colonization in this institution was consistent with recent national rates. Smoking and maternal age were identified as two independent risk factors for GBS colonization during pregnancy. Further studies are needed to confirm these findings.

IntroductionRemoval of tobacco industry branding from cigarette packs may reduce their appeal. Adding graphic warning labels (GWLs) should enhance this effect. We investigate whether willingness to pay for various packaging designs changes after 3 months’ use of: (1) US branded packs without GWLs (US), (2) non-branded packs without GWLs (Blank), and (3) rotating non-branded packs with GWLs (gangrene; throat cancer; neonatal baby) covering >75% of pack (GWL).MethodsCalifornian adult daily smokers not planning to quit (n=287; 56% female; mean age=39.6) completed a discrete choice purchase task before and after 3 months’ experience using one of three packaging options. Conjoint analysis and pre-post modelling evaluated the change in importance of pack attributes and willingness to pay for US, Blank or GWL (blindness; teeth; gangrene) pack designs.ResultsPrice determined ~70% of purchase choices, while pack design determined ~22%. Irrespective of intervention arm, US packaging generated appeal valuations compared with Blank packaging, while GWLs consistently provoked strong aversive valuations at baseline and follow-up. Compared with the US pack arm, using GWL packs for 3 months decreased willingness to pay for US packaging (β=−$0.38, 95% CI −0.76 to 0.00). Wear-out effects were detected in the discount needed to willingly purchase the gangrene-GWL pack (β=$0.49, 95% CI 0.16 to 0.82) and Blank pack (β=$0.42, 95% CI 0.09 to 0.74) but not for GWLs (blindness, teeth) not used in trial.ConclusionCompared with US branded packs, the negative valuation of non-branded GWL packs attenuates with even 3 months’ use but does not generalise to non-used GWLs. This suggests that GWLs should be regularly refreshed. The appeal valuation of industry imagery suggests that the US plan to retain such imagery on packs may ameliorate the effect of GWLs.

Author(s): Leas, Eric C; Pierce, John P; Benmarhnia, Tarik; White, Martha M; Noble, Madison L; Trinidad, Dennis R; Strong, David R | Abstract: Background:Despite strong efficacy in randomized trials, the population effectiveness of pharmaceutical aids in long-term smoking cessation is lacking, possibly because of confounding (factors that are associated with both pharmaceutical aid use and difficulty quitting). Matching techniques in longitudinal studies can remove this confounding bias. Methods:Using the nationally representative Tobacco Use Supplement to the Current Population Survey (TUS-CPS), we assessed the effectiveness of medications to aid quitting among baseline adult smokers who attempted to quit prior to one year of follow-up in two longitudinal studies: 2002-2003 and 2010-2011. Pharmaceutical aid users and nonusers with complete data (n = 2129) were matched using propensity score models with 12 potential confounders (age, sex, race-ethnicity, education, smoking intensity, nicotine dependence, previous quit history, self-efficacy to quit, smoke-free homes, survey year, and cessation aid use). Using matched data sets, logistic regression models were fit to assess whether use of any individual pharmaceutical aid increased the proportion of patients who were abstinent for 30 days or more at follow-up. Results:Propensity score matching markedly improved balance on the potential confounders between the pharmaceutical aid use groups. Using matched samples to provide a balanced comparison, there was no evidence that use of varenicline (adjusted risk difference [aRD] = 0.01, 95% confidence interval [CI] = -0.07 to 0.11), bupropion (aRD = 0.02, 95% CI = -0.04 to 0.09), or nicotine replacement (aRD = 0.01, 95% CI = -0.03 to 0.06) increased the probability of 30 days or more smoking abstinence at one-year follow-up. Conclusions:The lack of effectiveness of pharmaceutical aids in increasing long-term cessation in population samples is not an artifact caused by confounded analyses. A possible explanation is that counseling and support interventions provided in efficacy trials are rarely delivered in the general population.

The role of tobacco marketing in tobacco use, particularly among the vulnerable ethnic and socioeconomic sub-populations is a regulatory priority of the U.S. Food and Drug Administration. There currently exist both ethnic and socioeconomic disparities in the use of tobacco products. Monitoring such inequalities in exposure to tobacco marketing is essential to inform tobacco regulatory policy that may reduce known tobacco-related health disparities. We use data from the Population Assessment of Tobacco and Health (PATH) Wave 1 youth survey to examine (1) recalled exposure to and liking of tobacco marketing for cigarettes, non-large cigars, and e-cigarettes, (2) self-reported exposure to specific tobacco marketing tactics, namely coupons, sweepstakes, and free samples, and (3) self-reported impact of tobacco marketing and promotions on product use. Findings indicate that African Americans and those of lower SES were more likely to recall having seen cigarette and non-large cigar ads. Reported exposure to coupons, sweepstakes and free samples also varied ethnically and socioeconomically. African Americans and those of lower SES were more likely than other respondents to report that marketing and promotions as played a role in their tobacco product use. Better understanding of communication inequalities and their influence on product use is needed to inform tobacco regulatory action that may reduce tobacco company efforts to target vulnerable groups. Tobacco education communication campaigns focusing on disproportionately affected groups could help counter the effects of targeted industry marketing.

BackgroundIn the 1990s, California led the USA in state-level tobacco control strategies. However, after 2000, California lost ground on cigarette taxes, although it maintained higher levels of smoke-free homes among smokers.MethodsTrends in per capita cigarette consumption were assessed through taxed sales data and from self-report in repeated national cross-sectional surveys. Linear regressions identified changes in trends after year 2000 separately for California and the rest of the USA. Using data from each state, a linear regression tested the association between different tobacco control strategies and per capita consumption. Change in self-reported per capita consumption was partitioned into contributions associated with initiation, quitting and reduction in cigarette consumption level.ResultsBoth taxed cigarette sales and per capita consumption declined rapidly in the USA from 1985 to 2015. Declines were particularly fast in California before 2000 but slowed thereafter. In 2014, per capita consumption in California was 29.4 packs/adult/year, but 90% higher in the rest of the USA. Modelling state-level data, every $1 increase in cigarette taxes reduced consumption by 4.8 (95% CI 2.9 to 6.8) packs/adult/year. Every 5% increase in the proportion of smokers with smoke-free homes reduced consumption by 8.0 (95% CI 7.0 to 8.9) packs/adult/year. The different patterns in California and the rest of the USA are at least partially explained by these two variables. The slow down in per capita consumption in California can be attributed to changes in initiation, quitting and especially smokers reducing their consumption level.ConclusionsTobacco control strategies need to be continually updated to maintain momentum towards a smoke-free society.

PurposeTo examine whether baseline sleep duration or changes in sleep duration are associated with breast cancer prognosis among early-stage breast cancer survivors in the multi-center Women's Healthy Eating and Living Study.MethodsData were collected from 1995 to 2010. Analysis included 3047 women. Sleep duration was self-reported at baseline and follow-up intervals. Cox proportional hazard models were used to investigate whether baseline sleep duration was associated with breast cancer recurrence, breast cancer-specific mortality, and all-cause mortality. Time-varying models investigated whether changes in sleep duration were associated with breast cancer prognosis.ResultsCompared to women who slept 7-8h/night at baseline, sleeping ≥9h/night was associated with a 48% increased risk of breast cancer recurrence (Hazard ratio [HR] 1.48, 95% Confidence interval [CI] 1.01, 2.00), a 52% increased risk of breast cancer-specific mortality (HR 1.52, 95% CI 1.09, 2.13), and a 43% greater risk of all-cause mortality (HR 1.43, 95% CI 1.07, 1.92). Time-varying models showed analogous increased risk in those who inconsistently slept ≥9h/night (all P&nbsp

Author(s): Pierce, John P; Leas, Eric C; Benmarhnia, Tarik; McMenamin, Sara B; Strong, David R; Chen, Ruifeng; Messer, Karen

Objectives To describe advertising tactics of cigarette, e-cigarette, little cigar/cigarillo and smokeless tobacco manufacturers. Methods We conducted a content analysis of tobacco 827 ads run in the US in 2016. Ads were double coded by trained coders across ten domains: promotions, web/social media presence, use cues, warnings and disclaimers, descriptors, claims, activities, setting, imagery, and themes. Results Cigarette ads relied on promotional tactics like discounts and sweepstakes and featured links to websites and mobile apps, all of which can increase brand loyalty and customer engagement. E-cigarette ads used tactics that appear to target new consumers, such as highlighting the product's qualities and modeling product use. Little cigar/cigarillo ads often positioned the product as social and featured music, urban and nightlife settings. Smokeless tobacco ads frequently featured themes, activities and settings stereotypically thought of as masculine. Conclusions The tactics used to advertise tobacco products can help generate new consumers, encourage product/brand switching, and escalate use among current users. Understanding how different products are advertised can inform the Food and Drug Administration's regulatory efforts, and tobacco counter-marketing campaigns.

Background: There is substantial variation in breast cancer survival rates, even among patients with similar clinical and genomic profiles. New biomarkers are needed to improve risk stratification and inform treatment options. Our aim was to identify novel miRNAs associated with breast cancer survival and quantify their prognostic value after adjusting for established clinical factors and genomic markers. Methods: Using the Women's Healthy Eating and Living (WHEL) breast cancer cohort with >15 years of follow-up and archived tumor specimens, we assayed PAM50 mRNAs and 25 miRNAs using the Nanostring nCounter platform. Results: We obtained high-quality reads on 1,253 samples (75% of available specimens) and used an existing research-use algorithm to ascertain PAM50 subtypes and risk scores (ROR-PT). We identified miRNAs significantly associated with breast cancer outcomes and then tested these in independent TCGA samples. miRNAs that were also prognostic in TCGA samples were further evaluated in multiple regression Cox models. We also used penalized regression for unbiased discovery. Conclusions: Two miRNAs, 210 and 29c, were associated with breast cancer outcomes in the WHEL and TCGA studies and further improved risk stratification within PAM50 risk groups: 10-year survival was 62% in the node-negative high miR-210-high ROR-PT group versus 75% in the low miR-210- high ROR-PT group. Similar results were obtained for miR-29c. We identified three additional miRNAs, 187-3p, 143-3p, and 205-5p, via penalized regression. Impact: Our findings suggest that miRNAs might be prognostic for long-term breast cancer survival and might improve risk stratification. Further research to incorporate miRNAs into existing clinicogenomic signatures is needed.