Consolidated guidance for behavioral intervention pilot and feasibility studies.

BACKGROUND: In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. METHODS: To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. RESULTS: A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. CONCLUSION: We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

Prevalence and perceptions of flavour capsule cigarettes among adults who smoke in Brazil, Japan, Republic of Korea, Malaysia and Mexico: findings from the ITC surveys.

INTRODUCTION: The global market of flavour capsule cigarettes (FCCs) has grown significantly over the past decade; however, prevalence data exist for only a few countries. This study examined prevalence and perceptions of FCCs among adults who smoke across five countries. METHODS: Cross-sectional data among adults who smoked cigarettes came from the International Tobacco Control Policy Evaluation Project Surveys-Brazil (2016/2017), Japan (2021), Republic of Korea (2021), Malaysia (2020) and Mexico (2021). FCCs use was measured based on reporting one's usual/current brand or favourite variety has flavour capsule(s). Perceptions of the harmfulness of one's usual brand versus other brands were compared between those who used capsules versus no capsules. Adjusted logistic regression models examined correlates of FCC use. RESULTS: There were substantial differences in the prevalence of FCC use among adults who smoke across the five countries: Mexico (50.3% in 2021), Republic of Korea (31.8% in 2021), Malaysia (26.5% in 2020), Japan (21.6% in 2021) and Brazil (6.7% in 2016/2017). Correlates of FCC use varied across countries. Capsule use was positively associated with being female in Japan and Mexico, younger age in Japan, Republic of Korea and Malaysia, high education in Brazil, Japan and Mexico, non-daily smoking in Republic of Korea, and having plans to quit in Japan and Republic of Korea. There was no consistent pattern of consumer perceptions of brand harmfulness. CONCLUSION: Our study documented the high prevalence of FCCs in some countries, pointing to the need to develop and implement regulatory strategies to control these attractive products.

Changes in substance use among adolescents before and during the COVID-19 pandemic in Guatemala.

Objectives: Due to the COVID-19 pandemic, on March 16th, schools had to be closed in Guatemala and went to online teaching. We sought to analyze the change in substance use among high school students in Guatemala associated with the lockdown. Methods: Data from two surveys (2019, n=2096, and 2020, n=1606) of a student cohort in private high schools in Guatemala City was used. Logistic models for past 30-day cigarette, e-cigarette, marijuana, and alcohol (including binge drinking) were used, regressing these on survey wave, while adjusting for sex, scholastic performance, high school year of student, parental education, substance use, and household member tobacco use. Results: Prevalence declined for smoking (10% to 3%, p<0.001), e-cigarette (31% to 14%, p<0.001), marijuana (4.3% to 1.9%, p<0.001), and alcohol use (47% to 38.5%, p<0.001), and binge drinking (24% to 13%, p<0.001). Adjusted models showed wave 2 associated with lower odds of using cigarettes (AOR=0.44, 95%CI=0.32-0.62), e-cigarettes (AOR=0.41, 95% CI=0.35-0.49, p<0.001), and binge drinking (AOR=0.73, 95%CI=0.59-0.89; p=0.002). Conclusion: Among Guatemalan adolescents, COVID-19 restrictions were associated with a significant decrease in smoking, e-cigarette use, and binge drinking.

Are the Risk of Generalizability Biases Generalizable? A Meta-Epidemiological Study.

Background: Preliminary studies (e.g., pilot/feasibility studies) can result in misleading evidence that an intervention is ready to be evaluated in a large-scale trial when it is not. Risk of Generalizability Biases (RGBs, a set of external validity biases) represent study features that influence estimates of effectiveness, often inflating estimates in preliminary studies which are not replicated in larger-scale trials. While RGBs have been empirically established in interventions targeting obesity, the extent to which RGBs generalize to other health areas is unknown. Understanding the relevance of RGBs across health behavior intervention research can inform organized efforts to reduce their prevalence. Purpose: The purpose of our study was to examine whether RGBs generalize outside of obesity-related interventions. Methods: A systematic review identified health behavior interventions across four behaviors unrelated to obesity that follow a similar intervention development framework of preliminary studies informing larger-scale trials (i.e., tobacco use disorder, alcohol use disorder, interpersonal violence, and behaviors related to increased sexually transmitted infections). To be included, published interventions had to be tested in a preliminary study followed by testing in a larger trial (the two studies thus comprising a study pair). We extracted health-related outcomes and coded the presence/absence of RGBs. We used meta-regression models to estimate the impact of RGBs on the change in standardized mean difference (ΔSMD) between the preliminary study and larger trial. Results: We identified sixty-nine study pairs, of which forty-seven were eligible for inclusion in the analysis (k = 156 effects), with RGBs identified for each behavior. For pairs where the RGB was present in the preliminary study but removed in the larger trial the treatment effect decreased by an average of ΔSMD=-0.38 (range - 0.69 to -0.21). This provides evidence of larger drop in effectiveness for studies containing RGBs relative to study pairs with no RGBs present (treatment effect decreased by an average of ΔSMD =-0.24, range - 0.19 to -0.27). Conclusion: RGBs may be associated with higher effect estimates across diverse areas of health intervention research. These findings suggest commonalities shared across health behavior intervention fields may facilitate introduction of RGBs within preliminary studies, rather than RGBs being isolated to a single health behavior field.

Prevalence and correlates of flavored novel oral nicotine product use among a national sample of youth.

BACKGROUND: Flavored novel oral nicotine products (ONP), such as pouches, gum, lozenges, tablets, and gummies, have recently entered the US market but have not been authorized for smoking cessation. This study assessed the prevalence and correlates of ONPs in a national sample of youth who smoked little filtered cigars or cigarillos (LCCs) or were susceptible to LCCs. METHODS: We conducted a national online survey from September-October 2022, as part of a study to develop cigar warnings among youth. Those aged 15-20 years old who reported using (ever or current) or susceptibility to little filtered cigars or cigarillos (LCCs) were eligible. Descriptive statistics and chi-square analyses assessed the prevalence of flavored ONP use and associations with other past 30-day tobacco product use and participant characteristics. RESULTS: Approximately one-fifth (17.1 %) of the sample (n = 680) reported past month flavored ONP use. Any past month tobacco use was correlated with past month flavored ONP use (ps < 0.001), increasing from 17.1 % in the overall sample to 26.8 % among those reporting e-cigarette use, 41.4 % (LCCs), 47.8 % (waterpipe tobacco), 61.8 % (large cigars), and 69.1 % (smokeless tobacco). The number of products used in the past month was significantly associated with higher odds of ONPs in the past month in a multivariable logistic regression model (aOR2.26; 95 % CI: 1.92, 2.65). DISCUSSION: Almost one-fifth of participants who use or are susceptible to cigar use in our national sample of youth use ONPs. Dual/poly use of other tobacco products and ONPs among youth suggests that many of these youth may be addicted to nicotine. Additional surveillance and regulation of ONPs that exhibit enticing characteristics, such as flavors, kid-friendly formulations, and targeted marketing/branding may be needed.

Early Real-World Performance of the MiniMed™ 780G Advanced Hybrid Closed-Loop System and Recommended Settings Use in the United States.

Background: The MiniMed™ 780G system (MM780G) with Guardian™ 4 sensor includes a 100 mg/dL glucose target (GT) and automated insulin corrections up to every 5 min and was recently approved for use in the United States. In the present study, early real-world MM780G performance and the use of recommended system settings (100 mg/dL GT with an active insulin time of 2 h), by individuals with type 1 diabetes, were evaluated. Methods: CareLink™ personal data uploaded between the launch of the MM780G to August 22, 2023 were aggregated and underwent retrospective analysis (based on user consent) and if users had ≥10 days of continuous glucose monitoring (CGM) data. The 24-h day CGM metrics, including mean glucose, percentage of time spent in (%TIR), above (%TAR), and below (%TBR) target range (70-180 mg/dL), in addition to delivered insulin and closed-loop (CL) exits, were compared between an overall group (n = 7499) and individuals who used recommended settings (each, for >95% of the time). An analysis of the same metrics for MiniMed™ 770G system (MM770G) users (n = 3851) who upgraded to the MM780G was also conducted (paired t-test or Wilcoxon signed-rank test, P < 0.05 considered statistically significant). Results: For MM780G users, CGM use, and time in CL were >90% and all MM780G CGM metrics exceeded consensus-recommended goals. With recommended settings (22% of all users), mean %TIR and %TITR (70-140 mg/dL) were 81.4% and 56.4%, respectively. For individuals who upgraded from the MM770G, %TIR and %TITR increased from 73.2% to 78.3% and 45.8% to 52.6%, respectively, while %TAR reduced from 25.1% to 20.2% (P < 0.001, for all three). CL exits/week averaged <1, for all MM780G users. Conclusions: Early real-world MM780G use in the United States demonstrated a high percentage of time in range with low time above and below range. These outcomes are similar to those observed for real-world MM780G use in other countries.

Factors Associated With the Changes in Smoking and Electronic cigarette use in Adolescents During the COVID-19 Pandemic: A Longitudinal Analysis.

PURPOSE: Explore the factors associated with the changes in smoking and electronic cigarette (e-cigarette) use and susceptibility among adolescents during the COVID-19 pandemic. METHODS: We surveyed a cohort of students (7th-12th grade) from private schools in Guatemala. Baseline (May-September 2019) was conducted in-person and follow-up (June-November 2020) online during the lockdown. Separate Generalized Estimating Equations logistic models regressed current smoking (n = 3,729), current e-cigarette use (n = 3,729), smoking susceptibility among never-smokers (n = 2,596), and susceptibility to e-cigarette use among never-users (n = 1,597) on online ad exposure, visiting stores, social network smoking/e-cigarette use, substance use (alcohol, marihuana, and cigarette or e-cigarette), perceived harm of using cigarettes/e-cigarettes, sociodemographic characteristics, and survey wave. Interactions were assessed between time and ad exposures, friends smoking and e-cigarette use. RESULTS: Frequency of store visits, exposure to online ads, and the use of cigarette and e-cigarette lowered at follow-up. Online e-cigarette ads, having family and friends who smoke, and current e-cigarette use increased the likelihood of being a current smoker. Frequent exposure to online e-cigarette ads, having family who use e-cigarettes, and being a current smoker were associated with higher likelihood of current e-cigarette use. Exposure to either online ads or having friends that smoke or use e-cigarettes, increased susceptibility to using either product. Interaction results showed that high exposure to online e-cigarette ads overtime increased the susceptibility to use e-cigarettes. DISCUSSION: Exposure to online ads and friends and family cigarette and e-cigarette use increased adolescent consumption and susceptibility during the pandemic.

Chapter 4: Summary and a Patient Perspective on Living with Heart Failure.

This chapter is intended to provide a plain language overview of heart failure suitable for non-medical professionals, including patients and caregivers, and a patient perspective on living with heart failure.

Nicotine beliefs and perceptions of low nicotine labels and mitigating statements among people who do and do not smoke: a cross-sectional study from Aotearoa New Zealand.

BACKGROUND: Aotearoa New Zealand proposed a new maximum nicotine content of 0.8 mg/g for smoked tobacco products, although the new government plans to repeal this legislation. Requiring 'Very low nicotine' (VLN) messages on cigarettes meeting this standard may reinforce misperceptions that they are less harmful than cigarettes currently sold. METHODS: To explore knowledge of nicotine and very low nicotine cigarettes (VLNCs), and perceptions of cigarette packs featuring different low nicotine messages (eg, 'Very low nicotine') and mitigating statements (eg, 'No cigarettes are safe'), we surveyed 354 people who smoked, 142 who formerly smoked, and 214 people who had never smoked regularly. RESULTS: Around half of all respondents believed VLNCs were less harmful than regular cigarettes and around two-thirds incorrectly thought nicotine causes most of the related health problems resulting from smoking. Nearly a third thought VLNCs would be less harmful than regular cigarettes; 34% believed they would be just as harmful. Mitigating statements did not affect perceptions of people who smoked, although people who formerly, or who had never smoked regularly, perceived mitigating statements referring to poisons and cancer as significantly more likely than the VLN message to discourage smoking. CONCLUSIONS: Misunderstanding of VLNCs as less harmful than regular cigarettes is widespread; VLN messages may reinforce this misperception, which mitigating statements did not correct among people who smoke. As an alternative to VLN messages, policy makers could consider introducing VLNCs on a specified date and developing public information campaigns; these measures would avoid phase-in confusion and obviate the need for VLN messaging.

Assessing transnational spillover effects of Mexico's front-of-package nutritional labeling system among Mexican Americans in the US.

OBJECTIVE: In 2020, Mexico implemented innovative front-of-package nutrition warning labels (FoPWLs) for packaged foods to increase the salience and understanding of nutrition information. This study evaluated Mexican Americans' self-reported exposure to Mexican FoPWLs and self-reported effects of FoPWLs on purchasing behavior. METHODS: The 2021 International Food Policy Study surveyed online panels of adult Mexican Americans in the US (n = 3361) to self-report on buying food at Mexican-oriented stores, noticing Mexican FoPWLs, and being influenced by FoPWLs to purchase less of eight different unhealthy foods (each assessed separately). After recoding the frequency of buying foods in Mexican stores and noticing FoPWLs (i.e., "often" or "very often" vs. less often), logistic models regressed these outcomes on sociodemographics, adjusting for post-stratification weights. RESULTS: Most participants (88.0%) purchased foods in Mexican stores. Of these, 64.1% reported noticing FoPWLs, among whom many reported that FoPWLs influenced them to buy fewer unhealthy foods (range = 32% [snacks like chips] - 44% [colas]). Participants were more likely to buy foods in Mexican stores and notice FoPWLs if they were younger, had ≥two children at home vs no children (AOR = 1.40, 95%CI = 1.15-1.71; AOR = 1.37, 95%CI = 1.03-1.80, respectively), and more frequently used Spanish (AOR = 1.91, 95%CI = 1.77-2.07; AOR = 1.87, 95%CI = 1.69-2.07). Also, high vs. low education (AOR = 1.51, 95%CI = 1.17-1.94) and higher income adequacy (AOR = 1.37, 95%CI = 1.25-1.51) were positively associated with noticing FoPWLs. Being female and more frequent Spanish use were consistently associated with reporting purchase of fewer unhealthy foods because of FoPWLs. CONCLUSIONS: Many Mexican Americans report both exposure to Mexican FOPWLs and reducing purchases of unhealthy foods because of them.

Smoking Dependence, Time-Discounting, and Sustained Cessation Behavior: A Longitudinal Study of Predominantly Light Smokers.

INTRODUCTION: This study aimed to assess whether two established psychosocial predictors of smoking abstinence, nicotine dependence and time-discounting, also apply to a population of predominantly cigarette light smokers, which is the dominant pattern of smoking in countries like Mexico. Relatively infrequent smoking is increasingly prevalent, yet still harmful, making it important to understand the predictors of cessation in this population. AIMS AND METHODS: Mexican adult smokers recruited from an online consumer panel were surveyed every 4 months between November 2018 and July 2020. We considered respondents who reported a quit attempt in between surveys (n = 1288). Dependence was measured with a 10-item version of the Wisconsin Inventory of Smoking Dependence Motives (WISDM). Time-discounting was assessed with five branching questions about hypothetical reward scenarios. Logistic models regressed sustained quit attempts (≥30 days of abstinence) at time t + 1 on study variables at time t. RESULTS: We found strong interitem reliability (α = 0.92) and intraindividual consistency of our brief WISDM (ρ = 0.68), but moderate intraindividual consistency of the time-discounting measure (ρ = 0.48). Forty-eight percent of the sample reported sustained quit attempts, and 79% were non-daily or light daily smokers (≤5 cigarettes per day). Smokers with higher WISDM-10 had lower odds of sustained quitting and this result remained when controlling for smoking frequency and the Heaviness of Smoking Index (adjusted odds ratio [AOR] = 0.768). Time-discounting was unassociated with sustained quitting. CONCLUSIONS: Our findings suggest that a brief, 10-item multidimensional measure of dependence is useful for predicting sustained quitting in a context of relatively light smoking; time-discounting appears less relevant, although our results are not conclusive because of the low test-retest reliability of our measure. IMPLICATIONS: Given the increase in non-daily and light daily cigarette smoking in many countries, including in Mexico, and the health risks this still poses, it is important to understand the predictors of cessation among relatively light smokers. The WISDM-10 multidimensional measure seems to be a good instrument to assess dependence and predict successful quitting in this population, and possibly more appropriate than physical dependence measures. As such, it could help design and target more suitable cessation treatments for non-daily and daily light cigarette smokers. While this study did not find time-discounting to be a relevant predictor of smoking abstinence, future studies should explore other measures.

Reactions to Messages About a Nicotine Reduction Policy: A Focus Group Study Among People Who Use Little Cigars and Cigarillos.

INTRODUCTION: The U.S. Food and Drug Administration (FDA) has proposed rulemaking to reduce the nicotine content in cigarettes and other combusted tobacco products to non-addictive levels. This qualitative study documents reactions to messages communicating this policy among people who use little cigars and cigarillos (LCCs). AIMS AND METHODS: We conducted eight focus groups with participants from four populations with the highest prevalence of cigar use (African American males and females, white males and females). Participants described their reactions to eight messages about the policy: Three messages about the equal risk of LCCs with regular and low nicotine levels; three quit efficacy messages about low nicotine LCCs being easier to quit; one "compensation" message to correct misperceptions about the policy causing people to smoke more to get desired nicotine; and one message about using alternative nicotine sources (eg, e-cigarettes). RESULTS: Participants perceived risk messages as the most motivating to quit, whereas efficacy messages made some participants feel that the policy would cause former users of LCCs to relapse. Many participants expressed favorable responses to the compensation message. The message about using alternative nicotine sources sparked intense responses, with many participants expressing outrage and mistrust of the message. Participants' beliefs that they were not addicted to LCCs dampened their perceptions of the effectiveness of the policy. CONCLUSIONS: Perceptions of the addictiveness and relative harms of LCCS influenced responses to policy messages. The FDA should consider using different messages to communicate with people who use LCCs because they perceive LCCs as different from cigarettes. IMPLICATIONS: This is the first study to document affective and cognitive responses to the FDA's reduced nicotine policy among people who use LCCs. The false belief that cigar products are less harmful than cigarettes may be influencing people's lack of support for the reduced nicotine policy and difficulty in understanding its potential positive impact. To maximize the public health benefit of the reduced nicotine policy, the FDA should include LCC products in the policy; however, it is crucial that they use educational messaging to clarify misperceptions regarding nicotine and harm as it applies to LCCs.

Combining Inserts With Warning Labels on Cigarette Packs to Promote Smoking Cessation: A 2-Week Randomized Trial.

BACKGROUND: Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation. PURPOSE: To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes. METHODS: We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups. RESULTS: Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes. CONCLUSIONS: This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts.

Cigarette pack inserts (small leaflets inside packs) with messages about quitting benefits and tips to quit may promote smoking cessation. We randomly assigned 367 adult smokers to one of four groups: control group with small health warning labels (HWLs) on the side of packs; inserts with cessation messages and small HWLs; large picture HWLs showing health effects from smoking; inserts and large picture HWLs. Participants received a 14-day supply of their preferred cigarettes in packs that reflected their assigned group. Over 2 weeks, we surveyed participants 4­5 times a day during times when they smoked, asking their feelings about smoking and smoking-related harms, confidence to reduce cigarettes and quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported on the prior 24 hr: how often they thought about smoking harms and cessation benefits; conversations about smoking cessation or harms; and foregoing or stubbing out cigarettes before they finished smoking. People whose packs had inserts (with or without picture HWLs) were more likely than those whose packs did not include inserts (control group or picture HWLs only) to report foregoing or stubbing out of cigarettes. This study provides some evidence that inserts with cessation messages may promote smoking cessation.

Self-reported decreases in the purchases of selected unhealthy foods resulting from the implementation of warning labels in Mexican youth and adult population.

Background: Front-of-package nutritional warning labels (WLs) are designed to facilitate identification and selection of healthier food choices. We assessed self-reported changes in purchasing different types of unhealthy foods due to WLs in Mexico and the association between the self-reported reductions in purchases of sugary beverages and intake of water and sugar-sweetened beverages. Methods: Data came from 14-17 year old youth (n=1,696) and adults ≥18 (n=7,775) who participated in the Mexican arm of the 2020-2021 International Food Policy Study, an annual repeat cross-sectional online survey. Participants self-reported whether the WLs had influenced them to purchase less of each of ten unhealthy food categories due to WLs. Among adults, a 23-item Beverage Frequency Questionnaire was used derive past 7-day intake of water and sugary beverages analyzed to determine the relationship between self-reported reductions in purchasing sugary drinks due to the WLs. Multilevel mixed-effects logistic regression models were fitted to estimate the percentage of participants who self-reported reducing purchases within each food group, and overall. Sociodemographic characteristics associated with this reduction were investigated as well. Results: Overall, 44.8% of adults and 38.7% of youth reported buying less of unhealthy food categories due to the implementation of WL, with the largest proportion reporting decreased purchases of cola, regular and diet soda. A greater impact of WLs on the reported purchase of unhealthy foods was observed among the following socio-demographic characteristics: females, individuals who self-identified as indigenous, those who were overweight, individuals with lower educational levels, those with higher nutrition knowledge, households with children, and those with a significant role in household food purchases. In addition, adults who reported higher water intake and lower consumption of sugary beverages were more likely to report reduced purchases of sugary drinks due to the WLs. Adults who reported greater water intake and lower sugary beverages intake were significantly more likely to report buying fewer sugary drinks due to the WLs. Conclusion: Our findings suggest that implementation of WLs has reduced purchases of unhealthy foods in Mexico. These results underscore the positive impact of the labeling policy particularly in subpopulations with lower levels of education and among indigenous adults.

Support for nicotine reduction in cigarettes: findings from the 2016 and 2020 ITC Four Country Smoking and Vaping Surveys.

INTRODUCTION: The USA and New Zealand have sought to establish a product standard to set a maximum nicotine level for cigarettes to reduce their addictiveness. This study examined support for very low nicotine cigarettes (VLNCs) in Australia, Canada, England and the USA between 2016 and 2020. METHODS: Repeated cross-sectional data were analysed from participants who currently smoke, formerly smoked or vaped and/or currently vape in the 2016 (n=11 150) and/or 2020 (n=5432) International Tobacco Control (ITC) Four Country Smoking and Vaping Survey. Respondents were asked if they would support a law that reduces the amount of nicotine in cigarettes to make them less addictive. Adjusted and weighted logistic regression analyses estimated the prevalence and predictors of support, such as country, age, sex, education, income, race and smoking/vaping status for VLNCs (support vs oppose/do not know). RESULTS: A majority of respondents supported a VLNC law, with support highest in Canada (69%; 2016 and 2020 combined), followed by England (61%), Australia (60%) and the USA (58%). Overall, support decreased from 62% in 2016 to 59% in 2020 (p=0.004), which did not differ by country. Levels of support differed by smoking/vaping status, where those who exclusively smoked daily showed the lowest level of support (59%) and those who exclusively vaped non-daily had the highest level of support (72%). CONCLUSION: More than half of respondents in all four countries-including those who smoked daily-supported a hypothetical VLNC standard to render cigarettes less addictive. It is important to examine if support is sustained after policies are implemented.

Cigarette Prices and Disparities in Cessation in the United States.

INTRODUCTION: Achieving cessation in people with established smoking patterns remains a challenge. Increasing cigarette prices has been one of the most effective strategies for lowering smoking rates. It remains unclear how effective it has been in encouraging cessation among adults in recent years and how the effectiveness varies by sociodemographic characteristics. METHODS: Using repeated cross-sectional data collected by the Tobacco Use Supplement of the Current Population Survey, we investigate the relationship between cigarette prices and cessation from 2003 to 2019 in adults 25+. We examine the associations between price and cessation in the population overall and by sex, race/ethnicity, and socioeconomic status. RESULTS: We found mixed support for associations between greater local prices and cessation. Unadjusted models showed that greater local prices were associated with greater odds of cessation, but the associations did not persist after controlling for sociodemographic characteristics. The associations did not significantly differ by respondent characteristics. Sensitivity analysis using alternative specifications and retail state price as the main predictor showed similar results. Sensitivity analysis with controls for e-cigarette use in the 2014-2019 period showed that greater local price was associated with cessation among adults with less than a high school degree. When stratified by year of data collection, results show that greater local prices were associated with cessation after 2009. CONCLUSIONS: Overall, the study adds to the conflicting evidence on the effectiveness of increasing prices on smoking cessation among adults with established smoking patterns. IMPLICATIONS: Higher cigarette prices have been one of the most effective tools for lowering smoking prevalence. It remains unclear how effective they are in encouraging adults with established smoking patterns to quit. Results show that greater local prices were associated with higher odds of cessation, but the association did not persist after sociodemographic adjustment. In a sensitivity analysis, greater local price was associated with cessation among people with less than a high school degree in models controlling for e-cigarette use. We also found evidence that greater local price was associated with cessation after 2009. More comprehensive smoke-free coverage was also associated with greater odds of cessation. The study's results highlight that encouraging cessation among adults with an established smoking pattern remains a challenging policy problem even when cigarette prices rise.

Chemicals in cigarette flavor capsules from Guatemala and Mexico.

BACKGROUND: The global market share for cigarettes with flavor capsules has grown exponentially over the last decade, particularly in Latin America. When smoking, consumers crush a liquid capsule in the filter that flavors the smoke. Little is known about the chemical constituents of the liquids in capsules or their potential health risks. METHODS: Based on consumer data and availability in Mexico and Guatemala, 31 flavor capsule brands were purchased (19 and 12, respectively) in 2020. Since some cigarettes included multiple capsules in a stick (up to 2) or pack (up to 4), the final analytic sample included 50 capsules. We conducted qualitative and quantitative analysis using gas chromatography with mass spectrometry (GC-MS, Agilent Technologies, Inc.). RESULTS: The qualitative analysis detected 296 compounds (range=9 to 67 per capsule), and all capsules contained menthol. Among the compounds detected in more than half the sample were limonene, menthone, benzaldehyde, eucalyptol and triacetin. Traces of nicotine were found in 22% of the capsules. In the quantitative analysis, menthol concentrations were 33 times greater than the next most common compound (limonene). Benzyl alcohol and vanillin were also found in high concentrations. Comparing same brand varieties across countries showed substantial variability in the concentration of menthol and other compounds. CONCLUSION: Menthol is an omnipresent constituent in capsule cigarettes, perhaps because of its anesthetizing and reinforcing addictive properties. Other compounds found are toxic, potentially carcinogenic, and may enhance addictiveness. Variance in the presence and concentrations of such compounds highlights the importance of product standards to regulate capsule content. IMPLICATIONS: This study evaluated the chemical content of capsule cigarettes from two Latin American countries that have two of the highest market shares for capsule cigarettes worldwide. Compared to other studies, our assessment included brand varieties from two countries to compare the differences in chemical content by country. Our results yield that menthol is found in all capsules, and that other chemicals found may prolong nicotine exposure and therefore reinforce the addictive properties of cigarettes.

Trends in E-Cigarette and Tobacco Cigarette Purchasing Behaviors by Youth in the United States, Canada, and England, 2017-2022.

Objectives: This paper describes trends in youth e-cigarette (EC) and tobacco cigarette (TC) purchasing behaviors in Canada, England, and the United States (US) in relationship to changing minimum legal age (MLA) laws. Methods: Data are from eight cross-sectional online surveys among national samples of 16- to 19-year-olds in Canada, England, and the US conducted from 2017 to 2022 (N = 104,467). Average wave percentage change in EC and TC purchasing prevalence and purchase locations were estimated using Joinpoint regressions. Results: EC purchasing increased between 2017 and 2022, although the pattern of change differed by country. EC purchasing plateaued in 2019 for the US and in 2020 for Canada, while increasing through 2022 for England. TC purchasing declined sharply in the US, with purchasing from traditional retail locations declining, while purchasing from social sources increased. Vape shops were the most common location for EC purchasing, although declining in England and the US. Conclusion: Trends in EC and TC purchasing trends in the US are consistent with the expected impact of the federal MLA law increasing the legal age to 21 years in December 2019.

Reduction in Depressive Symptoms in People who Inject Drugs who Are Cured of Hepatitis C Virus Infection: The HERO Study.

Background: Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome. Methods: We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models. Depressive symptoms (primary outcome) were measured using the Patient Health Questionnaire (PHQ-9) at baseline, end of treatment (EOT), and at follow-up 12 and 24 weeks after EOT. Sustained virologic response (SVR) was defined as undetectable HCV RNA at ≥12 weeks following EOT. Baseline drug use was defined as having a positive urine screening test for amphetamine, methamphetamine, benzodiazepine, cocaine, cannabis, opiate, or oxycodone. Results: The sample (n = 498) was 72.3% male, 64.2% White, and on average 43.9 years old. In patients who achieved SVR (F(3432) = 4.58; P = .004) and those with drug use at baseline (F(3478) = 5.11; P < .01), PHQ-9 scores significantly declined over time, with scores lower at EOT and both follow-ups as compared with baseline. Mean PHQ-9 scores at EOT and follow-ups were significantly lower than at baseline, except for those with no depression or mild depression at baseline. Conclusions: This study showed that HCV treatment in PWID is associated with sustained declines in depression up to 24 weeks post-treatment among those who achieve SVR and that drug use does not interfere with improvement in depressive symptoms.