Strengthening Tobacco 21 implementation and enforcement to reduce tobacco-related health disparities: A stakeholder engagement project.

INTRODUCTION: As a part of a priority-setting stakeholder engagement project to strengthen the impact of the federal Tobacco 21 (T21) law, we conducted a qualitative study to solicit input from a nationwide sample of tobacco control stakeholders regarding the implementation, enforcement, and equity implications of the T21 law. METHODS: Following the T21 policy evaluation guidance developed by the Centers for Disease Control (CDC), we identified T21 experts in four domains: policy, evaluation, subject matter, and implementation from a national search of stakeholders (invitations, n=1279) to account for geographical variation. This study presents results from five focus groups conducted in December 2021 among stakeholders (n=31) with experience in T21 policy, evaluation, subject matter, and implementation. RESULTS: Participating T21 stakeholders reported on eight themes from four main topic areas: 1) Implementation, 2) Enforcement, 3) Equity outcomes, and 4) Recommended changes from stakeholders. Stakeholders shared insights on both passive and active implementation methods used in their communities, and highlighted major barriers such as the absence of a standardized tobacco retail licensing mandate and insufficient resources. Regarding T21 enforcement, stakeholders believed that current deterrents for retail violations might not be effective. They noted that vape and tobacco shops and online sales of tobacco products are emerging major challenges in T21 enforcement. Stakeholders also discussed possible health inequities that may be exacerbated by heterogenous implementation of the T21 law. CONCLUSIONS: To strengthen T21 and mitigate potential exacerbation of existing health inequities, greater alignment of federal, state, and local efforts to reduce heterogeneity of implementation and enforcement of the T21 law is recommended.

The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial.

Importance: Tobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries. Objective: To evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco. Design, Setting, and Participants: In Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021. Interventions: At bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medical staff provided opt-out patients with inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls. Patients could opt out of any or all elements of care. Opt-in patients willing to quit were offered each element of treatment described previously. Opt-in patients who were unwilling to quit received motivational counseling. Main Outcomes and Measures: The main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization. Results: Of a total of 1000 eligible adult patients who were randomized, most consented and enrolled (270 [78%] of opt-in patients; 469 [73%] of opt-out patients). Adaptive randomization assigned 345 (64%) to the opt-out group and 645 (36%) to the opt-in group. The mean (SD) age at enrollment was 51.70 (14.56) for opt-out patients and 51.21 (14.80) for opt-out patients. Of 270 opt-in patients, 123 (45.56%) were female, and of 469 opt-out patients, 226 (48.19%) were female. Verified quit rates for the opt-out group vs the opt-in group were 22% vs 16% at month 1 and 19% vs 18% at 6 months. The Bayesian posterior probability that opt-out care was better than opt-in care was 0.97 at 1 month and 0.59 at 6 months. Treatment use for the opt-out group vs the opt-in group was 60% vs 34% for postdischarge cessation medication (bayesian posterior probability of 1.0), and 89% vs 37% for completing at least 1 postdischarge counseling call (bayesian posterior probability of 1.0). The incremental cost-effectiveness ratio was $678.60, representing the cost of each additional quit in the opt-out group. Conclusions and Relevance: In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients' sense of agency and alliance with practitioners. Stronger and longer treatment could increase cessation. Trial Registration: ClinicalTrials.gov Identifier: NCT02721082.

"I'm a transgender man I have to quit smoking for treatment and surgery": Describing the experience of a Latino transgender man during his attempt to quit smoking.

OBJECTIVE: To describe the experience of a Latino transgender man during his attempt to quit smoking using a text messaging intervention. METHODS: A Latino transgender man enrolled in a smoking cessation randomized controlled trial for Latino smokers. The participant was randomized to Decídetexto, a smoking cessation mobile intervention. The participant received a 24-week text messaging intervention. We assessed text messaging interactivity with the program, satisfaction, and self-reported abstinence at Week 12 and Month 6. RESULTS: During the 24-week intervention period, the participant sent a total of 287 text messages to the program. When analyzing the content of the text messages sent by the participants, four important themes were identified: 1) gender identity, 2) low social support, 3) stressors (e.g., gender dysphoria), and 4) gender affirmation surgery as a reason to quit smoking. At both Week 12 and Month 6, the participant reported being extremely satisfied with the intervention and self-reported cigarette use. CONCLUSION: A smoking cessation mobile intervention generated high satisfaction and frequent interactivity among a Latino transgender man. This case report provides important insights into the experience of one Latino transgender man during his attempt to quit smoking. There is an urgent need to develop or adapt existing smoking cessation interventions to better meet the needs of transgender people.

Effectiveness of Recruitment Strategies of Latino Smokers: Secondary Analysis of a Mobile Health Smoking Cessation Randomized Clinical Trial.

BACKGROUND: Latinos remain disproportionately underrepresented in clinical trials, comprising only 2%-3% of research participants. In order to address health disparities, it is critically important to increase enrollment of Latino smokers in smoking cessation trials. There is limited research examining effective recruitment strategies for this population. OBJECTIVE: The purpose of this study was to compare the effectiveness of direct versus mass and high- versus low-effort recruitment strategies on recruitment and retention of Latino smokers to a randomized smoking cessation trial. We also examine how the type of recruitment might have influenced the characteristics of enrolled participants. METHODS: Latino smokers were enrolled into Decídetexto from 4 states-New Jersey, Kansas, Missouri, and New York. Participants were recruited from August 2018 until March 2021. Mass recruitment strategies included English and Spanish advertisements to the Latino community via flyers, Facebook ads, newspapers, television, radio, church bulletins, and our Decídetexto website. Direct, high-effort strategies included referrals from clinics or community-based organizations with whom we partnered, in-person community outreach, and patient registry calls. Direct, low-effort strategies included texting or emailing pre-existing lists of patients who smoked. A team of trained bilingual (English and Spanish) recruiters from 9 different Spanish-speaking countries of origin conducted recruitment, assessed eligibility, and enrolled participants into the trial. RESULTS: Of 1112 individuals who were screened, 895 (80.5%) met eligibility criteria, and 457 (457/895, 51.1%) enrolled in the trial. Within the pool of screened individuals, those recruited by low-effort recruitment strategies (both mass and direct) were significantly more likely to be eligible (odds ratio [OR] 1.67, 95% CI 1.01-2.76 and OR 1.70, 95% CI 0.98-2.96, respectively) and enrolled in the trial (OR 2.60, 95% CI 1.81-3.73 and OR 3.02, 95% CI 2.03-4.51, respectively) compared with those enrolled by direct, high-effort strategies. Among participants enrolled, the retention rates at 3 months and 6 months among participants recruited via low-effort strategies (both mass and direct) were similar to participants recruited via direct, high-effort methods. Compared with enrolled participants recruited via direct (high- and low-effort) strategies, participants recruited via mass strategies were less likely to have health insurance (44.0% vs 71.2% and 71.7%, respectively; P<.001), lived fewer years in the United States (22.4 years vs 32.4 years and 30.3 years, respectively; P<.001), more likely to be 1st generation (92.7% vs 76.5% and 77.5%, respectively; P=.007), more likely to primarily speak Spanish (89.3% vs 65.8% and 66.3%, respectively), and more likely to be at high risk for alcohol abuse (5.8 mean score vs 3.8 mean score and 3.9 mean score, respectively; P<.001). CONCLUSIONS: Although most participants were recruited via direct, high-effort strategies, direct low-effort recruitment strategies yielded a screening pool more likely to be eligible for the trial. Mass recruitment strategies were associated with fewer acculturated enrollees with lower access to health services-groups who might benefit a great deal from the intervention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03586596; https://clinicaltrials.gov/ct2/show/NCT03586596. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-DOI: 10.1016/j.cct.2020.106188.

Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment.

Background: Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen's design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial. Methods: At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen's d measure of effect size to evaluate differences. Results: Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen's d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen's d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance. Conclusions: The modified Zelen's design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.

Shared Decision Making in Health Care: Theoretical Perspectives for Why It Works and For Whom.

Applying both theoretical perspectives and empirical evidence, we address 2 key questions regarding shared decision making (SDM): 1) When should SDM be more patient driven, and when should it be more provider driven? and 2) Should health care providers match their SDM style/strategy to patient needs and preferences? Self-determination theory, for example, posits a distinction between autonomy and independence. A patient may autonomously seek their health care provider's input and guidance, perhaps due to low perceived competence, low coping resources, or high emotional arousal. Given their need state, they may autonomously require nonindependence. In this case, it may be more patient centered and need supportive to provide more provider-driven care. We discuss how other patient characteristics such as personality attributes, motivational state, and the course of illness and other parameters such as time available for an encounter may inform optimal provider decision-making style and strategy. We conclude that for some types of patients and clinical circumstances, a more provider-driven approach to decision making may be more practical, ethical, and efficacious. Thus, while all decision making should be patient centered (i.e., it should consider patient needs and preferences), it does not always have to be patient driven. We propose a flexible model of SDM whereby practitioners are encouraged to tailor their decision making behaviors to patient needs, preferences, and other attributes. Studies are needed to test whether matching decision-making behavior based on patient states and traits (i.e., achieving concordance) is more effective than simply providing all patients with the same type of decision making, which could be tested using matching/mismatching designs.

Feasibility and Effectiveness of Recruiting Latinos in Decídetexto-A Smoking Cessation Clinical Trial from an Emergency Department Patient Registry.

There is an underrepresentation of Latinos in smoking cessation clinical trials. This study describes the feasibility and effectiveness of recruiting Latino smokers in the U.S. from an emergency department (ED) patient registry into a randomized smoking cessation clinical trial. Recruitment occurred from the Hackensack University Medical Center ED. Potential participants were contacted from a patient registry. The primary outcome was whether the participant responded to a call or text. Secondary outcomes included the best day of the week, week of the month, and time of day to obtain a response. Of the 1680 potential participants, 1132 were called (67.5%), while 548 (32.5%) were texted. For calls, response rate was higher compared to text (26.4% vs 6.4%; p < 0.001). More participants were interested in the study when contacted by calls compared to text (11.4% vs. 1.8%) and more participants were enrolled in the study when contacted by calls compared to text (1.1% vs. 0.2%). Regression models showed that ethnicity, age, time of day, and week of the month were not significantly associated with response rates. Recruitment of Latinos from an ED patient registry into a smoking cessation clinical trial is feasible using call and text, although enrollment may be low.

Translation and Examination of the Reliability and Validity of the Spanish Version of the Smoking Self-Efficacy Questionnaire Among Latino Smokers.

The 12-item Smoking Self-Efficacy Questionnaire (SEQ-12) is a valid and reliable instrument to assess confidence in one's ability to refrain from smoking in a variety of different situations. This study evaluated the psychometric properties of the Spanish version of the 12-item Smoking Self-Efficacy Questionnaire (SEQ-12) among a sample of Spanish-speaking Latino smokers engaged in a smoking cessation research study. A forward-backward translation procedure guided the translation of the SEQ-12 into Spanish. The Spanish version of the SEQ-12 showed promising internal consistency reliability and construct validity among Latino smokers, with potential applications in both research and clinical settings.

Stress, Depression and Quit Attempt Outcomes among Unmotivated Smokers.

INTRODUCTION: Stress and depressive symptoms have been linked to a reduced likelihood of sustaining smoking cessation. Because stress and depressive symptoms may negatively affect motivation to quit, stress and depression may also be important for whether or not smokers make a quit attempt. OBJECTIVE: To examine the relationship between perceived stress and depressive symptoms and initiating a quit attempt in a smoking cessation induction trial. METHODS: We conducted a secondary analysis of existing data from a randomized clinical trial (N = 255) comparing motivational interviewing to health education and brief advice for smoking cessation induction in smokers with low motivation to quit. RESULTS: We observed positive associations between baseline predictors and quit attempts at week 12 (r = 0.192, p < 0.01 for depressive symptoms and r = 0.136, p < 0.05 for perceived stress). Logistic regression models revealed similar significant positive associations between baseline perceived stress and baseline depressive symptoms and making a quit attempt by week 12 (OR = 1.5, CI:1.03, 2.19 and OR = 1.03, 95% CI: 1.01, 1.06; respectively). CONCLUSION: Unexpectedly, this study found generally small but consistently positive associations between baseline depressive symptoms and baseline perceived stress and making a quit attempt by week 12. The results can be viewed as encouraging in that interventions to encourage quit attempts do not appear counter-productive for individuals higher in stress and depressive symptoms, but these patients very likely will need additional supports to sustain abstinence.

Differential mechanisms of change in motivational interviewing versus health education for smoking cessation induction.

Objective: To determine if Motivational Interviewing (MI) versus health education (HE) elicited different types of client language and whether these differences were associated with outcomes in a randomized clinical trial (RCT) for cessation induction among people who smoke with low motivation to quit. Methods: A secondary data analysis was conducted using data from the MI and HE arms of a trial in which people who smoke (N = 202) with low desire to quit were randomly assigned to four sessions of MI, HE or brief advice. Mediation analyses examined two types of client language: change talk (CT) and a novel form of client speech called "learning talk" (LT). Outcomes were assessed at baseline, 3 and 6 months. Results: With HE as the reference group, MI resulted in greater CT (OR = 3.0, 95% CI: 1.7-5.5) which was associated with better outcomes (average d = .34, SD = .13) and HE resulted in greater LT (OR = .05, 95% CI: .02-.10) which was also associated with better outcomes (average d = .42, SD = .08). Indirect parallel mediation effects on quit attempts were significant for both MI-CT (OR = 1.4, 95% CI: 1.1-1.7) and HE-LT (OR = .4, 95% CI: .2-.7). Conclusions: MI and HE were both efficacious via different pathways to change, confirming the utility of MI in this RCT as well as highlighting the potential of HE based on the "5R's" for smoking cessation. These findings emphasize the value of exploring theorized mechanisms of action of interventions evaluated in RCTs. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Rural-Urban Differences in Changes and Effects of Tobacco 21 in Youth E-cigarette Use.

BACKGROUND: The prevalence of current electronic cigarette (e-cigarette) use has increased dramatically among US youth. It is unknown how the impact of policies to curb e-cigarette use might differ across rural and urban areas. METHODS: Data were collected from an annual statewide survey of middle and high school students in Kansas. Multivariable logistic regression was performed to examine the temporal change in current e-cigarette use in 2018 and 2019 across rural and urban areas and across the areas with and without a Tobacco 21 (T21) policy that raises the minimum age of tobacco sales to 21 years. RESULTS: Of 132 803 participants, the prevalence of current e-cigarette use increased from 8.2% in 2018 to 12.6% in 2019. The increase was larger in rural areas (from 6.7% in 2018 to 13.4% in 2019, difference = 6.7%) than in urban areas (9.8%-11.9%, difference = 2.1%), with a significant interaction effect of year × urbanicity/T21 group (P < .0001). In urban areas, e-cigarette use increased significantly for middle school students in T21 areas (3.3%-4.5%; P = .01) and all students in non-T21 areas (8.1%-12.0%; P < .0001). In rural areas, the increase in e-cigarette use was significant in both T21 and non-T21 areas for all students, but the increase was smaller in T21 (7.9%-10.8%, difference = 3.0%) than in non-T21 areas (6.5%-13.7%, difference = 7.1%). CONCLUSIONS: In this study, we reported marked disparities in the increase of youth e-cigarette use, with a larger recent increase in rural than in urban areas. T21 policies appear to mitigate these increases in both rural and urban youth.

Trends in Incidence of Nicotine Use Disorder Among Adolescents in the Pediatric Hospital, 2012-2019.

OBJECTIVES: To assess trends in the incidence of nicotine use disorder (NUD) and describe associated factors among adolescents in the pediatric emergency department (ED) and inpatient settings. METHODS: We conducted a retrospective cohort study of all adolescents (11-18 years) with a hospital encounter (inpatient, observation, or ED) in the Pediatric Health Information System between January 1, 2012, and September 30, 2019. After excluding adolescents with a previous International Classification of Diseases, Ninth Revision, and International Classification of Diseases, Tenth Revision, NUD diagnosis in the past 2 years, adolescents with new NUD diagnosis (ie, NUD incidence) were identified. A multivariable generalized liner mixed model was used to assess adjusted NUD incidence and investigate the relationship of NUD with patient characteristics and any interactions between characteristics and time. Spearman's correlation coefficient was used to assess the correlation between NUD incidence and e-cigarette use reported among youth. RESULTS: Of 3 963 754 adolescents, 15 376 (0.4%) had a new diagnosis of NUD. Between 2012 and 2019, NUD incidence increased from 0.3% to 0.4% (P < .001). Findings from the time interaction effect analysis revealed increasing NUD incidence among certain subpopulations, including boys, those with a commercial or other insurance type, adolescents seen in the ED, those from the lowest and highest median household income quartile, and those in the South and West US Census regions. The correlation between NUD incidence and e-cigarette use among high school students was ρ = 0.884 (P = .006). CONCLUSIONS: The incidence of NUD among adolescents is increasing. Efforts to increase the screening and treatment of NUD among adolescents in the hospital, particularly among the at-risk populations identified, are needed.

Barriers to Tobacco Cessation for Caregivers of Hospitalized Children: Perspectives of Pediatric Hospitalists.

OBJECTIVES: Secondhand smoke exposure is associated with adverse health outcomes in children, yet tobacco cessation efforts for caregivers of hospitalized children are lacking. We sought to explore pediatric hospitalists' attitudes and barriers to providing tobacco cessation for caregivers of hospitalized children. METHODS: We conducted a cross-sectional survey of pediatric hospitalists and fellows at 7 hospitals from November 1, 2018, to November 30, 2019. A 70-question anonymous survey was used to assess participants' perceptions of current practices, attitudes, and barriers to providing tobacco cessation support for caregivers of hospitalized children. We used descriptive statistics to summarize the data. RESULTS: Of 207 eligible participants, 100 responded (48%). A majority (79%) agreed that offering tobacco cessation counseling for caregivers is an important part of their role in caring for hospitalized children, but 79% never received tobacco cessation training. Only half of the participants were comfortable providing brief advice and few were comfortable prescribing nicotine replacement therapy. Identified barriers included lack of time (74%), perceived lack of interest from patients' caregivers (71%), and other medical conditions of the patient taking priority (70%). The majority of participants were interested in further training in tobacco cessation support. CONCLUSIONS: In this survey of 100 pediatric hospitalists, we found overall agreement that tobacco cessation support for caregivers of hospitalized children is important. However, most participants did not feel comfortable with provision of evidence-based counseling or pharmacotherapy because of identified barriers. Future work should target actionable barriers to improve provision of tobacco cessation support in this clinical setting.

Youth Knowledge of Tobacco 21 and its Association With Intention to Use Tobacco.

BACKGROUND: Raising the minimum legal age (MLA) of tobacco sales from 18 to 21 (Tobacco 21 [T21]) has recently been implemented nationwide as a method to reduce tobacco use, but empirical data on youth knowledge of T21 policies and related pathways to tobacco use are limited. METHODS: Data were collected from the 2018 Kansas Communities That Care Student Survey. Knowledge of the MLA was compared between T21 and non-T21 regions using a quasi-experimental design. Logistic regression and mediation analysis were conducted to assess the association between knowledge of the MLA, influencing factors, and intention to use tobacco. RESULTS: Of 16 949 students (aged between 11 and 18) completing the T21 survey, fewer students responded correctly about the MLA in T21 than in non-T21 regions (37.4% vs. 46.3% responded correctly, 27.6% vs. 24.2% responded incorrectly, respectively). In T21 regions, Hispanics and students who support T21 were more likely to respond correctly about the MLA. Among current non-tobacco users in T21 regions, students who responded correctly about the MLA were less likely to report intention to use tobacco (adjusted odds ratio [AOR] = 0.7, 95% confidence interval [CI]: [0.6-0.8]) than those who responded incorrectly. The pathway from knowledge of the MLA to intention to use tobacco was significantly mediated by increased support for T21 (p = .002), perceived difficulty in accessing cigarettes (p = .042), and reduced susceptibility to peer influence (p = .027). CONCLUSIONS: Knowledge of the MLA was inversely associated with intention to use tobacco among youth. Educational campaigns to raise awareness and support for T21 among youth may improve the impact of T21 policies. IMPLICATIONS: This study examined youth knowledge of the MLA to purchase tobacco products, and whether knowledge of the MLA was associated with reduced intention to use tobacco. It also examined other influencing factors (eg, perceived support for T21) and potential mediation pathways linking knowledge of the MLA with intention to use tobacco. Given the nationwide adoption of T21, educational campaigns to promote knowledge of the policy may improve its impact.

Decídetexto: Mobile cessation support for Latino smokers. Study protocol for a randomized clinical trial.

INTRODUCTION: Latinos, the largest minority group in the U.S., experience tobacco-related disparities, including limited access to cessation resources. Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging. OBJECTIVES: To describe the methodology of a randomized clinical trial to evaluate the impact of Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence) at Month 6 among Latino smokers. METHODS: Latino smokers (N = 618) will be randomized to one of two conditions: 1) Decídetexto or 2) standard of care. Decídetexto is a mobile smoking cessation intervention (available in English and Spanish) that incorporates three integrated components: 1) a tablet-based software that collects smoking-related information to develop an individualized quit plan, 2) a 24-week text messaging counseling program with interactive capabilities, and 3) pharmacotherapy support. Decídetexto follows the Social Cognitive Theory as theoretical framework. Standard of care consists of printed smoking cessation materials along with referral to telephone quitline. Participants in both groups are given access to free pharmacotherapy (nicotine patches or gum) by calling study phone number. Promotores de Salud will rely on community-based approaches and clinical settings to recruit smokers into the study. All participants will complete follow-up assessments at Week 12 and Month 6. DISCUSSION: If successful, Decídetexto will be ready to be implemented in different community- and clinic-based settings to reduce tobacco-related disparities.

Retail violations of sales to minors on e-cigarettes and cigars.

OBJECTIVES: The finalized 'Deeming Rule' extended the Food and Drug Administration (FDA) authority to regulate e-cigarettes, cigars, and other newly deemed tobacco products. We seek to assess the neighborhood characteristics associated with retail violations of sales to minors (RVSM) by tobacco product. STUDY DESIGN: We collected national inspection data on tobacco retailers during August 8, 2016, and May 31, 2018, from the FDA compliance check database. METHODS: A web scraping tool was applied to text mine the FDA decision letters and extract information on the tobacco product involved in RVSM. Separate logistic regression models with random effects were performed to examine the association between zip code-level neighborhood characteristics and RVSM by tobacco product. RESULTS: Of 268,317 minor-involved compliance inspections, 35,403 (13.2%) were identified as RVSM. Among 23,352 warning letters included in the final analysis, e-cigarettes, cigars, cigarettes, and smokeless tobacco accounted for 20.0% (n = 4673), 40.4% (9439), 35.6% (8303), and 4.0% (937) of RVSM, respectively. Flavored tobacco products were abundant among underage sales. For e-cigarettes, RVSM were more likely to occur in zip codes with a larger proportion of youth population aged 10-17 years (adjusted odds ratio [AOR] = 1.17 [1.02-1.34]). A larger proportion of African Americans was associated with a higher risk of RVSM for cigars (AOR = 1.09 [1.07-1.11]) but a lower risk of RVSM for e-cigarettes (AOR = 0.90 [0.87-0.93]). CONCLUSIONS: Retail violations of underage sales for cigars and e-cigarettes are prevalent and neighborhood characteristics associated with violations differ by tobacco product. Continued inspections with tailored strategies to reduce RVSM of all tobacco products are needed.

Trial-by-Trial Fluctuations in Brain Responses to Stress Predict Subsequent Smoking Decisions That Occur Several Seconds Later.

BACKGROUND: To investigate the neurobiological mechanisms that determine self-regulation of smoking urges when a person encounters stress, we investigated brain network interactions of smoking self-regulation by employing a real-time smoking (nicotine delivery) decision paradigm and a brain-as-predictor neuroimaging approach. METHODS: While in the functional magnetic resonance imaging scanner, 25 cigarette smokers who abstained from smoking overnight made 200 real smoking decisions regarding whether or not to take a puff of an electronic cigarette during 3 different stress conditions (cognitive stress, emotional stress, and no stress). Cognitive stress was induced by a concurrent working memory load, and emotional stress was induced by manipulating a chance of aversive electric shock. RESULTS: Behaviorally, both cognitive and emotional stress manipulations increased the probability of making a decision to smoke (i.e., taking a puff). In magnetic resonance imaging trial-by-trial analyses, the dorsolateral prefrontal cortex activity measured at the time of the stress cue significantly predicted future smoking decisions that occurred several seconds later. Furthermore, the influence of dorsolateral prefrontal cortex activity on smoking decisions was mediated by the ventral striatum activity at the time of smoking decisions. CONCLUSIONS: Our study demonstrated that brain responses at the time of a stressful moment determine subsequent trial-by-trial smoking decisions by systematically altering brain executive (dorsolateral prefrontal cortex) and reward (ventral striatum) system network activities. Our results further suggest potential translational importance of neuroscientific approaches to predicting self-regulation failures at critical stressful moments.

Feasibility and Acceptability of a Culturally- and Linguistically-Adapted Smoking Cessation Text Messaging Intervention for Latino Smokers.

Objective: Assess the feasibility and acceptability of a culturally- and linguistically-adapted smoking cessation text messaging intervention for Latino smokers. Methods: Using a community-based strategy, 50 Latino smokers were recruited to participate in a smoking cessation pilot study. Participants received a 12-week text messaging intervention and were offered Nicotine Replacement Therapy (NRT) at no cost. We assessed biochemically verified abstinence at 12 weeks, text messaging interactivity with the program, NRT utilization, self-efficacy, therapeutic alliance, and satisfaction. Results: Participants were 44.8 years old on average (SD 9.80), and they were primarily male (66%) and had no health insurance (78%). Most of the participants were born in Mexico (82%) and were light smokers (1-10 CPD) (68%). All participants requested the first order of NRT, and 66% requested a refill. Participants sent an average of 39.7 text messages during the 12-week intervention (SD 82.70). At 12 weeks, 30% of participants were biochemically verified abstinent (88% follow-up rate) and working alliance mean value was 79.2 (SD 9.04). Self-efficacy mean score increased from 33.98 (SD 10.36) at baseline to 40.05 (SD 17.65) at follow-up (p = 0.04). The majority of participants (90.9%, 40/44) reported being very or extremely satisfied with the program. Conclusion: A culturally- and linguistically-adapted smoking cessation text messaging intervention for Latinos offers a promising strategy to increase the use of NRT, generated high satisfaction and frequent interactivity, significantly increased self-efficacy, produced high therapeutic alliance, and resulted in noteworthy cessation rates at the end of treatment. Additional testing as a formal randomized clinical trial is warranted.

A Multilevel Diabetes and CVD Risk Reduction Intervention in African American Churches: Project Faith Influencing Transformation (FIT) Feasibility and Outcomes.

Wide-reaching health promotion interventions are needed in influential, accessible community settings to address African American (AA) diabetes and CVD disparities. Most AAs are overweight/obese, which is a primary clinical risk factor for diabetes/CVD. Using a faith-community-engaged approach, this study examined feasibility and outcomes of Project Faith Influencing Transformation (FIT), a diabetes/CVD screening, prevention, and linkage to care pilot intervention to increase weight loss in AA church-populations at 8 months. Six churches were matched and randomized to multilevel FIT intervention or standard education control arms. Key multilevel religiously tailored FIT intervention components included: (a) individual self-help materials (e.g., risk checklists, pledge cards); (b) YMCA-facilitated weekly group Diabetes Prevention Program (DPP) weight loss classes; (c) church service activities (e.g., sermons, responsive readings); and (d) church-community text/voice messages to promote healthy eating and physical activity. Health screenings (e.g., weight, blood pressure, blood glucose) were held during church services to identify participants with diabetes/CVD risks and refer them to their church's DPP class and linkage to care services. Participants (N = 352 church members and community members using churches' outreach ministries) were primarily female (67%) and overweight/obese (87%). Overall, FIT intervention participants were significantly more likely to achieve a > 5 lb weight loss (OR = 1.6; CI = 1.24, 2.01) than controls. Odds of intervention FIT-DPP participants achieving a > 5 lb weight loss were 3.6 times more than controls (p < .07). Exposure to sermons, text/email messages, brochures, commitment cards, and posters was significantly related to > 5 lb. weight loss. AA churches can feasibly assist in increasing reach and impact of diabetes/CVD risk reduction interventions with intensive weight loss components among at risk AA church-populations.

Changes in opioid prescriptions for Medicaid-enrolled children and young adults, 2012-2016.

OBJECTIVES: To describe current trends in filled opioid prescriptions for Medicaid-enrolled children, adolescents and young adults (AYAs) from 2012 to 2016, and to identify patient characteristics and clinical settings associated with a higher probability of filled opioid prescriptions. DESIGN: Retrospective cohort study of children and young adults enrolled in Medicaid from 2012 to 2016. SETTING: 10-12 states participating in the Medicaid Marketscan claims database. PARTICIPANTS: Medicaid-enrolled children and young adults (0-21 years old). EXPOSURE: Healthcare encounter(s) that could result in a new opioid prescription. MAIN OUTCOME MEASURE: "Opioid visits," defined as healthcare encounters associated with a new opioid prescription filled within 7 days. Each opioid visit was assigned to the clinical provider most likely to have prescribed an opioid. RESULTS: There were 113,068,027 visits among 4,427,838 Medicaid-enrollees and 1 percent (n = 1,130,006) of these were considered an opioid visit. Adjusted probabilities decreased from 1.2 percent to 0.8 percent from 2012 to 2016. The most frequently prescribed opioids were hydrocodone (48 percent; n = 653,011), codeine (23 percent; n = 305,644), and oxycodone (14 percent; n = 189,700); most of these were in combination with acetaminophen. The high-est adjusted percentages by clinical setting were seen in dental surgery (29 percent), outpatient surgery (21 percent), and inpatient (upon discharge, 10 percent). CONCLUSIONS: Opioid prescriptions filled for Medicaid-enrolled children, adolescents, and young adults are relatively rare and adjusted probabilities decreased from 2012 to 2016. Among opioids filled, combination opioids and those with pedi-atric safety warnings remain commonly prescribed. Further research is critical to better understand drivers of prescribing practices and clinical indications for appropriate opioid use to inform improvements in pain management guidelines in this population.