Association Between Cardiovascular Event Type and Smoking Cessation Rates Among Outpatients With Atherosclerotic Cardiovascular Disease: Insights From the NCDR PINNACLE Registry.

BACKGROUND: It is unclear how the type of an atherosclerotic cardiovascular disease (ASCVD) event potentially influences patients' likelihood of smoking cessation. METHODS: Using 2013 to 2018 data from the US based National Cardiovascular Data Registry Practice Innovation and Clinical Excellence outpatient cardiac registry, we identified patients who were current smokers at a clinic visit and followed them over time for a subsequent ASCVD event. Self-reported smoking status was assessed at each consecutive visit and used to determine smoking cessation after each interim ASCVD event (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, stroke/transient ischemic attack, peripheral artery disease). We constructed separate multivariable Cox models with nonproportional hazards to examine the association of each interim ASCVD event with smoking cessation, compared with not having an interim ASCVD event. We estimated the relative association of ASCVD event type with smoking cessation using contrast tests. Analyses were stratified by presence versus absence of ASCVD at baseline. RESULTS: Across 530 cardiology practices, we identified 1 933 283 current smokers (mean age 62±15, male 54%, ASCVD at baseline 50%). Among the 322 743 patients who had an interim ASCVD event and were still smoking, 41 336 (12.8%) quit smoking by their first subsequent clinic visit, which was higher among those with baseline ASCVD (13.4%) as compared with those without baseline ASCVD (11.5%). Each type of ASCVD event was associated with an increased likelihood of smoking. Patients who had an myocardial infarction, underwent coronary artery bypass graft (hazard ratio, 1.60 [95% CI, 1.55-1.65]), or had a stroke or transient ischemic attack were more likely to quit smoking as compared with those who underwent elective percutaneous coronary intervention or had a new diagnosis of peripheral artery disease (hazard ratio, 1.20 [95% CI, 1.17-1.22]). CONCLUSIONS: Only 13% of patients reported smoking cessation after an ASCVD event, with the type of event being associated with the likelihood of smoking cessation, prompting the need for patient-centered interventions.

Early Treatment Response in Black Smokers Undergoing Pharmacotherapy for Smoking Cessation: A Secondary Analysis of a Randomized Clinical Trial.

This secondary analysis of a randomized clinical trial investigates the association of early treatment response with smoking cessation among Black smokers.

Evolution of Population Health Within US Schools of Medicine and Academic Medical Centers.

Schools of medicine are increasingly focusing on efforts beyond the immediate needs of individual patients and addressing the needs of whole populations. This study examined the characteristics of population health departments and related programs within, and affiliated with, schools of medicine and how these programs address the schools' educational, clinical care, research, and service missions. Structured reviews of school of medicine websites were used to identify population health departments and related programs. An on-line survey was distributed to a subset of these programs to capture details on their activities and organizational characteristics. The authors convened leaders of population health programs to elaborate on core themes. Of 154 school of medicine websites reviewed, 37 (24%) had affiliated population health programs, including 28 (18%) with distinct departments of population health. Departments reported a variety of teaching activities related to undergraduate medical education, graduate degree programs, and certificate programs addressing a variety of population health domains including public health, health administration, epidemiology, biostatistics, informatics, and research methods. Research was a core activity for most departments with significant support coming from federal funding, with many playing major roles in clinical and translational research institutes and cancer centers. Most departments had research, data sharing, and other collaborations with affiliated health systems. All departments engaged in community service activities, including activities supporting the response to the COVID-19 pandemic. Population health programs are playing an increasingly important role in the teaching, clinical care, research, and community service missions in schools of medicine and academic medical centers.

Determinants of targeted cancer therapy use in community oncology practice: a qualitative study using the Theoretical Domains Framework and Rummler-Brache process mapping.

BACKGROUND: Precision medicine holds enormous potential to improve outcomes for cancer patients, offering improved rates of cancer control and quality of life. Not all patients who could benefit from targeted cancer therapy receive it, and some who may not benefit do receive targeted therapy. We sought to comprehensively identify determinants of targeted therapy use among community oncology programs, where most cancer patients receive their care. METHODS: Guided by the Theoretical Domains Framework, we conducted semi-structured interviews with 24 community cancer care providers and mapped targeted therapy delivery across 11 cancer care delivery teams using a Rummler-Brache diagram. Transcripts were coded to the framework using template analysis, and inductive coding was used to identify key behaviors. Coding was revised until a consensus was reached. RESULTS: Intention to deliver precision medicine was high across all participants interviewed, who also reported untenable knowledge demands. We identified distinctly different teams, processes, and determinants for (1) genomic test ordering and (2) delivery of targeted therapies. A key determinant of molecular testing was role alignment. The dominant expectation for oncologists to order and interpret genomic tests is at odds with their role as treatment decision-makers' and pathologists' typical role to stage tumors. Programs in which pathologists considered genomic test ordering as part of their staging responsibilities reported high and timely testing rates. Determinants of treatment delivery were contingent on resources and ability to offset delivery costs, which low- volume programs could not do. Rural programs faced additional treatment delivery challenges. CONCLUSIONS: We identified novel determinants of targeted therapy delivery that potentially could be addressed through role re-alignment. Standardized, pathology-initiated genomic testing may prove fruitful in ensuring patients eligible for targeted therapy are identified, even if the care they need cannot be delivered at small and rural sites which may have distinct challenges in treatment delivery. Incorporating behavior specification and Rummler-Brache process mapping with determinant analysis may extend its usefulness beyond the identification of the need for contextual adaptation.

Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke: A Randomized Clinical Trial.

Importance: Adapting to different smoking cessation medications when an individual has not stopped smoking has shown promise, but efficacy has not been tested in racial and ethnic minority individuals who smoke and tend to have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Objective: To evaluate efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily. Design, Setting, and Participants: This randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC) included non-Hispanic Black adults who smoke and was conducted from May 2019 to January 2022 at a federally qualified health center in Kansas City, Missouri. Data analysis took place from March 2022 to January 2023. Interventions: Both groups received 18 weeks of pharmacotherapy with long-term follow-up through week 26. The ADT group consisted of 196 individuals who received a nicotine patch (NP) and up to 2 pharmacotherapy adaptations, with a first switch to varenicline at week 2 and, if needed, a second switch to bupropion plus NP (bupropion + NP) based on carbon monoxide (CO)-verified smoking status (CO ≥6 ppm) at week 6. The UC group consisted of 196 individuals who received NP throughout the duration of treatment. Main Outcomes and Measures: Anabasine-verified and anatabine-verified point-prevalence abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points). The χ2 test was used to compare verified abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points) between ADT and UC. A post hoc sensitivity analysis of smoking abstinence at week 12 was performed with multiple imputation using a monotone logistic regression with treatment and gender as covariates to impute the missing data. Results: Among 392 participants who were enrolled (mean [SD] age, 53 [11.6] years; 224 [57%] female; 186 [47%] ≤ 100% federal poverty level; mean [SD] 13 [12.4] cigarettes per day), 324 (83%) completed the trial. Overall, 196 individuals were randomized to each study group. Using intent-to-treat and imputing missing data as participants who smoke, verified 7-day abstinence was not significantly different by treatment group at 12 weeks (ADT: 34 of 196 [17.4%]; UC: 23 of 196 [11.7%]; odds ratio [OR], 1.58; 95% CI, 0.89-2.80; P = .12), 18 weeks (ADT: 32 of 196 [16.3%]; UC: 31 of 196 [15.8%]; OR, 1.04; 95% CI, 0.61-1.78; P = .89), and 26 weeks (ADT: 24 of 196 [12.2%]; UC: 26 of 196 [13.3%]; OR, 0.91; 95% CI, 0.50-1.65; P = .76). Of the ADT participants who received pharmacotherapy adaptations (135/188 [71.8%]), 11 of 135 (8.1%) were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had CO-verified abstinence at week 2 had 4.6 times greater odds of being abstinent at week 12 (37 of 129 [28.7%] abstinence) than those who did not respond to treatment (19 of 245 [7.8%] abstinence; OR; 4.6; 95% CI, 2.5-8.6; P < .001). Conclusions and Relevance: In this randomized clinical trial of adapted vs standard of care pharmacotherapy, adaptation to varenicline and/or bupropion + NP after failure of NP monotherapy did not significantly improve abstinence rates for Black adults who smoke relative to those who continued treatment with NP. Those who achieved abstinence in the first 2 weeks of the study were significantly more likely to achieve later abstinence, highlighting early treatment response as an important area for preemptive intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03897439.

Development and Demonstration of Tobacco Treatment Measures for Cancer Registries: Novel Metrics for Quality Improvement.

BACKGROUND: Individuals undergoing cancer treatment have better outcomes when they discontinue tobacco use. Few cancer centers systematically provide evidence-based cessation services. As part of a national quality improvement initiative [Cancer Center Cessation Initiative (C3i)], we collaborated with our cancer registry to develop and implement two tobacco treatment metrics for tracking the provision of behavioral support and pharmacotherapy. METHODS: Post-development, the tobacco treatment metrics were integrated into the registry for all future patients. We used means and frequencies to summarize tobacco treatment for cases treated between 2017 and 2019, coinciding with the timeframe of C3i participation. RESULTS: Of 17,735 cancer cases reviewed, both measures were captured on 17,654 (99.5%) of patients, with 3,091 (17.4%) identified as users of tobacco. Across the 3 years, 557 (18%) of individuals who used tobacco received either tobacco cessation pharmacotherapy or behavioral support; with 478 (15.5%) receiving behavioral counseling, 352 (11.4%) receiving pharmacotherapy, and 273 (8.8%) receiving both-considered gold standard care. Tobacco treatment varied substantially across cancer types. The odds of receiving gold standard care were 2.37 times greater in 2019 compared with 2017. (OR, 2.37; 95% confidence interval, 1.63-3.46; P < 0.0001). CONCLUSIONS: The new metrics demonstrated high completion rates and their potential to track quality improvement efforts over time. They identified suboptimal treatment reach, but a potential increase in treatment over time and greater treatment among tobacco-related versus nontobacco-related cancers. IMPACT: Continued tobacco use worsens cancer care outcomes. Integrating measures into cancer registries is a viable option for tracking tobacco treatment and cessation in the context of cancer care.

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.

Smoking Status, Nicotine Medication, Vaccination, and COVID-19 Hospital Outcomes: Findings from the COVID EHR Cohort at the University of Wisconsin (CEC-UW) Study.

INTRODUCTION: Available evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown. METHODS: Electronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission. RESULTS: Current (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06-1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04-1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50-0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16-0.66) and former smokers (aOR, 0.47; 95% CI, 0.39-0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66-0.83) than never smokers (aOR, 0.87; 95% CI, 0.79-0.97). CONCLUSIONS: Former but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers. IMPLICATIONS: Prior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke.

Background: The standard of care in tobacco treatment is to continue individuals who smoke on the same cessation medication, even when they do not stop smoking. An alternative strategy is to adapt pharmacotherapy based on non-response. A handful of studies have examined this approach, but they have adapted pharmacotherapy only once and/or focused on adaptation distal rather than proximal to a failed quit attempt. Few studies have included racial/ethnic minorities who have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Methods: The current study is comparing the efficacy of optimized (OPT) versus enhanced usual care (UC) for smoking cessation in African Americans (AA) who smoke cigarettes. AAs who smoke (n = 392) are randomized 1:1 to OPT or UC. Participants in both groups receive 7 sessions of smoking cessation counseling and18-weeks of pharmacotherapy with long-term follow-up through Week 26. OPT participants receive nicotine patch and up to two pharmacotherapy adaptations to varenicline and bupropion plus patch based on carbon monoxide verified smoking status (≥6 ppm) at Weeks 2 and 6. UC participants receive patch throughout the duration of treatment. We hypothesize that OPT will be more effective than UC on the primary outcome of biochemically verified abstinence at Week 12. Discussion: If effective, findings could broaden the scope of tobacco dependence treatment and move the field toward optimization strategies that impro ve abstinence for AA who smoke. Trial registration: NCT03897439.

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.

Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.

Importance: African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels. Objectives: To evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers. Design, Setting, and Participants: The Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018. Interventions: Participants were provided 6 sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]). Main Outcomes and Measures: The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d). Results: Among 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; P = .002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; P < .001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]). Conclusions and Relevance: Among African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American adults who are daily smokers. Trial Registration: ClinicalTrials.gov Identifier: NCT02360631.

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.

Hospital-based tobacco treatment for inpatients with a history of cancer.

OBJECTIVE: To describe treatment engagement and outcomes of patients who smoke with cancer and received tobacco cessation treatment during hospitalization. METHOD: We analyzed treatment engagement and cessation outcomes for hospitalized patients who smoke with a current or former history of cancer receiving treatment from an inpatient tobacco treatment service between July, 2018 to October, 2019. RESULTS: The service treated 407 inpatients. Patients had an overall high level of interest in quitting (7.6, 0-10 scale). One in three accepted cessation pharmacotherapies during hospitalization or at discharge (35%) and/or referral to the state tobacco quitline (37%). Of 189 patients reached at one-month post-discharge, 73 (39%) reported tobacco abstinence (18% intent to treat-ITT-quit rate); 35.5% had used cessation pharmacotherapy and 6.5% had engaged in quitline counseling. Of 151 patients reached at 6 months post-discharge, 29% reported abstinence (11%, ITT). CONCLUSION: Inpatients with a history of cancer are interested in quitting. Post-discharge quit rates and pharmacotherapy use were high but quitline use was low. Hospitalization is an under-utilized, prime treatment opportunity and teachable moment for people with a history of cancer who continue to use tobacco.

Implementation of cancer screening in rural primary care practices after joining an accountable care organisation: a multiple case study.

OBJECTIVE: To describe common strategies and practice-specific barriers, adaptations and determinants of cancer screening implementation in eight rural primary care practices in the Midwestern United States after joining an accountable care organisation (ACO). DESIGN: This study used a multiple case study design. Purposive sampling was used to identify a diverse group of practices within the ACO. Data were collected from focus group interviews and workflow mapping. The Consolidated Framework for Implementation Research (CFIR) was used to guide data collection and analysis. Data were cross-analysed by clinic and CFIR domains to identify common themes and practice-specific determinants of cancer screening implementation. SETTING: The study included eight rural primary care practices, defined as Rural-Urban Continuum Codes 5-9, in one ACO in the Midwestern United States. PARTICIPANTS: Providers, staff and administrators who worked in the primary care practices participated in focus groups. 28 individuals participated including 10 physicians; one doctor of osteopathic medicine; three advanced practice registered nurses; eight registered nurses, quality assurance and licensed practical nurses; one medical assistant; one care coordination manager; and four administrators. RESULTS: With integration into the ACO, practices adopted four new strategies to support cancer screening: care gap lists, huddle sheets, screening via annual wellness visits and information spread. Cross-case analysis revealed that all practices used both visit-based and population-based cancer screening strategies, although workflows varied widely across practices. Each of the four strategies was adapted for fit to the local context of the practice. Participants shared that joining the ACO provided a strong external incentive for increasing cancer screening rates. Two predominant determinants of cancer screening success at the clinic level were use of the electronic health record (EHR) and fully engaging nurses in the screening process. CONCLUSIONS: Joining an ACO can be a positive driver for increasing cancer screening practices in rural primary care practices. Characteristics of the practice can impact the success of ACO-related cancer screening efforts; engaging nurses to the fullest extent of their education and training and integrating cancer screening into the EHR can optimise the cancer screening workflow.

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.

Genetic Variants in Smoking-Related Genes in Two Smoking Cessation Programs: A Cross-Sectional Study.

Previous studies have identified variants in genes encoding proteins associated with the degree of addiction, smoking onset, and cessation. We aimed to describe thirty-one single nucleotide polymorphisms (SNPs) in seven candidate genomic regions spanning six genes associated with tobacco-smoking in a cross-sectional study from two different interventions for quitting smoking: (1) thirty-eight smokers were recruited via multimedia to participate in e-Decídete! program (e-Dec) and (2) ninety-four attended an institutional smoking cessation program on-site. SNPs genotyping was done by real-time PCR using TaqMan probes. The analysis of alleles and genotypes was carried out using the EpiInfo v7. on-site subjects had more years smoking and tobacco index than e-Dec smokers (p < 0.05, both); in CYP2A6 we found differences in the rs28399433 (p < 0.01), the e-Dec group had a higher frequency of TT genotype (0.78 vs. 0.35), and TG genotype frequency was higher in the on-site group (0.63 vs. 0.18), same as GG genotype (0.03 vs. 0.02). Moreover, three SNPs in NRXN1, two in CHRNA3, and two in CHRNA5 had differences in genotype frequencies (p < 0.01). Cigarettes per day were different (p < 0.05) in the metabolizer classification by CYP2A6 alleles. In conclusion, subjects attending a mobile smoking cessation intervention smoked fewer cigarettes per day, by fewer years, and by fewer cumulative pack-years. There were differences in the genotype frequencies of SNPs in genes related to nicotine metabolism and nicotine dependence. Slow metabolizers smoked more cigarettes per day than intermediate and normal metabolizers.

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.

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.

Cancer survivorship and its association with perioperative opioid use for minor non-cancer surgery.

PURPOSE: Reducing high-risk prescription opioid use after surgery has become a key strategy in mitigating the opioid crisis. Yet, despite their vulnerabilities, we know little about how cancer survivors use opioids for non-cancer perioperative pain compared to those with no history of cancer. The purpose was to examine the association of cancer survivorship with the likelihood of receiving perioperative opioid therapy for non-cancer minor surgery. METHODS: Using 2007-2014 SEER-Medicare data for breast, colorectal, prostate, and non-cancer populations, we conducted retrospective cohort study of opioid-naïve Medicare beneficiaries who underwent one of six common minor non-cancer surgeries. Modified Poisson regression estimated the relative risk of receiving a perioperative opioid prescription associated with cancer survivorship compared to no history of cancer. Stabilized inverse probability of treatment weights were used to balance measurable covariates between cohorts. RESULTS: We included 1486 opioid-naïve older adult cancer survivors and 3682 opioid-naïve non-cancer controls. Cancer survivorship was associated with a 5% lower risk of receiving a perioperative opioid prescription (95% confidence interval: 0.89, 1.00; p = 0.06) compared to no history of cancer. Cancer survivorship was not associated with the extent of perioperative opioid exposure. CONCLUSION: Cancer survivors were slightly less likely to receive opioid therapy for non-cancer perioperative pain than those without a history of cancer. It is unclear if this reflects a reduced risk of opioid-related harms for cancer survivors or avoidance of appropriate perioperative pain therapy. Further examination of cancer survivors' experiences with and attitudes about opioids may inform improvements to non-cancer pain management for cancer survivors.