Search

ObjectivesTo test the feasibility, acceptability, and preliminary efficacy of CuidaTEXT: a tailored text message intervention to support Latino dementia family caregivers.MethodsCuidaTEXT is a six-month, bilingual, and bidirectional intervention tailored to caregiver needs (e.g., education, problem-solving, resources). We enrolled 24 Latino caregivers in a one-arm trial, and assessed feasibility, acceptability, and preliminary efficacy within six months.ResultsRecruitment took 61 days and enrollment took 20. None of the participants unsubscribed from CuidaTEXT, and 83.3% completed the follow up survey. Most participants (85.7%) reported reading most text messages thoroughly. Participants reported high levels of satisfaction with the intervention (3.6 on a scale from 1 to 4). CuidaTEXT helpfulness was high (3.5-3.8 on a 1 to 4 scale). Compared to baseline, at six months caregiver behavioral symptom distress (0–60) decreased from 19.8 to 12.0, and depression (0-30) from 8.8 to 5.4 (pConclusionsCuidaTEXT demonstrated high levels of feasibility, acceptability, and preliminary efficacy among Latino caregivers.Clinical implicationsCuidaTEXT’s feasibility and potential for widespread implementation holds promise in supporting Latino caregivers of people with dementia.

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

ImportanceTobacco 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.ObjectiveTo evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco.Design, Setting, and ParticipantsIn 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.InterventionsAt 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 MeasuresThe main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization.ResultsOf 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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT02721082

Objective Obesity and chronic pain often co‐occur and exert bidirectional influences on one another. How patients with obesity and chronic pain respond to weight loss treatments, however, remains unclear. This study evaluated body weight, physical activity, and diet outcomes in participants with and without chronic pain in a 2‐year behavioral weight loss trial. Methods An analytical cohort of 397 adults was assembled from a Midwestern healthcare system that participated in the larger trial. Participants with chronic pain 1 year prior to, or during, the trial were identified using a validated medical records algorithm. Mixed models were used to estimate changes in outcomes over 24 months. Results One‐third of participants (n = 130) had chronic pain. After adjustment for age, sex, body mass index, and trial arm, weight loss was similar in both groups at 6‐months (−7.0 ± 0.8 kg with chronic pain vs. −7.7 ± 0.6 kg without). Participants with chronic pain had significantly less weight loss at 24‐months relative to those without (−3.6 ± 0.5 vs. −5.2 ± 0.4 kg; p = 0.007). Physical activity, screen time, dietary fat, fruit/vegetable consumption, and sugar‐sweetened beverage intake improved similarly in both groups over time. Conclusions Participants with chronic pain lost ∼33% less weight over 2 years, which was driven by greater weight regain after the first 6 months. Future research should test tailored weight loss maintenance strategies for individuals with chronic pain.

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.

Background Precision medicine has enormous potential to improve cancer outcomes. Over one third of the 1.5 million Americans diagnosed with cancer each year have genetic mutations that could be targeted with an FDA-approved drug to treat their disease more effectively. However, the current uptake of targeted cancer therapy in clinical practice is suboptimal. Tumor testing is not widely used, and treatments based on molecular and genomic profiling are often not prescribed when indicated. Challenges with the uptake of precision medicine may disproportionately impact cancer patients in rural communities and other underserved populations. The objective of this study is to identify the determinants of adoption and implementation of precision cancer therapy to design an implementation strategy for community oncology practices, including those in rural areas. Methods This study is an explanatory sequential mixed methods study to identify factors associated with the use of targeted cancer therapy. Levels of targeted therapy use will be ascertained by secondary analysis of medical records to identify concordance with 18 national guideline recommendations for use of precision medicine in the treatment of breast, colorectal, lung, and melanoma skin cancer. Concurrently, facilitators and barriers associated with the use of precision cancer therapy will be elicited from interviews with up to a total of 40 oncologists, administrators, pathology, and pharmacy staff across the participating sites. Qualitative analysis will be a template analysis based on the Theoretical Domains Framework. Quantitative data aggregated at the practice level will be used to rank oncology practices’ adherence to targeted cancer therapy guidelines. Determinants will be compared among high and low users to isolate factors likely to facilitate targeted therapy use. The study will be conducted in eight community oncology practices, with an estimated 4121 targeted therapy treatment decision-making opportunities over a 3-year period. Discussion Despite unprecedented investment in precision medicine, translation into practice is suboptimal. Our study will identify factors associated with the uptake of precision medicine in community settings. These findings will inform future interventions to increase equitable uptake of evidence-based targeted cancer treatment.

Introduction: Changes in reimbursement policy have made nicotine replacement therapy (NRT) much more available, but little is known about what happens to patients after they receive their prescription. This study describes rates of successfully filling prescriptions for NRT and its association with type of insurance. Methods: We identified 224 patients who received a prescription for NRT during an outpatient visit to an academic medical center between January 1st 2016 and February 10th 2017. We conducted telephone surveys to assess whether they tried to fill their prescriptions and if so, determine the effects of insurance type on the ability to successfully fill the prescription. Results: Of 117 patients completing the survey, 23 (19.6%) did not attempt to fill and 6 (5.1%) had no insurance. Of the 90 patients with insurance who attempted to fill their prescription, 67 (74.4%) were successful and 23 (25.6%) were unsuccessful in obtaining medications. Success varied by insurance with successful fills ranging from 34 (87.2%) of those with commercial insurance, 24 (70.6%) with Medicaid, to 9 (52.9%) with Medicare. Of 37 participants living with another smoker, 31 (83.7%) wanted an NRT prescription specifically for their partner; several volunteered that they had shared patches with their partner. Conclusions: Despite widespread coverage for NRT, many patients may still encounter difficulties in getting their prescriptions filled. Some tobacco users might also benefit from getting NRT prescriptions for their partners that smoke.

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 6 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 1,486 opioid-naïve older adult cancer survivors and 3,682 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.

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.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.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.NCT03897439.

ObjectiveTo 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).DesignThis 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.SettingThe study included eight rural primary care practices, defined as Rural-Urban Continuum Codes 5–9, in one ACO in the Midwestern United States.ParticipantsProviders, 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.ResultsWith 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.ConclusionsJoining 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.

In this secondary analysis of the Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER) randomized trial, the authors determined the effectiveness of weight-loss interventions in people with diabetes compared with those without diabetes living in rural areas.The RE-POWER study was a randomized trial designed to determine the effectiveness of nonpharmacological behavioral weight-loss interventions in rural participants with obesity, comparing the individual in-clinic visit model to in-person group sessions and phone group sessions over 24 months. In this secondary analysis, weight loss was compared in participants with and without diabetes. The effects of factors such as medications, insulin, and behavioral factors were compared.Participants with diabetes were less likely to lose weight during the study compared with those without diabetes up to 18 months (4.12% vs. 5.31%; net difference = 1.46%; 95% CI: 0.63%-2.28%). Participants with diabetes on insulin lost less weight than patients with diabetes not on insulin at 6 months (4.52% vs. 6.88%; net difference = 2.35%; 95% CI: 0.55%-4.16%). The group with diabetes had significantly lower changes in blood pressure and lipid parameters versus the group without diabetes.Patients with diabetes in rural areas were less likely to lose weight, and metabolic parameters were less responsive to weight loss, compared with patients without diabetes.

ObjectivesTo describe the development of CuidaTEXT: a tailored text message intervention to support Latino dementia family caregivers.MethodsCuidaTEXT is informed by the Stress Process Framework and Social Cognitive Theory. We developed and refined CuidaTEXT using a mixed-method approach that included thematic analysis and descriptive statistics. We followed six user-centered design stages, including the selection of design principles, software vendor collaboration, evidence-based foundation, caregiver and research/clinical advisory board guidance, sketching and prototyping, and usability testing among five Latino caregivers.ResultsCuidaTEXT is a bilingual 6-month long intervention tailored to caregiver needs that includes: 1) 1-3 daily automatic messages (n=244) about logistics, dementia education, self-care, social support, end-of-life, care of the person with dementia, behavioral symptoms and problem-solving strategies; 2) 783 keyword-driven text messages for further help with the above topics; 3) live chat interaction with a coach for further help; 4) a 19-page reference booklet summarizing the purpose and functions of the intervention. CuidaTEXT’s prototype scored 97 out of 100 in the System Usability Scale.ConclusionsCuidaTEXT’s prototype demonstrated high usability among Latino caregivers. CuidaTEXT’s feasibility is ready to be tested.Clinical ImplicationsCuidaTEXT’s usability and its potential for widespread implementation holds promise in supporting Latino caregivers.

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; PPP=.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 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. CLINICALTRIAL ClinicalTrials.gov identifier: NCT03586596; https://clinicaltrials.gov/ct2/show/NCT03586596 INTERNATIONAL REGISTERED REPORT RR2-DOI: 10.1016/j.cct.2020.106188

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 &lt, 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.

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.

Main objective There is limited information on how patient outcomes have changed during the COVID-19 pandemic. This study characterizes changes in mortality, intubation, and ICU admission rates during the first 20 months of the pandemic. Study design and methods University of Wisconsin researchers collected and harmonized electronic health record data from 1.1 million COVID-19 patients across 21 United States health systems from February 2020 through September 2021. The analysis comprised data from 104,590 adult hospitalized COVID-19 patients. Inclusion criteria for the analysis were: (1) age 18 years or older; (2) COVID-19 ICD-10 diagnosis during hospitalization and/or a positive COVID-19 PCR test in a 14-day window (+/- 7 days of hospital admission); and (3) health system contact prior to COVID-19 hospitalization. Outcomes assessed were: (1) mortality (primary), (2) endotracheal intubation, and (3) ICU admission. Results and significance The 104,590 hospitalized participants had a mean age of 61.7 years and were 50.4% female, 24% Black, and 56.8% White. Overall risk-standardized mortality (adjusted for age, sex, race, ethnicity, body mass index, insurance status and medical comorbidities) declined from 16% of hospitalized COVID-19 patients (95% CI: 16% to 17%) early in the pandemic (February-April 2020) to 9% (CI: 9% to 10%) later (July-September 2021). Among subpopulations, males (vs. females), those on Medicare (vs. those on commercial insurance), the severely obese (vs. normal weight), and those aged 60 and older (vs. younger individuals) had especially high mortality rates both early and late in the pandemic. ICU admission and intubation rates also declined across these 20 months. Conclusions Mortality, intubation, and ICU admission rates improved markedly over the first 20 months of the pandemic among adult hospitalized COVID-19 patients although gains varied by subpopulation. These data provide important information on the course of COVID-19 and identify hospitalized patient groups at heightened risk for negative outcomes. Trial registration ClinicalTrials.gov Identifier: NCT04506528 (https://clinicaltrials.gov/ct2/show/NCT04506528).

To describe treatment engagement and outcomes of patients who smoke with cancer and received tobacco cessation treatment during hospitalization.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.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).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.

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.

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 &lt, 0.05, both), in CYP2A6 we found differences in the rs28399433 (p &lt, 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 &lt, 0.01). Cigarettes per day were different (p &lt, 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.

Introduction Over the last few decades, Latino migration to the U.S.has re-shaped the ethnic composition of the country, and influencedthe meaning of “ethnic” and “racial” identity. The purpose of thisqualitative study was to explore the definition and meaning of beingLatino and how this may guide the development of interventions topromote their health. Methods Twenty-six Latino immigrants living in Kansas completeda socio-demographic survey and semi-structured interviews to assessand explore personal immigration experiences and perspectives onthe meaning of being Latino in the U.S. Results Participant reports were grouped into eight themes on Latinoidentity that were organized by geographic origin, family roots/ties,and acculturation. Immigration experiences were described as bothpositive and negative with most participants experiencing discriminationand loneliness, but also reports of improved quality of life.Further, most participants reported a strong sense of Latinidad; thatLatino immigrant communities in the U.S. are interdependent andsupportive of each other. Conclusions The experience of being a member of a minority groupmight contribute to the development of a cohesive sense of Latinoidentity as participants acculturate to the U.S. while preserving asense of attachment to their culture of origin. Future interventionsshould be sensitive to migration experiences as they might influencechanges in health behaviors.

Introduction Mobile health interventions are a promising mode to address tobacco-related disparities among Latinos, the largest minority group and the highest users of text messaging technology. The purpose of this pilot study was to assess engagement in a smoking cessation intervention delivered via text message (Kick Buts) among Latino smokers. Methods We relied on a community-based recruitment strategy to enroll 20 Latino smokers in Kick Buts. Outcome measures included biochemically verified abstinence at 12 weeks, participant text messaging interactivity with the program, and satisfaction. Results Participants' mean age was 40.7 years old (SD=14.6). Most of the participants were male (70%), did not have health insurance (75%), and reported low nicotine-dependence (60%). The majority of participants (75%) sent at least one text message to the program. On average, participants who interacted with the program sent 31.8 (SD=39.7) text messages. Eight themes were identified in participants' messages (eg, well-being, self-efficacy, strategies to quit, extra-treatment social support, etc). At 12 weeks, 30% of the participants were biochemically verified as abstinent. Conclusion A smoking cessation text message intervention generated high engagement among Latinos and resulted in noteworthy cessation rates. Future studies should assess the relationship of text messaging interactions with psychological effects (eg, intra-treatment social support, therapeutic alliance, and perceived autonomy support).

Objective:To describe the relationship between adherence to distinct dietary patterns and nutrition literacy.Design:We identified distinct dietary patterns using principal covariates regression (PCovR) and principal components analysis (PCA) from the Diet History Questionnaire II. Nutrition literacy was assessed using the Nutrition Literacy Assessment Instrument (NLit). Cross-sectional relationships between dietary pattern adherence and global and domain-specific NLit scores were tested by multiple linear regression. Mean differences in diet pattern adherence among three predefined nutrition literacy performance categories were tested by ANOVA.Setting:Metropolitan Kansas City, USA.Participants:Adults (n 386) with at least one of four diet-related diseases.Results:Three diet patterns of interest were derived: a PCovR prudent pattern and PCA-derived Western and Mediterranean patterns. After controlling for age, sex, BMI, race, household income, education level and diabetes status, PCovR prudent pattern adherence positively related to global NLit score (P < 0·001, β = 0·36), indicating more intake of prudent diet foods with improved nutrition literacy. Validating the PCovR findings, PCA Western pattern adherence inversely related to global NLit (P = 0·003, β = −0·13) while PCA Mediterranean pattern positively related to global NLit (P = 0·02, β = 0·12). Using predefined cut points, those with poor nutrition literacy consumed more foods associated with the Western diet (fried foods, sugar-sweetened beverages, red meat, processed foods) while those with good nutrition literacy consumed more foods associated with prudent and Mediterranean diets (vegetables, olive oil, nuts).Conclusions:Nutrition literacy predicted adherence to healthy/unhealthy diet patterns. These findings warrant future research to determine if improving nutrition literacy effectively improves eating patterns.

IntroductionDisparities exist among Latino smokers with respect to knowledge and access to smoking cessation resources. This study tested the feasibility of using case management (CM) to increase access to pharmacotherapy and quitlines among Latino smokers.MethodsLatino smokers were randomized to CM (n = 40) or standard care (SC, n = 40). All participants received educational materials describing how to utilize pharmacy assistance for cessation pharmacotherapy and connect with quitlines. CM participants received four phone calls from staff to encourage pharmacotherapy and quitline use. At 6-months follow-up, we assessed the utilization of pharmacotherapy and quitline. Additional outcomes included self-reported smoking status and approval for pharmacotherapy assistance.ResultsUsing intention-to-treat analysis, CM produced higher utilization than SC of both pharmacotherapy (15.0% versus 2.5%; P = 0.108) and quitlines (12.5% versus 5.0%; P = 0.432), although differences were not statistically significant. Approval for pharmacotherapy assistance programs (20.0% versus 0.0%; P = 0.0005) was significantly higher for CM than SC participants. Self-reported point-prevalence smoking abstinence at 6-months were 20.0% and 17.5% for CM and SC, respectively (P = 0.775).ConclusionsCM holds promise as an effective intervention to connect Latino smokers to evidence-based cessation treatment.

Background Black-white differences in smoking abstinence are not well understood. This trial sought to confirm previously reported differences in quitting between blacks and whites and to identify factors underlying this difference. Methods During enrollment, 224 black and 225 white low-income smokers were stratified on race and within race on age and sex to ensure balance on these factors known to impact abstinence. The intervention included varenicline for 12 weeks and six guideline-based smoking cessation counseling sessions. The primary endpoint was cotinine-verified 7-day point prevalence smoking abstinence at week 26. A priori socioeconomic, smoking, treatment process (eg, treatment utilization, side effects, withdrawal relief), psychosocial, and biological factors were assessed to investigate race differences in abstinence. Unadjusted odds ratios (OR) were used to compare abstinence between blacks and whites. Adjusted odds ratios from logistic regression models were used to examine predictors of abstinence. All statistical tests were two-sided. Results Blacks were less likely to achieve abstinence at week 26 (14.3% vs 24.4%, OR = 0.51, 95% confidence interval [CI] = 0.32 to 0.83, P = .007). Utilizing best subsets logistic regression, five factors associated with race jointly predicted abstinence: home ownership (yes/no, OR = 3.03, 95% CI = 1.72 to 5.35, P Conclusions The race difference in abstinence was fully explained by lack of home ownership, lower income, greater neighborhood problems, higher baseline cotinine, and higher visit completion, which were disproportionately represented among blacks. Findings illuminate factors that make it harder for blacks in the United States to quit smoking relative to whites and provide important areas for future studies to reduce tobacco-related health disparities.

Introduction. Smoking is the number one preventable cause of deathin the United States. Under the Affordable Care Act, Kansas Medicaidcovers all seven FDA-approved smoking cessation therapies.However, it is estimated only 3% of Kansas Medicaid smokers usetreatment compared to the national estimate of 10%. The objectiveis to determine systemic barriers in place that prevent optimal utilizationof Medicaid smoking cessation benefits among KU MedicalCenter Internal Medicine patients. Methods. For this quality improvement project, a population of 169Kansas Medicaid smokers was identified who had been seen at the KUInternal Medicine Clinic from January 1, 2015 - February 16, 2016.Phone surveys were completed with 62 individuals about smokingstatus, interest in using smoking cessation treatment options, andawareness of Medicaid coverage of treatment. Results. Of the 62 respondents, 24 (39%) were prescribed pharmacotherapyand 41 (66%) were interested in using smoking cessationtreatment. There were eight who had quit smoking. Of the remaining54 smokers, 31 (57%) were unaware that Medicaid would coverpharmacotherapy. Of 24 participants who received a prescription forpharmacotherapy, 13 (54%) were able to fill the prescription at no costusing the Medicaid benefit. Conclusion. The majority of respondents were interested in usingsmoking cessation treatment, yet three main barriers existed to usingMedicaid smoking cessation benefits: physicians not prescribingtreatment to patients, patients not aware of Medicaid coverage, andinadequate pharmacy filling. Improved physician and patient awarenessof Medicaid coverage will facilitate more patients receivingsmoking cessation therapy and ultimately quitting smoking.KS J Med 2017;10(4):88-91.

Introduction. Smokefree for Kansas Kids is a program designedto train pediatric clinic staff to assess for tobaccoexposure and provide brief smoking cessation interventionsto caregivers and patients. The purpose of this studywas to evaluate the impact of this program and improvefuture tobacco intervention efforts in pediatric clinics. Methods. Eighty-six pediatric physicians and staff attendedat least one of three training sessions. A randomsample of pediatric medical records was selected pre-intervention(n = 49) and post-intervention (n = 150). Electronicmedical records were reviewed to assess for documentationof tobacco use intervention implemented in the clinic. Results. Of the 199 pediatric clinic visits reviewed, 197 metthe study criteria. All but one visit documented an assessmentof tobacco exposure. Among children exposed to tobacco (n= 42), providers were more likely to discuss tobacco use withcaregivers post-intervention (35.7%) compared to pre-intervention(7.1%; p < 0.05). One in five caregivers in the postinterventiongroup were advised to quit (21.4%) compared tothe pre-intervention group (7.1%). In the post-interventiongroup, 14.3% were referred to the state quitline compared tono referrals in the pre-intervention group. The difference inrates for providing advice and referral between pre-interventionand post-intervention were not statistically significant. Conclusions. Implementation of the Smoke Free for Kansas Kidsintervention was associated with modest improvements in clinictobacco intervention efforts, but many patients still failed toreceive optimal assessments or interventions. Additional effortsmay be needed to enhance this program. KS J Med 2017;10(1):7-11.

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 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

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.

Background Clinical practice guidelines recommend active surveillance as the preferred treatment option for low-risk prostate cancer, but only a minority of eligible men receive active surveillance, and practice variation is substantial. The aim of this study is to describe barriers to urologists’ recommendation of active surveillance in low-risk prostate cancer and explore variation of barriers by setting. Methods We conducted semi-structured interviews among 22 practicing urologists, evenly distributed between academic and community practice. We coded barriers to active surveillance according to a conceptual model of determinants of treatment quality to identify potential opportunities for intervention. Results Community and academic urologists were generally in agreement on factors influencing active surveillance. Urologists perceived patient-level factors to have the greatest influence on recommendations, particularly tumor pathology, patient age, and judgements about the patient’s ability to adhere to follow-up protocols. They also noted cross-cutting clinical barriers, including concerns about the adequacy of biopsy samples, inconsistent protocols to guide active surveillance, and side effects of biopsy procedures. Urologists had differing opinions on the impact of environmental factors, such as financial disincentives and fear of litigation. Conclusions Despite national and international recommendations, both academic and community urologists note a variety of barriers to implementing active surveillance in low risk prostate cancer. These barriers will need to be specifically addressed in efforts to help urologists offer active surveillance more consistently.

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.

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 Decidetexto, 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) Decidetexto or 2) standard of care. Decidetexto 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. Decidetexto 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, Decidetexto will be ready to be implemented in different community- and clinic-based settings to reduce tobacco-related disparities.

Introduction Nicotine Replacement Therapy (NRT) is an effective treatment for smoking cessation. However, medication usage and adherence remain a challenge that contributes to low smoking cessation rates. In Mexico, 8 in 10 smokers are interested in quitting. However, only 6% of Mexican smokers use medication for smoking cessation. The objective of this study is to assess the feasibility and acceptability of a mobile health (mHealth) intervention to increase usage and adherence of NRT in Mexico. Methods The study involves a secondary data analysis. Forty smokers were recruited to participate in a single-arm pilot study. Participants received an mHealth intervention that uses tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support. The intervention allows two-way interactivity text messaging between participants and a tobacco treatment specialist. NRT was offered to participants in accordance with practice guidelines in Mexico. Outcome measures included utilization of NRT, text messaging interactivity with the program, and biochemically verified abstinence at 12 weeks. Results Thirty smokers met the criteria for use of NRT. Average age of participants was 38.1 years (SD=10.7), and they were primarily male (56.7%) with at least an undergraduate degree (60%). All participants requested NRT at baseline, and 60% requested a refill at week 4. During the 12-week intervention period, participants sent 620 messages to the program (mean=20.6, SD=18.34) of which 79 messages (12.7%) were related to NRT. Three themes were identified in the messages related to NRT: enthusiasm, instructions, and side effects. At 12 weeks, 40% of participants reported using NRT

Introduction: Understanding the factors that drive cessation may help inform patient counseling and improve quit rates. We aimed to determine if the type of atherosclerotic cardiovascular disease (ASCVD) event impacts the patient’s likelihood of quitting, independent of patient factors. Hypothesis: We assessed the hypothesis that more impactful ASCVD events would be associated with a greater likelihood of smoking cessation (e.g., more likely to quit after CABG vs PCI). Methods: Using 2013-2016 data from the NCDR PINNACLE outpatient cardiac registry, we identified patients who were current smokers and had an eventual diagnosis of ASCVD. Self-reported smoking status was assessed at each consecutive visit and rates of smoking cessation after each interim ASCVD event (MI, PCI, CABG, stroke/TIA, and PAD diagnosis) were examined. We then constructed separate Cox models with non-proportional hazards for interim ASCVD events (time-dependent covariates), adjusting for age, sex, race, dyslipidemia, diabetes, hypertension, and heart failure; and compared models using AIC. Results: Across 358 cardiology practices, 378478 patients were smokers who eventually had ASCVD (mean age 65.8±11.9, male 63.6%). Cessation rates after each ASCVD event were: MI 30.5%, PCI 30.7%, CABG 28.5%, stroke/TIA 24.7%, and PAD 24.6% (Table). After multivariable adjustment, patients were more likely to quit smoking after a stroke/TIA (HR 2.46, 95% CI 2.40-2.52) followed by CABG (HR 2.45, 95% CI 2.37-2.53), PCI (HR 1.85, 95% CI 1.79-1.91), MI (HR 1.79, 95% CI 1.72-1.86), and a new diagnosis of PAD (HR 1.47, 95% CI 1.42-1.51); p Conclusion: In a large US registry, we found that only ~25-30% of patients reported quitting smoking after an ASCVD event, but the type of ASCVD event significantly impacts the likelihood of smoking cessation. Using these data to inform patient counseling—targeting cessation efforts to those most likely to quit—may help improve outcomes.

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.

To describe use of human papilloma virus (HPV) and meningococcal (MenACWY) vaccines among sixth and seventh grade Kansas children receiving their school-required tetanus, diphtheria, and acellular pertussis (Tdap) booster.We used Medicaid and commercial claims data in Kansas from 2013, 2014, and 2015 to identify HPV and MenACWY vaccinations among sixth and seventh graders receiving a Tdap booster. Rates of concomitant vaccinations were calculated at the state and county level, and logistic regression was used to identify predictors of concomitant vaccination.Of sixth and seventh graders in Kansas receiving their required Tdap booster, 53-82% failed to receive a concomitant HPV vaccine and 36-47% failed to receive a concomitant MenACWY vaccine from 2013 to 2015. Rates of concomitant vaccinations varied more than four-fold across counties. Female gender, younger age, and Medicaid (versus commercial insurance) were positively associated with concomitant vaccination; concomitant vaccination rates increased from 2013 to 2015 (p 0.001). Of children continuously enrolled in Medicaid from 2013 to 2015, who did not receive concomitant vaccination in 2013, 72.3% and 68.6% remained unvaccinated against HPV and MenACWY, respectively by the end of 2015.Failure to get a concomitant vaccination at the time of their Tdap booster identifies children at high risk of not getting immunized in the ensuing 2-3 years. 'Back to school' programs focusing only on school-required vaccinations could have negative impacts on overall vaccination rates. Tracking rates of concomitant vaccination might be useful in supporting quality assessment and improvement efforts.This study was not a clinical trial.

Objectives Although many states have expanded Medicaid coverage of cessation medications, utilization remains low. Anecdotal reports suggest that beneficiaries are at times denied coverage of cessation medications at the pharmacy counter. We conducted an observational community-wide case study of Medicaid beneficiary attempts to fill over-the-counter nicotine replacement therapy at pharmacies. Methods We recruited tobacco-using beneficiaries from a Federally Qualified Health Center, whose providers wrote paper prescriptions for nicotine patches. Study staff escorted beneficiaries to all eligible pharmacies (n = 18) in a Midwestern community to observe fill attempts. Study staff recorded encounters via smartphone into a secure database on a university server. Results Seven of 18 pharmacies (39%) did not fill the prescription on the day of the attempt. Of these, 6 offered to order the patch for pick-up at a later date. All (4/4) chain pharmacies filled the prescription; 2/3 mass merchant pharmacies failed to fill. Combining successful same-day fills with offers to order for pick-up, 17/18 (94%) would ultimately have been able to obtain patches. Conclusion This pilot study found that many beneficiaries left pharmacies without a prescription in hand. Successful same-day fills varied markedly by store type. For people with low incomes, transportation presents a major barrier for delayed pick-up. In addition, delays can fuel ambivalence toward quitting. Future research based on this pilot study might address whether patients who fail to secure a same-day prescription ever fill the prescription and, if not, the degree to which this barrier contributes to success or failure in quitting.

Adults in rural areas have a higher prevalence of obesity and some mental health conditions. The degree to which mental health influences weight loss among rural residents remains unclear. This study evaluated changes in body weight, physical activity, diet, and program engagement outcomes in a cohort of participants with vs. without an affective disorder in a behavioral weight loss trial.A sample of 1407 adults with obesity were recruited from rural U.S. primary care practices to participate in a weight loss trial. In this secondary analysis, participants were stratified by those with vs. without an affective disorder at baseline. Mixed models were used to estimate changes in outcomes over 24 months.One-third of participants (n = 468) had an affective disorder. After covariate adjustment, both groups experienced significant weight loss over 24 months, but weight loss was significantly less among those with an affective disorder at all follow-up times (all p's 0.001; 24-month weight loss -2.7 ± 0.4 vs. -4.8 ± 0.3 kg). Compared to those without an affective disorder, participants with an affective disorder also had significantly less improvement in physical activity and fruit/vegetable consumption, lower attendance at weight loss sessions, and less engagement in setting weight loss goals and strategies.Participants with an affective disorder lost less body weight and less improvement in lifestyle measures over 24 months. These trends paralleled reduced engagement in critical intervention activities such as weight loss session attendance. Future interventions should consider additional methods to minimize disengagement in adults with underlying affective disorders.

IntroductionThe translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.MethodsIn 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.ResultsThis paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.ConclusionsWe anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

BACKGROUND AND AIMS One-third of US tobacco users are non-daily smokers (NDS). Black NDS have strikingly high levels of nicotine and carcinogen exposure. No smoking cessation studies have been conducted with this high-risk group. This study compared the effectiveness in black NDS of smoking cessation counseling alone or in combination with the participant's choice of nicotine replacement therapy. DESIGN Two-arm parallel-group individually randomized clinical trial (allocation ratio of 2 : 1 intervention to control) SETTING: Academic medical and federally qualified health centers in three US cities. PARTICIPANTS Non-Hispanic black adult NDS receiving counseling with nicotine replacement therapy (C + NRT, n = 185) or counseling alone (C, n = 93). INTERVENTIONS Twelve weeks of in-person and telephone smoking cessation counseling in combination with nicotine replacement therapy (NRT; C + NRT) or counseling alone (C). All participants received five sessions of counseling; those randomized to C + NRT received their choice of nicotine gum, patch and/or lozenge after a 9-day product trial period. The target quit day was set at 2 weeks post-baseline for both groups. MEASUREMENTS Primary outcome was biochemically verified 30-day abstinence at week 12. Secondary outcomes were change in nicotine and carcinogen exposure [4-(methynitrosamino)-1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns. FINDINGS Abstinence was 11.4% in C + NRT and 8.6% in C [odds ratio (OR) = 1.4, 95% confidence interval (CI) = 0.6, 3.2, P = 0.48]. Both groups experienced significant reduction in NNAL (C + NRT: 53% reduction, C: 50% reduction, within-group P

BACKGROUND: Cessation counseling and pharmacotherapy are recommended for hospitalized smokers, but better coordination between cessation counselors and providers might improve utilization of pharmacotherapy and enhance smoking cessation. OBJECTIVE: To compare smoking cessation counseling combined with care coordination post-hospitalization to counseling alone on uptake of pharmacotherapy and smoking cessation. DESIGN: Unblinded, randomized clinical trial PARTICIPANTS: Hospitalized smokers referred from primarily rural hospitals INTERVENTIONS: Counseling only (C) consisted of telephone counseling provided during the hospitalization and post-discharge. Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker’s health care team and help for the smoker in obtaining pharmacotherapy. At 6 months post-hospitalization, persistent smokers were re-engaged with either CCC or C. MAIN MEASURES: Utilization of pharmacotherapy and smoking cessation at 3, 6, and 12 months post-discharge. KEY RESULTS: Among 606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis. Use of any cessation pharmacotherapy between 0 and 6 months (55.2%) and between 6 and 12 months (47.1%) post-discharge was similar across treatment arms though use of prescription-only pharmacotherapy between months 6–12 was significantly higher in the CCC group (30.1%) compared with the C group (18.6%) (RR, 1.61 (95% CI, 1.08, 2.41)). Self-reported abstinence rates of 26.2%, 20.3%, and 23.4% at months 3, 6, and 12, respectively, were comparable across the two treatment arms. Of those smoking at month 6, 12.5% reported abstinence at month 12. Validated smoking cessation at 12 months was 19.3% versus 16.9% in the CCC and C groups, respectively (RR, 1.13 (95% CI, 0.80, 1.61)). CONCLUSION: Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone. Re-engagement of smokers 6 months post-discharge can lead to new quitters, at which time care coordination might facilitate use of prescription medications. TRIAL REGISTRATION: NCT01063972

Purpose To analyze the literature on advance care planning (ACP) in primary care through the lens of implementation science, with a focus on implications for rural settings. Design Scoping review of the literature. Methods The Cumulative Index of Nursing and Allied Health Literature (CINAHL), Medline, PsycINFO, and the Psychology and Behavioral Sciences Collection databases were searched for studies related to ACP adoption and implementation in primary care. The Theoretical Domains Framework was used to map the literature to 14 determinants that serve as barriers or facilitators to ACP. The Conceptual Model of Evidence-Based Practice Implementation in Public Service Sectors was used to analyze the stage of implementation for each of the included studies. Findings Four steps to ACP were specified: identification, conversation, documentation, and follow-up. Determinants were identified for each step, but studies largely focused on the conversation step. Professional role and identity, environmental context and resources, and emotion were the most frequently cited determinants in initiating conversations. The identification step was largely determined by behavioral regulation. For documenting ACP, environmental context and resource determinants were most prevalent. In the few studies that addressed follow-up, providers expressed a desire for electronic reminders as a behavioral regulator to follow-up. Conclusions While ACP has been shown to have patient, family, and societal benefits, its uptake in primary care has been minimal. Because ACP is a complex process that is highly context dependent, implementation science is critical to inform its successful adoption and implementation. Smaller healthcare networks, adaptable professional roles, trusted relationships, and tight-knit community might be important facilitators of ACP in rural primary care. Clinical relevance Findings from this study can be used to accelerate ACP implementation in rural primary care.

Introduction: While smoking remains one of the leading causes of death in Mexico, uptake of evidence-based cessation therapy remains low. Widespread use of mobile devices and internet in Mexico has created new avenues for providing access to cessation treatment. Methods: We assessed the feasibility and acceptability of “Vive Sin Tabaco… ¡Decídete!” (English: Live without Tobacco…. Decide!), a web-based, informed decision-making tool designed to help Mexican smokers develop a quit plan and take advantage of cessation resources. We invited 164 smokers in two primary care clinics. Measures included physical, situational, and psychological nicotine dependence, interest in using pharmacotherapy and counseling, smoking status at 3 months, and satisfaction with the program. Results: Most participants were light smokers and reported low-to-moderate nicotine dependence. Immediately after using ¡Vive Sin Tabaco… ¡Decídete!, the majority were interested in quitting, set a quit date, and reported interest in using pharmacotherapy and cessation counseling. Follow-up rate at 3 months was 81.5%; seven-day point prevalence abstinence was 19.1% using intention-to-treat analysis. Conclusion: Integration of e-Health tools in primary healthcare settings has the potential to improve knowledge about cessation treatments among smokers and integrate smoking cessation into routine of care.

Key Points Question Compared with standard cessation approaches, can long-term nicotine replacement therapy lead to higher rates of cessation or reductions in carcinogen exposure among smokers with chronic obstructive pulmonary disease? Findings In this randomized clinical trial of 398 smokers with chronic obstructive pulmonary disease, 23 of 197 (11.7%) receiving a standard smoking cessation intervention had quit at 12 months, compared with 24 of 197 (12.2%) receiving long-term nicotine replacement therapy. Both groups had comparable reductions in carcinogen and smoke exposure. Meaning Long-term nicotine replacement therapy provides an option for smokers with chronic obstructive pulmonary disease but does not result in greater rates of cessation or harm reduction., This randomized clinical trial compares the effect of long-term nicotine replacement therapy vs standard smoking cessation on exposure to cigarette smoke, harm related to smoking, and smoking cessation among smokers with chronic obstructive pulmonary disease., Importance Smokers with chronic obstructive pulmonary disease (COPD) have particular difficulty quitting. Long-term nicotine replacement therapy (LT-NRT) might offer a strategy for reducing harm from cigarettes and provide a pathway for later cessation. Objective To compare the effect of LT-NRT vs standard smoking cessation (SSC) on exposure to cigarette smoke, harm related to smoking, and cessation among smokers with COPD. Design, Setting, and Participants This unblinded, randomized clinical trial recruited smokers who self-reported a diagnosis of COPD at any level of readiness to quit from May 23, 2014, through November 30, 2015. The 12-month follow-up was completed December 6, 2016. Patients were recruited at a clinical research unit of an academic medical center. Analysis was based on intention to treat and performed from March 8 through November 30, 2017. Interventions Standard smoking cessation treatment included 10 weeks of NRT and 4 follow-up counseling sessions for those willing to make a quit attempt. Long-term NRT included 12 months of NRT and 6 follow-up counseling sessions regardless of initial willingness to quit. Overall, 198 patients were randomized to SSC, and 197 were included in the primary analysis; 200 patients were randomized to LT-NRT, and 197 were included in the primary analysis. Main Outcomes and Measures The primary outcome was 7-day abstinence verified by carbon monoxide (CO) levels at 12 months. Secondary outcomes included cigarettes smoked per day (CPD), exposure to CO, urinary excretion of 4-methylnitrosamino-1-3-pyridyl-1-butanol (NNAL) (a smoking-related carcinogen), and adverse events. Results Among 398 patients who were randomized (59.8% female; mean [SD] age, 56.0 [9.3] years), the mean (SD) CPD was 23.1 (12.3). Twelve-month follow-up was completed by 373 participants (93.7%), and 394 (99.0%) were included in the primary analysis. At 12 months, CO-verified abstinence occurred in 23 of 197 participants (11.7%) in the SSC arm and 24 of 197 (12.2%) in the LT-NRT arm (risk difference, 0.5%; 95% CI, −5.9% to 6.9%). Continuing smokers in the SSC and LT-NRT arms had similar, significantly reduced harms caused by smoking, including cigarette consumption by 12.4 and 14.5 CPD, respectively, exhaled CO level by 5.5 and 7.8 ppm, respectively, and mean urinary NNAL excretion by 21.7% and 23.0%, respectively. In multivariate analyses, continuing smokers with greater adherence to NRT experienced less reduction in NNAL exposure. The frequency of major adverse cardiac events was similar in both groups. Conclusions and Relevance Similar rates of cessation and similar reductions in exposure to tobacco smoke resulted with LT-NRT and SSC. Among continuing smokers, ongoing use of NRT was not associated with reductions in smoke exposure. Trial Registration ClinicalTrials.gov Identifier: NCT02148445

Importance Rural populations have a higher prevalence of obesity and poor access to weight loss programs. Effective models for treating obesity in rural clinical practice are needed. Objective To compare the Medicare Intensive Behavioral Therapy for Obesity fee-for-service model with 2 alternatives: in-clinic group visits based on a patient-centered medical home model and telephone-based group visits based on a disease management model. Design, setting, and participants Cluster randomized trial conducted in 36 primary care practices in the rural Midwestern US. Inclusion criteria included age 20 to 75 years and body mass index of 30 to 45. Participants were enrolled from February 2016 to October 2017. Final follow-up occurred in December 2019. Interventions All participants received a lifestyle intervention focused on diet, physical activity, and behavior change strategies. In the fee-for-service intervention (n = 473), practice-employed clinicians provided 15-minute in-clinic individual visits at a frequency similar to that reimbursed by Medicare (weekly for 1 month, biweekly for 5 months, and monthly thereafter). In the in-clinic group intervention (n = 468), practice-employed clinicians delivered group visits that were weekly for 3 months, biweekly for 3 months, and monthly thereafter. In the telephone group intervention (n = 466), patients received the same intervention as the in-clinic group intervention, but sessions were delivered remotely via conference calls by centralized staff. Main outcomes and measures The primary outcome was weight change at 24 months. A minimum clinically important difference was defined as 2.75 kg. Results Among 1407 participants (mean age, 54.7 [SD, 11.8] years; baseline body mass index, 36.7 [SD, 4.0]; 1081 [77%] women), 1220 (87%) completed the trial. Mean weight loss at 24 months was -4.4 kg (95% CI, -5.5 to -3.4 kg) in the in-clinic group intervention, -3.9 kg (95% CI, -5.0 to -2.9 kg) in the telephone group intervention, and -2.6 kg (95% CI, -3.6 to -1.5 kg) in the in-clinic individual intervention. Compared with the in-clinic individual intervention, the mean difference in weight change was -1.9 kg (97.5% CI, -3.5 to -0.2 kg; P = .01) for the in-clinic group intervention and -1.4 kg (97.5% CI, -3.0 to 0.3 kg; P = .06) for the telephone group intervention. Conclusions and relevance Among patients with obesity in rural primary care clinics, in-clinic group visits but not telephone-based group visits, compared with in-clinic individual visits, resulted in statistically significantly greater weight loss at 24 months. However, the differences were small in magnitude and of uncertain clinical importance. Trial registration ClinicalTrials.gov Identifier: NCT02456636.

Introduction Despite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing for inducing cessation-related behaviors among smokers with low motivation to quit. Design Randomized clinical trial. Setting/participants Two-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010–2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014. Intervention Four sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients' own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit. Main outcomes measures Self-reported quit attempts; smoking abstinence (biochemically verified); use of cessation pharmacotherapies; motivation; and confidence to quit were assessed at baseline and 3- and 6-month follow-ups. Results Unexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p =0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% risk difference, 95% CI=3%, 13%, p =0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p =0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all p d =0.36, 95% CI=0.12, 0.60). Conclusions Although Motivational Interviewing was generally more efficacious than brief advice in inducing cessation behaviors, health education appeared the most efficacious. These results highlight the need to identify the contexts in which Motivational Interviewing may be most efficacious and question recommendations to use Motivational Interviewing rather than other less complex cessation induction interventions. Trial registration This study is registered at www.clinicaltrials.gov NCT01188018.

Background/Aims: Whether angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) are differentially associated with reductions in cardiovascular events and mortality in patients receiving maintenance dialysis is uncertain. We compared outcomes between ACE and ARB users among hypertensive, maintenance dialysis patients. Methods: National retrospective cohort study of hypertensive, Medicare-Medicaid eligible patients initiating chronic dialysis between 1/1/2000 to 12/31/2005. The exposure of interest was new use of either an ACEI or ARB. Outcomes were all-cause mortality (ACM) and combined cardiovascular hospitalization or death (CV-endpoint). Cox proportion hazards models were used to compare the effect of ACEI vs ARB use on ACM and, separately, CV-endpoint. Results: ACM models were based on 3,555 ACEI and 1,442 ARB new users, while CV-endpoint models included 3,289 ACEI and 1,346 ARB new users. After statistical adjustments, ACEI users had higher hazard ratios for ACM (AHR = 1.22, 99% CI 1.05-1.42) and CV-endpoint (AHR = 1.12, 99% CI 0.99-1.27). Conclusions: Patients initiating maintenance dialysis who received an ACEI faced an increased risk for mortality and a trend towards an increased risk for CV-endpoints when compared to patients who received an ARB. Validation of these results in a rigorous clinical trial is warranted.