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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 Of the 14.3 million Mexicans who smoke, only a minority take advantage of evidence-based approaches to smoking cessation. Mobile health interventions have the potential to increase the reach of effective cessation interventions in Mexico. OBJECTIVE This study aimed to assess the feasibility and acceptability of an innovative, personalized, and interactive smoking cessation mobile intervention developed for Mexican smokers. METHODS We recruited 40 Mexican smokers to participate in Vive sin Tabaco... ¡Decídete!, a smoking cessation program that uses a tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support. Outcome measures included participant text messaging interactivity with the program, participant satisfaction, and 12-week verified abstinence using urinary cotinine testing or exhaled carbon monoxide. RESULTS Average age of the participants was 36 years (SD 10.7), and they were primarily male (65%, 26/40) with at least an undergraduate degree (62%, 25/40). Most participants (95%, 38/40) smoked daily and were interested in quitting in the next 7 days. As an indicator of participant interactivity, participants sent an average of 21 text messages during the 12-week intervention (SD 17.62). Of the 843 messages that participants sent to the program, only 96 messages (11.3%, 96/843) used keywords. At 12 weeks, 40% (16/40) of participants were biochemically verified (87%, 35/40, follow-up rate). The majority of participants (85%, 30/35) reported being very satisfied or extremely satisfied with the program. CONCLUSIONS The Vive sin Tabaco... ¡Decídete! smoking cessation mobile intervention was accepted by participants, generated high satisfaction and high text messaging interactivity, and resulted in a noteworthy cessation rate at the end of treatment. This intervention is a promising strategy for smoking cessation in Mexico. Additional testing as a formal randomized clinical trial appears warranted.

Background Smoking is the most important risk factor for peripheral artery disease ( PAD ). Smoking cessation is key in PAD management. We aimed to examine smoking rates and smoking cessation interventions offered to patients with PAD consulting a vascular specialty clinic; and assess changes in smoking behavior over the year following initial visit. Methods and Results A total of 1272 patients with PAD and new or worsening claudication were enrolled at 16 vascular specialty clinics (2011–2015, PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry). Interviews collected smoking status and cessation interventions at baseline, 3, 6, and 12 months. Among smokers, transition state models analyzed smoking transitions at each time point and identified factors associated with quitting and relapse. On presentation, 474 (37.3%) patients were active, 660 (51.9%) former, and 138 (10.8%) never smokers. Among active smokers, only 16% were referred to cessation counseling and 11% were prescribed pharmacologic treatment. At 3 months, the probability of quitting smoking was 21%; among those continuing to smoke at 3 months, the probability of quitting during the next 9 months varied between 11% and 12% ( P Conclusions More than one third of patients with claudication consulting a PAD provider are active smokers and few received evidence‐based cessation interventions. Patients appear to be most likely to quit early in their treatment course, but many quickly relapse and 72% of all patients smoking at baseline are still smoking at 12 months. Better strategies are needed to provide continuous cessation support. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifier: NCT 01419080.

Background Non-daily smokers (NDS) who smoke on some but not all days are a growing subset of United States (US) tobacco users. Racial/ethnic minorities are more likely to be NDS. African American NDS have strikingly high levels of nicotine and carcinogen exposure, making treatment of this high risk group a priority. Methods The current study is one of three ongoing federally-funded clinical trials of NDS and, to our knowledge the only RCT focused on racial/ethnic minority NDS. The design has been guided by input from Patient and Stakeholder Advisory Panels who helped develop the research questions, design the intervention, and select the outcomes. The objective is to compare the effectiveness of smoking cessation counseling alone (C) or smoking cessation counseling plus participant's choice of nicotine replacement therapy (NRT; C + NRT) for African American NDS. Two-hundred seventy-eight African American NDS will be randomized in a 2:1 fashion to C + NRT or C. All participants receive five sessions of smoking cessation counseling; those randomized to C + NRT receive their choice of nicotine gum, patch, and/or lozenge. Treatment in both groups lasts for 12 weeks. We hypothesize that C + NRT will be more effective than C on the primary outcome of biochemically-confirmed abstinence from smoking at week 12. Secondary aims will compare C + NRT and C on patient- and provider-desired outcomes including abstinence from smoking at week 26, change in biochemically-verified nicotine and carcinogen exposure, days abstinent, and treatment process measures (e.g., NRT use and side effects). Predictors of abstinence will also be explored. Discussion Findings will illuminate effective treatment options for African American NDS and contribute to development of evidence-based guidelines for treating the 8.9 million US adult NDS for whom no guidelines currently exist. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov : NCT02244918

Background Most smokers struggle to overcome tobacco addiction. Neuroscientific models of addiction emphasize the importance of brain regions associated with cognitive control and reward to understand the cycle of addiction and relapse. During an attempt at abstinence, the cognitive control system appears to be underpowered to override the heightened reward system of the addicted brain. Thus, one neural target for treatment is to strengthen the cognitive control system. It may be possible to improve the functioning of the cognitive control system via deliberate practice. Methods/design This study will determine the effects of practicing delaying smoking on brain and behavioral measures of cognitive control. Smoking patterns will be monitored for 1 week and then smokers (N = 80) will be randomized to either practice cognitive control by delaying their first cigarette of the day for 2 weeks (practice group) or they will continue monitoring only (no practice group). Functional magnetic resonance imaging will be performed while smokers regulate their responses to smoking images (i) at baseline and (ii) after 2 weeks of practice (or no practice). Discussion The primary aim of this study will be to identify the impact of practicing cognitive control on functional brain activation changes in response to smoking cues. If successful, this project will establish a neurobiological biomarker for increasing cognitive control and demonstrate the feasibility of neuroimaging methods to predict the efficacy of an intervention without a large clinical trial. Trial Registration ClinicalTrials.gov, NCT03080844. Registered March 15, 2017 Electronic supplementary material The online version of this article (10.1186/s13063-018-2984-x) contains supplementary material, which is available to authorized users.

BACKGROUND: Cigarettes have been strongly associated with subsequent marijuana use among adolescents, but electronic cigarettes (e-cigarettes) are now rapidly replacing traditional cigarettes among youth. This study examines associations between youth e-cigarette use and subsequent marijuana use in a national sample. METHODS: Youth (aged 12–17 years) never marijuana users at wave 1 (n = 10 364; 2013–2014) from the Population Assessment of Tobacco and Health study were followed-up in 1 year (wave 2, 2014–2015). Multivariable logistic regressions were performed to evaluate associations between e-cigarette use at wave 1 and ever/heavy marijuana use in the past 12 months (P12M) and at wave 2. RESULTS: Among never marijuana users, e-cigarette ever use (versus never use) at wave 1 was associated with increased likelihood of marijuana P12M use (adjusted odds ratio [aOR] = 1.9; 95% confidence interval [CI]: 1.4–2.5) at wave 2. There was a significant interaction between e-cigarette use and age (P < .05) with aOR = 2.7 (95% CI: 1.7–4.3) for adolescents aged 12 to 14 and aOR = 1.6 (95% CI: 1.2–2.3) for adolescents aged 15 to 17. The association with heavy marijuana use was significant among younger adolescents (aOR = 2.5; 95% CI: 1.2–5.3) but was not among older adolescents. Heavier e-cigarette use at wave 1 yielded higher odds of P12M and heavy marijuana use at wave 2 for younger adolescents. CONCLUSIONS: E-cigarette use predicts subsequent marijuana use among youth, with a stronger associations among young adolescents. Reducing youth access to e-cigarettes may decrease downstream marijuana use.

Introduction Smokefree for Kansas Kids is a program designed to train pediatric clinic staff to assess for tobacco exposure and provide brief smoking cessation interventions to caregivers and patients. The purpose of this study was to evaluate the impact of this program and improve future tobacco intervention efforts in pediatric clinics. Method Eighty-six pediatric physicians and staff attended at least one of three training sessions. A random sample of pediatric medical records was selected pre-intervention (n = 49) and post-intervention (n = 150). Electronic medical records were reviewed to assess for documentation of tobacco use intervention implemented in the clinic. Results Of the 199 pediatric clinic visits reviewed, 197 met the study criteria. All but one visit documented an assessment of tobacco exposure. Among children exposed to tobacco (n = 42), providers were more likely to discuss tobacco use with caregivers post-intervention (35.7%) compared to pre-intervention (7.1%; p < 0.05). One in five caregivers in the post-intervention group were advised to quit (21.4%) compared to the pre-intervention group (7.1%). In the post-intervention group, 14.3% were referred to the state quitline compared to no referrals in the pre-intervention group. The difference in rates for providing advice and referral between pre-intervention and post-intervention were not statistically significant. Conclusions Implementation of the Smoke Free for Kansas Kids intervention was associated with modest improvements in clinic tobacco intervention efforts, but many patients still failed to receive optimal assessments or interventions. Additional efforts may be needed to enhance this program.

Objective To test the reliability and validity of the Nutrition Literacy Assessment Instrument (NLit) in adult primary care and identify the relationship between nutrition literacy and diet quality. Design This instrument validation study included a cross-sectional sample participating in up to 2 visits 1 month apart. Setting/Participants A total of 429 adults with nutrition-related chronic disease were recruited from clinics and a patient registry affiliated with a Midwestern university medical center. Main Outcome Measures Nutrition literacy was measured by the NLit, which was composed of 6 subscales: nutrition and health, energy sources in food, food label and numeracy, household food measurement, food groups, and consumer skills. Diet quality was measured by Healthy Eating Index–2010 with nutrient data from Diet History Questionnaire II surveys. Analysis The researchers measured factor validity and reliability by using binary confirmatory factor analysis; test-retest reliability was measured by Pearson r and the intraclass correlation coefficient, and relationships between nutrition literacy and diet quality were analyzed by linear regression. Results The NLit demonstrated substantial factor validity and reliability (0.97; confidence interval, 0.96–0.98) and test-retest reliability (0.88; confidence interval, 0.85–0.90). Nutrition literacy was the most significant predictor of diet quality (β = .17; multivariate coefficient = 0.10; P Conclusions The NLit is a valid and reliable tool for measuring nutrition literacy in adult primary care patients.

Background The Self-management and Care of Heart Failure through Group Clinics Trial evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high-risk heart failure (HF) patients. Objective The purpose of this article is to (1) describe key Self-management and Care of Heart Failure through Group Clinics Trial group clinic interactive learning strategies, (2) describe resources and materials used in the group clinic appointment, and (3) present results supporting this patient-centered group intervention. Methods This clinical trial included 198 HF patients (randomized to either group clinical appointments or to standard care). Data were collected from 72 group clinic appointments via patients' (1) group clinic session evaluations, (2) HF self-care behaviors skills, (3) HF-related discouragement and quality of life scores, and (4) HF-related reshopitalizations during the 12-month follow-up. Also, the costs of delivery of the group clinical appointments were tabulated. Results Overall, patients rated group appointments as 4.8 of 5 on the "helpfulness" in managing HF score. The statistical model showed a 33% decrease in the rate of rehospitalizations (incidence rate ratio, 0.67) associated with the intervention over the 12-month follow-up period when compared with control patients (χ(2)1=3.9, P=.04). The total cost for implementing 5 group appointments was $243.58 per patient. Conclusion The intervention was associated with improvements in HF self-care knowledge and home care behavior skills and managing their for HF care. In turn, better self-care was associated with reductions in HF-related hospitalizations.

Less than 10% of all adult patients with cancer participate in cancer clinical trials (Baquet, Ellison, & Mishra, 2009; Comis, Miller, Aldige, Krebs, & Stoval, 2003; Sateren et al., 2002). Participation in clinical cancer research studies is even lower for patients from vulnerable minority populations (Murthy, Krumholz, & Gross, 2004), and little is known about the participation rates of rural Latinos. Multi-level barriers hinder participation in clinical research among minority patients (Anwuri et al., 2013; Hubbard, Kidd, Donaghy, McDonald, & Kearney, 2007; Schmotzer, 2012). Among Latinos and other immigrant groups, limited English proficiency serves as a barrier to participation in clinical research, with about half of U.S. Latino families reporting Spanish as their primary language (Schnoll et al., 2005). Temporary pending migrant or undocumented status further impedes access to clinical research and services among immigrant Latinos in the United States (Loue, Faust, & Bunce, 2000). Fortunately, evidence suggests that when they are provided with opportunities to participate, minority patients participate in clinical research studies, including those focused on cancer, at the same rate as non-Latino Caucasians (Wendler et al., 2005). Building community infrastructure to enhance participation in cancer research is critical, particularly in vulnerable ethnic minority and rural communities that typically face the additional burden of geographic isolation (Chiu, Mitchell, & Fitch, 2013; Schensul & Trickett, 2009). Interventions that use multi-level networking and capacity-building strategies have effectively engaged Latino communities in cancer research. Including multi-ethnic populations in all stages of the cancer research continuum is more likely to generate research programs that are more responsive to the groups largely affected by cancer disparities (Baquet, Commiskey, Daniel Mullins, & Mishra, 2006). In fact, a systematic review of community-based participatory approaches to conducting randomized clinical trials found that most of these were effective in recruiting and retaining minority populations and resulted in significant health improvement (De las Nueces, Hacker, DiGirolamo, & Hicks, 2012). A community-participatory model that has been employed effectively in minority communities and fits well within the Latino cultural context is the use of promotores de salud, or community lay health workers. Promotores programs have used social networks to successfully disseminate information on prevention (e.g., immunizations, physical activity) (Ayala, Vaz, Earp, Elder, & Cherrington, 2010), early detection (e.g., cancer screening) (Larkey et al., 2012; Wells et al., 2011), and self-management of chronic illnesses (e.g., diabetes self-care) (McCloskey, 2009). Recently, promotores have been used to increase participation in cancer research studies (Elliott, Belinson, Ottolenghi, Smyth, & Belinson, 2013; Guadagnolo et al., 2009; Livaudais et al., 2010), but the feasibility of extending these models to rural Latino communities requires further evaluation. The aims of this study were to describe community-based participatory processes used to develop a promotore leadership and cancer research education training curriculum for use among rural, Spanish-speaking Latinos, and to assess the feasibility of training a core of rural, Spanish-speaking promotores to disseminate information on cancer and cancer research among rural Latinos. The intent was to build community capacity to test in a future study the effects of the promotore-delivered intervention on attitudes and willingness to participate in cancer research among rural Latino communities in Kansas.

Context Low-income and racial/ethnic minority populations experience disproportionate colorectal cancer (CRC) burden and poorer survival. Novel behavioral strategies are needed to improve screening rates in these groups. Background The study aimed to test a theoretically based "implementation intentions" intervention for improving CRC screening among unscreened adults in urban safety-net clinics. Design Randomized controlled trial. Setting/participants Adults ( N =470) aged ≥50 years, due for CRC screening, from urban safety-net clinics were recruited. Intervention The intervention (conducted in 2009−2011) was delivered via touchscreen computers that tailored informational messages to decisional stage and screening barriers. The computer then randomized participants to generic health information on diet and exercise (Comparison group) or "implementation intentions" questions and planning (Experimental group) specific to the CRC screening test chosen (fecal immunochemical test or colonoscopy). Main outcome measures The primary study outcome was completion of CRC screening at 26 weeks based on test reports (analysis conducted in 2012−2013). Results The study population had a mean age of 57 years and was 42% non-Hispanic African American, 28% non-Hispanic white, and 27% Hispanic. Those receiving the implementation intentions−based intervention had higher odds (AOR=1.83, 95% CI=1.23, 2.73) of completing CRC screening than the Comparison group. Those with higher self-efficacy for screening (AOR=1.57, 95% CI=1.03, 2.39), history of asthma (AOR=2.20, 95% CI=1.26, 3.84), no history of diabetes (AOR=1.86, 95% CI=1.21, 2.86), and reporting they had never heard that "cutting on cancer" makes it spread (AOR=1.78, 95% CI=1.16, 2.72) were more likely to complete CRC screening. Conclusions The results of this study suggest that programs incorporating an implementation intentions approach can contribute to successful completion of CRC screening even among very low-income and diverse primary care populations. Future initiatives to reduce CRC incidence and mortality disparities may be able to employ implementation intentions in large-scale efforts to encourage screening and prevention behaviors.

Background Most health care providers do not treat tobacco dependence routinely. This may in part be due to the treatment “default.” Current treatment guidelines recommend that providers (1) ask patients if they are willing to quit and (2) provide cessation-focused medications and counseling only to smokers who state that they are willing to quit. The default is that patients have to “opt in” to receive cessation assistance: providers ask smokers if they are willing to quit, and only offer medications and cessation support to those who say “yes.” This drastically limits the reach of cessation services because, at any given encounter, only one in three smokers say that they are ready to quit. The objective of this study is to determine the impact of providing all smokers with tobacco-cessation treatment unless they refuse it (OPT OUT) versus current practice—screening for readiness and only offering treatment to smokers who say they are ready to quit (OPT IN). Methods This individually randomized clinical trial is conducted in a tertiary-care hospital. We will conduct the trial among up to 1000 randomly selected hospitalized smokers to determine the population impact of changing the treatment default, identify mediators of outcome, and determine the cost-effectiveness of this new, highly proactive approach. This is a population-based study that targets an endpoint of vital interest; applies minimal eligibility criteria to broaden generalizability; and utilizes hospital staff for interventions to ensure long-term sustainability. The study employs delayed consent and an innovative Bayesian adaptive design to evaluate a major shift in our approach to care. If effective, this change would expand the reach of tobacco-cessation treatment from 30% to 100% of smokers. Discussion Regardless of outcome, the trial will provide a model of how to alter and evaluate the impact of health care defaults. If OPT OUT proves to be more effective, it will expand the population eligible for cessation treatment by over 300%. It will also simplify the tobacco-cessation treatment algorithm, and relieve busy health care providers of the burden of evaluating readiness to quit. Trial registration Clinical Trials Registration, ID: NCT02721082. Registered on 22 March 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2119-9) contains supplementary material, which is available to authorized users.

Objective: To determine the effects of motivational interviewing (MI) counselling versus a minimal intervention control on the enrollment of smokers in the Minnesota QUITPLAN Helpline.Study design: Two-group randomized controlled trial of 235 community-dwelling adult smokers. Participants were randomly assigned to receive either a three-session phone based motivational interviewing intervention (n = 118) or the control (n = 117) consisting of mailed printed materials about the Minnesota QUITPLAN helpline services.Data collection: Participants completed demographic and smoking-related survey questionnaire at baseline (by mail) and at weeks 4 and 26 (by phone) follow-up. Quitline enrollment status data was provided by the Minnesota QUITPLAN Helpline.Principal findings: At week 4 follow-up, a higher proportion of participants in the MI group (22.3%) had enroled in the Minnesota QUITPLAN Helpline compared to those in the control arm (13.6%; p = 0.098). At week 26 follow-up, enrollment rates were similar for MI (28.0%) and control (26.5%) arms. Of those who enroled in the Helpline, participants in the MI group reported completing more Helpline sessions than those in control group (4.9 vs. 3.2; p = 0.087).There was no significant interaction between readiness to quit and intervention for the outcome of enrollment in the Helpline.Conclusions: A minimal intensity control such as mailing printed materials resulted in quitline enrollment rates similar to a more resource intensive intervention like motivational interviewing and several folds higher than the current state or national averages. We recommend that health plans should consider mailing smoking cessation promotional messages to encourage smokers to enrol in quitlines.

Background— This trial tested the effects of multidisciplinary group clinic appointments on the primary outcome of time to first heart failure (HF) rehospitalization or death. Methods and Results— HF patients (n=198) were randomly assigned to standard care or standard care plus multidisciplinary group clinics. The group intervention consisted of 4 weekly clinic appointments and 1 booster clinic at month 6, where multidisciplinary professionals engaged patients in HF self-management skills. Data were collected prospectively for 12 months beginning after completion of the first 4 group clinic appointments (2 months post randomization). The intervention was associated with greater adherence to recommended vasodilators ( P =0.04). The primary outcome (first HF-related hospitalization or death) was experienced by 22 (24%) in the intervention group and 30 (28%) in standard care. The total HF-related hospitalizations, including repeat hospitalizations after the first time, were 28 in the intervention group and 45 among those receiving standard care. The effects of treatment on rehospitalization varied significantly over time. From 2 to 7 months post randomization, there was a significantly longer hospitalization-free time in the intervention group (Cox proportional hazard ratio=0.45 (95% confidence interval, 0.21–0.98; P =0.04). No significant difference between groups was found from month 8 to 12 (hazard ratio=1.7; 95% confidence interval, 0.7–4.1). Conclusions— Multidisciplinary group clinic appointments were associated with greater adherence to selected HF medications and longer hospitalization-free survival during the time that the intervention was underway. Larger studies will be needed to confirm the benefits seen in this trial and identify methods to sustain these benefits. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00439842.

The World Health Organization estimates that 1 billion people will die from tobacco-related illnesses this century. Most health-care providers, however, fail to treat tobacco dependence. This may be due in part to the treatment 'default'. Guidelines in many countries recommend that health-care providers: (i) ask patients if they are 'ready' to quit using tobacco; and (ii) provide treatment only to those who state they are ready to quit. For other health conditions--diabetes, hypertension, asthma and even substance abuse--treatment guidelines direct health-care providers to identify the health condition and initiate evidence-based treatment. As with any medical care, patients are free to decline--they can 'opt out' from care. If patients do nothing, they will receive care. For tobacco users, however, the treatment default is often that they have to 'opt in' to treatment. This drastically limits the reach of tobacco treatment because, at any given encounter, a minority of tobacco users will say they are ready to quit. As a result, few are offered treatment. It is time to change the treatment default for tobacco dependence. All tobacco users should be offered evidence-based care, without being screened for readiness as a precondition for receiving treatment. Opt-out care for tobacco dependence is warranted because changing defaults has been shown to change choices and outcomes for numerous health behaviors, and most tobacco users want to quit; there is little to no evidence supporting the utility of assessing readiness to quit, and an opt-out default is more ethical.

Objectives To (1) identify the amount patients spend for insurance premiums, co-payments, deductibles, and other out-of-pocket costs related to HF and chronic health care services and estimate their annual non-reimbursed and out-of-pocket costs; and (2) identify patients' concerns about nonreimbursed and out-of-pocket expenses. Background HF is one of the most expensive illnesses for our society with multiple health services and financial burdens for families. Methods Mixed methods with quantitative questionnaires and qualitative interviews. Results Patients ( N = 149) reported annual averages for non-reimbursed health services co-payments and out-of-pocket costs ranging from $3913 to $5829 depending on insurance coverage. Thirty one patients (21%) reported inadequate health coverage related to their non-reimbursed costs. Conclusions Non-reimbursed costs related to HF care are substantial and vary depending on their insurance, health services use, and out-of-pocket costs. Patient referral to social services to assist with expenses could provide some relief from the burden of high HF-related costs.

Patients with Type 2 diabetes are increasingly turning to the Web for information about diabetes and self-management. These sites, however, fail to address the cultural and linguistic needs of the growing community of Latinos with diabetes. The Juntos Controlamos la Diabetes Web site was designed as a low-cost patient education tool to be used by patients, caregivers, and healthcare providers to provide ongoing information about diabetes self-management tailored to the needs of the regional Latino community.

Objectives The purpose of this study was to identify the predictors of left ventricular (LV) recovery in patients with peripartum cardiomyopathy (PPCM) and to record rates of implantable cardioverter-defibrillator (ICD) use. Background PPCM is a rare, life-threatening disease. The use of ICDs has not been clearly understood in this patient group. Identification of the predictors of persistent LV dysfunction can help select patients at risk for sudden cardiac death. Methods A retrospective study was conducted at 2 academic centers between January 1, 1999, and December 31, 2012. Clinical and demographic variables and delivery records of patients with a diagnosis of PPCM (International Classification of Diseases, 9th Revision code 674.5) were reviewed. Improvement in LV function was noted from echocardiography reports. Results The total sample comprised 100 patients, of whom 55% were African Americans, 39% were Caucasians, and 6% were Hispanic, with a mean age of 30 ± 6 years. Mean left ventricular ejection fraction (LVEF) at diagnosis was 28 ± 9%. Forty-two percent of patients showed improvement in LVEF over a mean duration of 33 ± 21 months. Postpartum diagnosis (hazard ratio: 3.0; p = 0.01) and Caucasian/Hispanic race (hazard ratio: 2.2; p = 0.01) were predictors of improvement in LVEF. Only 7 of the 58 patients (12%) who did not have improvement in their LVEF had an ICD implanted. There were 11 deaths, with a trend toward higher mortality in those who did not display improved LV function (15% vs. 5%; p = 0.1). Conclusions More than one-third of women with PPCM improve LV function with delayed recovery noted in the majority of these patients. Caucasians and those diagnosed in the postpartum period appear to be the most likely to recover. The rate of ICD implantation for primary prevention of sudden cardiac death in this patient group is low.

In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiveness and cost-effectiveness of integrated telemedicine counseling delivered by 2-way webcams mounted on desktop computers in participant's physician office examining rooms (ITM) versus quitline counseling delivered by telephone in participant's homes (Phone) for helping rural smokers quit.C2Q was implemented in twenty primary care and safety net clinics. Integrated telemedicine consisted of real-time video counseling, delivered to patients in their primary care physician's (PCP) office. Phone counseling, was delivered to patients in their homes. All participants received educational materials and guidance in selecting cessation medications.The 566 participants were predominantly Caucasian (92%); 9% were Latino. Most (65%) earned200% of Federal Poverty Level. One out of three lacked home internet access, 40% were not comfortable using computers, and only 4% had been seen by a doctor via telemedicine in the past. Hypertension, chronic lung disease, and diabetes were highly prevalent. Participants smoked nearly a pack a day and were highly motivated to quit.C2Q is reaching a rural low-income population, with comorbid chronic diseases, that would benefit greatly from quitting smoking. ITM is a good delivery model, which integrates care by holding counseling sessions in the patient's PCP office and keeps the primary care team updated on patients' progress.NCT00843505.

Background Mobile technologies have wide-scale reach and disseminability, but no known studies have examined mobile technologies as a stand-alone tool to improve obesity-related behaviors of at-risk youth. Purpose To test a 12-week mobile technology intervention for use and estimate effect sizes for a fully powered trial. Methods Fifty-one low-income, racial/ethnic-minority girls aged 9−14 years were randomized to a mobile technology ( n =26) or control ( n =25) condition. Both conditions lasted 12 weeks and targeted fruits/vegetables (FVs; Weeks 1−4); sugar-sweetened beverages (SSBs; Weeks 5−8), and screen time (Weeks 9−12). The mobile intervention prompted real-time goal setting and self-monitoring and provided tips, feedback, and positive reinforcement related to the target behaviors. Controls received the same content in a written manual but no prompting. Outcomes included device utilization and effect size estimates of FVs, SSBs, screen time, and BMI. Data were collected and analyzed in 2011−2012. Results Mobile technology girls used the program on 63% of days and exhibited trends toward increased FVs (+0.88, p =0.08) and decreased SSBs (−0.33, p =0.09). The adjusted difference between groups of 1.0 servings of FVs ( p =0.13) and 0.35 servings of SSBs ( p =0.25) indicated small to moderate effects of the intervention (Cohen's d=0.44 and −0.34, respectively). No differences were observed for screen time or BMI. Conclusions A stand-alone mobile app may produce small to moderate effects for FVs and SSBs. Given the extensive reach of mobile devices, this pilot study demonstrates the need for larger-scale testing of similar programs to address obesity-related behaviors in high-risk youth.

Background/Aims: Our understanding of the effectiveness of cardioprotective medications in maintenance dialysis patients is based upon drug exposures assessed at a single point in time. We employed a novel, time-dependent approach to modeling medication use over time to examine outcomes in a large national cohort. Methods: We linked Medicaid prescription claims with United States Renal Data System registry data and Medicare claims for 52,922 hypertensive maintenance dialysis patients. All-cause mortality and a combined cardiovascular disease (CVD)-endpoint were modeled as functions of exposure to cardioprotective antihypertensive medications (renin angiotensin system antagonists, β-adrenergic blockers, and calcium channel blockers) measured with three time-dependent covariates (weekly exposure status, proportion of prior weeks with exposure, and number of switches in exposure status) and with propensity adjustment. Results: Current cardioprotective medication exposure status as compared to not exposed was associated with lower adjusted hazard ratios (AHRs) for mortality, though the magnitude depended upon the proportion of prior weeks with medication (duration) and the number of switches between active and non-active use (switches) (AHR range 0.54-0.90). Combined CVD-endpoints depended upon the proportion of weeks on medication: AHR = 1.18 for 10% and AHR = 0.90 for 90% of weeks. Combined CVD-endpoint was also lower for patients with fewer switches. Conclusions: Effectiveness depends not only on having a drug available but is tempered by duration and stability of use, likely reflecting variation in clinical stability and patient behavior.

BackgroundOf the 14.3 million Mexicans who smoke, only a minority take advantage of evidence-based approaches to smoking cessation. Mobile health interventions have the potential to increase the reach of effective cessation interventions in Mexico. ObjectiveThis study aimed to assess the feasibility and acceptability of an innovative, personalized, and interactive smoking cessation mobile intervention developed for Mexican smokers. MethodsWe recruited 40 Mexican smokers to participate in Vive sin Tabaco... ¡Decídete!, a smoking cessation program that uses a tablet-based decision support software to drive a 12-week text messaging smoking cessation program and pharmacotherapy support. Outcome measures included participant text messaging interactivity with the program, participant satisfaction, and 12-week verified abstinence using urinary cotinine testing or exhaled carbon monoxide. ResultsAverage age of the participants was 36 years (SD 10.7), and they were primarily male (65%, 26/40) with at least an undergraduate degree (62%, 25/40). Most participants (95%, 38/40) smoked daily and were interested in quitting in the next 7 days. As an indicator of participant interactivity, participants sent an average of 21 text messages during the 12-week intervention (SD 17.62). Of the 843 messages that participants sent to the program, only 96 messages (11.3%, 96/843) used keywords. At 12 weeks, 40% (16/40) of participants were biochemically verified (87%, 35/40, follow-up rate). The majority of participants (85%, 30/35) reported being very satisfied or extremely satisfied with the program. ConclusionsThe Vive sin Tabaco... ¡Decídete! smoking cessation mobile intervention was accepted by participants, generated high satisfaction and high text messaging interactivity, and resulted in a noteworthy cessation rate at the end of treatment. This intervention is a promising strategy for smoking cessation in Mexico. Additional testing as a formal randomized clinical trial appears warranted.

Objective: Assess the impact of intercurrent respiratory infections in infants

Latino immigrants are less likely to be involved in addressing health-related issues affecting their own community. Community health workers have played a significant role in addressing the health of underserved communities in several countries. The objective of this article is to describe the development, implementation, and evaluation of a community-based training program that empowers promotores to identify the health needs of recent Latino immigrants. Promotores were able to develop interventions based on the needs of recent Latino immigrants. Latino community members participated in a 30-hour training program. Training was provided in 15 two-hour sessions over 3 months. Training included field-work accompanied by skills development in leadership, organization, interpersonal communication, and survey implementation. Upon completion of the training, promotores conducted household surveys designed to identify community health needs. The evaluation employed quantitative measures to track promotores’ canv...

Racial minorities typically have less exposure than non-minorities to antihypertensive medications, as has been noted across an array of cardiovascular conditions in the general population.1–10 Even in environments in which there is “universal” access to care, such as the US Veterans Administration system (a healthcare system for which all United States military veterans are eligible, regardless of socioeconomic status)11,12 or state Medicaid programs in the United States (which provide financial assistance with prescription drug costs for socioeconomically disadvantaged persons),13 minorities have lower rates of treatment for cardiovascular disorders. Although race-based differences in care have been noted in the chronic dialysis environment for the creation of arteriovenous fistulas14–16 and outcomes after renal transplantation,17,18 there is little understanding of whether chronic dialysis patients face the same race-based differences in exposure to antihypertensive medications as does the general population. Patients undergoing chronic dialysis have high rates of cardiovascular disease19 and are frequently treated with antihypertensive agents that have demonstrated cardioprotective properties in other populations20–32 or in animal models,33,34 such as angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), β-adrenergic antagonists (β-blockers), and calcium-channel blockers (CCBs). Our previous work in the dually Medicaid-and-Medicare–eligible dialysis population showed, perhaps paradoxically, that non-Caucasians are treated with these classes of antihypertensive agents at higher rates than are Caucasians when a cross-sectional approach is used,35 but to date, the cumulative exposure of these groups to these medications over the course of time has not been specifically investigated. To study this issue in detail, we created a novel linkage of data from the United States Renal Data System (USRDS), which contains Medicare claims data in chronic dialysis patients, with Medicaid prescription claims data,35 to create a large cohort of incident dialysis patients who, by virtue of their geographic diversity, are subject to a wide spectrum of policies, procedures, and cultures of care. Chronic dialysis patients who have dual eligibility for Medicare and Medicaid, and who are therefore indigent, constitute a uniquely informative population in which to study how prescribing patterns vary by race, because: (i) such patients have ready access to care and prescription medications via these two public programs, and (ii) chronic dialysis is a setting in which all patients have similarly frequent contact with health care providers. We determined the percentage of time that patients had exposure to ACEIs or ARBs or both, β-blockers, and CCBs. The term “exposure” was deliberately selected because a filled prescription cannot be used to infer either “use” (which suggests proof of ingestion), or adherence (which implies a volitional action by a patient to take a drug as prescribed). To confine our analysis to individuals who were judged suitable candidates for a drug, we deliberately modeled only individuals who received at least one prescription for these antihypertensive agents. Given the importance of studying the way in which race influences care,36 we reasoned that if race is associated with differential exposure to medication over time, further work would be imperative to understand the factors that undermine or facilitate exposure.

Introduction Few hospitals treat patients' tobacco dependence. To be effective, hospital-initiated cessation interventions must provide at least 1 month of supportive contact post-discharge. Study design Individually randomized clinical trial. Recruitment commenced July 2011; analyses were conducted October 2014–June 2015. Setting/participants The study was conducted in two large Midwestern hospitals. Participants included smokers who were aged ≥18 years, planned to stay quit after discharge, and spoke English or Spanish. Intervention Hospital-based cessation counselors delivered the intervention. For patients randomized to warm handoff, staff immediately called the quitline from the bedside and handed the phone to participants for enrollment and counseling. Participants randomized to fax were referred on the day of hospital discharge. Main outcome measures Outcomes at 6 months included quitline enrollment/adherence, medication use, biochemically verified cessation, and cost effectiveness. Results Significantly more warm handoff than fax participants enrolled in quitline (99.6% vs 59.6%; relative risk, 1.67; 95% CI=1.65, 1.68). One in four (25.4% warm handoff, 25.3% fax) were verified to be abstinent at 6-month follow-up; this did not differ significantly between groups (relative risk, 1.02; 95% CI=0.82, 1.24). Cessation medication use in the hospital and receipt of a prescription for medication at discharge did not differ between groups; however, significantly more fax participants reported using cessation medication post-discharge (32% vs 25%, p =0.01). The average incremental cost-effectiveness ratio of enrolling participants into warm handoff was $0.14. Hospital-borne costs were significantly lower in warm handoff than in fax ($5.77 vs $9.41, p Conclusions One in four inpatient smokers referred to quitline by either method were abstinent at 6 months post-discharge. Among motivated smokers, fax referral and warm handoff are efficient and comparatively effective ways to link smokers with evidence-based care. For hospitals, warm handoff is a less expensive and more effective method for enrolling smokers in quitline services.

Participation in cancer prevention trials (CPT) is lower than 3 % among high-risk healthy individuals, and racial/ethnic minorities are the most under-represented. Novel recruitment strategies are therefore needed. Online health risk assessment (HRA) serves as a gateway component of nearly all employee wellness programs (EWPs) and may be a missed opportunity. This study aimed to explore employees' interest, willingness, motivators, and barriers of releasing their HRA responses to an external secure research database for recruitment purpose. We used qualitative research methods (focus group and individual interviews) to examine employees' interest and willingness in releasing their online HRA responses to an external, secure database to register as potential CPT participants. Fifteen structured interviews (40 % of study participants were of racial/ethnic minority) were conducted, and responses reached saturation after four interviews. All employees showed interest and willingness to release their online HRA responses to register as a potential CPT participant. Content analyses revealed that 91 % of participants were motivated to do so, and the major motivators were to (1) obtain help in finding personally relevant prevention trials, (2) help people they know who are affected by cancer, and/or (3) increase knowledge about CPT. A subset of participants (45 %) expressed barriers of releasing their HRA responses due to concerns about credibility and security of the external database. Online HRA may be a feasible but underutilized recruitment method for cancer prevention trials. EWP-sponsored HRA shows promise for the development of a large, centralized registry of racially/ethnically representative CPT potential participants.

Introduction: Smokers benefit from ongoing cessation support upon leaving the hospital and returning to their home environment. This study examined the impact of telephone-delivered care coordination on utilization of and adherence to cessation pharmacotherapy after hospital discharge. Methods: Inpatient smokers (n = 606) were randomized to receive counseling with care coordination (CCC) or counseling alone (C) for smoking cessation. Both groups received written materials and telephone-based cessation counseling during hospitalization and postdischarge. CCC recipients received help in selecting, obtaining, and refilling affordable pharmacotherapy prescriptions during and after hospitalization. Study outcomes included self-reported utilization, duration of use, and type of medication during the 3 months postdischarge. Results: Of the 487 (80%) of participants completing 3-month follow-up, 211 (43.3%) reported using cessation pharmacotherapy postdischarge; this did not differ by study arm (CCC: 44.7%, C: 42.0%,p = .55). Use of pharmacotherapy postdischarge was associated with smoking at least 20 cigarettes/day at baseline (odds ratio [OR]: 1.48; 95% confidence interval [CI]: 1.00–2.19) and receipt of pharmacotherapy during hospitalization (OR: 4.00; 95% CI: 2.39–6.89). Smokers with Medicaid (OR: 2.29; 95% CI: 1.32–4.02) or other insurance (OR: 1.69; 95% CI: 1.01–2.86) were more likely to use pharmacotherapy postdischarge than those with no health care coverage. Less than one in four (23.8% of CCC; 22.2% of C) continued pharmacotherapy beyond 4 weeks. Conclusions: Supplemental care coordination did not improve use of postdischarge pharmacotherapy beyond that of inpatient treatment and behavioral counseling. Insurance coverage and use of medications during the hospitalization are associated with higher use of evidence-based treatment postdischarge. Implications: Many hospitalized smokers do not receive the benefits of cessation pharmacotherapy postdischarge and telephone quitline programs often fail to help smokers procure pharmacotherapy. Thus, effective strategies are needed to improve utilization and adherence to evidence-based cessation therapies when smokers leave the hospital. We found that use of postdischarge pharmacotherapy was strongly associated with receipt of pharmacotherapy during the hospitalization and with the availability of insurance to cover the costs of treatment. Additional efforts to coordinate pharmacotherapy services did not improve either utilization or adherence to therapy.

IntroductionTraining for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.MethodsClinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.ResultsForty-eight competency statements in 8 domains were developed.ConclusionsTraining is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

Correspondence avoid surgery in rapidly progressive or chemo-insensitive disease. 4 Genotyping of pancreatic tumours via fine needle aspiration could influence the clinical management of pancreatic cancer. Fine-needle aspiration sequencing was used to identify subgroups of patients with specific actionable mutations related to resectable or locally advanced tumours. 5 In patients with radiologically resectable or borderline resectable tumours, preoperative fine-needle aspiration sequencing could distinguish between patients with a genetic pattern associated with micrometastatic tumours, who should undergo neoadjuvant therapy, and those with a truly localised disease that would be amenable to a surgery-first strategy. Michele Reni has served as a consultant for or on the advisory boards of Celgene, Boehringer-Ingelheim, Lilly, Genentech, Baxalta, Novocure, Astra-Zeneca, Pfizer, and Merck-Serono, and has received honoraria from Celgene. Massimo Falconi has received honoraria from Celgene, Ipsen and Novartis. The other authors declare no competing interests. *Stefano Crippa, Michele Reni, Gianpaolo Balzano, Claudio Doglioni, Massimo Falconi crippa1.stefano@hsr.it Division of Pancreatic Surgery, IRCCS San Raffaele Hospital, Milan, Italy (SC, GB, MF); Medical Oncology Department, IRCCS San Raffaele Hospital , Milan, Italy (MR); Department of Pathology, IRCCS San Raffaele Hospital , Milan, Italy (CD); Clinical and Translational Research Program on Pancreatic Cancer, IRCCS San Raffaele Hospital, Milan, Italy (SC, MR, GB, CD, MF) e178 Barreto SG, Windsor JA. Justifying vein resection with pancreatoduodenectomy. Lancet Oncol 2016; 17: e118–24 Giovinazzo F, Turri G, Katz MH, Heaton N, Ahmed I. Meta-analysis of benefit of portal-superior mesenteric vein resection in pancreatic resection for ductal adenocarcinoma. Br J Surg 2016; 103: 179–91. Bapat AA, Hostetter G, Von Hoff DD, Han H. Perineural invasion and associated pain in pancreatic cancer. Nat Rev Cancer 2011; Sohal DP, Walsh RM, Ramanathan RK, Khorana AA. Pancreatic adenocarcinoma: treating a systemic disease with systemic therapy. J Natl Cancer Inst 2014; 106: dju011 Valero V, Saunders TJ, He J, et al. Reliable detection of somatic mutations in fine needle aspirates of pancreatic cancer with next-generation sequencing: implications for surgical management. Ann Surg 2016; Author’s reply Stefano Crippa and colleagues, in responding to our manuscript, 1 agree that increasing the radicality of surgery for pancreatic ductal adenocarcinoma, including synchronous vein resection, is suspect. Indeed, a recent meta-analysis 2 indicates that synchronous vein resection, as reported, increases mortality and decreases survival. Crippa and colleagues put forward two interesting ideas that warrant further discussion. The first is that the surgery-first approach for pancreatic ductal adenocarcinoma might ultimately be retired, given that pancreatic ductal adenocarcinoma is usually systemic at presentation, local treatments have little effect, and neoadjuvant therapy has possible benefits. For now, the absence of high-level evidence for neoadjuvant therapy leaves largely theoretical benefits; namely that neoadjuvant therapy will reveal the biology (ie, those patients that can progress on neoadjuvant therapy will avoid futile surgery), or alter the biology (ie, those patients that are downstaged will become resectable). The preliminary results of the ALLIANCE trial 3 damages the lustre of these purported benefits with no improvement in the number of resections (10 [50%] of 20 patients who completed all preoperative therapy), and no rescue of aggressive tumour biology. This leads to the second idea, in which Crippa and colleagues suggest a biological (rather than radiological) basis for selecting patients for neoadjuvant therapy with a view to reduce the number of synchronous vein resections. Endoscopic ultrasonography- guided genotyping is a possible way to select subgroups of patients with heterogenous pancreatic ductal adenocarcinoma 4 who will benefit from neoadjuvant therapy. In support of this method, Hruban and colleagues 5 suggested that an intact SMAD4/DPC4 gene might be used to select surgery because there is lesser risk of distant metastases for this genotype. 6 In the future, we hope to more accurately select a subgroup of patients in whom a surgery-first approach, and even synchronous vein resection, is justified, but it is much more likely that precision neoadjuvant therapy will ultimately result in less radical surgery and the introduction of non-surgical techniques to support the response to neoadjuvant therapy. We declare no competing interests. Savio G Barreto, *John A Windsor j.windsor@auckland.ac.nz Department of Gastrointestinal Surgery, Gastrointestinal Oncology, and Bariatric Surgery, Medanta Institute of Digestive and Hepatobiliary Sciences, Medanta, The Medicity, Gurgaon, India (SGB); Hepatobiliary Pancreatic and Upper GI Unit, Department of General Surgery, Auckland City Hospital, Auckland, New Zealand (JAW) Barreto S, Windsor J. Justifying vein resection with pancreatoduodenectomy. Lancet Oncol 2016; 17: e118–24. Giovinazzo F, Turri G, Katz MH, Heaton N, Ahmed I. Meta-analysis of benefits of portal-superior mesenteric vein resection in pancreatic resection for ductal adenocarcinoma. Br J Surg 2016; Varadhachary G, Fleming J, Crane C, et al. Phase II study of preoperation mFOLFIRINOX and chemoradiation for high-risk resectable and borderline resectable pancreatic adenocarcinoma. Proc Am Soc Clin Oncol 2015; 33 (suppl 3): abstr 362. Killock D. Pancreatic cancer: a problem quartered—new subtypes, new solutions? Nat Rev Clin Oncol 2016; 13: 201. Hruban RH, Adsay NV. Molecular classification of neoplasms of the pancreas. Hum Pathol Iacobuzio-Donahue CA, Fu B, Yachida S, et al. DPC4 gene status of the primary carcinoma correlates with patterns of failure in patients with pancreatic cancer. J Clin Oncol 2009; The US Cancer Moonshot initiative We recently sent the following letter to Vice President of the USA, Joe Biden, to state that we, as Deans and Directors of Public Health schools and programmes around the USA, strongly support the goals of the Cancer Moonshot initiative to www.thelancet.com/oncology Vol 17 May 2016

Background Within-class comparative effectiveness studies of β-blockers have not been performed in the chronic dialysis setting. With widespread cardiac disease in these patients and potential mechanistic differences within the class, we examined whether mortality and morbidity outcomes varied between cardio-selective and non-selective β-blockers. Methods Retrospective observational study of within class β-blocker exposure among a national cohort of new chronic dialysis patients (N = 52,922) with hypertension and dual eligibility (Medicare-Medicaid). New β-blocker users were classified according to their exclusive use of one of the subclasses. Outcomes were all-cause mortality (ACM) and cardiovascular morbidity and mortality (CVMM). The associations of cardio-selective and non-selective agents on outcomes were adjusted for baseline characteristics using Cox proportional hazards. Results There were 4938 new β-blocker users included in the ACM model and 4537 in the CVMM model: 77 % on cardio-selective β-blockers. Exposure to cardio-selective and non-selective agents during the follow-up period was comparable, as measured by proportion of days covered (0.56 vs. 0.53 in the ACM model; 0.56 vs 0.54 in the CVMM model). Use of cardio-selective β-blockers was associated with lower risk for mortality (AHR = 0.84; 99 % CI = 0.72–0.97, p = 0.0026) and lower risk for CVMM events (AHR = 0.86; 99 % CI = 0.75–0.99, p = 0.0042). Conclusion Among new β-blockers users on chronic dialysis, cardio-selective agents were associated with a statistically significant 16 % reduction in mortality and 14 % in cardiovascular morbidity and mortality relative to non-selective β-blocker users. A randomized clinical trial would be appropriate to more definitively answer whether cardio-selective β-blockers are superior to non-selective β-blockers in the setting of chronic dialysis.

Mobile technologies hold promise for improving diet and physical activity, but little attention is given to creating programs that adolescents like and will use. This study developed a personal digital assistant (PDA) program to promote increased intake of fruits and vegetables (FV) in predominately low-income, ethnic minority girls. This study used a three-phase community-engaged process, including (i) engagement of a Student Advisory Board (SAB) to determine comfort with PDAs; (ii) early testing of Prototype I and rapid re-design by the SAB and (iii) feasibility testing of Prototype II in a new sample of girls. Phase 1 results showed that girls were comfortable with the PDA. Testing of Prototype I in Phase 2 showed that acceptability was mixed, with girls responding to 47.3% of the prompts. Girls wanted more reminders, accountability in monitoring FV, help in meeting daily goals and free music downloads based on program use. The PDA was reprogrammed and testing of Prototype II in Phase 3 demonstrated marked improvement in use (78.3%), increases in FV intake (1.8 ± 2.6 daily servings) and good overall satisfaction. Findings suggest that mobile technology designed with the early input of youth is a promising way to improve adolescent health behaviors.

Purpose To uncover perceptive differences in mammography experiences (from scheduling the mammography appointment to receipt and reporting of mammography results) between women from two different racial/ethnic groups. Methods Focus groups ( n = 9) were conducted with Hispanic, and non-Hispanic White women ( n = 88) who were aged 40 years or older and had a mammogram within the preceding 36 months. We used a qualitative ethnographic approach with content analysis to identify key categories present in the transcripts and domain analysis to discover domains of meaning. A matrix was designed to determine which domains differed by racial/ethnic group. The primary mammography-related topics of focus group discussion included 1) the scheduling process, 2) the day of the mammogram, 3) receipt of results, and 4) recommendations to improve the mammography process. Main Findings Six domains uniquely described issues women of the differing racial/ethnic groups experience and perceive as important. Hispanic women highlighted embarrassment surrounding the examination and fear of negative news about their mammography results. Non-Hispanic White women focused on instructions given before or during the examination as a critical process feature. Conclusions Perceptions of the mammography experience vary by race/ethnicity. Mammography experiences might be improved through enhanced sensitivity of healthcare personnel to cultural differences in perceptions of mammogram testing. Future research to investigate the extent to which the domains of meanings uncovered in this study influence a women's decision to return for routine mammograms would be of great value.

Background: The utility of employee wellness programs (EWPs) in cancer prevention and control is not well established. Purpose: This project is to determine the potential value of EWPs in preventing cancer by examining the characteristics of EWP participants and their prevalence of cancer risk factors. Methods: A secondary data analysis of health risk assessment (HRA) participants' data in the 2009 Kansas state EWP. Results: Among the 60,006 eligible participants, 9,202 (15.3%) completed an HRA. The prevalence of cancer risk factors were 59.7% for family cancer history, 7.7% for smoking, and 69.7% for overweight or obesity. Non-adherence rates in colorectal cancer screening, breast cancer screening, and cervical cancer screening were 28%, 12.2%, and 12.6%, respectively. Discussion: Overall, 94.4% of all HRA participants had at least one cancer risk factor. The majority of HRA participants were at risk for cancer, indicating the potential high impact of EWP-based cancer prevention programs. Howeve...

Despite uncertainty about their effectiveness in chronic dialysis patients, statin use has increased in recent years. Little is known about the demographic, clinical, and geographic factors associated with statin exposure in end-stage renal disease (ESRD) patients.To analyze the demographic, clinical, and geographic factors associated with use of statins among chronic dialysis patients.Cross-sectional analysis.Prevalent dialysis patients across the U.S.55,573 chronic dialysis patients who were dually eligible for Medicaid and Medicare services during the last four months of 2005.Using Medicaid prescription drug claims and United States Renal Data System core data, we examined demographics, comorbid conditions, and state of residence using hierarchical logistic regression models to determine their associations with statin use.Prescription for a statin.Factors associated with a prescription for a statin.Statin exposure was significantly associated with older age, female sex, Caucasian (versus African-American) race, body mass index, use of self-care dialysis, diabetes, and comorbidity burden. Moreover, there was substantial state-by-state variation in statin use, with a greater than 2.3-fold difference in adjusted odds ratios between the highest- and lowest-prescribing states.Among publicly insured chronic dialysis patients, there were marked differences between states in the use of HMG-CoA reductase inhibitors above and beyond patient characteristics. This suggests substantial clinical uncertainty about the utility of these medications. Understanding how such regional variations impact patient care in this high-risk population is an important focus for future work.

Although the United States has seen a large reduction in smoking rates over the past 50 years, the rate of decline appears to have stalled in recent years.1 This appears to be particularly problematic in rural communities.2 It has been hypothesized that as smoking rates have declined, we may have encountered an increasingly “hardcore” group of smokers for whom cessation may be particularly difficult.3 Indeed, smokers participating in cessation trials have experienced decreasing rates of success over time.4 This could have important implications for health care practitioners as they try to engage smokers in repeated quit attempts. Although cigarette smoking can be conceptualized as a chronic disease with repeated cycles of quitting and relapse,5–7 most smoking cessation studies have offered only a single treatment, and little is known about how resistance to quitting might accumulate after repeated interventions. KanQuit, the parent study of the current analysis, was the first controlled smoking cessation trial in rural primary care that examined a chronic disease management model for tobacco dependence.8 In KanQuit, rates of successfully quitting did not diminish during the 4 cycles of treatment spread out over 2 years.9 Nevertheless, despite 2 years of intervention, a large portion of the rural smokers in the KanQuit study failed to quit. In the present study, we followed this group of recalcitrant smokers and examined their ongoing efforts to quit in the absence of any ongoing interventions. Furthermore, we tried to identify factors that were associated with quit attempts, use of pharmacotherapy, and successful cessation.

Atrial fibrillation is an important comorbidity with substantial therapeutic implications in dialysis patients but its prevalence varies in different studies. We used a database that includes patients in the United States on hemodialysis who were eligible for government assistance with prescription drugs. We then used ICD-9 codes from billing claims in this database to identify patients with chronic atrial fibrillation. Multivariable logistic regression was used to determine adjusted prevalence odds ratios for associated factors. Of 63,884 individuals, the prevalence of chronic atrial fibrillation was 7%. The factors of age over 60 years, male, Caucasian, body mass index over 25 kg/m(2), coronary artery disease, and heart failure were all significantly associated with chronic atrial fibrillation. Prevalence rates, particularly in younger patients, were far higher than those reported in an age group-matched nondialysis population. Thus, given its clinical impact, future efforts are needed to examine risk factors for adverse outcomes in chronic atrial fibrillation, and to identify appropriate management strategies for this disorder, as well as opportunities for quality improvement in this vulnerable population.

Overview:Many U.S. hospitals use fax-referral to quitlines to provide outpatient follow-up. It is important to understand whether it is better to refer all smokers, or only those ready to quit, to quitline services. The purpose of this pilot project was to evaluate the feasibility and intermediate out-comes of a proactive (offering fax referral to all smokers) versus a reactive (pre-screening for readiness to quit within the next 30 days) approach to quitline fax-referral.Method:We employed a pre-test, post-test comparison group design in which a script-based reactive approach was employed over a two-week period and a script-based proactive approach was employed in the following two-week period. Scripts were inserted into the counselling protocols of a pre-existing inpatient treatment program.Major Findings:We enrolled 45 patients — 25 during the reactive, and 20 during the proactive block. In the reactive group, 12 (48%) indicated that they were ready to quit smoking and accepted fax-referral to the quitline. Nine (75%) were successfully contacted and enrolled in the quitline, for an overall quitline enrolment rate of 36% (9/25). In the proactive group, all accepted fax-referral to the quitline and 11 were successfully contacted and enrolled by the quitline for an overall enrolment rate of 55% (11/20). Quitlines were able to reach and enrol a higher proportion of patients referred to them, when patients were pre-screened for readiness to quit. Offering quitline referral, regardless of readiness to quit, potentially expands the reach and possibly the impact of quitline counselling.

Although motivational interviewing (MI) has been shown to be effective in changing health behaviors, its effects on smoking cessation have been mixed. The purpose of the present study is to assess factors of motivation and self-efficacy as they mediate the relationship between MI and smoking cessation. This is a secondary analysis of an MI based smoking cessation randomized trial. MI counseling was associated with change in smoking behaviors during a 12 months intervention but was not related to autonomous motivation, controlled motivation, or self-efficacy at baseline and 6 months, the hypothesized mediators. This study confirmed the pathway to quit smoking through increase in self-efficacy.

Varenicline, a first-line non-nicotine medication, has not been evaluated in Black smokers, and limited attention has been paid to pharmacotherapy adherence in smoking cessation trials. This pilot study estimated quit rates for Black smokers treated with varenicline and tested a behavioral intervention to aid varenicline adherence.Seventy-two Black smokers (10 cigarettes per day; cpd) were randomly assigned to adherence support (AS; n = 36) or standard care (n = 36). All participants received 3 months of varenicline and a single counseling session focused on making a quit plan. AS participants received 5 additional counseling sessions to encourage medication use. Outcome measures included salivary cotinine, and carbon monoxide confirmed smoking abstinence, reductions in self-reported cpd, and pill counts of varenicline adherence at Months 1, 2, and 3.Sixty-one participants (84.7%) completed follow-up at Month 3. Participants were female (62.5%), 46.8 years of age, and smoked 16.3 cpd. No treatment group differences were found on the smoking or adherence outcome measures (p.05). Collapsing across treatment, varenicline adherence was adequate (86.1%), yet despite a reduction of 12.2 (6.5) cpd from baseline to Month 3 (p0.001), only 23.6% were confirmed quit at Month 3. Participants who were quit at Month 3 had higher varenicline adherence rates (95.8%) than those who continued to smoke (80.8%, p ≤ .05).Studies are needed to examine the efficacy of varenicline among Black smokers. Interventions to facilitate adherence to pharmacotherapy warrant further attention as adherence is linked to improved tobacco abstinence.