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

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

Translating pediatric primary care best practice guidelines for addressing tobacco in the WIC system.

Tobacco smoke exposure (TSE) adversely affects child health. Intervention research on reducing childhood TSE and uptake of evidence-based smoking cessation programs has had limited reach in high-risk communities. Intervening in clinics delivering the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) could address overlapping public health priorities essential for healthy child development-nutrition and smoke-free environments. The Babies Living Safe and Smokefree (BLiSS) trial addresses existing gaps by implementing and evaluating a WIC in-clinic evidence-based training based on Ask, Advise, and Refer (AAR) guidelines. WIC nutrition staff (n = 67) completed surveys pre- and post-training as part of the larger BLiSS trial. Staff sociodemographic data, knowledge, and attitudes about maternal smoking and child TSE prevention, and AAR practices in clinic were collected using self-administered surveys. Pre-post outcomes were assessed using bivariate statistics and multiple regression models. Controlling for baseline AAR-related practices and other covariates, nutrition managers were more likely to engage in post-training AAR practices than nutrition assistants. Sociodemographics and smoking status were not related to post-training AAR. Lower perceived barriers and higher reported frequency of tobacco intervention practices at baseline were associated with higher engagement in post-test AAR practices. WIC-system interventions aimed at reducing child TSE and maternal tobacco smoking may be more effective if nutrition management-level staff are involved in assessment and by addressing barriers related to TSE among nutrition assistants. Findings suggest that WIC in-clinic training may help to increase self-efficacy for staff engagement in brief screening, intervention, and referral practices.

Intervention research on reducing childhood tobacco smoke exposure (TSE) and uptake of evidence-based smoking cessation programs has had limited reach in high-risk communities. Intervening in clinics delivering the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) could address overlapping public health priorities essential for healthy child development­nutrition and smoke-free environments. The Babies Living Safe and Smokefree (BLiSS) trial implemented and evaluated training on evidence-based guidelines in WIC clinics to nutrition managers and nutrition assistants. Findings suggest that WIC in-clinic training may help to increase self-efficacy for staff engagement in brief screening, intervention, and referral practices. Further, our results indicate that interventions aimed at reducing child TSE and maternal tobacco smoking may be more effective if nutrition management-level staff are involved in assessment and by addressing barriers related to TSE among nutrition assistants.

Quitting Smoking before and after Pregnancy: Study Methods and Baseline Data from a Prospective Cohort Study.

Smoking during pregnancy and postpartum remains an important public health problem. No known prior study has prospectively examined mutual changes in risk factors and women's smoking trajectory across pregnancy and postpartum. The objective of this study was to report methods used to implement a prospective cohort (Msgs4Moms), present participant baseline characteristics, and compare our sample characteristics to pregnant women from national birth record data. The cohort study was designed to investigate smoking patterns, variables related to tobacco use and abstinence, and tobacco treatment quality across pregnancy through 1-year postpartum. Current smokers or recent quitters were recruited from obstetrics clinics. Analyses included Chi-square and independent sample t-tests using Cohen's d. A total of 62 participants (41 smokers and 21 quitters) were enrolled. Participants were Black (45.2%), White (35.5%), and multiracial (19.3%); 46.8% had post-secondary education; and most were Medicaid-insured (64.5%). Compared with quitters, fewer smokers were employed (65.9 vs 90.5%, Cohen's d = 0.88) and more reported financial strain (61.1% vs 28.6%; Cohen's d = 0.75). Women who continue to smoke during pregnancy cope with multiple social determinants of health. Longitudinal data from this cohort provide intensive data to identify treatment gaps, critical time points, and potential psychosocial variables warranting intervention.

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

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

The effect of area-level disadvantage and race on smoking abstinence in a clinical trial.

Reasons for Black-White disparities in smoking abstinence are not well understood. This study examined area-level socioeconomic disadvantage as a contributor to lower quit rates for Blacks who smoke among 223 Black and 221 White low-income individuals who smoke enrolled in a smoking cessation trial. Outcome was cotinine-verified abstinence at week 26. Census tract-level disadvantage was measured using 5-year estimates linked to participants' home address and included percentage of: female headed households; public assistance; unemployed; < 100% of the federal poverty level; and whether there was > 25% having less than a high school education. A neighborhood disadvantage index score (DIS) was calculated as the sum of z scores for each variable. Black participants lived in more disadvantaged areas than White participants [DIS mean (SD): 3.2 (4.3), -1.0 (3.2), p < .001]. Similar rates of abstinence were observed at the same level of disadvantage [DIS ≥ 50th percentile (less disadvantage): 21.9% Blacks, 26.2% Whites, p = .50; DIS < 50th percentile (more disadvantage): 10.7% Blacks, 15.8% Whites, p = .31]. Only DIS but neither race nor the interaction was retained in the final model predicting abstinence; each unit increase in DIS was associated with 9% reduced odds of abstinence, OR: 0.91, 95% CI [0.87,0.96]. Findings point to the importance of examining factors associated with race that contribute to health inequities and underscore the need to consider how consequences of systemic racism, such as neighborhood context and other consequences not captured by the DIS, can constrain or facilitate smoking cessation when developing interventions. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Use of implementation science in tobacco control intervention studies in the USA between 2000 and 2020: a scoping review protocol.

INTRODUCTION: Despite continuing efforts to reduce tobacco use in the USA, decline in smoking rates have stalled and smoking remains a major contributor to preventable death. Implementation science could potentially improve uptake and impact of evidence-based tobacco control interventions; however, no previous studies have systematically examined how implementation science has been used in this field. Our scoping review will describe the use of implementation science in tobacco control in the USA, identify relevant gaps in research and suggest future directions for implementation science application to tobacco control. METHODS AND ANALYSIS: Our team, including a medical research librarian, will conduct a scoping review guided primarily by Arksey and O'Malley's methodology. We will search English language peer-reviewed literature published from 2000 to 31 December 2020 for terms synonymous with 'tobacco use', 'prevention', 'cessation' and 'implementation science'. The databases included in this search are MEDLINE (PubMed), Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (ProQuest), ERIC (ProQuest) and the Cochrane Library (Wiley). We will include cohort and quasi-experimental studies, single-group experiments and randomised trials that report qualitative and/or quantitative data related to applying implementation science to the planning and/or delivery of interventions to prevent or decrease the use of tobacco products. Studies must target potential or active tobacco users, intervention providers such as educators or healthcare professionals, or US policy-makers. A minimum of two reviewers will independently examine each title and abstract for relevance, and each eligible full text for inclusion and analysis. Use of implementation science, demonstrated by explicit reference to implementation frameworks, strategies or outcomes, will be extracted from included studies and summarised. ETHICS AND DISSEMINATION: This study is exempt from ethics board approval. We will document the equity-orientation of included studies with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Equity Extension checklist. Results will be submitted for conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: Open Science Framework Registry (6YRK8).

Social determinants of alcohol and cigarette use by race/ethnicity: Can we ignore measurement issues?

Psychometric critiques of cross-cultural research emphasize testing whether instruments measure the same construct across cultural groups. We tested for measurement invariance (by race/ethnicity) of instruments used to evaluate the relationship between alcohol and tobacco use with perceived discrimination and socioeconomic status (SES). Tests of psychometric equivalence across race/ethnicity focused on: the latent organization of constructs (configural invariance); if observed indicators have equal factor loadings or "true score" variance (metric invariance); and whether manifest indicators change uniformly contingent on change in the latent variable (scalar invariance). A cross-sectional survey of 2,376 cigarette smokers (794 Black, 786 Latinx, 796 White; mean age = 43 [SD = 12]; 58% female) was recruited via an online research panel. Discrimination was indicated by self-report; SES was indicated by self-reported education, employment, income, and the "SES Ladder;" alcohol use was indicated by frequency and typical quantity of drinking, and frequency of heavy drinking; tobacco use was indicated by frequency of smoking, cigarettes per smoking day, and time to first cigarette. All instruments demonstrated configural invariance; either full metric invariance (alcohol and discrimination) or partial metric invariance (tobacco and SES); and all constructs demonstrated partial scalar invariance. Results support psychometric critiques; for example, all of the SES indicators violated assumptions of classical measurement theory for valid between group comparisons. All of our instruments displayed some degree of systematic bias in measurement across race/ethnicity. Studies testing ethnic/racial differences may need to move beyond classical measurement theory, and may benefit from using statistical approaches that can test for (and model) bias in measurement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

The Role of Neighborhood Experiences in Psychological Distress among African American and White Smokers.

Residential area characteristics and discrimination have been associated with psychological distress. Differences in these relationships across racial groups are not well understood. We examined the relative role of perceived discrimination, neighborhood problems and neighborhood cohesion/trust in explaining differences in psychological distress (indicated by anxiety and depressive symptoms) between 224 African American and 225 White smokers (income ≤ 400% federal poverty level) in a smoking cessation intervention study. Surveys were linked to US census-tract data. We conducted random intercept Poisson multi-level regression models and examined interactions between race and neighborhood experiences. African Americans had greater risk of anxiety and depressive symptoms and greater individual and neighborhood disadvantage than Whites. Controlling for objective neighborhood characteristics, when perceived discrimination and perceived neighborhood characteristics were added to the regression models the association between anxiety symptoms and race were no longer statistically significant; the association between depressive symptoms and race decreased but remained statistically significant. Lower neighborhood social cohesion/trust and greater neighborhood problems increased depressive symptoms for African Americans, but not for Whites. Perceived discrimination and neighborhood social cohesion/trust outweighed the importance of race in explaining anxiety symptoms. These findings underscore the need for multi-level interventions addressing social and environmental contexts.

Rapid relapse to smoking following hospital discharge.

Many of nearly 7 million smokers who are hospitalized each year plan to stay quit after they leave the hospital. Most, however, relapse after discharge. This is a secondary analysis of a large Midwestern hospital-based smoking cessation trial that occurred between July 2011 and May 2013 to better understand how quickly smokers relapse and the predictors of rapid relapse. Of 942 participants who completed follow up, 25% returned to smoking within a day after hospital discharge. Among these rapid relapses, 36.6% relapsed within one-hour of leaving the hospital, 35.3% between one and 24 h, and 28.1% relapsed one-day post-discharge. Predictors with the highest odds for rapid relapse (within a day of hospital discharge) included tobacco use during hospitalization (OR, 7.37, [95% CI, 3.85-14.13], P < 0.01); low confidence for quitting (OR, 2.07, [95% CI, 1.49-2.88], P < 0.01); and not setting a quit date (OR, 1.76, [95% CI, 1.25-2.48], P < 0.01). Other significant predictors included higher nicotine dependence, shorter length of stay, and depression. Patients who are vulnerable to rapid relapse may benefit from policies that discourage leaving the hospital to smoke. In addition, hospital interventions that target smokers' confidence in quitting, encourage setting a quit date, and addressing nicotine dependence and depression may also be effective at supporting smoker's intentions to make their pre-admission cigarette their last. Clinical Trials Registration NCT01305928.

Critical steps in the path to using cessation pharmacotherapy following hospital-initiated tobacco treatment.

BACKGROUND: Hospital-initiated smoking cessation interventions utilizing pharmacotherapy increase post-discharge quit rates. Use of smoking cessation medications following discharge may further increase quit rates. This study aims to identify individual, smoking-related and hospitalization-related predictors of engagement in three different steps in the smoking cessation pharmacotherapy utilization process: 1) receiving medications as inpatient, 2) being discharged with a prescription and 3) using medications at 1-month post-hospitalization, while accounting for associations between these steps. METHODS: Study data come from a clinical trial (N = 1054) of hospitalized smokers interested in quitting who were randomized to recieve referral to a quitline via either warm handoff or fax. Variables were from the electronic health record, the state tobacco quitline, and participant self-report. Relationships among the predictors and the steps in cessation medication utilization were assessed using bivariate analyses and multivariable path analysis. RESULTS: Twenty-eight percent of patients reported using medication at 1-month post-discharge. Receipt of smoking cessation medications while hospitalized (OR = 2.09, 95%CI [1.39, 3.15], p < .001) and discharge with a script (OR = 4.88, 95%CI [3.34, 7.13], p < .001) were independently associated with medication use at 1-month post-hospitalization. The path analysis also revealed that the likelihood of being discharged with a script was strongly influenced by receipt of medication as an inpatient (OR = 6.61, 95%CI [4.66, 9.38], p < .001). A number of other treatment- and individual-level factors were associated with medication use in the hospital, receipt of a script, and use post-discharge. CONCLUSIONS: To encourage post-discharge smoking cessation medication use, concerted effort should be made to engage smokers in tobacco treatment while in hospital. The individual and hospital-level factors associated with each step in the medication utilization process provide good potential targets for future implementation research to optimize treatment delivery and outcomes. TRIAL REGISTRATION: Number: NCT01305928 . Date registered: February 24, 2011.

Factors That Explain Differences in Abstinence Between Black and White Smokers: A Prospective Intervention Study.

BACKGROUND: Black-white differences in smoking abstinence are not well understood. This trial sought to confirm previously reported differences in quitting between blacks and whites and to identify factors underlying this difference. METHODS: During enrollment, 224 black and 225 white low-income smokers were stratified on race and within race on age and sex to ensure balance on these factors known to impact abstinence. The intervention included varenicline for 12 weeks and six guideline-based smoking cessation counseling sessions. The primary endpoint was cotinine-verified 7-day point prevalence smoking abstinence at week 26. A priori socioeconomic, smoking, treatment process (eg, treatment utilization, side effects, withdrawal relief), psychosocial, and biological factors were assessed to investigate race differences in abstinence. Unadjusted odds ratios (OR) were used to compare abstinence between blacks and whites. Adjusted odds ratios from logistic regression models were used to examine predictors of abstinence. All statistical tests were two-sided. RESULTS: Blacks were less likely to achieve abstinence at week 26 (14.3% vs 24.4%, OR = 0.51, 95% confidence interval [CI] = 0.32 to 0.83, P = .007). Utilizing best subsets logistic regression, five factors associated with race jointly predicted abstinence: home ownership (yes/no, OR = 3.03, 95% CI = 1.72 to 5.35, P < .001), study visits completed (range = 0-6, OR = 2.81, 95% CI = 1.88 to 4.20, P < .001), income (household member/$1000, OR = 1.03, 95% CI = 1.01 to 1.06, P = .02), plasma cotinine (per 1 ng/mL, OR = 0.997, 95% CI = 0.994 to 0.999, P = .002), and neighborhood problems (range = 10-30, OR = 0.88, 95% CI = 0.81 to 0.96, P = .003). CONCLUSIONS: The race difference in abstinence was fully explained by lack of home ownership, lower income, greater neighborhood problems, higher baseline cotinine, and higher visit completion, which were disproportionately represented among blacks. Findings illuminate factors that make it harder for blacks in the United States to quit smoking relative to whites and provide important areas for future studies to reduce tobacco-related health disparities.

Intent to quit, quit attempts, and perceived health risk reduction among African American, Latino, and White nondaily and daily smokers in the United States.

Objective: Ethnic and racial differences in smoking patterns and behaviors have been well documented and most African American and Latino smokers are nondaily or light smokers. However, differences within smoking levels are understudied. Our primary aim was to determine whether there are racial and ethnic differences among African American, Latino, and White nondaily, light daily, and moderate to heavy daily smokers on (1) perceived health risk reduction, (2) intentions to quit, and (3) past year quit attempts. Design: Smokers were recruited through an online research panel for a cross-sectional survey (n = 2376). Sampling quotas were used to obtain equal numbers of African American, Latino, and White nondaily and daily smokers. Results: African American (59.6%) and Latino (54%) nondaily smokers were more likely than White nondaily smokers (45%) to currently limit their cigarettes per day (cpd) as a perceived health risk reduction strategy (p < 0.05). African American nondaily smokers were more likely than Latino and White nondaily smokers (p < 0.05) to limit their smoking in the past year as a perceived health risk reduction strategy (range: 0 'never' to 5 'always'; Means = 3.2, 2.9, 3.0, standard deviations [SD] = 1.1, 1.1, 1.2, respectively). African American nondaily smokers (15%) were more likely than either Latinos (7.8%) or Whites (8.5%) to intend to quit in the next 30 days (p < 0.01). African American (61.6%) and Latino (60.3%) nondaily smokers were more likely than Whites (49%) to have made a quit attempt in the past year (p < 0.01). Fewer racial and ethnic differences were found among daily smokers. Conclusions: Racial and ethnic group differences were more pronounced among nondaily smokers compared to light daily smoker and moderate to heavy daily smokers. Smoking level is an important consideration in understanding racial and ethnic variation in perceived health risk reduction and cessation-related behaviors.

Predictors of engagement in post-discharge quitline counseling among hospitalized smokers.

Quitlines provide evidence-based tobacco treatment and multiple calls yield higher quit rates. This study aimed to identify subgroups of smokers with greater quitline engagement following referral during hospitalization. Data were from a randomized clinical trial assessing the effectiveness of fax referral (referral faxed to proactive quitline) versus warm handoff (patient connected to quitline at bedside) (n = 1054). Classification and regression trees analyses evaluated individual and treatment/health system-related variables and their interactions. Among all participants, warm handoff, higher ratings of the tobacco treatment care transition, and being older predicted completing more quitline calls. Among patients enrolled in the quitline, higher transition of care ratings, being older, and use of cessation medication post-discharge predicted completing more calls. Three of the four factors influencing engagement were characteristics of treatment within the hospital (quality of tobacco treatment care transition and referral method) and therapy (use of cessation medications), suggesting potential targets to increase quitline engagement post-discharge.

Enhancing partner support to improve smoking cessation.

BACKGROUND: While many cessation programmes are available to assist smokers in quitting, research suggests that support from individual partners, family members, or 'buddies' may encourage abstinence. OBJECTIVES: To determine if an intervention to enhance one-to-one partner support for smokers attempting to quit improves smoking cessation outcomes, compared with cessation interventions lacking a partner-support component. SEARCH METHODS: We limited the search to the Cochrane Tobacco Addiction Group Specialised Register, which was updated in April 2018. This includes the results of searches of the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (via OVID); Embase (via OVID); and PsycINFO (via OVID). The search terms used were smoking (prevention, control, therapy), smoking cessation and support (family, marriage, spouse, partner, sexual partner, buddy, friend, cohabitant and co-worker). We also reviewed the bibliographies of all included articles for additional trials. SELECTION CRITERIA: We included randomised controlled trials recruiting people who smoked. Trials were eligible if they had at least one treatment arm that included a smoking cessation intervention with a partner-support component, compared to a control condition providing behavioural support of similar intensity, without a partner-support component. Trials were also required to report smoking cessation at six months follow-up or more. DATA COLLECTION AND ANALYSIS: Two review authors independently identified the included studies from the search results, and extracted data using a structured form. A third review author helped resolve discrepancies, in line with standard methodological procedures expected by Cochrane. Smoking abstinence, biochemically verified where possible, was the primary outcome measure and was extracted at two post-treatment intervals where possible: at six to nine months and at 12 months or longer. We used a random-effects model to pool risk ratios from each study and estimate a summary effect. MAIN RESULTS: Our update search identified 465 citations, which we assessed for eligibility. Three new studies met the criteria for inclusion, giving a total of 14 included studies (n = 3370). The definition of partner varied among the studies. We compared partner support versus control interventions at six- to nine-month follow-up and at 12 or more months follow-up. We also examined outcomes among three subgroups: interventions targeting relatives, friends or coworkers; interventions targeting spouses or cohabiting partners; and interventions targeting fellow cessation programme participants. All studies gave self-reported smoking cessation rates, with limited biochemical verification of abstinence. The pooled risk ratio (RR) for abstinence was 0.97 (95% confidence interval (CI) 0.83 to 1.14; 12 studies; 2818 participants) at six to nine months, and 1.04 (95% CI 0.88 to 1.22; 7 studies; 2573 participants) at 12 months or more post-treatment. Of the 11 studies that measured partner support at follow-up, only two reported a significant increase in partner support in the intervention groups. One of these studies reported a significant increase in partner support in the intervention group, but smokers' reports of partner support received did not differ significantly. We judged one of the included studies to be at high risk of selection bias, but a sensitivity analysis suggests that this did not have an impact on the results. There were also potential issues with detection bias due to a lack of validation of abstinence in five of the 14 studies; however, this is not apparent in the statistically homogeneous results across studies. Using the GRADE system we rated the overall quality of the evidence for the two primary outcomes as low. We downgraded due to the risk of bias, as we judged studies with a high weighting in analyses to be at a high risk of detection bias. In addition, a study in both analyses was insufficiently randomised. We also downgraded the quality of the evidence for indirectness, as very few studies provided any evidence that the interventions tested actually increased the amount of partner support received by participants in the relevant intervention group. AUTHORS' CONCLUSIONS: Interventions that aim to enhance partner support appear to have no impact on increasing long-term abstinence from smoking. However, most interventions that assessed partner support showed no evidence that the interventions actually achieved their aim and increased support from partners for smoking cessation. Future research should therefore focus on developing behavioural interventions that actually increase partner support, and test this in small-scale studies, before large trials assessing the impact on smoking cessation can be justified.

Daily and Nondaily Smoking Varies by Acculturation among English-Speaking, US Latino Men and Women.

Background: Higher smoking prevalence and quantity (cigarettes per day) has been linked to acculturation in the United States among Latinas, but not Latino men. Our study examines variation between a different and increasingly important target behavior, smoking level (nondaily vs daily) and acculturation by sex. Methods: An online English-language survey was administered to 786 Latino smokers during July through August 2012. The Brief Acculturation Rating Scale for Mexican Americans-II (ARSMA-II) and other acculturation markers were used. Multinomial logistic regression models were implemented to assess the association between smoking levels (nondaily, light daily, and moderate/heavy daily) with acculturation markers. Results: Greater ARMSA-II scores (relative risk ratio, RRR=.81, 95% CI: .72-.91) and being born inside the United States (RRR=.42, 95% CI: .24-.74) were associated with lower relative risk of nondaily smoking. Greater Latino orientation (RRR=1.29, 95% CI: 1.11-1.48) and preference for Spanish language (RRR=1.06, 95% CI: 1.02-1.10) and media (RRR=1.12, 95% CI: 1.05-1.20) were associated with higher relative risk of nondaily smoking. The relationship between acculturation and smoking level did not differ by sex. Conclusion: This study found that among both male and female, English-speaking Latino smokers, nondaily smoking was associated with lower acculturation, while daily smoking was linked with higher acculturation.

Accuracy of self-reported smoking abstinence in clinical trials of hospital-initiated smoking interventions.

AIMS: To estimate the prevalence and predictors of failed biochemical verification of self-reported abstinence among participants enrolled in trials of hospital-initiated smoking cessation interventions. DESIGN: Comparison of characteristics between participants who verified and those who failed to verify self-reported abstinence. SETTINGS: Multi-site randomized clinical trials conducted between 2010 and 2014 in hospitals throughout the United States. PARTICIPANTS: Recently hospitalized smokers who reported tobacco abstinence 6 months post-randomization and provided a saliva sample for verification purposes (n = 822). MEASUREMENTS: Outcomes were salivary cotinine-verified smoking abstinence at 10 and 15 ng/ml cut-points. Predictors and correlates included participant demographics and tobacco use; hospital diagnoses and treatment; and study characteristics collected via surveys and electronic medical records. FINDINGS: Usable samples were returned by 69.8% of the 1178 eligible trial participants who reported 7-day point prevalence abstinence. The proportion of participants verified as quit was 57.8% [95% confidence interval (CI) = 54.4, 61.2; 10 ng/ml cut-off] or 60.6% (95% CI = 57.2, 63.9; 15 ng/ml). Factors associated independently with verification at 10 ng/ml were education beyond high school education [odds ratio (OR) = 1.51; 95% CI = 1.07, 2.11], continuous abstinence since hospitalization (OR = 2.82; 95% CI = 2.02, 3.94), mailed versus in-person sample (OR = 3.20; 95% CI = 1.96, 5.21) and race. African American participants were less likely to verify abstinence than white participants (OR = 0.64; 95% CI = 0.44, 0.93). Findings were similar for verification at 15 ng/ml. Verification rates did not differ by treatment group. CONCLUSIONS: In the United States, high rates (40%) of recently hospitalized smokers enrolled in smoking cessation trials fail biochemical verification of their self-reported abstinence.

Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial.

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.

Medicaid Coverage of Smoking Cessation Counseling and Medication Is Underutilized for Pregnant Women.

INTRODUCTION: Policies to promote smoking cessation among Medicaid-insured pregnant women have the potential to assist a significant proportion of pregnant smokers. In 2010, Kansas Medicaid began covering smoking cessation counseling for pregnant smokers. Our aim was to evaluate the use of smoking cessation benefits provided to pregnant women as a result of the Kansas Medicaid policy change that provided reimbursement for physician-provided smoking cessation counseling. METHODS: We examined Kansas Medicaid claims data to estimate rates of delivery of smoking cessation treatment to Medicaid-insured pregnant women in Kansas from fiscal year 2010 through 2013. We analyzed the number of pregnant women who received physician-provided smoking cessation counseling indicated by procedure billing codes (ie, G0436 and G0437) and medication (ie, nicotine replacement therapy, bupropion, or varenicline) located in outpatient managed care encounter and fee-for-service claims data. We estimated the number of Medicaid-insured pregnant smokers using the national smoking prevalence (14%) in this population and the number of live births reported in Kansas. RESULTS: Annually from 2010 to 2013, approximately 27.2%-31.6% of pregnant smokers had claims for nicotine replacement therapy, bupropion, or varenicline. Excluding claims for bupropion, a medication commonly prescribed to treat depression, claims ranged from 9.3% to 11.1%. Following implementation of Medicaid coverage for smoking cessation counseling, less than 1% of estimated smokers had claims for counseling. CONCLUSIONS: This low claims rate suggests that simply changing policy is not sufficient to ensure use of newly implemented benefits, and that there probably remain critical gaps in smoking cessation treatment. IMPLICATIONS: This study evaluates the use of Medicaid reimbursement for smoking cessation counseling among low-income pregnant women in Kansas. We describe the Medicaid claims rates of physician-provided smoking cessation counseling for pregnant women, an evidence-based and universally recommended treatment approach for smoking cessation in this population. Our findings show that claims rates for smoking cessation benefits in this population are very low, even after policy changes to support provision of cessation assistance were implemented. Additional studies are needed to determine whether reimbursement is functioning as intended and identify potential gaps between policy and implementation of evidence-based smoking cessation treatment.

An Evaluation of SmokeFree for Kansas Kids: An Intervention to Promote Tobacco Cessation in Pediatric Clinics.

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.