What to do after smoking relapse? A sequential multiple assignment randomized trial of chronic care smoking treatments.

AIM: To compare effects of three post-relapse interventions on smoking abstinence. DESIGN: Sequential three-phase multiple assignment randomized trial (SMART). SETTING: Eighteen Wisconsin, USA, primary care clinics. PARTICIPANTS: A total of 1154 primary care patients (53.6% women, 81.2% White) interested in quitting smoking enrolled from 2015 to 2019; 582 relapsed and were randomized to relapse recovery treatment. INTERVENTIONS: In phase 1, patients received cessation counseling and 8 weeks nicotine patch. Those who relapsed and agreed were randomized to a phase 2 relapse recovery group: (1) reduction counseling + nicotine mini-lozenges + encouragement to quit starting 1 month post-randomization (preparation); (2) repeated encouragement to quit starting immediately post-randomization (recycling); or (3) advice to call the tobacco quitline (control). The first two groups could opt into phase 3 new quit treatment [8 weeks nicotine patch + mini-lozenges plus randomization to two treatment factors (skill training and supportive counseling) in a 2 × 2 design]. Phase 2 and 3 interventions lasted ≤ 15 months. MEASUREMENTS: The study was powered to compare each active phase 2 treatment with the control on the primary outcome: biochemically confirmed 7-day point-prevalence abstinence 14 months post initiating phase 2 relapse recovery treatment. Exploratory analyses tested for phase 3 counseling factor effects. FINDINGS: Neither skill training nor supportive counseling (each on versus off) increased 14-month abstinence rates; skills on versus off 9.3% (14/151) versus 5.2% (8/153), P = 0.19; support on versus off 6.6% (10/152) versus 7.9% (12/152), P = 0.73. Phase 2 preparation did not produce higher 14-month abstinence rates than quitline referral; 3.6% (8/220) versus 2.1% [3/145; risk difference = 1.5%, 95% confidence interval (CI) = -1.8-5.0%, odds ratio (OR) = 1.8, 95% CI = 0.5-6.9]. Recycling, however, produced higher abstinence rates than quitline referral; 6.9% (15/217) versus 2.1% (three of 145; risk difference, 4.8%, 95% CI = 0.7-8.9%, OR = 3.5, 95% CI = 1.0-12.4). Recycling produced greater entry into new quit treatment than preparation: 83.4% (181/217) versus 55.9% (123/220), P < 0.0001. CONCLUSIONS: Among people interested in quitting smoking, immediate encouragement post-relapse to enter a new round of smoking cessation treatment ('recycling') produced higher probability of abstinence than tobacco quitline referral. Recycling produced higher rates of cessation treatment re-engagement than did preparation/cutting down using more intensive counseling and pharmacotherapy.

Explaining COVID-19 related mortality disparities in American Indians and Alaska Natives.

American Indian and Alaska Native (AI/AN) individuals are more likely to die with COVID-19 than other groups, but there is limited empirical evidence to explain the cause of this inequity. The objective of this study was to determine whether medical comorbidities, area socioeconomic deprivation, or access to treatment can explain the greater COVID-19 related mortality among AI/AN individuals. The design was a retrospective cohort study of harmonized electronic health record data of all inpatients with COVID-19 from 21 United States health systems from February 2020 through January 2022. The mortality of AI/AN inpatients was compared to all Non-Hispanic White (NHW) inpatients and to a matched subsample of NHW inpatients. AI/AN inpatients were more likely to die during their hospitalization (13.2% versus 7.1%; odds ratio [OR] = 1.98, 95% confidence interval [CI] = 1.48, 2.65) than their matched NHW counterparts. After adjusting for comorbidities, area social deprivation, and access to treatment, the association between ethnicity and mortality was substantially reduced (OR 1.59, 95% CI 1.15, 2.22). The significant residual relation between AI/AN versus NHW status and mortality indicate that there are other important unmeasured factors that contribute to this inequity. This will be an important direction for future research.

Factors associated with 60-day readmission among inpatients with COVID-19 at 21 United States health systems.

Identifying patients at risk for readmission after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection could facilitate care planning and prevention. This retrospective cohort study of 60-day readmission included 105 543 COVID-19 patients at 21 US healthcare systems who were discharged alive between February 2020 and November 2021. Generalized linear mixed regression analyses tested predictors of 60-day readmission and severity. The all-cause readmission rate was 15% (95% confidence interval [CI] = 10%-21%), with 22% (95% CI = 18%-26%) of readmitted patients needing intensive care, and 6% (95% CI = 05%-07%) dying. Factors associated with readmission included male sex, government insurance, positive smoking history, co-morbidity burden, longer index admissions, and diagnoses at index admission (e.g., cancer, chronic kidney disease, and liver disease). Death and intensive care rates at readmission declined postvaccine availability. Receiving at least two COVID-19 vaccine doses, which were more common among older patients and those with comorbid conditions, was not independently associated with readmission but predicted a reduced risk of death at readmission. This retrospective cohort study identified factors associated with all-cause readmission for patients re-admitted to the same health system after hospitalization with SARS-CoV-2 infection. Patients who are male, who smoke, who have a higher comorbidity burden, and have government insurance may benefit from additional postacute care planning.

A machine learning analysis of correlates of mortality among patients hospitalized with COVID-19.

It is vital to determine how patient characteristics that precede COVID-19 illness relate to COVID-19 mortality. This is a retrospective cohort study of patients hospitalized with COVID-19 across 21 healthcare systems in the US. All patients (N = 145,944) had COVID-19 diagnoses and/or positive PCR tests and completed their hospital stays from February 1, 2020 through January 31, 2022. Machine learning analyses revealed that age, hypertension, insurance status, and healthcare system (hospital site) were especially predictive of mortality across the full sample. However, multiple variables were especially predictive in subgroups of patients. The nested effects of risk factors such as age, hypertension, vaccination, site, and race accounted for large differences in mortality likelihood with rates ranging from about 2-30%. Subgroups of patients are at heightened risk of COVID-19 mortality due to combinations of preadmission risk factors; a finding of potential relevance to outreach and preventive actions.

The Relationship of COVID-19 Vaccination with Mortality Among 86,732 Hospitalized Patients: Subpopulations, Patient Factors, and Changes over Time.

BACKGROUND: Information on COVID-19 vaccination effects on mortality among patients hospitalized with COVID-19 could inform vaccination outreach efforts and increase understanding of patient risk. OBJECTIVE: Determine the associations of vaccination status with mortality in adult patients hospitalized with COVID-19. DESIGN: This retrospective cohort study assessed the characteristics and mortality rates of adult patients hospitalized with COVID-19 across 21 healthcare systems in the USA from January 1, 2021, to January 31, 2022. PARTICIPANTS: Adult patients admitted to participating hospitals who had COVID-19 diagnoses and/or positive PCR tests and completed their hospital stay via discharge or death. MAIN MEASURE: In-hospital mortality vs. discharge (outcome) and patient age, sex, race, ethnicity, BMI, insurance status, comorbidities, and vaccination status extracted from the electronic health record (EHR). KEY RESULTS: Of 86,732 adult patients hospitalized with COVID-19, 45,082 (52%) were female, mean age was 60 years, 20,800 (24%) were Black, and 22,792 (26.3%) had one or more COVID-19 vaccinations. Statistically adjusted mortality rates for unvaccinated and vaccinated patients were 8.3% (95% CI, 8.1-8.5) and 5.1% (95% CI, 4.8-5.4) respectively (7.9% vs. 4.5% with no immune compromise). Vaccination was associated with especially large reductions in mortality for obese (OR = 0.67; 95% CI 0.56-0.80) and severely obese (OR = 0.52; 95% CI, 0.41-0.67) patients and for older patients (OR = 0.99; 95% CI, 0.98-0.99). Mortality likelihood was higher later in the study period (August 2021-January 31, 2022) than earlier (January 1, 2021-July 30, 2021) (OR = 1.10; 95% CI = 1.04-1.17) and increased significantly for vaccinated patients from 4.6% (95% CI, 3.9-5.2%) to 6.5% (95% CI, 6.2-6.9%). CONCLUSIONS: Patients vaccinated for COVID-19 had reduced mortality, especially for obese/severely obese and older individuals. Vaccination's protective effect against mortality declined over time and hospitalized obese and older individuals may derive especially great benefit from prior vaccination against SARS-CoV-2.

Relations of Current and Past Cancer with Severe Outcomes among 104,590 Hospitalized COVID-19 Patients: The COVID EHR Cohort at the University of Wisconsin.

BACKGROUND: There is mixed evidence about the relations of current versus past cancer with severe COVID-19 outcomes and how they vary by patient and cancer characteristics. METHODS: Electronic health record data of 104,590 adult hospitalized patients with COVID-19 were obtained from 21 United States health systems from February 2020 through September 2021. In-hospital mortality and ICU admission were predicted from current and past cancer diagnoses. Moderation by patient characteristics, vaccination status, cancer type, and year of the pandemic was examined. RESULTS: 6.8% of the patients had current (n = 7,141) and 6.5% had past (n = 6,749) cancer diagnoses. Current cancer predicted both severe outcomes but past cancer did not; adjusted odds ratios (aOR) for mortality were 1.58 [95% confidence interval (CI), 1.46-1.70] and 1.04 (95% CI, 0.96-1.13), respectively. Mortality rates decreased over the pandemic but the incremental risk of current cancer persisted, with the increment being larger among younger vs. older patients. Prior COVID-19 vaccination reduced mortality generally and among those with current cancer (aOR, 0.69; 95% CI, 0.53-0.90). CONCLUSIONS: Current cancer, especially among younger patients, posed a substantially increased risk for death and ICU admission among patients with COVID-19; prior COVID-19 vaccination mitigated the risk associated with current cancer. Past history of cancer was not associated with higher risks for severe COVID-19 outcomes for most cancer types. IMPACT: This study clarifies the characteristics that modify the risk associated with cancer on severe COVID-19 outcomes across the first 20 months of the COVID-19 pandemic. See related commentary by Egan et al., p. 3.

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

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

The first 20 months of the COVID-19 pandemic: Mortality, intubation and ICU rates among 104,590 patients hospitalized at 21 United States health systems.

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

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial.

Importance: Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness. Objective: To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration). Design, Settings, and Participants: Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized. Interventions: All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). Main Outcomes and Measures: The primary outcome was carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks. Results: Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, -0.4% [95% CI, -5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, -4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups. Conclusions and Relevance: Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration. Trial Registration: ClinicalTrials.gov Identifier: NCT03176784.

Measuring Therapeutic Alliance for Tobacco Cessation Counseling for Behavioral Health Clinicians.

INTRODUCTION: Those coping with significant mental illness smoke at a high prevalence rate. Increasingly, behavioral health clinicians (BHCs) are being asked to provide tobacco-dependence interventions. In this context, it is important to measure their success at doing so. While the Working Alliance Inventory (WAI) is a well-established measurement of the effectiveness of therapeutic alliance, it is not specific to tobacco-dependence interventions. The Working Alliance Inventory for Tobacco (WAIT-3) has been found valid for tobacco cessation counselors (health providers who address tobacco), but its validity has not been established when BHCs address tobacco cessation as part of addressing all other needs of their patients. The purpose of this study was to examine the validity of the WAIT-3 in the context of behavioral health clinicians. METHODS: Wisconsin Community Support Programs and Comprehensive Community Services programs distributed an anonymous, brief (14 items) survey to 1,930 of their clients. Measured variables included smoking status, behavioral intentions regarding quitting, and perception of help received from their clinic. Respondents could enter a chance to win a gift card as a thank you. RESULTS: WAIT-3 scores were correlated with quitting-related variables. Compared to those with lower WAIT-3 scores, those with higher scores reported more attempts to quit, were more motivated to quit, were more likely to have a smoking cessation/reduction goal in their general treatment plan, had more conversations about quitting with their BHC, and wanted more help from their BHC to quit. CONCLUSIONS: The WAIT-3 may be a valid way to measure the effectiveness of BHCs to address the tobacco use of their patients. Next steps include establishing its predictive validity.

Evaluating four motivation-phase intervention components for use with primary care patients unwilling to quit smoking: a randomized factorial experiment.

AIMS: To assess the effectiveness of intervention components designed to increase quit attempts and promote abstinence in patients initially unwilling to quit smoking. DESIGN: A four-factor, randomized factorial experiment. SETTING: Sixteen primary care clinics in southern Wisconsin. PARTICIPANTS: A total of 577 adults who smoke (60% women, 80% White) recruited during primary care visits who were currently willing to reduce their smoking but unwilling to try to quit. Interventions Four factors contrasted intervention components administered over a 1-year period: (i) nicotine mini-lozenge versus none; (ii) reduction counseling versus none; (iii) behavioral activation (BA) counseling versus none; and (iv) motivational 5Rs counseling versus none. Participants could request cessation treatment at any time. MEASUREMENTS: The primary outcome was 7-day point-prevalence abstinence at 52 weeks post enrollment; secondary outcomes were point-prevalence abstinence at 26 weeks and making a quit attempt by weeks 26 and 52. FINDINGS: No abstinence main effects were found but a mini-lozenge × reduction counseling × BA interaction was found at 52 weeks; P = 0.03. Unpacking this interaction showed that the mini-lozenge alone produced the highest abstinence rate (16.7%); combining it with reduction counseling produced an especially low abstinence rate (4.1%). Reduction counseling decreased the likelihood of making a quit attempt by 52 weeks relative to no reduction counseling (P = 0.01). CONCLUSIONS: Nicotine mini-lozenges may increase smoking abstinence in people initially unwilling to quit smoking, but their effectiveness declines when used with smoking reduction counseling or other behavioral interventions. Reduction counseling decreases the likelihood of making a quit attempt in people initially unwilling to quit smoking.

Revision of the Wisconsin Smoking Withdrawal Scale: Development of brief and long forms.

The assessment of tobacco withdrawal is important for both research and clinical purposes. This study describes the psychometric development of a revised version of the 28-item Wisconsin Smoking Withdrawal Scale (WSWS; Welsch et al., Experimental and Clinical Psychopharmacology, 1999, 7, p. 354). Because the different contexts of use sometimes permit only brief assessment, this revision has produced both a brief and longer form using an updated pool of candidate items. For the revised Wisconsin Smoking Withdrawal Scale 2 (WSWS2), a candidate pool of 37 items was developed to measure nine putative withdrawal constructs. The stem and wording of items were revised as was the response scale. Data for psychometric analyses were derived from three smoking cessation randomized clinical trials conducted at the University of Wisconsin Center for Tobacco Research and Intervention. Dimensionality, internal consistency, and item characteristic analyses of the candidate items were conducted in a derivation sample to ascertain the factor structure and to identify items that could be used in the WSWS2 scales. Confirmatory factor analyses (CFAs) of reduced item sets and factor structure were conducted in two validation samples along with reliability and validity analyses. Derivation and validation sample analyses yielded a longer version of the WSWS2 (WSWS2-L) with 19 items and six subscales (Craving, Negative Affect, Hunger, Sleep, Restlessness, and Concentration) and a brief 6-item version (WSWS2-B). In validation sample analyses, both the WSWS2-L and the WSWS2-B demonstrated good reliability and validity as well as good fit in CFAs. The WSWS2-L and WSWS2-B possess improved construct coverage, fewer items, and other enhancements relative to the WSWS. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Barriers to Building More Effective Treatments: Negative Interactions Amongst Smoking Intervention Components.

Meaningfully improved mental and behavioral health treatment is an unrealized dream. Across three factorial experiments, inferential tests in prior studies showed a pattern of negative interactions suggesting that better clinical outcomes are obtained when participants receive fewer rather than more intervention components. Further, relatively few significant main effects were found in these experiments. Modeling suggested that negative interactions amongst components may account for these patterns. This paper evaluates factors that may contribute to such declining benefit: increased attentional or effort burden; components that produce their effects via the same capacity limited mechanisms, making their effects subadditive; and a tipping point phenomenon in which those near a hypothesized "tipping point" for change will benefit markedly from weak intervention while those far from the tipping point will benefit little from even strong intervention. New research should explore factors that cause negative interactions amongst components and constrain the development of more effective treatments.

Addressing Environmental Smoke Exposure During Pediatric Hospitalization: Attitudes and Practices of Pediatric Nurses Versus Respiratory Therapists.

BACKGROUND: Tobacco smoke exposure leads to numerous adverse health effects in children. Providing cessation interventions to caregivers who smoke during pediatric hospitalizations can help protect children from such exposure. Both pediatric registered nurses (RNs) and pediatric respiratory therapists (RTs) are well positioned to provide these interventions. Little is known about their rates of participation in cessation efforts. Our objective was to compare the attitudes and practice of pediatric RNs versus pediatric RTs to evaluate their relative cessation-intervention practices in the in-patient pediatric setting. METHODS: An online survey was sent to pediatric RNs and RTs at 4 tertiary pediatric hospitals in California. The survey assessed individual demographics, work environment, experience, beliefs, and practices related to smoking cessation activities. Questions used 3-point and 5-point Likert scales and were compared with the chi-square test. Institutions with a response rate < 20% were excluded. RESULTS: A total of 401 respondents were included in the final analysis (292 RNs, 109 RTs). RTs versus RNs were older (42.0 y vs 35.4 y, respectively, P < .001) and more likely to be former smokers (29.9% vs 13.3%, respectively, P < .001). RNs reported lower levels of confidence in discussing smoking cessation with parents, with 11.7% saying they felt "very confident" compared to 29.0% of RTs (P < .001). RNs also reported screening for smoke exposure less frequently than RTs, with 18.8% responding "often" or "always" compared to 28.9% of RTs (P = .033). RNs had lower rates of advising parents "to make a smoke-free home policy" compared to RTs (ie, 13.4% vs 26.9%, respectively, P = .002). CONCLUSIONS: Compared to in-patient pediatric RNs, RTs reported higher rates of confidence in providing cessation interventions, screening for smoke exposure, and counseling on reducing smoke exposure, suggesting that they may be better positioned for intervening. These results can inform the design of an in-patient cessation intervention for caregivers of hospitalized children.

Longitudinal effects of smoking cessation on carotid artery atherosclerosis in contemporary smokers: The Wisconsin Smokers Health Study.

BACKGROUND AND AIMS: We quantified the effects of smoking and smoking cessation on carotid artery atherosclerosis and wall thickness in two unique cohorts of smokers making a quit attempt. METHODS: Our primary analysis included 726 smokers making a quit attempt in a randomized clinical trial with long-term follow-up. Our secondary analysis included 889 smokers making a quit attempt in a subsequent trial. Participants underwent carotid artery ultrasonography at baseline and up to 3 subsequent visits. Primary outcomes were changes in carotid plaque score and intima media-thickness (IMT). We calculated a smoking burden score (SBS) that reflected the number of visits in which participants reported smoking after the quit attempt. Multivariable regression examined relations between SBS and carotid artery outcomes with adjustments for cardiovascular disease risk factors. RESULTS: In the primary analysis, participants were mean (standard deviation) 46.1 (10.3) years old (57.9% female) and smoked 21.1 (8.9) cigarettes per day (CPD). After a median of 7 years, lower SBS predicted less increase in carotid plaque score (Chi-squared = 13.0, p = 0.012). SBS independently predicted change in carotid plaque score (p = 0.007; SBS 0 vs 4) as did baseline CPD (p = 0.024) and age (p<0.0001). SBS did not affect carotid IMT change. In the secondary analysis, increasing SBS was associated with increased likelihood of new plaques over 3 years among participants that smoked ≥15 CPD, (Chi-squared = 6.51, p = 0.011). CONCLUSIONS: Smoking cessation is associated with less progression of carotid plaque, but not IMT. Salutary associations of smoking cessation with carotid plaque progression are related to degree of abstinence.

Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relationship With Lapse and Relapse.

INTRODUCTION: Greater use of nicotine replacement therapy (NRT) is related to smoking cessation success, but the causal direction is unclear. This study characterized the relationship between NRT use and smoking lapse and relapse. METHODS: Participants (N = 416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD). Participants were randomized to counseling and 8 versus 26 weeks of nicotine patch plus nicotine gum post-TQD. Participants carried electronic dispensers that timestamped each gum use. Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with nonlapsers (n = 146 pairs) on multiple variables. We compared lapsers' versus matched nonlapsers' gum use in the 5 days before and after the lapsers' first lapse. RESULTS: By week 6 post-TQD, 63% of participants lapsed. Compared with nonlapsers, lapsers used less gum 1 and 2 days pre-"lapse" and on the 5 days post-lapse. Lapsers used less gum during the 5 days post-lapse than the 5 days pre-lapse. Univariate survival analyses with lapsers showed greater gum use during both pre- and post-lapse periods predicted longer latency to relapse in the first 6 weeks. CONCLUSIONS: In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched nonlapsers used less gum immediately preceding and following their first lapse. Lower mean gum use before and after lapses predicted a more rapid escalation to relapse. Decreased nicotine gum use both precedes and follows returns to smoking during cessation attempts. IMPLICATIONS: This research examined electronically monitored nicotine gum use collected in real time and found that among smokers engaged in a quit attempt, lapsers (vs. matched nonlapsers) tended to decrease their gum use 1-2 days prior to lapsing and to further decrease their gum use from pre- to post-lapse. Decreased gum use pre-lapse may signal heightened lapse risk in 1-2 days, with lower level of gum use predicting a more precipitous course of relapse. These results encourage further exploration of objective measures of smoking medication use patterns to examine their signaling properties and to inform understanding of cessation failure. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01120704.

Financial incentives to Medicaid smokers for engaging tobacco quit line treatment: maximising return on investment.

BACKGROUND: Low-income smokers experience greater difficulty in quitting smoking than do other smokers. Providing financial incentives for treatment engagement increases smoking cessation success. This study models the cost-effectiveness of varying levels of financial incentives to maximise return on investment (ROI) for engaging low-income Medicaid recipients who smoke to take calls from a tobacco quit line. METHODS: Participants (N=1900) were recruited from May 2013 to June 2015 through quit line-based (n=980), clinic-based (n=444) or community-based referrals (n=476) into the Wisconsin Medicaid Quit Line Incentive project. Incentive (n=948) and control group participants (n=952) received $30 versus $0 per call, respectively, for taking up to five Wisconsin Tobacco Quit Line (WTQL) calls. Cost-effectiveness analyses estimated the incremental cost-effectiveness ratio for alternative financial incentives for engagement with WTQL calls. Probabilistic sensitivity analysis was employed to determine an optimal strategy for financial incentives to minimise the cost per individual who quit smoking. RESULTS: Using fixed payments, the incremental cost-effectiveness ratio of $2316 per smoker who quit in the randomised trial decreased to $2150 per smoker who quit when the incentives were modelled at $20 per each of five WTQL calls taken. Using variable payments, the minimal cost per additional smoker who quit was $2125 when incentives for the first four WTQL calls were set at $20, and the financial payment for the fifth WTQL call was set at $70. CONCLUSIONS: Modelling suggests that financial incentives in the amount of $20 per call for taking the first four quit line calls and $70 for taking a fifth quit line call maximise ROI to engage low-income smokers with evidence-based smoking cessation treatment.

Anxiety Sensitivity and Distress Tolerance in Smokers: Relations With Tobacco Dependence, Withdrawal, and Quitting Success†.

INTRODUCTION: This study examined relations of two affective vulnerabilities, high anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response. METHODS: Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African American) were randomized to 12 weeks of nicotine patch, nicotine patch plus nicotine lozenge, or varenicline. Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence. Withdrawal was assessed the first-week post-quit via ecological momentary assessment. RESULTS: DT, but not AS, predicted biochemically confirmed point-prevalence abstinence at multiple endpoints: weeks 4, 12, 26, and 52 post-quit (ps < .05); relations remained after controlling for pharmacotherapy treatment, AS, baseline negative affect, anxiety, and anxiety disorder history (ps < .05). Additional exploratory analyses examining week 4 abstinence showed DT predicted abstinence (p = .004) even after controlling for baseline dependence, post-quit withdrawal (craving and negative affect), and treatment. DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at week 4 with patch plus lozenge versus patch alone. CONCLUSIONS: DT, but not AS, predicted abstinence over 1 year post-quit (higher DT was associated with higher quit rates), with little overlap with other affective measures. DT also predicted early abstinence independent of dependence and withdrawal symptoms. Results suggest low DT may play a meaningful role in motivation to use tobacco and constitute an additional affective risk factor for tobacco cessation failure beyond negative affect or clinical affective disorders. IMPLICATIONS: People in a stop-smoking study who reported a greater ability to tolerate distress were more likely to quit smoking and remain smoke-free 1 year later. Smokers with high DT were more likely to be smoke-free 4 weeks after their target quit day if they received nicotine patch plus nicotine lozenge rather than nicotine patch alone. TRIAL REGISTRATION: NCT01553084.

E-cigarette Dependence Measures in Dual Users: Reliability and Relations With Dependence Criteria and E-cigarette Cessation.

BACKGROUND: Electronic cigarettes (e-cigarettes) have drastically changed the nicotine and tobacco product landscape. However, their potential public health impact is still unclear. A reliable and valid measure of e-cigarette dependence would likely advance assessment and prognostication of the public health impact of e-cigarettes. The aim of this research was to examine the internal consistency, structure, and validity of three e-cigarette dependence scales. METHODS: Adult dual users (smokers who also vape, N = 256) enrolled in an observational cohort study (45.1% women, 70.7% white). At baseline, participants completed the e-cigarette Fagerström Test of Cigarette Dependence (e-FTCD), the e-cigarette Wisconsin Inventory of Smoking Dependence Motives (e-WISDM), and the Penn State Electronic Cigarette Dependence Index (PS-ECDI). All participants provided a urine sample for cotinine analysis and reported e-cigarette use at 1 year. RESULTS: The e-WISDM subscales had the highest internal consistency (α = .81-.96), then the PS-ECDI (α = .74) and e-FTCD (α = .51). A single-factor structure for the e-FTCD and an 11-factor structure for the e-WISDM were supported, but the PS-ECDI did not have a single-factor structure. All three e-cigarette dependence scales were highly correlated with validation criteria including continued e-cigarette use at 1 year, but not with e-liquid nicotine concentration or cotinine. CONCLUSIONS: The e-WISDM and PS-ECDI had stronger internal consistency than did the e-FTCD, despite the e-FTCD's single-factor structure, but all 3 measures appear to be valid measures of e-cigarette dependence as suggested by their significant relations with self-perceived addiction, heavy use, early use after overnight deprivation, and continued use over time. IMPLICATIONS: This research provides empirical support for three e-cigarette dependence measures: the e-FTCD, the PS-ECDI, and the e-WISDM among dual users of e-cigarettes and combustible cigarettes. The PS-ECDI and e-WISDM are more reliable, but all three measures were strongly correlated with key dependence constructs such as heavy use and continued use over time.

Changes in carotid artery structure with smoking cessation.

Carotid artery grayscale ultrasound echogenicity and texture features predict cardiovascular disease events. We evaluated the longitudinal effects of smoking cessation on four grayscale ultrasound measures. This was a secondary analysis of data from 188 age, sex, and body mass index (BMI)-matched smokers (94 eventual abstainers [EA], 94 continued smokers [CS]) from a smoking cessation trial that had carotid ultrasound examinations at baseline and after 3 years. General linear models that included time, smoking group (EA or CS), and a time*smoking interaction term were used to examine the impact of smoking abstinence on carotid artery grayscale marker values at year 3. Participants were mean (SD) 50.3 (11.4) years old (57% female, 86% white). The baseline grayscale median value (GSM) was inversely correlated with age, BMI, insulin resistance, and smoking pack-years (r = -0.20 to -0.30, p < 0.007 for all). There was a significant time*smoking status interaction for predicting GSM at year 3: GSM decreased significantly in the EA group compared to the CS group (-3.63 [13.00] vs CS 0.39 [12.06] units; p = 0.029). BMI increased more in the EA than the CS group (2.42 [3.00] vs CS 0.35 [2.57] kg/m2; p < 0.001). After adjusting for changes in BMI, the time*smoking status interaction no longer was significant (p = 0.138). From baseline to year 3, contrast increased similarly in both groups. Entropy and angular second moment did not change significantly in either group. Changes in carotid ultrasound echogenicity and grayscale texture features during a smoking cessation attempt are modest and mostly related to weight gain. Clinicaltrials.gov Identifier: NCT01553084.