Optimizing Longitudinal Tobacco Cessation Treatment in Lung Cancer Screening: A Sequential, Multiple Assignment, Randomized Trial.

Importance: Nearly half of the 14.8 million US adults eligible for lung cancer screening (LCS) smoke cigarettes. The optimal smoking cessation program components for the LCS setting are unclear. Objective: To assess the effect of adding a referral to prescription medication therapy management (MTM) to the tobacco longitudinal care (TLC) program among patients eligible for LCS who smoke and do not respond to early tobacco treatment and to assess the effect of decreasing the intensity of TLC among participants who do respond to early treatment. Design, Setting, and Participants: This randomized clinical trial included patients who currently smoked cigarettes daily and were eligible for LCS. Recruitment took place at primary care centers and LCS programs at 3 large health systems in the US and began in October 2016, and 18-month follow-up was completed April 2021. Interventions: (1) TLC comprising intensive telephone coaching and combination nicotine replacement therapy for 1 year with at least monthly contact; (2) TLC with MTM, MTM offered pharmacist-referral for prescription medications; and (3) Quarterly TLC, intensity of TLC was decreased to quarterly contact. Intervention assignments were based on early response to tobacco treatment (abstinence) that was assessed either 4 weeks or 8 weeks after treatment initiation. Main outcomes and Measures: Self-reported, 6-month prolonged abstinence at 18-month. Results: Of 636 participants, 228 (35.9%) were female, 564 (89.4%) were White individuals, and the median (IQR) age was 64.3 (59.6-68.8) years. Four weeks or 8 weeks after treatment initiation, 510 participants (80.2%) continued to smoke (ie, early treatment nonresponders) and 126 participants (19.8%) had quit (ie, early treatment responders). The 18 month follow-up survey response rate was 83.2% (529 of 636). Across TLC groups at 18 months follow-up, the overall 6-month prolonged abstinence rate was 24.4% (129 of 529). Among the 416 early treatment nonresponders, 6-month prolonged abstinence for TLC with MTM vs TLC was 17.8% vs 16.4% (adjusted odds ratio [aOR] 1.13; 95% CI, 0.67-1.89). In TLC with MTM, 98 of 254 participants (39%) completed at least 1 MTM visit. Among 113 early treatment responders, 6-month prolonged abstinence for Quarterly TLC vs TLC was 24 of 55 (43.6%) vs 34 of 58 (58.6%) (aOR, 0.54; 95% CI, 0.25-1.17). Conclusions and Relevance: In this randomized clinical trial, adding referral to MTM with TLC for participants who did not respond to early treatment did not improve smoking abstinence. Stepping down to Quarterly TLC among early treatment responders is not recommended. Integrating longitudinal tobacco cessation care with LCS is feasible and associated with clinically meaningful quit rates. Trial Registration: ClinicalTrials.gov Identifier: NCT02597491.

InCISE: Instrument for Comprehensive Incisional and Surgical Evaluation.

OBJECTIVE: The evaluation of healing after head and neck surgery is currently qualitative and non-standardized, limiting the quality of surgical healing assessments in clinical and research settings. We sought to develop an objective, standardized wound assessment score, and hypothesize that a reliable instrument can be developed to evaluate head and neck surgical wounds. METHODS: A prospective cohort study was conducted in a tertiary-care, academic head and neck surgery practice. Patients undergoing head and neck surgery were enrolled. A digital photograph protocol was developed for evaluating healing surgical wounds. A panel of experts developed and refined a wound healing score and established reliability, reproducibility, internal consistency, and validity of the score. RESULTS: InCISE: Instrument for comprehensive incisional and surgical evaluation was created. The utility of our wound healing score was assessed using classical test theory. We performed the major steps of establishing reliability in head and neck surgeons: (1) internal consistency (Cronbach's α = 0.81), (2) inter-observer reliability (intra-class correlation = 0.76), and (3) intra-rater reliability (intra-class correlation = 0.87), and content validity (through focus groups). Our composite measure was found to have strong internal consistency, inter-rater reliability, and intra-rater reliability. Preliminary work suggests criterion validity via associations with physical health related quality of life (SF-12). CONCLUSION: A wound healing score for head and neck surgery, InCISE, has been developed and is reliable, reproducible, and consistent. Although content validity is present and criterion validity is suggested, work continues to establish validity in this instrument to allow for expanded clinical and research use. LEVEL OF EVIDENCE: NA Laryngoscope, 133:2166-2173, 2023.

Design considerations and analytical framework for reliably identifying a beneficial individualized treatment rule.

An individualized treatment rule (ITR) formalizes personalized medicine by assigning treatment as a function of patients' clinical information, which contrasts with a static treatment rule that assigns everyone the same treatment. ITR identification has become a common aim in randomized clinical trials but sample size considerations for this aim are lacking. One approach is to select a sample size that will reliably identify an ITR with a performance close to the theoretical optimal rule. However, this approach could still lead to identifying ITRs that perform worse than the optimal static rule, particularly in the absence of substantial effect heterogeneity. This limitation motivates sample size considerations aimed at reliable identification of a beneficial ITR, which outperforms the optimal static rule, and analysis methods that identify the estimated optimal static rule when there is substantial uncertainty about whether an ITR will improve outcomes. To address these limitations, we propose a sample size approach based on the probability of identifying a beneficial ITR and introduce an approach for selecting the LASSO penalty parameter such that in the absence of treatment effect heterogeneity the estimated optimal static rule is identified with high probability. We apply these approaches to the PLUTO trial aimed at developing methods to assist with smoking cessation.

Latent constructs identified in older individuals who smoke cigarettes and are eligible for lung cancer screening: Factor analysis of baseline data from the PLUTO smoking cessation trial.

Introduction: Lung cancer screening (LCS) combined with smoking cessation intervention is currently recommended for older individuals with a history of heavy smoking. Tailoring tobacco treatment for this patient population of older, people who smoke (PWS) may improve cessation rates while efficiently using limited smoking cessation resources. Although some older people who smoke will need more intensive treatment to achieve sustained abstinence, others may be successful with less intensive treatment. A framework to identify them a priori would be helpful to distribute smoking cessation resources accordingly. Methods: Baseline demographic, smoking, and health data are reported from a randomized clinical trial of longitudinal smoking cessation interventions delivered in the setting of LCS. Candidate variables were factor analyzed to identify latent factors, or constructs, to identify subgroups of older participants among the heterogenous population of older people who smoke. Results: We identified three factor-derived constructs: self-reported health status, heaviness of smoking, and nicotine dependence. Nicotine dependence was moderately correlated with both of the other two factors. Conclusions: This factor analysis of baseline participant characteristics identified a set of latent constructs - based on a few practical clinical variables -- that can be used to classify the heterogenous population of older people who smoke to identify. We propose this framework to identify subgroups of people who smoke who might successfully quit with less intense treatment at the time of lung cancer screening.

National Cancer Institute Smoking Cessation at Lung Examination Trials Brief Report: Baseline Characteristics and Comparison With the U.S. General Population of Lung Cancer Screening-Eligible Patients.

Introduction: The National Cancer Institute Smoking Cessation at Lung Examination (SCALE) Collaboration includes eight clinical trials testing smoking cessation interventions delivered with lung cancer screening (LCS). This investigation compared pooled participant baseline demographic and smoking characteristics of seven SCALE trials to LCS-eligible smokers in three U.S. nationally representative surveys. Methods: Baseline variables (age, sex, race, ethnicity, education, income, cigarettes per day, and time to the first cigarette) from 3614 smokers enrolled in SCALE trials as of September 2020 were compared with pooled data from the Tobacco Use Supplement-Current Population Survey (2018-2019), National Health Interview Survey (2017-2018), and Population Assessment of Tobacco and Health (wave 4, 2016-2017) using the U.S. Preventive Services Task Force 2013 (N = 4803) and 2021 (N = 8604) LCS eligibility criteria. Results: SCALE participants have similar average age as the U.S. LCS-eligible smokers using the 2013 criteria but are 2.8 years older using the 2021 criteria (p < 0.001). SCALE has a lower proportion of men, a higher proportion of Blacks, and slightly higher education and income levels than national surveys (p < 0.001). SCALE participants smoke an average of 17.9 cigarettes per day (SD 9.2) compared with 22.4 (SD 9.3) using the 2013 criteria and 19.6 (SD 9.7) using the 2021 criteria (p < 0.001). The distribution of time to the first cigarette differs between SCALE and the national surveys (p < 0.001), but both indicate high levels of nicotine dependence. Conclusions: SCALE participants smoke slightly less than the LCS-eligible smokers in the general population, perhaps related to socioeconomic status or race. Other demographic variables reveal small but statistically significant differences, likely of limited clinical relevance with respect to tobacco treatment outcomes. SCALE trial results should be applicable to LCS-eligible smokers from the U.S. population.

Gender Distribution of Authors of Evaluation Letters for Promotion at One Medical School.

PURPOSE: Women remain underrepresented in key leadership positions and advanced ranks in academic medicine. This study examines the numbers of men and women letter writers for promotion candidates during a 5-year period across departments, tracks, ranks, and candidate gender. METHOD: A descriptive study characterized the gender of evaluation letter writers for candidates for promotion to associate or full professor at the University of Minnesota Medical School between 2015 and 2020. Letter writer and candidate gender were characterized by self-identified pronouns in the faculty biography or dossier. Letter writer gender was described by candidate department, promotion track, rank, terminal degree, and gender. RESULTS: Among 299 candidates for promotion, 172 (58%) were men and 127 (42%) were women; dossiers included 3,995 evaluation letters. Across all years, men wrote more letters than women (external letters, range, 69% in 2019-2020 to 75% in 2015-2016; internal letters, range, 67% in 2018-2019 to 77% in 2015-2016). Candidates in the family medicine and pediatrics departments had the highest percentages of letters written by women (44% and 40%, respectively). No differences were found in the number of women letter writers by candidate promotion track; however, differences were found by candidate rank (associate professor, 30%; full professor, 23%) and terminal degree (MD/DO, 25%; PhD, 33%; MD-PhD, 20%). Regardless of candidate gender, most evaluation letters were written by men. Women candidates had 15% to 20% more letters authored by women than men candidates (34%-40% vs 18%-23%). CONCLUSIONS: The gender pattern of letter writers may reflect implicit biases regarding gender and perceived leadership status, expertise, and success. Adopting policies that promote or require gender diversity among letter writers for promotion candidates may provide an opportunity to encourage faculty to seek diverse networks and recognize the achievements of women faculty.

Smoking reduction among homeless smokers in a randomized controlled trial targeting cessation.

INTRODUCTION: Homeless populations have high rates of smoking and unique barriers to quitting. General cessation strategies have been unsuccessful in this population. Smoking reduction may be a good intermediate goal. We conducted a secondary analysis to identify predictors of smoking reduction in a cohort of homeless smokers enrolled in a 26-week randomized clinical trial (RCT) targeting smoking cessation. METHODS: Data are from an RCT comparing motivational interviewing counseling plus nicotine replacement therapy (NRT) to brief advice to quit (standard care) plus NRT among homeless smokers. Using bivariate analyses and multinomial logistic regression, we compared demographics, health and psychosocial variables, tobacco use, substance use, and NRT adherence among those who reported: quitting; reducing smoking by 50-99%; and not reducing smoking by 50%. RESULTS: Of 324 participants who completed 26-week follow-up, 18.8% and 63.9% self-reported quitting and reducing, respectively. Compared to those who did not reduce smoking, participants reporting reducing indicated higher baseline cigarette use (OR=1.08; CI:1.04-1.12) and menthol use (OR=2.24; CI:1.05-4.77). Compared to participants who reduced, participants reporting quitting were more likely to be male (OR=1.998; CI:1.00-3.98), experience more housing instability (OR=1.97; CI:1.08-3.59), indicate higher importance of quitting (OR=1.27; CI:1.041.55), have higher NRT adherence (OR=1.75; CI:1.00-3.06), and lower odds of reported illicit drug use (OR=0.48; CI:0.24-0.95). CONCLUSIONS: Over half of participants reduced smoking by at least 50%, indicating reduction is feasible among homeless smokers. Further research is required to understand the impact of reduction on future cessation attempts in homeless smokers. This study shows that reduction is achievable and may be a valid intermediate goal.

The implementation of a smoking cessation and alcohol abstinence intervention for people experiencing homelessness.

BACKGROUND: In the United States, eighty percent of the adult homeless population smokes cigarettes compared to 15 percent of the general population. In 2017 Power to Quit 2 (PTQ2), a randomized clinical trial, was implemented in two urban homeless shelters in the Upper Midwest to address concurrent smoking cessation and alcohol treatment among people experiencing homelessness. A subset of this study population were interviewed to assess their experiences of study intervention. The objective of this study was to use participants' experiences with the intervention to inform future implementation efforts of combined smoking cessation and alcohol abstinence interventions, guided by the Consolidated Framework for Implementation Research (CFIR). METHODS: Qualitative semi-structured interviews were conducted with 40 PTQ2 participants between 2016-2017 and analyzed in 2019. Interviews were audio-recorded, transcribed, and analyzed using a socially constructivist approach to grounded theory. RESULTS: Participants described the PTQ2 intervention in positive terms. Participants valued the opportunity to obtain both counseling and nicotine-replacement therapy products (intervention characteristics) and described forming a bond with the PTQ2 staff and reliance on them for emotional support and encouragement (characteristics of individuals). However, the culture of alcohol use and cigarette smoking around the shelter environment presented a serious challenge (outer setting). The study setting and the multiple competing needs of participants were reported as the most challenging barriers to implementation (implementation process). CONCLUSION: There are unique challenges in addressing smoking cessation with people experiencing homelessness. For those in shelters there can be the difficulty of pro-smoking norms in and around the shelter itself. Considering pairing cessation with policy level interventions targeting smoke-free spaces, or pairing cessation with housing support efforts may be worthwhile.. Participants described a discord in their personal goals of reduction compared with the study goals of complete abstinence, which may pose a challenge to the ways in which success is defined for people experiencing homelessness. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01932996 , registered 08/30/2013.

Proposing a Model of Proactive Outreach to Advance Clinical Research and Care Delivery for Patients Who Use Tobacco.

There are evidence-based treatments for tobacco dependence, but inequities exist in the access to and reach of these treatments. Traditional models of tobacco treatment delivery are "reactive" and typically provide treatment only to patients who are highly motivated to quit and seek out tobacco treatment. Newer models involve "proactive" outreach, with benefits that include increasing access to tobacco treatment, prompting quit attempts among patients with low motivation, addressing health disparities, and improving population-level quit rates. However, the definition of "proactive" is not clear, and adoption has been slow. This commentary introduces a comprehensive yet flexible model of proactive outreach and describes how proactive outreach can optimize clinical research and care delivery in these domains: (1) identifying the population, (2) offering treatment, and (3) delivering treatment. Dimensions relevant to each domain are the intensity of proactive outreach (low to high) and the extent to which proactive outreach activities rely on human interaction or are facilitated by information technology (IT). Adoption of the proposed proactive outreach model could improve the precision and rigor with which tobacco cessation research and tobacco treatment programs report data, which could have a positive effect on care delivery and patient outcomes.

The effect of pre-aggregation scale on spatially adaptive filters.

Choropleth mapping continues to be a dominant mapping technique despite suffering from the Modifiable Areal Unit Problem (MAUP), which may distort disease risk patterns when different administrative units are used. Spatially adaptive filters (SAF) are one mapping technique that can address the MAUP, but the limitations and accuracy of spatially adaptive filters are not well tested. Our work examines these limitations by using varying levels of data aggregation using a case study of geocoded breast cancer screening data and a synthetic georeferenced population dataset that allows us to calculate SAFs at the individual-level. Data were grouped into four administrative boundaries (i.e., county, Zip Code Tabulated Areas, census tracts, and census blocks) and compared to individual-level data (control). Correlation assessed the similarity of SAFs, and map algebra calculated error maps compared to control. This work describes how pre-aggregation affects the level of spatial detail, map patterns, and over and under-prediction.

A Randomized Trial of Nicotine versus No-nicotine E-cigarettes Among African American Smokers: Changes in Smoking and Tobacco Biomarkers.

INTRODUCTION: The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers. METHODS: African American smokers (n = 234) were enrolled in a 12-week, single blind, randomized controlled trial and assigned to ad lib use of nicotine e-cigarettes with or without menthol (2.4% nicotine [equivalent to combustible cigarettes], n = 118), or no-nicotine e-cigarettes (n = 116) for 6 weeks. Surveys were administered at baseline, 2, 6, and 12 weeks, and urinary biomarkers 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) and total nicotine equivalents (TNE) were assessed at baseline and 6 weeks. RESULTS: Participants smoked an average of 11.4 cigarettes per day (CPD) and 88% used menthol cigarettes at baseline. At Week 6, the nicotine group reported using e-cigarettes 9.1 times per day compared to 11.4 times in the no-nicotine group (p = 0.42). Combustible cigarette smoking decreased 3.0 CPD in the nicotine group compared to 2.7 CPD in the no-nicotine group (p = 0.74). Neither TNE nor NNAL changed significantly between baseline and Week 6. There were no differences in nicotine withdrawal symptoms between treatment groups. Smoking reduction persisted in both groups at Week 12. CONCLUSIONS: Contrary to our hypotheses, nicotine e-cigarettes did not significantly reduce the use of combustible cigarettes compared to no-nicotine e-cigarettes in this cohort of African American smokers. Findings suggest e-cigarettes are modestly associated with the decreased use of combustible cigarettes among non-treatment seeking smokers, regardless of nicotine content, but without a reduction in tobacco toxicants. IMPLICATIONS: Although e-cigarettes have the potential to reduce harm if substituted for combusted cigarettes (or if they promoted cessation) because of lower levels of tobacco toxicants, this study suggests ad lib use of e-cigarettes among African American smokers, with or without nicotine, results in modest smoking reduction but does not change toxicant exposure in a cohort where smoking cessation or reduction is not the goal. These data suggest that testing future harm reduction interventions using e-cigarettes should include more specific behavioral change coaching, including substituting for or completely stopping combusted cigarettes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov - NCT03084315.

Self-reported exercise capacity among current smokers eligible for lung cancer screening: Distribution and association with key comorbidities.

ONE CONCERN: as lung cancer screening (LCS) is implemented is that patients will be screened who are too ill to benefit. Poor exercise capacity (EC) predicts adverse outcomes following lung resection. OBJECTIVE: Describe the distribution of EC among smokers eligible for LCS and examine associations with comorbidities. METHODS: Cross-sectional analysis of baseline data from a randomized controlled trial of tobacco treatment in the context of LCS. Participants responded regarding limitations in moderate activities, ability to climb stairs, and frequency of dyspnea on a scale from never/almost never to all or most of the time. Responses were assigned a numeric score and summed to categorize exercise limitation. Associations between poor EC and key comorbidities were examined using adjusted logistic regression. RESULTS: 660 participants completed a survey with the following characteristics: 64.4% male, 89.5% white, mean age 64.5. Overall EC categories were: good 39.0%, intermediate 41.6%, and poor 19.4%.  Prevalence of poor EC was higher among patients with COPD (OR 4.62 95%CI 3.05-7.02), heart failure (OR 3.07 95%CI 1.62-5.82) and cardiovascular disease (OR 2.24, 95%CI 1.45-3.47), and was highest among patients with multimorbidity. Among patients with COPD and heart failure, 57% had poor and 0% had good EC. In adjusted logistic regression, only COPD and Charlson comorbidity index remained significantly associated with poor EC. CONCLUSIONS: Many patients eligible for LCS reported poor EC, with increased odds of poor EC among patients with comorbidities. More research is needed to determine how to best integrate EC and comorbidity into eligibility and shared decision-making conversations.

Novel mapping methods to describe utilization of free breast cancer screening from a state program.

INTRODUCTION: The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) is a cancer screening program whose mission is to reduce cancer morbidities for uninsured and underinsured women. A primary activity is to connect women to breast cancer screening. The eligible population and utilization of NBCCEDP screening services have never been quantified at a sub-state level, which hampers effective program evaluation. Here, the Minnesota NBCCEDP, "Sage", serves as a case study to demonstrate novel spatial analysis methods that depict variation of screening rates at the local level. METHODS: Women who received breast cancer screening through Sage between 2011 and 2015 were geocoded (N = 74,712 screenings); analysis occurred between 2017 and 2019. We determine an eligible population using a synthetic population dataset that provides geographic residence and demographic information. We introduce a novel spatial analysis technique, spatially adaptive filters (SAFs), to create a utilization map of Sage breast screening services by Minnesota women. RESULTS: Between 2011 and 2015, an average of 36,979 women per year were eligible for NBCCEDP breast cancer screening services, representing 3% of the Minnesota female population 40 and older. For Minnesota NBCCEDP eligible women, the state average breast cancer screening utilization rate was 37.2%, but varied considerably by local regions within the state (range 0% to 131%, SD = 18.7%). CONCLUSIONS: This geospatial model estimated screening service utilization at the local level and enables Minnesota's Sage program to target specific areas they have yet to reach. Similar programs could employ this model to direct program activities.

Predictors of Enrollment of Older Smokers in Six Smoking Cessation Trials in the Lung Cancer Screening Setting: The Smoking Cessation at Lung Examination (SCALE) Collaboration.

SIGNIFICANCE: Increased rates of smoking cessation will be essential to maximize the population benefit of low-dose CT screening for lung cancer. The NCI's Smoking Cessation at Lung Examination (SCALE) Collaboration includes eight randomized trials, each assessing evidence-based interventions among smokers undergoing lung cancer screening (LCS). We examined predictors of trial enrollment to improve future outreach efforts for cessation interventions offered to older smokers in this and other clinical settings. METHODS: We included the six SCALE trials that randomized individual participants. We assessed demographics, intervention modalities, LCS site and trial administration characteristics, and reasons for declining. RESULTS: Of 6285 trial- and LCS-eligible individuals, 3897 (62%) declined and 2388 (38%) enrolled. In multivariable logistic regression analyses, Blacks had higher enrollment rates (OR 1.5, 95% CI 1.2,1.8) compared to Whites. Compared to "NRT Only" trials, those approached for "NRT + prescription medication" trials had higher odds of enrollment (OR 6.1, 95% CI 4.7,7.9). Regarding enrollment methods, trials using "Phone + In Person" methods had higher odds of enrollment (OR 1.6, 95% CI 1.2,1.9) compared to trials using "Phone Only" methods. Some of the reasons for declining enrollment included "too busy" (36.6%), "not ready to quit" (8.2%), "not interested in research" (7.7%), and "not interested in the intervention offered" (6.2%). CONCLUSION: Enrolling smokers in cessation interventions in the LCS setting is a major priority that requires multiple enrollment and intervention modalities. Barriers to enrollment provide insights that can be addressed and applied to future cessation interventions to improve implementation in LCS and other clinical settings with older smokers. IMPLICATIONS: We explored enrollment rates and reasons for declining across six smoking cessation trials in the lung cancer screening setting. Offering multiple accrual methods and pharmacotherapy options predicted increased enrollment across trials. Enrollment rates were also greater among Blacks compared to Whites. The findings offer practical information for the implementation of cessation trials and interventions in the lung cancer screening context and other clinical settings, regarding intervention modalities that may be most appealing to older, long-term smokers.

Cost-Effectiveness of Smoking Cessation Interventions in the Lung Cancer Screening Setting: A Simulation Study.

BACKGROUND: Guidelines recommend offering cessation interventions to smokers eligible for lung cancer screening, but there is little data comparing specific cessation approaches in this setting. We compared the benefits and costs of different smoking cessation interventions to help screening programs select specific cessation approaches. METHODS: We conducted a societal-perspective cost-effectiveness analysis using a Cancer Intervention and Surveillance Modeling Network model simulating individuals born in 1960 over their lifetimes. Model inputs were derived from Medicare, national cancer registries, published studies, and micro-costing of cessation interventions. We modeled annual lung cancer screening following 2014 US Preventive Services Task Force guidelines plus cessation interventions offered to current smokers at first screen, including pharmacotherapy only or pharmacotherapy with electronic and/or web-based, telephone, individual, or group counseling. Outcomes included lung cancer cases and deaths, life-years saved, quality-adjusted life-years (QALYs) saved, costs, and incremental cost-effectiveness ratios. RESULTS: Compared with screening alone, all cessation interventions decreased cases of and deaths from lung cancer. Compared incrementally, efficient cessation strategies included pharmacotherapy with either web-based cessation ($555 per QALY), telephone counseling ($7562 per QALY), or individual counseling ($35 531 per QALY). Cessation interventions continued to have costs per QALY well below accepted willingness to pay thresholds even with the lowest intervention effects and was more cost-effective in cohorts with higher smoking prevalence. CONCLUSION: All smoking cessation interventions delivered with lung cancer screening are likely to provide benefits at reasonable costs. Because the differences between approaches were small, the choice of intervention should be guided by practical concerns such as staff training and availability.

Effects of culturally tailored smoking prevention and cessation messages on urban American Indian youth.

American Indians (AI) face significant disparities in smoking-related diseases. In addition, smoking prevalence increases exponentially between ages 11 and 18. Smoking prevention and cessation efforts aimed at AI youth therefore are important. In order to strengthen understanding of evidence-based message strategies for smoking prevention and cessation among AI youth. The objective of this study was to test whether a message that was tailored to AI cultural values associated with the sacredness of traditional tobacco can change variables that behavioral theories have identified as predictors of smoking (i.e., instrumental and experiential attitudes, injunctive and descriptive norms, perceived capacity and autonomy, and intention with respect to smoking). We conducted a randomized field experiment among 300 never-smoking and ever-smoking urban AI youth in Minneapolis-Saint Paul between May 18 and July 27, 2019. We used a 3 (message condition: cultural benefits of not smoking cigarettes, health benefits of not smoking cigarettes, comparison message about benefits of healthy eating) × 2 (smoking status: ever-smoked, never-smoked) between-subjects design. Multivariate analysis of variance showed that for ever-smokers, the cultural consequences of smoking message significantly lowered instrumental attitude (partial eta2 = 0.029), experiential attitude (partial eta2 = 0.041), perceived capacity (partial eta2 = 0.051), and smoking intention (partial eta2 = 0.035) compared to the healthy eating comparison message and the health consequences of smoking message. This was not observed among never-smokers, who already had very negative smoking perceptions. We conclude that messages that tailor to AI culture may be effective tools for discouraging smoking among AI youth.

Testing the Feasibility and Acceptability of a Religiously-Tailored Text Messaging Intervention to Reduce Smoking Among Somali Muslim Men During Ramadan.

INTRODUCTION: The prevalence of smoking among Somali Muslim male immigrants residing in Minnesota is estimated at 44%, however smoking reduction is common during the month of Ramadan. This study evaluated the feasibility and impact of a religiously tailored text message intervention delivered during Ramadan to encourage smoking reduction among Somali Muslim men who smoke. METHODS: Fifty Somali men were recruited. Participants received two text messages per day starting 1 week prior to and throughout the month of Ramadan. Approximately half were religiously tailored and half were about the risks of smoking and benefits of quitting. Smoking behavior was assessed at baseline, and at weeks 4 (end of Ramadan), 8, and 16. Outcomes included feasibility, acceptability, and preliminary impact of the text message intervention on smoking reduction and bioverified abstinence. RESULTS: The average age was 41 years. Average time to first cigarette was 1.8 hours at baseline, and 46% of participants smoked menthol cigarettes. Eighteen of 50 participants selected English and 32 selected Somali text messages. Subjects significantly reduced self-reported cigarettes per day (CPD) from 12.4 CPD at baseline to 5.8 CPD at week 16 (p < 0.001). Seven subjects reported quitting at week 16, five completed CO testing, confirming self-reported abstinence. The majority of participants found the cultural and religious references encouraging at the end of the week 16 survey. CONCLUSIONS: Religiously tailored text messages to decrease smoking are feasible and acceptable to Somali Muslim men who smoke during Ramadan. This intervention for addressing smoking disparities is worthy of further study. IMPLICATIONS: Recruitment of Somali Muslim men who smoke is feasible and supports the idea that further studies targeting smoking during Ramadan are practical. Ramadan presents a window of opportunity upon which to build smoking cessation interventions for smokers who identify as Muslim. These preliminary findings suggest that text messaging is a feasible and acceptable intervention strategy, and that religious tailoring was well received. Such an approach may offer potential for addressing smoking disparities among Somali Muslim male smokers. TRIAL REGISTRATION: ClinicalTrial.gov: NCT03379142.

Pragmatic Application of the RE-AIM Framework to Evaluate the Implementation of Tobacco Cessation Programs Within NCI-Designated Cancer Centers.

Tobacco cessation after cancer diagnosis leads to better patient outcomes. However, tobacco treatment services are frequently unavailable in cancer care settings, and multilevel implementation challenges can impede uptake of new programs. The National Cancer Institute (NCI) dedicated Cancer Moonshot funding through the Cancer Center Cessation Initiative (C3I) for NCI-Designated Cancer Centers to implement or enhance the implementation of tobacco treatment services. We examined a pragmatic application of the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate tobacco treatment programs implemented within Cancer Centers funded through C3I. Using three C3I-funded Centers as examples, we describe how each RE-AIM construct was operationalized to evaluate the implementation of a wide range of cessation services (e.g., tobacco use screening, counseling, Quitline referral, pharmacotherapy) in this heterogeneous group of cancer care settings. We discuss the practical challenges encountered in assessing RE-AIM constructs in real world situations, including using the electronic health record (EHR) to aid in assessment. Reach and effectiveness evaluation required that Centers define the setting(s) where cessation services were implemented (to determine the "denominator"), enumerate the patient population, report current patient tobacco use, patient engagement in tobacco treatment, and 6-month cessation outcomes. To reduce site heterogeneity, increase data accuracy, and reduce burden, reach was frequently captured via standardized EHR enhancements that improved the identification of current smokers and tobacco treatment referrals. Effectiveness was determined by cessation outcomes (30-day point prevalence abstinence at 6-months post-engagement) assessed through a variety of data collection approaches. Adoption was measured by the characteristics and proportion of targeted cancer care settings and clinicians engaged in cessation service delivery. Implementation was assessed by examining the delivery of tobacco screening assessments and intervention components across sites, and provider-level implementation consistency. Maintenance assessments identified whether tobacco treatment services continued in the setting after implementation and documented the sustainability plan and organizational commitment to continued delivery. In sum, this paper demonstrates a pragmatic approach to using RE-AIM as an evaluation framework that yields relevant outcomes on common implementation metrics across widely differing tobacco treatment approaches and settings.

An unusual case of remitting seronegative symmetrical synovitis with pitting edema: Case report and literature review.

Remitting seronegative symmetrical synovitis with pitting edema is a rare but well-recognized clinical entity that is easily overlooked due to lack of clinical vigilance. It is classically described as an acute onset of symmetrical tenosynovitis of both upper and lower extremities with pitting edema, mostly noted in elderly population. Young patients with other rheumatological diseases and unilateral involvement had also been reported, but symmetrical remitting seronegative symmetrical synovitis with pitting edema in a young patient is a rare observation. We hereby report a case of a remitting seronegative symmetrical synovitis with pitting edema in a young male affected by no rheumatological diseases in the past, typically fulfilling the diagnostic criteria and well responded to low-dose steroid therapy. The salient features of the present case in terms of age, remitting seronegative symmetrical synovitis with pitting edema possibly related to undifferentiated arthropathy, reactive arthritis, or diabetes mellitus.