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ObjectivePrevious studies have shown that treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) therapy in patients with depression may improve depression symptoms and response to antidepressant therapy. We investigated the association between PAP therapy adherence, self-harm events, healthcare resource utilization (HCRU), and costs over 2 years in a national sample of patients with pre-existing depression and newly diagnosed comorbid OSA.MethodsAdministrative claims data were linked to objective PAP therapy usage. Inverse probability treatment weighting was used to compare outcomes over 2 years across PAP adherence levels. The predicted numbers of emergency room (ER) visits and hospitalizations by adherence level were assessed using risk-adjusted generalized linear models.Results37,459 patients were included. Relative to non-adherent patients, consistently adherent patients had fewer self-harm events (0.04 vs 0.05, p

Fatigue is a hallmark symptom of systemic lupus erythematosus (SLE), often associated with flares, side effects of treatment, and extensive organ damage and may have a significant impact on health-related quality of life (HrQoL). To date, the experience of fatigue in patients with SLE is underexplored. This study explored the experience of fatigue in patients with SLE and its impact on their lives through qualitative interviews.This cross-sectional qualitative study was conducted with 22 adult patients with SLE, recruited from two clinical sites in the United States. In-person semi-structured interviews were conducted and thematic analysis was performed focusing on the experience of fatigue in SLE.Results indicated that 21 out of 22 patients experienced fatigue due to SLE. Patients reported that fatigue was variable in nature in terms of both severity and frequency. Fatigue was described as having an impact on multiple aspects of a patient’s life: emotions, cognition, work, activities of daily living, leisure activities, social activities, and family activities.Understanding how patients with SLE describe the symptom of fatigue and how it impacts their lives is the key to better understanding how to measure fatigue in clinical studies evaluating new treatments for SLE. [ABSTRACT FROM AUTHOR]

Peer violence perpetration and victimization are the most common types of violence among youth. This study determined the associations among violent attitudes toward peers, involvement in peer violence perpetration, and experience with peer violence victimization among boys and girls in a high-risk, urban community. Analyses were based on data from the 2004 Youth Violence Survey, which was administered to over 80% of public school students in grades 7, 9, 11, and 12 (N = 4,131) in a disadvantaged, urban, school district in the USA. Logistic regression analyses were conducted to test the associations between attitudes in support of violence and involvement in violent behaviors. Results show that among youth, attitudes supporting boys hitting boys significantly increased the odds of peer violence perpetration after controlling for potential confounders (adjusted odds ratio [AOR], 1.35; 95% confidence interval [CI] = 1.07, 1.72). However, stratified analyses for boys and girls show that attitudes supporting boys hitting boys increased the odds of peer violence perpetration for girls only after controlling for potential confounders (AOR, 1.49; 95% CI = 1.05, 2.13). The findings demonstrate that there are important differences between boys and girls in terms of their associations with violent attitudes and involvement in actual violent behaviors. However, additional research is needed to determine how attitude modifications can be incorporated into youth violence prevention programs. [ABSTRACT FROM AUTHOR]

Introduction: Less than half of college students who have smoked in the past month identify themselves as smokers. Thus, we examined (a) how college students define the term "smoker" and (b) how this definition impacts smoking behavior and attitudes.Methods: We conducted 12 focus groups with a total of 73 college student smokers drawn from survey participants at two colleges in Minnesota (a two-year technical college and a four-year university). Each group was homogenous in terms of gender and school (two-year, four-year).Results: The majority (56.2%) were female, 49.3% attended a 2-year college, and 32.9% were regular smokers (smoked > or = 25 of the last 30 days). Participants described a "smoker" in terms of (a) smoking frequency, ranging from smoking infrequently to smoking daily; (b) contextual factors, such that smoking alone indicates being a smoker rather than smoking at parties; (c) time since initiation; (d) whether one purchases cigarettes, such that "smokers" buy cigarettes while nonsmokers borrow them; (e) addiction and being able to quit without great effort; (f) whether smoking is habitual; and (g) personality and physical characteristic. These beliefs had implications on experiences in quitting smoking, motivation to quit, and perceived barriers. Many participants indicated confidence in being able to quit but believed that they were not "smokers" and thus did not need to quit.Discussion: College students use a broad range of criteria to define who is a smoker. These criteria impact how motivated students are to quit smoking and their perception of needing to "quit smoking." [ABSTRACT FROM AUTHOR]

Obstructive sleep apnea (OSA) is a highly prevalent yet underdiagnosed disease that creates a large economic burden on the United States healthcare system. In this retrospective study, we tested the hypothesis that adherence to positive airway pressure (PAP) therapy, the 'gold standard' treatment for OSA, is associated with reduced healthcare resource utilisation and costs. We linked de-identified payer-sourced medical claims and objective PAP usage data for patients newly diagnosed with OSA. Inverse probability of treatment weighting was used to create balanced groups of patients who were either adherent, intermediately adherent, or non-adherent to PAP therapy. From a sample of 179,542 patients (average age 52.5 years, 61% male), 37% were adherent, 40% intermediate, and 23% non-adherent. During the first year, PAP adherence was significantly associated with fewer emergency room visits (mean [SD] adherent: 0.39 [1.20] versus intermediate: 0.47 [1.30], p < 0.001; versus non-adherent: 0.54 [1.44], p < 0.001), all-cause hospitalisations (mean [SD] adherent: 0.09 [0.43] versus intermediate: 0.12 [0.51], p < 0.001; versus non-adherent: 0.13 [0.55], p < 0.001), and lower total costs (mean [SD] adherent $5874 [8045] versus intermediate $6523 [9759], p < 0.001; versus non-adherent $6355 [10,517], p < 0.001). Results were similar in the second year of PAP use. These results provide additional evidence from a large, diverse sample to support the diagnosis and treatment of OSA and encourage long-term adherence to PAP therapy., (© 2023 Resmed and The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.)

Background: Obstructive sleep apnea (OSA) contributes to the generation, recurrence, and perpetuation of atrial fibrillation, and it is associated with worse outcomes. Little is known about the economic impact of OSA therapy in atrial fibrillation. This retrospective cohort study assessed the impact of positive airway pressure (PAP) therapy adherence on health care resource use and costs in patients with OSA and atrial fibrillation., Methods and Results: Insurance claims data for ≥1 year before sleep testing and 2 years after device setup were linked with objective PAP therapy use data. PAP adherence was defined from an extension of the US Medicare 90-day definition. Inverse probability of treatment weighting was used to create covariate-balanced PAP adherence groups to mitigate confounding. Of 5867 patients (32% women; mean age, 62.7 years), 41% were adherent, 38% were intermediate, and 21% were nonadherent. Mean±SD number of all-cause emergency department visits (0.61±1.21 versus 0.77±1.55 [ P =0.023] versus 0.95±1.90 [ P <0.001]), all-cause hospitalizations (0.19±0.69 versus 0.24±0.72 [ P =0.002] versus 0.34±1.16 [ P <0.001]), and cardiac-related hospitalizations (0.06±0.26 versus 0.09±0.41 [ P =0.023] versus 0.10±0.44 [ P =0.004]) were significantly lower in adherent versus intermediate and nonadherent patients, as were all-cause inpatient costs ($2200±$8054 versus $3274±$12 065 [ P =0.002] versus $4483±$16 499 [ P <0.001]). All-cause emergency department costs were significantly lower in adherent and intermediate versus nonadherent patients ($499±$1229 and $563±$1292 versus $691±$1652 [ P <0.001 and P =0.002], respectively)., Conclusions: These data suggest clinical and economic benefits of PAP therapy in patients with concomitant OSA and atrial fibrillation. This supports the value of diagnosing and managing OSA and highlights the need for strategies to enhance PAP adherence in this population.

Introduction: Menthol cigarettes and flavored cigars (MC/FC) bring profits to U.S. tobacco companies at the cost of Black/African American (B/AA) lives. This exploratory cross-sectional study describes perceptions of tobacco company engagement and activities in B/AA communities related to MC/FC., Aims and Methods: Among 2307 U.S. adults aged 18-45 surveyed in 2022, six items addressed beliefs about tobacco company funding of B/AA community organizations, payment of B/AA lobbyists to oppose public health policies, support of health equity efforts in B/AA communities, and targeted marketing of MC/FC in B/AA communities. Adjusted proportions were calculated for each belief overall and by race and cigarette smoking status., Results: Among all adults, 37% believed that tobacco companies deny the harms of MC/FCs, 20% believed they pay Black lobbyists to oppose health policies, and 12% believed they fund Black community organizations. Compared with non-B/AA adults, a higher proportion of B/AA adults believed that tobacco companies target Black communities with MC/FC marketing (62% vs. 46%). More adult smokers (ie, menthol or non-MC) than nonsmokers thought that tobacco companies support health equity efforts and did not target Black communities with MC/FC marketing nor deny the harms of MC/FCs to B/AA communities., Conclusions: Few B/AAs and adult smokers believed that tobacco companies used B/AA organizations and lobbyists to oppose MC/FC policies in the B/AA community as well as reject MC/FC's harmfulness. Culturally tailored and community-engaged communication efforts are needed to correct disinformation about MC/FC tobacco companies' engagement and activities in B/AA communities among B/AA and menthol cigarette smokers., Implications: Tobacco companies have a history of predatory marketing that promotes flavored tobacco products to Black/African American (B/AA) individuals and more recently has spread disinformation to dissuade policy support for menthol cigarette/flavored cigar (MC/FC) bans. It is unclear what are the perceptions of tobacco company engagement and activities in B/AA communities related to MC/FC. Our study shows that B/AA adults and current cigarette smokers hold misperceptions about tobacco companies' role in spreading disinformation about MC/FC. This study identified beliefs about the industry's role in funding B/AA organizations and lobbyists who oppose policy, as well as the industry's denial of menthol cigarette and flavored cigar harms as potential messaging targets for communication efforts designed to correct disinformation about MC/FC policies among B/AA and those who currently smoke MC., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Positive airway pressure (PAP) therapy is first-line therapy for OSA, but consistent use is required for it to be effective. Previous studies have used Medicare fee-for-service claims data (eg, device, equipment charges) as a proxy for PAP adherence to assess its effects. However, this approach has not been validated in a US commercially insured population, where coverage rules are not standardized., Research Question: In a commercially insured population in the United States, how well do claims-based algorithms for defining PAP adherence correspond with objective PAP device usage?, Study Design and Methods: Deidentified administrative claims data of commercially insured patients (aged 18-64 years) with OSA were linked to objective PAP therapy usage data from cloud-connected devices. Adherence was defined based on device use (using an extension of Centers for Medicare & Medicaid Services 90-day compliance criteria) and from claims-based algorithms to compare usage metrics and identify potential misclassifications., Results: The final sample included 213,341 patients. Based on device usage, 48% were adherent in the first year. Based on claims, between 10% and 84% of patients were identified as adherent (accuracy, sensitivity, and specificity ranges: 53%-68%, 12%-95%, and 26%-92%, respectively). Relative to patients who were claims-adherent, patients who were device-adherent had consistently higher usage across all metrics (mean, 339.9 vs 260.0-290.0 days of use; 6.6 vs 5.1-5.6 d/wk; 6.4 vs 4.6-5.2 h/d). Consistent PAP users were frequently identified by claims-based algorithms as nonadherent, whereas many inconsistent users were classified by claims-based algorithms as adherent., Interpretation: In aggregate US commercial data with nonstandardized PAP coverage rules, concordance between existing claims-based definitions and objective PAP use was low. Caution is warranted when applying existing claims-based algorithms to commercial populations., Competing Interests: Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: N. A., K. V. C., R. B. D., and K. L. S. are employees of ResMed. E. M. W.’s institution has received research support from the AASM Foundation, Department of Defense, Merck, NIH/NIA, ResMed, ResMed Foundation, and SRS Foundation. E. M. W. has served as a scientific consultant to DayZz, Eisai, EnsoData, Idorsia, Merck, Nox Health, Purdue, ResMed, and Primasun, and is an equity shareholder in WellTap., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: Previous studies have shown that treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) therapy in patients with depression may improve depression symptoms and response to antidepressant therapy. We investigated the association between PAP therapy adherence, self-harm events, healthcare resource utilization (HCRU), and costs over 2 years in a national sample of patients with pre-existing depression and newly diagnosed comorbid OSA., Methods: Administrative claims data were linked to objective PAP therapy usage. Inverse probability treatment weighting was used to compare outcomes over 2 years across PAP adherence levels. The predicted numbers of emergency room (ER) visits and hospitalizations by adherence level were assessed using risk-adjusted generalized linear models., Results: 37,459 patients were included. Relative to non-adherent patients, consistently adherent patients had fewer self-harm events (0.04 vs 0.05, p < 0.001) after 1 year, and significantly (all p < 0.001) fewer ER visits (0.66 vs 0.86) and all-cause hospitalizations (0.13 vs 0.17), and lower total ($11,847 vs $11,955), inpatient hospitalization ($1634 vs $2274), and ER visit ($760 vs $1006) costs per patient in the second year of PAP therapy. Consistently adherent patients showed lower risk for hospitalizations and ER visits., Limitations: Using observational claims data, we were unable to assess clinical characteristics including sleep, sleepiness, and daytime symptoms, or important social determinants of health. We were limited in assessing care received outside of the included health plans., Conclusion: Consistent adherence to PAP therapy over 2 years was associated with improved HCRU outcomes for patients with pre-existing depression newly diagnosed with comorbid OSA., Competing Interests: Declaration of competing interest EMW's institution has received research support from the AASM Foundation, Department of Defense, Merck, ResMed, and the ResMed Foundation. EMW has served as a scientific consultant to DayZz, Eisai, EnsoData, Idorsia, Merck, Nox Health, Purdue, ResMed, and Primasun, and is an equity shareholder in WellTap. AM is funded by NIH. He reports income related to medical education from Livanova, Jazz, Zoll and Eli Lilly. ResMed provided a philanthropic donation to UC San Diego, but Dr. Malhotra has not received personal income from ResMed or medXcloud. PAC has an appointment to an endowed academic Chair at the University of Sydney that was established from ResMed funding, has received research support from ResMed and SomnoMed, and is a consultant to ResMed, SomnoMed, Signifier Medical Technologies, Bayer, and Sunrise Medical. JLP is supported by the French National Research Agency in the framework of the Investissements d'Avenir program [Grant ANR-15-IDEX-02] and the e-Health and Integrated Care and Trajectories Medicine and MIAI Artificial Intelligence chairs of excellence from the Grenoble Alpes University Foundation. He has received lecture fees or conference traveling grants from ResMed, Philips, Jazz Pharmaceuticals, Agiradom, and Bioprojet. KVC, RBD, KLS are all employees of ResMed. medXcloud is an academic-industry collaboration involving employees and consultants of ResMed and global academic thought leaders in the fields of sleep and respiratory medicine. Representatives of the study sponsor were involved in the study design, collection, analysis, and interpretation of data, writing of the report, and in the decision to submit the paper for publication. Emerson Wickwire had final responsibility for the decision to submit for publication., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Current use of tobacco and marijuana products is largely defined as use within the past 30-days or more recently. These products are not used in the same manner, frequency, or context especially among young adults who are increasingly at risk for poly-product use. The purpose of this study was to examine patterns of most recent product use across select tobacco and marijuana products., Materials and Methods: Data used in this study come from a cross-sectional survey conducted among a nationally representative sample of young adults ages 18-34 (n = 1,189) in the U.S. from October-November 2020. Respondents were asked about past product and most recent use of select tobacco/nicotine products (cigarettes, little filtered cigars and cigarillos, large cigars, e-cigarettes, hookah/water pipes) and marijuana products (blunts, e-cigarettes with marijuana, and other products with marijuana)., Results: A high proportion of young adults reported having used at least one tobacco (79.6%) or marijuana (68.6%) products. There is variability in the distribution of most recent use across different tobacco and marijuana users even within the past 3 to past 6 months where nearly one in five users of any product report last use. The average number of tobacco/nicotine products used as well as concurrent marijuana use were lowest when looking at those whose most recent use was within the past 30-days. As the measures of most recent use became more broad, the number of tobacco/nicotine products used increased as did the prevalence of concurrent marijuana use which extended through the past 6-months., Conclusion: Measures of current use may need to be expanded beyond the past 30-days to include through the past 6-months to better encapsulate usage patterns when considering poly-tobacco and marijuana co-use., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Introduction: Young adults are at risk for cigar smoking, which is associated with cancers and pulmonary and cardiovascular diseases. Little is known about young adults' beliefs about smoking cigarillos, little filtered cigars, and large cigars, and how these beliefs may vary across cigar types and by cigar susceptibility., Aims and Methods: The larger study surveyed a U.S. sample of young adults (18-30 years old) who never used tobacco products (n = 948) through Qualtrics online panel services in August 2021-January 2022. We assessed participants' susceptibility to using different cigar types. Participants were randomly assigned to open-ended questions about one of the three cigar types to elicit behavioral, normative, and control beliefs. We conducted thematic analysis to code emergent themes within each belief and examined the frequency of reported themes at the intersection of cigar type and cigar susceptibility., Results: Cigar susceptible participants reported positive behavioral beliefs (eg, anticipated relaxation, mood regulation, being cool), friends as supportive referents, and easy-to-smoke control beliefs (eg, high accessibility, low cost) more frequently than non-susceptible participants. Varied frequency by cigar type also emerged. For example, cigarillo and little filtered cigar features were mentioned more frequently as easy-to-smoke control beliefs, while low accessibility was reported more frequently as a hard-to-smoke control belief for large cigars., Conclusions: Findings identify salient beliefs about cigarillo, little filtered cigar, and large cigar smoking among young adult tobacco never-users. Future research should investigate the potential importance of these beliefs in cigar smoking susceptibility and initiation among young adults, and their potential utility in prevention research., Implications: This thematic analysis identified salient beliefs about cigarillos, little filtered cigars, and large cigars among a U.S. young adult sample, and differentiated emergent beliefs by cigar susceptibility status and by cigar type. Given the lack of cigar smoking prevention media campaigns, identifying these beliefs is the one of the first steps in developing effective cigar smoking prevention strategies. Future quantitative studies are needed to confirm the relationships between these beliefs and smoking initiation of each cigar type to further inform the types of beliefs to be targeted in strategic communication and help prevent cigar smoking initiation among susceptible young adults., (Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2023.)

Rationale: Positive airway pressure (PAP) is the first-choice treatment for obstructive sleep apnea (OSA). However, its real-world effectiveness is often questioned because of usage issues. The relationship between patient sleepiness and PAP usage has been assessed in relatively small and selected populations within the research context. Objectives: To assess the impact of patient-reported sleep outcomes, particularly self-reported sleepiness and its change during therapy, on PAP usage in the real-world setting. Methods: Deidentified data for U.S.-based patients receiving PAP therapy were examined. Eligible patients were registered in the myAir app and provided self-reported sleepiness at baseline and after 7, 14, 21, and 28 days of PAP between November 2019 and April 2020. Results: A total of 95,397 registered patients met all eligibility criteria and were included in the analysis (mean age, 49.6 ± 13.0 yr; 61.6% male). Daytime sleepiness was the most common reason for PAP therapy initiation (57.1% of patients), and 42.2% of all patients had self-reported moderate to severe OSA. Self-reported sleepiness improved with PAP therapy in most patients over the assessment period, with 62.1% of patients reporting "no" or "slight" sleepiness at Day 28. There was a dose-dependent association between improvement in self-reported sleepiness at Day 28 and PAP usage, and this finding was maintained at Day 360. Self-reported sleepiness at Day 28 was associated with achieving U.S. Centers for Medicare & Medicaid Services compliance at 90 days (approximately 90% for those with no or slight sleepiness vs. <70% for those with residual very or extreme sleepiness); average daily PAP usage over 360 days was ⩾5.0 and ⩽3.7 hours, respectively, for those with no or slight versus very or extreme sleepiness. Conclusions: This study demonstrates the feasibility of capturing patient-reported outcomes via a digital platform. Patient-reported outcomes appear to be associated with PAP usage, especially self-reported sleepiness and its response to therapy. Capturing patient-reported outcomes using digital solutions during the course of treatment has the potential to enhance patient outcomes by providing actionable insights.

Introduction: Although lifestyle magazines are an important marketing tool for premium cigars, little is known about their recent portrayal of the products. We expand on research conducted for the National Academies of Sciences, Engineering, and Medicine's Committee on Patterns of Use and Health Effects of "Premium Cigars" and Priority Research., Aims and Methods: A content analysis of magazine covers, articles, and advertisements published in 2021 from Cigar Aficionado and Cigar Snob (five issues each) and Cigar Journal (three issues) assessed magazine themes and mentions of lower harm. Magazine covers (n = 14), advertisements (n = 105), and every fifth article (n = 45) were coded., Results: In total, 92% of the magazine covers, 72.4% of advertisements, and 62.2% of articles had premium cigar content. Celebrities (e.g. musicians and actors) appeared on 92.9% of covers. The most common themes in the advertisements and articles were "high quality." Regarding article content, 80% portrayed the premium cigars' quality (e.g. superior materials), and the taste of featured products (e.g. "tones," "aromas," and "notes") was portrayed in 42.4%. While no articles described their health risks, 6.7% described the positive health effects of premium cigar use (e.g. stress relief and clear cognition). Additionally, a digital search of Cigar Snob and Cigar Aficionado for terms related to lower harm (e.g. "organic," "healthy," "clean," "pure," and "natural") found 7.7 mentions of lower-harm words per issue., Conclusions: Our findings indicate that lifestyle magazines are an important marketing strategy that promotes and normalizes premium cigar use as a high-quality product that can have positive health effects for users., Implications: Our manuscript characterized the premium cigar companies' use of selling propositions, including promoting the products' features, safety, taste, and flavors, as a part of their advertising promotion practices. Premium cigar companies used digital and print lifestyle magazines as marketing tools to promote and normalize the use of their products by emphasizing their high quality and positive health benefits (e.g. reducing stress). Premium cigars were promoted as a symbol of power and success, featured in advertisements of upscale social events (e.g. exclusive trade shows, social clubs, and lounges), and often juxtaposed with expensive alcohol, food, and other luxurious goods. Future research should assess if exposure to premium cigar content increases consumer appeal and detracts from the products' potential adverse health outcomes., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.)

Background: Chronic obstructive pulmonary disease (COPD) is a progressive debilitating condition with frequent exacerbations that have a high burden for patients and society. Digital tools may help to reduce the economic burden for patients and payers by improving outcomes. The Propeller platform is a digital self-management tool that facilitates passive monitoring of inhaler medication utilization, potentially assisting the healthcare team to identify patients at risk of a COPD exacerbation who may require further intervention. This study estimated the budget impact of Propeller from commercial payer and Medicare fee-for-service payer perspectives., Methods: An Excel-based model was used to estimate the budget impact of Propeller for COPD patients in commercial and Medicare population sizes of 5 million members. Data on prevalence, baseline healthcare resource utilization (HCRU), and baseline use of rescue and controller inhaler medications with unit costs (adjusted to 2020 US dollars) were obtained from peer-reviewed literature. Data on reductions in HCRU during Propeller usage were based on direct evidence. Estimates for costs of remote monitoring were obtained from publicly available information. All patients were assumed to have insurance claims related to ongoing remote monitoring., Results: The estimated number of annual eligible COPD patients for commercial and Medicare was 212,200 and 606,600, respectively. Propeller decreased costs by an estimated $2,475 (commercial) and $915 (Medicare) per enrolled patient. The greatest increase in expenditure was for remote monitoring related expenses. After accounting for estimated reductions in hospitalizations, emergency department visits and short-acting beta-agonist use, total net savings were approximately $1.60 and $1.70 per-member per-month for commercial and Medicare payers, respectively., Conclusion: Propeller is projected to be cost saving from both the commercial and Medicare payer perspectives., (© 2023. The Author(s).)

Rationale: Clear definition of optimal positive airway pressure therapy usage in patients with obstructive sleep apnea is not possible because of scarce data on the relationship between usage hours and major clinical outcomes. Objective: To investigate the dose-response relationship between positive airway pressure usage and healthcare resource utilization and determine the minimum device usage required for benefit. Methods: A linked data set combined deidentified payer-sourced administrative medical/pharmacy claims data from more than 100 U.S. health plans and individual patient positive airway pressure usage data. Eligible adults (age ⩾18 yr) had a new obstructive sleep apnea diagnosis between June 2014 and April 2018. All received positive airway pressure therapy (AirSense 10; ResMed) with claims data for ⩾1 year before, and 2 years after, device setup. Healthcare resource utilization was determined on the basis of the number of all-cause hospitalizations and emergency room visits over 3, 12, and 24 months after positive airway pressure initiation. Results: Data from 179,188 patients showed a clear dose-response relationship between daily positive airway pressure usage and healthcare utilization. Minimum device usage required for benefit was 1-3 hours per night. There was a statistically significant decrease in hospitalizations and emergency room visits at all time points (all P s < 0.0001) with increasing positive airway pressure usage. Each additional hour of usage per night decreased hospitalizations and emergency room visits by 5-10% and 5-7%, respectively. Conclusions: These data provide compelling evidence for a dose-response relationship between positive airway pressure usage and healthcare utilization, with benefits seen even when usage was as low as 1-2 hours per night.

Study Objectives: There is a complex interplay between obstructive sleep apnea (OSA) and type 2 diabetes. There are minimal data regarding the effects of treating OSA with positive airway pressure (PAP) therapy on outcomes and health care resource utilization (HCRU) in patients with OSA and type 2 diabetes. We investigated the impact of PAP adherence on HCRU and costs in this population., Methods: A retrospective analysis was conducted with a cohort of OSA patient from a US administrative claims dataset linked to objective device data (AirView, ResMed Corp., San Diego, California). Propensity score matching was used to control for potential imbalance in baseline covariates between PAP-adherent and -nonadherent patients. Newly diagnosed patients with OSA aged ≥ 18 years with type 2 diabetes were included. PAP adherence was defined as meeting Centers for Medicare and Medicaid Services compliance criteria in all 8 90-day periods over 2 years. HCRU was based on the number of all-cause doctor visits, emergency room visits, inpatient hospitalizations, and PAP equipment and supplies., Results: In years 1 and 2 of PAP therapy, HCRU was significantly lower in adherent vs nonadherent patients (number/patient for emergency room visits 0.68 ± 1.47 vs 0.99 ± 1.91 [year 1], 0.69 ± 1.43 vs 0.95 ± 1.89 [year 2]; for hospitalizations 0.16 ± 0.58 vs 0.22 ± 0.62 [year 1], 0.15 ± 0.51 vs 0.21 ± 0.74 [year 2]; all P  < .001). Changes in estimated total 24-month payments were higher for nonadherent patients ($2,282, 95% confidence interval: $1,368, $3,205)., Conclusions: Consistent use of PAP therapy over 2 years was associated with decreased HCRU in patients with OSA and type 2 diabetes, strongly suggesting a role for screening and treating OSA in type 2 diabetes., Citation: Sterling KL, Cistulli PA, Linde-Zwirble W, et al. Association between positive airway pressure therapy adherence and health care resource utilization in patients with obstructive sleep apnea and type 2 diabetes in the United States. J Clin Sleep Med . 2023;19(3):563-571., (© 2023 American Academy of Sleep Medicine.)

Introduction: Little filtered cigars and cigarillos (LCCs) are consumed infrequently, co-administered with marijuana, and concurrently used with other tobacco products. Reliance on the past 30-day use estimate, a marker of tobacco user status, may underestimate the dynamic nature of intermittent LCC and other tobacco product use. We developed a framework to capture the intermittent nature of exclusive LCC use and dual/poly use with cigarettes and large cigars using broader timing of last product use categories and product use modality (e.g., with marijuana)., Methods: Data come from the baseline C'RILLOS study, a U.S. nationally representative sample of young adults aged 18-34 ( n = 1063) collected in October 2019. We developed a consumption taxonomy framework that accounted for respondents' modality of LCC use (i.e., use with tobacco, LCC-T, or use with marijuana as blunts, LCC-B), the exclusive use of LCCs and other tobacco products (i.e., cigarettes, and large cigars) or their co-use and the timing of last product use (i.e., ever and past 30 days, past 3 months, past 6 months, greater than 6 months)., Results: Seventy-five percent of our sample reported ever use of any combustible tobacco product, including LCCs. The most common ever use pattern was poly use of LCC-T + LCC-B + cigarettes (16%). Our consumption taxonomy framework demonstrated the fluid nature of combustible tobacco product use among LCC users. For instance, among past 30-day cigarette users, 48% reported using LCC-T, 39% reported using LCC-B, and 32% reported using large cigars in the past 3 months or more., Discussion: The tobacco use field currently classifies 'tobacco users' based on the product they smoked in the past 30 days. Any tobacco product use beyond the past 30-day period is considered 'discontinued use' and not the focus of intervention or tobacco regulatory science decisions. We documented the substantial proportion of young adult LCC, cigarette, and large cigar users who either exclusively or dual/poly used these combustible products in recent (e.g., past 3 months) periods. To prevent underestimation of use, surveillance measures should assess the use modality, timing of last product use, and exclusive/multiple product use to more accurately identify the smoking status of young adult LCC users.

Context: Youth tobacco use remains a prominent United States public health issue with a high economic and health burden., Method: We pooled never and ever users at youth's first wave of PATH participation (waves 1-3) to estimate age of initiation for hookah, e-cigarettes, cigarettes, traditional cigars, cigarillos, and smokeless tobacco prospectively (waves 2-4). Age of initiation of each tobacco product was estimated using weighted interval-censored survival analyses. Weighted interval censoring Cox-proportional hazards regression models were used to assess the association of ever use of the TP at the first wave of PATH participation, sex, and race/ethnicity on the age of initiation of ever use of each tobacco product. Sensitivity analyses were performed to understand the impact of the recalled age of initiation for the left-censored participants by replacing the recalled age of initiation with a uniform "6" years lower bound., Results: The proportion of those who ever used each tobacco product at the first wave of PATH participation ranged from 1.8% for traditional cigars to 10.4% for cigarettes. There was a significant increase in ever use of each tobacco product after the age of 14, with e-cigarettes and cigarettes showing the highest cumulative incidence of initiation by age 21, while smokeless and cigarillos recorded the lowest cumulative incidence by age 21. The adjusted Cox models showed boys initiated at earlier ages for all of these tobacco products except for hookah, which showed no difference. Similarly, apart from ever use of hookah, non-Hispanic White youth were more likely to initiate each tobacco product at earlier ages compared to Hispanic, non-Hispanic Black, and non-Hispanic Other youth., Conclusion: The increased sample size and the inclusion of ever users yielded greater precision for age of initiation of each tobacco product than analyses limited to never users at the first wave of PATH participation. These analyses can help elucidate population selection criteria for estimating the age of initiation of tobacco products.

We examined the smoking behaviors of U.S. young adults ages 18-36 regarding little cigars and cigarillos (LCCs) during the COVID-19 pandemic. Survey data were collected from a nationally representative sample of young adults between October and November 2020. Respondents who reported using LCCs with tobacco (CAI) and/or with marijuana (CAB) within the past 6 months prior to the survey ( n = 399) were included in the study. Logistic regression analyses assessed the association between their perceived risk of having COVID when smoking LCCs and pandemic-related behavioral changes in CAI and CAB use (e.g., worrying, quit attempts, smoking more, smoking less). Findings showed that users with a higher perceived risk of getting COVID-19 when smoking LCCs were more likely to endorse trying to quit CAI and CAB during the pandemic. Compared to the non-Hispanic White population, the non-Hispanic Black population were less likely to endorse smoking less CAI and trying to quit CAB during the pandemic. Dual users of CAI and CAB and females were more likely to endorse smoking more CAB compared to CAB-only users and males, respectively. Tailored cessation strategies are needed for dual users, non-Hispanic Black young adults, and young women. Raising awareness about the risks of LCC use can be an effective strategy for LCC smoking cessation.

Rationale: The co-occurrence of obstructive sleep apnea and chronic obstructive pulmonary disease, termed overlap syndrome, has a poor prognosis. However, data on positive airway pressure (PAP) treatments and their impact on outcomes and costs are lacking. Objectives: This retrospective observational study investigated the effects of PAP on health outcomes, resource usage, and costs in patients with overlap syndrome. Methods: Deidentified adjudicated claims data for patients with overlap syndrome in the United States were linked to objectively measured PAP user data. Patients were considered adherent to PAP therapy if they met Centers for Medicare and Medicaid Services criteria for eight 90-day timeframes from device setup through 2-year follow-up. Propensity score matching was used to create comparable groups of adherent and nonadherent patients. Healthcare resource usage was based on the number of doctor visits, all-cause emergency room visits, all-cause hospitalizations, and PAP equipment and supplies, and proxy costs were obtained. Measurements and Main Results: A total of 6,810 patients were included (mean age, 60.8 yr; 56% female); 2,328 were nonadherent. Compared with the year before therapy, there were significant reductions in the number of emergency room visits, hospitalizations, and severe acute exacerbations during 2 years of PAP therapy in patients who were versus were not adherent (all P  < 0.001). This improvement in health status was paralleled by a significant reduction in the associated healthcare costs. Conclusions: PAP usage by patients with overlap syndrome was associated with reduced all-cause hospitalizations and emergency room visits, severe acute exacerbations, and healthcare costs.

This study asks young adult cigarillo users to categorize their preferred flavor in order to examine user consensus and potential methodological and regulatory implications of flavor name-based categorization systems. Young adult (21-28 years) cigarillo users ( n = 426) named and categorized their favorite cigarillo flavor into one of seven categories: Fruit, Sweet and Candy, Mint, Alcohol, Menthol, Tobacco, and Other. Flavor responses were coded as characterizing (ex: Grape, Wine) or concept (ex: Jazz, Diamond) flavors. Variation within and between categories was assessed, including the presence of concept flavors and the placement of flavors in multiple categories. Of the 66 unique flavor names provided, participants placed 20 (30.1%) in more than one flavor category. Most of the Tobacco (76.9%) and Other (69.2%) flavor names appeared in multiple categories. The majority of flavor names in the Tobacco (69.2%) and Other (61.5%) categories were concept flavors. Concept flavors were placed in multiple categories (45.0%) twice as often as characterizing flavors (23.9%). This study has identified dissonance among cigarillo users' flavor categorizations, particularly for concept flavored and unflavored products. Flavor names may obscure how and whether a product is flavored. Research on and regulation of flavored tobacco products should classify products by flavor additives rather than by name alone.

Significance: Young adults, especially those who identify as racial/ethnic minorities, are legal targets of the tobacco industry. Cigarillo initiation is a risk among these vulnerable groups. Estimating the age of initiation of cigarillo use among young adults may inform the timing of prevention interventions., Methods: Weighted interval-censored survival analyses of the Population Assessment of Tobacco and Health (PATH) young adult (ages 18-24 at their first wave of adult participation) annual datasets were conducted (2013-2017). Young adult never cigarillo users (n = 7,101; represents N = 24,023,488) at their first wave of adult participation (2013-2016) were followed-up through 2014-2017 to estimate the age of initiation of ever, past 30-day and fairly regular cigarillo use outcomes. Differences by sex and by race/ethnicity, accounting for previous use of other tobacco products and marijuana and blunt use, were assessed using weighted interval-censored Cox proportional hazards models., Results: Among PATH young adults, by age 21, 5.8% initiated ever cigarillo use, 4.1% initiated past 30-day cigarillo use, and 1.4% initiated fairly regular cigarillo use. By age 26, 15% initiated ever cigarillo use, and 10.4% initiated past 30-day cigarillo use. Males had higher risk of initiating ever (AHR: 1.63, 95% CI: 1.37-1.95) and past 30-day cigarillo use (AHR: 1.65, 95% CI: 1.32-2.06) at earlier ages than females. Non-Hispanic Blacks had higher risk of initiating ever (AHR: 2.81, 95% CI: 2.26-3.50), past 30-day (AHR: 4.88, 95% CI: 2.95-5.09) and fairly regular cigarillo use (AHR: 4.62, 95% CI: 2.70-7.93) at earlier ages than non-Hispanic Whites. Hispanics had higher risk of initiating past 30-day cigarillo use at earlier ages than non-Hispanic Whites (AHR: 1.51, 95% CI: 1.12-2.03). Non-Hispanic Other race (i.e., Asian, multiracial, etc.) had lower risk of initiating ever (AHR: 0.43, 95% CI: 0.28-0.65) and past 30-day cigarillo use (AHR: 0.40, 95% CI: 0.26-0.63) at earlier ages than Non-Hispanic Whites., Conclusion: Along with those aged 21 and younger, interventions should target young adults over the age of 21, specifically males, non-Hispanic Black and Hispanic young adults, to stall initiation and progression of cigarillo use behaviors., Competing Interests: Competing Interest: The authors have no conflicts of interest to disclose except Dr. Harrell is a consultant in litigation involving the vaping industry. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Introduction: Young people with depression and/or anxiety may self-medicate with tobacco or tobacco with marijuana to reduce their symptoms. This study sought to differentiate between the use of tobacco products as intended and tobacco products modified to accommodate marijuana, and to explore their relationships with symptoms of depression and anxiety among youth and young adults., Methods: The study is a secondary analysis of Wave 9 (Spring 2019) data from the Texas Adolescent Tobacco and Marketing Surveillance (TATAMS) (n=2439, N=274030). Anxiety and major depressive symptoms were measured by GAD-7 and PHQ-9, respectively., Results: The odds of reporting current use of e-cigarettes without marijuana (adjusted prevalence odds ratio, APOR=2.34; 95% CI: 1.30-4.21, p=0.005) and current use of combustible tobacco without marijuana (APOR=2.99; 95% CI: 1.26-7.09, p=0.014) were significantly higher among those who reported depression/anxiety comorbidity compared to those who reported no symptoms of major depressive symptoms (MDS), anxiety or comorbidity. The odds of reporting ever use of e-cigarettes with marijuana (APOR=3.68; 95% CI: 1.69- 8.00, p=0.001), current use of e-cigarettes with marijuana (APOR=2.76; 95% CI: 1.28-5.97, p=0.01) and ever use of combustible tobacco with marijuana (APOR=3.99; 95% CI: 1.66-9.58, p=0.002) were significantly higher among those reporting only MDS compared to those who reported no symptoms of MDS, anxiety or comorbidity., Conclusions: The study findings can have implications for intervention planning, as interventions need to address marijuana and nicotine use in tobacco products and address anxiety and depression., Competing Interests: The authors have each completed and submitted an ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors declare that they have no competing interests, financial or otherwise, related to the current work. M. B. Harrell and S. Clendennen report being consultants in litigation involving the vaping industry., (© Sumbe A. et al.)

Introduction: Initiation of tobacco products is increasing in young adulthood. This study prospectively estimated the age of onset of susceptibility to cigarettes, e-cigarettes, hookah, smokeless tobacco, and cigarillos among young adults, which is a cognitive precursor to initiation., Methods: Secondary data analyses of the Population Assessment of Tobacco and Health (PATH) study, a nationally representative longitudinal cohort study of US adults. Young adults (18-24 years) who were non-susceptible to each tobacco product (cigarettes, e-cigarettes, hookah, smokeless tobacco, and cigarillos) at waves 2 or 3 were followed-up into waves 3-4 to prospectively estimate the age of onset of susceptibility to each tobacco product. Weighted interval-censored survival methods and interval-censored Cox regression models were implemented to estimate the age of onset of susceptibility, and to estimate differences in the hazard function by sex and by race/ethnicity, while controlling for the total number of other tobacco products ever used at their first wave of participation in PATH., Results: By age 21, 16.5%, 16.0%, 12.6%, 12.4%, and 5.9% of young adults reported onset of susceptibility to hookah, e-cigarettes, cigarillos, cigarettes, and smokeless tobacco, respectively. Among young adults who were non-susceptible to each tobacco product at waves 2 or 3, the highest increase in onset of susceptibility occurred between ages 18 and 19 for cigarettes, e-cigarettes, and hookah, while the highest increase in onset of susceptibility occurs between ages 22 and 23 for cigarillos. Young adult males had increased risk of onset of susceptibility to cigarillos and smokeless tobacco at earlier ages than young adult females. Differences in onset of susceptibility to each tobacco product were also observed by race/ethnicity among young adults., Conclusions: With the changing landscape of tobacco products, monitoring the age of onset of susceptibility of tobacco product use among non-susceptible young adults longitudinally is critical to prevent initiation. Communication and education campaigns tailored to address differences in susceptibility among young adults by tobacco product and sociodemographic factors will be useful., Competing Interests: Declaration of Conflicting Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article, except Dr. Harrell is a consultant in litigation involving the vaping industry., (© The Author(s) 2021.)

Study Objectives: There is minimal guidance around how to optimize inspiratory positive airway pressure (IPAP) levels during use of adaptive servo ventilation (ASV) in clinical practice. This real-world data analysis investigated the effects of IPAP and minimum pressure support settings on respiratory parameters and adherence in ASV-treated patients., Methods: A United States-based telemonitoring database was queried for patients starting ASV between August 1, 2014 and November 30, 2019. Patients meeting the following criteria were included: United States-based patients aged ≥ 18 years; AirCurve 10 device (ResMed); and ≥ 1 session with usage of ≥ 1 hour in the first 90 days. Key outcomes were mask leak and residual apnea-hypopnea index at different IPAP settings, adherence and therapy termination rates, and respiratory parameters at different minimum pressure support settings., Results: There were 63,996 patients included. Higher IPAP was associated with increased residual apnea-hypopnea index and mask leak but did not impact device usage per session (average > 6 h/day at all IPAP settings; 6.7 h/day at 95th percentile IPAP 25 cm H 2 O). There were no clinically relevant differences in respiratory rate, minute ventilation, leak, and residual apnea-hypopnea index across all possible minimum pressure support settings. Patients with a higher 95th percentile IPAP or with minimum pressure support of 3 cm H 2 O were most likely to remain on ASV therapy at 1 year., Conclusions: Our findings showed robust levels of longer-term adherence to ASV therapy in a large group of real-world patients. There were no clinically important differences in respiratory parameters across a range of pressure and pressure support settings. Future work should focus on the different phenotypes of patients using ASV therapy., Citation: Malhotra A, Benjafield AV, Cistulli PA, et al. Characterizing respiratory parameters, settings, and adherence in real-world patients using adaptive servo ventilation therapy: big data analysis. J Clin Sleep Med . 2021;17(12):2355-2362., (© 2021 American Academy of Sleep Medicine.)

Objective: To prospectively estimate the age of initiation of ever, past 30-day, and fairly regular hookah use among young adults (ages 18-24) overall, by sex, by race/ethnicity, and to explore the association of prior use of other tobacco products with these hookah use behaviors., Methods: Secondary data analyses of the first four waves (2013-2017) of the PATH study, a nationally representative longitudinal cohort study of US young adults. Young adult never hookah users at the first wave of adult participation in PATH waves 1-3 (2013-2016) were followed-up into waves 2-4 (2014-2017) to estimate the age of initiation of three outcomes: (i) ever use, (ii) past 30-day use, and (iii) fairly regular hookah use. Weighted interval-censoring Cox proportional hazards regression models were used to examine the differences in the estimated age of initiation by sex and by race/ethnicity while controlling for the total number of other tobacco products ever used at participants' first wave of PATH participation. In addition, to examine if prior use of other tobacco products was associated with the age of hookah initiation behaviors, six additional Cox models are reported for each hookah initiation behaviors., Results: The largest increase in hookah use occurred between ages 18 and 19: 5.8% for ever use and 2.7% for past 30-day hookah use. By age 21, 10.5%, 4.7% and 1.2% reported initiation of ever, past 30-day and fairly regular hookah use, respectively. There were statistically significance differences in the age of initiation of hookah use behaviors by race/ethnicity., Conclusion: Educational interventions should target young adults before the age of 21, focusing efforts specifically on males, non-Hispanic Blacks and Hispanics, to stall initiation and progression of hookah use behaviors., Competing Interests: The authors have no conflicts of interest to disclose except Dr. Harrell is a consultant in litigation involving the vaping industry. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Introduction: Although the FDA prohibits using inaccurate, reduced-risk descriptors on tobacco product advertising, descriptors that imply reduced risk or an enhanced user experience may be present on cigar product advertising in retail outlets near schools. Therefore, to inform the development of federal labeling and advertising requirements that reduce youth appeal of cigars, we conducted a content analysis of cigar ads in retailers near schools to document the presence of implied health claims and other selling propositions that may convey enhanced smoking experience., Aims and Methods: Up to four interior and exterior little cigar and cigarillo advertisements were photographed in a random sample of licensed tobacco retailers (n = 530) near California middle and high schools. Unique ads (n = 234) were coded for brand, flavor, and presence of implicit health claims, premium branding descriptors, and sensory descriptors. Logistic regressions assessed the association among flavored ads and presence of implicit health claims, premium branding, or sensory descriptors., Results: Seventeen cigar brands were advertised near schools; Black & Mild (20.1%) and Swisher Sweets (20.1%) were most common. Flavor was featured in 64.5% of ads, with explicit flavor names (eg, grape) being more prevalent than ambiguous names (eg, Jazz) (49.6% vs. 34.2%). Compared to ads without flavors, ads with ambiguous flavors were more likely to feature implicit health claims (OR = 1.83, 95% CI = 1.06% to 3.19%) and sensory descriptors (OR = 2.64, 95% CI = 1.39% to 5.04%); ads with explicit flavors were more likely to feature premium branding (OR = 2.84, 95% CI = 1.53% to 5.41%)., Conclusions: Cigar ads that featured implicit health claims and premium branding, and sensory selling propositions are present at retailer stores near schools., Implications: We document the presence of implied health claims, premium branding, and sensory descriptors on cigar ads found in retail settings near schools. This study adds to the body of evidence that supports the development of federal labeling and advertising requirements for cigar products to reduce their appeal among vulnerable groups., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: The prevalence of little cigar and cigarillo (LCC) use among young adults is high. Research shows there are racial/ethnic differences in this prevalence, with Black/African American users more likely to report current LCC use. Given these discrepancies in LCC use, the present study aimed to assess potential differences in reasons for LCC use between White and Black/African American young adult ever and past 30-day users., Methods: Participants were White (n = 2150), and Black/African American (n = 308) young adults (aged 18 to 24) recruited from Amazon Mechanical Turk who completed an online survey of tobacco use (December 2018-January 2019). LCC users were asked eight reasons for using LCCs., Results: Flavoring was cited as the most popular reason for LCC use among White ever users while affordability was the most popular among Black/African American ever users. Adjusted logistic regressions among ever users revealed that Black/African American respondents (vs White) were more likely to use LCCs because of their affordability, the perception that LCCs are less harmful than cigarettes, and because of LCC advertising appeal. Among past 30-day users, adjusted logistic regression models showed that Black/African American respondents (vs White) were more likely to use LCCs because of their affordability., Conclusions: Findings align with previous studies showing that LLCs are more heavily marketed in predominantly Black/African American communities. Prevention efforts should account for racial differences in reasons for use in message development., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Introduction: Understanding which non-cigarette tobacco products precede smoking in youth across different racial/ethnic groups can inform policies that consider tobacco-related health disparities., Methods: We used nationally representative, longitudinal data from the Population Assessment of Tobacco and Health Study waves 1-4. The sample was a dynamic cohort of cigarette-naïve youth aged 12-17 years. Mixed-effects models were used to assess non-cigarette product (e-cigarette, cigar product, or other product) use with cigarette use over 1-year intervals., Results: Of the 28 788 observations pooled across waves 1-4, respondents were 48.7% non-Hispanic white, 13.9% non-Hispanic black, and 23.1% Hispanic. Odds of cigarette initiation over 1-year follow-up were higher among youth with prior use of e-cigarettes (odds ratio [OR], 2.76; 95% confidence interval [CI], 2.21-3.45), cigars (OR, 2.00; 95% CI, 1.42-2.80), or other products (OR, 1.66; 95% CI, 1.28-2.14) compared to never users. At the population level, 20.6% of cigarette initiation was attributable to e-cigarette use among white youth and 21.6% among Hispanic youth, while only 3.5% of cigarette initiation was attributable to e-cigarette use among black youth. In contrast, 9.1% of cigarette initiation for black youth was attributable to cigar use compared to only 3.9% for both white and Hispanic youth., Conclusions: Prior use of e-cigarettes, cigars, and other non-cigarette products were all associated with subsequent cigarette initiation. However, white and Hispanic youth were more likely to initiate cigarettes through e-cigarette use (vs. cigar or other product use), while black youth were more likely to initiate cigarettes through cigar use (vs. e-cigarette or other product use)., Implications: Our findings suggest that previous studies on effects of non-cigarette tobacco products may overlook the critical role of cigar products as a pathway into cigarette smoking among US youth, particularly black youth. While our data support the importance of e-cigarette use as a pathway into smoking, regulatory actions aimed at addressing youth e-cigarette use alone may contribute to disparities in black versus white tobacco use and further exacerbate inequities in tobacco-related disease. Thus, contemporary policy development and discourse about the effects of non-cigarette tobacco products on cigarette initiation should consider cigar and other non-cigarette products as well as e-cigarettes., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.)

Objectives: To prospectively estimate the age of cigarette initiation among young adults (18-24 years old) who were never cigarette users at their first wave of adult study participation overall, by sex, and by race/ethnicity given recent increases in cigarette initiation occurring in young adulthood., Methods: Secondary analyses were conducted using the PATH restricted-use adult datasets among young adult never users of cigarettes in waves 1-3 (2013-2016) with outcomes followed-up in waves 2-4 (2014-2017). Interval censoring survival methods were used to estimate the age of initiation of (i) ever, (ii) past 30-day, and (iii) fairly regular cigarette use. Among never cigarette users when they first entered the adult study, interval censoring Cox proportional hazard models were used to explore differences in the estimated age of initiation of the three cigarette use outcomes by sex and by race/ethnicity, controlling for the effect of previous e-cigarette use and the total number of other tobacco products ever used (0-5 products) before cigarette initiation outcomes., Results: Among the young adults who were never cigarette users at their first wave of adult participation, the highest increase in cigarette initiation occurred between 18 and 19 years old. By age 21, 10.6% (95% CI: 9.5-11.7) initiated ever cigarette use, 7.7% (95% CI: 6.1-8.1) initiated past 30-day of cigarette use, and 1.9% (95% CI: 1.4-2.5) initiated fairly regular cigarette use. After controlling for other tobacco products: (a) males were 83% more likely to initiate past 30-day cigarette use at earlier ages than females; (b) Hispanic and Non-Hispanic Black young adults had increased risk to initiate past 30-day cigarette use at earlier ages than Non-Hispanic White young adults (62% and 34%, respectively)., Conclusions: The substantial amount of cigarette initiation among young adults reinforces the need for prevention strategies among this population. Although, interventions are needed for all young adult populations, strategies should target 18-21-year-olds, with potentially differential prevention targets by sex and by race/ethnicity., Competing Interests: The authors have no conflicts of interest to disclose except Dr. Harrell is a consultant in litigation involving the vaping industry. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Introduction: Few studies examine the impact of objective exposure to point-of-sale (POS) marketing for cigars including little cigars and cigarillos (LCCs) on tobacco use. The present study aimed to examine the relationship between exposure to LCC marketing at the POS and current and future use of LCCs and cigarettes among young adult college students., Method: Data on LCC and cigarette use from 4201 young adult students (mean age = 22.8 [SD = 2.3]; 35.9% non-Hispanic whites) attending 24 Texas colleges was linked to objective assessments of POS marketing at 220 tobacco retail outlets within one mile of the colleges. Multilevel logistic regression analyses examined the impact of LCC marketing at the POS on use of LCCs and cigarettes currently and 6-months later., Results: Participants were, on average, exposed to 43 LCC marketing materials per week. Results from cross-sectional analyses indicated that exposure to LCC POS marketing was associated with higher odds of current use of LCCs (AOR = 1.003, 95% CI = 1.0002, 1.0053) and cigarettes (AOR = 1.006, 95% CI = 1.0050, 1.0075). The relationship between LCC POS marketing exposure and LCC use was not significant in longitudinal models; however, exposure to LCC POS marketing at baseline did predict current cigarette use at 6-month follow-up (AOR = 1.004, 95% CI = 1.0021, 1.0052)., Conclusion: Findings suggest a substantial influence of LCC marketing exposure at the POS. Regulations on LCC marketing at the POS, especially around college campuses, should be considered., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Significance: Early age of initiation of tobacco use is associated with sustained tobacco use and lower rates of smoking cessation. Although much is known about age of initiation of cigarette use, much less is known about the age of initiation of cigar product use among youth., Methods: Survival analyses of the Population Assessment of Tobacco and Health youth annual datasets (ages 12-17) from 2013 to 2017 were conducted for any cigar product use, cigarillos or filtered cigars, and traditional cigars across four cigar use outcomes, age of initiation of: susceptibility to use, ever use, past 30-day use and "fairly regular" use. An interval censoring survival method was implemented to estimate the probability of each outcome for age of initiation of each cigar product overall. Differences in age of initiation by sex and race/ethnicity were assessed using weighted Cox proportional hazards models for interval-censored data., Results: For each outcome across the three cigar products, striking increases in the probability of initiation begin before 17 years old. For cigarillo or filtered cigars, males had a higher risk of onset of susceptibility to use, initiating ever use, and initiating past 30-day use at earlier ages than females. Compared to Non-Hispanic Whites, Hispanic and Non-Hispanic Other had lower risk of initiating ever use and past 30-day use at earlier ages. Non-Hispanic Black youth had higher risk of initiating past 30-day use and "fairly regular" use than Non-Hispanic White youth at earlier ages. Similar findings are reported for any cigar use and traditional cigar use., Conclusion: Developmentally and culturally appropriate cigar use interventions and communication campaigns should be provided to youth before 17 years of age to prevent the onset and progression of cigar products. Regulatory policies that reduce appeal of all cigar products should be implemented to curb cigar initiation among youth., Competing Interests: The authors have no conflicts of interest to disclose except Dr. Harrell is a consultant in litigation involving the vaping industry. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Importance: Almost two-thirds of adolescents who smoke blunts also report using cigars. Although adolescent co-use of blunts and cigars is prevalent, whether adolescent blunt use is associated with progression to current cigar use (past 30-day use) and increased frequency of use is unknown., Objective: To determine whether adolescent use of blunts is associated with progression to cigar use (past 30-day use) and increased number of days used (in the past 30 days) across the subsequent 24 months compared with adolescents who have never used blunts., Design, Setting, and Participants: In this prospective cohort study of adolescents from 4 public high schools outside of Philadelphia, Pennsylvania, in-classroom surveys were administered at baseline (fall 2016, beginning of 9th grade) and at 6-month intervals for the following 24 months (fall 2018, beginning of 11th grade). Data analyses were conducted in September and October 2019., Exposures: Self-report of lifetime (ever) blunt use at baseline (age 14 years)., Main Outcomes and Measures: Progression to current cigar use (use in the past 30 days) and escalation in the frequency of use (number of days used in the past 30 days) across the subsequent 24 months., Results: Of 1825 participants, 907 (49.7%) were female, 1330 (72.9%) were white, and 376 (20.6%) were Hispanic; the mean (SD) age at baseline was 14.38 (0.55) years. In all, 257 participants (14.0%) reported ever blunt use. Mixed-effects models revealed that ever blunt use at baseline vs never blunt use was associated with progression to current cigar use (past 30 days use: odds ratio, 22.66; 95% CI, 11.34-45.27) but not escalation in the number of days used across the following 24 months (β = 0.13; 95% CI, -0.17 to 0.43)., Conclusions and Relevance: These findings highlight the risk that blunt use may pose for subsequent cigar use among adolescents. Policies and public health campaigns addressing marijuana as well as cigars will be important to reduce adolescent blunt use and cigar use.

Aims: To identify change in glycated haemoglobin (HbA1c) for 1 year after treatment intensification in patients with HbA1c >53 mmol/mol (7.0%) while on two classes of oral antidiabetic drugs (OADs)., Material and Methods: A retrospective cohort study was conducted using a regional health plan claims database for the period January 1, 2010 to March 31, 2017. Patients with type 2 diabetes (T2DM) whose treatment was intensified with insulin, a glucagon-like peptide-1 receptor agonist or a third OAD within 365 days of having HbA1c ≥53 mmol/mol (7.0%) on two OADs were included. The HbA1c trajectory for 1 year after intensification was estimated using a mixed-effects regression model., Results: The analysis included 1226 patients with a mean ± SD HbA1c at treatment intensification of 74.2 ± 18.7 mmol/mol (8.93 ± 1.7%). HbA1c was higher in the insulin group (74.2 mmol/mol) than in the non-insulin group (70.6 mmol/mol), as was the HbA1c decrease (P < 0.01) over the 1-year follow-up, particularly in patients with baseline HbA1c >9%. After intensification, insulin- and non-insulin-treated patients achieved an average change by month in HbA1c of -4.7 mmol/mol and -2.6 mmol/mol points, respectively. The analysis predicted HbA1c to be the lowest at 6 to 10 months post intensification, depending on intensification treatment and HbA1c at intensification; however, on average, HbA1c remained above 64.0 mmol/mol (8.0%)., Conclusion: In patients with T2DM, intensification following an HbA1c value ≥53 mmol/mol (7.0%) while on two OADs was associated with a significant improvement in glycaemic control. Patients intensified with insulin had a higher baseline HbA1c but greater HbA1c reduction than those intensified with a non-insulin agent. However, HbA1c remained above 64 mmol/mol (8.0%) overall. Additional opportunity exists to further intensify therapy to improve glycaemic control., (© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Objectives: Affect is an important dimension of risk perceptions, which are proximal determinants of little cigar and cigarillo (LCC) smoking. We examined the association among affect, risk perceptions, and current LCC use and susceptibility in a national probability sample of US young adults, aged 18-29., Methods: Structural equation models examined the effect of affect, via risk perceptions, on LCC current use and susceptibility for 772 young adults who took the 2015 Tobacco Products and Risk Perceptions Survey, which asked about affect for images related to LCCs and health risks of daily LCC use., Results: Positive affect toward LCCs was associated with lower perceived risks of daily LCC smoking (p < .001). Lower perceived risks were associated with higher probability of current LCC smoking (p = .008) among young adults who were aware of LCCs and with susceptibility to use among young adult never LCC users (p < .001). A direct effect of positive affect on current LCC use (p < .02) and susceptibility to use LCCs also was found., Conclusions: Future research should investigate how regulatory policy or enforcement actions can be used to regulate LCC components (eg, flavoring, advertising, etc) that influence affect and risk perceptions., Competing Interests: Conflicts of Interest Statement The authors have no conflicts of interest to declare.

Background: In the United States, more than 50% of patients with type 2 diabetes mellitus (T2DM) have hemoglobin A1c (A1c) levels that fail to achieve the recommended target of < 7.0%. Of these, 30%-45% have an A1c > 9.0%, the threshold for poorly controlled T2DM per National Committee for Quality Assurance (NCQA) measures. Treatment inertia is a known challenge. However, recent treatment intensification patterns and outcomes after treatment fails 2 classes of oral antidiabetic agents (OADs) are not well understood., Objective: To characterize treatment intensification patterns and glycemic control outcomes in patients with A1c ≥ 7.0% on 2 OADs., Methods: A retrospective cohort study was conducted in patients with T2DM from a regional health plan claims dataset augmented with A1c results between January 1, 2010, and March 31, 2017. Patients were identified with an A1c ≥ 7.0% (baseline), while on 2 OADs, and whose treatment was intensified with basal/biphasic insulin (insulin), glucagon-like peptide-1 receptor antagonist (GLP-1RA), or a third OAD within 365 days after the baseline A1c ≥ 7.0%. Patients had at least 1 A1c value 60-365 days (follow-up period) after treatment intensification. The proportion of patients with an A1c < 7.0% and < 9.0% at follow-up were identified by therapeutic intensification strategy. Odds ratios for achieving A1c < 7.0% and < 9.0% were calculated., Results: 1,226 patients were included in the analysis, and 33.5% of the patients had a baseline A1c ≥ 9.0%. 24% of patients received insulin; 16% received GLP-1RA; and 60% received a third OAD for the treatment intensification. Overall, 26.0% achieved A1c < 7.0% and 76.1% of patients achieved < 9.0%, with a median follow-up of 119 days. The proportion of patients intensified with insulin who had an A1c ≥ 9.0% at follow-up was 34.6% versus 53.2% at baseline (P < 0.01). The corresponding percentages for those intensified with a GLP-1RA and OAD were 21.6% versus 27.1% (P = 0.24) and 20.1% versus 27.3% (P < 0.01). After controlling for baseline characteristics, the odds ratio (95% CI) of achieving A1c < 7.0% and < 9.0% was 2.05 (1.45-2.90) for GLP-1RA and 0.92 (0.61-1.40) for OAD. The association between goal attainment and GLP-1RA versus OAD intensification was influenced by the time to the A1c follow-up and baseline A1c., Conclusions: Treatment intensification was associated with improved glycemic control in patients after therapy failed 2 OADs. Patients with higher A1c at baseline were likely to initiate insulin, which was associated with a greater drop in A1c. GLP-1RA was associated with a higher likelihood of achieving NCQA-suggested glycemic control compared with a third OAD. However, the association varied by the follow-up period. These findings are important to health plans seeking to improve patient outcomes as reflected in high performance on NCQA diabetes quality measures by promoting effective and timely treatment intensification., Disclosures: Research funding was provided by Sanofi to the Pharmacotherapy Outcomes Research Center at the University of Utah and SelectHealth to conduct this study. Thomas, Sterling, and Johnstone are employees and stock/shareholders of Sanofi. Kim, Unni, McAdam-Marx, and Brixner are employees of the Department of Pharmacotherapy at the University of Utah. Brixner also has served as an advisory board member and presenter for Sanofi. McAdam-Marx also reports grants to the Department of Pharmacotherapy, University of Utah, from AstraZeneca and Janssen, outside of the submitted work. Olsen is employed by SelectHealth. Part of the results of this study was presented at the Academy of Managed Care & Specialty Pharmacy Annual Meeting 2018 in Boston, MA, during April 23-26, 2018.

Introduction: Similar to cigarette smoking, consumption of cigars delivers nicotine and byproducts of tobacco combustion and elevates the risk of addiction, illness, and premature death. This study examined the relationship of affect, perceived relative harm, and LCC smoking behavior among U.S. adults., Methods: Data were from Tobacco Products and Risk Perceptions Survey conducted in 2015. The study included a probability based sample of 6051 adults (18+) drawn from an online research panel. A current LCC smoker was defined as having ever smoked LCCs and was currently smoking LCCs every day, somedays, or rarely. Participants were asked whether smoking LCCs was less harmful, had about the same level of harm, or was more harmful than smoking regular cigarettes. Feelings about LCCs were collected using word association technique. Descriptive and multinomial logistic regression analyses were conducted., Results: About 7% of the study participants were current LCC smokers. Adults with positive feelings had four-fold the adjusted odds to be current LCC smokers. Perceiving LCCs to be less harmful had 2.7 higher adjusted odds of being current LCC smokers., Conclusions: Compared to cigarettes, LCCs evoked more positive feelings among adults and these positive feelings were strongly associated with both perceiving LCCs as less harmful than cigarettes and with current LCC smoking. Cessation and prevention interventions would benefit from applying the principles of social marketing in which information is provided not only to inform consumers but also to evoke negative feelings and associations with LCC smoking., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Introduction: Flavored little cigars, cigarillos, and filtered cigars (LCCs) are popular and pose unique health risks. This study explored risk perceptions of flavors in LCCs and the relationship between perceptions and use among U.S. adults., Methods: Data were from the 2015 Tobacco Products and Risk Perceptions Survey of a national probability sample of 6051 adults, conducted online, August-September, 2015. The analytic sample consisted of 5105 adults aware of LCCs and 2174 who had ever used any type of LCCs., Results: Just over half of adults reported flavors in LCCs as "very" or "somewhat" risky, while more than one-third of adults reported they did not know the risks of flavors in LCCs. Younger adults, males, and users of any LCCs were more likely than older adults, females and non-users, respectively, to perceive LCC flavors as less risky. Those who perceived LCC flavors as "not at all risky" or "a little risky" were roughly twice as likely to have ever used flavored LCCs compared to those who reported not knowing the risks (AOR = 2.07, 95% CI = 1.16 to 3.69 and AOR = 1.96, 95% CI = 1.26 to 3.06). Those who reported LCC flavors as "very risky" were also more likely to have ever used flavored LCCs than those who reported not knowing the risks (AOR = 1.50, 95% CI = 1.13 to 1.98)., Conclusions: Though the proportion of adults assigning low risk to flavors in LCCs is small, these adults are more likely to use flavored LCCs. The association of use with risk perceptions of flavors in LCCs should be addressed in health risk campaigns., Implications: Flavored LCCs are popular, particularly among young adults. While understanding the impact of flavors is an FDA research priority, little is currently known about perceptions of risk associated with flavors in LCCs. This study explores the nature of risk perceptions of flavors in LCCs, and the relationship between perceptions and flavored LCC use. We conclude that perception of risk of flavors in LCCs is related to use of these products, particularly perception of less risk. Considering the relationship between use and risk perceptions would be helpful in constructing health risk messaging.

Introduction: Prevalence of cigar use has been increasing among youth. Research indicates that youth are modifying cigar products either by "freaking" (ie, removing the filter paper) or "blunting" (removing the tobacco and supplementing or replacing with marijuana), yet little is known about youth who engage in this behavior. Thus, this study examines demographic and concurrent substance use behaviors of youth who modify cigars., Methods: Data from the 2013 Cuyahoga County Youth Risk Behavior survey were examined (n = 16 855). The survey collected data on demographics, cigar product use, cigar modification behaviors, and current cigarette, hookah and marijuana use. Responses to cigar product use items were used to create a composite to classify youth in one of eight unique user categories. Univariate and bivariate statistics were calculated using SPSS complex samples procedures., Results: Overall, 15.2% reported current cigar product use, 11.0% reported current freaking, and 18.5% reported current blunt use; taken together, 25.3% of respondents reported any current use of a cigar product. When examined by user category, of those who endorsed any cigar product use, cigars, cigarillos, and little cigars use only was most endorsed (26.3%), followed by Blunt only (25.2%) and all three (ie, cigars, cigarillos, and little cigars, freaking, and blunting; 17.4%)., Conclusion: A substantial proportion of high school youth who report using cigar products are modifying them in some way, with nearly half freaking and nearly two-thirds blunting. Given the FDA Center for Tobacco products recent extension of its regulatory authority to include cigar products, it is imperative to understand more about the prevalence of and reasons for cigar modification behaviors., Implications: Although the FDA has recently enacted regulatory authority over cigar products, little is known about cigar product modification. This is the first study to concurrently examine two unique cigar modification behaviors, "freaking" (ie, removing the filter paper) and "blunting" (removing the tobacco and supplementing or replacing with marijuana). A significant proportion of high school youth are modifying cigar products to be used as a tobacco product and as a mechanism to smoke marijuana. More research is needed to understand these behaviors to prevent and reduce the use of cigar products among youth., (© The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Few studies have examined the perceptions of risk of little cigar and cigarillo (LCC) smoking among cigarette smokers, which is important for expanding regulatory policies and developing prevention programs. We examined current cigarette smokers' perceived harm of LCC smoking, and determined whether these perceptions were associated with susceptibility and intention to continue smoking LCCs., Methods: Data were from the 2014 Tobacco Products and Risk Perceptions Survey of a probability sample of 5717 US adults. Data were analyzed for a subsample of 1191 current cigarette smokers who were stratified into three groups: (1) dual current cigarette smokers who had ever used LCCs, (2) current smokers susceptible to LCC smoking, and (3) current smokers who were not susceptible to LCC smoking., Results: Overall, 47.2% of participants were dual smokers, 12.7% were susceptible to LCC smoking, and 40.1% were not susceptible. Perceptions of risk of LCCs varied across the groups. Dual smokers were more likely to perceive that daily LCC smoking is "very risky" (OR = 1.64, 95% CI = 1.08, 2.41) while occasional LCC smoking is only "somewhat risky" (OR = 1.71, 95% CI = 1.02, 2.87). Of the dual smokers, 20.7% intended to continue smoking LCCs in the future. Perceptions of addiction and risk of daily LCC smoking significantly predicted intention to continue LCC smoking. Addiction perceptions also significantly predicted susceptibility to initiate LCC smoking., Conclusions: Perceptions about harms from and addiction to LCCs could predict future LCC smoking. Health communication campaigns need to address the harms of LCCs., Implications: Our data suggest that perceptions of risk about the addictiveness of LCCs and frequency of use are important determinants of the LCC smoking susceptibility among some cigarette smokers and intended continued use among cigarette smokers with a history of LCC use. Health communication campaigns should address misperceptions related to LCCs., (© The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

This study aimed to determine the prevalence and factors associated with hookah smoking and perceptions of harm among U.S. adults. Data were pooled from the Tobacco Products and Risk Perceptions Surveys conducted separately in the summers of 2014 and 2015, among a probability sample selected from an online research panel. Descriptive, logistic regression, and multinomial logistic regression analyses were conducted. In 2014/2015, prevalence of ever and past 30-day hookah smoking among U.S. adults were 15.8% (95% C.I.: 15.0%, 16.7%) and 1.5% (95% C.I.: 1.2%, 1.8%), respectively. Adults who used other alternative tobacco products had a higher odds of hookah smoking than those who did not. Adults with some college education (AOR, 1.53) and with a college degree or more (AOR, 2.21), those identified as non-Hispanic other (AOR, 1.38) were more likely to be ever hookah smokers. Being a young adult (AOR, 2.7), college-educated (AOR, 2.3), never smoker (AOR, 2.1), and an ever hookah smoker (AOR, 2.8) were associated with lower perceptions of harm. Findings suggest that young college students are at higher risk of smoking hookah and that hookah smoking is more prevalent among individuals who use other tobacco products, such as little cigars and cigarillos, traditional cigars, and e-cigarettes, indicating a distinct group of users of alternative tobacco products. Regarding potential harm of hookah, the study highlights a knowledge gap and misperception especially among young, college-educated, and never smokers. Public health interventions should target these subpopulations to provide them with accurate information on hookah smoking., (Copyright © 2017 Elsevier Ltd. All rights reserved.)