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.

Increased Levels of the Acrolein Metabolite 3-Hydroxypropyl Mercapturic Acid in the Urine of e-Cigarette Users.

Carcinogen and toxicant uptake by e-cigarette users have not been fully evaluated. In the study reported here, we recruited 30 e-cigarette users, 63 nonsmokers, and 33 cigarette smokers who gave monthly urine samples over a period of 4-6 months. Their product use status was confirmed by measurements of exhaled CO, urinary total nicotine equivalents, cyanoethyl mercapturic acid (CEMA), and total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol. Urinary biomarkers of exposure to the carcinogens acrolein (3-hydroxypropyl mercapturic acid, 3-HPMA), benzene (S-phenyl mercapturic acid, SPMA), acrylonitrile (CEMA), and a combination of crotonaldehyde, methyl vinyl ketone, and methacrolein (3-hydroxy-1-methylpropyl mercapturic acid, HMPMA) were quantified at each visit. Data from subject visits with CEMA > 27 pmol/mL were excluded from the statistical analysis of the results because of possible unreported exposures to volatile combustion products such as secondhand cigarette smoke or marijuana smoke exposure; this left 22 e-cigarette users with 4 or more monthly visits and all 63 nonsmokers. Geometric mean levels of 3-HPMA (1249 versus 679.3 pmol/mL urine) were significantly higher (P = 0.003) in e-cigarette users than in nonsmokers, whereas levels of SPMA, CEMA, and HMPMA did not differ between these two groups. All analytes were significantly higher in cigarette smokers than in either e-cigarette users or nonsmokers. The results of this unique multimonth longitudinal study demonstrate consistent significantly higher uptake of the carcinogen acrolein in e-cigarette users versus nonsmokers, presenting a warning signal regarding e-cigarette use.

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.

Adult Hematology/Oncology Patient Perspectives on Telemedicine Highlight Areas of Focus for Future Hybrid Care Models.

Introduction: Telemedicine use expanded rapidly during the COVID-19 pandemic, but publications analyzing patient perspectives on telemedicine are few. We aimed to study whether patient perspectives offer insights into how best to utilize telemedicine in the future for hematology and cancer care. Methods: A modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) was sent to adult hematology/oncology outpatients at the University of Minnesota Masonic Cancer Clinic who had ≥1 prior phone and/or video visit between March 15, 2020, and March 31, 2021. Two focus groups were subsequently conducted with volunteers who completed the survey. We evaluated dichotomized TSUQ items using logistic regression, and focus group data were analyzed qualitatively using constant comparison analysis. Results: Of 7,848 invitations, 588 surveys were completed. Focus groups included 16 survey respondents. Most respondents found telemedicine satisfactory, easy to use, and convenient, with the majority preferring a hybrid approach going forward. Oncology patients, females, and higher income earners endorsed decreased telemedicine satisfaction. Concerns were voiced about fewer in-person interactions, communication gaps, and provider style variability. Discussion: Adult hematology/oncology patients had varied perspectives on telemedicine utilization success based on gender, income, and disease burden, suggesting that a one-size-fits-all approach, as was implemented nearly universally during the COVID-19 pandemic, is not an ideal approach for the long term. Given that telemedicine use is likely to remain in some form in most centers, our findings suggest that a nuanced and tailored approach for some patient subgroups and using feedback from patients will make implementation more effective.

Prospective Trial of Neutrophil/Lymphocyte Ratio and Other Blood Counts as Biomarkers of Survival among Patients with High-Grade Soft Tissue Sarcomas Treated with Pegylated Liposomal Doxorubicin and Ifosfamide.

Several studies have reported an association between levels of circulating blood cells, in particular the neutrophil to lymphocyte ratio (absolute neutrophil count (ANC)/absolute lymphocyte count (ALC)) and outcomes in patients with cancer. In the current study, the association between lymphocyte, neutrophil, monocyte, and platelet counts and survival was examined in a prospective trial of preoperative pegylated-liposomal doxorubicin and ifosfamide for high-grade soft-tissue sarcomas. A statistically significant association between overall survival, but not progression free-survival, was observed with the ANC/ALC ratio at a cutoff value of ≥2 and a statistically significant trend using a cutoff of ≥5. Our results suggest that a balance between the lymphocyte count and the number of circulating myeloid cells that can suppress lymphocyte function may be predictive of survival in patients with soft-tissue sarcomas. Future research should therefore examine the role of lymphocyte-myeloid cell balance in sarcoma biology.

Prospective Trial of Monocyte Count as a Biomarker of Hand-Foot Syndrome Among Patients With Soft Tissue Sarcomas Treated With Pegylated Liposomal Doxorubicin and Ifosfamide.

Pegylated liposomal doxorubicin (PLD) is widely used and can be used for prolonged periods, with the limiting toxicity usually being hand-foot syndrome (HFS). The pharmacokinetics of PLD is variable between patients, leading to variability in the risk of developing HFS. Dosing based on body surface area does not decrease variability in PLD clearance; thus, other predictive markers could be useful. The peripheral blood absolute monocyte count (AMC) has been suggested as a possible marker of both reticuloendothelial system function and PLD pharmacokinetics. The present study examined the AMC as a potential predictive biomarker in a prospective trial of pre-operative PLD combined with ifosfamide in soft tissue sarcomas (STSs). While our results suggest a relationship between pre-treatment AMC and PLD-induced HFS, the association did not reach statistical significance. The clinical utility of the AMC as a predictor of PLD-induced HFS appears limited, at least when given with ifosfamide.

Characterization of Baseline Temperature Characteristics Using Thermography in The Clinical Setting.

BACKGROUND: Thermography is a diagnostic method based on the ability to record infrared radiation emitted by the skin and is unique in its ability to accurately show physiological and/or pathological cutaneous temperature changes in a non-invasive way. This method can be used to indirectly assess changes or impairments in cutaneous perfusion. Significant technological advancements have allowed thermography to be more commonly utilized by clinicians, yet a basic consensus of patient characteristics that may affect temperature recordings is not established. MATERIALS AND METHODS: We evaluated cutaneous temperature in a cohort of outpatients to understand what factors, including tobacco use and other high-risk characteristics, contribute to cutaneous tissue perfusion as measured by thermography. Participants were prospectively enrolled if they were a combustible cigarette smoker, an electronic cigarette (e-cigarette) user, or a never smoker. Standardized thermographic images of the subject's facial profiles, forearms, and calves were taken and demographic characteristics, medical comorbidities, and tobacco product use were assessed. These variables were statistically tested for associations with temperature at each anatomic site. RESULTS: We found that gender had a significant effect on thermographic temperature that differed by anatomic site, and we found a lack of significant difference in thermographic temperature by race. Our regression analysis did not support significant differences in thermographic temperatures across smoking groups, while there was a trend for decreased perfusion in smokers relative to non-smokers and e-cigarette users relative to non-smokers. CONCLUSION: Thermographic imaging is a useful tool for clinical and research use with consideration of sex and other perfusion-affecting characteristics.

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.

The New Normal? Patient Satisfaction and Usability of Telemedicine in Breast Cancer Care.

BACKGROUND: Telemedicine was adopted to minimize exposure risks for patients and staff during the coronavirus disease 2019 pandemic. This study measured patient satisfaction and telemedicine usability in breast cancer care. METHODS: Adult breast cancer patients who had a telemedicine visit at a single academic institution (with surgical, radiation, or medical oncology) from 15 June 2020 to 4 September 2020 were surveyed anonymously. Patient and cancer characteristics were collected, and patient satisfaction and telemedicine usability were assessed using a modified Telehealth Usability Questionnaire with a 7-point Likert scale. Associations of satisfaction and usability with patient characteristics were analyzed using Wilcoxon rank-sum and Kruskal-Wallis tests. RESULTS: Of 203 patients who agreed to be contacted, 78 responded, yielding a response rate of 38%. The median age of the respondents was 63 years (range 25-83 years). The majority lived in an urban area (61%), were white (92%), and saw a medical oncologist (62%). The median patient satisfaction score was 5.5 (interquartile range [IQR] 4.25-6.25). The median telemedicine usability score was 5.6 (IQR 4.4-6.2). A strong positive correlation was seen between satisfaction and usability, with a Spearman correlation coefficient (ρ) of 0.80 (p < 0.001). Satisfaction and usability scores did not vary significantly according to patient age, race, location of residence, insurance status, previous visit commute time, oncology specialty seen, prior telemedicine visits, or whether patients were actively receiving cancer treatment. CONCLUSIONS: Breast cancer patients were satisfied with telemedicine and found it usable. Patient satisfaction and telemedicine usability should not limit the use of telemedicine in future post-pandemic breast cancer care.

Impact of nicotine reduction in cigarettes on smoking behavior and exposure: Are there differences by race/ethnicity, educational attainment, or gender?

BACKGROUND: Lowering nicotine in cigarettes may reduce smoking prevalences; however, it is not known whether an immediate or gradual reduction in nicotine is the optimal approach for all population groups. OBJECTIVES: We examined whether the optimal approach to nicotine reduction depended on the education, gender, or race of people who smoke and whether the optimal approach differentially benefited people who smoke based on their education, gender, or race. METHODS: Secondary analysis was conducted on a randomized clinical trial (N = 1250) comparing (1) immediate reduction from 15.5 to 0.4 mg of nicotine per gram of tobacco(mg/g);(2) gradual reduction to 0.4 mg/g;(3) control group with normal nicotine cigarettes(15.5 mg/g). Outcomes included cigarettes per day(CPD), carbon monoxide(CO), total nicotine equivalents(TNE), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides(NNAL), phenanthrene tetraol(PheT), N-Acetyl-S-(2-cyanoethyl)-l-cysteine(CEMA). Data were analyzed as area under the curve(AUC). RESULTS: Results were presented by education (High school[HS] or less n = 505, more than HS n = 745), gender (males n = 701, females n = 549), and race (Black participants n = 373,White participants n = 758). Regardless of education, gender, and race, CPD, CO, TNE, NNAL, PheT, and CEMA were lower in immediate versus gradual nicotine reduction. Comparing immediate versus the control, outcomes were lower for all subgroups; however, the magnitude of the effect for TNE varied by race. Specifically, geometric mean of the AUC of TNE in immediate versus gradual was 49 % lower in Black participants and 61 % lower in White participants (p-value = 0.047). CONCLUSIONS: Immediately reducing nicotine in cigarettes has the potential to benefit people who smoke across lower and higher educational attainment, male and female gender, and Black and White race.

Clinical Characteristics of Idiopathic Intracranial Hypertension in Patients Over 50 Years of Age: A multicenter clinical cohort study.

PURPOSE: To characterize the clinical features of idiopathic intracranial hypertension (IIH) in patients >50 years of age compared to the typical IIH population and existing data for this older cohort. DESIGN: Retrospective, clinical cohort study. METHODS: Medical records of 65 patients >50 years of age at first diagnosis of IIH were reviewed based on the Modified Dandy Criteria from 4 academic centers. Each center provided randomly selected controls from IIH patients <50 years of age for each study patient at their location. Data recorded included patient demographics, presenting symptoms, medications, coexisting medical conditions, cerebrospinal fluid (CSF) opening pressure, treatments, and neuro-ophthalmic data from initial and final visits. RESULTS: Compared to controls, the older cohort showed the following characteristics: fewer females (n = 51 [78.5%] vs. controls: n = 60 [92.3%]; P = .045), fewer headaches (n = 33 [50.8%] vs. controls: 52 [80.0%]; P = .001), more frequent incidental discoveries of papilledema (n = 19 [29.2%] vs. controls: 7 [10.8%]; P = .015), and lower CSF opening pressure [median: 33 cm H2O [range: 21-58 cm H2O] vs. the median for controls: 34 cm H2O [range: 24-67 cm H2O; P = .029). CONCLUSIONS: Patients with IIH diagnosed at >50 years of age were less often female and had lower CSF opening pressure, fewer headaches, a higher chance of incidentally identified papilledema, and body mass index similar to that of younger IIH patients. Older IIH onset was not associated with worse visual outcome.

The role of subjective responses in electronic cigarette uptake and substitution in adult smokers.

BACKGROUND: While a majority of cigarette smokers who use electronic cigarettes (e-cigarettes) choose to continue using cigarettes, completely switching to e-cigarettes is necessary to reduce tobacco-related harm. Whether specific subjective responses to e-cigarettes are associated with extent of smoking reduction and complete switching from cigarettes to e-cigarettes is unclear. This study determined whether initial subjective responses to e-cigarettes related to the successful substitution of e-cigarettes for cigarettes and extent of cigarette and e-cigarette use. METHODS: Adult cigarette smokers (N = 58) uninterested in quitting were asked to completely substitute their cigarettes with an e-cigarette (Vuse Solo) for 8 weeks. At week 1, subjective responses to e-cigarettes were measured using the Product Evaluation Scale and Drug Effects/Liking Survey. A Poisson regression examined whether any of these initial subjective responses were associated with smoke-free days, e-cigarette puffs, and cigarettes smoked between weeks 6 and 8 after adjustment for potential confounders. A logistic regression examined the relationship between subjective measures and exhaled carbon monoxide (CO) verified 7-day abstinence at week 8 after adjustment for potential confounders. RESULTS: Following Holm's p-value adjustment, e-cigarette liking and desire were associated with increased e-cigarette use (adjusted p < 0.01) and decreased cigarette use (adjusted p < 0.05). Measures of psychological reward and drug liking were associated with 7-day abstinence, however this association was no longer significant following p-value adjustment. CONCLUSIONS: Initial subjective responses were related to cigarette and e-cigarette use at weeks 6-8, but not smoke-free days or CO-verified 7-day abstinence.

A Randomized Clinical Trial of Snus Examining the Effect of Complete Versus Partial Cigarette Substitution on Smoking-Related Behaviors, and Biomarkers of Exposure.

INTRODUCTION: This 8-week multisite, randomized controlled trial of snus examined the differential effects of instructions on (1) snus use, (2) smoking and smoking-related measures, and (3) exposure to tobacco-related constituents. METHOD: US adult daily cigarette smokers (n = 150; 43.3% female; Medianage = 43.5) were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio; and Buffalo, New York. Following a 1-week sampling phase of snus, participants who used at least 7 pouches were randomized to either (1) partial substitution (PS; "use snus as you like with your cigarettes"), (2) complete substitution (CS; "avoid cigarettes"), or (3) usual brand cigarettes (UB). Analyses included between-group analyses (eg, PS vs. CS) using Wilcoxon rank sum test of cigarettes per day and snus pouches per day, and a linear mixed model (biomarkers). RESULTS: Compared to the PS and UB groups, smokers assigned to CS reported greater reductions in cigarettes per day (ps < .001), using more snus pouches per day (p = .02), and more smoke-free days (CS median = 14.5, PS and UB medians = 0, p < .001). In addition, results demonstrated reductions in carbon monoxide (p < .001), total nicotine equivalents (p = .02), and four out of five measured volatile organic compounds (ps < .01) over time among the CS group. Exposure to N'-nitrosonornicotine increased by trial end only among the PS group (p < .04). Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups. CONCLUSIONS: Instructions to completely switch from cigarettes to snus resulted in the greatest reduction in cigarettes and exposure to harmful constituents. IMPLICATIONS: Directly instructing smokers to switch completely to snus, rather than using ad libitum (with no instructions to avoid cigarettes), is necessary for reductions in smoking and subsequent exposure to harmful constituents.

A Randomized Clinical Trial Examining the Effects of Instructions for Electronic Cigarette Use on Smoking-Related Behaviors and Biomarkers of Exposure.

INTRODUCTION: Electronic cigarettes (e-cigarettes) have the potential to significantly reduce exposure to harmful constituents associated with cigarette smoking when smokers completely substitute cigarettes with e-cigarettes. This study examined patterns of e-cigarette and cigarette use, and extent of toxicant exposure, if smokers were instructed and incentivized to completely switch to e-cigarettes compared to instructions to use the product ad libitum. AIMS AND METHODS: US adult daily smokers (n = 264; 49.2% female; Mage = 47.0), uninterested in quitting smoking immediately, were recruited from Minneapolis, MN, Columbus, OH, and Buffalo, NY. Participants were randomized to 8 weeks of instructions for (1) ad libitum use of e-cigarettes (AD-E), (2) complete substitution of cigarettes with e-cigarettes (CS-E), (3) complete substitution of cigarettes with nicotine gum or lozenge (CS-NRT), or (4) continue smoking of usual brand cigarettes (UB). Participants were incentivized for protocol compliance, including complete switching in the CS-E and CS-NRT groups. Outcome variables were cigarette smoking rate and tobacco-related biomarkers of exposure. RESULTS: Smokers in the CS-E and CS-NRT groups showed lower rates of smoking and lower exposure to carbon monoxide, tobacco carcinogens, and other toxicants than smokers in the AD-E group. In general, no significant differences were observed between CS-E versus CS-NRT or between AD-E versus UB for most biomarkers. Significantly higher 7-day point prevalence smoke-free rates were observed for CS-E versus CS-NRT. CONCLUSIONS: Smokers instructed and incentivized to completely switch to e-cigarettes resulted in lower smoking rates and greater reductions in exposures to harmful chemicals than smokers instructed to use the product ad libitum. IMPLICATIONS: Smokers instructed to completely substitute e-cigarettes for cigarettes displayed significantly lower levels of smoking and biomarkers of exposure to carcinogens and toxicants, compared to smokers instructed to use e-cigarettes ad libitum and similar levels as smokers instructed to completely substitute with nicotine replacement therapies. Furthermore, a higher rate of complete switching was achieved with e-cigarettes versus nicotine replacement therapies. Approaches to maximize complete substitution with e-cigarettes are an important area for future research.

Smoking Topography Characteristics During a 6-Week Trial of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.

INTRODUCTION: A nicotine-reduction policy could have major benefits for smokers with serious mental illness (SMI). However, potential unintended consequences, such as compensatory smoking, should be considered to ensure that such a policy does not negatively affect this population. The purpose of this secondary analysis was to examine the impact of smoking very low nicotine content (VLNC) cigarettes for 6 weeks on smoking topography characteristics, indicators of compensatory smoking, among smokers with SMI. AIMS AND METHODS: After a baseline usual brand smoking phase, smokers with SMI (N = 58) were randomly assigned under double-blind conditions to receive either VLNC (0.4 mg nicotine per g tobacco) or normal nicotine content (NNC; 15.8 mg nicotine per g tobacco) research cigarettes for 6 weeks. During two study visits scheduled 6 weeks apart, participants smoked either their usual brand (baseline) or assigned study cigarettes (postrandomization) through a handheld smoking topography device. Univariate analysis of variance compared smoking topography indices with cigarette condition (VLNC vs. NNC) as the between-subjects factor with corresponding baseline topography results included as covariates. RESULTS: At week 6, participants in the VLNC condition smoked fewer puffs per cigarette and had shorter interpuff intervals compared to participants in the NNC condition (ps < .05). There were no differences between research cigarette conditions at week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost. CONCLUSIONS: Findings are consistent with acute VLNC cigarette topography studies and indicate that a nicotine-reduction policy is unlikely to lead to compensation among smokers with SMI. IMPLICATIONS: Given the high smoking rates among people with SMI, understanding how a nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if nicotine content is lowered to minimally addictive levels.

Effects of 6-Week Use of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.

INTRODUCTION: The US Food and Drug Administration is considering implementing a reduced-nicotine standard for cigarettes. Given the high rate of smoking among people with serious mental illness (SMI), it is important to examine the responses of these smokers to very low nicotine content (VLNC) cigarettes. METHODS: This trial compared the effects of VLNC (0.4 mg nicotine/g tobacco) and normal nicotine content cigarettes (15.8 mg/g) over a 6-week period in non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58). Linear regression was used to examine the effects of cigarette condition on cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms. RESULTS: At week 6, participants in the VLNC condition smoked fewer cigarettes per day, had lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction than those in the normal nicotine content condition (ps < .05). Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05). There were no differences across conditions on total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence. CONCLUSIONS: These results suggest that a reduced-nicotine standard for cigarettes would reduce smoking among smokers with SMI. However, the lack of effect on total nicotine exposure indicates VLNC noncompliance, suggesting that smokers with SMI may respond to a reduced-nicotine standard by substituting alternative forms of nicotine. IMPLICATIONS: Results from this trial suggest that a reduced-nicotine standard for cigarettes would reduce smoking rates and smoke exposure in smokers with SMI, without increasing psychiatric symptoms. However, noncompliance with VLNC cigarettes was observed, suggesting that these smokers might respond to a reduced-nicotine standard by substituting alternative forms of nicotine.

Transitional care practices, services, and delivery in childhood cancer survivor programs: A survey study of U.S. survivorship providers.

PURPOSE: There are limited reports describing transition of young adult childhood cancer survivors (CCS) from pediatric to adult-focused survivorship care. The purpose of this study was to characterize current transitional care practices in the United States. PROJECT DESCRIPTION: An online survey was sent to one preselected respondent at 163 Children's Oncology Group member institutions in the United States. Data were collected about (i) the availability and type of long-term follow-up services for adult CCS and (ii) policies and procedures for transitioning. Logistic regression was used to evaluate factors related to care for CCS. RESULTS: The response rate was 60% (97/163). Eighty-one respondents (84%) represented centers with specialized pediatric-focused CCS programs. Thirty-nine percent (38/97) of programs delivered specialized transitional care for adult CCS. Adult-centered care was delivered in both pediatric (39%, 15/38) and adult oncology clinics (39%, 15/38). The most common perceived transition barriers were lack of available partnering adult providers and adult providers' lack of knowledge regarding CCS. The larger the program in terms of new diagnoses, the more likely they were to offer formal transitional care (<50 vs >200: odds ratios [OR] 20.0; 95% CI 3.2, 100.0, P = 0.004). CONCLUSIONS: A variety of models are utilized for delivering care to adult CCS. Our results suggest that interventions to establish effective partnerships with adult providers on appropriate care of CCS may facilitate expanded availability of these services.