A Pilot Study to Test the Feasibility for a Randomized Controlled Trial of E-cigarettes as Harm Reduction Tools Among People Who Smoke and Previously Failed to Quit with Pharmacotherapy.

INTRODUCTION: We conducted a pilot study to test the feasibility of a future randomized controlled trial comparing e-cigarettes to traditional pharmacotherapy among people who smoke daily, were motivated to quit, and failed to quit within the past 5 years using pharmacotherapy. METHODS: Eligible participants were assigned to either: 1) an e-cigarette (n=20) or 2) combination nicotine replacement therapy (patches and lozenges) (n=10). Participants received 5 weeks of product and selected a quit date 1 week later. Assessments were completed weekly, and electronic diaries were completed each day. As a pilot randomized controlled trial, outcomes focus on effects sizes and not statistical significance. RESULTS: Participants in the e-cigarette and NRT groups had a mean age of 51 (SD=13) and 50 (SD=10) years old, were 55% and 60% female, and were 15% and 0% non-white, respectively. At least 90% of participants completed each weekly assessment, and 77% of participants completed at least 80% of daily diaries. Mean cigarettes smoked per day reduced from 18 (SD=6.2) to 2.4 (SD=4.4) per day in the e-cigarette group and 16.5 (SD=8.5) to 4.9 (SD=5.9) per day in the NRT group. Rates of biochemically confirmed 7-day point prevalence abstinence at the end of treatment were numerically, but not statistically, higher in the e-cigarette group than the NRT group (35% vs. 10%, OR=4.8, 95% CI=0.5-46.5). CONCLUSIONS: Among current daily cigarette smokers who have previously tried to quit and failed using standard pharmacotherapies, provision of an e-cigarette is a feasible intervention. A larger adequately powered trial is warranted. IMPLICATIONS: This pilot study suggests that e-cigarettes may serve as an acceptable harm reduction intervention for people who smoke who cannot quit smoking with traditional pharmacotherapy, but adequately powered randomized controlled trials are needed.

Remote Carbon Monoxide Capture via REDCap: Evaluation of an Integrated Mobile Application.

INTRODUCTION: To improve the feasibility of remote biochemical verification of smoking status, our team developed "COast", a mobile app integrated with REDCap that allows a research participant to complete self-report research assessments and provide a breath sample via the iCOQuit® Smokerlyzer® for the purposes of carbon monoxide (CO) testing. The aims of the present study were to examine: 1) the validity of remote CO data capture using COast as compared to gold standard approaches (salivary cotinine, stand-alone CO monitor) and 2) the feasibility of remote CO data capture using COast as applied to both daily and weekly CO collection schedules. METHODS: Participants (N=143, 59% Female), including recently quit (n=36) and current (n=107) smokers, completed a baseline video session to capture validity data, and then were randomized to daily or weekly CO monitoring for a period of one month. RESULTS: Balancing both sensitivity and specificity, optimal cut-points for defining abstinence using the COast system were < 4 parts per million (ppm) with salivary cotinine as the referent (Sensitivity = 100%, Specificity = 92.8%) and < 8ppm with the stand-alone CO monitor as the referent (Sensitivity = 100%, Specificity = 88.9%). Compliance across groups with CO monitoring was high with average compliance of 74% for the daily group and 84% for the weekly group. Self-reported feasibility and acceptability of using the system were strong. CONCLUSIONS: Pairing the iCOQuit with REDCap via the COast app was both valid and feasible among a sample of adults who smoke cigarettes enrolled remotely. This integration may help to improve the rigor of decentralized smoking cessation trials. IMPLICATIONS: With increasing prevalence of decentralized trial designs, innovative methods are needed to remotely capture biomarkers. Methods that leverage existing widely available research data capture platforms may be particularly useful for promoting adoption. The COast app, which integrates a Bluetooth-enabled carbon monoxide monitor with REDCap, is a fitting, valid, feasible solution to remotely biochemically verify smoking status.

Measuring success: A comparison of ultrasound and landmark guidance for knee arthrocentesis in a cadaver model.

OBJECTIVE: Knee arthrocentesis can be performed by landmark (LM) or ultrasound (US) guidance. The goal of performing knee arthrocentesis is to obtain synovial fluid, however, it is also important to consider the number of attempts required and accidental bone contacts that occur. This study evaluates procedural success without bone contact in knee arthrocentesis and compares both LM and US guided techniques in a cadaver model. METHODS: This was a randomized crossover study comparing US vs LM guidance for arthrocentesis in a single academic center. Volunteers were randomized to perform both LM and US guided knee arthrocentesis on cadavers. The primary outcome was procedural success, defined as first attempt aspiration of synovial fluid without bone contact. Secondary outcomes included number of attempts, number of bone contacts, time to aspiration, and confidence. RESULTS: Sixty-one participants completed the study with a total of 122 procedures performed. Procedural success without bone contact was greater in the US group (84% vs 64% p = 0.02). Time to aspiration was longer for US (38.75 s vs 25.54 s p = 0.004). Participants were more confident with US compared to LM both before the procedure on a Visual Analog Scale from 1 to 100 (29 vs 21 p = 0.03) as well as after the procedure (83 vs 69 p = 0.0001). Participants had a greater median increase in confidence with US following training (44 vs 26 p = 0.01). CONCLUSIONS: Study participants had greater procedural success without bone contact when US guidance was used. The increase in confidence following training was greater for US guidance than the LM method. Use of US guidance may offer a benefit by allowing for better needle control and avoidance of sensitive structures for clinicians performing knee arthrocentesis.

Mask Adherence to Mask Mandate: College Campus Versus the Surrounding Community.

Adherence to masking recommendations and requirements continues to have a wide variety of impacts in terms of viral spread during the ongoing pandemic. As governments, schools, and private sector businesses formulate decisions around mask requirements, it is important to observe real-life adherence to policies and discern subsequent implications. The CDC MASCUP! observational study tracked mask-wearing habits of students on higher-education campuses across the country to collect stratified data about mask typologies, correct mask usage, and differences in behaviors at locations on a college campus and in the surrounding community. Our findings from a single institution include a significant adherence difference between on-campus (86%) and off-campus sites (72%) across the course of this study as well as a notable change in adherence at the on-campus sites with the expiration of a county-wide governmental mandate, despite continuance of a university-wide mandate. This study, completed on and around the campus of East Tennessee State University in Washington County TN, was able to pivotally extract information regarding increased adherence on campus versus the surrounding community. Changes were also seen when mask mandates were implemented and when they expired.

Behavioral Activation-Based Digital Smoking Cessation Intervention for Individuals With Depressive Symptoms: Randomized Clinical Trial.

BACKGROUND: Depression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers. OBJECTIVE: This study aimed to determine whether a mobile app-based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation. METHODS: A 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app ("Goal2Quit") provided behavioral strategies for treating depression and quitting smoking based on Behavioral Activation Treatment for Depression. Goal2Quit participants also received a 2-week sample of combination NRT. Treatment as usual participants received a self-help booklet for quitting smoking that was not tailored for depression. Primary end points included Goal2Quit usability, change in depression (Beck Depression Inventory-II) across 12 weeks, and smoking cessation including reduction in cigarettes per day, incidence of 24-hour quit attempts, floating abstinence, and 7-day point prevalence abstinence (PPA). RESULTS: In total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was strong with a mean usability rating on the System Usability Scale of 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability. Retention data for app use were generally strong immediately following trial enrollment and declined in subsequent weeks. Those who received Goal2Quit and the NRT sample reported lower mean depressive symptoms over the trial duration as compared to treatment as usual (difference of mean 3.72, SE 1.37 points less; P=.01). Across time points, all cessation outcomes favored Goal2Quit. Regarding abstinence, Goal2Quit participants reported significantly higher rates of 7-day PPA at weeks 4 (11% vs 0%; P=.02), 8 (7-day PPA: 12% vs 0%; P=.02), and 12 (16% vs 2%; P=.02). CONCLUSIONS: A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379.

Patent Ductus Arteriosus Response to Treatment by Course and Associations with Perinatal and Clinical Factors.

OBJECTIVE: The objective of this study is to examine patent ductus arteriosus (PDA) response by treatment course and investigate associations with postmenstrual age (PMA), chronological age (CA), gestational age (GA), antenatal steroid exposure (ANS), birthweight (BW), weight at treatment initiation (WT), and PDA/left pulmonary artery (LPA) ratio. STUDY DESIGN: This is a single-center retrospective cohort study of preterm infants less than 37 weeks' GA born January 1, 2016 to December 31, 2018 who received acetaminophen and/or indomethacin for PDA treatment. Cox proportional hazards regression models were used to determine whether factors of interest were associated with PDA response to medical treatment. RESULTS: In total, 289 treatment courses were administered to 132 infants. Thirty-one (23%) infants experienced treatment-associated PDA closure. Ninety-four (71%) infants had evidence of PDA constriction following any treatment course. Ultimately, 84 (64%) infants experienced definitive PDA closure. For each 7-day increase in CA at the time of treatment initiation, the PDA was 59% less likely to close (p = 0.04) and 42% less likely to respond (i.e., constrict or close) to treatment (p < 0.01). PDA/LPA ratio was associated with treatment-associated PDA closure (p = 0.01). For every 0.1 increase in the PDA/LPA ratio, the PDA was 19% less likely to close in response to treatment. CONCLUSION: In this cohort, PDA closure is independent of PMA, GA, ANS, BW, and WT; however, CA at treatment initiation predicted both treatment-associated PDA closure and PDA response (i.e., constriction or closure), and PDA/LPA ratio was associated with treatment-associated closure. Most infants experienced PDA constriction rather than closure, despite receiving up to four treatment courses. KEY POINTS: · Detailed PDA responses for up to four treatment courses provide a novel perspective.. · Chronological age at the start of treatment predicted treatment-associated PDA closure and response.. · For each 7-day increase in chronological age, the PDA was 59% less likely to close..

A randomized, open-label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft-tissue sarcoma.

BACKGROUND: Therapeutic options for patients with advanced soft-tissue sarcoma (STS) are limited. The goal of the current phase 2 study was to examine the clinical activity and safety of the combination of gemcitabine plus pazopanib, a multityrosine kinase inhibitor with activity in STS. METHODS: The current randomized, phase 2 trial enrolled patients with advanced nonadipocytic STS who had received prior anthracycline-based therapy. Patients were assigned 1:1 to receive gemcitabine at a dose of 1000 mg/m2 on days 1 and 8 with pazopanib at a dose of 800 mg daily (G+P) or gemcitabine at a dose of 900 mg/m2 on days 1 and 8 and docetaxel at a dose of 100 mg/m2 on day 8 (G+T) every 3 weeks. Crossover was allowed at the time of disease progression. The study used a noncomparative statistical design based on the precision of 95% confidence intervals for reporting the primary endpoints of median progression-free survival (PFS) and rate of grade ≥3 adverse events (AEs) for these 2 regimens based on the intent-to-treat patient population (AEs were graded using version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events). RESULTS: A total of 90 patients were enrolled: 45 patients on each treatment arm. The median PFS was 4.1 months for each arm (P = .3, log-rank test). The best overall response of stable disease or better (complete response + partial response + stable disease) was the same for both treatment arms (64% for both the G+T and G+P arms). The rate of related grade ≥3 AEs was 82% for the G+T arm and 78% for the G+P arm. Related grade ≥3 AEs occurring in ≥10% of patients in the G+T and G+P arms were anemia (36% and 20%, respectively), fatigue (29% and 13%, respectively), thrombocytopenia (53% and 49%, respectively), neutropenia (20% and 49%, respectively), lymphopenia (13% and 11%, respectively), and hypertension (2% and 20%, respectively). CONCLUSIONS: The data from the current study have demonstrated the safety and efficacy of G+P as an alternative to G+T for patients with nonadipocytic STS.

A Pilot Randomized Clinical Trial of Remote Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation.

INTRODUCTION: Medication sampling is a clinically useful tool to engage smokers in the quitting process. Whether varenicline is suitable for sampling purposes is unclear. The purpose of this study was to examine the feasibility, uptake, and preliminary outcomes of varenicline sampling. METHODS: Smokers (N = 99), both motivated to quit and not, were recruited and randomized to varenicline sampling versus not, with 12 week follow-up. The intervention consisted of mailing one-time samples of varenicline (lasting 2-4 wks), with minimally suggestive guidance on use. RESULTS: Uptake of varenicline was strong, at 2 weeks (54% any use, 66% daily use) and 4 weeks (38%, 46%), with 58% of medication users seeking additional medication. Most users followed conventional titration patterns, self-titrating from 0.5 mg to 2 mg. Relative to control, varenicline sampling increased motivation (p = 0.006) and confidence to quit (p = 0.02), and decreased cigarette smoking (p = 0.02). Smokers receiving varenicline samples were significantly more likely to achieve 50% reduction in cigarettes per day (CPD), both immediately following the sampling exercise (Adjusted Odds Ratio [AOR] = 4.12; 95% CI: 1.39 to 12.17) and at final follow-up (AOR = 4.50; 95% CI: 1.56 to 13.01). Though cessation outcomes were not statistically significant, there was a 1.5 to 3-fold increase in quit attempts and abstinence from varenicline sampling throughout follow-up. These outcomes were comparable among smokers motivated to quit and not. CONCLUSIONS: Unguided, user-driven sampling of varenicline sampling is a concrete behavioral exercise that is feasible to do and seems to suggest clinical utility. Sampling is a pragmatic clinical approach to engage more smokers in quitting. IMPLICATIONS: Use of evidence-based pharmacotherapies for smoking cessation is low. Medication sampling is a pragmatic behavioral exercise that allows smokers to experience the benefits of using them, while promoting positive downstream effects towards quitting. While previous studies have shown that nicotine replacement therapy (NRT) sampling is viable and effective, whether this extends to varenicline is unclear. Results from this trial demonstrate that varenicline sampling is feasible, safe, and suggestive of clinically important steps toward quitting, deserving of a larger trial. CLINICAL TRIAL REGISTRATION: NCT #03742154.

Incorporating Absolute Phagocyte Count With Absolute Neutrophil Count as a Measure for Safe Discharge for Pediatric Oncology Febrile Neutropenia: A Pilot Study.

Adequate bone marrow recovery is a discharge requirement after admission for febrile neutropenia in oncology patients, without specific threshold in consensus guidelines. In January 2016, our institution implemented count recovery criteria of absolute neutrophil count ≥100 cells/µL and absolute phagocyte count ≥300 cells/µL compared with prior criteria of absolute neutrophil count ≥500 cells/µL. Retrospective analysis comparing pre (July 2013 to December 2015, N=68) and post (January 2016 to June 2018, N=30) groups showed no difference in readmissions (P>0.9), no patient deaths, and decreased average length of stay in the post group (P<0.0001). Updated count recovery criteria seem feasible and safe.

A Preliminary Examination of Endogenous Peripheral Oxytocin in a Pilot Randomized Clinical Trial of Oxytocin-Enhanced Psychotherapy for Posttraumatic Stress Disorder.

BACKGROUND: Preclinical and clinical research suggests that the oxytocin system is implicated in the development and maintenance of stress and anxiety-related psychiatric conditions, such as posttraumatic stress disorder (PTSD). Recent research also suggests that intranasal oxytocin holds promise as a treatment for PTSD. However, little is known about the relationship between levels of peripheral oxytocin and PTSD symptom severity, PTSD treatment response, and repeated intranasal oxytocin administration. METHODS: In the current study, we examined associations between PTSD symptom severity and peripheral oxytocin levels measured in plasma before and after a course of prolonged exposure (PE) for PTSD (n = 13); participants were randomized to adjunctive intranasal oxytocin (n = 6) or placebo (n = 7). RESULTS: Baseline peripheral oxytocin levels were not associated with baseline PTSD symptom severity. Change in peripheral oxytocin levels did not differ by treatment condition and did not correspond to change in PTSD symptoms. CONCLUSIONS: This proof-of-concept study illustrates the acceptability and feasibility of measuring peripheral oxytocin among individuals engaged in psychotherapy for PTSD and informs the utilization of these procedures in future adequately powered studies.

The differential impact of nicotine replacement therapy sampling on cessation outcomes across established tobacco disparities groups.

Cigarette smoking is increasingly concentrated among marginalized populations with limited access to evidence-based cessation treatment. This includes racial/ethnic minorities, lower income individuals, those with lower educational attainment, and residents of rural areas. To reach Healthy People 2020 objectives, successful cessation interventions must narrow these disparities. Nicotine replacement therapy (NRT) sampling is an easily translatable and scalable intervention that could enhance treatment access and thus narrow disparities. The present study examined individual-level demographic moderators of the impact of NRT sampling on cessation-related behaviors including: 1) use of a cessation medication, 2) making a 24-hour quit attempt, 3) floating abstinence, and 4) 7-day point prevalence abstinence at 6-months. Study participants included N = 1245 adult smokers enrolled in the Tobacco Intervention in Primary Care Treatment Opportunities for Providers (TIP TOP) study, a recently concluded large-scale clinical trial of NRT sampling relative to standard care within 22 primary care clinics across South Carolina. Generalized linear models examined individual-level demographic moderators of treatment effect. Results suggest that NRT sampling may be more effective among some of the most disadvantaged groups of smokers, including smokers with lower income and education, as well those who live in more rural areas. The effects of NRT sampling did not differ by race. In sum, NRT sampling is a low-cost, low-burden intervention that could be disseminated broadly to reach large numbers of smokers and potentially narrow cessation disparities.

Impact of E-cigarette Sampling on Cigarette Dependence and Reinforcement Value.

INTRODUCTION: E-cigarettes have risen in prevalence in recent years, and most public health experts agree they deliver fewer toxicants than combustible tobacco products such as cigarettes. Thus, it is important to understand how use of e-cigarettes by current smokers impacts dependence on combustible cigarettes. METHODS: The present study is a secondary analysis of a randomized pilot trial of e-cigarette sampling. Nontreatment seeking current smokers were randomized in a 2:1 ratio to either receive or not receive a weekly supply of e-cigarettes for 3 weeks. Participants completed the Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM) scale and the cigarette purchase task before and after the sampling period and at monthly follow-up visits for 3 months. RESULTS: Individuals assigned to receive an e-cigarette had significantly lower mean WISDM scores at the end of sampling and the end of the follow-up period compared with those in the control group. Both frequency of e-cigarette use as well as nicotine concentration of the e-cigarette given to smokers were significant predictors of changes in the mean WISDM score. E-cigarette sampling significantly reduced the demand parameter Omax, which measures the maximum amount of money participants estimate they would spend on cigarettes in a single day. CONCLUSIONS: These data suggest that current smokers who try using an e-cigarette may experience reductions in dependence on combustible cigarettes. IMPLICATIONS: The present analysis suggests that providing an e-cigarette to current cigarette smokers is likely to reduce cigarette dependence, especially if the e-cigarette delivers sufficient nicotine and is used frequently.

The Impact of E-liquid Propylene Glycol and Vegetable Glycerin Ratio on Ratings of Subjective Effects, Reinforcement Value, and Use in Current Smokers.

INTRODUCTION: Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics that may affect reinforcement value and use. One characteristic is the ratio of two solvents commonly used in most e-liquids: propylene glycol (PG) and vegetable glycerin (VG). The goal of this study was to understand how PG/VG ratio affects subjective effects, reinforcement value, and tobacco use patterns among current smokers who try using ENDS. AIMS AND METHODS: Current smokers with minimal ENDS use history (n = 30) sampled, in a double-blind fashion, three different e-liquids that varied in PG/VG ratio (70/30, 50/50, 0/100) while holding constant other aspects of the e-liquid and ENDS. Participants tried each e-liquid before rating the subjective effects on a modified version of the Cigarette Evaluation Questionnaire. Reinforcement value was assessed using a preference task where participants chose between the three e-liquids. The impact of each e-liquid on cigarette reinforcement was assessed using a modified version of the Cigarette Purchase Task. Participants were randomly assigned to receive one e-liquid to take home for 1 week. RESULTS: PG/VG ratio had minimal impact on most of the tested outcomes. Participants rated the highest PG concentration as having a stronger "throat hit" than the other two. There was no significant difference between the number of participants who preferred each of the PG/VG ratios in the preference assessment. PG/VG ratio did not affect cigarette or ENDS use during the sampling week. CONCLUSIONS: These data suggest that PG/VG ratio has minimal impact on subjective effects and reinforcement value in ENDS naive current smokers. IMPLICATIONS: These data suggest that PG/VG ratio, within the range that is commonly used, has minimal impact on subjective effects, reinforcement value, or uptake in current smokers with minimal ENDS experience.

State Tobacco Excise Taxation, Comprehensive Smoke-free Air Laws, and Tobacco Control Appropriations as Predictors of Smoking Cessation Success in the United States.

The purpose of the present study was (1) to examine demographic differences between smokers who successfully quit (n = 1809), who relapsed (n = 6548), and who did not attempt to quit (n = 11 102) within the last year, and (2) to examine state-level tobacco policies/programs as predictors of quit success. Data were utilized from the 2014-2015 Tobacco Use Supplement to the Current Population Survey, which were paired with 2014 data on taxation, appropriations, and smoke-free air laws. As compared with smokers who relapsed, those who successfully quit were more likely to be white, married, more highly educated, of higher income, and heavier smokers. Compared with those who did not attempt to quit, those who attempted to quit, regardless of success, were younger and more likely to be Hispanic. State comprehensive smoke-free air laws and tobacco excise taxation significantly predicted quit success. Thus, expansions of these policies should be considered to promote successful quitting.

Using REDCap for ambulatory assessment: Implementation in a clinical trial for smoking cessation to augment in-person data collection.

BACKGROUND: The use of ambulatory assessment to study behavior and physiology in daily life is becoming more common, yet barriers to implementation remain. Limitations in budget, time, and expertise may inhibit development or purchase of dedicated ambulatory assessment software. Research Electronic Data Capture (REDCap) is widely used worldwide, offering a cost-effective and accessible option for implementing research studies. OBJECTIVES: To present a step-by-step guideline on how to implement ambulatory assessment using REDCap and provide preliminary evidence of feasibility. METHODS: Feasibility and acceptability data are presented for randomized participants (N ranged from 19 to 36, depending on analysis) from an ongoing 8-week smoking cessation pharmacological clinical trial (ClinicalTrials.gov Identifier: NCT02737358). Participants (N = 36; 50% female) completed up to three ambulatory assessment surveys per day, depending on the phase of the study. These included self-report and video confirmation of smoking biomarkers and medication adherence. RESULTS: Participants completed 74.8% of morning reports (86.6% for study completers), 73.8% of videos confirming smoking biomarkers, and 70.4% of videos confirming medication adherence. Study completers reported that the REDCap assessments were easy to use, and 78.9% of participants preferred the REDCap assessments to traditional, paper measures. CONCLUSIONS: These data from a pharmacological trial suggest feasibility of remote data collection using REDCap. As REDCap functionality is continually evolving, it is likely that options for collecting ambulatory assessment data via this platform will progressively improve allowing for greater individualization of assessment scheduling for enhancing data collection in clinical trials.

The Accuracy of Large Vessel Occlusion Recognition Scales in Telestroke Setting.

Introduction: A significant proportion of acute ischemic stroke (AIS) patients who are evaluated through telestroke consultation are transferred to thrombectomy-capable stroke centers (TSCs) for concern of large vessel occlusion (LVO). Patient triage selection is commonly based on the clinical suspicion of LVO, which lacks specificity and could result in unnecessary transfers. In this study, we aimed to assess the accuracy of the most commonly used LVO recognition scales in telestroke setting. Methods: AIS patients transferred to TSCs for suspicion of an LVO were included in this retrospective study. Patients were evaluated by a stroke neurologist through a telestroke consult before transfer. The National Institute of Health Stroke Scale (NIHSS) score documented by the stroke neurologist was retrieved from medical records and used to calculate five other LVO recognition scales (Rapid Arterial Occlusion Evaluation Scale [RACE], Field Assessment Stroke Triage for Emergency Destination [FAST-ED], Cincinnati Prehospital Stroke Severity Scale [CPSSS], 3-item stroke scale [3I-SS], and Prehospital Acute Stroke Severity Scale [PASS]). We calculated the sensitivity, specificity, accuracy, positive and negative predictive values, false positive rate (FPR), and false negative rate (FNR) of each score using published cutoffs and then examined all possible cutoff values for each of these scales in addition to the NIHSS. Results: A total of 439 patients were included in the final analysis. A total of 48.5% of patients had an LVO confirmed on computed tomography angiogram. RACE score had the highest accuracy (78%). Overall, the five derived LVO recognition scores have at least 10% FNR. When examining all possible cutoff values, the NIHSS (cutoff of 6) had a 3% FNR but 73% FPR (false transfer). Conclusion: The use of the NIHSS and other LVO recognition scores over telestroke may result in unnecessary transfers. Better diagnostic tools that could maximize sensitivity with acceptable specificity are urgently needed.

State Tobacco Policies as Predictors of Evidence-Based Cessation Method Usage: Results From a Large, Nationally Representative Dataset.

Introduction: Evidence-based cessation methods including nicotine replacement therapy (NRT), non-NRT medications, quitlines, and behavioral treatments are underutilized by smokers attempting to quit. Although a number of studies have demonstrated a relationship between state-level tobacco policies (eg, taxation, appropriations) and cessation, whether such state-level factors influence likelihood of using an evidence-based treatment is unclear. Accordingly, the aims of the present study were: (1) to describe evidence-based cessation method utilization by state and (2) to examine the effect of state-level factors on cessation method utilization above and beyond individual-level predictors. Methods: Data were utilized from the 2010-2011 Tobacco Use Supplement to the Current Population Survey (TUS-CPS). Participants included 9232 smokers who reported a past-year quit attempt. Data on 11 state-level predictors were collated from national datasets. Analyses were based on: (1) descriptive characterization of quit method usage, (2) logistic regression models to determine state-level factors as predictors of quit method utilization, controlling for individual-level predictors, (3) cluster analyses grouping states with similar state-level factors, and (4) examination of cluster as a predictor of cessation method. Results: Tobacco control appropriations significantly predicted NRT, quitline, and behavioral treatment utilization. Additional state-level factors that demonstrated significant relationships included Medicaid coverage of non-NRT medications and behavioral treatment, tobacco tax rate, smoking prevalence, and percentage of population uninsured. State clustering significantly predicted quit method across all four methods. Conclusions: State-level factors influence the likelihood of residents utilizing evidence-based quit methods. Results are discussed in terms of implications for tobacco policy at the state level. Implications: Results from the present study highlight state tobacco control appropriations as a robust predictor of evidence-based cessation method utilization. Other significant state-level predictors of evidence-based cessation method utilization included Medicaid coverage of non-NRT medications and behavioral treatment, tobacco tax rate, smoking prevalence, and percentage of population uninsured. Moreover, state-level predictors clustered together to significantly predict evidence-based cessation method utilization. Thus, increasing tobacco control appropriations, extending health insurance coverage, maximizing revenue from tobacco taxation and tobacco settlements, and ultimately decreasing smoking prevalence are important targets for individual states to promote utilization of evidence-based cessation methods.

Effect of time to initiation of postoperative radiation therapy on survival in surgically managed head and neck cancer.

BACKGROUND: The objective of this study was to determine the effects of National Comprehensive Cancer Network (NCCN) guideline-adherent initiation of postoperative radiation therapy (PORT) and different time-to-PORT intervals on the overall survival (OS) of patients with head and neck squamous cell carcinoma (HNSCC). METHODS: The National Cancer Data Base was reviewed for the period of 2006-2014, and patients with HNSCC undergoing surgery and PORT were identified. Kaplan-Meier survival estimates, Cox regression analysis, and propensity score matching were used to determine the effects of initiating PORT within 6 weeks of surgery and different time-to-PORT intervals on survival. RESULTS: This study included 41,291 patients. After adjustments for covariates, starting PORT >6 weeks postoperatively was associated with decreased OS (adjusted hazard ratio [aHR], 1.13; 99% confidence interval [CI], 1.08-1.19). This finding remained in the propensity score-matched subset (hazard ratio, 1.21; 99% CI, 1.15-1.28). In comparison with starting PORT 5 to 6 weeks postoperatively, initiating PORT earlier was not associated with improved survival (aHR for ≤ 4 weeks, 0.93; 99% CI, 0.85-1.02; aHR for 4-5 weeks, 0.92; 99% CI, 0.84-1.01). Increasing durations of delay beyond 7 weeks were associated with small, progressive survival decrements (aHR, 1.09, 1.10, and 1.12 for 7-8, 8-10, and >10 weeks, respectively). CONCLUSIONS: Nonadherence to NCCN guidelines for initiating PORT within 6 weeks of surgery was associated with decreased survival. There was no survival benefit to initiating PORT earlier within the recommended 6-week timeframe. Increasing durations of delay beyond 7 weeks were associated with small, progressive survival decrements. Cancer 2017;123:4841-50. © 2017 American Cancer Society.

The differential impact of state tobacco control policies on cessation treatment utilization across established tobacco disparities groups.

Tobacco control policies are effective in promoting quit attempts and increase the likelihood that smokers use evidence-based cessation treatments (e.g., nicotine replacement therapies (NRT), non-NRT medications, behavioral treatment, and/or quitlines). However, what is less clear is how these policies might differentially impact different groups of smokers, perhaps in some cases even widening disparities in the use of evidence-based tobacco dependence treatments. This paper examined how different state-level tobacco control policies impact the use of evidence-based cessation treatments by race/ethnicity, gender, socio-economic status (SES), age, and smoking history. Participants included 9110 adult smokers reporting a past-year quit attempt within the 2010-2011 Tobacco Use Supplement to the Current Population Survey. Lasso regression modeling was used to identify a subset of interactions between tobacco policies and individual smoker characteristics that predicted use of evidence-based cessation treatment. Significant interactions were fitted via participant-weighted generalized linear models to determine effect sizes and relations to each cessation treatment outcome. Results highlighted that various state level tobacco control policies differentially impacted the reported use of both prescription and non-prescription stop smoking medications by race/ethnicity, age, and SES. The relationship between state level tobacco control policies and the use of behavioral treatments and quitlines did not differ by smoker characteristics. In sum, tobacco control policies differentially impact the use of FDA approved stop smoking medications across different race/ethnicity, age, and SES groups. Understanding such effects can help to target interventions to ensure equal access to evidence-based tobacco dependence treatments.

One-Year Smoking Trajectories Among Established Adult Smokers With Low Baseline Motivation to Quit.

INTRODUCTION: The majority of smokers do not intend to quit in the near term, making unmotivated smokers a key group to target in public health efforts. Although it is often assumed that continuing smokers will have stable rates of smoking over time, limited research has addressed this issue, particularly among smokers not seeking treatment. In the current study, the aims were to (1) characterize the trajectory of naturalistic smoking among unmotivated smokers and (2) examine relationships between naturalistic smoking trajectories and other smoking-related variables. METHODS: The study sample comprised 579 control-group (ie, untreated) smokers within a parent clinical trial, who completed a total of nine assessments over 1 year. RESULTS: Trajectory modeling identified four smoking trajectory groups: stable (72%), shallow decreasers (20%), steep decreasers (5%), and increasers (3%). Membership in the decreasing groups was associated with higher motivation to quit, greater history of quit attempts, and higher cigarettes per day. Females were more likely to be in the increasing versus stable group. CONCLUSIONS: Findings provide needed information on stability and change in cigarette consumption over the course of 1 year among an untreated sample of smokers and identified baseline sociodemographic and smoking-related predictors of smoking trajectory group. Refining understanding of these groups is critical in updating population-based tobacco policy modeling efforts and informing cessation induction efforts that capitalize on naturalistic changes in smoking rate over time. IMPLICATIONS: In the current study, we found that approximately 25% of smokers who endorsed low quit motivation at baseline reduced their cigarette consumption over the course of a year, while 3% increased their cigarette consumption and the majority of smokers (72%) maintained a stable pattern. Refining understanding of smoking trajectories is critical in updating population-based tobacco policy modeling efforts and informing cessation induction efforts that capitalize on naturalistic changes in smoking rate over time.