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Venous thromboembolism (VTE) with concurrent thrombocytopenia is frequently encountered in patients with cancer. Therapeutic anticoagulation in the setting of thrombocytopenia is associated with a high risk of hemorrhage. Retrospective analyses suggest the utility of modified-dose anticoagulation in this population. To assess the incidence of hemorrhage or thrombosis according to anticoagulation strategy, we performed a prospective, multicenter, observational study. Patients with active malignancy, acute VTE, and concurrent thrombocytopenia (platelet count <100 000/µL) were enrolled. The cumulative incidences of hemorrhage or recurrent VTE were determined considering death as a competing risk. Primary outcomes were centrally adjudicated and comparisons made according to initial treatment with full-dose or modified-dose anticoagulation. A total of 121 patients were enrolled at 6 hospitals. Seventy-five patients were initially treated with full-dose anticoagulation (62%) and 33 (27%) with modified-dose anticoagulation; 13 (11%) patients received no anticoagulation. Most patients who received modified-dose anticoagulation had a hematologic malignancy (31 of 33 [94%]) and an acute deep vein thrombosis (28 of 33 [85%]). In patients who initially received full-dose anticoagulation, the cumulative incidence of major hemorrhage at 60 days was 12.8% (95% confidence interval [CI], 4.9-20.8) and 6.6% (95% CI, 2.4-15.7) in those who received modified-dose anticoagulation (Fine-Gray hazard ratio, 2.18; 95% CI, 1.21-3.93). The cumulative incidence of recurrent VTE at 60 days in patients who initially received full-dose anticoagulation was 5.6% (95% CI, 0.2-11) and 0% in patients who received modified-dose anticoagulation. In conclusion, modified-dose anticoagulation appears to be a safe alternative to therapeutic anticoagulation in patients with cancer who develop deep vein thrombosis in the setting of thrombocytopenia.

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OBJECTIVE: The WHO Framework Convention on Tobacco Control and its Guidelines recommend nations ban the use of misleading terms, such as 'light' and 'mild' on tobacco product advertising, packaging and labelling. Many nations, including the USA, have implemented such bans and some have introduced or passed legislation requiring plain packaging on tobacco products. We previously reported that manufacturers in the USA responded by replacing lights terms with colour terms and related colour-coding of packages. This study examines population outcomes and public health impact of the US ban. METHODS: We examined available data regarding a) per cent filter ventilation strata used to designate lights subbrand categories; b) market share per tar yield; c) initiation and use of cigarettes by lights categories and d) overall cigarette consumption to identify changes from before to after the ban. We used interrupted time series multivariable logistic regression and joinpoint regression models to test for changes in rates and temporal trends associated with the ban. RESULTS: The per cent filter ventilation strata used to designate lights subbrand categories were maintained in the colour named subbrands. No change was observed following the ban in lights market share, relative prevalence of lights versus non-lights smoking or relative smoking initiation on lights versus non-lights among all ages or among youth in particular. The rate of decline in per capita cigarette consumption slowed by 37% from the period 2007-2010 to 2010-2014. CONCLUSIONS: This study strongly suggests that manufacturers' circumvention prevented the lights descriptor ban from succeeding as intended, most likely perpetuating the misleading consumer perceptions about relative risks, while failing to increase smoking cessation and reduce initiation. Laws requiring generic (plain) and elimination of subbrand descriptors should prevent evasion of legislation banning the use of specific terms through marketing, regulatory and legal challenges.

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The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 creates the first national system of premarket regulation of tobacco products in American history. The FDA must now review and give marketing authorization to all new tobacco products, based on a public health standard, before they can be legally marketed. Yet the law also contains an alternative pathway for market entry-the substantial equivalence (SE) clause-by which novel and altered tobacco products can be marketed by demonstrating their substantial equivalence to existing products. Over 99 percent of tobacco product applications sent to the FDA under the new law have used this mechanism, and loose application of the SE mechanism carries the risk of undoing the FDA's gatekeeping power under the law. We review the statutory and regulatory precedent for SE, examining the FSPTCA itself as well as regulatory precedent from drug and device regulation (from which the term substantial equivalence and much of the associated statutory language was derived). Our review of standards and scientific precedent demonstrates that exacting scrutiny under the public health standard should govern all SE reviews and that clinical data incorporating social scientific evidence should be routinely required for SE claims by tobacco product sponsors.

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BACKGROUND: Nicotine is known as the drug that is responsible for the addicted behaviour of tobacco users, but it has poor reinforcing effects when administered alone. Tobacco product design features enhance abuse liability by (A) optimising the dynamic delivery of nicotine to central nervous system receptors, and affecting smokers' withdrawal symptoms, mood and behaviour; and (B) effecting conditioned learning, through sensory cues, including aroma, touch and visual stimulation, to create perceptions of pending nicotine reward. This study examines the use of additives called 'pyrazines', which may enhance abuse potential, their introduction in 'lights' and subsequently in the highly market successful Marlboro Lights (Gold) cigarettes and eventually many major brands. METHODS: We conducted internal tobacco industry research using online databases in conjunction with published scientific literature research, based on an iterative feedback process. RESULTS: Tobacco manufacturers developed the use of a range of compounds, including pyrazines, in order to enhance 'light' cigarette products' acceptance and sales. Pyrazines with chemosensory and pharmacological effects were incorporated in the first 'full-flavour, low-tar' product achieving high market success. Such additives may enhance dependence by helping to optimise nicotine delivery and dosing and through cueing and learned behaviour. CONCLUSIONS: Cigarette additives and ingredients with chemosensory effects that promote addiction by acting synergistically with nicotine, increasing product appeal, easing smoking initiation, discouraging cessation or promoting relapse should be regulated by the US Food and Drug Administration. Current models of tobacco abuse liability could be revised to include more explicit roles with regard to non-nicotine constituents that enhance abuse potential.

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BACKGROUND: Electronic cigarettes (e-cigarettes) represent an emerging public health issue. These devices deliver nicotine along with other constituents, including flavorants, via an inhalable aerosol. Their uptake is rapidly increasing in both adults and youths, primarily among current smokers. Public debate is increasing on how these devices should be regulated and used, yet only limited peer-reviewed research exists. To develop a informed policy for e-cigarettes, their effects on human behavior, physiology, and health need to be understood. PURPOSE: This paper describes proceedings from a National Institutes of Health-sponsored workshop, which was held in November 2013, to identify research needs related to the effects of e-cigarettes. Discussion topics included e-cigarette risks and abuse potential; the potential role for e-cigarettes in harm reduction and smoking cessation; unintended consequences of e-cigarette use, such as becoming a gateway to conventional cigarettes; and dual use of both e-cigarettes and conventional cigarettes. RESULTS AND CONCLUSIONS: The research needs identified by the workshop participants included the following: standards to measure the contents and emissions of e-cigarettes; biomarkers of exposure; physiological effects of e-cigarettes on tissues and organ systems, including pulmonary and cardiovascular; information on e-cigarette users, how the devices are used, and identification of the best tools to assess these measures; factors that drive use and influence patterns of use; and appropriate methods for evaluating a potential role for e-cigarettes in smoking or nicotine cessation. To understand fully the challenges and the opportunities that e-cigarettes represent, expertise will be needed in basic, behavioral, translational, and clinical sciences.

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OBJECTIVE: The aim of this study is to describe trends in the consumption of manufactured and roll-your-own cigarettes between 1991 and 2012 in Spain, and to project these trends up to 2020. METHODS: We estimated daily consumption per capita during 1991-2012 using data on sales of manufactured cigarettes (20-packs) and rolling tobacco (kg) from the Tobacco Market Commission, and using data of the Spanish adult population from the National Statistics Institute. We considered different weights (0.5, 0.8 and 1 g) to compute the number of rolled cigarettes per capita. We computed the annual per cent of change and assessed possible changes in trends using joinpoint regression, and projected the consumption up to 2020 using Bayesian methods. RESULTS: Daily consumption per capita of manufactured cigarettes decreased on average by 3.0% per year in 1991-2012, from 7.6 to 3.8 units, with three trend changes. However, daily consumption per capita of roll-your-own cigarettes increased on average by 14.1% per year, from 0.07 to 0.92 units of 0.5 g, with unchanged trends. Together, daily consumption per capita decreased between 2.9% and 2.5%, depending on the weight of the roll-your-own cigarettes. Projections up to 2020 indicate a decrease of manufactured cigarettes (1.75 units per capita) but an increase of roll-your-own cigarettes (1.25 units per capita). CONCLUSIONS: While the consumption per capita of manufactured cigarettes has decreased in the past years in Spain, the consumption of roll-your-own cigarettes has increased at an annual rate around 14% over the past years. Whereas a net decrease in cigarette consumption is expected in the future, use of roll-your-own cigarettes will continue to increase.

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BACKGROUND: Currently, there is an intensive debate about the regulation of the use of electronic cigarettes (e-cigarettes) in indoor places. The aim of this study was to assess the attitudes toward e-cigarette use in indoor workplaces and selected public and private venues among the general population in Barcelona (Spain) in 2013-2014. METHODS: This is a cross-sectional study of a representative sample of the population of Barcelona (n = 736). The field work was conducted between May 2013 and February 2014. We computed the prevalence and the adjusted odds ratios (OR) derived from multivariable logistic regression models. RESULTS: The awareness of e-cigarettes was 82.3%. Forty five percent of respondents did not agree with the use of e-cigarettes in public places and 52.3% in workplaces. The proportion of disapproval of the use of e-cigarettes in indoor places was higher at 71.5% for schools and 65.8% for hospitals and health care centers; while the prevalence of disapproval of e-cigarette use in homes and cars was lower (18.0% and 32.5%, respectively). Respondents who disagreed on the use of e-cigarettes in indoor workplaces were more likely to be older (OR = 1.64 and 1.97 for groups 45-64 and ≧65 years old, respectively), those with a high educational level (OR = 1.60), and never and former smokers (OR = 2.34 and 2.16, respectively). Increased scores in the Fagerström test for cigarette dependence were also related to increased support for their use. CONCLUSIONS: Based on this population based study, half of the general population of Barcelona does not support the use of e-cigarettes in indoor workplaces and public places, with the percentage reaching 65% for use in schools, hospitals and health care centers. Consequently, there is good societal support in Spain for the politicians and legislators to promote policies restricting e-cigarettes use in workplaces and public places, including hospitality venues.

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OBJECTIVE: This study seeks to analyse the prevalence and correlates of electronic cigarette (e-cigarette) use, purchase location and satisfaction with its use in a sample of the general population of the city of Barcelona, Spain. DESIGN, SETTING AND PARTICIPANTS: We used participants from a longitudinal study of a representative sample of the adult (≥16 years old) population of Barcelona (336 men and 400 women). The field work was conducted between May 2013 and February 2014. We computed the prevalence, adjusted odds ratios (ORs) and their corresponding 95% confidence interval (CI). RESULTS: The prevalence of ever e-cigarette use was 6.5% (95% CI 4.7% to 8.3%): 1.6% current use, 2.2% past use and 2.7% only e-cigarette experimentation. 75% (95% CI 62.8% to 87.3%) of ever e-cigarette users were current cigarette smokers at the moment of the interview. E-cigarette use was more likely among current smokers (OR=54.57; 95% CI 7.33 to 406.38) and highly dependent cigarette smokers (OR=3.96; 95% CI 1.60 to 9.82). 62.5% of the ever users charged their e-cigarettes with nicotine with 70% of them obtaining the liquids with nicotine in a specialised shop. 39.6% of ever e-cigarette users were not satisfied with their use, a similar percentage of not satisfied expressing the smokers (38.9%) and there were no statistically significant differences in the satisfaction between the users of e-cigarettes with and without nicotine. CONCLUSIONS: E-cigarette use is strongly associated with current smoking (dual use) and most users continue to be addicted to nicotine. Six out of 10 e-cigarette users preferred devices that deliver nicotine. The satisfaction with e-cigarette use is very low.

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Platelets have a newly appreciated and important role in many cancer-related processes, including tumor growth and metastases, angiogenesis, and promotion of a hypercoagulable state. Cancer patients commonly experience venous thromboembolism (VTE), a leading cause of mortality and a source of considerable morbidity and cost. The role of platelets in arterial thrombosis is well established, but emerging evidence supports the concept that platelets are also involved in initiation of VTE. This is particularly true in cancer-associated thrombosis as extensive new evidence shows that thrombocytosis and platelet activation are predictive biomarkers of VTE. The role of therapeutic anti-platelet agents has been proven effective at preventing VTE in non-cancer patients, and there are early data suggesting benefit in cancer patients as well. This review summarizes platelet-related predictive biomarkers of cancer-associated thrombosis, platelet-mediated mechanisms for VTE promotion in cancer patients, and anti-platelet agents in prevention of VTE.

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PURPOSE: Hospitalized patients with cancer are considered to be at high risk for venous thromboembolism (VTE). Despite strong recommendations in numerous clinical practice guidelines, retrospective studies have shown that pharmacologic thromboprophylaxis is underutilized in hospitalized patients with cancer. PATIENTS AND METHODS: We conducted a prospective, cross-sectional study of hospitalized patients with cancer at five academic hospitals to determine prescription rates of thromboprophylaxis and factors influencing its use during hospitalization. RESULTS: A total of 775 patients with cancer were enrolled across five academic medical centers. Two hundred forty-seven patients (31.9%) had relative contraindications to pharmacologic prophylaxis. Accounting for contraindications to anticoagulation, the overall rate of pharmacologic thromboprophylaxis was 74.2% (95% CI, 70.4% to 78.0%; 392 of 528 patients). Among the patients with cancer without contraindications for anticoagulation, individuals hospitalized with nonhematologic malignancies were significantly more likely to receive pharmacologic thromboprophylaxis than those with hematologic malignancies (odds ratio [OR], 2.34; 95% CI, 1.43 to 3.82; P=.007). Patients with cancer admitted for cancer therapy were significantly less likely to receive pharmacologic thromboprophylaxis than those admitted for other reasons (OR, 0.37; 95% CI, 0.22 to 0.61; P<.001). Sixty-three percent of patients with cancer classified as low risk, as determined by the Padua Scoring System, received anticoagulant thromboprophylaxis. Among the 136 patients who did not receive anticoagulation, 58.8% were considered to be high risk by the Padua Scoring System. CONCLUSION: We conclude that pharmacologic thromboprophylaxis is frequently administered to hospitalized patients with cancer but that nearly one third of patients are considered to have relative contraindications for prophylactic anticoagulation. Pharmacologic thromboprophylaxis in hospitalized patients with cancer is commonly prescribed without regard to the presence or absence of concomitant risk factors for VTE.

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INTRODUCTION: The concurrent use of multiple tobacco products (i.e., poly-tobacco use) might hinder efforts to reduce overall tobacco use, particularly considering that use of some non-cigarette tobacco products may be popular in some regions due to social, cultural, or economic reasons. This study assessed poly-tobacco use patterns among persons aged ≥15 years old from 44 countries. METHODS: Data from 44 countries in all six World Health Organization regions were obtained from the 2008 to 2012 Global Adult Tobacco Surveys (n=19 countries), and the Special Eurobarometer 385 (77.1) survey, 2012 (n=25 countries). Correlates of poly-tobacco use were assessed using multivariate logistic regression analyses (p<0.05). RESULTS: Overall prevalence of poly-tobacco use ranged from 0.8% (Mexico) to 11.9% (Denmark). In 28 countries, 20% or more of current smokers of manufactured cigarettes concurrently used at least one other tobacco product and this proportion was highest in India (66.2%) and lowest in Argentina (4.4%). After adjusting for other factors, the likelihood of being a poly-tobacco user among all respondents was lower among females (aOR=0.09; 95% CI: 0.08-0.11), and among respondents from upper-middle-income (aOR=0.53, 95% CI: 0.43-0.66), and lower-middle-income countries (aOR=0.64; 95% CI: 0.51-0.81) compared to high-income countries. Increased likelihood of poly-tobacco use was observed among respondents from the South-East Asian region compared to those from the European region (aOR=1.58, 95% CI: 1.35-1.85), as well as among respondents aged ≥65 years (aOR=2.10; 95% CI: 1.73-2.54), compared to those aged <25 years. CONCLUSIONS: The pattern of tobacco use varied widely, underscoring the need for intensified efforts towards implementing policies that address all tobacco products, not only manufactured cigarettes.

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BACKGROUND: Economic crises may have a significant impact on public health. The objective of this study was to assess trends in health-related behaviours and cardiovascular risk factors within Greece before, at the beginning and during the current financial crisis by comparing data from three waves of the Greek cross-sectional household 'Hellas Health' surveys. METHODS: Data from three waves were analysed. The first wave was conducted in 2006 (n = 1005), the second in 2008 (n = 1490) and the third in 2011 (n = 1008). Samples were representative of the Greek adult population in terms of age and residency. Smoking status, height, weight and fruit and vegetable consumption were self-reported. Physical activity levels were assessed with the International Physical Activity Questionnaire. RESULTS: The prevalence of smoking in Greece decreased from 42.6 to 38.1% during the crisis period 2008-11 (P = 0.026), but not during 2006-8. The prevalence of high levels of physical activity increased among Greek adults (from 21.9 to 31.7%, P < 0.001) in all socio-economic and demographic groups, with the exception of the highest socio-economic status (SES) group. On the contrary, the consumption of at least five portions of fruit and vegetables per day significantly decreased during the crisis among those of lower SES (from 9.0 to 4.1%, P = 0.006). Prevalence of obesity did not show significant trends. CONCLUSIONS: During the economic crisis, fruit and vegetable consumption alarmingly decreased, especially among those of lower SES, whereas trends in smoking prevalence and physical activity levels seem favourable. These results indicate that the economic crisis may unequally impact cardiovascular risk factors among different socio-economic groups.

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OBJECTIVES: This study aimed to measure the 5-year progress in the implementation of WHO Framework Convention on Tobacco Control (FCTC) in Armenia by applying the Tobacco Control Scale, a rapid assessment tool developed to assess the strength of tobacco control policies in Europe. SETTING: Armenia, an economy in transition, has extreme smoking rates among men (62.5%) despite acceding to FCTC in 2004. However, little research has been carried out to evaluate Armenia's progress in tobacco control. METHODS: The Tobacco Control Scale total score was estimated for Armenia using the original methodology; however, a different source of data was used in estimating the subscores on tobacco price and tobacco control spending. RESULTS: Armenia's total score on Tobacco Control Scale has considerably improved from 2005 to 2009, mostly due to larger health warnings and advertising ban, and increased public spending on tobacco control. The scores for smoke-free public places, advertising ban, health warnings and treatment categories were below the European average in 2005 and 2007, while the price score was higher. Neither total tobacco control score nor any of its components showed a significant predictive value in a simple regression analysis using the total score and subscores as predictors for log-transformed per capita tobacco consumption. CONCLUSIONS: Higher than the European average price score for Armenia cannot be explained by the concept of affordability alone and may reflect a measurement error due to peculiarities of transition economies. The applicability of the Tobacco Control Scale could be limited to countries with mature economies, but not to transition countries such as Armenia with different social, political and economic environment. The scale modification, such as an adjustment for the policy enforcement and the effectiveness of public tobacco control spending along with alternative measures of affordability would be warranted to enhance its applicability in low-income and middle-income countries.

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INTRODUCTION: The 2009 Family Smoking Prevention and Tobacco Control Act prohibited the use of characterizing flavors in cigarettes; however, some of these flavors are still used in cigarettes at varying levels. We reviewed tobacco industry internal documents to investigate the role of one of these flavors, cocoa, with the objective of understanding its relationship to sensory and risk perception, promotion of dependence, and enhancement of attractiveness and acceptability. METHODS: We used the Legacy Tobacco Documents Library to identify documents relevant to our research questions. Initial search terms were generated following an examination of published literature on cocoa, other cigarette additives, and sensory and risk perception. Further research questions and search terms were generated based on review of documents generated from the initial search terms. RESULTS: Cocoa is widely applied to cigarettes and has been used by the tobacco industry as an additive since the early 20th century. Cocoa can alter the sensory properties of cigarette smoke, including by providing a more appealing taste and decreasing its harshness. The tobacco industry has experimented with manipulating cocoa levels as a means of achieving sensory properties that appeal to women and youth. CONCLUSIONS: Although cocoa is identified as a flavor on tobacco industry Web sites, it may serve other sensory purposes in cigarettes as well. Eliminating cocoa as an additive from tobacco products may affect tobacco product abuse liability by altering smokers' perceptions of product risk, and decreasing product appeal, especially among vulnerable populations.

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OBJECTIVES: We evaluated the Massachusetts Fire Safe Cigarette Law's (FSCL's) effectiveness in preventing residential fires. METHODS: We examined unintentional residential fires reported to the Massachusetts Fire Incident Reporting System from 2004 to 2010. We analyzed FSCL effect on the likelihood of cigarette- versus noncigarette-caused fires and effect modification by fire scenario factors by using an interrupted time series regression model. We analyzed the effect of FSCL on monthly fire rates with Poisson regression. RESULTS: Cigarettes caused 1629 unintentional residential fires during the study period. The FSCL was associated with a 28% (95% confidence interval = 12%, 41%) reduction in the odds of cigarette- versus noncigarette-caused fires, although not in analyses restricted to casualty fires, with smaller sample size. The largest reductions were among fires in which human factors were involved; that were first ignited on furniture, bedding, or soft goods; that occurred in living areas; or that occurred in the summer or winter. CONCLUSIONS: The FSCL appears to have decreased the likelihood of cigarette-caused residential fires, particularly in scenarios for which the ignition propensity standard was developed. Current standards should be adopted, and the need for strengthening should be considered.

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BACKGROUND: Cigarette rod length as a design feature may play a specific role in harm perception and tobacco use. Internal tobacco industry documents have shown targeting of females with long/ultra-long cigarettes. This study assessed trends and differences in smoking of long/ultra-long cigarettes among U.S. smokers aged ≥20 years during 1999 through 2012. METHODS: Data were obtained from the 1999/2000 through 2011/2012 National Health and Nutrition Examination Survey. The proportion of current smokers who reported using long/ultra-long cigarettes during each survey year was calculated and compared using χ(2) statistics. Linear and quadratic trends during 1999 through 2012 were assessed using binary logistic regression (p<0.05). Multi-variable analyses were performed to assess current disparities in smoking of long/ultra-long cigarettes. RESULTS: Despite overall declines in current smoking of long/ultra-long cigarettes during the 1999 through 2012 period (p<0.001 for both linear and quadratic trends), the proportion of smokers of long/ultra-long brands increased in recent years, with over a third (38.7%) of current smokers reporting smoking of long/ultra-long cigarettes during 2011/2012. Current smokers of long/ultra-long cigarettes were more likely to be female compared to males (aOR=3.09; 95%CI: 2.09-4.58), of black race compared to whites (aOR=2.07; 95%CI: 1.30-3.28), or aged 45-64, or ≥65 years (aOR=2.39 and 5.27, respectively), compared to 18-24 year olds. CONCLUSIONS: Specific gender, age and race/ethnic characteristics of smokers of long/ultra-long cigarettes were noted, hence potentially contributing to the widening of health disparities. Cigarette rod length should be considered an important aspect of cigarette engineering/design in regulatory efforts to reduce the burden of tobacco-related disease.

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This study assessed differences among health professions students in exposure to didactic tobacco cessation training in asking about patients' tobacco use status ("ask") and assisting smoking patients to quit by providing educational materials ("assist"). Data from the 2005-08 Global Health Professions Student Survey were analyzed for 28,420 medical, dental, nursing, and pharmacy students in eight low- and middle-income countries. Country-specific prevalence of exposure to training in tobacco cessation was calculated for each profession category; differences were assessed using logistic regression analysis (p<0.05). The proportion of dental students taught to implement the "ask" intervention ranged from 45.4 percent (Armenia) to 95.2 percent (Chile). Only about one-third of these dental students reported being taught to implement the "assist" intervention in most countries. After adjusting for survey year, country, gender, and tobacco use, the odds of dental students' being taught to implement the "ask" intervention were lower than for medical students (adjusted odds ratio [aOR]=0.63; 95% CI: 0.42-0.96). Similarly, the odds of being taught to implement the "assist" intervention were significantly higher for medical (aOR=1.65; 95% CI: 1.26-2.17), nursing (aOR=2.84; 95% CI: 2.37-3.40), and pharmacy students (aOR=1.36; 95CI:1.05-1.76) than for dental students. These findings underscore the need for enhanced measures to incorporate tobacco cessation training as a formal component of dental education globally.

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