Allison M. Glasser

Overview of Electronic Nicotine Delivery Systems: A Systematic Review

CONTEXT Rapid developments in e-cigarettes, or electronic nicotine delivery systems (ENDS), and the evolution of the overall tobacco product marketplace warrant frequent evaluation of the published literature. The purpose of this article is to report updated findings from a comprehensive review of the published scientific literature on ENDS. EVIDENCE ACQUISITION The authors conducted a systematic review of published empirical research literature on ENDS through May 31, 2016, using a detailed search strategy in the PubMed electronic database, expert review, and additional targeted searches. Included studies presented empirical findings and were coded to at least one of nine topics: (1) Product Features; (2) Health Effects; (3) Consumer Perceptions; (4) Patterns of Use; (5) Potential to Induce Dependence; (6) Smoking Cessation; (7) Marketing and Communication; (8) Sales; and (9) Policies; reviews and commentaries were excluded. Data from included studies were extracted by multiple coders (October 2015 to August 2016) into a standardized form and synthesized qualitatively by topic. EVIDENCE SYNTHESIS There were 687 articles included in this systematic review. The majority of studies assessed patterns of ENDS use and consumer perceptions of ENDS, followed by studies examining health effects of vaping and product features. CONCLUSIONS Studies indicate that ENDS are increasing in use, particularly among current smokers, pose substantially less harm to smokers than cigarettes, are being used to reduce/quit smoking, and are widely available. More longitudinal studies and controlled trials are needed to evaluate the impact of ENDS on population-level tobacco use and determine the health effects of longer-term vaping.

Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013-2014).

INTRODUCTION The 2009 Family Smoking Prevention and Tobacco Control Act banned characterizing flavors other than menthol in cigarettes but did not restrict their use in other forms of tobacco (e.g., smokeless, cigars, hookah, e-cigarettes). METHODS A cross-sectional analysis of Wave 1 data from 45,971 U.S. adults and youth, aged ≥12 years in the Population Assessment of Tobacco and Health (PATH) Study collected in 2013-2014, was conducted in 2016. This study examined (1) the prevalence and reasons for use of flavored tobacco products; (2) the proportion of ever tobacco users reporting that their first product was flavored; and (3) correlates of current flavored tobacco product use. RESULTS Current flavored (including menthol) tobacco product use was highest in youth (80%, aged 12-17 years); and young adult tobacco users (73%, aged 18-24 years); and lowest in older adult tobacco users aged ≥65 years (29%). Flavor was a primary reason for using a given tobacco product, particularly among youth. Eighty-one percent of youth and 86% of young adult ever tobacco users reported that their first product was flavored versus 54% of adults aged ≥25 years. In multivariable models, reporting that ones first tobacco product was flavored was associated with a 13% higher prevalence of current tobacco use among youth ever tobacco users and a 32% higher prevalence of current tobacco use among adult ever users. CONCLUSIONS These results add to the evidence base that flavored tobacco products may attract young users and serve as starter products to regular tobacco use.

How do we determine the impact of e-cigarettes on cigarette smoking cessation or reduction? Review and recommendations for answering the research question with scientific rigor

AIMS To propose a hierarchy of methodological criteria to consider when determining whether a study provides sufficient information to answer the question of whether e-cigarettes can facilitate cigarette smoking cessation or reduction. DESIGN A PubMed search to 1 February 2017 was conducted of all studies related to e-cigarettes and smoking cessation or reduction. SETTINGS Australia, Europe, Iran, Korea, New Zealand and the United States. PARTICIPANTS AND STUDIES 91 articles. MEASUREMENTS Coders organized studies according to six proposed methodological criteria: (1) examines outcome of interest (cigarette abstinence or reduction), (2) assesses e-cigarette use for cessation as exposure of interest, (3) employs appropriate control/comparison groups, (4) ensures that measurement of exposure precedes the outcome, (5) evaluates dose and duration of the exposure and (6) evaluates the type and quality of the e-cigarette used. FINDINGS Twenty-four papers did not examine the outcomes of interest. Forty did not assess the specific reason for e-cigarette use as an exposure of interest. Twenty papers did not employ prospective study designs with appropriate comparison groups. The few observational studies meeting some of the criteria (duration, type, use for cessation) triangulated with findings from three randomized trials to suggest that e-cigarettes can help adult smokers quit or reduce cigarette smoking. CONCLUSIONS Only a small proportion of studies seeking to address the effect of e-cigarettes on smoking cessation or reduction meet a set of proposed quality standards. Those that do are consistent with randomized controlled trial evidence in suggesting that e-cigarettes can help with smoking cessation or reduction.

Frequency of Youth E-Cigarette and Tobacco Use Patterns in the United States: Measurement Precision Is Critical to Inform Public Health.

Introduction E-cigarette use occurs with tobacco product use in youth. Methods Using the 2014 National Youth Tobacco Survey (NYTS), we examined past 30-day frequency of cigarette, cigar, smokeless, and e-cigarette use in the context of past 30-day and ever tobacco product use in US middle and high school students (N = 22 007). Frequency of product-specific use was examined by exclusive versus concurrent use with another product in the past 30 days (poly-use). Results In 2014, the majority (83%) of US middle and high school students had not used tobacco or e-cigarettes in the past 30 days. In the 9.3% of youth reporting any past 30-day e-cigarette use, 63% also reported using a tobacco product; among the 3.3% past 30-day exclusive e-cigarette users, about two-thirds (2.1%) had ever used combustible or non-combustible tobacco products and one-third (1.2%) had not. Few never tobacco users had used e-cigarettes on 10 or more days in the past month (absolute percent < 0.1%). Among past 30-day cigarette and smokeless users, the two highest frequency categories were 1-2 days and daily use; among past 30-day e-cigarette and cigar users, prevalence decreased with increasing frequency of use. The majority of past 30-day cigarette, cigar, smokeless, and e-cigarette users reported poly-use. Conclusions Prevalence estimates for a single product mask the complex patterns of frequency, temporality, and poly-use in youth. Two-thirds of past 30-day exclusive e-cigarette users have ever used tobacco. Poly-use is the dominant pattern of tobacco and e-cigarette use among US middle and high school students. Implications Our study highlights the complexity of tobacco use patterns in US middle and high school students. Future studies addressing the full public health impact of movement into or out of combustible tobacco use will require longitudinal data with appropriate measures of tobacco and e-cigarette product-specific use (eg, frequency and intensity), as well as adequate sample size and a sufficient number of waves to determine how use of individual products, like e-cigarettes, impact progression into or out of more stable patterns of tobacco and e-cigarette use.

Harm Minimization and Tobacco Control: Reframing Societal Views of Nicotine Use to Rapidly Save Lives

Inhalation of the toxic smoke produced by combusting tobacco products, primarily cigarettes, is the overwhelming cause of tobacco-related disease and death in the United States and globally. A diverse class of alternative nicotine delivery systems (ANDS) has recently been developed that do not combust tobacco and are substantially less harmful than cigarettes. ANDS have the potential to disrupt the 120-year dominance of the cigarette and challenge the field on how the tobacco pandemic could be reversed if nicotine is decoupled from lethal inhaled smoke. ANDS may provide a means to compete with, and even replace, combusted cigarette use, saving more lives more rapidly than previously possible. On the basis of the scientific evidence on ANDS, we explore benefits and harms to public health to guide practice, policy, and regulation. A reframing of societal nicotine use through the lens of harm minimization is an extraordinary opportunity to enhance the impact of tobacco control efforts.

Recommended core items to assess e-cigarette use in population-based surveys

A consistent approach using standardised items to assess e-cigarette use in both youth and adult populations will aid cross-survey and cross-national comparisons of the effect of e-cigarette (and tobacco) policies and improve our understanding of the population health impact of e-cigarette use. Focusing on adult behaviour, we propose a set of e-cigarette use items, discuss their utility and potential adaptation, and highlight e-cigarette constructs that researchers should avoid without further item development. Reliable and valid items will strengthen the emerging science and inform knowledge synthesis for policy-making. Building on informal discussions at a series of international meetings of 65 experts from 15 countries, the authors provide recommendations for assessing e-cigarette use behaviour, relative perceived harm, device type, presence of nicotine, flavours and reasons for use. We recommend items assessing eight core constructs: e-cigarette ever use, frequency of use and former daily use; relative perceived harm; device type; primary flavour preference; presence of nicotine; and primary reason for use. These items should be standardised or minimally adapted for the policy context and target population. Researchers should be prepared to update items as e-cigarette device characteristics change. A minimum set of e-cigarette items is proposed to encourage consensus around items to allow for cross-survey and cross-jurisdictional comparisons of e-cigarette use behaviour. These proposed items are a starting point. We recognise room for continued improvement, and welcome input from e-cigarette users and scientific colleagues.

Misperceptions of harm among Natural American Spirit smokers: results from wave 1 of the Population Assessment of Tobacco and Health (PATH) study (2013–2014)

Introduction This study estimated differences in cigarette harm perceptions among smokers of the Natural American Spirit (NAS) brand—marketed as ‘natural’, ‘organic’ and ‘additive-free’—compared to other smokers, and examined correlates of NAS use. Methods Data were drawn from wave 1 of the Population Assessment of Tobacco and Health (PATH) study, a nationally representative study of US adults (2013–2014). Weighted analyses using a subset of current adult smokers (n=10 565) estimated the prevalence of NAS use (vs all other brands) and examined associations between NAS use and sociodemographics, tobacco/substance use, tobacco harm perceptions, quit intentions, quit attempts and mental/behavioural health. Results Overall, 2.3% of adult smokers (920 000 people in the USA) reported NAS as their usual brand. Nearly 64% of NAS smokers inaccurately believed that their brand is less harmful than other brands compared to 8.3% of smokers of other brands, after controlling for potential confounders (aOR 22.82). Younger age (18–34 vs 35+; aOR 1.54), frequent thinking about tobacco harms (aOR 1.84), past 30-day alcohol use (aOR 1.57), past 30-day marijuana use (aOR 1.87) and sexual orientation (lesbian, gay, bisexual, ‘other’ or ‘questioning’ vs heterosexual; aOR 2.07) were also associated with increased odds of smoking NAS. Conclusions The majority of NAS smokers inaccurately believes that their cigarettes are less harmful than other brands. Given the brands rapid growth and its more common use in vulnerable groups (eg, young adults, lesbian, gay, bisexual, ‘other’ or ‘questioning’ adults), corrective messaging and enforcement action are necessary to correct harm misperceptions of NAS cigarettes.

Mathematical Modeling in Tobacco Control Research: Initial Results From a Systematic Review

OBJECTIVES The US Food and Drug Administration has expressed interest in using mathematical models to evaluate potential tobacco policies. The goal of this systematic review was to synthesize data from tobacco control studies that employ mathematical models. METHODS We searched five electronic databases on July 1, 2013 to identify published studies that used a mathematical model to project a tobacco-related outcome and developed a data extraction form based on the ISPOR-SMDM Modeling Good Research Practices. We developed an organizational framework to categorize these studies and identify models employed across multiple papers. We synthesized results qualitatively, providing a descriptive synthesis of included studies. RESULTS The 263 studies in this review were heterogeneous with regard to their methodologies and aims. We used the organizational framework to categorize each study according to its objective and map the objective to a model outcome. We identified two types of study objectives (trend and policy/intervention) and three types of model outcomes (change in tobacco use behavior, change in tobacco-related morbidity or mortality, and economic impact). Eighteen models were used across 118 studies. CONCLUSIONS This paper extends conventional systematic review methods to characterize a body of literature on mathematical modeling in tobacco control. The findings of this synthesis can inform the development of new models and the improvement of existing models, strengthening the ability of researchers to accurately project future tobacco-related trends and evaluate potential tobacco control policies and interventions. These findings can also help decision-makers to identify and become oriented with models relevant to their work.

Electronic nicotine delivery devices, and their impact on health and patterns of tobacco use: a systematic review protocol

Introduction E-cigarettes or electronic nicotine delivery systems (ENDS) have recently attracted considerable attention. Among some individuals there is strong debate and a polarisation of views about the public health benefits versus harms of ENDS. With little regulation, the ENDS market is evolving, and new products are introduced and marketed constantly. Rapid developments in manufacturing, marketing and consumer domains related to ENDS will warrant frequent re-evaluation, based on the state of the evolving science. The purpose of this article is to describe a protocol for an ongoing comprehensive review of the published scientific literature on ENDS. Methods and analysis We will undertake a systematic review of published empirical research literature on ENDS using the National Library of Medicines PubMed electronic database to search for relevant articles. Data from included studies will be extracted into a standardised form, tables with study details and key outcomes for each article will be created, and studies will be synthesised qualitatively. Ethics and dissemination This review synthesises published literature and presents no primary data. Therefore, no ethical approval is required for this study. Subsequent papers will provide greater detail on results, within select categories, that represent gaps in the literature base.

Mathematical modelling in tobacco control research: protocol for a systematic review.

Introduction Tobacco control researchers have recently become more interested in systems science methods and mathematical modelling techniques as a means to understand how complex inter-relationships among various factors translate into population-level summaries of tobacco use prevalence and its associated medical and social costs. However, there is currently no resource that provides an overview of how mathematical modelling has been used in tobacco control research. This review will provide a summary of studies that employ modelling techniques to predict tobacco-related outcomes. It will also propose a conceptual framework for grouping existing modelling studies by their objectives. Methods and analysis We will conduct a systematic review that is informed by Cochrane procedures, as well as guidelines developed for reviews that are specifically intended to inform policy and programme decision-making. We will search 5 electronic databases to identify studies that use a mathematical model to project a tobacco-related outcome. An online data extraction form will be developed based on the ISPOR-SMDM Modeling Good Research Practices. We will perform a qualitative synthesis of included studies. Ethics and dissemination Ethical approval is not required for this study. An initial paper, published in a peer-reviewed journal, will provide an overview of our findings. Subsequent papers will provide greater detail on results within each study objective category and an assessment of the risk of bias of these grouped studies.