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      Cohort study of electronic cigarette use: effectiveness and safety at 24 months

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          Abstract

          Objective

          To evaluate the safety and effectiveness of e-cigarettes, by comparing users of only e-cigarettes, smokers of only tobacco cigarettes and dual users.

          Design

          Prospective cohort study. We update previous 12-month findings and report the results of the 24-month follow-up.

          Data sources

          Direct contact and questionnaires by phone or via internet.

          Methods

          Adults (30–75 years) were classified as: (1) tobacco smokers, if they smoked ≥1 tobacco cigarette/day, (2) e-cigarette users, if they inhaled ≥50 puffs/week of any type of e-cigarette and (3) dual users, if they smoked tobacco cigarettes and also used e-cigarettes. Carbon monoxide levels were tested in 50% of those declaring tobacco smoking abstinence. Hospital discharge data were used to validate possibly related serious adverse events in 46.0% of the sample.

          Main outcome measures

          Sustained abstinence from tobacco cigarettes and/or e-cigarettes after 24 months, the difference in the number of tobacco cigarettes smoked daily between baseline and 24 months, possibly related serious adverse events.

          Results

          Data at 24 months were available for 229 e-cigarette users, 480 tobacco smokers and 223 dual users (overall response rate 68.8%). Of the e-cigarette users, 61.1% remained abstinent from tobacco (while 23.1% and 26.0% of tobacco-only smokers and dual users achieved tobacco abstinence). The rate (18.8%) of stopping use of either product (tobacco and/or e-cigarettes) was not higher for e-cigarette users compared with tobacco smokers or dual users. Self-rated health and adverse events were similar between all groups. Among those continuing to smoke, there were no differences in the proportion of participants reducing tobacco cigarette consumption by 50% or more, the average daily number of cigarettes and the average self-rated health by baseline group. Most dual users at baseline abandoned e-cigarettes and continued to smoke tobacco. Those who continued dual using or converted from tobacco smoking to dual use during follow-up experienced significant improvements in the 3 outcomes compared with those who continued or switched to only smoking tobacco (p<0.001).

          Conclusions

          E-cigarette use alone might support tobacco quitters remaining abstinent from smoking. However, dual use did not improve the likelihood of quitting tobacco or e-cigarette use, but may be helpful to reduce tobacco consumption. Adverse event data were scarce and must be considered preliminary.

          Trial registration number

          NCT01785537.

          Related collections

          Most cited references10

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          Logistic regression: a brief primer.

          Regression techniques are versatile in their application to medical research because they can measure associations, predict outcomes, and control for confounding variable effects. As one such technique, logistic regression is an efficient and powerful way to analyze the effect of a group of independent variables on a binary outcome by quantifying each independent variable's unique contribution. Using components of linear regression reflected in the logit scale, logistic regression iteratively identifies the strongest linear combination of variables with the greatest probability of detecting the observed outcome. Important considerations when conducting logistic regression include selecting independent variables, ensuring that relevant assumptions are met, and choosing an appropriate model building strategy. For independent variable selection, one should be guided by such factors as accepted theory, previous empirical investigations, clinical considerations, and univariate statistical analyses, with acknowledgement of potential confounding variables that should be accounted for. Basic assumptions that must be met for logistic regression include independence of errors, linearity in the logit for continuous variables, absence of multicollinearity, and lack of strongly influential outliers. Additionally, there should be an adequate number of events per independent variable to avoid an overfit model, with commonly recommended minimum "rules of thumb" ranging from 10 to 20 events per covariate. Regarding model building strategies, the three general types are direct/standard, sequential/hierarchical, and stepwise/statistical, with each having a different emphasis and purpose. Before reaching definitive conclusions from the results of any of these methods, one should formally quantify the model's internal validity (i.e., replicability within the same data set) and external validity (i.e., generalizability beyond the current sample). The resulting logistic regression model's overall fit to the sample data is assessed using various goodness-of-fit measures, with better fit characterized by a smaller difference between observed and model-predicted values. Use of diagnostic statistics is also recommended to further assess the adequacy of the model. Finally, results for independent variables are typically reported as odds ratios (ORs) with 95% confidence intervals (CIs). © 2011 by the Society for Academic Emergency Medicine.
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            A systematic review of health effects of electronic cigarettes.

            To provide a systematic review of the existing literature on health consequences of vaporing of electronic cigarettes (ECs). Search in: PubMed, EMBASE and CINAHL. Original publications describing a health-related topic, published before 14 August 2014. PRISMA recommendations were followed. We identified 1101 studies; 271 relevant after screening; 94 eligible. We included 76 studies investigating content of fluid/vapor of ECs, reports on adverse events and human and animal experimental studies. Serious methodological problems were identified. In 34% of the articles the authors had a conflict of interest. Studies found fine/ultrafine particles, harmful metals, carcinogenic tobacco-specific nitrosamines, volatile organic compounds, carcinogenic carbonyls (some in high but most in low/trace concentrations), cytotoxicity and changed gene expression. Of special concern are compounds not found in conventional cigarettes, e.g. propylene glycol. Experimental studies found increased airway resistance after short-term exposure. Reports on short-term adverse events were often flawed by selection bias. Due to many methodological problems, severe conflicts of interest, the relatively few and often small studies, the inconsistencies and contradictions in results, and the lack of long-term follow-up no firm conclusions can be drawn on the safety of ECs. However, they can hardly be considered harmless. Copyright © 2014. Published by Elsevier Inc.
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              • Article: not found

              The Impact of Trying Electronic Cigarettes on Cigarette Smoking by College Students: A Prospective Analysis.

              We assessed the impact of trying electronic cigarettes (e-cigarettes) on future cigarette smoking in a sample of smokers enrolled in college.
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                Author and article information

                Journal
                Tob Control
                Tob Control
                tobaccocontrol
                tc
                Tobacco Control
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0964-4563
                1468-3318
                May 2017
                6 June 2016
                : 26
                : 3
                : 284-292
                Affiliations
                [1 ]Department of Medicine and Aging Sciences, University of Chieti , Chieti, Italy
                [2 ]Local Health Unit of Pescara, Pescara, Italy
                [3 ]“University G. d'Annunzio” Foundation , Chieti, Italy
                [4 ]Regional Healthcare Agency of Abruzzo , Pescara, Italy
                [5 ]Department “G. F. Ingrassia”—Hygiene and Public Health, University of Catania , Catania, Italy
                [6 ]Department of Clinical Sciences and Community Health, University of Milan , Milan, Italy
                [7 ]Department of Public Health Sciences, University of Turin , Turin, Italy
                [8 ]Italian National Institute of Health , Rome, Italy
                [9 ]Institute of Public Health, Università Cattolica del Sacro Cuore, Rome, Largo Francesco Vito , Roma, Italy
                [10 ]Department of Public Health and Infectious Diseases, Sapienza University of Rome , Roma, Italy
                Author notes
                [Correspondence to ] Dr Lamberto Manzoli, Palazzina di Odontoiatria, University of Chieti, Via dei Vestini 5, Chieti 66100, Italy; lmanzoli@ 123456post.harvard.edu

                LM and MEF equally contributed to the present study.

                Article
                tobaccocontrol-2015-052822
                10.1136/tobaccocontrol-2015-052822
                5520273
                27272748
                596c77a6-5098-4410-ac6e-dd26f54ceb78
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 11 November 2015
                : 19 April 2016
                Categories
                1506
                Research Paper
                Custom metadata
                unlocked

                Public health
                electronic nicotine delivery devices,cessation,harm reduction
                Public health
                electronic nicotine delivery devices, cessation, harm reduction

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