Development, validation and application of a device to measure e-cigarette users' puffing topography.
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ABSTRACT:
SUBMITTER: Cunningham A
PROVIDER: S-EPMC5056340 | biostudies-literature | 2016 Oct
REPOSITORIES: biostudies-literature
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Development, validation and application of a device to measure e-cigarette users' puffing topography.
Cunningham Anthony A Slayford Sandra S Vas Carl C Gee Jodie J Costigan Sandra S Prasad Krishna K
Scientific reports 20161010
With the rapidly rising popularity and substantial evolution of electronic cigarettes (e-cigarettes) in the past 5-6 years, how these devices are used by vapers and consumers' exposure to aerosol emissions need to be understood. We used puffing topography to measure directly product use. We adapted a cigarette puffing topography device for use with e-cigarettes. We performed validation using air and e-cigarette aerosol under multiple regimes. Consumer puffing topography was measured for 60 vaper ...[more]
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Project description:Objectives:The aim of this study was to examine puffing behavior and topography over 24 hours among regular electronic cigarette (e-cigarette) users. Methods:Twenty-four adult e-cigarette users (15 male) vaped their personal e-cigarettes ad-lib over the course of 24 hours. Participants took each puff via calibrated CReSS pocket topography monitors. We analyzed: number of puffs per day per session, mean puff volume, mean puff flow rate, mean duration of puff, and mean interval between puffs. Results:Over 24 hours participants took on average 156.2±10.3 puffs, clustered in 10.2±7.9 puffs per puffing session with an average puff interval of 15.4±22.0 sec. A single puff lasted on average 3.0±1.2 sec, had a volume of 73.4±51.5 ml, and was taken with the average flow rate of 24.7±10.2 ml/sec. Conclusions:There is substantial variability among e-cigarette users in the way they puff on these devices. When e-cigarette aerosol is generated for laboratory studies, there is a need for validated puffing protocols that not only reflects the most-common pattern but also intensive puffing behaviors observed among some e-cigarette users.
| S-EPMC6377077 | biostudies-literature
Project description:IntroductionBehavioral economic purchase tasks are used to estimate the reinforcing value of drugs by asking participants how much they would purchase across a range of increasing prices. We sought to validate such a task for e-cigarettes in experienced users of advanced generation, tank-style devices.MethodsDual users of cigarettes and e-cigarettes (N = 54) and exclusive e-cigarette users (N = 59) attended one session during which they completed assessments including two versions of the E-cigarette Purchase Task: one that asked how many puffs of their e-cigarette they would purchase in 24 hours at varying prices and one that asked how many mLs of e-liquid they would purchase. We correlated purchase task outcomes with other measures of e-cigarette use. We also compared the tasks across dual and exclusive users.ResultsIndices derived from the mLs-based task were more likely to be correlated with self-reported use rates, e-cigarette dependence, and cotinine levels than the puffs-based task. Exclusive users showed greater demand on than dual users only on the mLs version when using an F-test comparison method, while multivariate analysis of variance (MANOVA) results showed that dual users showed greater demand only on the puffs task.ConclusionsResults indicate that the mLs version had greater validity than the puffs version in terms of clinical indices. Dual users may still be on a trajectory to fully switching to e-cigarettes; thus, puffs as a measure may be more intuitive, as this measure is shared by cigarettes and e-cigarettes. For exclusive users, the unit they purchase their e-liquid in may be the most relevant unit and better capture their demand for that product.ImplicationsBehavioral economic purchase tasks have been widely used to understand nicotine use. We have developed two versions of a purchase task for e-cigarette use and compared the two versions in users of advanced generation e-cigarette devices. We found that the mLs version of the task better-reflected use patterns relative to a puffs version, which suggests that participants struggle to place monetary value on a unit of consumption (ie, puffs). Validated measures of e-cigarette reinforcement will be important as researchers and regulators determine which features of these products contribute to reinforcing efficacy.
| S-EPMC7542643 | biostudies-literature
Project description:Actual use studies play a key part in evaluating the reduced risk potential of tobacco and nicotine products. This study was undertaken to determine the puffing topography, mouth level exposure (MLE) and average daily consumption (ADC) relating to two commercially available tobacco heating products (THPs) and a prototype electronic cigarette (or e-cigarette) among Italian non-mentholated 7 mg ISO tar cigarette smokers. The study was conducted in Milan, Italy, with three groups of approximately 50 participants. Groups 1 and 3 included adult smokers of 7 mg ISO tar tobacco cigarettes, and Group 2 consisted of both solus vapers and dual users of vapour and tobacco products. Amongst smokers, e-cigarette mean puff volumes (41.6 mL vs 41.3 mL) and mean puff durations (1.4 s vs 1.5 s) were similar to that of the cigarette, although the average usage session was significantly longer (1064.8 s vs 289.5 s) with a higher total number of puffs (58.6 vs 17.3), however this may be attributable to differences in product operation. There were no significant differences across puffing topography measurements observed between smokers (Group 1) and regular vapers/dual users (Group 2) when using the e-cigarette. As consistent with previous research, users took, on average, larger mean puff volumes when using a THP compared to the reference cigarette (C651), although puff numbers and puff durations remained similar. The average interval between puffs was considerably shorter for THP1.0(T) compared to THS2.4(T) (11.0 s vs 17.1 s). MLE to nicotine-free dry particulate matter and nicotine was significantly reduced for THP1.0(T) and THS2.4(T) compared to the tobacco cigarette (C651). MLE to nicotine was also significantly reduced for the e-cigarette (IS1.0(T)) compared to C651. The average daily consumption (ADC) of cigarettes by groups 1 and 3 were higher than the respective ADCs of both THP consumables. There were no significant differences in ADC when comparing the same product between different groups. Differences seen between sensory scores for each of the product categories may be attributed to fundamental differences in design and mode of operation resulting in very different characteristics of the aerosol generated.
| S-EPMC6949288 | biostudies-literature
Project description:Endorsing prototypes of cigarette smokers predicts cigarette smoking, but less is known about prototypes of users of other tobacco products. Our study sought to establish the reliability and validity of a measure of prototypes of smokers and e-cigarette users. Participants were from a national survey of smokers and non-smokers (n = 1414), a randomized clinical trial (RCT) of adult smokers (n = 2149), and adolescent children of adults in the trial (n = 112). The Prototypes of Tobacco Users Scale (POTUS) has four positive adjectives (cool, sexy, smart, and healthy) and four negative adjectives (disgusting, unattractive, immature, and inconsiderate) describing cigarette smokers and e-cigarette users. Confirmatory factor analyses identified a two-factor solution. The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up). In the RCT, smokers more often agreed with negative prototypes for smokers than for e-cigarette users (mean = 2.03 vs. 1.67, p < 0.05); negative prototypes at baseline were also associated with more forgoing of cigarettes and making a quit attempt at the end of the trial (Week 4 follow-up). The POTUS may be useful to public health researchers seeking to design interventions that reduce tobacco initiation or cessation through the manipulation of tobacco user prototypes.
| S-EPMC7503746 | biostudies-literature
Project description:RationaleThere is limited understanding regarding how various e-cigarette flavorings may influence the behavior of non-regular e-cigarette users who are regular cigarette smokers.ObjectivesTo assess differences in nicotine delivery, puffing topography, subjective effects, and user satisfaction from different flavored e-liquids.MethodsEighteen daily smokers (average age, 44.1 ± 7.0; 9 males; average CPD, 13.0 ± 5.8) smoked their tobacco cigarettes during an initial visit and returned five times to try an e-cigarette (eGo type) refilled with a nicotine solution (24 mg/ml) of five different flavors: cherry, tobacco, espresso, menthol, and vanilla (randomized order). Assessments at each visit included puffing topography, blood samples for nicotine analysis, and subjective reports of nicotine effects and flavor satisfaction.ResultsVaping different flavors resulted in different levels of plasma nicotine. The flavor producing the highest plasma nicotine concentration (Cmax) was cherry (median 21.2 ng/ml), which was not significantly different than nicotine delivery from a combustible cigarette (29.2 ng/ml, p > .05). Vanilla e-liquid produced the lowest Cmax (9.7 ng/ml), and participants tended to puff less frequently on vanilla compared to tobacco flavor (p = .013). Flavors did not differ significantly in the speed of nicotine delivery (Tmax). During controlled use, puff duration for all flavors was significantly longer than a combustible cigarette (p < 0.05). After controlling for nicotine delivery, significant differences in flavor enjoyment were detected. Menthol flavored e-liquid was rated as more enjoyable than vanilla and tobacco flavored e-liquids (p < 0.05).ConclusionsFlavors tested in this study yielded different patterns of nicotine delivery and led to differences in reduction in smoking urges.Trial registrationClinicalTrials.gov Identifier: #NCT02575885.
| S-EPMC7691130 | biostudies-literature
Project description:BackgroundLeakage is a major concern for people who use a stoma, but people's experience and its impact is not well understood. This study aimed to establish a definition of leakage through clinical and user input. This information was used to develop and validate a new measurement tool to understand the impact of leakage for people using a stoma appliance, in the UK, US, France, and Denmark.MethodsParticipants were recruited from a panel of users, hosted by Coloplast, that includes people who currently use Coloplast products. Six clinicians and 41 users took part in concept elicitation interviews. The qualitative findings were used to draft items. A panel of clinical experts was organized to develop and validate items (N = 6). Cognitive debrief interviews were conducted with five users in each country, which resulted in removing some items and revising the measure. A psychometric validation was conducted with 340 people in four countries whereby participants were asked to complete a series of measures online. Full psychometric analyses including validity and reliability were conducted.ResultsA final tool was established consisting of three domains related to the burden of leakage: "Emotional impact," "Usual and social activities," and "Coping and control." Convergent validity was evaluated by benchmarking to existing health-related quality of life instruments (domains of SF-36 and Ostomy-Q). This showed high correlation between domains of the leakage tool and other measures, in particular for the Emotional impact domain when compared with SF-36 Emotional well-being and Ostomy-Q Confidence domain (p < 0.001). Coping and control correlated moderately well with most PROs tested for except the physical functioning domains, which showed only modest correlation (p < 0.001). Usual and social activities correlated equally well with all domains. Internal consistency was high for Emotional impact and Usual and social activities (> 0.92).ConclusionThe study highlights how users define leakage and its impact in a way that is meaningful to them. This information has been used to develop an instrument to measure leakage which can potentially be used by clinicians and researchers. The instrument demonstrated evidence supporting its reliability and validity as an outcome measure to assess the impact of leakage in stoma care.
| S-EPMC6295083 | biostudies-literature
Project description:IntroductionThe ability to reliably measure real-world vaping behavior is critical to understand exposures to potential toxins. Commercially available mobile topography devices were originally designed to measure cigarette puffing behavior. Information regarding how applicable these devices are to the measurement of electronic cigarette (e-cigarette) vaping topography is needed.MethodsClinical Research Support System (CReSS; Pocket) and Smoking Puff Analyzer Mobile (SPA-M) topography devices were tested against the calibrated laboratory-based smoking puff analyzer duplicator (SPA-D) device combined with an analytical smoking machine that generates programmable puffs with high precision. Puff topography of e-cigarettes was measured over a range of puff volumes (10-130 mL) at 2 and 5 s puff durations (using bell- and square-shaped puffs). "Real-world" topography data collected from 10 participants during 1 week of at-home vaping were also analyzed. Recording anomalies and limitations of the devices, such as accuracy of detection of the puff end, flow rate dropouts, unreported puffs, and abandoned vaping sessions for the CReSS, and multi-peak puffs for the SPA-M were defined.ResultsThe accuracy of puff volumes and durations was determined for both devices. The error for SPA-M was generally within ±10%, whereas that for the CReSS varied more widely. The CReSS consistently underestimated puff duration at higher flow rates.ConclusionsCReSS and SPA-M topography devices can be used for real-world e-cigarette topography measurements, but researchers have to be aware of the limitations. Both devices can provide accurate measurements only under certain puff parameter ranges. The SPA-M provided more accurate measurements under a wider range of puffing parameters than the CReSS. Summary data reported by both devices require thorough analysis of the raw data to avoid misleading data interpretation.ImplicationsResults of this study provide researchers with valuable information about the capability of commercially available cigarette topography devices to measure real-world vaping behaviors. The differing measurement ranges of the two devices and puff recording limitations and anomalies should be taken into account during analysis and interpretation of real-world data.
| S-EPMC7171281 | biostudies-literature
Project description:IntroductionLimited research exists about the possible cardiovascular effects of electronic nicotine delivery systems (ENDS). We therefore sought to compare exposure to known or potentially cardiotoxic volatile organic compounds (VOCs) in ENDS users, smokers, and dual users.MethodsA total of 371 individuals from the Cardiovascular Injury due to Tobacco Use study, a cross-sectional study of healthy participants aged 21-45 years, were categorized as nonusers of tobacco (n = 87), sole ENDS users (n = 17), cigarette smokers (n = 237), and dual users (n = 30) based on 30-day self-reported tobacco product use patterns. Participants provided urine samples for VOC and nicotine metabolite measurement. We assessed associations between tobacco product use and VOC metabolite measures using multivariable-adjusted linear regression models.ResultsMean (SD) age of the population was 32 (±6.8) years, 55% men. Mean urinary cotinine level in nonusers of tobacco was 2.6 ng/mg creatinine, whereas cotinine levels were similar across all tobacco product use categories (851.6-910.9 ng/mg creatinine). In multivariable-adjusted models, sole ENDS users had higher levels of metabolites of acrolein, acrylamide, acrylonitrile, and xylene compared with nonusers of tobacco, but lower levels of most VOC metabolites compared with cigarette smokers or dual users. In direct comparison of cigarettes smokers and dual users, we found lower levels of metabolites of styrene and xylene in dual users.ConclusionAlthough sole ENDS use may be associated with lower VOC exposure compared to cigarette smoking, further study is required to determine the potential health effects of the higher levels of certain reactive aldehydes, including acrolein, in ENDS users compared with nonusers of tobacco.ImplicationsENDS use in conjunction with other tobacco products may not significantly reduce exposure to VOC, but sole use does generally reduce some VOC exposure and warrants more in-depth studies.
| S-EPMC7297089 | biostudies-literature
Project description:IntroductionThis study examined user behavior, e-cigarette dependence, and device characteristics on nicotine intake among users of pod-mod e-cigarettes.Aims and methodsIn 2019-2020, people who use pod-mods in the San Francisco Bay Area completed questionnaires and provided a urine sample for analysis of total nicotine equivalents (TNE). The relationship between TNE and e-cigarette use, e-cigarette brands, e-liquid nicotine strength, e-cigarette dependence, and urine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), as a measure of combustible cigarette exposure, were examined.ResultsOf 100 participants (64% male, 71% in the 18-34 age group, 45% white), 53 used JUUL primarily, 12 used Puff Bar primarily, and 35 used other brands, including Suorin; 48 participants reported current cigarette smoking. Participants most often reported use of e-liquid with 4.5%-6.0% nicotine (68%), fruit (35%), tobacco (28%), and menthol or mint flavors (26%), used e-cigarettes on 25.5 (SD = 6.3) days a month, 10.2 (SD = 14.2) times a day, and 40% used 1-2 pods/cartridges per week. In bivariate analysis, urinary TNE was higher with greater frequency (days used) and intensity (number of pods used) of e-cigarette use, e-cigarette dependence, and combustible cigarette use. In multivariable analysis, days of e-cigarette use in the last 30 days, number of pods used per week, and NNAL levels were significantly associated with TNE. There was no significant impact of e-liquid nicotine strength on TNE.ConclusionsNicotine intake among people who used pod-mod e-cigarettes increased with e-cigarette consumption and e-cigarette dependence, but not with e-liquid nicotine strength. Our findings may inform whether FDA adopts a nicotine standard for e-cigarettes.ImplicationsThe study examined how device and user characteristics influence nicotine intake among pod-mod e-cigarette users. Nicotine intake increased with frequency (days of e-cigarette use in past 30 days) intensity of use (number of pods used per day) and e-cigarette dependence but not with the flavor or nicotine concentration of the e-liquids. Regulation of nicotine concentration of e-liquids is unlikely to influence nicotine exposure among adult experienced pod-mod users.
| S-EPMC10347964 | biostudies-literature
Project description:BackgroundAn assessment tool is needed to measure the clinical severity of nursing home residents to improve the prediction of outcomes and provide guidance in treatment planning.ObjectiveThis study aims to describe the development of the Nursing Home Severity Index, a clinical severity measure targeted for nursing home residents with the potential to be individually tailored to different outcomes, such as pressure injury.MethodsA retrospective nonexperimental design was used to develop and validate the Nursing Home Severity Index using secondary data from 9 nursing homes participating in the 12-month preintervention period of the Turn Everyone and Move for Ulcer Prevention (TEAM-UP) pragmatic clinical trial. Expert opinion and clinical literature were used to identify indicators, which were grouped into severity dimensions. Index performance and validation to predict risk of pressure injury were accomplished using secondary data from nursing home electronic health records, Minimum Data Sets, and Risk Management Systems. Logistic regression models including a resident's Worst-Braden score with/without severity dimensions generated propensity scores. Goodness of fit for overall models was assessed using C statistic; the significance of improvement of fit after adding severity components to the model was determined using the likelihood ratio chi-square test. The significance of each component was assessed with odds ratios. Validation based on randomly selected 65% training and 35% validation data sets was used to confirm the reliability of the severity measure. Finally, the discriminating ability of models was evaluated using propensity stratification to evaluate which model best discriminated between residents with/without pressure injury.ResultsData from 1015 residents without pressure injuries on admission were used for the Nursing Home Severity Index-Pressure Injury and included laboratory, weights/vitals/pain, underweight, and locomotion severity dimensions. Logistic regression C statistic measuring predictive accuracy increased by 19.3% (from 0.627 to 0.748; P<.001) when adding four severity dimensions to Worst-Braden scores. Significantly higher odds of developing pressure injuries were associated with increasing dimension scores. The use of the three highest propensity deciles predicting the greatest risk of pressure injury improved predictive accuracy by detecting 21 more residents who developed pressure injury (n=58, 65.2% vs n=37, 42.0%) when both severity dimensions and Worst-Braden score were included in prediction modeling.ConclusionsThe clinical Nursing Home Severity Index-Pressure Injury was successfully developed and tested using the outcome of pressure injury. Overall predictive capacity was enhanced when using severity dimensions in combination with Worst-Braden scores. This index has the potential to significantly impact the quality of care decisions aimed at improving individual pressure injury prevention plans.Trial registrationClinicalTrials.gov NCT02996331; http://clinicaltrials.gov/ct2/show/NCT02996331.
| S-EPMC9951072 | biostudies-literature