Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: qualitative interview findings.

BACKGROUND: There is interest in participants using their own smartphones or tablets ("bring your own device"; BYOD) to complete patient-reported outcome (PRO) measures in clinical studies. Our study aimed to qualitatively evaluate participants' experience using a provisioned device (PD) versus their own smartphone (BYOD) for this purpose. METHODS: Participants with chronic obstructive pulmonary disease (COPD) were recruited for this observational, cross-over study and completed PRO measures daily on one device type for 15 days, then switched to the other device type to complete the same measures for another 15 days. After each 15-day period, semi-structured interviews were conducted about their experience with the device. RESULTS: Of 64 participants enrolled, the final qualitative analysis populations comprised those who participated in an interview without protocol violations. Thus, the qualitative longitudinal population (LP) included n = 57 (89%), while the qualitative cross-sectional population (CSP) included n = 60 (94%). CSP participants found both device types easy to use. Twenty CSP participants (33%) reported missing data entry on at least one day when using PD, and 24 (40%) reported missing at least one day when using BYOD. In the LP, preference for one of the device types was somewhat evenly split; 45.6% (n = 26) preferred PD and 50.9% (n = 29) preferred BYOD. The most common reason for preferring PD was that it was "dedicated" to the study; the "convenience" of carrying a single device was the main reason for preferring BYOD. CONCLUSION: The findings from the interviews demonstrated few differences in participants' experience completing PRO measures on a PD versus BYOD. Our study supports the use of BYOD as a potential addition to PD for collecting PRO data and contributes evidence that BYOD may be employed to collect PRO data in demographically diverse patient populations.

E-cigarettes for the management of nicotine addiction.

In this review, we discuss current evidence on electronic cigarettes (ECs), a rapidly evolving class of nicotine delivery system, and their role in managing nicotine addiction, specifically in helping smokers to quit smoking and/or reduce the amount of tobacco they smoke. The current evidence base is limited to three randomized trials (only one compares ECs with nicotine replacement therapy) and a growing number of EC user surveys (n=6), case reports (n=4), and cohort studies (n=8). Collectively, these studies suggest modest cessation efficacy and a few adverse effects, at least with the short-term use. On this basis, we provide advice for health care providers on providing balanced information for patients who enquire about ECs. More research, specifically well-conducted large efficacy trials comparing ECs with standard smoking cessation management (eg, nicotine replacement therapy plus behavioral support) and long-term prospective studies for adverse events, are urgently needed to fill critical knowledge gaps on these products.

Effects of Switching to Electronic Cigarettes with and without Concurrent Smoking on Exposure to Nicotine, Carbon Monoxide, and Acrolein.

Concern has been raised about the presence of toxicants in electronic cigarette (EC) aerosol, particularly carbonyl compounds (e.g., acrolein) that can be produced by heating glycerol and glycols used in e-liquids. We investigated exposure to carbon monoxide (CO), nicotine (by measuring cotinine in urine), and to acrolein (by measuring its primary metabolite, S-(3-hydroxypropyl)mercapturic acid (3-HPMA) in urine) before and after 4 weeks of EC (green smoke, a "cig-a-like" EC, labeled 2.4% nicotine by volume) use, in 40 smokers. Thirty-three participants were using EC at 4 weeks after quitting, 16 (48%) were abstinent (CO-validated) from smoking during the previous week (EC only users), and 17 (52%) were "dual users." A significant reduction in CO was observed in EC-only users [-12 ppm, 95% confidence interval (CI), -16 to -7, 80% decrease) and dual users (-12 ppm, 95%CI, -19 to -6, 52% decrease). Cotinine levels also declined, but to a lesser extent (EC-only users: -184 ng/mg creatinine; 95% CI, -733 to -365, 17% decrease; and dual users: -976 ng/mg creatinine; 95%CI, -1,682 to -270, 44% decrease). Mean 3-HPMA levels had decreased at 4 weeks by 1,280 ng/mg creatinine (95%CI, -1,699 to -861, 79% decrease) in EC-only users and by 1,474 ng/mg creatinine (95%CI, -2,101 to -847, 60% decrease) in dual users. In dual users, EC use significantly reduced exposure to CO and acrolein because of a reduction in smoke intake. EC may reduce harm even in smokers who continue to smoke, but long-term follow-up studies are needed to confirm this.

E-cigarettes versus NRT for smoking reduction or cessation in people with mental illness: secondary analysis of data from the ASCEND trial.

BACKGROUND: People with mental illness have higher rates of smoking than the general population and are at greater risk of smoking-related death and disability. In smokers from the general population, electronic cigarettes (e-cigarettes) have been shown to have a similar effect on quit rates as nicotine replacement therapy, but little is known about their effect in smokers with mental illness. METHODS: Secondary analysis of data from the ASCEND trial involving 657 dependent adult smokers motivated to quit, randomised to 16 mg nicotine e-cigarette, 21 mg nicotine patch, or 0 mg nicotine e-cigarette, with minimal behavioural support. Using self-reported medication use and the Anatomical Therapeutic Chemical Classification System, we identified 86 participants with mental illness and analysed their cessation and smoking reduction outcomes. RESULTS: For e-cigarettes alone, and all interventions pooled, there was no statistically significant difference in biochemically verified quit rates at six months between participants with and without mental illness, nor in smoking reduction, adverse events, treatment compliance, or acceptability. Rates of relapse to smoking were higher in participants with mental illness. Among this group, differences between treatments were not statistically significant for cessation (patch 14% [5/35], 16 mg e-cigarette 5% [2/39], 0 mg e-cigarette 0% [0/12], p = 0.245), adverse events or relapse rates. However, e-cigarette users had higher levels of smoking reduction, treatment compliance, and acceptability. CONCLUSIONS: The use of e-cigarettes for quitting appears to be equally effective, safe, and acceptable for people with and without mental illness. For people with mental illness, e-cigarettes may be as effective and safe as patches, yet more acceptable, and associated with greater smoking reduction. TRIAL REGISTRATION: Australian New Zealand Clinical trials Registry, number: ACTRN12610000866000.

Nicotine intake from electronic cigarettes on initial use and after 4 weeks of regular use.

INTRODUCTION: Electronic cigarettes (EC) have the potential to generate a substantial public health benefit if there is a switch from smoking to EC use on a population scale. The nicotine delivery from EC is likely to play a major role in their attractiveness to smokers. We assessed nicotine delivery from a first-generation EC and the effect of experience with its use on nicotine intake. METHODS: Six smokers provided pharmacokinetic (PK) data after their first use of EC and again following 4 weeks of use. RESULTS: The peak nicotine levels were achieved within 5 min of starting the EC use, which suggests that EC may provide nicotine via pulmonary absorption. There were large individual differences in nicotine intake. Compared with the PK profile when using EC for the first time, 4 weeks of practice generated a 24% increase in the peak plasma concentrations (from 4.6 to 5.7 ng/ml; nonsignificant) and a 79% increase in overall nicotine intake (AUC(0 → inf) increased from 115 to 206 ng*min/ml; p < .05). CONCLUSIONS: First-generation EC provide faster nicotine absorption than nicotine replacement products, but to compete successfully with conventional cigarettes, EC may need to provide higher doses of nicotine. Nicotine intake from EC can increase with practice, but further studies are needed to confirm this effect.

Do e-cigarettes have the potential to compete with conventional cigarettes?: a survey of conventional cigarette smokers' experiences with e-cigarettes.

BACKGROUND: Electronic cigarettes (ECs) are becoming increasingly popular globally. If they were to replace conventional cigarettes, it could have a substantial impact on public health. To evaluate EC's potential for competing with conventional cigarettes as a consumer product, we report the first data, to our knowledge, on the proportion of smokers who try ECs and become regular users. METHODS: A total of 2,012 people seen smoking or buying cigarettes in the Czech Republic were approached to answer questions about smoking, with no mention made of ECs to avoid the common bias in surveys of EC users. During the interview, the volunteers' experience with ECs was then discussed. RESULTS: A total of 1,738 smokers (86%) participated. One-half reported trying ECs at least once. Among those who tried ECs, 18.3% (95% CI, 0.15.7%-20.9%) reported using them regularly, and 14% (95% CI, 11.6%-16.2%) used them daily. On average, regular users used ECs daily for 7.1 months. The most common reason for using ECs was to reduce consumption of conventional cigarettes; 60% of regular EC users reported that ECs helped them to achieve this. Being older and having a more favorable initial experience with ECs explained 19% of the variance in progressing to regular EC use. CONCLUSIONS: Almost one-fifth of smokers who try ECs once go on to become regular users. ECs may develop into a genuine competitor to conventional cigarettes. Government agencies preparing to regulate ECs need to ensure that such moves do not create a market monopoly for conventional cigarettes.

Weight change during and after Ramadan fasting.

BACKGROUND: During Ramadan, observant Muslims fast from sunrise to sunset for a month. Knowing whether Ramadan fasting affects body weight has implications for health advice to the Muslim community, for understanding the effects of skipping meals on body weight, and for general weight management advice. METHODS: We compared body weight before and after the Ramadan fast and 1 month later in observant Muslims attending a Mosque in East London, UK. RESULTS: In 202 participants who provided weight at the beginning and the end of Ramadan, there was a small weight decrease (-0.84 kg, 95% CI = -0.6 to -1, P < 0.0001), with 46% of participants losing >1 kg. Participants who fasted throughout Ramadan lost significantly more weight (1 kg) than those who occasionally broke fast (0.3 kg, P = 0.013). In 87 participants who provided weight at the beginning and end of Ramadan and also 1 month later, all the lost weight was regained (+0.1 kg, 95% CI = 0.2-0.5, P = 0.504 compared with baseline). CONCLUSIONS: Observers of Ramadan lose on average about a kilogram of weight over 4 weeks, and the lost weight is quickly regained. Current weight management treatments generally assume that skipping meals leads to weight gain and advise against it. The finding suggests that further research is needed on the justification of the 'do not skip meals' advice.

'The smoking toolkit study': a national study of smoking and smoking cessation in England.

BACKGROUND: Up-to-date data tracking of national smoking patterns and cessation-related behaviour is required to evaluate and inform tobacco control strategies. The Smoking Toolkit Study (STS) was designed for this role. This paper describes the methodology of the STS and examines as far as possible the representativeness of the samples. METHODS: The STS consists of monthly, cross sectional household interviews of adults aged 16 and over in England with smokers and recent ex-smokers in each monthly wave followed up by postal questionnaires three and six months later. Between November 2006 and December 2010 the baseline survey was completed by 90,568 participants. STS demographic, prevalence and cigarette consumption estimates are compared with those from the Health Survey for England (HSE) and the General Lifestyle Survey (GLF) for 2007-2009. RESULTS: Smoking prevalence estimates of all the surveys were similar from 2008 onwards (e.g 2008 STS=22.0%, 95% C.I.=21.4% to 22.6%, HSE=21.7%, 95% C.I.=20.9% to 22.6%, GLF=20.8%, 95% C.I.=19.7% to 21.9%), although there was heterogeneity in 2007 (chi-square=50.30, p<0.001). Some differences were observed across surveys within sociodemographic sub-groups, although largely in 2007. Cigarette consumption was virtually identical in all surveys and years. CONCLUSION: There is reason to believe that the STS findings (see http://www.smokinginengland.info) are generalisable to the adult population of England.

Systematic review of the relationship between the 3-hydroxycotinine/cotinine ratio and cigarette dependence.

RATIONALE: Individual differences in the rate of nicotine metabolism (RNM) could be related to dependence and success in stopping smoking. A range of studies have examined RNM measured by the ratio of trans-3'-hydroxycotinine and cotinine in body fluids (the ratio). A systematic review of this literature is needed to draw conclusions and identify gaps in evidence. OBJECTIVE: The aim of this study is to review evidence on the association of the ratio to cigarette dependence and its role in individual tailoring of smoking cessation pharmacotherapy. RESULTS: We reviewed 27 studies of the ratio related to its reliability, validity, and relationship to dependence. The ratio is a reasonably accurate proxy for RNM. There is little evidence that the ratio is related to questionnaire measures of dependence, though the existing data are limited and the ratio has been linked to smoking at night and to some aspects of smoking topography. The ratio is also only weakly associated with cigarette consumption. Its relationship to the severity of withdrawal symptoms seems also weak at best, but limited data exist. One study suggests the ratio predicts outcome of unaided quitting. Importantly, the ratio seems to predict responses both to NRT and bupropion, and thus could guide pharmacotherapy. CONCLUSIONS: The evidence that the ratio is related to smoking behaviours and to cigarette dependence is limited, but the ratio seems to influence treatment response to two stop smoking medications. Further studies of the relationship between the ratio and cigarette dependence and trials of ratio-guided pharmacotherapy are needed.

Tobacco dependence and awareness of health risks of smoking in patients with inflammatory bowel disease.

BACKGROUND AND AIM: Smoking is a risk factor for developing Crohn's disease (CD) and worsens its outcome. Conversely, in ulcerative colitis (UC), the onset may be triggered by the smoking cessation and smoking may be beneficial. To help to ascertain whether patients with inflammatory bowel disease (IBD) would benefit from attending a smoking cessation clinic, we assessed: first, the prevalence of smoking; second, patients' awareness of the effects of smoking, and finally nicotine dependence in IBD patients compared with the healthy and disease-matched controls. METHODS: A total of 246 consecutive IBD outpatients (173 patients with CD, 73 patients with UC) completed a questionnaire on smoking habits and its effect on IBD. Smokers were assessed for dependence using the Fagerstrom test for nicotine dependence (FTND) score and their results were compared with those of age, sex, and ethnicity-matched healthy (five controls for each IBD patient) and asthma controls (one control for each IBD patient) attending a smoking cessation clinic. RESULTS: Thirty five out of 173 patients (20%) with CD and nine out of 73 patients (12%) with UC were current smokers, with 52 out of 173 patients (30%) with CD and 28 out of 73 patients (38%) with UC being ex-smokers. Ninety out of 173 patients (52%) with CD knew that smoking worsens CD, whereas only 15 out of 73 patients (21%) with UC knew of the beneficial effects of smoking on their disease (P=0.032). Knowledge was unrelated to smoking status. In patients with CD, the median (range) FTND score was 3 (0-8) compared with 7 (2-10) in healthy (P<0.001) and 6 (2-9) in asthma controls (P<0.0001). Only seven of the 35 (20%) smoking patients with CD were highly dependent (FTND score ≥6). Similarly, in the patients with UC, the FTND score was 1 (0-4), lower than in healthy, [6 (2-10)], and asthma controls, [7 (4-10); (P<0.004 for both groups)]. CONCLUSION: Patients with CD were better informed about the effects of smoking on their own disease than the patients with UC. Nicotine dependence in IBD patients is lower than in smokers' clinic clients and comparable with that of the general population. Their low nicotine dependence suggests that most IBD patients could be weaned off the smoking habit successfully in the IBD clinic and referral to a smoking cessation clinic was offered to the highly dependent minority and others expressing interest in attending.

Development and initial validation of a caffeine craving questionnaire.

Craving for caffeine has received little empirical attention, despite considerable research into the potential for caffeine dependence. The main aim of this study was to develop, and initially validate, a multi-item, multidimensional instrument to measure cravings for caffeine. Participants were 189 caffeine consumers who completed the Questionnaire of Caffeine Cravings, which was based on the Questionnaire of Smoking Urges (QSU), in one of five naturally occurring periods of abstinence; 1-15 min; 16-120 mins; 3-7 h; 12-48 h and +48 h. Exploratory factor analysis suggested a three-factor solution best described the data; Factor 1 reflected strong desires, intentions and positive reinforcement; Factor 2 reflected mild/general positive and negative reinforcement and Factor 3 reflected functional/mood-based negative reinforcement. Significantly higher Factor 1 and Factor 2 scores were recorded for high frequency users; significantly higher Factor 1 and Factor 3 scores were recorded as a function of increased levels of dependence. Duration of abstinence did not significantly effect cravings across all three factors. Regression analyses suggested level of dependence best predicted both current cravings and frequency of daily use. These findings suggest caffeine cravings may be conceptualized multidimensionally and further validates the use of multidimensional, multi-item instruments. Cravings for caffeine may manifest and be detected across varying levels of dependence and, frequency of use and independently of duration of abstinence.