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.