Electronic Nicotine-Delivery Systems for Smoking Cessation.

BACKGROUND: Electronic nicotine-delivery systems - also called e-cigarettes - are used by some tobacco smokers to assist with quitting. Evidence regarding the efficacy and safety of these systems is needed. METHODS: In this open-label, controlled trial, we randomly assigned adults who were smoking at least five tobacco cigarettes per day and who wanted to set a quit date to an intervention group, which received free e-cigarettes and e-liquids, standard-of-care smoking-cessation counseling, and optional (not free) nicotine-replacement therapy, or to a control group, which received standard counseling and a voucher, which they could use for any purpose, including nicotine-replacement therapy. The primary outcome was biochemically validated, continuous abstinence from smoking at 6 months. Secondary outcomes included participant-reported abstinence from tobacco and from any nicotine (including smoking, e-cigarettes, and nicotine-replacement therapy) at 6 months, respiratory symptoms, and serious adverse events. RESULTS: A total of 1246 participants underwent randomization; 622 participants were assigned to the intervention group, and 624 to the control group. The percentage of participants with validated continuous abstinence from tobacco smoking was 28.9% in the intervention group and 16.3% in the control group (relative risk, 1.77; 95% confidence interval, 1.43 to 2.20). The percentage of participants who abstained from smoking in the 7 days before the 6-month visit was 59.6% in the intervention group and 38.5% in the control group, but the percentage who abstained from any nicotine use was 20.1% in the intervention group and 33.7% in the control group. Serious adverse events occurred in 25 participants (4.0%) in the intervention group and in 31 (5.0%) in the control group; adverse events occurred in 272 participants (43.7%) and 229 participants (36.7%), respectively. CONCLUSIONS: The addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking-cessation counseling alone. (Funded by the Swiss National Science Foundation and others; ESTxENDS ClinicalTrials.gov number, NCT03589989.).

Development of a Communication Instrument to Address Sexuality in COPD: COSY.

Introduction: Sexuality, an important aspect of quality of life, is often overlooked in COPD. Our aim was to develop an instrument that facilitates communication and counseling on sexuality in persons living with chronic obstructive pulmonary disease (COPD). Methods: We searched for publications on sexuality in COPD focusing on communication about sexuality and tools to support such communication. We also performed a survey asking 25 patients and 36 health care professionals (HCPs) about their attitudes, experiences, barriers, and facilitators when talking about sexuality. We set up a project expert team of HCPs and 3 persons with COPD. In a half-day workshop, the team discussed the results of the literature review and the survey as a basis for the contents, the "when and how" to address communication about sexuality, and the design of the communication instrument. Results: The survey showed that although patients and HCPs wanted to talk about sexuality, it rarely happened due to communication barriers, lack of self-confidence, and misconceptions on both sides. In review rounds of the expert team, feedback on the drafts was collected and integrated into the final version of the communication instrument: COmmunication about SexualitY in COPD (COSY). The COSY instrument resulted in 4 tools: a communication leaflet, an application guide, a pictorial representation of the spectrum of intimacy for HCPs, and a comprehensible, picturized information booklet for patients. Conclusions: Addressing sexuality in persons living with COPD should not be neglected. The COSY instrument could help to start and shape communication and consultations about sexuality and a more holistic consideration of quality of life.

Nationwide indoor smoking ban and impact on smoking behaviour and lung function: a two-population natural experiment.

INTRODUCTION: Many countries have implemented indoor smoking bans over the past two decades. Although smoking bans have been shown to reduce cardiovascular outcomes, little is known about their impact on respiratory health. This study investigated the impact of a nationwide indoor smoking ban on smoking behaviour and lung function. METHODS: We used repeated cross-sectional data from two large cohorts of the general population comprising 31 807 Swiss and 62 093 Danish adults. We compared associations between smoking ban and smoking prevalence and prebronchodilator lung function trends in Denmark (indoor smoking ban introduced in 2007) and Switzerland (indoor smoking ban introduced in 2010) from 2005 to 2010 using a quasi-experimental study design. We performed difference-in-difference analyses with linear regression models adjusted for age, sex, weight and height. RESULTS: Denmark had a stronger decrease in active smokers compared with Switzerland. Also, forced expiratory volume in the first second was higher in Danish adults than in Swiss adults: 26 mL (95% CI 2.4 to 49) 1 year, 88 mL (65 to 112) 2 years, and 74 mL (51 to 98) 3 years after smoking ban implementation. Correspondingly, forced vital capacity was higher in Danish adults compared with Swiss adults (80 mL (50 to 109) after 1 year and 126 mL (97 to 155) after two and 3 years). Improvements were observed in both never-smokers and ever-smokers, most pronounced in ever-smokers. CONCLUSIONS: Nationwide indoor smoking ban is associated with less smoking and improved lung function in the general population. Implementing an indoor smoking ban can improve lung function by influencing smoking behaviour and reducing secondhand smoke.

Nationwide implementation of the self-management program "Living well with COPD": Process and effectiveness evaluation using a mixed-methods approach.

OBJECTIVE: To evaluate the nationwide implementation of the "Living well with COPD" program by the Swiss Lung Association in various cantons in Switzerland. METHODS: For the process evaluation, we used qualitative (interview, focus group) and quantitative (questionnaires, documentation analysis) methods to assess the implementation outcomes reach, dose, fidelity and acceptability. For the effectiveness, we performed a pre-post analysis of patient data collected at baseline and program end (after 14 months). RESULTS: Seven Cantonal Lung Associations implemented the program into their services according to plan, conducted it 13 times and included 122 COPD patients. Patients' attendance rate was 81% and coaches' fidelity to protocol 94%. Acceptance and satisfaction of all involved persons was high. Integration of the coaches' additional workload, uncertainties regarding roles and responsibilities and sustainable reimbursement were major challenges. Patients significantly improved in COPD specific quality of life and increased exercise capacity with on average 3.2 more repetitions in the 1-minute sit-to-stand test. CONCLUSION: The program was successfully implemented throughout Switzerland with high acceptability and positive association with patients' quality of life. PRACTICE IMPLICATIONS: Our findings support the broader multiplication throughout Switzerland and serves the international community since it is one of the first nationwide implementations beyond study settings.

NO2 and PM2.5 Exposures and Lung Function in Swiss Adults: Estimated Effects of Short-Term Exposures and Long-Term Exposures with and without Adjustment for Short-Term Deviations.

BACKGROUND: The impact of nitrogen dioxide (NO2) and particulate matter with an aerodynamic diameter of less than or equal to 2.5. microns (PM2.5) exposures on lung function has been investigated mainly in children and less in adults. Furthermore, it is unclear whether short-term deviations of air pollutant concentration need to be considered in long-term exposure models. OBJECTIVES: The aims of this study were to investigate the association between short-term air pollution exposure and lung function and to assess whether short-term deviations of air pollutant concentration should be integrated into long-term exposure models. METHODS: Short-term (daily averages 0-7 d prior) and long-term (1- and 4-y means) NO2 and PM2.5 concentrations were modeled using satellite, land use, and meteorological data calibrated on ground measurements. Forced expiratory volume within the first second (FEV1) of forced exhalation and forced vital capacity (FVC) were measured during a LuftiBus assessment (2003-2012) and linked to exposure information from the Swiss National Cohort for 36,085 adults (ages 18-95 y). We used multiple linear regression to estimate adjusted associations, and additionally adjusted models of long-term exposures for short-term deviations in air pollutant concentrations. RESULTS: A 10µg/m3 increase in NO2 and PM2.5 on the day of the pulmonary function test was associated with lower FEV1 and FVC (NO2: FEV1 -8.0 ml [95% confidence interval: -13.4, -2.7], FVC -16.7 ml [-23.4, -10.0]; PM2.5: FEV1 -15.3 ml [-21.9, -8.7], FVC -18.5 ml [-26.5, -10.5]). A 10µg/m3 increase in 1-y mean NO2 was also associated with lower FEV1 (-7.7 ml; -15.9, 0.5) and FVC (-21.6 ml; -31.9, -11.4), as was a 10µg/m3 increase in 1-y mean PM2.5 (FEV1: -42.2 ml; -56.9, -27.5; FVC: -82.0 ml; -100.1, -63.9). These associations were robust to adjustment for short-term deviations in the concentration of each air pollutant. CONCLUSIONS: Short- and long-term air pollution exposures were negatively associated with lung function, in particular long-term PM2.5 exposure with FVC. Our findings contribute substantially to the evidence of adverse associations between air pollution and lung function in adults. https://doi.org/10.1289/EHP7529.

Occupational exposure and the risk of airway obstruction and mortality.

OBJECTIVES: To identify occupational groups at high risk of airway obstruction (AO) and mortality and potential interactions with smoking. METHODS: Lung function data from the LuftiBus project were enriched with occupational and follow-up information from the Swiss National Cohort, resulting in a cohort of 10582 adults between 2000 and 2015. We assigned professions to occupational groups and estimated the risk of AO and mortality using adjusted logistic and Cox regression model. Additionally, we assessed multiplicative and additive interactions between occupational exposure and smoking. RESULTS: Chimney sweeps and male workers from the agriculture, construction and food industries had an increased risk of AO (odds ratios ranging from 1.43 to 2.21). The risk of mortality was increased among male workers from the food industry (hazard ratio 1.57, 95% CI 1.10-2.23). Interactions with smoking were present in most associations, but smoking had no effect on the increased risk of mortality in the food industry. CONCLUSIONS: Some occupational groups have a considerable risk of AO and mortality. The identification of the most affected occupations is of great importance enabling targeted risk reduction strategies.

Increase in Airway Obstruction between 1993 and 2012 in Switzerland. An Observational Study.

Rationale: Most studies determining the prevalence of airway obstruction are limited to short time periods.Objectives: Because temporal trends of obstruction in populations are largely unknown, we determined the prevalence of airway obstruction over 20 years in yearly general population samples in Switzerland between 1993 and 2012.Methods: We analyzed data of 85,789 participants aged 35 years and older who provided spirometric measurements as part of the LuftiBus lung function campaign. We linked data from the 2003-2012 period to the Swiss National Cohort to adjust for annual population differences. Spirometry was performed without bronchodilation, according to American Thoracic Society guidelines. We used Global Lung Initiative (GLI) and Hankinson reference equations to identify obstruction.Results: Obstruction prevalence increased between 1993 and 2012 from 6.1% (95% confidence interval [CI], 5.5 to 6.7) to 15.6% (95% CI, 13.8 to 17.3) based on GLI estimates and from 5.3% (95% CI, 4.7 to 5.9) to 15.4% (95% CI, 13.6 to 17.1) based on Hankinson estimates. When adjusted for participant demographics, air pollutant and occupational exposures, altitude, and season, the prevalence ratios of obstruction were 1.54 (95% CI, 1.22 to 1.93) and 1.65 (95% CI, 1.33 to 2.04) for GLI- and Hankinson-defined airway obstruction, respectively, for 2012 compared with 2003.Conclusions: Though prebronchodilator measurements likely overestimate the prevalence of airway obstruction in absolute terms compared with post-bronchodilator measurements, we found an increase in airway obstruction prevalence. Even with adjustment for several well-known risk factors for obstruction to make the populations across the years more comparable, we still saw a statistically significant increase in prevalence over this time period.

Predicting Fine-Scale Daily NO2 for 2005-2016 Incorporating OMI Satellite Data Across Switzerland.

Nitrogen dioxide (NO2) remains an important traffic-related pollutant associated with both short- and long-term health effects. We aim to model daily average NO2 concentrations in Switzerland in a multistage framework with mixed-effect and random forest models to respectively downscale satellite measurements and incorporate local sources. Spatial and temporal predictor variables include data from the Ozone Monitoring Instrument, Copernicus Atmosphere Monitoring Service, land use, and meteorological variables. We derived robust models explaining ∼58% (R2 range, 0.56-0.64) of the variation in measured NO2 concentrations using mixed-effect models at a 1 × 1 km resolution. The random forest models explained ∼73% (R2 range, 0.70-0.75) of the overall variation in the residuals at a 100 × 100 m resolution. This is one of the first studies showing the potential of using earth observation data to develop robust models with fine-scale spatial (100 × 100 m) and temporal (daily) variation of NO2 across Switzerland from 2005 to 2016. The novelty of this study is in demonstrating that methods originally developed for particulate matter can also successfully be applied to NO2. The predicted NO2 concentrations will be made available to facilitate health research in Switzerland.

Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation.

BACKGROUND: Telecoaching approaches can enhance physical activity (PA) in patients with chronic obstructive pulmonary disease (COPD). However, their effectiveness is likely to be influenced by intervention-specific characteristics. OBJECTIVE: This study aimed to assess the acceptability, actual usage, and feasibility of a complex PA telecoaching intervention from both patient and coach perspectives and link these to the effectiveness of the intervention. METHODS: We conducted a mixed-methods study based on the completers of the intervention group (N=159) included in an (effective) 12-week PA telecoaching intervention. This semiautomated telecoaching intervention consisted of a step counter and a smartphone app. Data from a project-tailored questionnaire (quantitative data) were combined with data from patient interviews and a coach focus group (qualitative data) to investigate patient and coach acceptability, actual usage, and feasibility of the intervention. The degree of actual usage of the smartphone and step counter was also derived from app data. Both actual usage and perception of feasibility were linked to objectively measured change in PA. RESULTS: The intervention was well accepted and perceived as feasible by all coaches present in the focus group as well by patients, with 89.3% (142/159) of patients indicating that they enjoyed taking part. Only a minority of patients (8.2%; 13/159) reported that they found it difficult to use the smartphone. Actual usage of the step counter was excellent, with patients wearing it for a median (25th-75th percentiles) of 6.3 (5.8-6.8) days per week, which did not change over time (P=.98). The smartphone interface was used less frequently and actual usage of all daily tasks decreased significantly over time (P<.001). Patients needing more contact time had a smaller increase in PA, with mean (SD) of +193 (SD 2375) steps per day, +907 (SD 2306) steps per day, and +1489 (SD 2310) steps per day in high, medium, and low contact time groups, respectively; P for-trend=.01. The overall actual usage of the different components of the intervention was not associated with change in step count in the total group (P=.63). CONCLUSIONS: The 12-week semiautomated PA telecoaching intervention was well accepted and feasible for patients with COPD and their coaches. The actual usage of the step counter was excellent, whereas actual usage of the smartphone tasks was lower and decreased over time. Patients who required more contact experienced less PA benefits. TRIAL REGISTRATION: ClinicalTrials.gov NCT02158065; http://clinicaltrials.gov/ct2/show/NCT02158065 (Archived by WebCite at http://www.webcitation.org/73bsaudy9).

Commonly Used Patient-Reported Outcomes Do Not Improve Prediction of COPD Exacerbations: A Multicenter 4½ Year Prospective Cohort Study.

BACKGROUND: Several cross-sectional and short-term studies suggest that patient-reported outcomes (PROs) may be useful to help predict COPD exacerbations, but evidence from long-term prospective cohort studies is lacking. Our aim was to assess if PROs add to the prediction of exacerbations. METHODS: Four hundred eight primary care patients with COPD participated in the multicenter prospective International Collaborative Effort on Chronic Obstructive Lung Disease: Exacerbation Risk Index Cohorts (ICE COLD ERIC) study. PROs included the Chronic Respiratory Disease Questionnaire, the Hospital Anxiety and Depression Scale, the Feeling Thermometer, and the LASA Physical Activity Questionnaire (LAPAQ). Exacerbations during 4½ years were adjudicated by experts. We used negative binomial regression to assess the association between PROs and exacerbations while considering age, sex, airflow obstruction, previous exacerbations, and smoking status. We then assessed if adding PROs improved the predictive properties of widely used indices. RESULTS: Lower levels of dyspnea, fatigue, and anxiety and higher levels of physical activity were associated with a lower risk of exacerbations (adjusted incidence rate ratio [IRR], 0.90; 95% CI, 0.84-0.97; P = .01; IRR, 0.93; 95% CI, 0.86-1.00; P = .04; IRR, 1.03; 95% CI, 1.00-1.06; P = .03; IRR, 0.93; 95% CI, 0.87-0.99; P = .04, respectively). The best prediction was when LAPAQ was added to the BMI, airflow obstruction, dyspnea, and previous exacerbations (BODEx) index (area under the curve Δ+0.02, from 0.72-0.74). However, this increase was not clinically relevant (net reclassification improvement, 0.03; 95% CI, -0.03 to 0.08). CONCLUSIONS: Some domains of PROs are independently associated with exacerbations but do not lead to clearly improved prediction when added to established indices to predict exacerbations. There is still much room for improvement in the prediction of exacerbations. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00706602.

The Inaccuracy of Patient Recall for COPD Exacerbation Rate Estimation and Its Implications: Results from Central Adjudication.

BACKGROUND: COPD exacerbation incidence rates are often ascertained retrospectively through patient recall and self-reports. We compared exacerbation ascertainment through patient self-reports and single-physician chart review to central adjudication by a committee and explored determinants and consequences of misclassification. METHODS: Self-reported exacerbations (event-based definition) in 409 primary care patients with COPD participating in the International Collaborative Effort on Chronic Obstructive Lung Disease: Exacerbation Risk Index Cohorts (ICE COLD ERIC) cohort were ascertained every 6 months over 3 years. Exacerbations were adjudicated by single experienced physicians and an adjudication committee who had information from patient charts. We assessed the accuracy (sensitivities and specificities) of self-reports and single-physician chart review against a central adjudication committee (AC) (reference standard). We used multinomial logistic regression and bootstrap stability analyses to explore determinants of misclassifications. RESULTS: The AC identified 648 exacerbations, corresponding to an incidence rate of 0.60 ± 0.83 exacerbations/patient-year and a cumulative incidence proportion of 58.9%. Patients self-reported 841 exacerbations (incidence rate, 0.75 ± 1.01; incidence proportion, 59.7%). The sensitivity and specificity of self-reports were 84% and 76%, respectively, those of single-physician chart review were between 89% and 96% and 87% and 99%, respectively. The multinomial regression model and bootstrap selection showed that having experienced more exacerbations was the only factor consistently associated with underreporting and overreporting of exacerbations (underreporters: relative risk ratio [RRR], 2.16; 95% CI, 1.76-2.65 and overreporters: RRR, 1.67; 95% CI, 1.39-2.00). CONCLUSIONS: Patient 6-month recall of exacerbation events are inaccurate. This may lead to inaccurate estimates of incidence measures and underestimation of treatment effects. The use of multiple data sources combined with event adjudication could substantially reduce sample size requirements and possibly cost of studies. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, NCT00706602.

Population-based reference values for the 1-min sit-to-stand test.

OBJECTIVES: To determine reference values for the 1-min sit-to-stand (STS) test in an adult population. METHODS: Cross-sectional study nested within a nationwide health promotion campaign in Switzerland. Adults performed the STS test and completed questions on demographics and health behavior. RESULTS: 6,926 out of 7,753 (89.3 %) adults were able to complete the STS test. The median number of repetitions ranged from 50/min (25-75th percentile 41-57/min) in young men and 47/min (39-55/min) in young women aged 20-24 years to 30/min (25-37/min) in older men and 27/min (22-30/min) in older women aged 75-79 years. CONCLUSIONS: The reference values support the interpretation of 1-min STS test performance and identification of subjects with decreased lower body muscular strength and endurance.