Recreational Cannabidiol: Awareness, Prevalence of use, and Associated Factors in a Representative Sample of the German Population.

BACKGROUND: Recreational cannabidiol (CBD) is frequently promoted as a medicinal or therapeutic cannabis product worldwide. Nationwide population-based data on awareness and use of recreational CBD are currently lacking. OBJECTIVE: This study estimates the prevalence of recreational CBD awareness and use among the population in Germany. It also explores potential associations with socio-demographic characteristics, tobacco smoking, and e-cigarette use. METHODS: We used data from a cross-sectional household survey (German Study on Tobacco Use, DEBRA) fielded across two waves in October-November 2020 and February-March 2021. Data were collected using computer-assisted face-to-face interviews among participants aged ≥14 years (n = 4026). Outcome variables were CBD awareness (yes/no) and CBD ever use (yes/no). The sample was weighted to ensure representativeness of the prevalence estimates. Associations with socio-demographic variables, tobacco smoking, and e-cigarette use were assessed using multivariable logistic regression. RESULTS: Approximately half of the population in Germany (48.3%, 95% CI: 46.8-49.9) was aware of recreational CBD products, and 4.3% (95% CI: 3.7-5.0) had ever used them (including 1.1% current users). Awareness was associated with younger age, higher education levels, female sex, living in urban regions, no migration background, tobacco smoking, and e-cigarette use. Ever use was associated with higher education levels, living in urban regions, tobacco smoking, and e-cigarette use. CONCLUSIONS: Awareness of recreational CBD products is high but ever use is currently low in Germany. Given the uncertain legal framework regarding the marketing of recreational CBD products, the changing retail landscape, and potential harms of CBD use, structured monitoring is warranted for public health purposes.

Development and Usability Assessment of a Connected Resistance Exercise Band Application for Strength-Monitoring.

Resistance exercise bands are a core component of any physical activity strengthening program. Strength training can mitigate the development of sarcopenia, the loss of muscle mass or strength and function with aging. Yet, the adherence of such behavioral exercise strategies in a home-based setting are fraught with issues of monitoring and compliance. Our group developed a Bluetooth-enabled resistance exercise band capable of transmitting data to an open-source platform. In this work, we developed an application to capture this information in real-time, and conducted three usability studies in two mixed-aged groups of participants (n=6 each) and a group of older adults with obesity participating in a weight-loss intervention (n=20). The system was favorable, acceptable and provided iterative information that could assist in future deployment on ubiquitous platforms. Our formative work provides the foundation to deliver home-based monitoring interventions in a high-risk, older adult population.

[Effectiveness of the Assessment of Burden of COPD tool: a cluster-randomised controlled trial]. / Effectiviteit van de 'Ziektelastmeter COPD'.

OBJECTIVE: Assessment of the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD). DESIGN: Cluster-randomised controlled trial. METHOD: This concerned a trial in 39 Dutch primary care practices and 17 hospitals, involving 357 patients with COPD (postbronchodilator FEV1/FVC ratio < 0.7) aged ≥ 40 years. Healthcare providers were randomized to an intervention or control group. Patients in the intervention group were treated with the ABC tool. This innovative tool consists of a short validated questionnaire and a number of objective parameters, which collectively give a visual overview of the combined integral health; the tool subsequently produces an individualized treatment plan by means of a treatment algorithm. Patients in the control group received usual care. The primary outcome measure was the proportion of patients with a clinically relevant improvement in disease-specific quality of life measured, as measured by means of the St. George's Respiratory Questionnaire (SGRQ) score, between baseline and 18 months follow-up. Secondary outcomes included the SGRQ total score and the Patient Assessment of Chronic Illness Care (PACIC) score. RESULTS: At 18-month follow-up, a significant and clinically relevant improvement in the SGRQ score was seen in 34% of the patients (N=49) in the intervention group, and in the control group this figure was 22% (N=33). This difference between the two groups was significant (OR 1.85, 95% CI 1.08 to 3.16). Patients in the intervention group experienced a higher quality of care than patients in the control group (0.32 points difference in PACIC, 95% CI 0.14 to 0.50). CONCLUSION: Use of the ABC tool increases the disease-specific quality of life and the quality of care for COPD patients; it may therefore offer a valuable contribution to improvements in the daily care of COPD. Replication of this study in other (non-Dutch) health-care settings is recommended.

The effect of financial incentives on top of behavioral support on quit rates in tobacco smoking employees: study protocol of a cluster-randomized trial.

BACKGROUND: Stimulating successful tobacco cessation among employees has multiple benefits. Employees who quit tobacco are healthier, more productive, less absent from work, and longer employable than employees who continue to use tobacco. Despite the evidence for these benefits of tobacco cessation, a successful method to stimulate employees to quit tobacco is lacking. The aim of this study is to evaluate whether adding a financial incentive to behavioral support (compared with no additional incentive) is effective and cost-effective in increasing abstinence rates in tobacco smoking employees participating in a smoking cessation group training. METHODS/DESIGN: In this cluster-randomized trial employees in the intervention and control group both participate in a smoking cessation group training consisting of seven weekly counseling sessions of ninety minutes each. In addition to the training, employees in the intervention group receive a voucher as an incentive for being abstinent from smoking at the end of the training (€50), after three months (€50), after six months (€50), and after one year (€200). The control group does not receive any incentive. The primary outcome is carbon monoxide validated 12-month continuous abstinence from smoking (Russel's standard). Additionally, an economic evaluation is performed from a societal and an employer perspective. DISCUSSION: The present paper describes the methods and design of this cluster-randomized trial in detail. We hypothesize that the financial incentive for abstinence in the form of vouchers increases abstinence rates over and above the group training. The results of this study can provide important recommendations for enhancement of employee tobacco cessation. TRIAL REGISTRATION: Dutch Trial Register: NTR5657 . First received 27-01-2016.

Combining intensive practice nurse counselling or brief general practitioner advice with varenicline for smoking cessation in primary care: study protocol of a pragmatic randomized controlled trial.

INTRODUCTION: Combining behavioural support and pharmacotherapy is most effective for smoking cessation and recommended in clinical guidelines. Despite that smoking cessation assistance from the general practitioner can be effective, dissemination of clinical practice guidelines and efforts on upskilling has not lead to the routine provision of smoking cessation advice among general practitioners. Intensive counselling from the practice nurse could contribute to better smoking cessation rates in primary care. However, the effectiveness of intensive counselling from a practice nurse versus usual care from a general practitioner in combination with varenicline is still unknown. MATERIALS AND METHODS: A pragmatic randomized controlled trial was conducted comparing: (a) intensive individual counselling delivered by a practice nurse and (b) brief advice delivered by a general practitioner; both groups received 12-weeks of open-label varenicline. A minimum of 272 adult daily smoking participants were recruited and treated in their routine primary care setting. The primary outcome was defined as prolonged abstinence from weeks 9 to 26, biochemically validated by exhaled carbon monoxide. Data was analysed blinded according to the intention-to-treat principle and participants with missing data on their smoking status at follow-up were counted as smokers. Secondary outcomes included: one-year prolonged abstinence, short-term incremental cost-effectiveness, medication adherence, and baseline predictors of successful smoking cessation. DISCUSSION: This trial is the first to provide scientific evidence on the effectiveness, cost-effectiveness, and potential mechanisms of action of intensive practice nurse counselling combined with varenicline under real-life conditions. This paper explains the methodology of the trial and discusses the pragmatic and/or explanatory design aspects. TRIAL REGISTRATION: Dutch Trial Register NTR3067.

Risk factors for mortality in patients with pulmonary infections with non-tuberculous mycobacteria: a retrospective cohort study.

BACKGROUND: Infections with non-tuberculous mycobacteria (NTM) represent an increasing problem. Their clinical relevance is still largely unknown as well as predictors for mortality in affected patients. The objective was to describe prevalence and clinical relevance of different NTM and to identify risk factors for mortality. METHODS: Retrospective cohort study of 124 patients with NTM detection between January 2001 and December 2011. Clinical characteristics like symptoms and radiological appearance were assessed at presentation. The primary outcome was all cause mortality during the follow-up period. Univariate and multivariate survival analyses using Cox proportional hazard models were employed for statistical analysis. RESULTS: Over the study period, the frequency of NTM isolation varied from 4 to 12 patients per year. Twenty-nine out of 124 patients (23%) had a clinically relevant infection, according to the criteria of the American Thoracic Society (ATS). Mycobacterium avium was isolated most frequently, but Mycobacterium kansasii, Mycobacterium malmoense and Mycobacterium xenopi had the highest clinical relevance. Symptoms were mostly diverse and non-specific. On radiology, cavities were observed more frequently than a nodular-bronchiectatic variant or consolidation. In 75% of all patients, follow up time was more than two years. Median survival was 6.5 years (95%CI = 2.7-10.3). Factors significantly influencing survival time were haemoptysis (HR = 0.2, 95%CI = 0.1-0.6) and a consolidation on imaging (HR = 5.1, 95%CI 1.4-18.2). CONCLUSIONS: The presentation of an infection with NTM can be diverse and depends mainly on the causative NTM pathogen. The most important predictor for increased mortality is the radiological appearance of a consolidation.

Predictive validity of the Motivation To Stop Scale (MTSS): a single-item measure of motivation to stop smoking.

BACKGROUND: Many different measures of motivation to stop smoking exist but it would be desirable to have a brief version that is standard for use in population surveys and for evaluations of interventions to promote cessation. The aim of this study was to assess the predictive validity and accuracy of the single-item Motivation To Stop Scale (MTSS). METHODS: This study is part of the "Smoking Toolkit Study;" a monthly survey of representative samples of the English population. We used data from 2483 respondents to the surveys from November 2008 to January 2011, who were smokers, used the MTSS, and were followed up 6 months later to provide information on quit attempts since baseline. The MTSS consists of one item with seven response categories ranging from 1 (lowest) to level 7 (highest level of motivation to stop smoking). RESULTS: A total of 692 smokers (27.9% (95% CI=26.1-29.6)) made an attempt to quit smoking between baseline and 6-month follow-up. The odds of quit attempts increased linearly with increasing level of motivation at baseline (p<0.001) and were 6.8 (95% CI=4.7-9.9) times higher for the highest level of motivation compared with the lowest. The accuracy of the MTSS for discriminating between smokers who did and did not attempt to quit was ROC(AUC)=0.67 (95% CI=0.65-0.70). CONCLUSIONS: The MTSS provides strong and accurate prediction of quit attempts and is a candidate for a standard single-item measure of motivation to stop smoking. Further research should assess the external validity of this measure in different smoking populations.

Predictors of 1-year mortality at hospital admission for acute exacerbations of chronic obstructive pulmonary disease.

BACKGROUND: Acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) are related to high mortality, especially in hospitalized patients. Predictors for severe outcomes are still not sufficiently defined. OBJECTIVES: To assess the mortality rate and identify potential determinants of mortality in a cohort of patients hospitalized for AE-COPD. METHODS: A retrospective, observational cohort study including all consecutive patients admitted between January 1, 2009, and April 1, 2010, for AE-COPD. Potential predictors were assessed at initial presentation at the emergency room. The primary outcome was mortality during 1-year follow-up. Univariate and multivariate time-to-event analyses using Cox proportional hazard models were employed for statistical analysis. RESULTS: A total of 260 patients were enrolled in this study. Mean age was 70.5 ± 10.8 years, 50.0% were male and 63.4% had severe COPD. The in-hospital mortality rate was 5.8% and the 1-year mortality rate was 27.7%. Independent risk factors for mortality were age [hazard ratio (HR) = 1.04; 95% confidence interval (CI) = 1.01-1.07], male sex (HR = 2.00; 95% CI = 1.15-3.48), prior hospitalization for AE-COPD in the last 2 years (HR = 2.56; 95% CI = 1.52-4.30), prior recorded congestive heart failure (HR = 1.75; 95% CI = 1.03-2.97), PaCO2 ≥6.0 kPa (HR = 2.90; 95% CI = 1.65-5.09) and urea ≥8.0 mmol/l (HR = 2.38; 95% CI = 1.42-3.99) at admission. CONCLUSIONS: Age, male sex, prior hospitalization for AE-COPD in the last 2 years, prior recorded congestive heart failure, hypercapnia and elevated levels of urea at hospital admission are independent predictors of mortality within the first year after admission.

How cost-effective is 'No Smoking Day'?

OBJECTIVE: To obtain a more rigorous estimate of the cost-effectiveness of No Smoking Day (NSD), an annual UK-wide campaign to encourage smokers to quit, than has been possible hitherto. DESIGN: Comparison of reported quit attempts in the month following NSD for three consecutive years with adjacent months using repeated national surveys of quit attempts. SETTING: England. PARTICIPANTS: A total of 1309 adults who had smoked in the past year who responded to the surveys in the month following NSD (April 2007-2009) and a comparison group of 2672 adults who smoked in the past year who responded to the survey in the two adjacent months (March and May 2007-2009). MAIN OUTCOME MEASURES: The number of additional smokers who quit permanently in response to NSD was estimated from the survey results. The incremental cost-effectiveness ratio (ICER) was calculated by combining this estimate with established estimates of life years gained and the known costs of NSD. RESULTS: The rate of quit attempts was 2.8 percentage points higher in the months following NSD (120/1309) compared with the adjacent months (170/2672; 95% CI 0.99% to 4.62%), leading to an estimated additional 0.07% of the 8.5 million smokers in England quitting permanently in response to NSD. The cost of NSD per smoker was £ 0.088. The discounted life years gained per smoker in the modal age group 35-44 years was 0.00107, resulting in an ICER of £ 82.24 (95% CI 49.7 to 231.6). ICER estimates for other age groups were similar. CONCLUSIONS: NSD emerges as an extremely cost-effective public health intervention.

Ethical analysis of the justifiability of labelling with COPD for smoking cessation.

BACKGROUND: Spirometry for early detection of chronic obstructive pulmonary disease (COPD) and smoking cessation is criticised because of the potential negative effects of labelling with disease. AIM: To assess the effects of opinions of smokers with mild to moderate COPD on the effectiveness of spirometry for smoking cessation, the justification of early detection of airflow limitation in smokers and the impact of confrontation with COPD. DESIGN: Qualitative study with data from a randomised controlled trial. SETTING: General population of Dutch and Belgian Limburg. METHODS: Semistructured ethical exit interviews were conducted with 205 smokers who were motivated to quit smoking and had no prior diagnosis of COPD but were detected with airflows limitation by means of spirometry. They received either (1) counselling, including labelling with COPD, plus with nortriptyline for smoking cessation, (2) counselling excluding labelling with COPD, plus nortriptyline for smoking cessation or (3) care as usual for smoking cessation by the general practitioner, without labelling with COPD. RESULTS: Of the participants, 177 (86%) agreed or completely agreed that it is justified to measure lung function in heavy smokers. These participants argued that measuring lung function raises consciousness of the negative effects of smoking, helps to prevent disease or increases motivation to stop smoking. Most of the 18 participants who disagreed argued that routinely measuring lung function in smokers would interfere with freedom of choice. CONCLUSIONS: Labelling with disease is probably a less important issue in the discussion about the pros and cons of early detection of COPD.

Efficacy of confronting smokers with airflow limitation for smoking cessation.

The objective of the present study was to test whether confronting smokers with previously undetected chronic obstructive pulmonary disease (COPD) increases the rate of smoking cessation. In total, 296 smokers with no prior diagnosis of COPD were detected with mild-to-moderate airflow limitation by means of spirometry and randomly allocated to: confrontational counselling by a nurse with nortriptyline for smoking cessation (experimental group); regular counselling by a nurse with nortriptyline (control group 1); or "care as usual" for smoking cessation by the general practitioner (control group 2). Only the experimental group was confronted with their abnormal spirometry (mean forced expiratory volume in one second (FEV(1)) post-bronchodilator 80.5% predicted, mean FEV(1)/forced vital capacity post-bronchodilator 62.5%). There was no difference in cotinine-validated prolonged abstinence rate between the experimental group (11.2%) and control group 1 (11.6%) from week 5-52 (odds ratio (OR) 0.96, 95% confidence interval (CI) 0.43-2.18). The abstinence rate was approximately twice as high in the experimental group compared with control group 2 (5.9%), but this difference was not statistically significant (OR 2.02, 95% CI 0.63-6.46). The present study did not provide evidence that the confrontational approach increases the rate of long-term abstinence from smoking compared with an equally intensive treatment in which smokers were not confronted with spirometry. The high failure rates (> or =88%) highlight the need for treating tobacco addiction as a chronic relapsing disorder.

Explaining the social gradient in smoking cessation: it's not in the trying, but in the succeeding.

OBJECTIVE: Smokers from more deprived socioeconomic groups are less likely to become ex-smokers. This study examined how far this is attributable in England to a social gradient in quit attempts, use of aids to cessation and/or the success of quit attempts. DESIGN: Cross-sectional household survey. SETTING: England. PARTICIPANTS: 6950 respondents aged 16+ who had smoked in the past year, of whom 2983 had tried to stop in the past year and 469 reported having stopped at the time of the survey. MAIN OUTCOME MEASURES: Reported attempts to stop smoking in the past year; the use of stop-smoking medications (nicotine replacement therapy, bupropion or varenicline); use of behavioural support offered by the National Health Service Stop Smoking Services; current smoking status. RESULTS: There was a large difference in success rates of quit attempts: 20.4% in social grade AB versus 11.4% in social grade E of those who made attempts were still not smoking by the time of the survey (p<0.001). However, there was no difference across social grades in the rate of attempts to stop (42.7% in social grade AB to 41.3% in E), use of medications to aid cessation (46.7% of those making quit attempts in AB to 50.9% in E) or use of NHS Stop Smoking Services (7.0% of those making quit attempts in AB to 4.8% in E). CONCLUSIONS: Smokers in more deprived socioeconomic groups are just as likely as those in higher groups to try to stop and use aids to cessation but there is a strong gradient across socioeconomic groups in success, with those in the lowest group being half as likely to succeed compared with the highest. Determining the cause of, and counteracting, this gradient is paramount in reducing health inequalities.

Smoking cessation treatment by Dutch respiratory nurses: reported practice, attitudes and perceived effectiveness.

OBJECTIVE: To describe Dutch respiratory nurses' current smoking cessation practices, attitudes and beliefs, and to compare these with a survey from the year 2000, before the national introduction of a protocol for the treatment of nicotine and tobacco addiction (the L-MIS protocol). METHODS: Questionnaire survey among all 413 registered respiratory nurses in the Netherlands in 2006. RESULTS: The response rate was 62%. Seventy-seven percent of the respondents reported to have "fairly good" or "good" knowledge of all steps of the L-MIS protocol. Seven out of 10 behavioural techniques for smoking cessation from the protocol were used by more than 94% of the respondents. Seventy-four percent of the respiratory nurses recommended the use of either nicotine replacement therapy (70%) or bupropion (44%). Almost two-thirds (65% of 254) perceived lack of patient's motivation as the most important barrier for smoking cessation treatment; a four-fold increase compared to the year 2000. CONCLUSION: We conclude that respiratory nurses are compliant with the L-MIS protocol. They offer intensive support and use behavioural techniques for smoking cessation more frequently than evidence-based pharmacological aids for smoking cessation. Perceived lack of patient's motivation forms the most important threat to respiratory nurses' future smoking cessation activities. PRACTICE IMPLICATIONS: International guidelines acknowledge that respiratory patients have a more urgent need to stop smoking but have more difficulty doing so. They should be offered the most intensive smoking cessation counselling in combination with pharmacotherapy. This kind of counselling may be more feasible for respiratory nurses than for physicians who often lack time. Their efforts could be increased by reimbursing pharmacological aids for smoking cessation and by developing simple tools to systematically assess motivation to quit and psychiatric co-morbidity in smoking patients.

Principles of confrontational counselling in smokers with chronic obstructive pulmonary disease (COPD).

Chronic obstructive pulmonary disease (COPD) is a major public health problem. The use of spirometry for early detection of COPD is a current issue of debate because of lack of convincing evidence of the additional positive effect of spirometry on smoking cessation. In this article, we present conditions under which early detection of COPD and confrontation may be effective, highlighting the principles of "confrontational counselling". Confronting patients with COPD is not an isolated approach but should be integrated into state-of-the-art smoking cessation treatment. Confrontational counselling should consist of several counselling sessions on an individual, face-to-face level, under supervision of a trained smoking cessation specialist, and in combination with evidence-based pharmacological treatment for smoking cessation.

External validation of a COPD diagnostic questionnaire.

The aim of the present study was to determine the external validity of a recently developed questionnaire for the identification of patients at increased risk of airflow limitation in smokers from the general population in the provinces of Dutch and Belgian Limburg (regions surrounding Maastricht, the Netherlands). As part of a study on the early detection of airflow limitation and subsequent smoking cessation treatment (International Standard Randomised Controlled Trial Number: 64481813), the recently developed chronic obstructive pulmonary disease (COPD) diagnostic questionnaire was used in current smokers aged 40-70 yrs, with a smoking history of >or=10 pack-yrs, who reported one or more respiratory symptom (cough, sputum production or dyspnoea), but who had no diagnosis of a respiratory disease (COPD or asthma). Spirometry performed according to American Thoracic Society/European Respiratory Society criteria served as a reference test. Of the 676 subjects who entered the analyses, 398 showed normal lung function and 278 had a diagnosis of COPD (post-bronchodilator forced expiratory volume in one second/forced vital capacity of <0.70). The ability of the COPD diagnostic questionnaire to discriminate between subjects with and without COPD was poor (area under the receiver operating characteristic curve of 0.65). In a high-risk population consisting of middle-aged current smokers with a smoking history of >or=10 pack-yrs, the chronic obstructive pulmonary disease diagnostic questionnaire is probably not useful as a diagnostic tool for the identification of patients with an increased risk of airflow limitation.