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1.  ‘To use or not to use’: a qualitative study to evaluate experiences of healthcare providers and patients with the assessment of burden of COPD (ABC) tool 
In the management of chronic conditions, such as chronic obstructive pulmonary disease (COPD), there is a shift from doctor-driven care to patient-centred integrated care with active involvement of and self-management by the patient. A recently developed tool, the assessment of burden of COPD (ABC) tool, can be used in this transition to facilitate self-management support and shared decision-making. We performed a qualitative study, in which we collected and analysed the data using the methods of conventional content analyses. We performed in-depth interviews consisting of mainly open questions. Fifteen healthcare providers and 21 patients were interviewed who had worked with the ABC tool in daily care. In general, participants responded positively to the tool. Healthcare providers felt the visual representation provided was effective and comprehensible for patients and provided them with insight into their disease, a finding that patients confirmed. If patients were allowed to choose between a consultation with or without the ABC tool, the majority would prefer using the tool: it provides them with an overview and insight, which makes it easier to discuss all relevant topics related to COPD. The tool can provide structure in consultations, and is compatible with the concepts of ‘motivational interviewing’ and ‘individualised care-planning’. Suggestions for improvement related to content and layout. So far, the tool has only been available as a stand-alone online program, that is not connected to the electronic medical record systems. It was therefore suggested that the tool be integrated into the systems to enhance its usability and its uptake by healthcare providers.
PMCID: PMC5113148  PMID: 27853139
2.  Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care 
BMJ Open  2016;6(7):e011519.
Assessing 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) measured with the St. George's Respiratory Questionnaire (SGRQ), compared with usual care.
A pragmatic cluster randomised controlled trial, in 39 Dutch primary care practices and 17 hospitals, with 357 patients with COPD (postbronchodilator FEV1/FVC ratio <0.7) aged ≥40 years, who could understand and read the Dutch language. Healthcare providers were randomly assigned to the intervention or control group. The intervention group applied the ABC tool, which consists of a short validated questionnaire assessing the experienced burden of COPD, objective COPD parameter (eg, lung function) and a treatment algorithm including a visual display and treatment advice. The control group provided usual care. Researchers were blinded to group allocation during analyses. Primary outcome was the number of patients with a clinically relevant improvement in SGRQ score between baseline and 18-month follow-up. Secondary outcomes were the COPD Assessment Test (CAT) and the Patient Assessment of Chronic Illness Care (PACIC; a measurement of perceived quality of care).
At 18-month follow-up, 34% of the 146 patients from 27 healthcare providers in the intervention group showed a clinically relevant improvement in the SGRQ, compared with 22% of the 148 patients from 29 healthcare providers in the control group (OR 1.85, 95% CI 1.08 to 3.16). No difference was found on the CAT (−0.26 points (scores ranging from 0 to 40); 95% CI −1.52 to 0.99). The PACIC showed a higher improvement in the intervention group (0.32 points (scores ranging from 1 to 5); 95% CI 0.14 to 0.50).
This study showed that use of the ABC tool may increase quality of life and perceived quality of care.
Trial registration number
NTR3788; Results.
PMCID: PMC4947734  PMID: 27401361
Chronic Obstructive Pulmonary Disease; Shared Decision Making; Patient-centred care; Quality of Life; Disease Management; Communication tool
3.  Comparative analysis of smoking cessation smartphone applications available in 2012 versus 2014 
Addictive Behaviors  2016;58:175-181.
Background and aims
Smartphone applications (apps) offer a potentially cost-effective and a wide-reach aid to smoking cessation. In 2012, a content analysis of smoking cessation apps suggested that most apps did not adopt behaviour change techniques (BCTs), which according to previous research had suggested would promote higher success rates in quitting smoking. This study examined whether or not, this situation had changed by 2014 for free smoking cessation apps available in the Apple App Store. It also compared the use of engagement and ease-of-use features between the two time points.
137 free apps available in the Apple App Sore in 2014 were coded using an established framework for the presence or absence of evidence-based BCTs, and engagement and ease-of-use features. The results from the 2014 data were compared with a similar exercise conducted on 83 free apps available in 2012.
BCTs supporting identity change, rewarding abstinence and advising on changing routines were less prevalent in 2014 as compared with 2012 (14.6% vs. 42.2%, 18.2% vs. 48.2%, and 17.5% vs. 24.1%, respectively). Advice on coping with cravings and advice on the use of stop-smoking medication were more prevalent in 2014 as compared with 2012 (27.7% vs. 20.5% and 14.6% vs 3.6%, respectively). The use of recognised engagement features was less common in 2014 than in 2012 (45.3% vs. 69.6%) while ease-of-use features remained very high (94.5% vs. 82.6%).
There was little evidence of improvement in the use of evidence-based BCTs in free smoking cessation iPhone-based apps between 2012 and 2014.
PMCID: PMC4821061  PMID: 26950256
Smoking; Smoking cessation; Smartphone; Apps; Applications; Mobile; Behaviour change intervention; Behaviour change techniques; Taxonomy; BCTs; Engagement; Ease-of-use; Content analysis
4.  Characterising smoking cessation smartphone applications in terms of behaviour change techniques, engagement and ease-of-use features 
The aim of this study was to assess whether or not behaviour change techniques (BCTs) as well as engagement and ease-of-use features used in smartphone applications (apps) to aid smoking cessation can be identified reliably. Apps were coded for presence of potentially effective BCTs, and engagement and ease-of-use features. Inter-rater reliability for this coding was assessed. Inter-rater agreement for identifying presence of potentially effective BCTs ranged from 66.8 to 95.1 % with ‘prevalence and bias adjusted kappas’ (PABAK) ranging from 0.35 to 0.90 (p < 0.001). The intra-class correlation coefficients between the two coders for scores denoting the proportions of (a) a set of engagement features and (b) a set of ease-of-use features, which were included, were 0.77 and 0.75, respectively (p < 0.001). Prevalence estimates for BCTs ranged from <10 % for medication advice to >50 % for rewarding abstinence. The average proportions of specified engagement and ease-of-use features included in the apps were 69 and 83 %, respectively. The study found that it is possible to identify potentially effective BCTs, and engagement and ease-of-use features in smoking cessation apps with fair to high inter-rater reliability.
Electronic supplementary material
The online version of this article (doi:10.1007/s13142-015-0352-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4987605  PMID: 27528530
Smoking; Smoking cessation; Smartphone; Apps; Applications; Mobile; Behaviour change interventions; Behaviour change techniques; Taxonomy; BCTs; Engagement; Ease-of-use; Feature
5.  Experiences of tobacco smoking and quitting in smokers with and without chronic obstructive pulmonary disease-a qualitative analysis 
BMC Family Practice  2015;16:164.
Smokers with chronic obstructive pulmonary disease (COPD) seem to be a special subgroup of smokers that have a more urgent need to quit smoking but might find it more difficult to do so. This study aimed to explore which justifications for tobacco smoking and experiences of quitting were commonly shared in smokers with and without COPD, and which, if any, were specific to smokers with COPD.
In ten primary healthcare centres in the Netherlands, we conducted semi-structured, in-depth interviews in 10 smokers with and 10 smokers without COPD.
Three themes were generated: ‘balancing the impact on health of smoking’, ‘challenging of autonomy by social interference’, ‘prerequisites for quitting’. All participants trivialized health consequences of smoking; those with COPD seemed to be less knowledgeable about smoking and health. Both groups of smokers found autonomy very important. Smokers with COPD were indignant about a perceived lack of empathy in their communication with doctors. Furthermore, smokers with COPD in particular had little faith in the efficacy of smoking cessation aids. Lastly, motivation for quitting was dominated by fluctuation and smokers with COPD specifically maintained that their vision of life was linked with quitting.
The participants showed many similarities in their reasoning about smoking and quitting. The corresponding themes argue for a less paternalistic regime in the communication with smokers with attention required for the motivational stage and room made for smokers’ own views, and with clear information and education. Furthermore, addressing social interactions, health perceptions and moral agendas in the communication with smokers with COPD may help to make smoking cessation interventions more suitable for them.
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-015-0382-y) contains supplementary material, which is available to authorized users.
PMCID: PMC4634152  PMID: 26537703
6.  Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study 
The Lancet. Respiratory Medicine  2015;3(10):761-768.
Varenicline is an effective pharmacotherapy to aid smoking cessation. However, its use is limited by continuing concerns about possible associated risks of serious adverse cardiovascular and neuropsychiatric events. The aim of this study was to investigate whether use of varenicline is associated with such events.
In this retrospective cohort study, we used data from patients included in the validated QResearch database, which holds data from 753 National Health Service general practices across England. We identified patients aged 18–100 years (registered for longer than 12 months before data extraction) who received a prescription of nicotine replacement treatment (NRT; reference group), bupropion, or varenicline. We excluded patients if they had used one of the drugs during the 12 months before the start date of the study, had received a prescription of a combination of these drugs during the follow-up period, or were temporary residents. We followed patients up for 6 months to compare incident cardiovascular (ischaemic heart disease, cerebral infarction, heart failure, peripheral vascular disease, and cardiac arrhythmia) and neuropsychiatric (depression and self-harm) events using Cox proportional hazards models, adjusted for potential confounders (primary outcomes).
We identified 164 766 patients who received a prescription (106 759 for nicotine replacement treatment; 6557 for bupropion; 51 450 for varenicline) between Jan 1, 2007, and June 30, 2012. Neither bupropion nor varenicline showed an increased risk of any cardiovascular or neuropsychiatric event compared with NRT (all hazard ratios [HRs] less than 1. Varenicline was associated with a significantly reduced risk of ischaemic heart disease (HR 0·80 [95%CI 0·72–0·87]), cerebral infarction (0·62 [0·52–0·73]), heart failure (0·61 [0·45–0·83]), arrhythmia (0·73 [0·60–0·88]), depression (0·66 [0·63–0·69]), and self-harm (0·56 [0·46–0·68]).
Varenicline does not seem to be associated with an increased risk of documented cardiovascular events, depression, or self-harm when compared with NRT. Adverse events that do not come to attention of general practitioners cannot be excluded. These findings suggest an opportunity for physicians to prescribe varenicline more broadly, even for patients with comorbidities, thereby helping more smokers to quit successfully than do at present.
Egton Medical Information Systems, University of Nottingham, Ministry of Innovation, Science and Research of the German Federal State of North Rhine-Westphalia, Cancer Research UK, Medical Research Council, Commonwealth Fund.
PMCID: PMC4593936  PMID: 26355008
7.  A Mobile App to Aid Smoking Cessation: Preliminary Evaluation of SmokeFree28 
Little is known about the effectiveness of mobile apps in aiding smoking cessation or their validity for automated collection of data on smoking cessation outcomes.
We conducted a preliminary evaluation of SF28 (SF28 is the name of the app, short for SmokeFree28)—an app aimed at helping smokers to be smoke-free for 28 days.
Data on sociodemographic characteristics, smoking history, number of logins, and abstinence at each login were uploaded to a server from SF28 between August 2012 and August 2013. Users were included if they were aged 16 years or over, smoked cigarettes at the time of registration, had set a quit date, and used the app at least once on or after their quit date. Their characteristics were compared with data from a representative sample of smokers trying to stop smoking in England. The percentage of users recording 28 days of abstinence was compared with a value of 15% estimated for unaided quitting. Correlations were assessed between recorded abstinence for 28 days and well-established abstinence predictors.
A total of 1170 users met the inclusion criteria. Compared with smokers trying to quit in England, they had higher consumption, and were younger, more likely to be female, and had a non-manual rather than manual occupation. In total, 18.9% (95% CI 16.7-21.1) were recorded as being abstinent from smoking for 28 days or longer. The mean number of logins was 8.5 (SD 9.0). The proportion recording abstinence for 28 days or longer was higher in users who were older, in a non-manual occupation, and in those using a smoking cessation medication.
The recorded 28-day abstinence rates from the mobile app, SF28, suggest that it may help some smokers to stop smoking. Further evaluation by means of a randomized trial appears to be warranted.
PMCID: PMC4319069  PMID: 25596170
smoking cessation intervention; mobile; smartphone; apps; PRIME theory
8.  Prospective cohort study of the effectiveness of varenicline versus nicotine replacement therapy for smoking cessation in the “real world” 
BMC Public Health  2014;14:1163.
It is important to know the comparative effectiveness of varenicline and nicotine replacement therapy (NRT) for smoking cessation when prescribed under routine circumstances and in the general population. Previous estimates relied on cross-sectional data. The objective of the current study was to use longitudinal data to compare the abstinence rates of smokers trying to stop having used varenicline versus NRT on prescription (Rx) when provided with minimal professional support in the general population while adjusting for key potential confounders.
Prospective cohort study in 270 adults who participated in a household survey, smoked at baseline, responded to the 6-month follow-up survey, and made at least one quit attempt between the two measurements with either varenicline or NRT Rx in their most recent quit attempt. The main outcome measure was self-reported abstinence up to the time of the survey, adjusted for key potential confounders including cigarette dependence (measured at baseline).
Users of varenicline were younger, reported more time spent with urges to smoke at baseline, and were less likely to stop abruptly during their last quit attempt (all p < 0.01). The adjusted odds of abstinence in users of varenicline were 3.83 (95% CI = 1.88-7.77) times higher compared with users of NRT Rx.
Varenicline use with minimal professional support in the general population of smokers appears more effective than NRT Rx in achieving abstinence.
PMCID: PMC4242476  PMID: 25392075
Smoking cessation; Varenicline; Nicotine replacement therapy; Behavioural support; Prospective cohort study
9.  Prospective Cohort Study of the Effectiveness of Smoking Cessation Treatments Used in the “Real World” 
Mayo Clinic Proceedings  2014;89(10):1360-1367.
To estimate the “real-world” effectiveness of commonly used aids to smoking cessation in England by using longitudinal data.
Patients and Methods
We conducted a prospective cohort study in 1560 adult smokers who participated in an English national household survey in the period from November 2006 to March 2012, responded to a 6-month follow-up survey, and made at least 1 quit attempt between the 2 measurements. The quitting method was classified as follows: (1) prescription medication (nicotine replacement therapy [NRT], bupropion, or varenicline) in combination with specialist behavioral support delivered by a National Health Service Stop Smoking Service; (2) prescription medication with brief advice; (3) NRT bought over the counter; (4) none of these. The primary outcome measure was self-reported abstinence up to the time of the 6-month follow-up survey, adjusted for key potential confounders including cigarette dependence.
Compared with smokers using none of the cessation aids, the adjusted odds of remaining abstinent up to the time of the 6-month follow-up survey were 2.58 (95% CI, 1.48-4.52) times higher in users of prescription medication in combination with specialist behavioral support and 1.55 (95% CI, 1.11-2.16) times higher in users of prescription medication with brief advice. The use of NRT bought over the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94).
Prescription medication offered with specialist behavioral support and that offered with minimal behavioral support are successful methods of stopping cigarette smoking in England.
PMCID: PMC4194355  PMID: 25282429
NHS, National Health Service; NRT, nicotine replacement therapy
10.  Cardiovascular and neuropsychiatric safety of varenicline and bupropion compared with nicotine replacement therapy for smoking cessation: study protocol of a retrospective cohort study using the QResearch general practice database 
BMJ Open  2014;4(8):e005281.
Cigarette smoking continues to be the leading cause of preventable death and is the main risk factor of major diseases such as chronic obstructive pulmonary disease (COPD). The best treatment to help smokers quit is a combination of behavioural support with pharmacotherapy. Varenicline is the newest drug on the market and has been shown to be effective in the general smoking population and in smokers with COPD. The safety profile of varenicline was initially established using standard approaches to pharmacovigilance, but postmarketing reports have raised concerns about a possible association between the use of varenicline and cardiovascular and neuropsychiatric events. Although recent studies have not confirmed such an association, further research is needed given the large number of smokers who are being prescribed varenicline, including important subgroups such as smokers with COPD who may be particularly vulnerable to side effects of drugs. The aim of this study is to assess the cardiovascular and neuropsychiatric safety of varenicline using data from the QResearch general practice (GP) database.
Methods and analysis
We will conduct a retrospective cohort study in the QResearch GP database. Patients will be categorised into three exposure groups: prescription of (1) varenicline, (2) bupropion or (3) nicotine replacement therapy (NRT Rx; =reference group). We will separately consider major incident neuropsychiatric and cardiovascular outcomes that occur during 6 months of follow-up using Cox proportional hazards models, adjusted for confounders. Furthermore, propensity score analysis will be used as an analytical approach to account for potential confounding by indication.
Ethics and dissemination
This work involves analysis of anonymised, routinely collected data. The protocol has been independently peer-reviewed by the QResearch Scientific Board and meets the requirements of the Trent research ethics committee. We plan to disseminate the results from this study via articles in international peer-reviewed journals and presentations at relevant national and international health conferences.
PMCID: PMC4156814  PMID: 25168037
Epidemiology; Mental Health
11.  Effectiveness of the Assessment of Burden of Chronic Obstructive Pulmonary Disease (ABC) tool: study protocol of a cluster randomised trial in primary and secondary care 
BMC Pulmonary Medicine  2014;14:131.
Chronic Obstructive Pulmonary Disease (COPD) is a growing worldwide problem that imposes a great burden on the daily life of patients. Since there is no cure, the goal of treating COPD is to maintain or improve quality of life. We have developed a new tool, the Assessment of Burden of COPD (ABC) tool, to assess and visualize the integrated health status of patients with COPD, and to provide patients and healthcare providers with a treatment algorithm. This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary. The aim of the current study is to analyse the effectiveness of the ABC tool compared with usual care on health related quality of life among COPD patients over a period of 18 months.
A cluster randomised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherlands. An intervention group, receiving care based on the ABC tool, will be compared with a control group receiving usual care. The primary outcome will be the change in score on a disease-specific-quality-of-life questionnaire, the Saint George Respiratory Questionnaire. Secondary outcomes will be a different questionnaire (the COPD Assessment Test), lung function and number of exacerbations. During the 18 months follow-up, seven measurements will be conducted, including a baseline and final measurement. Patients will receive questionnaires to be completed at home. Additional data, such as number of exacerbations, will be recorded by the patients’ healthcare providers. A total of 360 patients will be recruited by 40 general practitioners and 20 pulmonologists. Additionally, a process evaluation will be performed among patients and healthcare providers.
The new ABC tool complies with the 2014 Global Initiative for Chronic Obstructive Lung Disease guidelines, which describe the necessity to classify patients on both their airway obstruction and a comprehensive symptom assessment. It has been developed to classify patients, but also to provide visual insight into the burden of COPD and to provide treatment advice.
Trial registration
Netherlands Trial Register, NTR3788.
PMCID: PMC4130125  PMID: 25098313
Chronic obstructive pulmonary disease; Disease burden; Quality of life; Patient reported outcomes; Shared decision making; GPs; Pulmonologists; Patient empowerment
12.  Development and validation of a model to predict the 10-year risk of general practitioner-recorded COPD 
There is increasing interest in the earlier detection of, and intervention in, patients at highest risk of developing chronic obstructive pulmonary disease (COPD).
The objective of this research was to develop and validate a risk prediction model for general practitioner (GP)-recorded diagnosis of COPD.
We used data from 239 Scottish GP practices; two-thirds were randomly allocated to a derivation cohort and the other third to a validation cohort. We included patients aged 35–74 years at the cohort entry date, and excluded patients with a recorded diagnosis of COPD prior to the entry date and with missing data on smoking status.
There were 480,903 patients in the derivation cohort and 247,755 in the validation cohort. The incidence of COPD in the total cohort was 5.53/1,000 patient-years of follow-up (95% confidence interval (CI), 5.46–5.60). In the derivation cohort, the COPD risk for ever- versus never-smokers was substantially higher in women (hazard ratio (HR)=9.61, 95% CI, 8.92–10.34) than in men (HR=6.72, 95% CI, 6.19–7.30). Other risk factors for both sexes were level of deprivation and a previously recorded asthma diagnosis. In the validation cohort, the model discriminated well between patients who did and those who did not develop COPD: area under the receiver operating characteristics curve=0.845 (95% CI, 0.840–0.850) for females and 0.832 (95% CI, 0.827–0.837) for males.
We have developed and validated the first risk prediction model for COPD, which has the major advantage of being populated entirely by routinely collected data and consequently may be used for clinical practice.
PMCID: PMC4373306  PMID: 24841327
13.  How effective and cost-effective was the national mass media smoking cessation campaign ‘Stoptober’?☆ 
Drug and Alcohol Dependence  2014;135(100):52-58.
A national smoking cessation campaign based on behaviour change theory and operating through both traditional and new media was launched across England during late 2012 (‘Stoptober’). In addition to attempting to start a movement in which smokers would quit at the same time in response to a positive mass quitting trigger, the campaign set smokers the goal of being smoke-free for October and embodied other psychological principles in a range of tools and communications.
Data on quit attempts were obtained from 31,566 past-year smokers during nationally representative household surveys conducted monthly between 2007 and 2012. The effectiveness of the campaign was assessed by the increase in national quit attempt rate in October relative to other months in 2012 vs. 2007–2011.
Relative to other months in the year, more people tried to quit in October in 2012 compared with 2007–2011 (OR = 1.79, 95%CI = 1.20–2.68). In 2012 there was an approximately 50% increase in quitting during October compared with other months of the same year (9.6% vs. 6.6%; OR = 1.50, 95%CI = 1.05–2.15), whereas in 2007–2011 the rate in October was non-significantly less than in other months of the same period (6.4% vs. 7.5%; OR = 0.84, 95%CI = 0.70–1.00). Stoptober is estimated to have generated an additional 350,000 quit attempts and saved 10,400 discounted life years (DLY) at less than £415 per DLY in the modal age group.
Designing a national public health campaign with a clear behavioural target (making a serious quit attempt) using key psychological principles can yield substantial behaviour change and public health impact.
PMCID: PMC3929003  PMID: 24322004
Smoking; Cessation; Quitting; Mass media; Cost-effectiveness; Stoptober
14.  Adult tobacco use practice and its correlates in eastern Ethiopia: A cross-sectional study 
There is paucity of data on the smoking habits of rural populations in developing countries. This study aimed to explore cigarette smoking practices of a rural community in Ethiopia.
A community based cross-sectional study was conducted among 548 individuals from a random sample of households in a rural town and its surrounding rural districts. Descriptive statistics and logistic regression were performed.
Twenty-eight percent (95% CI: 24.3% - 31.6%) of the respondents were current smokers. A total of 105 (68%) smokers expressed an interest to quit while 37 (34%) had tried to quit previously but without success. There was high exposure to second-hand smoke: 285 (52%) homes allowed indoor smoking, and in 181 (33%) indoor smoking took place daily. Current smoking was strongly associated with male sex (OR = 83.0; 95% CI: 11.5 – 599.0), and being a student was found to be protective of smoking (OR = 0.04; 95% CI: 0.005 – 0.05).
Cigarette smoking is prevalent among the male rural town population in Ethiopia. In addition, a high level of exposure to indoor second-hand smoke exists. There is a need for investment in rural tobacco control, including educational campaigns and cost-effective smoking cessation services.
PMCID: PMC4175506  PMID: 24171800
Smoking; Tobacco; Cigarettes; Ethiopia; Practice; Attitude; Rural; Population; Correlates
15.  The efficacy and safety of a nicotine conjugate vaccine (NicVAX®) or placebo co-administered with varenicline (Champix®) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial 
BMC Public Health  2012;12:1052.
A potential new treatment in smoking cessation and relapse prevention is nicotine vaccination which is based on active immunization against the nicotine molecule. This immunization will elicit the immune system to produce nicotine-specific antibodies that sequester nicotine in the blood stream, after inhaling tobacco products. The resulting antibody-antigen is too large to cross the blood–brain barrier and is therefore postulated to attenuate the rewarding effect of nicotine by preventing the latter from reaching its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine NicVAX® co-administered with varenicline (Champix®) and intensive counseling as an aid in smoking cessation and relapse prevention.
Two centers will include a total of 600 smokers who are motivated to quit smoking. At week −2 these smokers will be randomized, in a 1:1 ratio, to either 6 injections of NicVAX® or placebo, both co-administered with 12-weeks of varenicline treatment, starting at week 0. The target quit day will be set after 7 days of varenicline treatment at week 1. Smokers will be followed up for 54 weeks. The primary outcome is defined as biochemically validated prolonged smoking abstinence from week 9 to 52. Secondary outcomes include safety, immunogenicity, smoking abstinence from week 37 to 52, abstinence from week 9 to 24, abstinence in the subset of subjects with the highest antibody response, and lapse/relapse rate.
This is the first study to assess the efficacy of a nicotine conjugate vaccine in combination with an evidence-based smoking cessation pharmacotherapy (varenicline) to quit smoking. Although NicVAX® is primarily designed as an aid to smoking cessation, our study is designed to explore its potential to maintain abstinence and prevent relapse. The results of this trial will give a unique insight in the potential of nicotine vaccination for relapse prevention.
Trial registration (NCT00995033)
PMCID: PMC3547752  PMID: 23216646
Nicotine vaccination; NicVAX; Varenicline; Combination therapy; Efficacy; Safety; Immunogenicity; Randomized controlled trial
16.  IL6 and CRP haplotypes are associated with COPD risk and systemic inflammation: a case-control study 
BMC Medical Genetics  2009;10:23.
Elevated circulating levels of C-reactive protein (CRP), interleukin (IL)-6 and fibrinogen (FG) have been repeatedly associated with many adverse outcomes in patients with chronic obstructive pulmonary disease (COPD). To date, it remains unclear whether and to what extent systemic inflammation is primary or secondary in the pathogenesis of COPD.
The aim of this study was to examine the association between haplotypes of CRP, IL6 and FGB genes, systemic inflammation, COPD risk and COPD-related phenotypes (respiratory impairment, exercise capacity and body composition).
Eighteen SNPs in three genes, representing optimal haplotype-tagging sets, were genotyped in 355 COPD patients and 195 healthy smokers. Plasma levels of CRP, IL-6 and FG were measured in the total study group. Differences in haplotype distributions were tested using the global and haplotype-specific statistics.
Raised plasma levels of CRP, IL-6 and fibrinogen were demonstrated in COPD patients. However, COPD population was very heterogeneous: about 40% of patients had no evidence of systemic inflammation (CRP < 3 mg/uL or no inflammatory markers in their top quartile). Global test for haplotype effect indicated association of CRP gene and CRP plasma levels (P = 0.0004) and IL6 gene and COPD (P = 0.003). Subsequent analysis has shown that IL6 haplotype H2, associated with an increased COPD risk (p = 0.004, OR = 4.82; 1.64 to 4.18), was also associated with very low CRP levels (p = 0.0005). None of the genes were associated with COPD-related phenotypes.
Our findings suggest that common genetic variation in CRP and IL6 genes may contribute to heterogeneity of COPD population associated with systemic inflammation.
PMCID: PMC2660301  PMID: 19272152
17.  Efficacy of confrontational counselling for smoking cessation in smokers with previously undiagnosed mild to moderate airflow limitation: study protocol of a randomized controlled trial 
BMC Public Health  2007;7:332.
The use of spirometry for early detection of chronic obstructive pulmonary disease (COPD) is still an issue of debate, particularly because of a lack of convincing evidence that spirometry has an added positive effect on smoking cessation. We hypothesise that early detection of COPD and confrontation with spirometry for smoking cessation may be effective when applying an approach we have termed "confrontational counselling"; a patient-centred approach which involves specific communication skills and elements of cognitive therapy. An important aspect is to confront the smoker with his/her airflow limitation during the counselling sessions. The primary objective of this study is to test the efficacy of confrontational counselling in comparison to regular health education and promotion for smoking cessation delivered by specialized respiratory nurses in current smokers with previously undiagnosed mild to moderate airflow limitation.
The study design is a randomized controlled trial comparing confrontational counselling delivered by a respiratory nurse combined with nortriptyline for smoking cessation (experimental group), health education and promotion delivered by a respiratory nurse combined with nortriptyline for smoking cessation (control group 1), and "care as usual" delivered by the GP (control group 2). Early detection of smokers with mild to moderate airflow limitation is achieved by means of a telephone interview in combination with spirometry. Due to a comparable baseline risk of airflow limitation and motivation to quit smoking, and because of the standardization of number, duration, and scheduling of counselling sessions between the experimental group and control group 1, the study enables to assess the "net" effect of confrontational counselling. The study has been ethically approved and registered.
Ethical as well as methodological considerations of the study are discussed in this protocol. A significant and relevant effect of confrontational counselling would provide an argument in favour of early detection of current smokers with airflow limitation. Successful treatment of tobacco dependence in respiratory patients requires repeated intensive interventions. The results of this study may also show that respiratory nurses are able to deliver this treatment and that intensive smoking cessation counselling is more feasible.
Trial registration:
Netherlands Trial Register (ISRCTN 64481813).
PMCID: PMC2234415  PMID: 18005415
18.  Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study 
Addiction (Abingdon, England)  2014;109(9):1531-1540.
Background and Aims
Electronic cigarettes (e-cigarettes) are rapidly increasing in popularity. Two randomized controlled trials have suggested that e-cigarettes can aid smoking cessation, but there are many factors that could influence their real-world effectiveness. This study aimed to assess, using an established methodology, the effectiveness of e-cigarettes when used to aid smoking cessation compared with nicotine replacement therapy (NRT) bought over-the-counter and with unaided quitting in the general population.
Design and Setting
A large cross-sectional survey of a representative sample of the English population.
The study included 5863 adults who had smoked within the previous 12 months and made at least one quit attempt during that period with either an e-cigarette only (n = 464), NRT bought over-the-counter only (n = 1922) or no aid in their most recent quit attempt (n = 3477).
The primary outcome was self-reported abstinence up to the time of the survey, adjusted for key potential confounders including nicotine dependence.
E-cigarette users were more likely to report abstinence than either those who used NRT bought over-the-counter [odds ratio (OR) = 2.23, 95% confidence interval (CI) = 1.70–2.93, 20.0 versus 10.1%] or no aid (OR = 1.38, 95% CI = 1.08–1.76, 20.0 versus 15.4%). The adjusted odds of non-smoking in users of e-cigarettes were 1.63 (95% CI = 1.17–2.27) times higher compared with users of NRT bought over-the-counter and 1.61 (95% CI = 1.19–2.18) times higher compared with those using no aid.
Among smokers who have attempted to stop without professional support, those who use e-cigarettes are more likely to report continued abstinence than those who used a licensed NRT product bought over-the-counter or no aid to cessation. This difference persists after adjusting for a range of smoker characteristics such as nicotine dependence.
PMCID: PMC4171752  PMID: 24846453
Cessation; cross-sectional population survey; e-cigarettes; electronic cigarettes; nicotine replacement therapy; NRT; quitting; smoking

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