Structured alcohol cessation support program versus current practice in acute alcoholic pancreatitis (PANDA):Study protocol for a multicentre cluster randomised controlled trial

Background/objectives: The most important risk factor for recurrent pancreatitis after an episode of acute alcoholic pancreatitis is continuation of alcohol use. Current guidelines do not recommend any specific treatment strategy regarding alcohol cessation. The PANDA trial investigates whether implementation of a structured alcohol cessation support program prevents pancreatitis recurrence after a first episode of acute alcoholic pancreatitis. Methods: PANDA is a nationwide cluster randomised superiority trial. Participating hospitals are randomised for the investigational management, consisting of a structured alcohol cessation support program, or current practice. Patients with a first episode of acute pancreatitis caused by harmful drinking (AUDIT score &gt;7 and &lt; 16 for men and &gt;6 and &lt; 14 for women) will be included. The primary endpoint is recurrence of acute pancreatitis. Secondary endpoints include cessation or reduction of alcohol use, other alcohol-related diseases, mortality, quality of life, quality-adjusted life years (QALYs) and costs. The follow-up period comprises one year after inclusion. Discussion: This is the first multicentre trial with a cluster randomised trial design to investigate whether a structured alcohol cessation support program reduces recurrent acute pancreatitis in patients after a first episode of acute alcoholic pancreatitis, as compared with current practice. Trial registration: Netherlands Trial Registry (NL8852). Prospectively registered.</p

Recruitment using mobile telephones in an Irish general population sexual health survey: challenges and practical solutions

BACKGROUND: Non-coverage of households without a landline telephone is a major concern of telephone survey researchers. Sampling mobile telephone users in national surveys is vital in order to gain access to the growing proportion of households that use mobile telephones extensively or exclusively. The complex logistics of conducting surveys with mobile telephones have been discussed in the literature. This paper outlines the actual challenges encountered during a recent national sexual health survey in Ireland, which utilized a mobile telephone sampling frame to recruit approximately half of the sample. METHOD: The 2010 Irish Contraception and Crisis Pregnancy Survey (ICCP-2010) is a nationally representative sample of adults aged 18-45 years living in Ireland (n = 3002; 1416 recruited by landline telephone and 1586 recruited by mobile telephone). The overall response rate for the survey was 69% (79% for the landline telephone strand; 61% for the mobile telephone strand). All interviews were conducted using computer-assisting telephone interviewing. RESULTS: During the 18-week fieldwork period, five main challenges relating to the use of mobile telephones were encountered: (1) explaining to respondents how random digit dialling works in relation to mobile telephones; (2) establishing the respondent\u27s eligibility; (3) calling the respondent with the Caller ID blocked or withheld; (4) calling the respondent when they are in any number of locations or situations; and (5) explaining to respondents the importance of refusal conversion calls for the response rate calculation. Details of how the survey protocols and procedures were monitored and adapted throughout the study to ensure a high response rate are outlined. CONCLUSION: It is undeniably more challenging to recruit respondents using mobile telephones as opposed to landline telephones. Respondents are generally not familiar with being contacted on their personal mobile telephone for the purposes of being recruited for a research study. The main challenge for survey methodologists and interviewers is to devise simple protocols to explain to respondents why they are being contacted on a mobile telephone. Recommendations for survey researchers interested in using this methodological approach in the future are discussed

Impact of complications after resection of pancreatic cancer on disease recurrence and survival, and mediation effect of adjuvant chemotherapy:nationwide, observational cohort study

Background: The causal pathway between complications after pancreatic cancer resection and impaired long-term survival remains unknown. The aim of this study was to investigate the impact of complications after pancreatic cancer resection on disease-free interval and overall survival, with adjuvant chemotherapy as a mediator.Methods: This observational study included all patients undergoing pancreatic cancer resection in the Netherlands (2014-2017). Clinical data were extracted from the prospective Dutch Pancreatic Cancer Audit. Recurrence and survival data were collected additionally. In causal mediation analysis, direct and indirect effect estimates via adjuvant chemotherapy were calculated.Results: In total, 1071 patients were included. Major complications (hazards ratio 1.22 (95 per cent c.i. 1.04 to 1.43); P = 0.015 and hazards ratio 1.25 (95 per cent c.i. 1.08 to 1.46); P = 0.003) and organ failure (hazards ratio 1.86 (95 per cent c.i. 1.32 to 2.62); P &lt; 0.001 and hazards ratio 1.89 (95 per cent c.i. 1.36 to 2.63); P &lt; 0.001) were associated with shorter disease-free interval and overall survival respectively. The effects of major complications and organ failure on disease-free interval (-1.71 (95 per cent c.i. -2.27 to -1.05) and -3.05 (95 per cent c.i. -4.03 to -1.80) respectively) and overall survival (-1.92 (95 per cent c.i. -2.60 to -1.16) and -3.49 (95 per cent c.i. -4.84 to -2.03) respectively) were mediated by adjuvant chemotherapy. Additionally, organ failure directly affected disease-free interval (-5.38 (95 per cent c.i. -9.27 to -1.94)) and overall survival (-6.32 (95 per cent c.i. -10.43 to -1.99)). In subgroup analyses, the association was found in patients undergoing pancreaticoduodenectomy, but not in patients undergoing distal pancreatectomy.Conclusion: Major complications, including organ failure, negatively impact survival in patients after pancreatic cancer resection, largely mediated by adjuvant chemotherapy. Prevention or adequate treatment of complications and use of neoadjuvant treatment may improve oncological outcomes.</p

Extent and correlates of self-reported exposure to tobacco advertising, promotion and sponsorship in smokers: Findings from the EUREST-PLUS ITC Europe Surveys

Introduction: Tobacco advertising, promotion and sponsorship (TAPS) are known to promote tobacco consumption and to discourage smoking cessation. Consequently, comprehensive TAPS bans are effective measures to reduce smoking. The objective of this study was to investigate to what extent smokers are exposed to TAPS in general, and in various media and localities, in different European countries. Methods: A cross-sectional analysis of national representative samples of adult smokers in 2016 from Germany, Greece, Hungary, Poland, Romania, and Spain (EUREST-PLUS Project, n=6011), as well as England (n=3503) and the Netherlands (n=1213) (ITC Europe Surveys) was conducted. Prevalence of self-reported TAPS exposure is reported by country, and socioeconomic correlates were investigated using logistic regression models. Results: Self-reported exposure to TAPS varied widely among the countries, from 15.4 % in Hungary to 69.2 % in the Netherlands. In most countries, tobacco advertising was most commonly seen at the point of sale, and rarely noticed in mass media. The multivariate analysis revealed some variation in exposure to TAPS by sociodemographic factors. Age showed the greatest consistency across countries with younger smokers (18–24 years) being more likely to notice TAPS than older smokers. Conclusions: TAPS exposure tended to be higher in countries with less restrictive regulation but was also reported in countries with more comprehensive bans, although at lower levels. The findings indicate the need for a comprehensive ban on TAPS to avoid a shift of marketing efforts to less regulated channels, and for stronger enforcement of existing bans

Patterns of tobacco use, quit attempts, readiness to quit and self-efficacy among smokers with anxiety or depression: Findings among six countries of the EUREST-PLUS ITC Europe Surveys

Introduction: We compared smoking behaviors, past quit attempts, readiness to quit and beliefs about quitting among current cigarette smokers with probable anxiety or depression (PAD) to those without PAD, from six European Union (EU) Member States (MS). Methods: A nationally representative cross-sectional sample of 6011 adult cigarette smokers from six EU MS (Germany, Greece, Hungary, Poland, Romania, Spain) was randomly selected through a multistage cluster sampling design in 2016. Respondents were classified as having PAD based on self-reported current diagnosis or treatment for anxiety or depression, or a positive screen for major depression, according to a validated two-item instrument. Sociodemographic characteristics, patterns of tobacco use, past quitting, readiness to quit, self-efficacy and beliefs about quitting were assessed for patients with and without PAD. Logistic regression was used to examine predictors of PAD. All analyses were conducted using the complex samples package of SPSS. Results: Among smokers sampled, 21.0% (95% CI: 19.3–22.9) were identified as having PAD. Logistic regression analyses controlling for socioeconomic variables and cigarettes smoked per day found smokers with PAD were more likely to have made an attempt to quit smoking in the past (AOR=1.48; 95% CI: 1.25–1.74), made a quit attempt in the last 12 months (AOR=1.75; 95% CI: 1.45–2.11), and report lower self-efficacy with quitting (AOR=1.83; 95% CI: 1.44–2.32) compared to smokers without PAD. Additionally, it was found that individuals with PAD were more likely to report having received advice to quit from a doctor or health professional and having used quitline support as part of their last quit attempt. Conclusions: Smokers with PAD report a greater interest in quitting in the future and more frequent failed quit attempts than smokers without PAD; however, the high rates of untreated anxiety or depression, nicotine dependence, low confidence in the ability to quit, infrequent use of cessation methods, as well as socioeconomic factors may make quitting difficult

Social norms towards smoking and electronic cigarettes among adult smokers in seven European Countries: Findings from the EUREST-PLUS ITC Europe Surveys

Introduction: This study explores whether current smokers’ social norms towards smoking and electronic cigarettes (e-cigarettes) vary across seven European countries alongside smoking and e-cigarette prevalence rates. At the time of surveying, England had the lowest current smoking prevalence and Greece the highest. Hungary, Romania and Spain had the lowest prevalence of any e-cigarette use and England the highest. // Methods: Respondents were adult (≥18 years) current smokers from the 2016 EUREST-PLUS ITC (Romania, Spain, Hungary, Poland, Greece, Germany) and ITC 4CV England Surveys (N=7779). Using logistic regression, associations between country and (a) smoking norms and (b) e-cigarette norms were assessed, adjusting for age, sex, income, education, smoking status, heaviness of smoking, and e-cigarette status. // Results: Compared with England, smoking norms were higher in all countries: reporting that at least three of five closest friends smoke (19% vs 65–84% [AOR=6.9–24.0; Hungary–Greece]), perceiving that people important to them approve of smoking (8% vs 14–57% [1.9–51.1; Spain–Hungary]), perceiving that the public approves of smoking (5% vs 6–37% [1.7–15.8; Spain–Hungary]), disagreeing that smokers are marginalised (9% vs 16–50% [2.3–12.3; Poland–Greece]) except in Hungary. Compared with England: reporting that at least one of five closest friends uses e-cigarettes was higher in Poland (28% vs 36% [2.7]) but lower in Spain and Romania (28% vs 6–14% [0.3–0.6]), perceiving that the public approves of e-cigarettes was higher in Poland, Hungary and Greece (32% vs 36–40% [1.5–1.6]) but lower in Spain and Romania in unadjusted analyses only (32% vs 24–26%), reporting seeing e-cigarette use in public at least some days was lower in all countries (81% vs 12–55% [0.1–0.4]; Spain–Greece). // Conclusions: Smokers from England had the least pro-smoking norms. Smokers from Spain had the least pro-e-cigarette norms. Friend smoking and disagreeing that smokers are marginalised broadly aligned with country-level current smoking rates. Seeing e-cigarette use in public broadly aligned with countrylevel any e-cigarette use. Generally, no other norms aligned with product prevalence

Smoking in public places in six European countries: Findings from the EUREST-PLUS ITC Europe Survey

Introduction: Surveillance of tobacco consumption in public places is an important measure to evaluate the impact of tobacco control interventions over time. The objective of this study was to estimate the prevalence of smoking as seen by smokers and their smoking behaviour in public places, in six European countries. Methods: We used baseline data of the International Tobacco Control Six European countries (ITC 6E) Survey, part of the EUREST-PLUS Project, conducted in 2016 in national representative samples of about 1000 adult smokers aged 18 years and older in Germany, Greece, Hungary, Poland, Romania and Spain. For each setting (workplaces, restaurants, bars/pubs and discos) participants were asked whether they had seen someone smoking during their last visit there and whether they too had smoked there. We report the overall and by-country weighted prevalence of seeing someone smoking and the smokers’ own smoking behaviour at each setting. We also assess the relationship between seeing someone smoking and smoking themselves at these settings. Results: The prevalence of smoking as seen by smokers was 18.8% at workplaces, with high variability among countries (from 4.7% in Hungary to 40.8% in Greece). Among smokers visiting leisure facilities in the last year, during their last visit 22.7% had seen someone smoking inside restaurants and 12.2% had smoked themselves there, while for bars/pubs the corresponding prevalences were 33.9% and 20.4%, and inside discos 44.8% and 34.8%. Conclusions: Smoking is still prevalent at leisure facilities, particularly at discos in Europe, with high variability among countries. More extensive awareness campaigns and stricter enforcement are needed to increase the compliance of smokefree regulations, especially in leisure facilities

Secondhand exposure to e-cigarette aerosols among smokers: A cross-sectional study in six European countries of the EUREST-PLUS ITC Europe Surveys

Introduction: Electronic cigarette (e-cigarette) use has grown significantly in some European Union (EU) Member States (MS). A better understanding of the exposure to secondhand e-cigarette aerosols (SHA) is necessary to develop and implement comprehensive regulations on e-cigarette use in public places. This study aims to assess the observation of e-cigarette use in public places, the self-reported exposure to SHA, and the level of users’ comfort using e-cigarettes in the presence of others. Methods: This is a cross-sectional study of the Wave 1 International Tobacco Control 6 European Countries Survey recruiting adult smokers (n=6011) across six EU MS: Germany, Greece, Hungary, Poland, Romania, and Spain, within the EURESTPLUS Project. A descriptive analysis was conducted to estimate the prevalence (%) of observed e-cigarette use in different places, frequency of self-reported exposure to SHA, and level of comfort using e-cigarettes in the presence of others. Results: In all, 31.0% of smokers observed others using e-cigarette in public places, 19.7% in indoor places where smoking is banned, and 14.5% indoors at work. Almost 37% of smokers reported to be ever exposed to SHA, ranging from 17.7% in Spain to 63.3% in Greece. The higher prevalence of observed e-cigarette use and passive exposure to SHA was reported by smokers of younger age, of higher educational level and those being current or former e-cigarette users. Part (8.8%) of the smokers who were also e-cigarette users reported feeling uncomfortable using e-cigarettes in the presence of others. Conclusions: A third of smokers from six EU MS reported being exposed to SHA. Prevalence differences were observed among the countries. In the context of scarce evidence on long-term health effects of exposure to SHA, precautionary regulations protecting bystanders from involuntary exposure should be developed