How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action.

Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what trade-offs patients are willing to make. IMI PREFER was a six-year European public-private partnership under the Innovative Medicines Initiative that developed recommendations on how to assess and use PPS in medical product decision-making, including in the regulatory evaluation of medicinal products. This paper aims to summarize findings and recommendations from IMI PREFER regarding i) PPS applications in regulatory evaluation, ii) when and how to consult with regulators on PPS, iii) how to reflect PPS in regulatory communication and iv) barriers and open questions for PPS in regulatory decision-making. Methods: PREFER performed six literature reviews, 143 interviews and eight focus group discussions with regulators, patient representatives, industry representatives, Health Technology Assessment bodies, payers, academics, and clincians between October 2016 and May 2022. Results: i) With respect to PPS applications, prior to the conduct of clinical trials of medicinal products, PPS could inform regulators' understanding of patients' unmet needs and relevant endpoints during horizon scanning activities and scientific advice. During the evaluation of a marketing authorization application, PPS could inform: a) the assessment of whether a product meets an unmet need, b) whether patient-relevant clinical trial endpoints and outcomes were studied, c) the understanding of patient-relevant effect sizes and acceptable trade-offs, and d) the identification of key (un-)favorable effects and uncertainties. ii) With respect to consulting with regulators on PPS, PPS researchers should ideally have early discussions with regulators (e.g., during scientific advice) on the PPS design and research questions. iii) Regarding external PPS communication, PPS could be reflected in the assessment report and product information (e.g., the European Public Assessment Report and the Summary of Product Characteristics). iv) Barriers relevant to the use of PPS in regulatory evaluation include a lack of PPS use cases and demonstrated impact on regulatory decision-making, and need for (financial) incentives, guidance and quality criteria for implementing PPS results in regulatory decision-making. Open questions concerning regulatory PPS use include: a) should a product independent broad approach to the design of PPS be taken and/or a product-specific one, b) who should optimally be financing, designing, conducting, and coordinating PPS, c) when (within and/or outside clinical trials) to perform PPS, and d) how can PPS use best be operationalized in regulatory decisions. Conclusion: PPS have high potential to inform regulators on key unmet needs, endpoints, benefits, and risks that matter most to patients and their acceptable trade-offs. Regulatory guidelines, templates and checklists, together with incentives are needed to foster structural and transparent PPS submission and evaluation in regulatory decision-making. More PPS case studies should be conducted and submitted for regulatory assessment to enable regulatory discussion and increase regulators' experience with PPS implementation and communication in regulatory evaluations.

Geriatric assessment for older people with cancer: policy recommendations.

Most cancers occur in older people and the burden in this age group is increasing. Over the past two decades the evidence on how best to treat this population has increased rapidly. However, implementation of new best practices has been slow and needs involvement of policymakers. This perspective paper explains why older people with cancer have different needs than the wider population. An overview is given of the recommended approach for older people with cancer and its benefits on clinical outcomes and cost-effectiveness. In older patients, the geriatric assessment (GA) is the gold standard to measure level of fitness and to determine treatment tolerability. The GA, with multiple domains of physical health, functional status, psychological health and socio-environmental factors, prevents initiation of inappropriate oncologic treatment and recommends geriatric interventions to optimize the patient's general health and thus resilience for receiving treatments. Multiple studies have proven its benefits such as reduced toxicity, better quality of life, better patient-centred communication and lower healthcare use. Although GA might require investment of time and resources, this is relatively small compared to the improved outcomes, possible cost-savings and compared to the large cost of oncologic treatments as a whole.

Balancing benefits and risks in lung cancer therapies: patient preferences for lung cancer treatment alternatives.

Background: In the treatment of Non-Small Cell Lung Cancer (NSCLC) the combination of Immuno- Oncotherapy (IO) and chemotherapy (CT) has been found to be superior to IO or CT alone for patients' survival. Patients and clinicians are confronted with a preference sensitive choice between a more aggressive treatment with a greater negative effect on quality of life versus alternatives that are less effective but have fewer side effects. Objectives: The aims of this study were to: (a) quantify patients' preferences for relevant attributes related to Immuno-Oncotherapy treatment alternatives, and (b) evaluate the maximum acceptable risk (MAR)/Minimum acceptable benefit (MAB) that patients would accept for treatment alternatives. Methods: An online preference survey using discrete-choice experiment (DCE) was completed by NSCLC patients from two hospitals in Italy and Belgium. The survey asked patients' preferences for five patient- relevant treatment attributes. The DCE was developed using a Bayesian D-efficient design. DCE analyses were performed using mixed logit models. Information regarding patient demographics, health literacy, locus of control, and quality of life was also collected. Results: 307 patients (158 Italian, 149 Belgian), stage I to IV, completed the survey. Patients preferred treatments with a higher 5-year survival chance as the most important attribute over all the other attributes. Preference heterogeneity for the attribute weights depended on health literacy, patients' age and locus of control. Patients were willing to accept a substantially increased risks of developing side effects in exchange for the slightest increase (1%) in the chance of surviving at least 5 years from the diagnosis of cancer. Similarly, patients were willing to accept a switch in the mode of administration or complete loss of hair to obtain an increase in survival. Conclusion: In this study, the proportion of respondents who systematically preferred survival over all other treatment attributes was particularly high. Age, objective health literacy and locus of control accounted for heterogeneity in patients' preferences. Evidence on how NSCLC patients trade between survival and other NSCLC attributes can support regulators and other stakeholders on assessing clinical trial evidence and protocols, based on patients' conditions and socio-demographic parameters.

UNCAN.eu, a European Initiative to UNderstand CANcer.

"UNCAN.eu" refers to a collective European effort seeking to enable a leap forward in our understanding of cancer. This initiative, which includes the creation of a European cancer research data hub, will pave the way to new advances in cancer care. Starting on September 1, 2022, a 15-month coordination and support action will generate a blueprint for UNCAN.eu. Here, we summarize the cancer research issues that the blueprint will propose to tackle at the European level.

European Head and Neck Society recommendations for head and neck cancer survivorship care.

Survivors of head and neck cancer can experience long-term consequences of the cancer and subsequent treatments even after the cancer has resolved. Increasingly clinicians are aware of the social, psychological, financial, and emotional impacts of these cancers, in addition to the support required for the physical symptoms. This review provides recommendations on the long-term management and support required for survivors of head and neck cancer in the European healthcare setting.

Progression-free survival and quality of life in metastatic breast cancer: The patient perspective.

INTRODUCTION: Treatment advances for metastatic breast cancer (mBC) have improved overall survival (OS) in some mBC subtypes; however, there remains no cure for mBC. Considering the use of progression-free survival (PFS) and other surrogate endpoints in clinical trials, we must understand patient perspectives on measures used to assess treatment efficacy. OBJECTIVE: To explore global patient perceptions of the concept of PFS and its potential relation to quality of life (QoL). MATERIALS AND METHODS: Virtual roundtables in Europe and the United States and interviews in Japan with breast cancer patients, patient advocates, and thought leaders. Discussions were recorded, transcribed, and analyzed thematically. RESULTS: Lengthened OS combined with no worsening or improvement in QoL remain the most important endpoints for mBC patients. Time when the disease is not progressing is meaningful to patients when coupled with improvements in QoL and no added treatment toxicity. Clinical terminology such as "PFS" is not well understood, and participants underscored the need for patient-friendly terminology to better illustrate the concept. Facets of care that patients with mBC value and that may be related to PFS include relief from cancer-related symptoms and treatment-related toxicities as well as the ability to pursue personal goals. Improved communication between patients and providers on managing treatment-related toxicities and addressing psychosocial challenges to maintain desired QoL is needed. CONCLUSION: While OS and QoL are considered the most relevant endpoints, patients also value periods of time without disease progression. Incorporation of these considerations into the design and conduct of future clinical trials in mBC, as well as HTA and reimbursement decision-making, is needed to better capture the potential value of a therapeutic innovation.

The LEGACy study: a European and Latin American consortium to identify risk factors and molecular phenotypes in gastric cancer to improve prevention strategies and personalized clinical decision making globally.

BACKGROUND: Gastric Cancer (GC) is the fourth most deadly cancer worldwide. Enhanced understanding of its key epidemiological and molecular drivers is urgently needed to lower the incidence and improve outcomes. Furthermore, tumor biology in European (EU) and Latin American (LATAM) countries is understudied. The LEGACy study is a Horizon 2020 funded multi-institutional research approach to 1) detail the epidemiological features including risk factors of GC in current time and 2) develop cost-effective methods to identify and integrate biological biomarkers needed to guide diagnostic and therapeutic approaches with the aim of filling the knowledge gap on GC in these areas. METHODS: This observational study has three parts that are conducted in parallel during 2019-2023 across recruiting centers from four EU and four LATAM countries: Part 1) A case-control study (800 cases and 800 controls) using questionnaires on candidate risk factors for GC, which will be correlated with clinical, demographic and epidemiological parameters. Part 2) A case-control tissue sampling study (400 cases and 400 controls) using proteome, genome, microbiome and immune analyses to characterize advanced (stage III and IV) GC. Patients in this part of the study will be followed over time to observe clinical outcomes. The first half of samples will be used as training cohort to identify the most relevant risk factors and biomarkers, which will be selected to propose cost-effective diagnostic and predictive methods that will be validated with the second half of samples. Part 3) An educational study, as part of our prevention strategy (subjects recruited from the general public) to test and disseminate knowledge on GC risk factors and symptoms by a questionnaire and informative video. Patients could be recruited for more than one of the three LEGACy studies. DISCUSSION: The LEGACy study aims to generate novel, in-depth knowledge on the tumor biological characteristics through integrating epidemiological, multi-omics and clinical data from GC patients at an EU-LATAM partnership. During the study, cost-effective panels with potential use in clinical decision making will be developed and validated. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: Part 1: NCT03957031 . Part 2: NCT04015466 . Part 3: NCT04019808 .

How well do European patients understand cancer-associated thrombosis? A patient survey.

Ongoing concerns regarding the morbidity and mortality from cancer-associated thrombosis led the European Cancer Patient Coalition (ECPC), the voice of cancer patients across Europe, to create a pan-European cancer-associated awareness patient survey to assess cancer-associated thrombosis (CAT) knowledge among a large population of patients with cancer. The ECPC survey represents the largest of its kind among patients/caregivers with CAT. It identified significant gaps in patient awareness and knowledge of CAT as well as a need for educational CAT-related discussions and interventions between healthcare professionals and patients with cancer and their caregivers. The aim of this paper is to highlight these gaps and to provide awareness of what/when information should be shared with patients/caregivers. Notably, the importance of providing information on how to reduce their risk of CAT, the role of anticoagulant prophylaxis and treatment (short- and long-term) including possible side-effects, and finally how to identify CAT symptoms early. Here we outline what type of information should be provided, as well as when and how to best discuss CAT with our oncology patients and their caregivers along the cancer care continuum, to reduce the risk of CAT and associated complications with a goal of improving patient outcomes.

Global Patterns and Prevalence of Dual and Poly-Tobacco Use: A Systematic Review.

INTRODUCTION: Improving understanding of the epidemiology of dual and poly-tobacco product use is essential for tobacco control policy and practice. The present study aimed to systematically review existing epidemiologic evidence on current dual and poly-tobacco use among adults globally. METHODS: We systematically searched online databases for studies published up to June 30, 2020. We included quantitative studies with measures of nationally representative prevalence of current dual or poly-tobacco use among adults. Prevalence estimates for each country were extracted manually and stratified by WHO regions and World Bank income classifications. RESULTS: Twenty studies with nationally representative prevalence data on current dual or poly-tobacco use in the adult population across 48 countries were included. Definitions of dual and poly-tobacco use varied widely. Prevalence of dual and poly-tobacco use was higher in low- and lower-middle-income countries compared to other higher-income countries. Current dual use of smoked and smokeless tobacco products among males ranged from 0.2% in Ukraine (2010) and Mexico (2009) to 17.9% in Nepal (2011). Poly-tobacco use among males ranged from 0.8% in Mexico (2009) and 0.9% in Argentina (2010) to 11.4% in the United Kingdom and 11.9% in Denmark in 2012. Dual tobacco use was generally higher in South-East Asia; poly-tobacco use was prevalent in Europe as well as in South-East Asia. CONCLUSIONS: This is the first systematic review of the prevalence estimates of dual and poly-tobacco use among adults globally. The results of the current study could significantly help health policy makers to implement effective tobacco control policies. IMPLICATIONS: This study demonstrates that dual/poly-tobacco use is common in many countries of the world, and highlights the need for in-depth exploration of this field in future studies, especially in high prevalence regions such as South-East Asian and European countries. In light of this, the global tobacco control community and health authorities should also agree upon a consistent operational definition of dual and poly-tobacco use to propel research and improve surveillance of dual/poly-use in health surveys for better communication and understanding of these phenomena.

Smokers' support for the ban on sale of slim cigarettes in six European countries: findings from the EUREST-PLUS ITC Europe Surveys.

Background: Efforts to regulate tobacco products and reduce consumption in the European Union (EU) include the European Tobacco Products Directive (TPD), which went into force in May 2016. Despite the initial discussion to include a ban on sale of slim cigarettes, it was excluded in the final TPD. The main goal of this study was to examine support for a ban on slim cigarettes among smokers in six European Countries. Methods: Data from the 2018 (Wave 2) International Tobacco Control Policy Evaluation Project 6 European Country (ITC 6E) EUREST-PLUS project survey, a cross sectional study of adult smokers (n=5592) from Germany, Greece, Hungary, Poland, Romania, and Spain, was analysed. Descriptive statistics were used to estimate support for a ban on slim cigarettes by sociodemographic characteristics and smoking behaviors. Logistic regression analysis was used to examine factors associated with support for a ban on slim cigarettes and perceptions of harm. Results: Support for a ban on slims varied across countries, with highest support in Romania (33.8%), and lowest in Greece (18.0%). Female smokers (OR=0.78; 95%CI=0.67-0.91, daily smokers (OR=0.68; 95%CI=0.47-0.97), menthol smokers (OR=0.55; 95%CI=0.36-0.86), and smokers who did not have plans to quit within next six months (OR=0.45; 95%CI=0.36-0.56) had significantly lower odds of supporting a ban on slim cigarettes. Overall, 21% of smokers perceived slim cigarettes as less harmful than regular cigarettes. Conclusions: Support for a ban of slim cigarettes was relatively low among smokers, while misperceptions that slim cigarettes are less harmful is high, particularly among countries where slim cigarette use is more prevalent. Findings support a ban on slim cigarettes to reduce misperceptions around slim cigarettes being less harmful.

Is the mental health of young students and their family members affected during the quarantine period? Evidence from the COVID-19 pandemic in Albania.

WHAT IS KNOWN ON THE SUBJECT?: Mental health is deteriorated during the quarantine period. Mental health status is affected by the quarantine even after the end of it and for an extended period. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: Depression levels among nursing/midwifery students during the quarantine period are high. Depression levels among students' family members during the quarantine period are high. Those who are not satisfied with COVID-19 prevention measures and those who believe that COVID-19 and quarantine can cause problems on health, have elevated levels of depression. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Provision of mental health services during the quarantine period should be a priority for the healthcare system. Offering mental health first aid training and support can improve the mental health status of students and their family members. ABSTRACT: Introduction The use of quarantine method has a significant impact on mental health status. Aim This study aimed to assess the levels of depression among bachelor and master university students (nurses/midwives) and their family members' during the quarantine period of COVID-19 pandemic. Method A cross-sectional study was conducted in Vlora University, Albania. Patient Health Questionnaire (PHQ-9) was used. Institutional e-mails of all active students were used for their recruitment. Results In total, 863 students and 249 family members participated in the study. The mean PHQ-9 score was 6.220 (SD = 5.803) and 6.280 (SD = 5.857) for students and family members, respectively. Being unsatisfied with COVID-19 prevention measures, beliefs that COVID-19 infection and quarantine process can cause problems on their health status were the key factors for students to be screened positive for mental problems in multiple regression analysis. For parents, the last two factors were found to contribute significantly. Discussion Our findings indicate that quarantine measures have a significant impact on the levels of depression among both university students and their family members. Broader population studies are necessary to safeguard these results. Implications for Practice Provision of mental health services during the quarantine period is of paramount significance. Mental health first aid training and support could benefit both students and their parents significantly. Additionally, follow-up services after the end of quarantine are recommended.

Profile of incidental exposures to e-cigarette liquids in Europe, 2018-2019.

BACKGROUND: Following the implementation of the European Union Tobacco Product Directive (EU TPD) regulations on e-cigarette products in 2016, we assessed the current profile of e-cigarette liquid exposure incidents and their associated health outcomes. METHODS: De-identified data were received from poison centers in eight EU Member States (Sweden, the Netherlands, Italy, Hungary Austria, Finland, Spain and Croatia) reporting on e-cigarette liquid exposure incidents between August 2018 to December 2019. Descriptive analysis was conducted to present incident characteristics and health outcomes. Chi-square tests and multivariable logistic regression analysis were used to test associations. RESULTS: Of the 223 e-liquid exposure incidents recorded by poison centers in multiple EU MS, 64.7% of the cases were unintentional exposures, ranging from 48.4% among adults aged ≥19 years to 100.0% among children aged 0-5 years (p < 0.05). The most frequent route of exposure was ingestion (73.5%) while55.2% experienced any clinical symptoms, including nausea (16.6%), vomiting (11.1%), and dizziness (9.0%). 57.8% of the cases were treated at the residence or on-site. CONCLUSION: Further monitoring is warranted, using uniform reporting requirements, to ensure the continued compliance to the EU TPD and assess its long-term impact on related incident characteristics.

Perceptions, Predictors of and Motivation for Quitting among Smokers from Six European Countries from 2016 to 2018: Findings from EUREST-PLUS ITC Europe Surveys.

The European Tobacco Products Directive (TPD) was introduced in 2016 in an effort to decrease prevalence of smoking and increase cessation in the European Union (EU). This study aimed to explore quitting behaviours, motivation, reasons and perceptions about quitting, as well as predictors (reported before the TPD implementation) associated with post-TPD quit status. A cohort study was conducted involving adult smokers from six EU countries (n = 3195). Data collection occurred pre-(Wave 1; 2016) and post-(Wave 2; 2018) TPD implementation. Bivariate and logistic regression analyses of weighted data were conducted. Within this cohort sample, 415 (13.0%) respondents reported quitting at Wave 2. Predictors of quitting were moderate or high education, fewer cigarettes smoked per day at baseline, a past quit attempt, lower level of perceived addiction, plans for quitting and the presence of a smoking-related comorbidity. Health concerns, price of cigarettes and being a good example for children were among the most important reasons that predicted being a quitter at Wave 2. Our findings show that the factors influencing decisions about quitting may be shared among European countries. European policy and the revised version of TPD could emphasise these factors through health warnings and/or campaigns and other policies.

Changes in electronic cigarette use and label awareness among smokers before and after the European Tobacco Products Directive implementation in six European countries: findings from the EUREST-PLUS ITC Europe Surveys.

BACKGROUND: Article 20 of the European Tobacco Product Directive (TPD), which went into effect in May 2016, regulates electronic cigarettes (e-cigarettes) in the European Union (EU). The aim of this study was to evaluate changes in e-cigarette use, design attributes of the products used and awareness of e-cigarette labelling and packaging among smokers from six EU Member States (MS) before and after TPD implementation. METHODS: Data come from Wave 1 (2016, pre-TPD) and Wave 2 (2018, post-TPD) of the ITC Six European Country Survey among a sample of smokers and recent quitters who use e-cigarettes from six EU MS. Weighted logistic generalized estimating equations regression models were estimated to test the change in binary outcomes between Waves 1 and 2 using SAS-callable SUDAAN. RESULTS: In 2018, current daily/weekly e-cigarette use among adult smokers was just over 2%, but this varied from the highest in Greece (4%) to lowest in Poland (1.2%). From Waves 1 to 2, there was a significant increase in respondents reporting noticing and reading health and product safety information on leaflets inside e-cigarette packaging (8.39-11.62%, P < 0.001). There were no significant changes between waves of respondents reporting noticing or reading warning labels on e-cigarette packages/vials. CONCLUSIONS: e-cigarette use among smokers in these six EU countries is low. Although reported noticing and reading leaflets included in the packaging of e-cigarettes increased significantly from before to after the TPD, there was no significant change in reported noticing and reading of warning labels. Findings indicate the importance of continued monitoring of TPD provisions around e-cigarettes.

Transitions in product use during the implementation of the European Tobacco Products Directive: cohort study findings from the EUREST-PLUS ITC Europe Surveys.

BACKGROUND: The emergence of new types of tobacco and tobacco-related products on the European Union (EU) market has precipitated the possibility for both poly-tobacco use and transitions between products. In the EU, the regulatory environment has shifted with the implementation of the European Tobacco Products Directive (TPD) in May 2016, which may influence consumer transitions between products. METHODS: The aim of this paper was to examine trends and transitions in tobacco products from 2016 to 2018 -before and after implementation of the TPD in the EU. Data come from Wave 1 (pre-TPD) and Wave 2 (post-TPD) of the EUREST-PLUS ITC Six European Country Survey, a cohort study of adults who at the time of recruitment were smokers from six EU countries- Germany, Greece, Hungary, Poland, Romania, and Spain. D (N = 3195). Bivariate and logistic regression analyses of weighted data was conducted using SAS-callable SUDAAN. RESULTS: Overall, among those who smoked factory-made cigarettes (FM) only at Wave 1, 4.3% switched to roll-your-own tobacco (RYO) only. Among RYO only users at Wave 1, 17.0% switched to FM only, however compared to all other countries, respondents from Hungary had the highest percentage of FM only users at Wave 1 switch to RYO only at Wave 2 (18.0%). CONCLUSIONS: The most prominent transition overall was from smoking RYO exclusively at Wave 1 to smoking FM tobacco exclusively at Wave 2, however this varied across countries. As the tobacco control regulatory environment of the EU develops, it is important to continue to monitor transitions between types of products, as well as trends in cessation.

Awareness and correlates of noticing changes to cigarette packaging design after implementation of the European Tobacco Products Directive: findings from the EUREST-PLUS ITC Europe Surveys.

BACKGROUND: The European Tobacco Products Directive (TPD), which went into effect in May 2016, regulates packaging design and labelling of cigarettes and roll-your-own (RYO) tobacco. The aim of the current study was to examine whether smokers and recent quitters in six European Union (EU) countries (Germany, Greece, Hungary, Poland, Romania and Spain) reported noticing TPD-related changes to packaging, and correlates of noticing these changes. METHODS: Cross-sectional data from the Wave 2 of the ITC 6 European Country Survey in 2018 after implementation of the TPD. Bivariate analyses included adult smokers (n = 5597) and recent quitters (n = 412). Adjusted logistic regression analyses were restricted to the subset of current smokers (n = 5597) and conducted using SAS-callable SUDAAN. RESULTS: Over half of smokers (58.2%) and 30% of quitters noticed at least one of five types of TPD-related pack changes. Over one-quarter of all respondents noticed changes to health warnings (30.0%), standardized openings (27.7%), minimum pack unit size (27.9%), and the removal of tar, nicotine and carbon monoxide information (26.7%) on packaging. Cross-country differences were observed across all measures, with noticing all pack changes markedly lower in Spain than the other countries. Correlates of noticing specific pack changes included sociodemographic characteristics, smoking behaviours and related to packaging. CONCLUSIONS: This is one of the first cross-country studies to examine the extent to which TPD changes to cigarette and RYO tobacco packaging are being noticed by smokers and recent quitters. Findings indicate that the majority of smokers noticed at least one type of pack change, but this varied across countries and sub-populations.

Quitting behaviours and cessation methods used in eight European Countries in 2018: findings from the EUREST-PLUS ITC Europe Surveys.

BACKGROUND: We examined quit attempts, use of cessation assistance, quitting beliefs and intentions among smokers who participated in the 2018 International Tobacco Control (ITC) Europe Surveys in eight European Union Member States (England, Germany, Greece, Hungary, the Netherlands, Poland, Romania and Spain). METHODS: Cross-sectional data from 11 543 smokers were collected from Wave 2 of the ITC Six European Country (6E) Survey (Germany, Greece, Hungary, Poland, Romania and Spain-2018), the ITC Netherlands Survey (the Netherlands-late 2017) and the Four Countries Smoking and Vaping (4CV1) Survey (England-2018). Logistic regression was used to examine associations between smokers' characteristics and recent quit attempts. RESULTS: Quit attempts in the past 12 months were more frequently reported by respondents in the Netherlands (33.0%) and England (29.3%) and least frequently in Hungary (11.5%), Greece (14.7%), Poland (16.7%) and Germany (16.7%). With the exception of England (35.9%), the majority (56-84%) of recent quit attempts was unaided. Making a quit attempt was associated with younger age, higher education and income, having a smoking-related illness and living in England. In all countries, the majority of continuing smokers did not intend to quit in the next 6 months, had moderate to high levels of nicotine dependence and perceived quitting to be difficult. CONCLUSIONS: Apart from England and the Netherlands, smokers made few quit attempts in the past year and had low intentions to quit in the near future. The use of cessation assistance was sub-optimal. There is a need to examine approaches to supporting quitting among the significant proportion of tobacco users in Europe and increase the use of cessation support as part of quit attempts.

Current practices and perceived barriers to tobacco-treatment delivery among healthcare professionals from 15 European countries. The EPACTT Plus project.

INTRODUCTION: The latest evidence-based Guidelines for Treating Tobacco Dependence highlight the significant role of healthcare professionals in supporting smokers interested to quit. This study aimed to identify the current practices of healthcare professionals in Europe and perceived barriers in delivering tobacco treatment to their patients who smoke. METHODS: In the context of EPACTT-Plus, collaborating institutions from 15 countries (Albania, Armenia, Belgium, Italy, France, Georgia, Greece, Kosovo, Romania, North Macedonia, Russia, Serbia, Slovenia, Spain, Ukraine) worked for the development of an accredited eLearning course on Tobacco Treatment Delivery available at http://elearning-ensp.eu/. In total, 444 healthcare professionals from the wider European region successfully completed the course from December 2018 to July 2019. Cross-sectional data were collected online on healthcare professionals' current practices and perceived barriers in introducing tobacco-dependence treatment into their daily clinical life. RESULTS: At registration, 41.2% of the participants reported having asked their patients if they smoked. Advise to quit smoking was offered by 47.1% of the participants, while 29.5% reported offering assistance to their patients who smoked in order to quit. From the total number of participants, 39.9% regarded the lack of patient compliance as a significant barrier. Other key barriers were lack of: interest from the patients (37.4%), healthcare professionals training (33.1%), community resources to refer patients (31.5%), and adequate time during their everyday clinical life (29.7%). CONCLUSIONS: The identification of current practices and significant barriers is important to build evidence-based guidelines and training programs (online and/or live) that will improve the performance of healthcare professionals in offering tobacco-dependence treatment for their patients who smoke.

Impact of the ENSP eLearning platform on improving knowledge, attitudes and self-efficacy for treating tobacco dependence: An assessment across 15 European countries.

INTRODUCTION: In 2018, the European Network for Smoking Cessation and Prevention (ENSP) released an update to its Tobacco Treatment Guidelines for healthcare professionals, which was the scientific base for the development of an accredited eLearning curriculum to train healthcare professionals, available in 14 languages. The aim of this study was to evaluate the effectiveness of ENSP eLearning curriculum in increasing healthcare professionals' knowledge, attitudes, self-efficacy (perceived behavioral control) and intentions in delivering tobacco treatment interventions in their daily clinical routines. METHODS: We conducted a quasi-experimental pre-post design study with 444 healthcare professionals, invited by 20 collaborating institutions from 15 countries (Albania, Armenia, Belgium, Italy, France, Georgia, Greece, Kosovo, Romania, North Macedonia, Russia, Serbia, Slovenia, Spain, Ukraine), which completed the eLearning course between December 2018 and July 2019. RESULTS: Healthcare professionals' self-reported knowledge improved after the completion of each module of the eLearning program. Increases in healthcare professionals' self-efficacy in delivering tobacco treatment interventions (p<0.001) were also documented. Significant improvements were documented in intentions to address tobacco use as a priority, document tobacco use, offer support, provide brief counselling, give written material, discuss available medication, prescribe medication, schedule dedicated appointment to develop a quit plan, and be persistent in addressing tobacco use with the patients (all p<0.001). CONCLUSIONS: An evidence-based digital intervention can be effective in improving knowledge, attitudes, self-efficacy and intentions on future delivery of tobacco-treatment interventions.