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Background: Advanced practice nursing (APN) roles offer improved access to care and increased quality and more timely care. Despite the advantages of APN roles, there is a disparity between European countries when it comes to implementing APN roles. Aim: To explore the implementation of APN roles in a range of European countries and to explore what factors facilitate or hinder the implementation of these roles. Methods: A case study evaluation of the process of implementing APN roles. The sample included four countries where APN roles were well developed (Ireland, Spain, Norway and the United Kingdom) and four where APN roles were implemented (Estonia, Slovenia, Cyprus and Romania). Interviews were conducted with key informants (n = 28) from government departments, regulatory bodies, nursing associations and universities. The consolidated criteria for reporting qualitative research (CPREQ) has been used throughout. Limitations: The small number of countries when considering the size of the region and key informants representing the view of only three to four people in each country. Results: Four themes were identified, including the rationale for the development of the roles, influence, the evolutionary nature of role development and evidence. The data also revealed a mismatch between the perceptions of how the roles develop among the different countries in the early stages of implementation. Conclusion: Successful role implementation is dependent upon a tripartite approach between managers, practitioners and educators. An evolutionary approach to role development was used. Regulation and policy come later on in the process of implementation. Implications for nursing policy: APN policy should be based on patient needs rather than on the workforce or professional imperatives. The process of implementation can take 15–20 years in total. Recognising the importance of the relationships between service managers and educators is key to the early development of these roles. [ABSTRACT FROM AUTHOR]

Background Studies confirm the positive effect of sugar-sweetened beverage (SSB) taxation on public health. However, only a few countries in Europe adopt SSB taxes. From a public policy perspective, we investigate the conditions under which countries do or do not follow this evidence. Methods Crisp-set Qualitative Comparative Analysis (QCA) of 26 European Organization of Economic Cooperation and Development countries with and without an SSB tax. We test which configurations of conditions (problem pressure, governmental composition, strategic planning, health care system, public health policies, inclusion of expert advice in policymaking) emerge as relevant in determining adoption and non-adoption between the years 1981 and 2021. Pathways that lead to the presence and absence of SSB taxes are identified separately. Results At least one of the following configurations of conditions is present in countries that introduced taxation: (i) high financial problem pressure, low regulatory impact assessment activity; (ii) high public health problem pressure, a contribution-financed health care system, no holistic strategy for combatting non-communicable diseases (NCDs); (iii) a tax-financed health care system, a holistic NCD strategy, high strategic and executive planning capacity. In countries that did not adopt SSB taxes, we find (i) high regulatory impact assessment activity, high levels of sugar export; (ii) no holistic NCD strategy, high spending on preventive care; (iii and iv) a lack of strategic planning capacity and either a high share of spending on preventive care or inclusion of expert advice. Discussion Evidence inclusion requires clear policy priorities in terms of strategy and resources to promote public health. [ABSTRACT FROM AUTHOR]

Background In Europe, more than 15 million people live with heart failure (HF). It imposes an enormous social, organizational and economic burden. As a reaction to impending impact on healthcare provision, different country-specific structures for HF-care have been established. The aim of this report is to provide an overview and compare the HF-care approaches of Germany, Ireland, the Netherlands and the UK, and to open the possibility of learning from each other's experience. Methods A mixed methods approach was implemented that included a literature analysis, interviews and questionnaires with HF-patients and caregivers, and expert interviews with representatives from healthcare, health service research and medical informatics. Results The models of HF-care in all countries analyzed are based on the European Society of Cardiology guidelines for diagnosis and treatment of HF. Even though the HF-models differed in design and implementation in practice, key challenges were similar: (i) unequal distribution of care between urban and rural areas, (ii) long waiting times, (iii) unequal access to and provision of healthcare services, (iv) information and communication gaps and (v) inadequate implementation and financing of digital applications. Conclusion Although promising approaches exist to structure and improve HF-care, across the four countries, implementation was reluctant to embrace novel methods. A lack of financial resources and insufficient digitalization making it difficult to adopt new concepts. Integration of HF-nurses seems to be an effective way of improving current models of HF-care. Digital solutions offer further opportunities to overcome communication and coordination gaps and to strengthen self-management skills. [ABSTRACT FROM AUTHOR]

Introduction: The benefits of completing household chores appear to transfer beyond managing day‐to‐day living. It is possible that chore engagement may improve executive functions, as engagement in chores require individuals to plan, self‐regulate, switch between tasks, and remember instructions. To date, little research has been conducted on household chores and executive functions in children, for whom these skills are still developing. Methods: Parents and guardians (N = 207) of children aged 5–13 years (M = 9.38, SD = 2.15) were asked to complete parent‐report questionnaires on their child's engagement in household chores and their child's executive functioning. Results: Results of the regression model indicated that engagement in self‐care chores (e.g., making self a meal) and family‐care chores (e.g., making someone else a meal) significantly predicted working memory and inhibition, after controlling for the influence of age, gender, and presence or absence of a disability. For families with a pet, there was no significant relationship between engagement in pet‐care chores and executive function skills. Conclusion: We strongly recommend that further research explore the relationship between chores and executive functions. It is possible that parents may be able to facilitate their child's executive function development through encouraging participation in chores, whereas chore‐based interventions (e.g., cooking programmes) may also be used to target deficits in ability. [ABSTRACT FROM AUTHOR]

Despite efforts to reduce adolescent smoking via minimum age-of-sale legislation, many young people continue to access tobacco through a mix of social and commercial sources. Little is known about the roles of habitus, capital, and social topographies in shaping under-age access to tobacco. This article draws on Bourdieu's theory of practice and data generated from 56 focus groups with 14- to 19-year-olds across seven European cities to answer the question "via what sources and by what means do adolescents obtain tobacco?" We find that adolescents use a range of personal capitals (social, cultural, and economic) to access tobacco, with the specific constitution and deployment of these capitals varying according to the regularities of different fields. Since adolescents access tobacco via culturally embedded practices, attempts to curtail this access are more likely to be effective if they are multi-pronged, culturally informed, and attuned to the lived experiences of adolescent smokers. [ABSTRACT FROM AUTHOR]

Aims: To investigate changes in alcohol consumption during the first months of the COVID‐19 pandemic in Europe as well as its associations with income and experiences of distress related to the pandemic. Design Cross‐sectional on‐line survey conducted between 24 April and 22 July 2020. Setting: Twenty‐one European countries. Participants: A total of 31 964 adults reporting past‐year drinking. Measurements Changes in alcohol consumption were measured by asking respondents about changes over the previous month in their drinking frequency, the quantity they consumed and incidence of heavy episodic drinking events. Individual indicators were combined into an aggregated consumption‐change score and scaled to a possible range of −1 to +1. Using this score as the outcome, multi‐level linear regressions tested changes in overall drinking, taking into account sampling weights and baseline alcohol consumption [Alcohol Use Disorder Identification Test (AUDIT‐C)] and country of residence serving as random intercept. Similar models were conducted for each single consumption‐change indicator. Findings The aggregated consumption‐change score indicated an average decrease in alcohol consumption of −0.14 [95% confidence interval (CI) = −0.18, −0.10]. Statistically significant decreases in consumption were found in all countries, except Ireland (−0.08, 95% CI = −0.17, 0.01) and the United Kingdom (+0.10, 95% CI = 0.03, 0.17). Decreases in drinking were mainly driven by a reduced frequency of heavy episodic drinking events (−0.17, 95% CI = −0.20, −0.14). Declines in consumption were less marked among those with low‐ or average incomes and those experiencing distress. Conclusions: On average, alcohol consumption appears to have declined during the first months of the COVID‐19 pandemic in Europe. Both reduced availability of alcohol and increased distress may have affected consumption, although the former seems to have had a greater impact in terms of immediate effects. [ABSTRACT FROM AUTHOR]

Background In responding to Covid-19, governments have tried to balance protecting health while minimizing gross domestic product (GDP) losses. We compare health-related net benefit (HRNB) and GDP losses associated with government responses of the UK, Ireland, Germany, Spain and Sweden from UK healthcare payer perspective. Methods We compared observed cases, hospitalizations and deaths under 'mitigation' to modelled events under 'no mitigation' to 20 July 2020. We thus calculated healthcare costs, quality adjusted life years (QALYs), and HRNB at £20,000/QALY saved by each country. On per population (i.e. per capita) basis, we compared HRNB with forecast reductions in 2020 GDP growth (overall or compared with Sweden as minimal mitigation country) and qualitatively and quantitatively described government responses. Results The UK saved 3.17 (0.32–3.65) million QALYs, £33 (8–38) billion healthcare costs and £1416 (220–1637) HRNB per capita at £20,000/QALY. Per capita, this is comparable to £1455 GDP loss using Sweden as comparator and offsets 46.1 (7.1–53.2)% of total £3075 GDP loss. Germany, Spain, and Sweden had greater HRNB per capita. These also offset a greater percentage of total GDP losses per capita. Ireland fared worst on both measures. Countries with more mask wearing, testing, and population susceptibility had better outcomes. Highest stringency responses did not appear to have best outcomes. Conclusions Our exploratory analysis indicates the benefit of government Covid-19 responses may outweigh their economic costs. The extent that HRNB offset economic losses appears to relate to population characteristics, testing levels, and mask wearing, rather than response stringency. [ABSTRACT FROM AUTHOR]

The World Health Organization recommends that "palliative care should be integrated as a routine element of all Undergraduate Medical Education." However, the provision of training for medical undergraduates is variable; only 18% of 51 European countries have mandatory training in palliative medicine. EDUPALL is an ERASMUS+ funded international collaborative project to develop and pilot an undergraduate program for training in palliative medicine. The objective of this study was to critically review and revise current European Association for Palliative Care (EAPC) Recommendations for the Development of Undergraduate Curricula in Palliative Medicine and translating these into an updated curriculum document. Clinicians, academics, and researchers from Romania, Ireland, Germany, Austria, Spain, and the United Kingdom reviewed the EAPC recommendations using a variant of consensus methodology, Nominal Group Technique. From the updated document, four working-groups translated each recommendation into a specific learning objective, and developed associated learning outcomes, stratified by domain: attitude, cognition, and skills. The outcomes and objectives were organized into discrete teaching units and transferred into a curriculum template, identifying notional hours, teaching, and assessment strategies. To ensure quality control, the draft template was circulated to experts from 17 European countries, together with a brief survey instrument, for peer review purposes. All 17 reviewers returned overwhelmingly positive comments. There was large agreement that: the teaching units were logically organized; learning outcomes covered core training needs; learning objectives provided guidance for teaching sessions; learning modalities were appropriately aligned; and assessment strategies were fit for purpose. An updated and standardized curriculum was developed, which provides a platform for the sequential development of the next phases of the EDUPALL project. [ABSTRACT FROM AUTHOR]

This study aimed to identify specific health and well-being issues that women firefighters may experience as part of their daily working practices. Issues identified from this under-represented population can drive future research, education, and strategy to guide safety and health practices. A total of 840 women firefighters from 14 separate countries (255 United Kingdom and Ireland, 320 North America, 177 Australasia, and 88 mainland Europe) completed the survey over a 4-month period. Questions related to general health and well-being and role-specific health concerns, gender-related issues, and available exercise facilities. Women firefighters in North America reported a higher prevalence of lower back (49%) and lower limb (51%) injuries than all other groups. North American respondents reported more heat illnesses (45%) than respondents from other places (36%). Although many participants did not respond, of those who did, 39% thought the menstrual cycle (199/512) or menopause (55/151) affected their work, and 36% were concerned for their ability to meet future job demands. Sixteen percent felt confident they could complete the role after 60 years of age. Women firefighters identified a lack of strength and conditioning support (50%) or lack of gym access (21%). There appears to be poor availability of female-specific personal protective equipment, with availability greatest in the United Kingdom (66%) compared with the sample as a whole (42%). There is a need for female-specific strength and conditioning support and facilities to decrease injury and illness risk and improve longevity. Research and education into gynecological issues, heat exposure, and their effects on women firefighters' fertility and cancer risk is required. [ABSTRACT FROM AUTHOR]

Introduction and aims: Since 2013 MenC and MenW disease incidence and associated mortality rates have increased in the Republic of Ireland. From 2002/2003 to 2012/2013, the average annual MenC incidence was 0.08/100,000, which increased to 0.34/100,000 during 2013/2014 to 2017/18, peaking in 2016/17 (0.72/100,000) with an associated case fatality rate (CFR) of 14.7%. MenW disease incidence has increased each year from 0.02/100,000 in 2013/2014, to 0.29/100,000 in 2017/18, with an associated CFR of 28.6%. We aimed to characterise and relate recent MenC isolates to the previously prevalent MenC:cc11 ET-15 clones, and also characterise and relate recent MenW isolates to the novel ‘Hajj’ clones. Methods: Using WGS we characterised invasive (n = 74, 1997/98 to 2016/17) and carried (n = 16, 2016/17) MenC isolates, and invasive (n = 18, 2010/11 to 2016/17) and carried (n = 15, 2016/17) MenW isolates. Genomes were assembled using VelvethOptimiser and stored on the PubMLST Neisseria Bacterial Isolate Genome Sequence Database. Isolates were compared using the cgMLST approach. Results: Most MenC and MenW isolates identified were cc11. A single MenC:cc11 sub-lineage contained the majority (68%, n = 19/28) of recent MenC:cc11 disease isolates and all carried MenC:cc11 isolates, which were interspersed and distinct from the historically significant ET-15 clones. MenW:cc11 study isolates clustered among international examples of both the original UK 2009 MenW:cc11, and novel 2013 MenW:cc11clones. Conclusions: We have shown that the majority of recent MenC disease incidence was caused by strain types distinct from the MenC:cc11 ET-15 clone of the late 1990s, which still circulate but have caused only sporadic disease in recent years. We have identified that the same aggressive MenW clone now established in several other European countries, is endemic in the RoI and responsible for the recent MenW incidence increases. This data informed the National immunisation Advisory Committee, who are currently deliberating a vaccine policy change to protect teenagers. [ABSTRACT FROM AUTHOR]

Background: Non-medical use of benzodiazepines and Z-drugs is common; however, there is limited information available on the extent of harm related to this in Europe, as well as the relationship between misuse and availability.Aim: To describe presentations to the emergency department in Europe related to the recreational use of benzodiazepines and Z-drugs and compare regional differences in these presentations with legal drug sales of benzodiazepines and Z-drugs within each country.Methods: Emergency department presentations with recreational misuse of benzodiazepines and Z-drugs were obtained from the Euro-DEN dataset for the period from October 2013 to September 2015; data extracted included demographics, clinical features, reported coused drugs, and outcome data. Sales figures obtained by QuintilesIMS™ (Atlanta, Georgia) were used to compare regional differences in the proportion of benzodiazepines and Z-drugs in the emergency department presentations and legal drug sales across Europe.Results: Over the 2 years, there were 2119 presentations to the Euro-DEN project associated with recreational use of benzodiazepines and/or Z-drugs (19.3% of all Euro-DEN presentations). Presentations with 25 different benzodiazepines and Z-drugs were registered in all countries, most (1809/2340 registered benzodiazepines and Z-drugs, 77.3%) of which were prescription drugs. In 24.9%, the benzodiazepine was not specified. Where the benzodiazepine/Z-drug was known, the most frequently used benzodiazepines and Z-drugs were respectively clonazepam (29.5% of presentations), diazepam (19.9%), alprazolam (11.7%), and zopiclone (9.4%). The proportions of types of benzodiazepines/Z-drugs related to ED-presentations varied between countries. There was a moderate (Spain, UK, Switzerland) to high (France, Ireland, Norway) positive correlation between ED presentations and sales data (Spearman Row's correlation 0.66-0.80, p < 0.005), with higher correlation in countries with higher ED presentation rates.Conclusion: Presentations to the emergency department associated with the non-medical use of benzodiazepines and/or Z-drugs are common, with variation in the benzodiazepines and/or Z-drugs between countries. There was a moderate to high correlation with sales data, with higher correlation in countries with higher ED presentation rates. However, this is not the only explanation for the variation in non-medical use and in the harm associated with the non-medical use of benzodiazepines/Z-drugs. [ABSTRACT FROM AUTHOR]

Purpose: To report the vitamin D status in adults from seven European countries and to identify behavioural correlates.Methods: In total, 1075 eligible adult men and women from Ireland, Netherlands, Spain, Greece, UK, Poland and Germany, were included in the study.Results: Vitamin D deficiency and insufficiency, defined as 25-hydroxy vitamin D3 (25-OHD3) concentration of <30 and 30-49.9 nmol/L, respectively, were observed in 3.3 and 30.6% of the participants. The highest prevalence of vitamin D deficiency was found in the UK and the lowest in the Netherlands (8.2 vs. 1.1%, P < 0.05). In addition, the prevalence of vitamin D insufficiency was higher in females compared with males (36.6 vs. 22.6%, P < 0.001), in winter compared with summer months (39.3 vs. 25.0%, P < 0.05) and in younger compared with older participants (36.0 vs. 24.4%, P < 0.05). Positive dose-response associations were also observed between 25-OHD3 concentrations and dietary vitamin D intake from foods and supplements, as well as with physical activity (PA) levels. Vitamin D intakes of ≥5 μg/day from foods and ≥5 μg/day from supplements, as well as engagement in ≥30 min/day of moderate- and vigorous-intensity PA were associated with higher odds (P < 0.05) for maintaining sufficient (≥50 nmol/L) 25-OHD3 concentrations.Conclusions: The prevalence of vitamin D deficiency varied considerably among European adults. Dietary intakes of ≥10 μg/day of vitamin D from foods and/or supplements and at least 30 min/day of moderate- and vigorous-intensity PA were the minimum thresholds associated with vitamin D sufficiency. [ABSTRACT FROM AUTHOR]

Background: ‘Paediatric bipolar disorder’ (PBD) is a controversial diagnosis where often prepubertal children as well as adolescents, who may have a range of psychiatric disorders or symptoms, are diagnosed with a severe mental illness requiring lifelong medication. Clinically, it has often been applied in the United States but rarely in most other countries. A meta‐analysis (Van Meter et al., Journal of Clinical Psychiatry, , 72, 1250) claimed that the prevalence of PBD was similar to adults at 1.8% with no difference between the United States and other countries. This conclusion has been highly cited. Methods: The heterogeneous nature of the original 12 epidemiological surveys warrants a qualitative analysis, rather than statistical meta‐analysis as performed by Van Meter et al. (Journal of Clinical Psychiatry, 2011, 72, 1250). Thus, the meta‐analysis and each of the 12 studies (six from the United States; six from other countries) were reexamined. Results: Most of the 12 surveys predated the emergence of the PBD hypothesis. The 12 surveys were mainly of adolescents and at times young adults with few prepubertal children. Prevalence rates in the 12 studies suggest a lower rate of bipolar disorder, especially in non‐US samples. For example, the Van Meter et al. (Journal of Clinical Psychiatry, 2011, 72, 1250) meta‐analysis chose a rate of 2.8% by summation of adolescent and parent responses in a Dutch survey, however the rate fell to 0% if requiring concordance of adolescent and parent responses. Indeed, it could be argued that four of the non‐US studies show 0% rates of PBD. Conclusions: Rates of PBD were generally substantially lower than 1.8%, particularly in non‐US surveys, and if both parent and adolescent reports were required to meet the diagnostic threshold they fell to close to zero. The reanalysis suggests that bipolar disorder is rare before the expected age of onset in later adolescence. [ABSTRACT FROM AUTHOR]

Background: Within the European Union (EU), substantial efforts are being made to achieve economic and social cohesion, and the reduction of health inequalities between EU regions is integral to this process. This paper is the first to examine how self-reported conditions and non-communicable diseases (NCDs) vary spatially between and within countries. Methods: Using 2014 European Social Survey (ESS) data from 20 countries, this paper examines how regional inequalities in self-reported conditions and NCDs vary for men and women in 174 regions (levels 1 and 2 Nomenclature of Statistical Territorial Units, 'NUTS'). We document absolute and relative inequalities across Europe in the prevalence of eight conditions: general health, overweight/obesity, mental health, heart or circulation problems, high blood pressure, back, neck, muscular or joint pain, diabetes and cancer. Results: There is considerable inequality in self-reported conditions and NCDs between the regions of Europe, with rates highest in the regions of continental Europe, some Scandinavian regions and parts of the UK and lowest around regions bordering the Alps, in Ireland and France. However, for mental health and cancer, rates are highest in regions of Eastern European and lowest in some Nordic regions, Ireland and isolated regions in continental Europe. There are also widespread and consistent absolute and relative regional inequalities in all conditions within countries. These are largest in France, Germany and the UK, and smallest in Denmark, Sweden and Norway. There were higher inequalities amongst women. Conclusion: Using newly available harmonized morbidity data from across Europe, this paper shows that there are considerable regional inequalities within and between European countries in the distribution of self-reported conditions and NCDs. [ABSTRACT FROM AUTHOR]

The article reports on a study which estimate prevalence of gambling among European professional athletes and explore factors that are associated with gambling practice and gambling problems in professional athletes. It states that self-completion questionnaire was designed for this study and socio-demographic variables, variables linked to gambling and impulsive behavior data were gathered. It mentions that instruments used for screening problem gambling were all validated.

Background: Primary malignant brain tumours are rare but represent a serious health burden due to their poor survival. This manuscript describes the survival of malignant brain tumours in adults diagnosed 2000-2007 in Europe. Methods: For this study we analysed patients archived in 86 European population-based cancer registries, followed up to 31st December 2008. Only primary malignant neuroepithelial brain tumours (with pathological confirmation) and primary malignant unspecified brain tumours without pathological confirmation were included. We estimated 1-year and 5-year relative survival (RS) weighted by age group and country. We also estimated country-specific and age-specific survival, together with survival differences between time periods (for 1999-2001, 2002-2004 and 2005-2007). Results: Glioblastoma represents 49% of all brain tumours, followed by other/unspecified astrocytoma (18%), oligodendroglioma/oligoastrocytoma (9%), ependymoma (1.5%) and embryonal tumours (1%). Five-year RS was 20% for all tumours combined, but ranged from 58% for ependymoma to only 6% for glioblastoma and sharply decreased with increasing age. Differences between countries were relatively small, but generally RS in Ireland/United Kingdom (UK) and Eastern Europe was below the average. An increase in 1-year RS (up to 10-12%) was noted over time, being largest in Central and Northern Europe in patients between 45 and 74 years of age. Conclusions: Despite an increase in 1-year RS in most European regions, the survival of primary malignant brain tumours is still poor. Disparities between countries were evident, being even larger at the end of the study period than at the beginning, suggesting differences in availability of the latest treatment modalities. [ABSTRACT FROM AUTHOR]

Background: Survival differences across Europe for patients with cancers of breast, uterus, cervix, ovary, vagina and vulva have been documented by previous EUROCARE studies. In the present EUROCARE-5 study we update survival estimates and investigate changes in country-specific and over time survival, discussing their relationship with incidence and mortality dynamics for cancers for which organised screening programs are ongoing. Methods: We analysed cases archived in over 80 population-based cancer registries in 29 countries grouped into five European regions. We used the cohort approach to estimate 5-year relative survival (RS) for adult (≥15 years) women diagnosed 2000-2007, by age, country and region; and the period approach to estimate time trends (1999-2007) in RS for breast and cervical cancers. Results: In 2000-2007, 5-year RS was 57% overall, 82% for women diagnosed with breast, 76% with corpus uteri, 62% with cervical, 38% with ovarian, 40% with vaginal and 62% with vulvar cancer. Survival was low for patients resident in Eastern Europe (34% ovary-74% breast) and Ireland and the United Kingdom [Ireland/UK] (31-79%) and high for those resident in Northern Europe (41-85%) except Denmark. Survival decreased with advancing age: markedly for women with ovarian (71% 15-44 years; 20% ≥75 years) and breast (86%; 72%) cancers. Survival for patients with breast and cervical cancers increased from 1999-2001 to 2005-2007, remarkably for those resident in countries with initially low survival. Conclusions: Despite increases over time, survival for women's cancers remained poor in Eastern Europe, likely due to advanced stage at diagnosis and/or suboptimum access to adequate care. Low survival for women living in Ireland/UK and Denmark could indicate late detection, possibly related also to referral delay. Poor survival for ovarian cancer across the continent and over time suggests the need for a major research effort to improve prognosis for this common cancer. [ABSTRACT FROM AUTHOR]

The article offers news briefs related to addiction as of 2016. The unregulated cannabidiol (CBD) market in Great Britain has been halted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The public is supporting minimum unit pricing (MUP) for alcohol products in Great Britain. A World Health Organization (WHO) report has found that the alcohol-attributable mortality burden has increased slightly in Europe since 1990.

Background: Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104–183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available. Methods: ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial. Conclusions: ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention. Trial registration: ClinicalTrials.gov Identifier: NCT02943993. [ABSTRACT FROM AUTHOR]