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Background The burden of mental health disorders in Europe is well above the world average and has increased from 11.5% to 13.9% of the total disease burden in 2000 and 2015. That from dementia has increased rapidly, and overtaken that from depression as the leading component. There have been no analyses of the research activity in Europe to combat this burden. Methodology We identified research papers in the Web of Science (WoS) with a complex mental health disorders filter based on title words and journal names in the years 2001-18, and downloaded their details for analysis. Results European mental health disorders research represented less than 6% of the total biomedical research. We estimate that research expenditure in Europe on mental health disorders amounted to about €5.4 billion in 2018. The Scandinavian countries, with Croatia and Estonia, published the most relative to their wealth, but the outputs of France and Romania were less than half the amounts expected. Discussion and conclusions The burden from mental health disorders is increasing rapidly in Europe, but research was only half what would have been proportional. Suicide & self-harm, and alcohol misuse, were also neglected by researchers, particularly since the latter also causes many physical burdens, such as foetal alcohol syndrome, interpersonal violence, and road traffic accidents. Other relatively neglected subjects are sexual disorders, obsessive compulsive disorder, post-traumatic stress disorder, attention-deficit hyperactivity and sleep disorders. There is an increasing volume of research on alternative (non-drug) therapies, particularly for post-traumatic stress and eating disorders, notably in Germany. [ABSTRACT FROM AUTHOR]

Background Despite alcohol and illicit drug dependence being one of the most common diagnoses in Europe, there is heterogeneity of research evidence used in policy and practice. Objective We sought to (1) evaluate European research outputs on alcohol misuse and drug addiction in 2002-2018 in the Web of Science, (2) compare these with their burden of disease and (3) determine their impact in several ways. Methods A bibliometric research was undertaken including an assessment of the citation counts, the influence of research on members of national health advisory committees, and their contribution to the evidence base of clinical practice guidelines (CPGs). Findings There were 3201 analysed references cited in 28 CPGs across 11 European Countries on alcohol misuse and illicit drug abuse. Research conducted in the USA dominated both sets of CPGs, while many European countries were overcited relative to their research presence. The illicit drug research appeared to be adequate relative to the evidence of harm in Europe. However, alcohol misuse research appeared grossly inadequate to the harm it causes by a factor of 20. Conclusions The volume of research on illicit drug addiction is commensurate to the European burden, whereas alcohol misuse is far below what is needed to curb a significant source of harm. Clinical implications The research asymmetries call for attention to the causes of the problem. Development of research-based solutions to a serious social harm is needed, including minimum pricing and collaborative work to harmonise efforts on disease management and treatment practices across European countries. [ABSTRACT FROM AUTHOR]

Background: No data on healthcare utilisation and associated costs for the many rare entities of children's interstitial lung diseases (chILD) exist. This paper portrays healthcare utilisation structures among individuals with chILD, provides a pan-European estimate of a 3-month interval per-capita costs and delineates crucial cost drivers.Methods: Based on longitudinal healthcare resource utilisation pattern of 445 children included in the Kids Lung Register diagnosed with chILD across 10 European countries, we delineated direct medical and non-medical costs of care per 3-month interval. Country-specific utilisation patterns were assessed with a children-tailored modification of the validated FIMA questionnaire and valued by German unit costs. Costs of care and their drivers were subsequently identified via gamma-distributed generalised linear regression models.Results: During the 3 months prior to inclusion into the registry (baseline), the rate of hospital admissions and inpatient days was high. Unadjusted direct medical per capita costs (€19 818) exceeded indirect (€1 907) and direct non-medical costs (€1 125) by far. Country-specific total costs ranged from €8 713 in Italy to €28 788 in Poland. Highest expenses were caused by the disease categories 'diffuse parenchymal lung disease (DPLD)-diffuse developmental disorders' (€45 536) and 'DPLD-unclear in the non-neonate' (€47 011). During a follow-up time of up to 5 years, direct medical costs dropped, whereas indirect costs and non-medical costs remained stable.Conclusions: This is the first prospective, longitudinal study analysing healthcare resource utilisation and costs for chILD across different European countries. Our results indicate that chILD is associated with high utilisation of healthcare services, placing a substantial economic burden on health systems. [ABSTRACT FROM AUTHOR]

Objectives: This paper aims to estimate the percentage of European men who have sex with men (MSM) who may benefit from pre-exposure prophylaxis (PrEP), applying the three most widely used HIV risk indices for MSM (MSM Risk Index, Menza score, San Diego Early Test (SDET) score) and drawing on a large-scale multisite bio-behavioural survey (Sialon II).Methods: The Sialon II study was a bio-behavioural survey among MSM implemented in 13 European cities using either time-location sampling or respondent-driven sampling. Biological and behavioural data from 4901 MSM were collected. Only behavioural data of HIV-negative individuals were considered. Three widely used risk indices to assess HIV acquisition risk among MSM were used to estimate individual HIV risk scores and PrEP eligibility criteria.Results: 4219 HIV-negative MSM were considered. Regardless the HIV risk score used and the city, percentages of MSM eligible for PrEP were found to range between 5.19% and 73.84%. Overall, the MSM Risk Index and the Menza score yielded broadly similar percentages, whereas the SDET Index provided estimates constantly lower across all cities. Although all the three scores correlated positively (r>0.6), their concordance was highly variable (0.01Conclusion: Our findings showed the impact of different scoring systems on the estimation of the percentage of MSM who may benefit from PrEP in European cities. Although our primary aim was not to compare the performance of different HIV risk scores, data show that a considerable percentage of MSM in each city should be offered PrEP in order to reduce HIV infections. As PrEP is highly effective at preventing HIV among MSM, our findings provide useful, practical guidance for stakeholders in implementing PrEP at city level to tackle HIV infections in Europe. [ABSTRACT FROM AUTHOR]

Objective Tobacco companies have made extensive efforts to build alliances against comprehensive smoke-free legislation. This article analyses the interaction between actors who opposed the development of the European Council Recommendation on smoke-free environments. Methods Drawing on data from 200 policy documents and 32 semistructured interviews and using qualitative textual analysis and organisational network analysis, opponents' positions on, and responses to, the policy initiative, strategies to oppose the policy, and efforts to build alliances were investigated. Results The non-binding nature of the policy, scientific evidence and clear political will to adopt EU-wide measures combined to limit the intensity of commercial sector opposition to the comprehensive EU smoke-free policy. Most tobacco companies, led by the Confederation of European Community Cigarette Manufacturers (CECCM), voiced reservations against the proposal, criticised the policy process and fought flanking measures on product regulation. However, some companies focused on instigating harm reduction debates. These divergent approaches and the reluctance of other commercial actors to demonstrate solidarity with the tobacco sector prevented the establishment of a cohesive commercial sector alliance. Conclusions The comparatively limited opposition to EU smoke-free policy contrasts with previous accounts of tobacco industry resistance to tobacco control. While context-specific factors can partially explain these differences, the paper indicates that the sector's diminished credibility and lack of unity hampered political engagement and alliance building. Industry efforts to emphasise the benefits of smokeless tobacco during smoke-free policy debates highlight the potential of harm reduction as a gateway for tobacco companies to re-enter the political arena. [ABSTRACT FROM AUTHOR]

While abortion has been legal in most developed countries for many years, the topic remains controversial. A major area of controversy concerns women's rights vis-a-vis the rights of health professionals to opt out of providing the service on conscience grounds. Although scholars from various disciplines have addressed this issue in the literature, there is a lack of empirical research on the topic. This paper provides a documentary analysis of three examples of conscientious objection on religious grounds to performing abortion-related care by midwives in different Member States of the European Union, two of which have resulted in legal action. These examples show that as well as the laws of the respective countries and the European Union, professional and church law each played a part in the decisions made. However, support from both professional and religious sources was inconsistent both within and between the examples. The authors conclude that there is a need for clear guidelines at both local and pan-European level for health professionals and recommend a European-wide forum to develop and test them. [ABSTRACT FROM AUTHOR]

Background Despite a concerted policy effort in Europe, social inequalities in health are a persistent problem. Developing a standardised measure of socioeconomic level across Europe will improve the understanding of the underlying mechanisms and causes of inequalities. This will facilitate developing, implementing and assessing new and more effective policies, and will improve the comparability and reproducibility of health inequality studies among countries. This paper presents the extension of the European Deprivation Index (EDI), a standardised measure first developed in France, to four other European countries--Italy, Portugal, Spain and England, using available 2001 and 1999 national census data. Methods and results The method previously tested and validated to construct the French EDI was used: first, an individual indicator for relative deprivation was constructed, defined by the minimal number of unmet fundamental needs associated with both objective (income) poverty and subjective poverty. Second, variables available at both individual (European survey) and aggregate (census) levels were identified. Third, an ecological deprivation index was constructed by selecting the set of weighted variables from the second step that best correlated with the individual deprivation indicator. Conclusions For each country, the EDI is a weighted combination of aggregated variables from the national census that are most highly correlated with a country-specific individual deprivation indicator. This tool will improve both the historical and international comparability of studies, our understanding of the mechanisms underlying social inequalities in health and implementation of intervention to tackle social inequalities in health. [ABSTRACT FROM AUTHOR]

Objective: In 2014, the European Society of Cardiology (ESC) recommended the use of a novel risk prediction model (HCM Risk-SCD) to guide use of implantable cardioverter defibrillators (ICD) for the primary prevention of sudden cardiac death (SCD) in patients with hypertrophic cardiomyopathy (HCM). We sought to determine the performance of HCM Risk-SCD by conducting a systematic review and meta-analysis of articles reporting on the prevalence of SCD within 5 years of evaluation in low, intermediate and high-risk patients as defined by the 2014 guidelines (predicted risk <4%, 4%-<6% and ≥6%, respectively).Methods: The protocol was registered with PROSPERO (registration number: CRD42017064203). MEDLINE and manual searches for papers published from October 2014 to December 2017 were performed. Longitudinal, observational cohorts of unselected adult patients, without history of cardiac arrest were considered. The original HCM Risk-SCD development study was included a priori. Data were pooled using a random effects model.Results: Six (0.9%) out of 653 independent publications identified by the initial search were included. The calculated 5-year risk of SCD was reported in 7291 individuals (70% low, 15% intermediate; 15% high risk) with 184 (2.5%) SCD endpoints within 5 years of baseline evaluation. Most SCD endpoints (68%) occurred in patients with an estimated 5-year risk of ≥4% who formed 30% of the total study cohort. Using the random effects method, the pooled prevalence of SCD endpoints was 1.01% (95% CI 0.52 to 1.61) in low-risk patients, 2.43% (95% CI 1.23 to 3.92) in intermediate and 8.4% (95% CI 6.68 to 10.25) in high-risk patients.Conclusions: This meta-analysis demonstrates that HCM Risk-SCD provides accurate risk estimations that can be used to guide ICD therapy in accordance with the 2014 ESC guidelines.Registration Number: PROSPERO CRD42017064203;Pre-results. [ABSTRACT FROM AUTHOR]

Objective To examine the relationship between the numbers of people walking or bicycling and the frequency of collisions between motorists and walkers or bicyclists. The common wisdom holds that the number of collisions varies directly with the amount of walking and bicycling. However, three published analyses of collision rates at specific intersections found a non-linear relationship, such that collisions rates declined with increases in the numbers of people walking or bicycling. Data This paper uses five additional data sets (three population level and two time series) to compare the amount of walking or bicycling and the injuries incurring in collisions with motor vehicles. Results The likelihood that a given person walking or bicycling will be struck by a motorist varies inversely with the amount of walking or bicycling. This pattern is consistent across communities of varying size, from specific intersections to cities and countries, and across time periods. Discussion This result is unexpected. Since it is unlikely that the people walking and bicycling become more cautious if their numbers are larger, it indicates that the behavior of motorists controls the likelihood of collisions with people walking and bicycling. It appears that motorists adjust their behavior in the presence of people walking and bicycling. There is an urgent need for further exploration of the human factors controlling motorist behavior in the presence of people walking and bicycling. Conclusion A motorist is less likely to collide with a person walking and bicycling if more people walk or bicycle. Policies that increase the numbers of people walking and bicycling appear to be an effective route to improving the safety of people walking and bicycling. [ABSTRACT FROM AUTHOR]

Objective: The original European League Against Rheumatism recommendations for managing fibromyalgia assessed evidence up to 2005. The paucity of studies meant that most recommendations were 'expert opinion'.Methods: A multidisciplinary group from 12 countries assessed evidence with a focus on systematic reviews and meta-analyses concerned with pharmacological/non-pharmacological management for fibromyalgia. A review, in May 2015, identified eligible publications and key outcomes assessed were pain, fatigue, sleep and daily functioning. The Grading of Recommendations Assessment, Development and Evaluation system was used for making recommendations.Results: 2979 titles were identified: from these 275 full papers were selected for review and 107 reviews (and/or meta-analyses) evaluated as eligible. Based on meta-analyses, the only 'strong for' therapy-based recommendation in the guidelines was exercise. Based on expert opinion, a graduated approach, the following four main stages are suggested underpinned by shared decision-making with patients. Initial management should involve patient education and focus on non-pharmacological therapies. In case of non-response, further therapies (all of which were evaluated as 'weak for' based on meta-analyses) should be tailored to the specific needs of the individual and may involve psychological therapies (for mood disorders and unhelpful coping strategies), pharmacotherapy (for severe pain or sleep disturbance) and/or a multimodal rehabilitation programme (for severe disability).Conclusions: These recommendations are underpinned by high-quality reviews and meta-analyses. The size of effect for most treatments is relatively modest. We propose research priorities clarifying who will benefit from specific interventions, their effect in combination and organisation of healthcare systems to optimise outcome. [ABSTRACT FROM AUTHOR]

Objectives: Men who have sex with men (MSM) are disproportionately impacted by HIV. Criminalisation of homosexuality may impede access to HIV services. We evaluated the effect of the enforcement of laws criminalising homosexuality on access to services.Methods: Using data from a 2012 global online survey that was published in a prior paper, we conducted a secondary analysis evaluating differences in perceived accessibility to health services (ie, 'how accessible are ____' services) between MSM who responded 'yes'/'no' to: 'have you ever been arrested or convicted for being gay/MSM?'Results: Of the 4020 participants who completed the study and were included in the analysis, 8% reported ever being arrested or convicted under laws relevant to being MSM. Arrests and convictions were most common in sub-Saharan Africa (23.6% (58/246)), Eastern Europe/Central Asia (18.1% (123/680)), the Caribbean (15% (15/100)), Middle East/North Africa (13.2% (10/76)) and Latin America (9.7% (58/599)). Those arrested or convicted had significantly lower access to sexually transmitted infection treatment (adjusted OR (aOR)=0.81; 95% CI 0.67 to 0.97), condoms (aOR=0.77; 95% CI 0.61 to 0.99) and medical care (aOR=0.70; 95% CI 0.54 to 0.90), compared with other MSM, while accounting for clustering by country and adjusting for age, HIV status, education and country-level income.Conclusions: Arrests and convictions under laws relevant to being MSM have a strong negative association with access to HIV prevention and care services. Creating an enabling legal and policy environment, and increasing efforts to mitigate antihomosexuality stigma to ensure equitable access to HIV services are needed, along with decriminalisation of homosexuality, to effectively address the public health needs of this population. [ABSTRACT FROM AUTHOR]

Background: The human papillomavirus (HPV) vaccine is recommended for adolescent girls in many European countries, however there is huge variation in vaccine uptake.Methods: A mixed methods systematic review to ascertain the level of HPV and HPV vaccine knowledge that exists among European adolescents. Two electronic databases, Ovid Medline and PsychInfo, were searched from origin to September 2014. Meta-analysis was performed for the two primary outcome measures ('have you heard of HPV?' and 'have you heard of the HPV vaccine?'), assessing for the correlation between gender and knowledge. This was supplemented with meta-synthesis for the remaining associations and secondary outcomes.Results: 18 papers were included in the final review. Overall European adolescents had poor understanding of basic HPV and HPV vaccine knowledge. Meta-analysis identified that female adolescents are more likely to have heard of HPV (n=2598/5028 girls versus n=1033/3464 boys; OR 2.73, 95% CI 1.86-3.99) and the HPV vaccine (n=1154/2556 girls versus n=392/2074 boys; OR 5.64, 95% CI 2.43-13.07), compared to males. Age, higher education and a positive vaccination status were also associated with increased awareness. There was limited appreciation of more detailed HPV knowledge and uncertainty existed regarding the level of protection offered by the vaccine and the need for cervical screening post vaccination.Conclusions: The delivery of HPV education to European adolescents needs to be re-evaluated, since at present there appears to be significant deficiencies in their basic knowledge and understanding of the subject. Increasing HPV knowledge will empower adolescents to make informed choices regarding participation with HPV related cancer prevention health strategies. [ABSTRACT FROM AUTHOR]

Background Between the 1990s and 2000s, relative inequalities in all-cause mortality increased, whereas absolute inequalities decreased in many European countries. Whether similar trends can be observed for inequalities in other health outcomes is unknown. This paper aims to provide a comprehensive overview of trends in socioeconomic inequalities in self-assessed health (SAH) in Europe between 1990 and 2010. Methods Data were obtained from nationally representative surveys from 17 European countries for the various years between 1990 and 2010. The age-standardised prevalence of less-than-good SAH was analysed by education and occupation among men and women aged 30-79 years. Socioeconomic inequalities were measured by means of absolute rate differences and relative rate ratios. Meta-analysis with random-effects models was used to examine the trends of inequalities. Results We observed declining trends in the prevalence of less-than-good SAH in many countries, particularly in Southern and Eastern Europe and the Baltic states. In al countries, less-than-good SAH was more prevalent in lower educational and manual groups. For all countries together, absolute inequalities in SAH were mostly constant, whereas relative inequalities increased. Almost no country consistently experienced a significant decline in either absolute or relative inequalities. Conclusions Trends in inequalities in SAH in Europe were generally less favourable than those found for inequalities in mortality, and there was generally no correspondence between the two when we compared the trends within countries. In order to develop policies or interventions that effectively reduce inequalities in SAH, a better understanding of the causes of these inequalities is needed. [ABSTRACT FROM AUTHOR]

Background During the 1990s, inequalities in smoking prevalence by socioeconomic status (SES) have widened in Europe. Since then, many tobacco control policies have been implemented. Yet, European overviews of recent trends in smoking inequalities are lacking. This paper aims to provide an overview of longterm trends of socioeconomic inequalities in smoking cessation in Europe. Methods We used data for 11 countries taken from Eurobarometer surveys from 1987 to 1995 and 2002- 2012, with a total study sample of 63 737 respondents. We performed multilevel logistic regression to model associations of the quit ratio (proportion former smokers of ever smokers) with SES, measured by education and occupation separately, with adjustments for age, sex and time. Results We found a significant, positive association for education and occupation with the quit ratio. The strength of the association decreased slightly from 1987 to 1995 and increased again from 2002 to 2012. Inequalities increased between the two periods in most countries and decreased in only one country. While in 1987-1995, the quit ratio increased among all SES groups and most strongly among the low SES group, in 2002-2012 it increased only among the high-education group (OR=1.38, 95% CI 1.02 to 1.87), and nonmanual occupation group (OR=1.59, 95% CI 1.19 to 2.12). Conclusions Socioeconomic inequalities in smoking cessation rates have strongly increased since the 1990s and during the 2000s. This suggests that the tobacco control policies implemented during the 2000s have not been able to counter the trend in increasing inequalities. [ABSTRACT FROM AUTHOR]

Objective To demonstrate, by a cost-effectiveness analysis, the efficiency of mechanical thrombectomy (MT) versus medical management (MM) in patients with a low Alberta Stroke Program Early CT Score (ASPECTS) from the RESCUE Study. Methods A cost-effectiveness model was designed to project both direct medical costs and quality-adjusted life-years (QALYs) of MT versus MM in eight European countries (Spain, UK, France, Italy, Belgium, Germany, Sweden, and the Netherlands). Our model was created based on previously published health-economic data in those countries. Procedure costs, acute, mid-term, and long-term care costs were projected based on expected modified Rankin Scale (mRS) scores as reported in the RESCUE-Japan LIMIT trial. Results MT was found to be a cost-effective option in eight different countries across Europe (Spain, Italy, UK, France, Belgium, Germany, the Netherlands, and Sweden). with a lifetime incremental cost-effectiveness ratio varying from US$2 875 to US$11 202/QALY depending on the country. A cost-effectiveness acceptability curve showed 100% acceptability of MT at the willingness to pay (WTP) of US$40 000 for the eight countries. Conclusions MT is efficient versus MM alone for patients with low ASPECTS in eight countries across Europe. Patients with a large ischemic core could be treated with MT because it is both clinically beneficial and economically sustainable. [ABSTRACT FROM AUTHOR]

Objective: To test whether different measuring techniques produce systematic differences in head size that could explain the large head circumferences found in Northern European children compared with the WHO standard.Design: Cross-sectional observational study.Setting: Scotland, UK.Patients: Study 1: 68 healthy children aged 0.4-18 months from mother and baby groups and a medical students teaching session. Study 2: 81 children aged 0.4 to 25 months from hospital wards and neonatal follow-up clinics.Interventions: Study 1: heads measured with plastic tape using both the WHO tight and UK loose technique. Study 2: heads measured using WHO research technique and a metal measuring tape and compared with routinely acquired measurements.Main Outcome Measures: Mean difference in head z-scores using WHO standard between the two methods.Results: The tight technique resulted in a mean (95% CI) z-score difference of 0.41 (0.27 to 0.54, p<0.001) in study 1 and 0.44 (0.36 to 0.53, p<0.001) in study 2. However, the mean WHO measurements in the healthy infants still produced a mean z-score that was two-third of a centile space (0.54 SD (0.28 to 0.79) p<0.001) above the 50th centile.Conclusion: The WHO measurement techniques produced significantly lower measures of head size, but average healthy Scottish children still had larger heads than the WHO standard using this method. [ABSTRACT FROM AUTHOR]

Background It has been argued that as smoking prevalence declines in countries, the smokers that remain include higher proportions of those who are unwilling or unable to quit (a process known as 'hardening'). Smokeless tobacco and e-cigarettes have been promoted as a strategy to deal with such smokers. If hardening is occurring, there would be a positive association between smoking prevalence and quitting, with less quitting at lower prevalence. There would also be a neutral or negative association between prevalence and the number of cigarettes smoked. Methods We examined US state-level associations using the Tobacco Use Supplement (1992/1993-2010/ 2011) and Eurobarometer surveys for 31 European countries (2006-2009-2012) using regressions of quit attempts, quit ratios, and number of cigarettes smoked on smoking prevalence over time. Results For each 1% drop in smoking prevalence, quit attempts increase by 0.55%±.07 (p<0.001) in the USA and remain stable in Europe ( p=0.53), US quit ratios increase by 1.13%±0.06 (p<0.001), and consumption drops by 0.32 cig/day±0.02 (p<0.001) in the USA and 0.22 cig/day±0.05 (p<0.001) in Europe. These associations remain stable over time ( p>0.24), with significantly lower consumption at any given prevalence level as time passed in the USA (-0.15 (cig/day)/year ±0.06, p<0.05). Conclusions Consistent with prior research using different data and methods, these population-level results reject the hypothesis of hardening as smoking prevalence drops, instead supporting softening of the smoking population as prevalence declines. [ABSTRACT FROM AUTHOR]

Background Reducing inequalities in health is a great challenge for public health, but how relative and absolute inequalities in mortality respond to changes in mortality by socioeconomic group is not well understood. Methods We derived arithmetically what combinations of changes and starting levels of mortality by socioeconomic group produce narrowing, and what combinations produce widening of relative and absolute inequalities in mortality. We then determined empirically how often these scenarios actually occur with data on inequalities in cause-specific mortality in five European countries spanning four decades (1970-2010). Results Changes in the rate ratio depend exclusively on the ratio of relative mortality change between socioeconomic groups, whereas changes in the rate difference depend on whether the ratio of relative mortality change between socioeconomic groups is larger or smaller than the rate ratio. This implies that, in case of declining mortality and faster relative mortality decline in higher socioeconomic groups, the rate difference will increase until the rate ratio becomes equal to the ratio of relative mortality decline, but will then start to decline. In the most common scenario in our data set (starting rate ratio above 1.00 and faster relative mortality decline in higher than lower socioeconomic groups), the rate ratio indeed always goes up but the rate difference goes down in about half of all cases, sometimes after a period of growth. Conclusions A narrowing of absolute inequalities occurs under a wider range of conditions than a narrowing of relative inequalities in mortality. [ABSTRACT FROM AUTHOR]

Background The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. Methods The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. Results Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. Conclusions The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms. [ABSTRACT FROM AUTHOR]

Background M2 segment occlusions represent approximately one-third of non-lacunar ischemic stroke and can lead to permanent neurological deficits. Various techniques are available for mechanical thrombectomy beyond the circle of Willis, but data evaluating their effectiveness and safety are lacking. Methods A retrospective review of patients with ischemic stroke undergoing mechanical thrombectomy for M2 occlusions from 13 centers in North American and Europe was performed. Tandem or multiple-territory occlusions were excluded. The primary outcome was 90-day modified Rankin Scale and reperfusion rates across stent-retriever, direct aspiration and combined techniques. Results There were 465 patients (mean age 71.48±14.03 years, 53.1% female) with M2 occlusions who underwent mechanical thrombectomy. Stentretriever alone was used in 133 (28.6%), direct aspiration alone in 93 (20.0%) and the combined technique in 239 (51.4%) patients. Successful reperfusion was achieved with the combined technique in 198 (82.2%; OR 2.6 (1.1-6.9)), with stent-retriever alone in 112 (84.2%; OR 9.2 (1.9-44.6)) and with direct aspiration alone in 62 (66.7%; referencecategory). Intraprocedural subarachnoid hemorrhages (iSAH) were 36 (7.7%) and were more likely to occur in patients treated with the stent-retrievers (OR 5.0 (1.1-24.3)) and combined technique (OR 4.6 (1.1-20.9)). Good clinical outcome was achieved in 260 (61.8%) patients, while 59 (14.0%) patients died. Older age, higher baseline NIHSS (National Institutes of Health Stroke Scale), parenchymal hemorrhage and iSAH were associated with poor outcome while successful recanalization and higher baseline ASPECTS (Alberta Stroke Program Early CT Score) were associated with good outcome. No differences were found among the three techniques in terms of clinical outcome. Conclusion Stent-retrievers and a combined approach for M2 occlusions seem more effective than direct aspiration, but with higher rates of iSAH. This leads to no detectable difference in clinical outcome at 3 months. [ABSTRACT FROM AUTHOR]

Objective: Clinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the variation of national legal and ethical requirements, and the lack of detailed guidance. The aim of this study was to design new easy-to-use guide publicly available on European Medicines Agency's, Enpr-EMA website for all stakeholders.Methods: Current EU legal, ethical and regulatory guidance for paediatric clinical trials were collated, analysed and divided into 30 subject elements in two tables. The European Network of Young Person's Advisory Group reviewed the data and provided specific comments. A three-level recommendation using 'traffic light' symbols was designed for four age groups of children, according to relevance and the requirements.Results: A single guide document includes two tables: (1) general information and (2) trial-specific information. In the age group of 6-9 years old, 92% of the trial-specific subject elements can be or should be included in the IC discussion. Even in the youngest possible age group (2-5 years old children), the number of elements considered was, on average, 52%.Conclusion: The EU Clinical Trial Regulation (2014) does not contain specific requirements exclusively for paediatric clinical trials. This work is the first to extensively collate all the current legal, regulatory and ethical documentation on the IC process, together with input from adolescents. This guide may increase the ethical standards in paediatric clinical trials. [ABSTRACT FROM AUTHOR]

Objective: To develop and validate classification criteria for microscopic polyangiitis (MPA).Methods: Patients with vasculitis or comparator diseases were recruited into an international cohort. The study proceeded in five phases: (1) identification of candidate items using consensus methodology, (2) prospective collection of candidate items present at the time of diagnosis, (3) data-driven reduction of the number of candidate items, (4) expert panel review of cases to define the reference diagnosis and (5) derivation of a points-based risk score for disease classification in a development set using least absolute shrinkage and selection operator logistic regression, with subsequent validation of performance characteristics in an independent set of cases and comparators.Results: The development set for MPA consisted of 149 cases of MPA and 408 comparators. The validation set consisted of an additional 142 cases of MPA and 414 comparators. From 91 candidate items, regression analysis identified 10 items for MPA, 6 of which were retained. The final criteria and their weights were as follows: perinuclear antineutrophil cytoplasmic antibody (ANCA) or anti-myeloperoxidase-ANCA positivity (+6), pauci-immune glomerulonephritis (+3), lung fibrosis or interstitial lung disease (+3), sino-nasal symptoms or signs (-3), cytoplasmic ANCA or anti-proteinase 3 ANCA positivity (-1) and eosinophil count ≥1×109/L (-4). After excluding mimics of vasculitis, a patient with a diagnosis of small- or medium-vessel vasculitis could be classified as having MPA with a cumulative score of ≥5 points. When these criteria were tested in the validation data set, the sensitivity was 91% (95% CI 85% to 95%) and the specificity was 94% (95% CI 92% to 96%).Conclusion: The 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for MPA are now validated for use in clinical research. [ABSTRACT FROM AUTHOR]