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Objectives: To identify overall disease course, progression patterns and risk factors predictive for progressive interstitial lung disease (ILD) in patients with systemic sclerosis-associated ILD (SSc-ILD), using data from the European Scleroderma Trials And Research (EUSTAR) database over long-term follow-up.Methods: Eligible patients with SSc-ILD were registered in the EUSTAR database and had measurements of forced vital capacity (FVC) at baseline and after 12±3 months. Long-term progressive ILD and progression patterns were assessed in patients with multiple FVC measurements. Potential predictors of ILD progression were analysed using multivariable mixed-effect models.Results: 826 patients with SSc-ILD were included. Over 12±3 months, 219 (27%) showed progressive ILD: either moderate (FVC decline 5% to 10%) or significant (FVC decline >10%). A total of 535 (65%) patients had multiple FVC measurements available over mean 5-year follow-up. In each 12-month period, 23% to 27% of SSc-ILD patients showed progressive ILD, but only a minority of patients showed progression in consecutive periods. Most patients with progressive ILD (58%) had a pattern of slow lung function decline, with more periods of stability/improvement than decline, whereas only 8% showed rapid, continuously declining FVC; 178 (33%) experienced no episode of FVC decline. The strongest predictive factors for FVC decline over 5 years were male sex, higher modified Rodnan skin score and reflux/dysphagia symptoms.Conclusion: SSc-ILD shows a heterogeneous and variable disease course, and thus monitoring all patients closely is important. Novel treatment concepts, with treatment initiation before FVC decline occurs, should aim for prevention of progression to avoid irreversible organ damage. [ABSTRACT FROM AUTHOR]

Purpose: Knowledge about polyphenols intakes and their determinants among adolescents might be helpful for planning targeted prevention strategies at an early age. Methods: In the European multicenter cross-sectional HELENA study of 2006–2007, 2428 subjects (47% boys) had data on dietary intake of polyphenols from 2 non-consecutive 24 h recalls via linking with the Phenol-Explorer database. Differences by sex, age, country, BMI, maternal education, paternal education, family affluence, smoking status, alcohol use, and physical activity were explored by linear regression. Results: Median, lower and upper quartiles of polyphenol intakes were 326, 167 and 564 mg/day, respectively. Polyphenol intake was significantly higher in the oldest (16–17.49 years), girls, non-Mediterranean countries, lowest BMI, highest paternal education, and alcohol consumers. Main food contributors were fruit (23%, mainly apple and pear, i.e., 16.3%); chocolate products (19.2%); and fruit and vegetable juices (15.6%). Main polyphenol classes were flavonoids (75–76% of total) and phenolic acids (17–19% of total). The three most consumed polyphenols were proanthocyanidin polymers (> 10 mers), hesperidin, and proanthocyanidin 4–6 oligomers. Conclusion: The current study provided for the first time numbers on the total polyphenol intake and their main food sources in a heterogeneous group of European adolescents. Major differences with adult populations are the lower polyphenol consumption and the major food sources, such as chocolate and biscuits. The discussed determinants and polyphenol types already point to some important population groups that need to be targeted in future public health initiatives. [ABSTRACT FROM AUTHOR]

The COBATEST Network of Community-Based Voluntary Counselling and STI/HIV Testing (CBVCT) services was created to standardise monitoring and evaluation of CBVCT services across Europe. This study aims to assess the quality of data collected in the network from 2015 to 2016. A survey was completed by 34 COBATEST Network members and an evaluation was performed of data quality based on three dimensions: transcription validity, completeness and consistency. The weakest area that we identified was data management processes. Only 8.8% of services had a written procedure to address data quality errors, 29.4% had procedures in place to resolve discrepancies and 35.3% performed quality control. We found that 41.2% of services utilised the COBATEST data, 11.8% made decisions based on the COBATEST data and 61.8% analysed their data in an independent manner for internal purposes. We conclude that while services have reliable data to support planning and management of services, improvements to quality procedures would ensure data are translated into evidence. This evidence would support further expansion of CBVCT services in the EU/EEA, including the integration of CBVCT-generated data into national surveillance systems. [ABSTRACT FROM AUTHOR]

Background: We aimed at describing the trends in antidepressants use (AD) by age and sex, during 2007-2011, in 5 European settings (Sweden, Norway, Denmark, Catalonia and Veneto), and to assess whether the differences found across settings could be related to economic, social and cultural determinants.Methods: We collected data of AD use expressed in defined daily doses (DDD). Data were retrieved from population-based databases. We calculated DDD/1000 inhabitants/day. We analysed which economic, social, and cultural covariates determined between-settings differences in AD consumption.Results: The use of AD showed an increasing trend during the study period, being Selective Serotonin Reuptake Inhibitors the most consumed, followed "others AD". Women and the elderly showed the highest AD consumption. Between-settings variability in AD consumption showed a positive correlation with pharmaceutical expenditure and a negative one with general practitioner's rate. After adjusting by pharmaceutical expenditure and general practitioners rate Masculinity, Long-Term Orientation and Individualism cultural dimensions were associated with AD use by using the Hofstede´s cultural dimensions model.Limitations: This study has been conducted in administrative databases, with no information on AD use by indication; differences among AD use could be related to their prescription for other disorders. Analyses were based on a small dataset and none of the results reached statistical significance.Conclusions: AD use increased through 2007-2011. Pharmaceutical expenditure and General Practitioners rate, Masculinity, Long-Term Orientation and Individualism explained the differences in AD use between countries. People's attitude should be considered when designing national campaigns to improve antidepressant use. [ABSTRACT FROM AUTHOR]

Introduction: Hypersensitivity reactions (HSRs) are among the known adverse events of intravenous (i.v.) iron products. Of these, particularly severe HSRs such as anaphylaxis are of great clinical concern due to their life-threatening potential.Methods: This was a retrospective pharmacoepidemiological study with a case-population design evaluating the number of reported severe HSRs following administration of the two i.v. iron products-ferric carboxymaltose and iron (III) isomaltoside 1000-in relation to exposure in European countries from January 2014 to December 2017. Exposure to both products was estimated using IQVIA MIDAS sales data in European countries. Information on spontaneously reported severe HSRs was obtained from and analysed separately for the two established safety surveillance databases EudraVigilance and VigiBase™ using the MedDRA® Preferred Terms anaphylactic reaction, anaphylactic shock, anaphylactoid reaction and anaphylactoid shock associated with administration of either product.Results: Between 2014 and 2017, the reporting rate of severe HSRs per 100,000 defined daily doses (100 mg dose equivalents of iron) varied from 0.3 to 0.5 for ferric carboxymaltose and from 2.4 to 5.0 for iron (III) isomaltoside 1000. The reporting rate ratio for iron (III) isomaltoside 1000 versus ferric carboxymaltose was between 5.6 (95% CI 3.5-9.0) and 16.2 (95% CI 9.4-27.8).Conclusions: Findings suggest that iron (III) isomaltoside 1000 is associated with a higher reporting rate of severe HSRs related to estimated exposure than ferric carboxymaltose in European countries. Future research investigating the occurrence of severe HSRs associated with i.v. ferric carboxymaltose and iron (III) isomaltoside 1000 is needed to broaden the evidence for benefit-risk assessment. [ABSTRACT FROM AUTHOR]

Background: Vaccine price is one of the most influential parameters in economic evaluations of HPV vaccination programmes. Vaccine tendering is a cost-containment method widely used by national or regional health authorities, but information on tender-based HPV vaccine prices is scarce.Methods: Procurement notices and awards for the HPV vaccines, published from January 2007 until January 2018, were systematically retrieved from the online platform for public procurement in Europe. Information was collected from national or regional tenders organized for publicly funded preadolescent vaccination programmes against HPV. The influence of variables on the vaccine price was estimated by means of a mixed-effects model.Findings: Prices were collected from 178 procurements announced in 15 European countries. The average price per dose for the first-generation HPV vaccines decreased from €101.8 (95% CI 91.3-114) in 2007 to €28.4 (22.6-33.5) in 2017, whereas the average dose price of the 9-valent vaccine in 2016-2017 was €49.1 (38.0-66.8). Unit prices were, respectively, €7.5 (4.4-10.6) and €34.4 (27.4-41.4) higher for the 4-valent and 9-valent vaccines than for the 2-valent vaccine. Contract volume and duration, level of procurement (region or country), per capita GDP and number of offers received had a significant effect on vaccine price.Interpretation: HPV vaccine procurement is widely used across Europe. The fourfold decrease in the average tender-based prices compared to list prices confirms the potential of tendering as an efficient cost-containment strategy, thereby expanding the indications for cost-effective HPV vaccination to previously ineligible target groups. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to analyse differences in clinical presentation in patients with early (< 3 years' duration) systemic sclerosis (SSc), comparing three age groups according to disease subsets.Method: Cross-sectional analysis of the prospective EULAR Scleroderma Trials and Research database (EUSTAR) was performed. Patients fulfilling preliminary American College of Rheumatology 1980 classification criteria for SSc, with < 3 years from the first non-Raynaud's SSc symptom at first entry, were selected. Patients with < 3 years from the first SSc symptom, including Raynaud's phenomenon, were also analysed. SSc-related variables, including antibodies, SSc subsets, and organ involvement, were examined. Age was categorized into ≤ 30, 31-59, and ≥ 60 years. We performed descriptive and bivariate analyses.Results: The study included 1027 patients: 90% Caucasian, 80% women, and 40% with diffuse disease. In early stages of SSc, younger patients had significantly more anti-Scl-70 antibodies and diffuse disease. With increasing age, we observed more elevation of estimated pulmonary systolic pressure on echocardiography (5%, 13%, and 30%, respectively, in the three age groups), cardiac conduction blocks (6%, 6%, and 15%), and left ventricular diastolic dysfunction (4%, 12%, and 27%). The results were similar for 650 patients with < 3 years from first SSc symptom, including Raynaud's.Conclusion: In early stages of SSc, older patients showed data indicating more severe disease with greater cardiac involvement. The diffuse subset was more frequent in the younger subgroup. The identification of such differences may help in selecting appropriate management for individual patients in clinical practice. [ABSTRACT FROM AUTHOR]

Background: Urbanization and ageing have important implications for public mental health and well-being. Cities pose major challenges for older citizens, but also offer opportunities to develop, test, and implement policies, services, infrastructure, and interventions that promote mental well-being. The MINDMAP project aims to identify the opportunities and challenges posed by urban environmental characteristics for the promotion and management of mental well-being and cognitive function of older individuals.Methods: MINDMAP aims to achieve its research objectives by bringing together longitudinal studies from 11 countries covering over 35 cities linked to databases of area-level environmental exposures and social and urban policy indicators. The infrastructure supporting integration of this data will allow multiple MINDMAP investigators to safely and remotely co-analyse individual-level and area-level data. Individual-level data is derived from baseline and follow-up measurements of ten participating cohort studies and provides information on mental well-being outcomes, sociodemographic variables, health behaviour characteristics, social factors, measures of frailty, physical function indicators, and chronic conditions, as well as blood derived clinical biochemistry-based biomarkers and genetic biomarkers. Area-level information on physical environment characteristics (e.g. green spaces, transportation), socioeconomic and sociodemographic characteristics (e.g. neighbourhood income, residential segregation, residential density), and social environment characteristics (e.g. social cohesion, criminality) and national and urban social policies is derived from publically available sources such as geoportals and administrative databases. The linkage, harmonization, and analysis of data from different sources are being carried out using piloted tools to optimize the validity of the research results and transparency of the methodology.Discussion: MINDMAP is a novel research collaboration that is combining population-based cohort data with publicly available datasets not typically used for ageing and mental well-being research. Integration of various data sources and observational units into a single platform will help to explain the differences in ageing-related mental and cognitive disorders both within as well as between cities in Europe, the US, Canada, and Russia and to assess the causal pathways and interactions between the urban environment and the individual determinants of mental well-being and cognitive ageing in older adults. [ABSTRACT FROM AUTHOR]

Background Safety data on routine clinical use of gadoxetate disodium in elderly patients is not reported yet. Purpose To assess the safety of liver specific gadoxetate disodium in contrast enhanced magnetic resonance imaging in elderly patients (≥65 years) in comparison to adults (18-64 years). Material and Methods Safety data on gadoxetate disodium were analyzed from 12 clinical phase II-III studies and from our pharmacovigilance database. A comparison between elderly (≥65 years) versus adults (18-64 years) was performed with respect to the frequency of drug-related adverse events (AEs) in clinical phase II-III studies and adverse drug reactions (ADRs) in the pharmacovigilance database. Results In clinical studies, 1989 patients were enrolled: 675 elderly and 1314 adults. Twenty-three elderly patients (3.4%) suffered at least one drug-related AE in contrast to 58 patients (4.4%) in the group of adults (odds ratio = 0.76; 95% confidence interval = 0.45-1.27). Since marketing authorization in 2004, more than 3.5 million patients have been exposed to gadoxetate disodium worldwide: 1.7 million (48.6%) in elderly and 1.8 million (51.4%) in adults. The number of patients with post-marketing ADRs (total n = 793) was 354 (0.021%) in the elderly group and 439 (0.024%) in the adult group. Thus, there were significantly fewer patients with ADRs reported in the group of elderly versus adults ( P = 0.028). Hypersensitivity/immune system disorders, gastrointestinal disorders, and respiratory disorders were the most frequent ADRs in both groups, elderly and adults. Conclusion The incidence of drug-related AEs in clinical studies was similar and that of patients with ADRs in the post-marketing setting was lower in elderly (≥65 years) compared with younger adults aged 18-64 years. Overall, gadoxetate disodium shows a favorable safety profile in both age groups. [ABSTRACT FROM AUTHOR]

Importance: People who immigrate face unique health literacy, communication, and system navigation challenges, and they may have diverse preferences that influence end-of-life care.Objective: To examine end-of-life care provided to immigrants to Canada in the last 6 months of their life.Design, Setting, and Participants: This population-based cohort study (April 1, 2004, to March 31, 2015) included 967 013 decedents in Ontario, Canada, using validated linkages between health and immigration databases to identify immigrant (since 1985) and long-standing resident cohorts.Exposures: All decedents who immigrated to Canada between 1985 and 2015 were classified as recent immigrants, with subgroup analyses assessing the association of time since immigration, and region of birth, with end-of-life care.Main Outcomes and Measures: Location of death and intensity of care received in the last 6 months of life. Analysis included modified Poisson regression with generalized estimating equations, adjusting for age, sex, socioeconomic position, causes of death, urban and rural residence, and preexisting comorbidities.Results: Among 967 013 decedents of whom 47 514 (5%) immigrated since 1985, sex, socioeconomic status, urban (vs rural) residence, and causes of death were similar, while long-standing residents were older than immigrant decedents (median [interquartile range] age, 75 [58-84] vs 80 [68-87] years). Recent immigrant decedents were overall more likely to die in intensive care (15.6% vs 10.0%; difference, 5.6%; 95% CI, 5.2%-5.9%) after adjusting for differences in age, sex, income, geography, and cause of death (relative risk, 1.30; 95% CI, 1.27-1.32). In their last 6 months of life, recent immigrant decedents experienced more intensive care admissions (24.9% vs 19.2%; difference, 5.7%; 95% CI, 5.3%-6.1%), hospital admissions (72.1% vs 68.2%; difference, 3.9%; 95% CI, 3.5%-4.3%), mechanical ventilation (21.5% vs 13.6%; difference, 7.9%; 95% CI, 7.5%-8.3%), dialysis (5.5% vs 3.4%; difference, 2.1%; 95% CI, 1.9%-2.3%), percutaneous feeding tube placement (5.5% vs 3.0%; difference, 2.5%; 95% CI, 2.3%-2.8%), and tracheostomy (2.3% vs 1.1%; difference, 1.2%; 95% CI, 1.1%-1.4%). Relative risk of dying in intensive care for recent immigrants compared with long-standing residents varied according to recent immigrant region of birth from 0.84 (95% CI, 0.74-0.95) among those born in Northern and Western Europe to 1.96 (95% CI, 1.89-2.05) among those born in South Asia.Conclusions and Relevance: Among decedents in Ontario, Canada, recent immigrants were significantly more likely to receive aggressive care and to die in an intensive care unit compared with other residents. Further research is needed to understand the mechanisms behind this association. [ABSTRACT FROM AUTHOR]

Aims Tobacco smoking is known to increase the long-term risk of developing Type 2 diabetes mellitus, but the mechanisms involved are poorly understood. This observational, cross-sectional study aims to compare measures of insulin sensitivity and β-cell function in current, ex- and never-smokers. Methods The study population included 1246 people without diabetes (mean age 44 years, 55% women) from the EGIR-RISC population, a large European multicentre cohort. Insulin sensitivity was measured using a hyperinsulinaemic, euglycaemic clamp and the homeostatic model assessment - insulin resistance (HOMA-IR) index. Two β-cell function parameters were derived from measures during an oral glucose tolerance test: the early insulin response index and β-cell glucose sensitivity. Additionally, the areas under the curve during the oral glucose tolerance test were calculated for glucose, insulin and C-peptide. Results According to smoking habits, there were differences in insulin sensitivity, which was lower in women who smoked, and in β-cell glucose sensitivity, which was lower in men who smoked, but these associations lost significance after adjustment. However, after adjustment, the areas under the glucose and the C-peptide curves during the oral glucose tolerance test were significantly higher in men who smoked. Conclusions Smoking habits were not independently associated with insulin sensitivity or β-cell function in a healthy middle-aged European population. Health-selection bias, methodological shortcomings or a true lack of causal links between smoking and impaired insulin sensitivity/secretion are possible explanations. The mechanisms behind the observed increased glucose and C-peptide areas under the curve during the oral glucose tolerance test in male smokers need to be further evaluated. [ABSTRACT FROM AUTHOR]

Despite established efficacy for cardiac implantable electrical devices (CIEDs), large differences in CIED implant rates have been documented across and within countries. The aim of this paper is to investigate the influence of socio-economic, epidemiological and supply side factors on CIED implant rates across 57 Regions in 5 EU countries and to assess the feasibility of using administrative data for this purpose. A total of 1 330 098 hospitalizations for CIED procedures extracted from hospital discharge databases in Austria, England, Germany, Italy and Slovenia from 2008 to 2012 was used in the analysis. Higher levels of tertiary education among the labour force and percent of aged population are positively associated with implant rates of CIED. Regional per capita GDP and number of implanting centres appear to have no significant effect. Institutional factors are shown to be important for the diffusion of CIED. Wide variation in CIED implant rates across and within five EU countries is undeniable. However, regional factors play a limited part in explaining these differences with few exceptions. Administrative databases are a valuable source of data for investigating the diffusion of medical technologies, while the choice of appropriate modelling strategy is crucial in identifying the drivers for variation across countries. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Job insecurity has been associated with certain health outcomes. We examined the role of job insecurity as a risk factor for incident diabetes.Methods: We used individual participant data from 8 cohort studies identified in 2 open-access data archives and 11 cohort studies participating in the Individual-Participant-Data Meta-analysis in Working Populations Consortium. We calculated study-specific estimates of the association between job insecurity reported at baseline and incident diabetes over the follow-up period. We pooled the estimates in a meta-analysis to produce a summary risk estimate.Results: The 19 studies involved 140 825 participants from Australia, Europe and the United States, with a mean follow-up of 9.4 years and 3954 incident cases of diabetes. In the preliminary analysis adjusted for age and sex, high job insecurity was associated with an increased risk of incident diabetes compared with low job insecurity (adjusted odds ratio [OR] 1.19, 95% confidence interval [CI] 1.09-1.30). In the multivariable-adjusted analysis restricted to 15 studies with baseline data for all covariates (age, sex, socioeconomic status, obesity, physical activity, alcohol and smoking), the association was slightly attenuated (adjusted OR 1.12, 95% CI 1.01-1.24). Heterogeneity between the studies was low to moderate (age- and sex-adjusted model: I2 = 24%, p = 0.2; multivariable-adjusted model: I2 = 27%, p = 0.2). In the multivariable-adjusted analysis restricted to high-quality studies, in which the diabetes diagnosis was ascertained from electronic medical records or clinical examination, the association was similar to that in the main analysis (adjusted OR 1.19, 95% CI 1.04-1.35).Interpretation: Our findings suggest that self-reported job insecurity is associated with a modest increased risk of incident diabetes. Health care personnel should be aware of this association among workers reporting job insecurity. [ABSTRACT FROM AUTHOR]

Background/Objectives: Polyphenols are plant secondary metabolites with a large variability in their chemical structure and dietary occurrence that have been associated with some protective effects against several chronic diseases. To date, limited data exist on intake of polyphenols in populations. The current cross-sectional analysis aimed at estimating dietary intakes of all currently known individual polyphenols and total intake per class and subclass, and to identify their main food sources in the European Prospective Investigation into Cancer and Nutrition cohort. Methods: Dietary data at baseline were collected using a standardized 24-h dietary recall software administered to 36,037 adult subjects. Dietary data were linked with Phenol-Explorer, a database with data on 502 individual polyphenols in 452 foods and data on polyphenol losses due to cooking and food processing. Results: Mean total polyphenol intake was the highest in Aarhus-Denmark (1786 mg/day in men and 1626 mg/day in women) and the lowest in Greece (744 mg/day in men and 584 mg/day in women). When dividing the subjects into three regions, the highest intake of total polyphenols was observed in the UK health-conscious group, followed by non-Mediterranean (non-MED) and MED countries. The main polyphenol contributors were phenolic acids (52.5-56.9 %), except in men from MED countries and in the UK health-conscious group where they were flavonoids (49.1-61.7 %). Coffee, tea, and fruits were the most important food sources of total polyphenols. A total of 437 different individual polyphenols were consumed, including 94 consumed at a level >1 mg/day. The most abundant ones were the caffeoylquinic acids and the proanthocyanidin oligomers and polymers. Conclusion: This study describes the large number of dietary individual polyphenols consumed and the high variability of their intakes between European populations, particularly between MED and non-MED countries. [ABSTRACT FROM AUTHOR]

Purpose: The European 'Healthy Lifestyle in Europe by Nutrition in Adolescence' (HELENA) project evaluated two different approaches to harmonize the matching procedures between 24-h recall data and food composition databases. In the first approach, the 24-h recall data were linked to the local/national food composition databases using standardized procedures, while in the second approach, the 24-h recall data were linked to the German BLS database which includes a larger food list. The aim of this paper was to compare the intakes of energy and eight nutrient components calculated via both approaches. Methods: Two non-consecutive 24-h recalls were performed in 1268 adolescents. Energy, carbohydrates, proteins, fat, fiber, water, alcohol, calcium and vitamin C were calculated via the two approaches at individual level. Paired samples t test and Pearson's correlations were used to compare the mean intakes of energy and the eight mentioned nutrients and to investigate the possible associations between the two approaches. Results: Small but significant differences were found between the intakes of energy and the eight food components when comparing both approaches. Very strong and strong correlations (0.70-0.95) were found between both methods for all nutrients. Conclusion: The dietary intakes obtained via the two different linking procedures are highly correlated for energy and the eight nutrients under study. [ABSTRACT FROM AUTHOR]

Introduction: Terrorists have used the explosive device successfully globally, with their effects extending beyond the resulting injuries. Suicide bombings, in particular, are being increasingly deployed due to the devastating effect of a combination of high lethality and target accuracy. The aim of this study was to identify trends and analyse the demographics and casualty figures of terrorist bombings worldwide.Methods: Analysis of the Global Terrorism Database (GTD) and a PubMed/Embase literature search (keywords "terrorist", and/or "suicide", and/or "bombing") from 1970 to 2014 was performed.Results: 58,095 terrorist explosions worldwide were identified in the GTD. 5.08% were suicide bombings. Incidents per year are increasing (P<0.01). Mean casualty statistics per incidents was 1.14 deaths and 3.45 wounded from non-suicide incidents, and 10.16 and 24.16 from suicide bombings (p<0.05). The kill:wounded ratio was statistically higher in suicide attacks than non-suicide attacks, 1:1.3 and 1:1.24 respectively (p<0.05). The Middle East witnessed the most incidents (26.9%), with Europe (13.2%) ranked 4th. The literature search identified 41 publications reporting 167 incidents of which 3.9% detailed building collapse (BC), 60.8% confined space (CS), 23.5% open space (OS) and 11.8% semi-confined space (SC) attacks. 60.4% reported on suicide terrorist attacks. Overall 32 deaths and 180 injuries per incident were seen, however significantly more deaths occurred in explosions associated with a BC. Comparing OS and CS no difference in the deaths per incident was seen, 14.2(SD±17.828) and 15.63 (SD±10.071) respectively. However OS explosions resulted in significantly more injuries, 192.7 (SD±141.147), compared to CS, 79.20 (SD±59.8). Extremity related wounds were the commonest injuries seen (32%).Discussion/conclusion: Terrorist bombings continue to be a threat and are increasing particularly in the Middle East. Initial reports, generated immediately at the scene by experienced coordination, on the type of detonation (suicide versus non-suicide), the environment of detonation (confined, open, building collapse) and the number of fatalities, and utilising the Kill:Wounded ratios found in this meta-analysis, can be used to predict the number of casualties and their likely injury profile of survivors to guide the immediate response by the medical services and the workload in the coming days. [ABSTRACT FROM AUTHOR]

Background: We aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.Methods: For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point (14-days after randomisation or prior discharge) and at 6-months and provide them as an analysable database.Results: The IST dataset includes data on 19 435 patients with acute stroke, with 99% complete follow-up. Over 26.4% patients were aged over 80 years at study entry. Background stroke care was limited and none of the patients received thrombolytic therapy.Conclusions: The IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Given the age distribution and nature of the background treatment given, the data may be of value in planning trials in older patients and in resource-poor settings. [ABSTRACT FROM AUTHOR]

Earlier studies on the association between health systems' economic performance and public satisfaction were based on between-countries comparisons. This approach can be challenged as it ignores the fact that subjective measures like 'satisfaction' might be relative. Cohort analysis is a way of dealing with this issue as it focuses on within-countries comparisons. The association between change in satisfaction with health care systems and change in economic performance, determined by an output-orientated constant returns to scale DEA Malmquist model over the period 1995 to 2000/2002 using OECD data, is explored. The results show that a health care systems' economic performance is not associated with public satisfaction. [ABSTRACT FROM AUTHOR]

Introduction: Visual impairment is a severe disability that puts a heavy burden on individuals, families and society. In developed countries, the two major diseases leading to irreversible visual impairment are glaucoma and age-related macular degeneration. Their prevalence will increase dramatically with population aging. The economic consequences of visual impairment are considerable, but have rarely been documented, apart from some ‘top-down’ estimates based on national statistics. We estimated the non-medical costs related to visual impairment in four European countries: France, Italy, Germany and the UK. Methods: Prevalence rates of visual impairment, defined according to local regulations, were taken from national registers and, for France, from two recent nationwide surveys conducted by the French Institute for National Statistics and Economic Studies (Institut National de la Statistique et des Etudes Economiques [INSEE]). Estimates of the number of non-registered persons were obtained from the literature and expert opinion. Estimates of non-medical costs included institutional care, non-medical devices, residential adaptations, burden on carer, paid home help, loss of income and social allowances related to visual impairment. Unit costs (year 2004) were extracted from national databases and manufacturers. Healthcare professionals were interviewed to estimate the duration of assistance required by visually impaired persons. These durations were used to evaluate the cost of paid assistance at home in the four countries. Results: The numbers of visually impaired persons were 1.27 million in France, 0.73 million in Germany, 1.03 million in Italy and 1.11 million in the UK, including, respectively, 56%, 11%, 80% and 72% non-registered persons. The frequency of institutionalisation for visually impaired persons were, respectively, 7.8%, 9.6%, 10.9% and 10%. Total annual costs for visually impaired persons were estimated at euro10 749 million in France, euro9214 million in Germany, euro12 069 million in Italy and euro15 180 million in the UK. This translated into average annual costs per affected individual of euro8434, euro12 662, euro11 701 and euro13 674, respectively. The main cost components of visual impairment in the community were ‘loss of income’ (23–43% of community costs), ‘burden on carer’ (24–39%) and ‘paid assistance’ (13–29%). Conclusion: Total non-medical costs associated with visual impairment are considerable. The present analysis demonstrates that the preponderant economic consequences of visual impairment lie beyond healthcare systems, and that visual impairment has a considerable negative impact on productivity. Considering the non-medical social dimensions of visual impairment related to the consequent incapacity and dependency should encourage payers to finance health innovations that aim to preserve vision. [ABSTRACT FROM AUTHOR]

Background: The prevalence and causes of anemia among patients with Fabry disease are unknown.Methods: In a cross-sectional study we examined hemoglobin concentrations of patients with Fabry disease using a large international database, the Fabry Outcome Survey (FOS), and analyzed the association of renal function, heart failure, gastrointestinal symptoms, and inflammation, with anemia (hemoglobin <12 g/dL in females and <13 g/dL in males).Results: Anemia was present in 34% of 345 patients with Fabry disease. Median hemoglobin in 158 females was 12.9 g/dL and the median hemoglobin of 187 male patients was 13.2 g/dL. The prevalence of anemia among females was 20%, and among males 47%. Among patients with normal renal function [estimated glomerular filtration rate (GFR) >90 mL/min/1.73 m(2)] and anemia, heart failure [New York Heart Association (NYHA) class II to IV] and/or elevated C-reactive protein (CRP) levels were documented in 82% of patients. Up to 67% of patients with decreased estimated GFR presented with anemia. There was also a trend for lower hemoglobin levels among patients with signs of inflammation (defined by an elevated CRP level). We observed no association of the presence of gastrointestinal symptoms with anemia. Analyses in 53 patients receiving enzyme replacement therapy for up to 2 years, suggest no effect on anemia.Conclusion: The results of this study point to a high prevalence of anemia among patients with Fabry disease that is in most instances related to impaired renal function, heart failure, and inflammation. This finding may be of clinical relevance, because anemia is a major risk factor for patients with kidney disease, heart failure, or stroke, which are important manifestations of Fabry disease. [ABSTRACT FROM AUTHOR]

Objectives: The European GEMSS Project is concerned with the creation of medical Grid service prototypes and their evaluation in a secure service-oriented infrastructure for distributed on demand/supercomputing. Key aspects of the GEMSS Grid middleware include negotiable QoS support for time-critical service provision, flexible support for business models, and security at all levels in order to ensure privacy of patient data as well as compliance to EU law.Methods: The GEMSS Grid infrastructure is based on a service-oriented architecture and is being built on top of existing standard Grid and Web technologies. The GEMSS infrastructure offers a generic Grid service provision framework that hides the complexity of transforming existing applications into Grid services. For the development of client-side applications or portals, a pluggable component framework has been developed, providing developers with full control over business processes, service discovery, QoS negotiation, and workflow, while keeping their underlying implementation hidden from view.Results: A first version of the GEMSS Grid infrastructure is operational and has been used for the set-up of a Grid test-bed deploying six medical Grid service prototypes including maxillo-facial surgery simulation, neuro-surgery support, radio-surgery planning, inhaled drug-delivery simulation, cardiovascular simulation and advanced image reconstruction.Conclusions: The GEMSS Grid infrastructure is based on standard Web Services technology with an anticipated future transition path towards the OGSA standard proposed by the Global Grid Forum. GEMSS demonstrates that the Grid can be used to provide medical practitioners and researchers with access to advanced simulation and image processing services for improved preoperative planning and near real-time surgical support. [ABSTRACT FROM AUTHOR]

Objectives: The GEMSS project is developing a secure Grid infrastructure through which six medical simulations services can be invoked. We examine the legal and security framework within which GEMSS operates.Methods: We provide a legal qualification to the operations performed upon patient data, in view of EU directive 95/46, when using medical applications on the GEMSS Grid. We identify appropriate measures to ensure security and describe the legal rationale behind our choice of security technology.Results: Our legal analysis demonstrates there must be an identified controller (typically a hospital) of patient data. The controller must then choose a processor (in this context a Grid service provider) that provides sufficient guarantees with respect to the security of their technical and organizational data processing procedures. These guarantees must ensure a level of security appropriate to the risks, with due regard to the state of the art and the cost of their implementation. Our security solutions are based on a public key infrastructure (PKI), transport level security and end-to-end security mechanisms in line with the web service (WS Security, WS Trust and SecureConversation) security specifications.Conclusion: The GEMSS infrastructure ensures a degree of protection of patient data that is appropriate for the health care sector, and is in line with the European directives. We hope that GEMSS will become synonymous with high security data processing, providing a framework by which GEMSS service providers can provide the security guarantees required by hospitals with regard to the processing of patient data. [ABSTRACT FROM AUTHOR]

Background: Guidelines (GLs) for the management of heart failure (HF) are of great importance in order to define and disseminate therapeutic recommendations based on scientific evidence. The aim was to analyse and to compare the methodological quality of HF GLs as well as to evaluate the consistency of therapeutic recommendations. Methods: Eleven international GLs for the management of chronic HF were identified by search of the internet, electronic databases and references of published literature. Their methodological quality was assessed by two different appraisal instruments: (1) according to the US National Guideline Clearinghouse (NGC) on a scale from 0 to 17 points, (2) according to the German Guideline Clearinghouse (Agency for Quality in Medicine, AQUMED) on a scale from 0 to 44 points. Clinical criteria for assessment of the consistency of the recommendations included diagnostic testing, pharmacological and non-pharmacological treatment. Results: The quality scores of the GLs varied substantially with a range of 1.5–15.5 points (NGC) and 8–30 points (AQUMED). The greatest variation was found in the dimensions ‘development’ and ‘evidence’. Only 3 of the 11 GLs (&ap;30%) were rated as methodologically well prepared. The recommendations on diagnostic procedures and medical management were rather consistent among the different GLs. Conclusions: Published international GL recommendations on medical management of patients with chronic HF are broadly consistent. The methodological quality of the GLs, however, varies to a great extent. Improvement is needed in most methodological aspects, especially in the dimensions ‘evidence’ and ‘applicability’. [Copyright &y& Elsevier]

The long-term ST database is the result of a multinational research effort. The goal was to develop a challenging and realistic research resource for development and evaluation of automated systems to detect transient ST segment changes in electrocardiograms and for supporting basic research into the mechanisms and dynamics of transient myocardial ischaemia. Twenty-four hour ambulatory ECG records were selected from routine clinical practice settings in the USA and Europe, between 1994 and 2000, on the basis of occurrence of ischaemic and non-ischaemic ST segment changes. Human expert annotators used newly developed annotation protocols and a specially developed interactive graphic editor tool (SEMIA) that supported paperless editing of annotations and facilitated international co-operation via the Internet. The database contains 86 two- and three-channel 24 h annotated ambulatory records from 80 patients and is stored on DVD-ROMs. The database annotation files contain ST segment annotations of transient ischaemic (1155) and heart-rate related ST episodes and annotations of non-ischaemic ST segment events related to postural changes and conduction abnormalities. The database is intended to complement the European Society of Cardiology ST-T database and the MIT-BIH and AHA arrhythmia databases. It provides a comprehensive representation of 'real-world' data, with numerous examples of transient ischaemic and non-ischaemic ST segment changes, arrhythmias, conduction abnormalities, axis shifts, noise and artifacts. [ABSTRACT FROM AUTHOR]

EDMUS is a minimal descriptive record developed for research purposes to document clinical and laboratory data in patients with multiple sclerosis (MS). It has been designed by a committee of the European Concerted Action for MS, organised under the auspices of the Commission of the European Communities. The software is user-friendly and fast, with a minimal set of obligatory data. Priority has been given to analytical data and the system is capable of automatically generating data, such as diagnosis classification, using appropriate algorithms. This procedure saves time, ensures a uniform approach to individual cases and allows automatic updating of the classification whenever additional information becomes available. It is also compatible with future developments and requirements since new algorithms can be entered in the programme when necessary. This system is flexible and may be adapted to the users needs. It is run on Apple and IBM-PC personal microcomputers. Great care has been taken to preserve confidentiality of the data. It is anticipated that this "common" language will enable the collection of appropriate cases for specific purposes, including population-based studies of MS and will be particularly useful in projects where the collaboration of several centres is needed to recruit a critical number of patients. [ABSTRACT FROM AUTHOR]

Objective: Limited information is available on the incidence of rare thyroid cancer (TC) subtypes: anaplastic (ATC) and medullary (MTC). The aim of this study was to describe incidence variations and trends across European countries of all TC subtypes.Materials and Methods: We used the RARECAREnet database including 80721 TC incident cases in the period 2000-2007 from 77 population-based cancer registries (CRs) in Europe. In the trend analyses, we included 68890 TC cases from 53 CRs with at least 6 years of incidence data in the years 2000-2007.Results: In Europe age-standardised incidence rates (ASR) in women were <0.3/100,000 for MTC and ATC whereas ASR were 5.3/100,000 for papillary thyroid cancer (PTC) and 1.1/100,000 for follicular TC (FTC). Corresponding ASRs in men were <0.2/100,000 for MTC and ATC, 1.5 for PTC and 0.4 for FTC. Across countries and in both sexes the incidence of FTC and MTC was moderately correlated (r ~ 0.5) with that of PTC, while a less marked correlation (r < 0.4) emerged for ATC ASRs. The changes of the PTC ASRs across countries and time were weakly (r < 0.3) or moderately (r ~ 0.5) correlated to the changes of the other subtypes for both sexes.Conclusion: The huge increase and heterogeneity between countries of PTC incidence has a small influence on the trends and variations of MTC and ATC in Europe. Large-scale epidemiological and clinical registry-based studies are warranted to increase knowledge about the rarest TC subtypes. This information would be fundamental for the design of new clinical trials and for inference. [ABSTRACT FROM AUTHOR]

Maternity leave policies are designed to safeguard the health of pregnant workers and their unborn children. We evaluate a maternity leave extension in Austria which increased mandatory prenatal leave from 6 to 8 weeks. We exploit that the assignment to the extended leave was determined by a cutoff date. We find no evidence for significant effects of this extension on children's health at birth or long-term health and labor market outcomes. Subsequent maternal health and fertility are also unaffected. We conclude that employment during the 33rd and 34th week of gestation is not harmful for expecting mothers (without major problems in pregnancy) and their unborn children. [ABSTRACT FROM AUTHOR]

Objectives: GRID technology, with initiatives like the GGF, will have the potential to allow both competition and interoperability not only among applications and toolkits, but also among implementations of key services. The pyramid of eHealth interoperability should be achieved from standards in communication and data security, storage and processing, to the policy initiatives, including organizational protocols, financing procedures, and legal framework. The open challenges for GRID use in clinical fields illustrate the potential of the combination of grid technologies with medical routine into a wider interoperable framework.Methods: The Telemedicine Alliance is a consortium (ESA, WHO and ITU), initiated in 2002, in building a vision for the provision of eHealth to European citizens by 2010. After a survey with more that 50 interviews of experts, interoperability was identified as the main showstopper to eHealth implementation.Results: There are already several groups and organizations contributing to standardization. TM-Alliance is supporting the "e-Health Standardization Coordination Group" (eHSCG).Conclusions: It is now, in the design and development phase of GRID technology in Health, the right moment to act with the aim of achieving an interoperable and open framework. The Health area should benefit from the initiatives started at the GGF in terms of global architecture and services definitions, as well as from the security and other web services applications developed under the Internet umbrella. There is a risk that existing important results of the standardization efforts in this area are not taken up simply because they are not always known. [ABSTRACT FROM AUTHOR]

Background: In accordance the WHO framework of health system functions and by using the indicators collected within the EURO-HEALTHY project, this work aims to contribute to the discussion on the classification of EU health systems.Methods: Three methods were used in this article: factor analysis, cluster analysis and descriptive analysis; data were mainly collected from the WHO and Eurostat databases.Results: The most relevant result is the proposed classification of health systems into the following clusters: Austria-Germany, Central and Northern Countries, Southern Countries, Eastern Countries 'A' and Eastern Countries 'B'.Conclusions: The proposed typology contributes to the discussion about how to classify health systems; the typology of EU health systems allows comparisons of characteristics and health system performance across clusters and policy assessment and policy recommendation within each cluster. [ABSTRACT FROM AUTHOR]

Objective: To study pregnancies in a large group of patients with growth hormone deficiency and hypopituitarism; and to investigate potential factors determining pregnancy outcomes and pregnancy complications.Design: We analyzed pregnancies reported in KIMS, the Pfizer International Metabolic Database, of adult patients with growth hormone deficiency treated with growth hormone.Setting: Outpatient clinics.Patient(s): A total of 201 pregnancies were reported: 173 in female patients and 28 in partners of male patients.Intervention(s): Growth hormone replacement therapy (GHRT) was prescribed according to the local clinical practice.Main Outcome Measure(s): Pregnancy outcomes (live births, gestational week at delivery, and birth weight), pregnancy complications, and their relationship to use of GHRT during pregnancy were analyzed with regression models.Result(s): Two-thirds of women underwent fertility treatment to achieve pregnancy. Growth hormone replacement therapy was stopped before pregnancy in 7.5% of the female patients, as soon as pregnancy was confirmed in 40.1%, and at the end of the second trimester in 24.7% of the patients, whereas 27.6% continued GHRT throughout pregnancy. Birth of a healthy child was reported in 79% of the female pregnancies, nonelective abortions occurred mainly in the first trimester, and one fetal malformation (cystic hygroma) was diagnosed in the second trimester. Pregnancy outcomes and pregnancy complications were not related to GHRT treatment patterns, method of conception, or number of additional pituitary deficiencies.Conclusion(s): These data on pregnancy outcomes in a large group of women with hypopituitarism revealed no relationship between GHRT regimens and pregnancy outcomes. [ABSTRACT FROM AUTHOR]