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Background/objectives: Monitoring of processed products at the brand level was implemented in Austria, France and Romania on the basis of the Oqali methodology during the Joint Action on Nutrition and Physical Activity (JANPA) to compare the nutritional quality of the food offering. The objective of this paper is to present the results obtained during this study.Subjects/methods: Collected data were those available on product packaging. In total, 2155 soft drinks and 943 breakfast cereals were classified in a standardised list of product families and analysed in a harmonised way. For each product family, mean values for sugar, fat, saturated fat, salt and dietary fibres were compared between countries. Common products across countries were also studied.Results: For all the studied nutrients, significant differences were observed between countries, with a higher sugar content for Romania in regular carbonated and non-carbonated beverages containing fruits, regular lemonades and regular tonics and bitters (together with Austria for tonics), for France in fruit beverages with more than 50% fruit, and for Austria in low-sugar beverages containing tea. For France, higher nutrient contents were also observed for sugar in chocolate-flavoured cereals, filled cereals and cornflakes, and other plain cereals (at a similar level as Romania for cornflakes), and for saturated fats in honey/caramel cereals and crunchy mueslis. These differences were explained by a different food offering in the three countries, but also by differences in nutrient contents for common products. This study also showed high variability of the nutrient content within a product family, suggesting a real potential for product reformulation.Conclusions: National tools, at the branded products level, are essential to monitor the nutritional quality of the food offering, and to follow up on processed food reformulations. [ABSTRACT FROM AUTHOR]

Purpose: Different health state utility (HSU) instruments produce different utilities for the same individuals, thereby compromising the intended comparability of economic evaluations of health care interventions. When developing crosswalks, previous studies have indicated nonlinear relationships. This paper inquires into the degree of nonlinearity across the four most widely used HSU-instruments and proposes exchange rates that differ depending on the severity levels of the health state utility scale.Methods: Overall, 7933 respondents from six countries, 1760 in a non-diagnosed healthy group and 6173 in seven disease groups, reported their health states using four different instruments: EQ-5D-5L, SF-6D, HUI-3 and 15D. Quantile regressions investigate the degree of nonlinear relationships between these instruments. To compare the instruments across different disease severities, we split the health state utility scale into utility intervals with 0.2 successive decrements in utility starting from perfect health at 1.00. Exchange rates (ERs) are calculated as the mean utility difference between two utility intervals on one HSU-instrument divided by the difference in mean utility on another HSU-instrument.Results: Quantile regressions reveal significant nonlinear relationships across all four HSU-instruments. The degrees of nonlinearities differ, with a maximum degree of difference in the coefficients along the health state utility scale of 3.34 when SF-6D is regressed on EQ-5D. At the lower end of the health state utility scale, the exchange rate from SF-6D to EQ-5D is 2.11, whilst at the upper end it is 0.38.Conclusion: Comparisons at different utility levels illustrate the fallacy of using linear functions as crosswalks between HSU-instruments. The existence of nonlinear relationships between different HSU-instruments suggests that level-specific exchange rates should be used when converting a change in utility on the instrument used, onto a corresponding utility change had another instrument been used. Accounting for nonlinearities will increase the validity of the comparison for decision makers when faced with a choice between interventions whose calculations of QALY gains have been based on different HSU-instruments. [ABSTRACT FROM AUTHOR]

Background: The role of the pharmacist has undergone profound changes over the recent years. In most European countries, the tendency seems to be that pharmacists are moving from being product-oriented to service-oriented. An interesting series of papers describing care related services of pharmacy in various countries has been published in 2006, but much has changed since then. This paper aims to provide an updated view on the overall health care sector in Europe, with a special focus on services in community pharmacy.Objective: To list and compare health care and community pharmacy structure in Europe; and to discuss the facilitators and barriers that can be found in health care systems and may promote or hinder the implementation of new community pharmacy services.Setting: European community pharmacy practice.Methods: A cross-sectional study was undertaken where data were collected using an online survey sent to a purposive sample of representatives from 27 European countries. Main outcome measure variation in professional community pharmacy services across Europe.Results: Data were obtained from 22 respondents in 19 countries (70.4%). Health care is mainly provided by a form of public National Health Services in 17 of the 19 countries. Demographic criteria for founding new pharmacies were present in 17 countries. Medicines are exclusively available in pharmacies in approximately one third of the countries. Smoking cessation (93.8%), drug waste management (81.3%) and pharmaceutical care programmes for specific diseases (77.8%) were reported as the most widely disseminated services in European pharmacies.Conclusions: There are still major differences between community pharmacy practice in Europe. Differences are mostly due to the legal framework and remuneration issues, which impact on the range of services available from pharmacies to the community of each country. [ABSTRACT FROM AUTHOR]

The European Biomedical Ethics Practitioner Education Project (EBEPE), funded by the BIOMED programme of the European Commission, is a five-nation partnership to produce open learning materials for healthcare ethics education. Papers and case studies from a series of twelve conferences throughout the European Union, reflecting the 'burning issues' in the participants' healthcare systems, have been collected by a team based at Imperial College, London, where they are now being edited into a series of seven activity-based workbooks for individual or group study. These draft workbooks are now being read by a network of critical readers across Europe, whose comments will be incorporated into the final versions of the workbooks. The result will be the first European-wide and Europe-centred resource for teaching students, practitioners, and members of ethics committees. Topics covered include: Resource allocation and rationing The rights of children and young people Long-term care of the elderly Mental health and mental illness Autonomy and patient choice Decisions at the end of life A study guide to using the workbooks. The collaborative nature of the project has highlighted differentiated national approaches in medical ethics. Against the British and Dutch rights-orientated approach have emerged two other alternative models: the Nordic preference for administrative resolution of entitlement disputes, and the southern European emphasis on deontological codes. A genuinely European reconstruction of autonomy and rights, using hermeneutic, feminist and narrative approaches to counterbalance individualistic models, is emerging across the workbooks. The programme has also uncovered national differences in how ethics should be taught, with the workbooks' style being an experiential approach. Thus the EBEPE project is developing new models in both substantive and pedagogic senses, about both what should be taught and how it should be presented. [ABSTRACT FROM AUTHOR]

This paper discusses recent migration to North America with reference to the 1962 and 1967 Canadian immigration regulations and the 1965 United States Immigration and Nationality Act. Despite the similar emphasis on manpower and kinship criteria as the basis for the admission of immigrants, differences between Canada and the United States exist with respect to the importance of immigration for the respective economies, the organization of immigration, the formal regulations, and the size and composition of migrant streams. After an examination of the volume, origin, and occupational composition of immigration to Canada and the United States, flows between the two countries are studied. The paper concludes with a scrutiny of changes in immigration regulations which are pending in both countries. [ABSTRACT FROM AUTHOR]

We conducted a cross-sectional study in 448 HIV positive patients attending five European outpatient clinics to determine prevalence of and factors associated with neurocognitive impairment (NCI) using computerized and pen-and-paper neuropsychological tests. NCI was defined as a normalized Z score ≤−1 in at least 2 out of 5 cognitive domains. Participants’ mean age was 45.8 years; 84% male; 87% white; 56% university educated; median CD4 count 550 cells/mm3; 89% on antiretroviral therapy. 156 (35%) participants had NCI, among whom 26 (17%; 5.8% overall) reported a decline in activities of daily living. Prevalence of NCI was lower in those always able to afford basic needs (adjusted prevalence ratio [aPR] 0.71, 95% confidence interval [CI] 0.54-0.94) or with a university education (aPR 0.72, 95% CI 0.54-0.97) and higher in those with severe depressive symptoms (aPR 1.53, 95% CI 1.09-2.14) or a significant comorbid condition (aPR 1.40, 95% CI 1.03-1.90). [ABSTRACT FROM AUTHOR]

While "integrated" systems regulate the quantity of health services, "Bismarckian" systems regulate their price. This paper compares the consumers' allocations implemented within the two reimbursement systems. In the model, illness has a negative impact on labor productivity while public insurance is financed through income tax. Consumers have private information with respect to a parameter which can be interpreted as heterogeneity either in intensity of their preferences for treatment or in the type of illness. The social planner may be constrained to adopt uniform insurance plans, or may be free to choose self selecting plans. The analysis of uniform plans shows that Bismarckian systems dominate integrated systems from the social welfare point of view; whereas the opposite ranking holds with self-selecting plans. [ABSTRACT FROM AUTHOR]

AIM:This paper deals with some methodological aspects of data collection in the context of measuring dietary intake in individuals in their adolescence life stage.METHOD:Experiences from three partners of the HELENA project in dietary intake measurement in children and adolescents are presented in this paper with emphasis on characteristics of under-reporting, long-term diet measurement and food patterns (Dortmund DONALD group), influences of survey duration on under-reporting (Ghent group) and meal habits (Spanish AVENA group).RESULTS:Under-reporters in the DONALD Study, particularly female adolescents, had a significantly higher body mass index (BMI) than non-under-reporters; BMI could not be explained by different long-term dietary patterns during childhood and adolescence clustered according to fat consumption; consumers of fast food had higher BMI values than nonconsumers. In the Ghent experience, the decline in population mean energy intake as calculated over selected clusters of days is 184 kcal (6.5%) in boys and 116 (5.6%) in girls; the cluster of 1 recording day and the cluster of 3 recording days were not significantly different but they were both significantly different from the 7-day cluster; no significant interaction was observed between the effect of time and BMI. In the AVENA Study, the percentage of adolescents skipping breakfast was higher in females (8.6%) than in males (3.5%, P<0.001); higher BMI values were observed in those skipping breakfast than in those notskipping breakfast, but differences were statistically significant in males at 15 y and in females at 14 and 17 y; adolescents avoiding some food groups for breakfast had higher BMI values (carbohydrates, fruits and pastries in males and milk, fruits and pastries in females).CONCLUSION:Dietary and nutrient intake data in the HELENA project will be obtained by means of repeated 24-h dietary recalls. Data from HELENA might be a basis for developing complex approaches like Healthy Eating Indices.International Journal of Obesity (2005) 29, S66–S77. doi:10.1038/sj.ijo.0803063 [ABSTRACT FROM AUTHOR]

Health care expenditure studies of the Organization for Economic Cooperation and Development (OECD) countries remain important because their findings often suggest cost containment and other policy initiatives. This paper focuses on the compatibility of OECD health data with the "expenditure inertia" (or lagged adjustments) hypothesis, by modeling individual country time-series data of 21 nations for the 1960-1993 period. Maximum likelihood estimates of the Box-Cox transformation regression models reveal that: (a) the hypothesized impact of health "expenditure inertia" is both pervasive and strong, averaging 0.64 across the countries; (b) the real GDP elasticities of health care expenditures vary widely among the countries and average 0.34 in the short run--implying that health care is a necessity; (c) the long run GDP elasticities are less than 1 in 8 countries, unitary elastic in 8 countries and elastic in 5 countries--suggesting that health care is not universally a necessity or a luxury commodity for the OECD countries; (d) physician-inducement effects (dis-inducement in a few countries) are weak, with a mean elasticity estimate of 0.17; and (e) no unique functional form approximation model is globally compatible with the data across the countries. Health care cost containment policy implications of these findings are explored. [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]

Summary: The quality of life during the first 4 months after fracture was estimated in 2,808 fractured patients from 11 countries. Analysis showed that there were significant differences in the quality of life (QoL) loss between countries. Other factors such as QoL prior fracture and hospitalisation also had a significant impact on the QoL loss. Introduction: The International Costs and Utilities Related to Osteoporotic Fractures Study (ICUROS) was initiated in 2007 with the objective of estimating costs and quality of life related to fractures in several countries worldwide. The ICUROS is ongoing and enrols patients in 11 countries (Australia, Austria, Estonia, France, Italy, Lithuania, Mexico, Russia, Spain, UK and the USA). The objective of this paper is to outline the study design of ICUROS and present results regarding the QoL (measured using the EQ-5D) during the first 4 months after fracture based on the patients that have been thus far enrolled ICUROS. Methods: ICUROS uses a prospective study design where data (costs and quality of life) are collected in four phases over 18 months after fracture. All countries use the same core case report forms. Quality of life was collected using the EQ-5D instrument and a time trade-off questionnaire. Results: The total sample for the analysis was 2,808 patients (1,273 hip, 987 distal forearm and 548 vertebral fracture). For all fracture types and countries, the QoL was reduced significantly after fracture compared to pre-fracture QoL. A regression analysis showed that there were significant differences in the QoL loss between countries. Also, a higher level of QoL prior to the fracture significantly increased the QoL loss and patients who were hospitalised for their fracture also had a significantly higher loss compared to those who were not. Conclusions: The findings in this study indicate that there appear to be important variations in the QoL decrements related to fracture between countries. [ABSTRACT FROM AUTHOR]

Objectives:Despite many years of research, there is currently no treatment available that results in major neurological or functional recovery after traumatic spinal cord injury (tSCI). In particular, no conclusive data related to the role of the timing of decompressive surgery, and the impact of injury severity on its benefit, have been published to date. This paper presents a protocol that was designed to examine the hypothesized association between the timing of surgical decompression and the extent of neurological recovery in tSCI patients.Study design:The SCI-POEM study is a Prospective, Observational European Multicenter comparative cohort study. This study compares acute (<12 h) versus non-acute (>12 h, <2 weeks) decompressive surgery in patients with a traumatic spinal column injury and concomitant spinal cord injury. The sample size calculation was based on a representative European patient cohort of 492 tSCI patients. During a 4-year period, 300 patients will need to be enrolled from 10 trauma centers across Europe. The primary endpoint is lower-extremity motor score as assessed according to the 'International standards for neurological classification of SCI' at 12 months after injury. Secondary endpoints include motor, sensory, imaging and functional outcomes at 3, 6 and 12 months after injury.Conclusion:In order to minimize bias and reduce the impact of confounders, special attention is paid to key methodological principles in this study protocol. A significant difference in safety and/or efficacy endpoints will provide meaningful information to clinicians, as this would confirm the hypothesis that rapid referral to and treatment in specialized centers result in important improvements in tSCI patients. [ABSTRACT FROM AUTHOR]

Vaccines against human papillomavirus (HPV), the primary causative agent in cervical cancer, are licensed. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on the introduction of HPV vaccines in central Europe. Eight countries currently have medical representatives on CEVAG: the Czech Republic, Estonia, Hungary, Lithuania, Poland, Romania, Slovakia and Turkey. By raising awareness and disseminating information, CEVAG aims to promote the efficient and safe use of vaccines to prevent, control and if possible eliminate infectious diseases. In January 2008, the European Centre for Disease Prevention and Control published a report entitled Guidance for the Introduction of HPV Vaccines in EU Countries. Members of CEVAG have taken the information relevant to their countries from this report and, with consideration of local issues, produced these guidance recommendations for the introduction of HPV vaccines in the CEVAG region, which may be adapted for use in individual countries. [ABSTRACT FROM AUTHOR]

Over the past 20 years, most European countries have introduced DRGs or similar grouping systems as instruments for hospital reimbursement. This paper compares and analyzes the methods used to determine prices for inpatient care within DRGs or similar grouping systems employed in nine EU member states (i.e., Denmark, France, Germany, Hungary, Italy, Tthe Netherlands, Poland, Spain and England). It categorizes the systems of patient classification used in these nine countries and compares them according to the three steps necessary in order to set prices: 1.) definition of a data sample, 2.) use of trimming methods and plausibility checks and 3.) definition of prices. It concludes with a discussion on the typical development path of DRG systems and the role of additional reimbursement components in this context. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQOL) assessment in children and adolescents with chronic health conditions is increasingly considered as a relevant topic. The aim of the EU-funded DISABKIDS project is to develop, test, and implement European instruments for the assessment of HRQOL of children and adolescents with disabilities and their families. The current paper describes the development and pilot testing of a chronic generic HRQOL measure. Using literature searches, expert consulting and focus groups with children/adolescents and their families, items of the instruments were developed and translated into the respective languages. A pilot test with 360 children and adolescents was conducted. Children and adolescents (8-12, 13-16 years) with different chronic health conditions (asthma, epilepsy, diabetes, arthritis, atopic dermatitis, cerebral palsy, and cystic fibrosis) as well as their families were included. Data were analysed according to predefined psychometric and content criteria. Psychometric analyses resulted in a 56-item chronic generic HRQOL questionnaire with six domains ('Medication', 'Physical', 'Emotion', 'Independence', 'Social Inclusion', 'Social Exclusion') with acceptable internal consistency. [ABSTRACT FROM AUTHOR]

Introduction: Laparoscopic gastric banding (LGB) is currently the most popular purely restrictive bariatric operation in Europe and many other countries. It has a low operative morbidity, but is associated with a substantial late complication rate. Many late complications have been attributed to technical errors or to the learning curve. The aim of this paper is to present our results with gastric banding after the learning curve in order to disclose the true incidence of long-term complications.Methods: LGB was introduced in our department in December 1995. Thirty patients were operated on until June 1997 using the early banding technique (band within the lesser sac), at which time the surgical technique was slightly modified in order to place the band above the lesser sac. Then another 300 patients underwent LGB using either the Lapband or the SAGB system. This report focuses on the latter patients. All the data were collected prospectively.Results: The series includes 300 patients (257 women and 43 men) with a mean age of 38.3 years (19-64). The mean initial weight was 119.2 kg (57-179), initial body mass index (BMI) was 43.3 kg/m2 (21-64), and initial excess weight was 96.5% (0-191). The mean duration of surgery was 90 min, decreasing over time to a mean of 75 min for the last 50 cases. Early overall morbidity was 6.6%. Major complications occurred in 7 patients (2.3%). Excess weight loss (EWL) was at least 50% in 66% of the patients after 2 years, averaging 60%, with no substantial change until 4 years, and the BMI stabilized between 30 and 31 kg/m2. Forty-nine patients developed a total of 52 long-term complications, of which 23 (7.6%) were related only to the port or catheter. Band erosion occurred in 17 (5.6%), pouch dilatation with slippage in 8 (2.6%), and infection in 4 (1.3%) patients. Fifty-five reoperations were necessary. Twenty-five of these were related only to the port. The band was removed from 26 (9%) patients, of whom 17 were converted to Roux-en-Y gastric bypass.Conclusions: LGB gives satisfactory results in terms of weight loss in about two-thirds of the patients. Even beyond the learning curve, the long-term morbidity is not negligible, but is acceptable compared to other procedures such as vertical banded gastroplasty. Conversion to gastric bypass is possible when complications occur and can be performed when the band is removed in most cases. [ABSTRACT FROM AUTHOR]

While most of the debate on "rationing in health care" focusses on the distribution of scarce medical resources among competing needs, which we propose to call "secondary rationing," this paper is concerned with "primary rationing," i.e., the conscious decision by society to limit the amount of resources devoted to a collectively financed health care system. Based upon a number of transparent normative criteria, we analyze whether primary rationing should be performed and, if so, what type should be chosen (hard vs. soft, explicit vs. implicit). Finally we discuss whether age should be used as a criterion in any systematic attempt at primary rationing of health care. [ABSTRACT FROM AUTHOR]

A shortage of donor liver grafts unfortunately results in approximately 10% of patients dying whilst listed for a liver transplant in Europe and the United States. Thus it is imperative that all available organs are used as efficiently as possible. This paper reports upon the application of a simulation modelling approach to assess the impact of several alternative allocation policies upon the cost effectiveness of this technology at one liver transplant centre in the UK. The impact of changes in allocation criteria on the estimated net life expectancy, average net costs and overall cost effectiveness of the transplantation programme were evaluated. The incremental cost effectiveness ratio (ICER) for the base case allocation policy, based upon the time spent on the waiting list (i.e., longest wait first) was 11,557 pounds sterling at 1999 prices. The ICERs associated with an allocation policy based upon age (lowest age first), and an allocation policy based upon the severity of the pre-transplant condition of the patient (with most severely ill patients given a lower priority) were lower than the base case at 10,424 pounds sterling and 9,077 pounds sterling, respectively. The results of this modelling study suggest that the overall cost effectiveness of the liver transplantation programme could be improved if the current allocation policy were modified to give more weight to the age of the patient and the reduced chances of success of the most severely ill patients. [ABSTRACT FROM AUTHOR]

This paper compares AIDS hospital care in several European-Union countries. For this purpose hospital-care utilisation studies on inpatient days and outpatient contacts were analysed in a generic approach controlling for severity stages of AIDS. Lifetime hospital-care needs for AIDS are derived, providing useful information for health-care policy makers. In a next step, lifetime estimates are linked to estimated annual new cases of AIDS, resulting from standardised epidemiological modelling. These results on AIDS impact at the population level are reported including statistical confidence limits. Both lifetime hospital- care needs at the patient level and AIDS impact at the population level are compared between countries and related to characteristics of the national AIDS epidemics and health-care systems. A person with AIDS has a contact - either inpatient day or outpatient visit - with the hospital in 14% (UK) to 24% (France) of the days spent in the AIDS stage. Related to the national AIDS epidemics (epidemiological impact), Italy and Greece have high levels of outpatient contacts per million population. Estimated hospital-bed needs for AIDS in 1995 are up to 2.13% (in Spain) of total national acute-care hospital beds available. Estimated per-capita needs for outpatient visits in 1995 are highest in Italy, corresponding to 108 doctor full-time equivalents. In a case-study for Greece and The Netherlands, differences in hospital-care utilisation patterns were assessed to correspond with differences in their health-care systems (number of hospital beds, doctors and nurses per capita and some qualitative characteristics of medical care in both countries). International comparison of AIDS hospital care is possible using standardised analysis of national hospital-care utilisation data and standardised epidemiological modelling. Estimates of lifetime hospital-care needs are an essential input for cost-effectiveness analyses used to aid health-care policy decision-making. [ABSTRACT FROM AUTHOR]

Objectives: To perform an online survey about the use of magnetic resonance arthrography (MRA) in clinical practice.Methods: We administered an online survey to all 1,550 members of the European Society of Musculoskeletal Radiology (ESSR) about MRA asking ten different questions. Subgroup analysis was performed between general and orthopaedic hospitals using χ2 and Mann-Whitney U statistics.Results: One-hundred forty-eight answers were included (148/1,550, 9.5% of ESSR members). A median of 3,000 (interquartile range: 1,567.5-5,324.5) musculoskeletal MR examinations and a median of 125.5 MRAs (50.75-249) per institution were performed in 2016. Ratio between MRA and musculoskeletal MR was 4.7% (1.6%-9.0%). Using MRA, the most investigated joint was the shoulder followed by the hip (96.6%). The most common indications were the evaluation of instability, labrum, and rotator cuff (85.1%). Fluoroscopy represented the preferred injection guidance. A self-prepared mixture of Gadolinium/saline is preferred in general hospitals, while pre-diluted Gadolinium-based syringes are mainly used in orthopaedic hospitals (P=.010). The number of MRA performed at orthopaedic hospitals (284;83.75-449.50) was higher (P=.006) than that performed at general hospitals (115.50;44.75-234.25).Conclusions: One out of twenty MR examinations is a MRA, with higher prevalence in orthopaedic hospitals. The shoulder and the hip are the most investigated joints. Instability, labrum, and cuff are the most common indications.Key Points: • The most common MRAs are shoulder and hip (96.6% of answers). • Most common clinical indications for MRA are instability, labrum, and rotator cuff (85.1% of answers). • Fluoroscopy represents the preferred guidance to inject joints (61.0% of answers). • The median number of MRA performed at orthopaedic hospitals (n=284) was significantly higher (P=.006) than that performed at general hospitals (n=115.50). • A self-prepared mixture of Gadolinium/saline solution is preferred in general hospitals (64.8%) compared to orthopaedic hospitals (36.0%; P=0.010). [ABSTRACT FROM AUTHOR]

To explore the value of antiandrogen therapy for advanced prostate cancer, two clinical trials of similar design were recently conducted in six countries throughout Europe. A total of 550 patients with previously untreated metastatic prostate cancer were randomized either to treatment with an antiandrogen or castration. While time to treatment failure, objective tumour response and survival were expected to be similar between study treatments, their effects on health-related quality of life (HRQOL) were expected to differ and were therefore a focus of concern in this trial. To assess these effects, we developed a brief self-administered patient questionnaire covering 10 domains of HRQOL (general health perceptions, pain, emotional well-being, vitality, social functioning, physical capacity, sexual interest, sexual functioning, activity limitation and bed disability), which we translated from English into several other languages. In this paper, we describe the development, content and translation of this survey instrument and report on its reliability and validity in six countries based on data collected for the first 487 patients to complete questionnaires at study entry. [ABSTRACT FROM AUTHOR]

Unexpected loads, which often occur in the working environment, can lead to high forces in the spine and, thus, may be a cause of low back injury. This paper discusses the effect of "sudden load" on the erector spine reaction and amplitude. Muscle responses were mediated by several factors, including fatigue, posture, expectation and rehabilitation, in chronic low back pain patients. The subjects were fatigued by holding a 20% maximum voluntary contraction for 1 min. A functional restoration program was tested for its efficacy in reducing reaction time and EMG amplitude in chronic low back pain patients. Reaction time was longer and EMG amplitude lower in patients than in their matched controls. EMG reaction time and magnitude decreased in patients after a 2-week rehabilitation program, including specific training of coordination and posture control. The results of the modelling showed higher spinal compressive load and lower shear forces when the load was expected than when the load was unexpected. The effect of sudden loads can be exacerbated if a worker is not standing on a flat surface or is fatigued. Chronic low back pain patients have less ability to protect themselves from sudden loads, but they can be trained to improve their response by means of an appropriate rehabilitation program. [ABSTRACT FROM AUTHOR]

Using an ecological perspective, one aspect of the relationship of social distance and physical distance is analyzed in the three largest cities in Israel. The principal aim of the paper is to examine ethnic (country of origin) residential segregation as an indicator of social patterning within the society. Despite the different demographic, topographical and functional characteristics of the three cities, fairly similar patterns of ethnic segregation are found using the technique of Smallest Space Analysis (SSA-I) to analyze index of dissimilarity matrices. Patterns of ethnic segregation are then related to the SES of sub-quarters to determine the nature of the internal structure of the cities. It is suggested that ethnicity is an important variable in the process of social stratification in urban Israel, at least insofar as ecological relationships are concerned. [ABSTRACT FROM AUTHOR]

In the early 1970s, aluminium toxicity was first implicated in the pathogenesis of clinical disorders in patients with chronic renal failure involving bone (renal osteomalacia) or brain tissue (dialysis encephalopathy). Before that time the toxic effects of aluminium ingestion were not considered to be a major concern because absorption seemed unlikely to occur. Meanwhile, aluminium toxicity has been investigated in countless epidemiological and clinical studies as well as in animal experiments and many papers have been published on the subject. It is now commonly acknowledged that aluminium toxicity can be induced by infusion of aluminium-contaminated dialysis fluids, by parenteral nutrition solutions, and by oral exposure as a result of aluminium-containing pharmaceutical products such as aluminium-based phosphate binders or antacid intake. Over-the-counter antacids are the most important source for human aluminium exposure from a quantitative point of view. However, aluminium can act as a powerful neurological toxicant and provoke embryonic and fetal toxic effects in animals and humans after gestational exposure. Despite these facts, the patient information leaflets from European antacids that are available OTC show substantial differences regarding warnings from aluminium toxicity. It seems advisable that all patients should receive the same information on aluminium toxicity from patient information leaflets, in particular with regard to the increased absorption through concomitant administration with citrate-containing beverages and the use of such antacids during pregnancy. [ABSTRACT FROM AUTHOR]

Objectives: Our study aimed to compare the clinical severity of lower respiratory tract infections (LRTI's) caused by Influenza and Respiratory Syncytial Virus (RSV). Methods: We conducted a retrospective cohort study of LRTI admissions with positive PCR results for Influenza or RSV from 2017 to 2019 in three teaching hospitals in southern Europe. Data on clinical characteristics, viral agents and disease outcome were collected. Nosocomial infection was excluded. Main outcomes were invasive mechanical ventilation and in-hospital death. Results: A total of 984 patients were included. Median age was 75 years. Influenza A was the most frequently identified virus (56.5%), of which 27.1% were subtype H1N1 and 53.0% H3N2. Influenza B was isolated in 22.3% and RSV in 21.0%. There were 10.5% of patients who died during admission and 8.3% submitted to IMV. Influenza A H1N1 was associated with lower age and less co-morbidity, while the opposite was observed for RSV. Influenza A H1N1 was independently associated with both higher risk of death (adjusted odds ratio 2.0 [1.2–3.4] p = 0.008) and IMV (adjusted odds ratio 5.1 [3.0–8.5] p < 0.001). Conclusion: Influenza A H1N1 was an independent predictor of mortality and IMV. These findings may have implications on hospital resource planning and vaccination policies. [ABSTRACT FROM AUTHOR]

Controversy continues over a proposed moratorium on elective genital surgery in childhood for disorders/differences of sex development (DSD). Empirical evidence on patient preference is needed to inform decision-making. We conducted a multicentre survey by cross-sectional questionnaire in 14 specialized clinics in six European countries. The sample comprised 459 individuals (≥ 16 years) with a DSD diagnosis, including individuals with congenital adrenal hyperplasia (CAH) (n = 192), XY DSD with prenatal androgen effect (A) (n = 150), and without (nA) (n = 117). Main outcome measures were level of agreement with given statements regarding genital surgery, including clitoris reduction, vaginoplasty, and hypospadias repair. A total of 66% of individuals with CAH and 60% of those with XY DSD-A thought that infancy or childhood were the appropriate age for genital surgery. Females with XY DSD were divided on this issue and tended to prefer vaginoplasty at a later age (XY DSD-A 39%, XY DSD-nA 32%). A total of 47% of males preferred early hypospadias surgery. Only 12% (CAH), 11% (XY DSD-A), and 21% (XY DSD-nA) thought they would have been better off without any surgery in childhood or adolescence. Individuals who had early genital surgery were more likely to approve of it. Outcome data failed to support a general moratorium on early elective genital surgery. Participant perspectives varied considerably by diagnostic category, gender, history of surgery, and contact with support groups. Case-by-case decision-making is better suited to grasping the ethical complexity of the issues at stake.Trial registration: German Clinical Trials Register DRKS00006072. [ABSTRACT FROM AUTHOR]

Anthropological studies of mortuary ceremonies have focused primarily on their social and structural correlates and functions. Little attention has been given to their role in facilitating the expression and resolution of grief by the bereaved. The elaborate and extended mortuary rites of the people of northeastern Arnhem Land, Australia (the "Murngin") have several characteristics which promote and structure the mourning process and facilitate the full reintegration of the bereaved into the social life of the community. [ABSTRACT FROM AUTHOR]

Background: Inclusion of productivity losses and gains in cost-effectiveness analyses for drugs is recommended by pharmacoeconomic guidelines in some countries and is considered optional in others. Often guidelines recommend analysis based on the payer perspective, but suggest that a supplemental analysis based on the societal perspective may be submitted that includes productivity losses/gains. However, there is no universally recognized framework for the approach to including productivity losses and gains in pharmacoeconomic analyses.Objectives: This study aimed to systematically review literature on cost-effectiveness analyses of drug interventions that included costs associated with productivity losses/gains and to summarize the types cost elements included and cost calculation methods employed. Moreover, this study examines variations in the calculation of productivity losses/gains by target disease type, geographic region, income group, period of analysis, and analysis time horizon-as well as the impact of their inclusion on the study outcomes.Methods: A search of three databases was performed, including MEDLINE, Embase, and the Cochrane Library, to identify cost-effectiveness and cost-utility analyses that included indirect costs such as productivity losses/gains. Publications from January 2010 to October 2019 were examined and selected for inclusion by two independent reviewers. In addition to the citation details, data on the country of analysis, country income group, target disease area, study sponsorship, type of analysis, study design, time horizon, analysis perspective, productivity loss/gain elements included, the approach used to estimate productivity losses/gains, and the impact of their inclusion on the study outcome-namely the incremental cost effectiveness ratio-were extracted and summarized.Results: The search strategy identified 5038 unique studies, and 208 were included in the final analysis. Among the studies reviewed, 165 (79%) were conducted in high-income countries and 160 (77%) were conducted for North American and European/Central Asian countries. The productivity loss/gain elements included in the analysis were reported for 169 studies (81%). Absenteeism only was included for 98 studies (47%), and absenteeism plus presenteeism was included for 29 studies (14%). Absenteeism plus some other element such as costs associated with unemployment and/or early retirement was included for 32 studies (15%) examined. Only one out of four of the studies reviewed included information on the approach used to estimate productivity losses/gains, which was predominantly the human capital approach. One-hundred forty-four studies (69%) reported the impact of including productivity losses/gains on the ICER, with 110 studies (53%) reporting that their inclusion contributed to more favorable cost-effectiveness.Conclusions: Although inclusion of productivity losses/gains was shown to have a favorable impact on evaluations for many studies, their impact and method of calculation was often not reported or was unclear. Further examination and discussion is needed to consider the optimal framework for considering productivity losses/gains in cost-effectiveness analyses, including the appropriate cost elements to include (e.g., patient absenteeism, caregiver absenteeism, presenteeism, unemployment, etc.) and how those costs should be estimated. [ABSTRACT FROM AUTHOR]

Since the introduction of the system of diagnosis related groups (DRGs) for USA Medicare patients in 1983, case payment mechanisms have gradually become the principal means of reimbursing hospitals in most developed countries. The use of case payments nevertheless poses severe technical and policy challenges, and there remain many unresolved issues in their implementation. This paper introduces a special issue of the journal that describes and compares experience with the use of case payments for reimbursing hospitals in nine European countries. The editorial sets the policy scene, and argues that DRG systems must be seen both as a technical reimbursement method and as a fundamental incentive mechanism within the health system. [ABSTRACT FROM AUTHOR]

Mantle cell lymphoma has a dismal prognosis at relapse or in the refractory setting. Among therapies, mTor pathway targeting by temsirolimus has been the first strategy approved for relapse in Europe. While its efficacy in monotherapy has long been demonstrated, its use remains limited. In the T3 phase Ib clinical trial, we investigated the recommended dose of temsirolimus in association with R-CHOP (R-CHOP-T), or high-dose cytarabine plus rituximab (R-DHA-T), or fludarabine, cyclophosphamide plus rituximab (R-FC-T). From November 11, 2011 to February 26, 2015, forty-one patients were enrolled. Patients presented with high MIPI (47.5%) at relapse and a median number of treatments of 1 (1-3). Patients were treated by R-CHOP-T (n = 10), R-FC-T (n = 14), or R-DHA-T (n = 17) according to the choice of local investigators. The maximum tolerated dose (MTD) was 15 mg in the R-CHOP-T arm and has not been determined in other treatment arms because of toxicities. All patients experienced ≥ Grade 3 adverse events, mainly thrombocytopenia (76%). Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n = 12) and progression of the disease (n = 8). Of note, 6 patients of the R-DHA-T arm reached complete remission (35%). Temsirolimus with immuno-chemotherapy is associated with a high rate of toxicities. Determination of MTD could only be achieved for R-CHOP-T arm. Associations between temsirolimus and other targeted therapies may be warranted for R/R MCL patients. [ABSTRACT FROM AUTHOR]

Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged ≥ 6 years. Pharmacokinetic data for children aged 6-11 years were extracted post hoc from a study in which children (2-11 years) with allergic rhinoconjunctivitis or urticaria received oral bilastine (10 mg/day). Maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC) data were compared with adult pharmacokinetic data from seven clinical studies (bilastine 20 mg/day). Safety data for children aged 6-11 years were extracted post hoc from a phase III randomized controlled trial of children (2-11 years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily bilastine 10 mg or placebo for 12 weeks. Exposure and Cmax values were similar for children (6-11 years) and adults: median pediatric/adult ratios for AUC0-24 and Cmax were 0.93 and 0.91, respectively. There was no significant difference in the incidence of treatment-emergent adverse in children (6-11 years) receiving bilastine 10 mg or placebo.Conclusion: Pharmacokinetic and safety analyses in children aged 6-11 years support the suitability of the pediatric dose of bilastine 10 mg and confirm that the safety profiles of bilastine and placebo are similar.What is Known:• Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults (20 mg/day) and children aged ≥ 6 years (10 mg/day).• An ontogenic model based on adult data and pharmacokinetic/pharmacodynamic simulations supported the selection of a bilastine dose of 10 mg/day in children aged 2-11 years. Bilastine 10 mg/day was shown to have a safety profile similar to that of placebo in a large phase III randomized clinical trial in children aged 2-11 years.What is New:• As bilastine is approved in Europe for children aged ≥6 years, the current study reports the results of two post hoc analyses of pharmacokinetic and safety data in children aged 6-11 years.• Analysis of pharmacokinetic and safety data in children aged 6-11 years supports the suitability of the pediatric dose of bilastine 10 mg and confirms that its safety profile is similar to that of placebo. [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]

Objectives: Cholangiocarcinoma is the second most common primary liver tumour with a poor overall prognosis. Percutaneous hepatic perfusion (PHP) is a directed therapy for primary and secondary liver malignancies, and its efficacy and safety have been shown in different entities. The purpose of this study was to prove the safety and efficacy of PHP in patients with unresectable intrahepatic cholangiocarcinoma (iCCA).Patients and Methods: We retrospectively reviewed data from 15 patients with unresectable iCCA treated with PHP in nine different hospitals throughout Europe. Overall response rates (ORR) were assessed according to response evaluation criteria in solid tumours (RECIST1.1). Overall survival (OS), progression-free survival (PFS) and hepatic PFS (hPFS) were analysed using the Kaplan-Meier estimation. Adverse events (AEs) and toxicity were evaluated.Results: Fifteen patients were treated with 26 PHPs. ORR was 20%, disease control was achieved in 53% after the first PHP. Median OS was 26.9 months from initial diagnosis and 7.6 months from first PHP. Median PFS and hPFS were 122 and 131 days, respectively. Patients with liver-only disease had a significantly longer median OS compared to patients with locoregional lymph node metastases (12.9 vs. 4.8 months, respectively; p < 0.01). Haematological toxicity was common, but manageable. No AEs of grade 3 or 4 occurred during the procedures.Discussion: PHP is a standardised and safe procedure that provides promising response rates and survival data in patients with iCCA, especially in non-metastatic disease.Key Points: • Percutaneous hepatic perfusion (PHP) offers an additional locoregional therapy strategy for the treatment of unresectable primary or secondary intrahepatic malignancies. • PHP is a standardised and safe procedure that provides promising response rates and survival data in patients with intrahepatic cholangiocarcinoma (iCCA), especially in non-metastatic disease. • Side effects seem to be tolerable and comparable to other systemic or local treatment strategies. [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]

Purpose: The objective of our study was to retrospectively compare the outcomes of non-operative management (NOM) and splenic artery embolization (SAE) in the management of hemodynamically stable patients with splenic injuries.Materials and Methods: In a 5-year period, 109 patients were recorded; 60/109 were treated with NOM and 49/109 with SAE. For each patient, the following parameters were assessed: Glasgow coma scale, injury severity score, American Association for the Surgery of Trauma splenic injury grade, transfusion requirements, hemoglobin level, presence of a splenic vascular lesion (SVL) and amount of hemoperitoneum (Bessoud scale). Different SAE techniques (proximal, distal, combined) with different materials were employed. Clinical success was defined as spleen conservation at 30 days; failure was defined as spleen re-bleeding within 30 days, requiring splenectomy. Student's t test or Chi-square analysis and the Kaplan-Mayer curve were used to analyse each group's results and compare them with those of the other group.Results: In the SAE group, AAST splenic injury grade was higher and serum hemoglobin levels were lower. The SAE group had significantly more SVL and hemoperitoneum compared to the NOM group. The clinical success rate was not significantly different between groups (NOM = 95%, SAE = 87.8%; p = 0.16). Sixty-six percent of NOM failures were related to inadequate patient selection, while 67% of SAE failures were due to technical/procedural issues.Conclusion: Our study observed a high splenic salvage rate with the use of SAE as an adjunct to NOM, and suggests that it may be further improved with appropriate patient selection and an improved embolization technique. [ABSTRACT FROM AUTHOR]

Research on sex-related differences in Autism Spectrum Disorder (ASD) has been impeded by small samples. We pooled 28 datasets from 18 sites across nine European countries to examine sex differences in the ASD phenotype on the ADI-R (376 females, 1763 males) and ADOS (233 females, 1187 males). On the ADI-R, early childhood restricted and repetitive behaviours were lower in females than males, alongside comparable levels of social interaction and communication difficulties in females and males. Current ADI-R and ADOS scores showed no sex differences for ASD severity. There were lower socio-communicative symptoms in older compared to younger individuals. This large European ASD sample adds to the literature on sex and age variations of ASD symptomatology. [ABSTRACT FROM AUTHOR]

The cumulative (dis)advantage hypothesis states that health disparities between education groups increase with age. The present study examined this hypothesis in a comparative analysis of the United States, the United Kingdom, the Netherlands, and Sweden. These countries offer sharp contrasts in the social conditions that may intensify or inhibit processes of cumulative (dis)advantage. Using harmonized panel data from the HRS, ELSA, and SHARE, the study applied Poisson multilevel regression models to trace changes in the number of chronic conditions and functional limitations of people aged 50-76 (N = 16,887 individuals; 71,154 observations). The four countries showed a clear gradient in levels of physical health and in the extent to which health trajectories were shaped by education. Across all ages and cohorts, health problems were most prevalent in the United States, less prevalent in the United Kingdom and the Netherlands, and least prevalent in Sweden. A similar cross-national gradient was found for the size of health gaps between education groups and for the extent to which these gaps widened with age. Gaps were largest in the United States, smaller in the United Kingdom and in the Netherlands, and smallest in Sweden. [ABSTRACT FROM AUTHOR]

Bullying is not included in Diagnostic and Statistical Manual for Mental Disorders (DSM) criteria (Criteria A, APA, 2013) for posttraumatic stress disorder (PTSD), however, several studies have demonstrated the association between bullying (including those being the bully, victim) and PTSD. The aim of the present study was to investigate the relationship between bullying and PTSD and suicide attempts among adolescents across nine countries. A total of 4051 adolescents with a mean age of 14.9 years found that 36.6% of the adolescents reported exposure to bullying. There were some gender differences across countries. Bullying was significantly associated with PTSD symptoms and suicide attempts among the adolescents. National prevention plans and interventions are needed to prevent bullying. [ABSTRACT FROM AUTHOR]

Public debates about both immigration policy and social safety net programs are increasingly contentious. However, little research has explored differences in health within America's diverse population of foreign-born workers, and the effect of these workers on public benefit programs is not well understood. We investigate differences in work disability by nativity and origins and describe the mix of health problems associated with receiving Social Security Disability Insurance benefits. Our analysis draws on two large national data sources-the American Community Survey and comprehensive administrative records from the Social Security Administration-to determine the prevalence and incidence of work disability between 2001 and 2010. In sharp contrast to prior research, we find that foreign-born adults are substantially less likely than native-born Americans to report work disability, to be insured for work disability benefits, and to apply for those benefits. Overall and across origins, the foreign-born also have a lower incidence of disability benefit award. Persons from Africa, Northern Europe, Canada, and parts of Asia have the lowest work disability benefit prevalence rates among the foreign-born; persons from Southern Europe, Western Europe, the former Soviet Union, and the Caribbean have the highest rates. [ABSTRACT FROM AUTHOR]

In recent years, population health research has focused on understanding the determinants of later-life health. Two strands of that work have focused on (1) international comparisons of later-life health and (2) assessing the early-life origins of disease and disability and the importance of life course processes. However, the less frequently examined intersection of these approaches remains an important frontier. The present study contributes to the integration of these approaches. We use the Health and Retirement Study family of data sets and a cohort dynamic approach to compare functional health trajectories across 12 high-income countries and to examine the role of life course processes and cohort dynamics in contributing to variation in those trajectories. We find substantial international variation in functional health trajectories and an important role of cohort dynamics in generating that variation, with younger cohorts often less healthy at comparable ages than the older cohorts they are replacing. We further find evidence of heterogeneous effects of life course processes on health trajectories. The results have important implications for future trends in morbidity and mortality as well as public policy. [ABSTRACT FROM AUTHOR]

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We compared the level of attention capacity between adolescents from the center and south of Europe. The study included 627 European adolescents (54% girls), aged 12.5-17.5 years, who participated in the HELENA Study. The d2 Test of Attention was administered to assess attention capacity. The main results showed that adolescents from the south of Europe had significantly higher score in attention capacity compared with adolescents from central Europe (score + 8.1; 95%CI, 2.44-13.61) after adjustment for age, sex, socioeconomic indicators, body mass index, cardiorespiratory fitness and diet quality index (p = 0.012).Conclusion: Adolescents from the south of Europe had higher levels of attention capacity than their counterparts from central Europe independently of sociodemographic and health-related factors. These differences should be taken into account by educational institutions when promoting new approaches for putting into the practice student's capacities. What is Known? • Attention is a crucial capacity during adolescence. • Several health-related factors (i.e., physical activity, fitness or fatness) may influence attention capacity in adolescents. What is New? • Adolescents from the south of Europe had higher levels of attention capacity than their counterparts from the center, after accounting for socioeconomic factors, fitness, fatness and quality of diet. • These differences should be taken into account by educational institutions when promoting new approaches for putting into the practice student's capacities. [ABSTRACT FROM AUTHOR]

Background: Attention-deficit/hyperactivity disorder (ADHD) is increasingly recognized as a persistent disorder requiring long-term management.Objectives: Our objective was to evaluate the 2-year safety and efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents with ADHD.Methods: Participants (aged 6-17 years) with ADHD received open-label, dose-optimized LDX 30, 50, or 70 mg/day for 104 weeks. Safety monitoring included treatment-emergent adverse events (TEAEs), vital signs, electrocardiography, and growth. The TEAEs decreased appetite, weight decrease, insomnia events (including insomnia, initial insomnia, middle insomnia, and terminal insomnia), headache, and psychiatric TEAEs were pre-defined as being of special interest. Efficacy was assessed as a secondary objective using the ADHD Rating Scale IV (ADHD-RS-IV), the Clinical Global Impressions-Improvement (CGI-I) scale, and the CGI-Severity (CGI-S) scale.Results: Of 314 participants enrolled, 191 completed the study. TEAEs were reported in 89.8% of participants, led to discontinuation in 12.4%, and were reported as serious in 8.9%. TEAEs that were reported by ≥5% of participants and considered by investigators as related to LDX were decreased appetite (49.4%), weight decrease (18.2%), insomnia (13.1%), initial insomnia (8.9%), irritability (8.6%), nausea (6.7%), headache (5.7%), and tic (5.1%). The median time to first onset and duration, respectively, of TEAEs of special interest were as follows: decreased appetite, 13.5 and 169.0 days; weight decrease, 29.0 and 225.0 days; insomnia, 17.0 and 42.8 days; and headache, 22.0 and 2.0 days. Reports of decreased appetite, weight decrease, insomnia, and headache were highest in the first 4-12 weeks. Psychiatric TEAEs were infrequent: psychosis and mania (n = 1), suicidal events (suicidal ideation, n = 2; suicide attempt, n = 1), and aggression events (aggression, n = 14; anger, n = 2; hostility, n = 1). At the last on-treatment assessment (LOTA), mean increases from baseline in vital signs were as follows: pulse rate, 7.0 bpm (95% confidence interval [CI] 5.7-8.2); systolic blood pressure (SBP), 3.4 mmHg (95% CI 2.2-4.5); and diastolic blood pressure (DBP), 3.2 mmHg (95% CI 2.2-4.2). Pre-defined thresholds for a potentially clinically important (PCI) high pulse rate were met at one or more visits by 22 participants (7.0%), for PCI high SBP were met by 45 children (22.4%) and 17 adolescents (15.2%), and for PCI high DBP were met by 78 children (38.8%) and 24 adolescents (21.4%). The mean QT interval corrected using Fridericia's formula (QTcF) decreased from baseline to LOTA (-0.6 ms [95% CI -2.3 to 1.2]; range -50 to +53). Mean changes in growth from baseline to LOTA were weight, 2.1 kg (95% CI 1.5-2.8); height, 6.1 cm (95% CI 5.6-6.7); and body mass index (BMI), -0.5 kg/m2 (95% CI -0.7 to -0.3). There was a general shift to lower z score categories for height, weight, and BMI from baseline to LOTA. The mean change in ADHD-RS-IV from baseline to LOTA was -25.8 (95% CI -27.0 to -24.5) for total score, -12.6 (95% CI -13.4 to -11.9) for the hyperactivity/impulsivity subscale score, and -13.1 (95% CI -13.8 to -12.4) for the inattention subscale score. At LOTA, 77.9% of participants had a CGI-I score of 1 or 2. In addition, 77.3 and 69.2% of participants were classified as treatment responders, based on a CGI-I score of 1 or 2 and a ≥30% or ≥50% reduction from baseline in ADHD-RS-IV total score, respectively.Conclusions: The safety profile of LDX in this longer-term study was similar to that reported in previous studies. The efficacy of LDX was maintained throughout the 2-year study period. CLINICALTRIALS.Gov Identifier: NCT01328756. [ABSTRACT FROM AUTHOR]

Introduction: New biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment. The rituximab biosimilar CT-P10 has recently been approved in Europe in all indications held by reference rituximab (RTX), including rheumatoid arthritis, non-Hodgkin's lymphoma, and chronic lymphocytic leukemia. We analyzed the budgetary impact of the introduction of CT-P10 into the European Union (EU) for use in patients with rheumatoid arthritis and cancer diagnoses, using a budget impact analysis model.Methods: The model used a base case scenario in which the 1-year uptake of CT-P10 was estimated at 30%, and the cost of CT-P10 was assumed to be 70% of the cost of RTX. A second 1-year scenario was also modeled, in which the market share of CT-P10 was assumed to be 50% (scenario 2). Finally, 3-year time horizon outcomes were calculated, in which the market share of CT-P10 was assumed to be 30%, 40%, and 50% in the first, second, and third years, respectively.Results: In the base case scenario, the introduction of CT-P10 was associated with projected savings of €90.04 million in the first year, which would allow 7531 additional patients to access rituximab treatment. This was equivalent to a 6.4% increase in the number of rituximab-treated patients. In scenario 2, budget savings were €150.10 million, with a total of 12,551 additional patients able to access rituximab, equivalent to a 10.7% increase. Over a 3-year time horizon, projected budget savings were approximately €570 million, equating to 47,695 additional patients able to access rituximab.Conclusions: The model predicted that the introduction of CT-P10 in the EU will be associated with significant budget savings, the reallocation of which will enable many more patients to access rituximab treatment. This is likely to have a significant impact on health gains at patient and societal levels.Funding: CELLTRION Healthcare Co., Ltd. sponsored the development and analysis of the budget impact analysis model. [ABSTRACT FROM AUTHOR]

Early and reliable screening for oropharyngeal dysphagia (OD) symptoms in at-risk populations is important and a crucial first stage in effective OD management. The Eating Assessment Tool (EAT-10) is a commonly utilized screening and outcome measure. To date, studies using classic test theory methodologies report good psychometric properties, but the EAT-10 has not been evaluated using item response theory (e.g., Rasch analysis). The aim of this multisite study was to evaluate the internal consistency and structural validity and conduct a preliminary investigation of the cross-cultural validity of the EAT-10; floor and ceiling effects were also checked. Participants involved 636 patients deemed at risk of OD, from outpatient clinics in Spain, Turkey, Sweden, and Italy. The EAT-10 and videofluoroscopic and/or fiberoptic endoscopic evaluation of swallowing were used to confirm OD diagnosis. Patients with esophageal dysphagia were excluded to ensure a homogenous sample. Rasch analysis was used to investigate person and item fit statistics, response scale, dimensionality of the scale, differential item functioning (DIF), and floor and ceiling effect. The results indicate that the EAT-10 has significant weaknesses in structural validity and internal consistency. There are both item redundancy and lack of easy and difficult items. The thresholds of the rating scale categories were disordered and gender, confirmed OD, and language, and comorbid diagnosis showed DIF on a number of items. DIF analysis of language showed preliminary evidence of problems with cross-cultural validation, and the measure showed a clear floor effect. The authors recommend redevelopment of the EAT-10 using Rasch analysis. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate early performance of contemporary dual mobility acetabular systems with second generation annealed highly cross-linked polyethylene for primary hip arthroplasty of patients under 55 years of age.Methods: A prospective observational five years study across five centers in Europe and the USA of 321 patients with a mean age of 48.1 years was performed. Patients were assessed for causes of revision, hip instability, intra-prosthetic dissociation, Harris hip score and radiological signs of osteolysis.Results: There were no dislocations and no intra-prosthetic dissociations. Kaplan Meier analysis demonstrated 97.51% survivorship for all cause revision and 99.68% survivorship for acetabular component revision at five years. Mean Harris hip score was 93.6. Two acetabular shells were revised for neck-rim implant impingement without dislocation and ten femoral stems were revised for causes unrelated to dual mobility implants.Conclusion: Contemporary highly cross-linked polyethylene dual mobility systems demonstrate excellent early clinical, radiological, and survivorship results in a cohort of patients that demand high performance from their implants. It is envisaged that DM and second generation annealed HXLPE may reduce THA instability and wear, the two most common causes of THA revision in hip arthroplasty. [ABSTRACT FROM AUTHOR]

Introduction: The present study aimed to assess the costs and consequences of using an innovative medical technology, misoprostol vaginal insert (MVI), for the induction of labor (IOL), in place of alternative technologies used as a standard of care.Methods: This was a retrospective study on cost and resource utilization connected with economic model development. Target population were women with an unfavorable cervix, from 36 weeks of gestation, for whom IOL is clinically indicated. Data on costs and resources was gathered via a dedicated questionnaire, delivered to clinical experts in five EU countries. The five countries participating in the project and providing completed questionnaires were Austria, Poland, Romania, Russia and Slovakia. A targeted literature review in Medline and Cochrane was conducted to identify randomized clinical trials meeting inclusion criteria and to obtain relative effectiveness data on MVI and the alternative technologies. A hospital perspective was considered as most relevant for the study. The economic model was developed to connect data on clinical effectiveness and safety from randomized clinical trials with real life data from local clinical practice.Results: The use of MVI in most scenarios was related to a reduced consumption of hospital staff time and reduced length of patients' stay in hospital wards, leading to lower total costs with MVI when compared to local comparators.Conclusions: IOL with the use of MVI generated savings from a hospital perspective in most countries and scenarios, in comparison to alternative technologies.Funding: Sponsorship, article processing charges, and the open access charge for this study were funded by Ferring Pharmaceuticals Poland. [ABSTRACT FROM AUTHOR]

Background: The etiology of small intestinal cancer (SIC) is largely unknown, and there are very few epidemiological studies published to date. No studies have investigated abdominal adiposity in relation to SIC.Methods: We investigated overall obesity and abdominal adiposity in relation to SIC in the European Prospective Investigation into Cancer and Nutrition (EPIC), a large prospective cohort of approximately half a million men and women from ten European countries. Overall obesity and abdominal obesity were assessed by body mass index (BMI), waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR). Multivariate Cox proportional hazards regression modeling was performed to estimate hazard ratios (HRs) and 95 % confidence intervals (CIs). Stratified analyses were conducted by sex, BMI, and smoking status.Results: During an average of 13.9 years of follow-up, 131 incident cases of SIC (including 41 adenocarcinomas, 44 malignant carcinoid tumors, 15 sarcomas and 10 lymphomas, and 21 unknown histology) were identified. WC was positively associated with SIC in a crude model that also included BMI (HR per 5-cm increase = 1.20, 95 % CI 1.04, 1.39), but this association attenuated in the multivariable model (HR 1.18, 95 % CI 0.98, 1.42). However, the association between WC and SIC was strengthened when the analysis was restricted to adenocarcinoma of the small intestine (multivariable HR adjusted for BMI = 1.56, 95 % CI 1.11, 2.17). There were no other significant associations.Conclusion: WC, rather than BMI, may be positively associated with adenocarcinomas but not carcinoid tumors of the small intestine.Impact: Abdominal obesity is a potential risk factor for adenocarcinoma in the small intestine. [ABSTRACT FROM AUTHOR]

Purpose: Osteoarthritis (OA) has been shown to be associated with decreased physical function, which may impact upon a person's self-rated health (SRH). Only a few studies have examined the association between OA and SRH in the general population, but to date none have used a clinical definition of OA. The objectives are: (1) To examine the cross-sectional association between clinical OA and fair-to-poor SRH in the general population; (2) To examine whether this association differs between countries; (3) To examine whether physical function is a mediator in the association between clinical OA and SRH.Methods: Baseline data of the European Project on OSteoArthritis (EPOSA) were used, which includes pre-harmonized data from six European cohort studies (n = 2709). Clinical OA was defined according to the American College of Rheumatology criteria. SRH was assessed using one question: How is your health in general? Physical function was assessed using the Western Ontario and McMaster Universities OA Index and Australian/Canadian OA Hand Index.Results: The prevalence of fair-to-poor SRH ranged from 19.8 % in the United Kingdom to 63.5 % in Italy. Although country differences in the strength of the associations were observed, clinical OA of the hip, knee and hand were significantly associated with fair-to-poor SRH in five out of six European countries. In most countries and at most sites, the association between clinical OA and fair-to-poor SRH was partly or fully mediated by physical function.Conclusions: Clinical OA at different sites was related to fair-to-poor SRH in the general population. Most associations were (partly) mediated by physical functioning, indicating that deteriorating physical function in patients with OA should be a point of attention in patient care. [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]