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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]

Presents information on meetings and awards related to spine surgery and research in Europe in 2005. Names of societies; GRAMMER "European Spine Journal" Awards; Orthopaedic spine surgery congress; International Spine Congress; International Society for the Study of the Lumbar Spine; Knee joint and spine congress; Cervical Spine Research Society meeting.

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]

The article focuses on gender inequality in the field of science in European countries. In 2007, women scientists in 27 countries of European Union accounted for 38% of active researchers and only 19% of full professors. It is said that the number of women PhD graduates is also increasing, however it does not suggest any self-correction in gender imbalance. It is said that Europe has still not reached its target of having 40% women in decision-making positions in science and research by 2001.

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]

Introduction: Lithuania has one of the highest mortality rates from coronary heart disease (CHD) among European countries. Most CHD are preventable, but when they occur, the management of these patients is important in secondary prevention. The purpose of the present analysis was to describe the demographics, clinical profile, and contemporary management of patients with stable CHD in the Lithuanian population and to compare data with other Central Eastern European countries.Methods: CLARIFY (prospective observational longitudinal registry of patients with stable CHD) is an international cohort study in outpatients with stable CHD. Treated outpatients with established CHD from the CLARIFY registry in Lithuania (214 patients) were compared with those from the rest of Central Eastern Europe (2794 patients).Results: Lithuanian patients were younger (p = 0.0275), had a higher body mass index (p = 0.0003), and more frequently received treatment for hypertension (p < 0.0001). Prevalence of dyslipidemia (p < 0.0001) was higher in Lithuanian patients but a smaller group of people had diabetes (p < 0.0001). The total cholesterol (p < 0.0001), low-density lipoprotein cholesterol (p < 0.0001), and blood pressure (p < 0.0001) were higher in the Lithuanian population. A smaller proportion of Lithuanian patients were physically inactive, and the majority of patients in Lithuania were engaged in light physical activity compared with Central Eastern European patients (p = 0.0018).Conclusion: The data analysis shows that management of hypertension, dyslipidemia, smoking, and obesity in patients with CHD in Lithuania is insufficient and needs further improvement. [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]

The article cites a U.S. report that states that Asian nations are catching up with Europe and the United States in terms of scientific output. According to the report, in 2004, countries from the Asia Pacific region including China, South Korea, Taiwan, Japan, Singapore and India produced 25 percent of the world's research papers. By comparison, Europe produced 38 percent of the world's scientific papers, and the United States produced 33 percent. Within Asia, China, South Korea, Singapore and Taiwan grew the most. In China, some institutions even pay researchers extra for publications in indexed journals, especially ones that carry widely cited articles.

The purpose of this paper is to formulate a professional and scientific view on the social, ethical, and legal issues that impact on data storage and DNA banking practices for biomedical research in Europe. Many aspects have been considered, such as the requirements for data storage and DNA banking in the public and private sectors in Europe and the issues relating to DNA banking, that is to say the consent requirements for the banking and further uses of DNA samples, their control and ownership, and the return of benefit derived from DNA exploitation to the community. The methods comprise primarily the review of the existing professional guidelines, legal frameworks and other documents related to the data storage and DNA banking practices in public and private sectors in Europe. Then, the issues related to DNA banking were examined during an international workshop organized by the European Society of Human Genetics Public and Professional Policy Committee in Paris, France, 07-08, April, 2000. A total of 50 experts from 12 European countries attended this workshop. It came out that DNA banking for medical and research purposes is indispensable. It facilitates the constitution of large collections, sharing of samples, multiple testing on the same samples, and repeating testing over the years. However, banking organization is complex, requires multiple actors, and concerns are expressed in various countries. International standardization of ethical requirements and policies with regard to DNA banking has been recommended. Such standardization would facilitate a greater protection of individuals as well as future international cooperation in biomedical research.European Journal of Human Genetics (2003) 11, Suppl 2, S88-S122. doi:10.1038/sj.ejhg.5201114 [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]

In contemporary society, digital media are fully integrated in our daily lives, indispensable for our routines, always connected and at-hand. Our research thus explores the parental mediation of portable digital devices in families with young children, addressing the following questions: (a) which are the most common parental mediation styles adopted towards young children; and (b) which individual features of the parents or contextual factors influence the parental mediation style adopted. Our methodology is exploratory and qualitative, considering as empirical corpus 14 national reports from the European-scale study 'Young Children (0-8) and Digital Technologies' for a comparative thematic analysis. The authoritative style was the most common parental mediation style related to technology use. In general, there are transversal rules to all parental mediation styles (except laissez-faire style), such as withdraw or give devices to children according to their behavior, control (inappropriate) content and control the time of use. Also, parental perceptions and attitudes about the technologies played a heavier weight on the parental mediation style adopted, and consequently influenced the relationship of the children with digital media. Some implications for future studies, preventive actions, and family therapy are discussed. [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]

The alteration of sex-specific body features and the establishment of a satisfactory body image are known to be particularly relevant for individuals with Gender Dysphoria (GD). The aim of the study was to first develop new scales and examine the psychometric properties of the Hamburg Body Drawing Scale (Appelt & Strauß 1988). For the second part of this study, the satisfaction with different body features in young GD adults before cross-sex treatment were compared to female and male controls. Data collection took place within the context of the European Network for the Investigation of Gender Incongruence (ENIGI) including 135 female-to-male (FtMs) and 115 male-to-female (MtFs) young GD adults and 235 female and 379 male age-adjusted controls. The five female and six male body feature subscales revealed good internal consistency. The ENIGI sample reported less satisfaction with overall appearance (d = 0.30) and with all of their body features than controls, but no subgroup differences for sexual orientation (FtM and MtF) and Age of Onset (FtM) were found. Body dissatisfaction was higher with regard to sex-specific body features (largest effect sizes of d = 3.21 for Genitalia in FtMs and d = 2.85 for Androgen-responsive features and genitalia in MtFs) than with those that appeared less related to the natal sex (d = 0.64 for Facial features in FtMs and d = 0.59 for Body shape in MtFs). Not only medical body modifying interventions, but also psychosocial guidance with regard to body image might be helpful for GD individuals before transitioning. [ABSTRACT FROM AUTHOR]

Objective: To estimate the social/economic costs of fragile X syndrome (FXS) in Europe and to assess the health-related quality of life (HRQOL) of patients and caregivers.Methods: A cross-sectional study was conducted in a sample of European countries. Patients were recruited through patients' associations. Data on their resource use and absence from the labour market were retrospectively obtained from an online questionnaire. Costs were estimated by a bottom-up approach and the EuroQol-5 Domain (EQ-5D) questionnaire was used to measure patients' and caregivers' HRQOL.Results: Five countries were included in the analysis. The mean annual cost of FXS per patient varied from €4951 in Hungary to €58,862 in Sweden. Direct non-healthcare costs represented the majority of costs in all countries but there were differences in the share incurred by formal and informal care among those costs. Costs were also shown to differ between children and adults. Mean EQ-5D utility score for adult patients varied from 0.52 in France (n = 42) to 0.73 in Hungary (n = 2), while for caregivers this score was consistently inferior to 0.87.Conclusion: Our findings underline that, although its prevalence is low, FXS is costly from a societal perspective. They support the development of tailored policies to reduce the consequences of FXS on both patients and their relatives. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to determine the social/economic costs and health-related quality of life (HRQOL) of patients with epidermolysis bullosa (EB) in eight EU member states.Methods: We conducted a cross-sectional study of patients with EB from Bulgaria, France, Germany, Hungary, Italy, Spain, Sweden and the United Kingdom. Data on demographic characteristics, health resource utilisation, informal care, labour productivity losses, and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire.Results: A total of 204 patients completed the questionnaire. Average annual costs varied from country to country, and ranged from €9509 to €49,233 (reference year 2012). Estimated direct healthcare costs ranged from €419 to €10,688; direct non-healthcare costs ranged from €7449 to €37,451 and labour productivity losses ranged from €0 to €7259. The average annual cost per patient across all countries was estimated at €31,390, out of which €5646 accounted for direct health costs (18.0 %), €23,483 accounted for direct non-healthcare costs (74.8 %), and €2261 accounted for indirect costs (7.2 %). Costs were shown to vary across patients with different disability but also between children and adults. The mean EQ-5D score for adult EB patients was estimated at between 0.49 and 0.71 and the mean EQ-5D visual analogue scale score was estimated at between 62 and 77.Conclusion: In addition to its negative impact on patient HRQOL, our study indicates the substantial social/economic burden of EB in Europe, attributable mostly to high direct non-healthcare costs. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with Duchenne muscular dystrophy (DMD) in Europe.Methods: We conducted a cross-sectional study of patients with DMD from Bulgaria, France, Germany, Hungary, Italy, Spain, Sweden, and the UK. Data on demographic characteristics, healthcare resource utilization, informal care, labor productivity losses, and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire. Costs have been estimated from a societal perspective adopting a bottom-up approach.Results: A total of 422 questionnaires were included in the study; 268 of which were collected from patients with DMD and 154 from caregivers. The average annual cost per person in 2012 ranged from €7657 in Hungary to €58,704 in France. Direct non-healthcare costs are the main component of whole costs and informal care is the main driver of non-healthcare costs. Costs are also shown to differ between children and adults. With regard to HRQOL of adult patients, the EQ-5D VAS score and EQ-5D index scores were 50.5 and 0.24, respectively. The corresponding EQ-5D VAS and EQ-5D index scores for caregivers were 74.7 and 0.71, respectively.Conclusions: We have estimated the average annual cost per patient with DMD in eight European countries adopting a social perspective, and to our knowledge this is the first study with such a wide perspective. The results on costs show a considerable gap between Eastern and Western European countries. Non-healthcare costs range from 64 to 89 % of overall costs and informal care is to a great extent the main driver of this cost category. The HRQOL of people with DMD is much lower than that of the general population. [ABSTRACT FROM AUTHOR]

Objectives: Our goal was to provide data on the economic burden and health-related quality of life (HRQOL) of patients with cystic fibrosis (CF) and their caregivers in Europe.Methods: A cross-sectional study was carried out on adults and children with CF in eight European countries. Patients completed an anonymous questionnaire regarding their socio-demographic characteristics, use of healthcare services and presence of a caregiver. Costs were calculated with a bottom-up approach using unit costs from each participating country, and HRQOL was assessed using EQ-5D. The principal caregiver also answered a questionnaire on their characteristics, HRQOL and burden.Results: A total of 905 patients with CF was included (399 adults and 506 children). The total average annual cost per patient varied from €21,144 in Bulgaria to €53,256 in Germany. Adults had higher direct healthcare costs than children, but children had much higher informal care costs (P < 0.0001). Total costs increased with patients' level of dependence. In adults, mean utility fell between 0.640 and 0.870, and the visual analogue scale ranged from 46.0 to 69.7. There was no difference in caregiver HRQOL regardless of whether they cared for an adult or a child. However, caregivers who looked after a child had a significantly higher burden (P = 0.0013).Conclusions: Our study highlights the burden of CF in terms of costs and decreased HRQOL for both patients and their caregivers throughout Europe. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with haemophilia in Europe.Methods: We conducted a cross-sectional study of patients with haemophilia from Bulgaria, France, Germany, Hungary, Italy, Spain Sweden and the UK. Data on demographic characteristics, health resource utilisation, informal care, loss of labour productivity and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire. The costs have been estimated from a societal perspective adopting a bottom-up approach.Results: A total of 401 questionnaires were included in the study, of which 339 were collected from patients with haemophilia and 62 from caregivers. The lowest average annual cost per person was reported in Bulgaria (€6,660) and the highest in Germany (€194,490). Our results demonstrate both a large difference from country to country in the average annual cost per patient in 2012 and the driving role of drugs in costs. Drugs represent nearly 90 % of direct healthcare costs in a majority of the countries analysed (Hungary, Italy, Spain and Germany). In Bulgaria, France and Sweden, however, healthcare services (visits, tests and hospitalisations) prevail. Costs are also shown to differ between children and adults. The mean EQ-5D index score for adult patients was 0.69 and mean EQ-5D VAS was 66.6. The mean EQ-5D index score for carers was 0.87 and mean EQ-5D VAS was 75.5. In the disability score, 60 % showed no disability and measuring caregiver burden with the Zarit Index produced an overall mean score of 25.3.Conclusion: We have shown that haemophilia is associated with a substantial economic burden and impaired HRQOL. Studies on cost of illness and HRQOL are important for haemophilia as the future of this disease is likely to change with the development of new innovative treatments. The introduction of these treatments will most likely impact future costs related to haemophilia. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with juvenile idiopathic arthritis (JIA) in Europe.Methods: We conducted a cross-sectional study of patients with JIA from Germany, Italy, Spain, France, the United Kingdom, Bulgaria, and Sweden. Data on demographic characteristics, healthcare resource utilization, informal care, labor productivity losses, and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D-5L) questionnaire.Results: A total of 162 patients (67 Germany, 34 Sweden, 33 Italy, 23 United Kingdom, 4 France, and 1 Bulgaria) completed the questionnaire. Excluding Bulgarian results, due to small sample size, country-specific annual health care costs ranged from €18,913 to €36,396 (reference year: 2012). Estimated direct healthcare costs ranged from €11,068 to €22,138; direct non-healthcare costs ranged from €7837 to €14,155 and labor productivity losses ranged from €0 to €8715. Costs are also shown to differ between children and adults. The mean EQ-5D index score for JIA patients was estimated at between 0.44 and 0.88, and the mean EQ-5D visual analogue scale score was estimated at between 62 and 79.Conclusions: JIA patients incur considerable societal costs and experience substantial deterioration in HRQOL in some countries. Compared with previous studies, our results show a remarkable increase in annual healthcare costs for JIA patients. Reasons for the increase are the inclusion of non-professional caregiver costs, a wider use of biologics, and longer hospital stays. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the economic burden from a societal perspective and health-related quality of life (HRQOL) of patients with Prader-Willi syndrome (PWS) in Europe.Methods: We conducted a cross-sectional study of patients with PWS from Spain, Bulgaria, Hungary, Germany, Italy, the UK, Sweden and France. Data on demographic characteristics, healthcare resource utilisation, informal care, labour productivity losses and HRQOL were collected from questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire.Results: A total of 261 patients completed the questionnaire. The average annual costs ranged from € 3937 to € 67,484 between countries; the reference year for unit prices was 2012. Direct healthcare costs ranged from € 311 to € 18,760, direct non-healthcare costs ranged from € 1269 to € 44,035, and loss of labour productivity ranged from € 0 to € 2255. Costs were also shown to differ between children and adults. The mean EQ-5D index score for adult PWS patients ranged between 0.40 and 0.81 and the mean EQ-5D visual analogue scale score ranged between 51.25 and 90.00.Conclusion: The main strengths of this study lie in our bottom-up approach to costing and in the evaluation of PWS patients from a broad societal perspective. This type of analysis is very scarce in the international literature on rare diseases in comparison with other illnesses. We conclude that PWS patients incur considerable societal costs and experience substantial deterioration in HRQOL. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with systemic sclerosis (SSc; scleroderma) in Europe.Methods: We conducted a cross-sectional study of patients with SSc (involving both localised and systemic sclerosis) from Germany, Italy, Spain, France, the UK, Hungary and Sweden. Data on demographic characteristics, healthcare resource utilisation, informal care, labour productivity losses and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire.Results: A total of 589 patients completed the questionnaire. The rate of patients with localised scleroderma, limited cutan and diffuse cutan SSc were 28, 68 and 4 %, respectively. Average annual costs varied from country to country and ranged from € 4607 to € 30,797 (reference year: 2012). Estimated direct healthcare costs ranged from € 1413 to € 17,300; direct non-healthcare costs ranged from € 1875 to € 4684 and labour productivity losses ranged from € 1701 to € 14,444. The mean EQ-5D index score for adult SSc patients varied from 0.49 to 0.75 and the mean EQ-5D visual analogue scale score was between 58.72 and 65.86.Conclusion: The main strengths of this study lie in our bottom-up approach to costing and our evaluation of SSs patients from a broad societal perspective. This type of analysis is very unusual in the international literature on rare diseases in comparison with other illnesses. We concluded that SSc patients incur considerable societal costs and experience substantial deterioration in HRQOL. [ABSTRACT FROM AUTHOR]

Objectives: To assess the health-related quality of life (HRQOL) of patients with mucopolysaccharidosis (MPS) and their caregivers and to quantify the disease-related costs from a societal perspective.Methods: In the context of a multi-country study of rare diseases (BURQOL-RD project), a cross-sectional survey was performed among MPS patients in seven European countries. Data on demographic characteristics, health resource utilization, informal care, and loss of labor productivity were collected. The EQ-5D, Barthel index (BI), and Zarit burden interview (ZBI) questionnaires were used to assess patients' and their informal caregivers' quality of life, patients' functional ability, and caregivers' burden, respectively.Results: Altogether, 120 patients (children 62 %, females 40 %) and 66 caregivers completed the questionnaire. Patients' mean age was 16.5 years and median age at diagnosis was 3 years. Adult patients' average EQ-5D and EQ VAS scores varied across countries from 0.13 to 0.43 and 30.0 to 62.2, respectively, mean BI was 46.7, and ZBI was 32.7. Mean informal care time was 51.3 h/week. The mean total annual cost per patient (reference year 2012) was €24,520 in Hungary, €25,993 in France, €84,921 in Italy, €94,384 in Spain, and €209,420 in Germany. Costs are also shown to differ between children and adults. Direct costs accounted for most of the costs in all five countries (80, 100, 99, 98, and 93 %, respectively).Conclusions: MPS patients experience substantial loss of HRQOL and their families take a remarkable part in their care. Although utilization of health and social care resources varies significantly across countries, MPS incurs considerable societal costs in all the countries studied. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with histiocytosis in Europe.Methods: We conducted a cross-sectional study of patients with histiocytosis from France, Germany, Italy, Spain, Bulgaria, the UK, and Sweden. Data on demographic characteristics, health resource utilisation, informal care, loss of labour productivity and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire.Results: A total of 134 patients (35 France, 32 Germany, 30 Italy, 24 Spain, 7 Bulgaria, 4 UK and 2 Sweden) completed the questionnaire. The average annual costs ranged from € 6832 to € 33,283 between countries, the year of reference being 2012. Estimated direct healthcare costs ranged from € 1698 to € 18,213; direct nonhealthcare costs ranged from € 2936 to € 17,622 and labour productivity losses ranged from € 1 to € 8855. The mean EQ-5D score for adult histiocytosis patients was estimated at between 0.32 and 0.85, and the mean EQ-5D visual analogue scale score was estimated at between 50.00 and 66.50.Conclusion: The main strengths of this study lie in our bottom-up approach to costing and in the evaluation of histiocytosis patients from a broad perspective (societal costs). This type of analysis is very scarce in international literature for rare diseases in comparison with other illnesses. We conclude that histiocytosis patients incur considerable societal costs and experience substantial deterioration in HRQOL. [ABSTRACT FROM AUTHOR]

The existing empirical evidence on the effects of birth order on wages does not distinguish between temporary and permanent effects. Using data from 11 European countries for males born between 1935 and 1956, we show that firstborns enjoy on average a 13.7% premium in their entry wage compared with later-borns. This advantage, however, is short-lived and disappears 10 years after labor market entry. Although firstborns start with a better job, partially because of their higher education, later-borns quickly catch up by switching earlier and more frequently to better-paying jobs. We argue that a key factor driving our findings is that later-borns have lower risk aversion than firstborns. [ABSTRACT FROM AUTHOR]

Many HIV intervention programs in sub-Saharan Africa have applied social cognitive theories such as the theory of planned behavior. However, a recent sub-Saharan African review was unable to show increased effectiveness for theory-based interventions. This study assessed whether the predictive value of attitudes, subjective norms, self-efficacy, and intention was similar to studies in Europe and the U.S., and whether there were differences between three sub-Saharan sites. Longitudinal multigroup structural equation modeling was used to assess whether attitudes, subjective norms, and self-efficacy predicted condom use intentions and condom use (after 6 months) among adolescents in three sites, namely Cape Town (South Africa; N = 625), Dar es Salaam (Tanzania; N = 271), and Mankweng (South Africa; N = 404). Condom use intentions were predicted by subjective norms and self-efficacy in all three sites. Attitudes were not related to intentions in Dar es Salaam and were moderately related to intentions in Cape Town and Mankweng. The proportions of explained variance in intentions and behavior were decent (37-52 and 9-19%, respectively). Although significant differences in predictive value were found between sites and in comparison to European and U.S. studies, intentions could adequately be explained by attitudes, subjective norms, and self-efficacy. However, the limited proportions of variance in behavior explained by intentions could signify the importance of contextual and environmental factors. Future studies are recommended to use an integrative approach that takes into account both individual and contextual factors, as well as social and environmental differences. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the study was to assess associations between intake of combined soft drinks (sugar sweetened and artificially sweetened) and fruit and vegetable juices and the risk of hepatocellular carcinoma (HCC), intrahepatic bile duct (IHBC) and biliary tract cancers (GBTC) using data from the European Prospective Investigation into Cancer and Nutrition cohort of 477,206 participants from 10 European countries. Methods: After 11.4 years of follow-up, 191 HCC, 66 IHBC and 236 GBTC cases were identified. Hazard ratios and 95 % confidence intervals (HR; 95 % CI) were estimated with Cox regression models with multivariable adjustment (baseline total energy intake, alcohol consumption and intake pattern, body mass index, physical activity, level of educational attainment and self-reported diabetes status). Results: No risk associations were observed for IHBC or GBTC. Combined soft drinks consumption of >6 servings/week was positively associated with HCC risk: HR 1.83; 95 % CI 1.11-3.02, p = 0.01 versus non-consumers. In sub-group analyses available for 91 % of the cohort artificially sweetened soft drinks increased HCC risk by 6 % per 1 serving increment (HR 1.06, 95 % CI 1.03-1.09, n = 101); for sugar-sweetened soft drinks, this association was null (HR 1.00, 95 % CI 0.95-1.06; n = 127, p = 0.07). Juice consumption was not associated with HCC risk, except at very low intakes (<1 serving/week: HR 0.60; 95 % CI 0.38-0.95; p = 0.02 vs. non-consumers). Conclusions: Daily intake of combined soft drinks is positively associated with HCC, but a differential association between sugar and artificially sweetened cannot be discounted. This study provides some insight into possible associations of HCC with sugary drinks intake. Further exploration in other settings is required. [ABSTRACT FROM AUTHOR]

Purpose: Low level falls are a common cause of traumatic brain injuries (TBI) and are associated with significant mortality and disability. The aim of this study was to analyse whether BMI, height and weight of patients were related to severity, patterns and outcomes of TBI caused by low level falls. Methods: Data on patients with TBI where cause of injury was a low level fall (fall < 3 m) with known body mass index (BMI) ( N = 683) were analysed. Patients were categorized into underweight, normal, pre-obese and obese based on BMI and demographic characteristics, injury severity, patterns and outcomes were compared. In addition, physiological status, comorbidities and length of hospitalization were analysed in a subset of patients where this information was available. Results: The median BMI was 25.6. About 1/10 of patients were obese. The mean age and proportion of male sex of patients was increasing with increasing BMI. The patients in all BMI groups were of similar injury severity and neurological status. There was also no difference in mortality and functional outcome based on patient's BMI. Obese and pre-obese patients required longer stay at ICU and in hospital. Conclusion: We found no associations between BMI and severity or outcome of TBI caused by low level falls. More detailed data and further studies are needed to fully elucidate these complex relationships. [ABSTRACT FROM AUTHOR]

Summary: In 27 centres across Europe, the prevalence of deforming spinal Scheuermann's disease in age-stratified population-based samples of over 10,000 men and women aged 50+ averaged 8 % in each sex, but was highly variable between centres. Low DXA BMD was un-associated with Scheuermann's, helping the differential diagnosis from osteoporosis. Introduction: This study aims to assess the prevalence of Scheuermann's disease of the spine across Europe in men and women over 50 years of age, to quantitate its association with bone mineral density (BMD) and to assess its role as a confounder for the radiographic diagnosis of osteoporotic fracture. Methods: In 27 centres participating in the population-based European Vertebral Osteoporosis Study (EVOS), standardised lateral radiographs of the lumbar and of the thoracic spine from T4 to L4 were assessed in all those of adequate quality. The presence of Scheuermann's disease, a confounder for prevalent fracture in later life, was defined by the presence of at least one Schmorl's node or irregular endplate together with kyphosis (sagittal Cobb angle >40° between T4 and T12) or a wedged-shaped vertebral body. Alternatively, the (rare) Edgren-Vaino sign was taken as diagnostic. The 6-point-per-vertebral-body (13 vertebrae) method was used to assess osteoporotic vertebral shape and fracture caseness. DXA BMD of the L2-L4 and femoral neck regions was measured in subsets. We also assessed the presence of Scheuermann's by alternative published algorithms when these used the radiographic signs we assessed. Results: Vertebral radiographic images from 4486 men and 5655 women passed all quality checks. Prevalence of Scheuermann's varied considerably between centres, and based on random effect modelling, the overall European prevalence using our method was 8 % with no significant difference between sexes. The highest prevalences were seen in Germany, Sweden, the UK and France and low prevalences were seen in Hungary, Poland and Slovakia. Centre-level prevalences in men and women were highly correlated. Scheuermann's was not associated with BMD of the spine or hip. Conclusions: Since most of the variation in population impact of Scheuermann's was unaccounted for by the radiological and anthropometric data, the search for new genetic and environmental determinants of this disease is encouraged. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate total, energy-adjusted dietary fiber (DF), water-soluble fiber (WSF), and water-insoluble fiber (WIF) intakes in European adolescents and to investigate their association with indicators of adiposity and serum biomarkers. Methods: This study, conducted from 2006 to 2007, included 1804 adolescents aged 12.5-17.5 years (47 % males) from eight European cities completing two non-consecutive computerized 24-h dietary recalls. GLM multivariate analysis was used to investigate associations. Results: Mean DF intake (20 g/day) of the sample met the European Food Safety Authority recommendation, but was below those of the World Health Organization and of the Institute of Medicine. Total DF, WSF and WIF intakes were higher in males ( P < 0.001), but following energy-adjustments significantly higher intakes were observed among females ( P < 0.001). Bread and cereals contributed most to total DF, WSF and WIF intakes, followed by potatoes and grains, energy-dense but low-nutritious foods, fruits and vegetables. Moreover, energy-adjusted WSF and WIF were positively associated with body fat percentage (BF%), waist to height ratio and low-density lipoprotein cholesterol, while energy-adjusted WSF was inversely associated with serum fasting glucose ( β = −0. 010, P = 0.020). Conclusion: Total DF intakes are rather low in European adolescents. An inverse association with serum fasting glucose might indicate a possible beneficial role of DF in preventing insulin resistance and its concomitant diseases, even though DF intakes were positively associated with adolescents' BF%. Therefore, further longitudinal studies should elaborate on these potential beneficial effects of DF intake in the prevention of obesity and related chronic diseases. [ABSTRACT FROM AUTHOR]

The current study aimed to investigate the Autism Diagnostic Interview-Revised (ADI-R) algorithms for toddlers and young preschoolers (Kim and Lord, J Autism Dev Disord 42(1):82-93, ) in a non-US sample from ten sites in nine countries (n = 1,104). The construct validity indicated a good fit of the algorithms. The diagnostic validity was lower, with satisfactorily high specificities but moderate sensitivities. Young children with clinical ASD and lower language ability were largely in the mild-to-moderate or moderate-to-severe concern ranges of the ADI-R, nearly half of the older and phrase speech ASD-group fell into the little-to-no concern range. Although broadly the findings support the toddler algorithms, further work is required to understand why they might have different properties in different samples to further inform research and clinical use. [ABSTRACT FROM AUTHOR]

Background: Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. Methods: This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours. Results: 606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72 %) was achieved in the dexketoprofen trometamol 25 mg plus tramadol hydrochloride 75 mg group (NNT 1.6, 95 % confidence interval 1.3 to 2.1). Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours (median duration of 8.1 h). Adverse events were unremarkable. Conclusions: Dexketoprofen trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae. Trial registration: EudraCT (2010-022798-32); Clinicaltrials.gov (). [ABSTRACT FROM AUTHOR]

Purpose: This study aims to analyse the association of European adolescents' ready-to-eat-cereal (RTEC) consumption frequency with their dietary intake by applying the concept of diet quality index and nutritional status. Methods: From the multi-centre European HELENA study, relevant data were available in 1,215 adolescents (12.5-17.5 years). RTEC consumption was identified from a food frequency questionnaire. A diet quality index, daily nutrient intakes and daily milk/yoghurt and fruit intake were calculated from two 24-h dietary recalls. BMI, waist and hip circumference and body fat were measured for body composition. Cross-sectional regression analyses were adjusted for sex, age, socio-economic status, city and breakfast skipping. Differences in sub-regions within Europe were explored. Results: RTEC consumers showed a more favourable daily micronutrient intake (vitamin B2, B5, B7, D, calcium, phosphorus and potassium), a better diet quality index, more frequent fruit (57 vs. 51 %) and milk/yoghurt consumption (81.2 vs. 56 %) and less breakfast skipping (25.1 vs. 36.7 %). No differences in energy and macronutrient intake were observed. Daily RTEC consumers were 57 % less likely to be overweight than RTEC non-consumers but did not differ in glucose and lipid status ( N = 387). Conclusion: This is the first comprehensive pan-European survey elucidating socio-demographic determinants of European adolescents' RTEC consumption and indicating better dietary habits in RTEC consumers. The improved dietary profile was reflected in a more beneficial body composition. Our results have also shown the advantage of using an all-integrating diet quality index by capturing the diet complexity. [ABSTRACT FROM AUTHOR]