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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]

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]

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]

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]

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]

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]