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Background: Tier 1 exposure tools recommended for use under REACH are designed to easily identify situations that may pose a risk to health through conservative exposure predictions. However, no comprehensive evaluation of the performance of the lower tier tools has previously been carried out. The ETEAM project aimed to evaluate several lower tier exposure tools (ECETOC TRA, MEASE, and EMKG-EXPO-TOOL) as well as one higher tier tool (STOFFENMANAGER®). This paper describes the results of the external validation of tool estimates using measurement data. Methods: Measurement data were collected from a range of providers, both in Europe and United States, together with contextual information. Individual measurement and aggregated measurement data were obtained. The contextual information was coded into the tools to obtain exposure estimates. Results were expressed as percentage of measurements exceeding the tool estimates and presented by exposure category (non-volatile liquid, volatile liquid, metal abrasion, metal processing, and powder handling). We also explored tool performance for different process activities as well as different scenario conditions and exposure levels. Results: In total, results from nearly 4000 measurements were obtained, with the majority for the use of volatile liquids and powder handling. The comparisons of measurement results with tool estimates suggest that the tools are generally conservative. However, the tools were more conservative when estimating exposure from powder handling compared to volatile liquids and other exposure categories. In addition, results suggested that tool performance varies between process activities and scenario conditions. For example, tools were less conservative when estimating exposure during activities involving tabletting, compression, extrusion, pelletisation, granulation (common process activity PROC14) and transfer of substance or mixture (charging and discharging) at nondedicated facilities (PROC8a; powder handling only). With the exception of STOFFENMANAGER® (for estimating exposure during powder handling), the tools were less conservative for scenarios with lower estimated exposure levels. Conclusions: This is the most comprehensive evaluation of the performance of REACH exposure tools carried out to date. The results show that, although generally conservative, the tools may not always achieve the performance specified in the REACH guidance, i.e. using the 75th or 90th percentile of the exposure distribution for the risk characterisation. Ongoing development, adjustment, and recalibration of the tools with new measurement data are essential to ensure adequate characterisation and control of worker exposure to hazardous substances. [ABSTRACT FROM AUTHOR]

BACKGROUND: Upper extremity function (UEF) is often compromised in multiple sclerosis (MS), although its importance is regularly underrecognized relative to ambulation. We explored the concurrent presence of impairment in UEF and ambulation by examining various aspects of UEF across different levels of ambulation. METHODS: The cohort consisted of 247 patients with clinically definite MS or clinically isolated syndrome according to the revised 2010 McDonald criteria. The Nine-Hole Peg Test and the Expanded Disability Status Scale were used to stratify patients into clinically different subgroups. For UEF, cerebellar function (finger-to-nose test), pyramidal function (pronator drift test), and the ability to perform a task of activities of daily living (drinking- from-cup test) were examined. Patient-reported limitations of UEF in daily life were assessed using the Arm Function in Multiple Sclerosis Questionnaire. RESULTS: Patients in more severely impaired ambulation groups displayed poorer performance on all UEF measures. Although most patients had normal to mild (n = 147) or moderate (n = 46) ambulatory impairment, 87.7% exhibited some level of UEF impairment as defined using the Nine-Hole Peg Test. Most patients had mild UEF impairment (n = 174), accounting for the largest proportion in all ambulation groups (51.9%-77.8%). CONCLUSIONS: A distinct pattern of impairment was found for ambulation and multiple aspects of UEF. Independent assessment of multiple aspects of disability may be helpful in treatment decision-making and could support the development of rehabilitation strategies that specifically target UEF impairment [ABSTRACT FROM AUTHOR]

Indirect methods for the indirect estimation of reference intervals are increasingly being used, especially for validation of reference intervals, as they can be applied to routine patient data. In this study, we compare three statistically different indirect methods for the verification and validation of reference intervals in eight laboratories distributed throughout Europe. The RefLim method is a fast and simple approach which calculates the reference intervals by extrapolating the theoretical 95 % of non-pathological values from the central linear part of a quantile-quantile plot. The Truncated Maximum Likelihood (TML) method estimates a smoothed kernel density function for the distribution of the mixed data, for which it is assumed that the "central" part of the distribution represents the healthy population. The refineR utilizes an inverse modelling approach. This algorithm identifies a model that best explains the observed data before transforming the data with the Box-Cox transformation. We show that the different indirect methods each have their advantages but can also lead to inaccurate or ambiguous results depending on the approximation of the mathematical model to real-world data. A combination of different methodologies can improve the informative value and thus the reliability of results. Based on routine measurements of four enzymes alkaline phosphatase (ALP), total amylase (AMY), cholinesterase (CHE) and gamma-glutamyl transferase (GGT) in adult women and men, we demonstrate that some reference limits taken from the literature need to be adapted to the laboratory's particular local and population characteristics. [ABSTRACT FROM AUTHOR]

Background: Traumatic injury is the fourth leading cause of death globally. Half of all trauma deaths are due to bleeding and most of these will occur within 6 h of injury. Haemorrhagic shock following injury has been shown to induce a clotting dysfunction within minutes, and this early trauma-induced coagulopathy (TIC) may exacerbate bleeding and is associated with higher mortality and morbidity. In spite of improved resuscitation strategies over the last decade, current transfusion therapy still fails to correct TIC during ongoing haemorrhage and evidence for the optimal management of bleeding trauma patients is lacking. Recent publications describe increasing the use of Viscoelastic Haemostatic Assays (VHAs) in trauma haemorrhage; however, there is insufficient evidence to support their superiority to conventional coagulation tests (CCTs).Methods/design: This multicentre, randomised controlled study will compare the haemostatic effect of an evidence-based VHA-guided versus an optimised CCT-guided transfusion algorithm in haemorrhaging trauma patients. A total of 392 adult trauma patients will be enrolled at major trauma centres. Participants will be eligible if they present with clinical signs of haemorrhagic shock, activate the local massive haemorrhage protocol and initiate first blood transfusion. Enrolled patients will be block randomised per centre to either VHA-guided or CCT-guided transfusion therapy in addition to that therapy delivered as part of standard care, until haemostasis is achieved. Patients will be followed until discharge or 28 days. The primary endpoint is the proportion of subjects alive and free of massive transfusion (less than 10 units of red blood cells) at 24 h. Secondary outcomes include the effect of CCT- versus VHA-guided therapy on organ failure, total hospital and intensive care lengths of stay, health care resources needed and mortality. Surviving patients will be asked to complete a quality of life questionnaire (EuroQol EQ-5DTM) at day 90.Discussion: CCTs have traditionally been used to detect TIC and monitor response to treatment in traumatic major haemorrhage. The use of VHAs is increasing, but limited evidence exists to support the superiority of these technologies (or comparatively) for patient-centred outcomes. This knowledge gap will be addressed by this trial.Trial Registration: ClinicalTrials.gov, ID: NCT02593877 . Registered on 15 October 2015. Trial sponsor Queen Mary University of London The contact person of the above sponsor organisation is: Dr. Sally Burtles, Director of Research Services and Business Development, Joint Research Management Office, QM Innovation Building, 5 Walden Street, London E1 2EF; phone: 020 7882 7260; Email: sponsorsrep@bartshealth.nhs.uk Trial sites Academic Medical Centre, Amsterdam, The Netherlands Kliniken der Stadt Köln gGmbH, Cologne, Germany Rigshospitalet (Copenhagen University Hospital), Copenhagen, Denmark John Radcliff Hospital, Oxford, United Kingdom Oslo University Hospital, Oslo, Norway The Royal London Hospital, London, United Kingdom Centre for Trauma Sciences, Blizard Institute, Queen Mary University of London, London, United Kingdom Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom Sites that are planning to start recruitment in mid/late 2017 Nottingham University Hospitals, Queen's Medical Centre, Nottingham, United Kingdom University of Kansas Hospital (UKH), Kansas City, MO, USA Protocol version: 3.0/14.03.2017 (Additional file 1). [ABSTRACT FROM AUTHOR]

This article discusses the changing social distribution of unemployment and long-term unemployment risks during the current financial and economic crisis. These risks are interpreted as the result of three different, overlapping forms of labour market segmentation: first, the institutionally stabilized polarization between labour market insiders and outsiders; second, the occupational dualization of high- and low-skilled employees and occupations; and third, the marginalization of disadvantaged social groups. On the basis of European Union-Survey on Income and Living Conditions (EU-SILC) data for 24 European countries (2005–2012), it can be shown that (long-term) unemployment risks increase especially for low-skilled persons and occupations, single parents, migrants and disabled persons. Women, older and permanently employed persons are relatively less affected by short-term unemployment but more affected by long-term unemployment. Hence, the current crisis strengthens the occupational and social dualization of labour markets, endangering the inclusiveness and long-term growth potential of the European economy and societies. [ABSTRACT FROM AUTHOR]

As a main contribution we present a new approach for studying the problem of optimal partial hedging of an American contingent claim in a finite and complete discrete-time market. We assume that at an early exercise time the investor can borrow the amount she has to pay for the option holder by entering a short position in the numéraire asset and that this loan in turn will mature at the expiration date. We model and solve a partial hedging problem, where the investor's purpose is to find a minimal amount at which she can hedge the above-mentioned loan with a given probability, while the potential shortfall is bounded above by a certain number of numéraire assets. A knapsack problem approach and greedy algorithm are used in solving the problem. To get a wider view of the subject and to make interesting comparisons, we treat also a closely related European case as well as an American case where a barrier condition is applied. [ABSTRACT FROM AUTHOR]

A telemedicine system for home haemodialysis was designed using a systems approach and a feedback model to produce the hardware and software specifications. Preliminary clinical trials at four European locations involved 29 patients and 305 sessions of haemodialysis. The evaluation included an evaluability assessment and formative evaluation. Central to the methodology was the detailed specification of a stakeholder/evaluation criterion matrix. Preliminary results indicated that the telemedicine system was capable of satisfying the requirements of formative evaluation as a precursor to evaluating its overall worth. [ABSTRACT FROM AUTHOR]