Cystic Fibrosis Foundation and European Cystic Fibrosis Society Survey of cystic fibrosis mental health care delivery

Background: Psychological morbidity in individuals with cystic fibrosis (CF) and their caregivers is common. The Cystic Fibrosis Foundation (CFF) and European Cystic Fibrosis Society (ECFS) Guidelines Committee on Mental Health sought the views of CF health care professionals concerning mental health care delivery. Methods: An online survey which focused on the current provision and barriers to mental health care was distributed to CF health care professionals. Results: Of the 1454 respondents, many did not have a colleague trained in mental health issues and 20% had no one on their team whose primary role was focused on assessing or treating these issues. Insufficient resources and a lack of competency were reported in relation to mental health referrals. Seventy-three percent of respondents had no experience with mental health screening. Of those who did, they utilized 48 different, validated scales. Conclusions: These data have informed the decision-making, dissemination and implementation strategies of the Mental Health Guidelines Committee sponsored by the CFF and ECFS.

European Cystic Fibrosis Society Standards of Care: Quality Management in cystic fibrosis

Since the earliest days of cystic fibrosis (CF) treatment, patient data have been recorded and reviewed in order to identify the factors that lead to more favourable outcomes. Large data repositories, such as the US Cystic Fibrosis Registry, which was established in the 1960s, enabled successful treatments and patient outcomes to be recognized and improvement programmes to be implemented in specialist CF centres. Over the past decades, the greater volumes of data becoming available through Centre databases and patient registries led to the possibility of making comparisons between different therapies, approaches to care and indeed data recording. The quality of care for individuals with CF has become a focus at several levels: patient, centre, regional, national and international. This paper reviews the quality management and improvement issues at each of these levels with particular reference to indicators of health, the role of CF Centres, regional networks, national health policy, and international data registration and comparisons. 

Dose-response relationship in phase 1 clinical trials: a European Drug Development Network (EDDN) Collaboration Study

Introduction: Because a dose–response relationship is characteristic of conventional chemotherapy, this concept is widely used for the development of novel cytotoxic (CTX) drugs. However, the need to reach the MTD to obtain optimal benefit with molecularly targeted agents (MTA) is controversial. In this study, we evaluated the relationship between dose and efficacy in a large cohort of phase I patients with solid tumors.

Experimental Design: We collected data on 1,182 consecutive patients treated in phase I trials in 14 European institutions in 2005–2007. Inclusion criteria were: (i) patients treated within completed single-agent studies in which a maximum-administered dose was defined and (ii) RECIST/survival data available.

Results: Seventy-two percent of patients were included in trials with MTA (N = 854) and 28% in trials with CTX (N = 328). The objective response (OR) rate was 3% and disease control at 6 months was 11%. OR for CTX was associated with higher doses (median 92% of MTD); this was not the case for MTA, where patients achieving OR received a median of 50% of MTD. For trials with MTA, patients treated at intermediate doses (40%–80%) had better survival compared with those receiving low or high doses (P = 0.038). On the contrary, there was a direct association between higher dose and better OS for CTX agents (P = 0.003).

Conclusion: Although these results support the development of novel CTX based on MTD, we found no direct relationship between higher doses and response with MTA in unselected patients. However, the longest OS was seen in patients treated with MTA at intermediate doses (40%–80% of MTD)

Analytical examination of animal remains from Borneo:the painting of bone and shell

Examination of a selection of shell and bone from archaeological assemblages excavated at Niah Cave and Gua Sireh, both of which are located in Sarawak, Borneo, has revealed the deliberate application of coloured material to one or more surfaces. Small fragments of the surface colourant were analysed using a variety of techniques, including microscopy, energy dispersive microwave analysis and infra-red spectrophotometry. These procedures established that, although red in colour, the applied coating in each instance was not red iron oxide. It is suggested that, based on the chemical components present, this coating was a tree resin or a similar organic substance. The paper further reports the presence of enhanced chloride values in the colourant recovered from the ancient human cranial fragment tested. It is suggested that elevated concentrations of this trace element may indicate that the site, the human remains or ingredients within the colourant were once in close proximity to the sea. (C) 2010 Elsevier Ltd. All rights reserved.

Managing Future offshore wind power variability in a European Supergrid

The future European power system will have a hierarchical structure created by layers of system control from a Supergrid via regional high-voltage transmission through to medium and low-voltage distribution. Each level will have generation sources such as large-scale offshore wind, wave, solar thermal, nuclear directly connected to this Supergrid and high levels of embedded generation, connected to the medium-voltage distribution system. It is expected that the fuel portfolio will be dominated by offshore wind in Northern Europe and PV in Southern Europe. The strategies required to manage the coordination of supply-side variability with demand-side variability will include large scale interconnection, demand side management, load aggregation and storage in the context of the Supergrid combined with the Smart Grid. The design challenge associated with this will not only include control topology, data acquisition, analysis and communications technologies, but also the selection of fuel portfolio at a macro level. This paper quantifies the amount of demand side management, storage and so-called 'back-up generation' needed to support an 80% renewable energy portfolio in Europe by 2050. © 2013 IEEE.

Managing the variability of supply in the European power system with high wind energy penetration

The power system of the future will have a hierarchical structure created by layers of system control from via regional high-voltage transmission through to medium and low-voltage distribution. Each level will have generation sources such as large-scale offshore wind, wave, solar thermal, nuclear directly connected to this Supergrid and high levels of embedded generation, connected to the medium-voltage distribution system. It is expected that the fuel portfolio will be dominated by offshore wind in Northern Europe and PV in Southern Europe. The strategies required to manage the coordination of supply-side variability with demand-side variability will include large scale interconnection, demand side management, load aggregation and storage in the concept of the Supergrid combined with the Smart Grid. The design challenge associated with this will not only include control topology, data acquisition, analysis and communications technologies, but also the selection of fuel portfolio at a macro level. This paper quantifies the amount of demand side management, storage and so-called ‘back-up generation’ needed to support an 80% renewable energy portfolio in Europe by 2050.

'Battling in Brussels': The DUP and the European union

Although the Democratic Unionist Party (DUP) does not conform to the model of Europeanization outlined by Ladrech (2002), there is some evidence of change along the lines identified by De Winter and Gomez-Reino (2002) with reference to other European ethnoregionalist parties. For example, the DUP has certainly adapted its behaviour and policies at both local and European levels with a view to exploiting new political opportunities offered by Europeanization. However, De Winter and Gomez-Reino's argument that participation in European institutions has made formerly-Eurosceptic ethnoregionalist parties 'moderate Eurocritics' does not fully apply to the DUP. The DUP continues to demonstrate a number of Eurosceptic characteristics, including ones grounded in extreme religious interpretations of the purpose and process of European integration. Nevertheless, the party's Eurosceptic outlook does not prevent it from being willing to 'battle in Brussels' (as put in its 2009 manifesto for the European elections) in order to serve domestic (party) interests - a tactic not dissimilar to the DUP's approach to Northern Ireland politics in general.

All-Cause Mortality up to and After Coronary Heart Disease and Stroke Events in European Middle-Aged Men The PRIME Study

Background and Purpose-The aim was to investigate prospectively the all-cause mortality risk up to and after coronary heart disease (CHD) and stroke events in European middle-aged men.

Methods-The study population comprised 10 424 men 50 to 59 years of age recruited between 1991 and 1994 in France (N=7855) and Northern Ireland (N=2747) within the Prospective Epidemiological Study of Myocardial Infarction. Incident CHD and stroke events and deaths from all causes were prospectively registered during the 10-year follow-up. In Cox's proportional hazards regression analysis, CHD and stroke events during follow-up were used as time-dependent covariates.

Results-A total of 769 CHD and 132 stroke events were adjudicated, and 569 deaths up to and 66 after CHD or stroke occurred during follow-up. After adjustment for study country and cardiovascular risk factors, the hazard ratios of all-cause mortality were 1.58 (95% confidence interval 1.18-2.12) after CHD and 3.13 (95% confidence interval 1.98-4.92) after stroke.

Conclusions-These findings support continuous efforts to promote both primary and secondary prevention of cardiovascular disease.

A Constitution of Social Governance for the European Union

This chapter considers the EU’s socio-economic constitution under the lens of humaneness. It argues that the EU’s unique socio-economic constitution demands equilibrium of socio-economic integration instead of widening the gap between economic integration at EU levels and social integration at national levels. While the EU lacks the legislative competences to achieve this equilibrium, the constitutional principle still prevails. Indeed, the EU competences reflect its own values as well as the socio-economic constitutions of its constituent Member States. These frequently do not allow for total state-governance of social spheres such as working life, education, care or other social services. Instead, societal actors are given scope to (co-)govern these spheres at national levels. Accordingly, the apparent tension between the EU’s socio-economic values and principles and its limited competences in the social policy field can be resolved through a dynamic interpretation of the EU Treaties towards a “constitution of social governance”. This interpretation reads the Treaties as authorising governance by societal actors. The chapter connects the idea of humanness to the ideals of social governance at EU level and proposes two options for practical application of the concept. These are rules for trans-national labour markets based on European collective labour agreements and a European higher education sector developed by agreements between universities.