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10.
PLoS One ; 15(4): e0231585, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32302326

RESUMO

The digital divide in Europe has not yet been bridged and thus more contributions towards understanding the factors affecting the different dimensions involved are required. This research offers some insights into the topic by analyzing the e-Government adoption or practical use of e-Government across Europe (26 EU countries). Based on the data provided by the statistical office of the European Union (Eurostat), we defined two indexes, the E-Government Use Index (EGUI) and an extreme version of it taking into account only null or complete use (EGUI+), and characterized the use/non use of e-Government tools using supervised learning procedures in a selection of countries with different e-Government adoption levels. These procedures achieved an average accuracy of 73% and determined the main factors related to the practical use of e-Government in each of the countries, e.g. the frequency of buying goods over the Internet or the education level. In addition, we compared the proposed indexes to other indexes measuring the level of e-readiness of a country such as the E-Government Development Index (EGDI) its Online Service Index (OSI) component, the Networked Readiness Index (NRI) and its Government usage component (GU). The ranking comparison found that EGUI+ is correlated with the four indexes mentioned at 0.05 significance level, as the majority of countries were ranked in similar positions. The outcomes contribute to gaining understanding about the factors influencing the use of e-Government in Europe and the different adoption levels.


Assuntos
Redes de Comunicação de Computadores , União Europeia/organização & administração , Governo , Tecnologia da Informação
14.
Eur J Cancer ; 129: 23-31, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32120272

RESUMO

OBJECTIVE: Health-related quality of life (HRQoL) is one of the most important patient-relevant study end-points for the direct measurement of the benefit of cancer drugs. Therefore, our aim is to detect cancer indications with no published information on HRQoL at the time of European Medicines Agency (EMA) approval and monitor any reported HRQoL evidence updates after at least three years of follow-up. METHODS: We included all cancer indications that were approved by the EMA between January 2009 and October 2015. Our main sources of information were the EMA website, clinicaltrials.gov and a systematic literature search in PubMed. Information on HRQoL outcomes was extracted alongside evidence on median overall survival. RESULTS: In total, we identified 110 indications, of which more than half (n = 58, 53%) were lacking available information on HRQoL assessments at the time of EMA approval. After a monitoring period of at least three years, 24 updates were identified, resulting in 34 (31%) therapies where information on HRQoL was still not available. For the 76 therapies with reported information on HRQoL, cancer-specific instruments were mostly used (n = 49/76). Regarding cumulative evidence on median overall survival and HRQoL, 33 (n = 33/110, 30%) as well as 15 (n = 15/110, 14%) cancer drugs were lacking information on both study end-points at the time of approval and after monitoring, respectively. CONCLUSION: Our results demonstrate that there is an urgent need of routine re-evaluation of reimbursed cancer drugs with initially missing information on major outcomes. Standardisation of the typology and quality of HRQoL assessments need to be improved to allow better comparability of results.


Assuntos
Antineoplásicos/uso terapêutico , Aprovação de Drogas/legislação & jurisprudência , União Europeia/organização & administração , Neoplasias/tratamento farmacológico , Qualidade de Vida , Antineoplásicos/economia , Ensaios Clínicos como Assunto , Aprovação de Drogas/organização & administração , Custos de Medicamentos/legislação & jurisprudência , Europa (Continente)/epidemiologia , Medicina Baseada em Evidências/economia , Medicina Baseada em Evidências/legislação & jurisprudência , Seguimentos , Humanos , Oncologia/economia , Oncologia/legislação & jurisprudência , Neoplasias/complicações , Neoplasias/economia , Neoplasias/mortalidade , Mecanismo de Reembolso/legislação & jurisprudência , Análise de Sobrevida , Resultado do Tratamento
15.
PLoS One ; 15(3): e0229974, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32163473

RESUMO

Heavy geographic patterning to the 2016 Brexit vote in UK and Trump vote in US has resulted in numerous ecological analyses of variations in area-level voting behaviours. We extend this work by employing modelling approaches that permit regionally-specific associations between outcome and explanatory variables. We do so by generating a large number of regional models using penalised regression for variable selection and coefficient evaluation. The results reinforce those already published in that we find associations in support of a 'left-behind' reading. Multivariate models are dominated by a single variable-levels of degree-education. Net of this effect, 'secondary' variables help explain the vote, but do so differently for different regions. For Brexit, variables relating to material disadvantage, and to a lesser extent structural-economic circumstances, are more important for regions with a strong industrial history than for regions that do not share such a history. For Trump, increased material disadvantage reduces the vote both in global models and models built mostly for Southern states, thereby undermining the 'left-behind' reading. The reverse is nevertheless true for many other states, particularly those in New England and the Mid-Atlantic, where comparatively high levels of disadvantage assist the Trump vote and where model outputs are more consistent with the UK, especially so for regions with closer economic histories. This pattern of associations is exposed via our regional modelling approach, application of penalised regression and use of carefully designed visualization to reason over 100+ model outputs located within their spatial context. Our analysis, documented in an accompanying github repository, is in response to recent calls in empirical Social and Political Science for fuller exploration of subnational contexts that are often controlled out of analyses, for use of modelling techniques more robust to replication and for greater transparency in research design and methodology.


Assuntos
Escolaridade , Modelos Estatísticos , Política , Ciências Sociais/métodos , União Europeia/organização & administração , Geografia , Humanos , Projetos de Pesquisa , Reino Unido , Estados Unidos
16.
Vet Rec ; 186(7): 202-203, 2020 02 22.
Artigo em Inglês | MEDLINE | ID: mdl-32086405
17.
Pharmaceut Med ; 34(1): 1-5, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32048215

RESUMO

The process for amending a European Union Risk Management Plan (EU-RMP) with new information requires the submission of a formal variation procedure, of which there are four distinct categories: Type IA, Type IB, Type II, and 'Extension of a marketing authorisation' (or simply 'extension'). A Type II variation, in accordance with the above-referenced European Commission regulation, is defined as 'a variation that is not an extension of the marketing authorisation (line extension) and that may have a significant impact on the quality, safety or efficacy of a medicinal product'. Additional detail regarding which type of variation should be submitted in specific circumstances is provided in the accompanying guideline. Common working practice for submission strategies when managing multiple Type II variations has been to either submit each in sequence or submit several parallel procedures each with its own corresponding EU-RMP. Submitting in sequence results in a prolonged, end-to-end process with each procedure resulting in a new, iterative version of the EU-RMP. Alternatively, submitting multiple parallel variations with their own corresponding EU-RMPs can result in very complicated procedural wrap-up activities and very short-lived approved versions. In this article, we describe an approach to the management of multiple Type II variations, which is now in line with the recently revised European Medicines Agency (EMA) frequently asked questions (FAQ) guidance on how to manage grouped Type II variation applications, whereby four parallel Type II variation procedures were successfully initiated simultaneously with a single EU-RMP.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , União Europeia/organização & administração , Aprovação de Drogas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Guias como Assunto , Humanos , Legislação de Medicamentos , Marketing de Serviços de Saúde , Farmacovigilância , Gestão de Riscos
18.
J Phys Act Health ; 17(4): 464-470, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-32106077

RESUMO

BACKGROUND: European Union member countries agreed on 23 health-enhancing physical activity (HEPA) policy measures in 2013; however, the implementation of these measures varies considerably between countries. Hitherto, no evaluations have yet addressed the efficacy of these policies. METHODS: Using a quantitative cross-country comparative approach and based on aggregate Eurobarometer data, this paper presents country-level associations between HEPA measures and the level of sports participation, the gender and educational inequalities of sports participation, and the change in sports participation from 2009 to 2017. FINDINGS: The number of implemented HEPA policy measures is associated with higher levels and smaller social inequalities of sports participation in European Union countries. Moreover, HEPA measures correlate with more positive time trends in sports participation from 2009 to 2017. CONCLUSION: In addition to the many influencing factors at the individual and social levels, these findings lend support to the notion that sports participation can also be promoted at the national level by implementing specific HEPA policies.


Assuntos
União Europeia/organização & administração , Exercício Físico/fisiologia , Política de Saúde/tendências , Fatores Socioeconômicos , Esportes/normas , Feminino , História do Século XXI , Humanos , Masculino
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