scholarly journals Improving knowledge and trust in vaccines: A survey-based assessment of the potential of the European Union Clinical Trial Regulation No 536/2014 plain language summary to increase health literacy

Vaccine ◽  
2022 ◽  
Author(s):  
Michael Penlington ◽  
Philibert Goulet ◽  
Beth Metcalfe
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
Health Literacy ◽  
The European Union ◽  
Plain Language ◽  
Clinical Trial Regulation

Addressing exploitation of poor clinical trial participants in North America and the European Union

2016 ◽  
Vol 34 ◽  
pp. e37-e38
Author(s):  
Rafael Dal-Ré ◽  
Annette Rid ◽  
Ezekiel Emanuel ◽  
David Wendler
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
North America ◽  
The European Union ◽  
Trial Participants

Regulation of Clinical Trials

2021 ◽  
pp. 195-212
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
Information System ◽  
Clinical Trials ◽  
Well Being ◽  
The European Union ◽  
Approval Process ◽  
Clinical Trials Regulation ◽  
Clinical Trial Information ◽  
The Eu

This chapter discusses the publication of the European Clinical Trials Directive in 2001 and its incorporation into the law of Member States. It explores the intention of the Directive in harmonising the rules for conducting clinical trials within the EU to facilitate the internal market in medicinal products and to protect the rights, safety, and well-being of participants. It also covers the passing of the new Clinical Trials Regulation (CTR) by the EU in 2014, which was prompted by concern that the system for approving clinical trials was overly bureaucratic and that it was hampering multinational trials. The CTR could not come into force until the Clinical Trial Information System (CTIS), which is intended to provide a single coordinated approval process, became fully functional. This happened too late for the CTR to be automatically incorporated into UK law by the European Union (Withdrawal) Act 2018.

scholarly journals Mapping Health Literacy Research in the European Union: A Bibliometric Analysis

PLoS ONE ◽  
2008 ◽  
Vol 3 (6) ◽  
pp. e2519 ◽  
Author(s):  
Barbara K. Kondilis ◽  
Ismene J. Kiriaze ◽  
Anastasia P. Athanasoulia ◽  
Matthew E. Falagas
Keyword(s):  
European Union ◽  
Health Literacy ◽  
Bibliometric Analysis ◽  
The European Union ◽  
Literacy Research

scholarly journals El Proceso de Modernización del Lenguaje Jurídico en el RU, EEUU y España y su Reflejo en el Lenguaje Utilizado por los Jueces

2017 ◽  
Vol 4 ◽  
pp. 85-101
Author(s):  
Mariana Relinque
Keyword(s):  
European Union ◽  
Legal Profession ◽  
The European Union ◽  
Legal Practice ◽  
Plain Language ◽  
Legal Language ◽  
Western Countries ◽  
Almost All

Resumen: El lenguaje jurídico tradicional se ha caracterizado por ser un lenguaje hermético, rebuscado y difícil de comprender. Sin embargo, debería poder expresarse con claridad, pues no tiene como destinatarios únicos a los juristas, sino también a los ciudadanos. De esta forma, han surgido movimientos en prácticamente todos los países occidentales para conseguir la simplificación del lenguaje jurídico. Los países de habla inglesa son los que más han avanzado en este campo, especialmente los Estados Unidos. En la Unión Europea se redactan los documentos de acuerdo con las normas del lenguaje jurídico simplificado. En España se ha avanzado muy poco en este tema, ya que a pesar de que se han puesto en marcha varias iniciativas desde el Gobierno, ninguna se ha visto reflejada en la práctica.Abstract: Traditional legal language has been described as cluttered, wordy and difficult to understand. However, legal language should be clear and correct, since it is not only the language of the legal profession, but it is also used to communicate with citizens. Thus, movements campaigning against legalese started to appear in almost all the Western countries. At present, Plain English movements have been the most successful ones, especially in theUnited States. In the European Union, documents are written following the rules of plain language. InSpain, despite different governmental initiatives, plain Spanish is not used in legal practice. 

scholarly journals Migrant health literacy in the European Union: A systematic literature review

2018 ◽  
Vol 78 (1) ◽  
pp. 81-95 ◽  
Author(s):  
Markia Ward ◽  
Maria Kristiansen ◽  
Kristine Sørensen
Keyword(s):  
European Union ◽  
Health Literacy ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Research Policy ◽  
Healthcare Delivery ◽  
Migrant Health ◽  
The European Union ◽  
Literacy Research ◽  
The Eu

Objective: The European Union (EU) has experienced an increasing intake of migrants in recent years. As its population diversifies, new challenges present themselves for healthcare delivery due to communication, cultural differences and health literacy of migrants. In the light of this, this systematic literature review examines the state of the art of migrant health literacy research within the EU. Methods: Based on PRISMA guidelines, a systematic literature review was conducted in 2013, 2016 and 2018 using the following databases: PubMed, Web of Science, CINAHL, MEDLINE and PsychINFO. Results: A total of 21 articles were selected for inclusion. EU-related migrant health literacy research dated from 2009, but only a small number of the EU member states were represented. Eight general research themes were identifiable. Definitions of migrants varied, however, or could not be identified within a particular study, which may hamper the further dissemination of research, policy and capacity building. Conclusion: The review shows the evolution of migrant health literacy research in the EU. More research is needed however to support health system responses, to increase the health literacy of migrants and to improve the quality of healthcare in the EU.

scholarly journals Health literacy policies and activities: developments in the past five years

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
J Rademakers
Keyword(s):  
European Union ◽  
Health Literacy ◽  
Geographical Distribution ◽  
Policy Agenda ◽  
The European Union ◽  
European Policy ◽  
Descriptive Data ◽  
Rigorous Evaluation ◽  
The Past ◽  
Synthesis Report

Abstract Background In the past five years, two inventory studies have been performed in which health literacy policies throughout Europe were described and analyzed: the ‘Study on sound evidence for a better understanding of health literacy in the European Union’(HEALIT4EU, 2015) and the recent HEN-synthesis report on the evidence on existing policies and linked activities and their effectiveness for improving health literacy (2018). In this presentation, data from these two studies will be compared to identify current developments regarding health literacy policy. Methods The descriptive data of both studies were, amongst others, compared with respect to the number of countries with policies or activities regarding health literacy, the geographical distribution over Europe, the content of the policies and level of implementation. Results More countries have developed policies and activities in the domain of health literacy, or are currently in the process of doing so. However, gaps remain in the geographical distribution of policy, and evidence on the effectiveness of policies and activities is still marginal. Conclusions Health literacy is more prominent on the European policy agenda. Rigorous evaluation is needed to demonstrate possible benefits of the policies for individuals, communities and society as a whole.

scholarly journals Opening doors to clinical trial participation among Hispanics: Lessons learned from the Spanish translation of ResearchMatch

2020 ◽  
pp. 1-7
Author(s):  
Loretta M. Byrne ◽  
Sarah K. Cook ◽  
Nan Kennedy ◽  
Michael Russell ◽  
Rebecca N. Jerome ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Health Literacy ◽  
Lessons Learned ◽  
Reading Level ◽  
Spanish Language ◽  
Trial Participation ◽  
Plain Language ◽  
Clinical Trial Participation ◽  
Spanish Translation ◽  
Language Version

Abstract Introduction: Clinical trial participation among US Hispanics remains low, despite a significant effort by research institutions nationwide. ResearchMatch, a national online platform, has matched 113,372 individuals interested in participating in research with studies conducted by 8778 researchers. To increase accessibility to Spanish speakers, we translated the ResearchMatch platform into Spanish by implementing tenets of health literacy and respecting linguistic and cultural diversity across the US Hispanic population. We describe this multiphase process, preliminary results, and lessons learned. Methods: Translation of the ResearchMatch site consisted of several activities including: (1) improving the English language site’s reading level, removing jargon, and using plain language; (2) obtaining a professional Spanish translation of the site and incorporating iterative revisions by a panel of bilingual community members from diverse Hispanic backgrounds; (3) technical development and launch; and (4) initial promotion. Results: The Spanish language version was launched in August 2018, after 11 months of development. Community input improved the initial translation, and early registration and use by researchers demonstrate the utility of Spanish ResearchMatch in engaging Hispanics. Over 12,500 volunteers in ResearchMatch self-identify as Hispanic (8.5%). From August 2018 to March 2020, 162 volunteers registered through the Spanish language version of ResearchMatch, and over 500 new and existing volunteers have registered a preference to receive messages about studies in Spanish. Conclusion: By applying the principles of health literacy and cultural competence, we developed a Spanish language translation of ResearchMatch. Our multiphase approach to translation included key principles of community engagement that should prove informative to other multilingual web-based platforms.

scholarly journals What is the Prevalence of Low Health Literacy in European Union Member States? A Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
V. Baccolini ◽  
A. Rosso ◽  
C. Di Paolo ◽  
C. Isonne ◽  
C. Salerno ◽  
...  
Keyword(s):  
European Union ◽  
Health Literacy ◽  
Meta Analysis ◽  
Assessment Method ◽  
Adverse Outcomes ◽  
The European Union ◽  
Literacy Assessment ◽  
Cross Sectional ◽  
Low Health Literacy ◽  
Pooled Prevalence

Abstract Background Many studies have shown that low health literacy (HL) is associated with several adverse outcomes. In this study, we systematically reviewed the prevalence of low HL in Europe. Methods PubMed, Embase, and Scopus were searched. Cross-sectional studies conducted in the European Union (EU), published from 2000, investigating the prevalence of low HL in adults using a reliable tool, were included. Quality was assessed with the Newcastle-Ottawa Scale. Inverse-variance random effects methods were used to produce pooled prevalence estimates. A meta-regression analysis was performed to assess the association between low HL and the characteristics of the studies. Results The pooled prevalence of low HL ranged from of 27% (95% CI: 18–38%) to 48% (95% CI: 41–55%), depending on the literacy assessment method applied. Southern, Western, and Eastern EU countries had lower HL compared to northern Europe (β: 0.87, 95% CI: 0.40–1.35; β: 0.59, 95% CI: 0.25–0.93; and β: 0.72, 95% CI: 0.06–1.37, respectively). The assessment method significantly influenced the pooled estimate: compared to word recognition items, using self-reported comprehensions items (β: 0.61, 95% CI: 0.15–1.08), reading or numeracy comprehensions items (β: 0.77, 95% CI: 0.24–1.31), or a mixed method (β: 0.66, 95% CI: 0.01–1.33) found higher rates of low HL. Refugees had the lowest HL (β: 1.59, 95% CI: 0.26–2.92). Finally, lower quality studies reported higher rates of low HL (β: 0.56, 95% CI: 0.06–1.07). Discussion We found that low HL is a public health challenge throughout Europe, where one in every three to almost one in every two Europeans may not be able to understand essential health-related material. Additional research is needed to investigate the underlying causes and to develop remedies. PROSPERO Registration CRD42019133377

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