EpiDoc® : a communication platform in epidemiology

Introdução: EpiDoc® é um modelo para transferência de conhecimento na área de metodologia da pesquisa. Está baseado no conceito de estratégias de colaboração para a aprendizagem (learning communities ou communities of practice) mediante a união de esforços entre os interesses comuns de um grupo de profissionais. O objetivo deste projeto é desenvolver uma plataforma de comunicação para a transferência de conhecimento e desenvolvimento de competências em uma comunidade de prática de metodologia da pesquisa em saúde. Métodos:. A plataforma de comunicação está desenvolvido com a tecnologia de páginas de servidor ASP (Active Server Pages), interagindo com uma base de dados Microsoft SQL Server 2000. Na fase da avaliação, tomou-se uma amostra de 38 pessoas para responder a pesquisa de opinião de 84 perguntas que inclui as diferentes áreas a avaliar como são os conteúdos, a tecnologia, o ambiente educativo, os problemas e dificuldades, assim como os elementos positivos do processo de aprendizagem. Resultados: A plataforma divide-se basicamente em 2 zonas, uma pública e outra privada, e pode ser observado em inglês, espanhol e português. A plataforma conta com os seguintes módulos: Controle de acesso; biblioteca; administração de cursos; apresentações; assinatura de usuários para distribuição eletrônica de materiais educativos; correio eletrônico e correio massivo; salas virtuais de Chat; foros de discussão; manipulação de documentos entre tutores e usuários; aplicação de provas de avaliação para os usuários; geração automática de certificados; métricas e relatórios de atividades. A avaliação foi feita com uma amostra de 38 estudantes de um curso de Epidemiologia Clínica. O 94 % dos estudantes ficaram satisfeitos ou muito satisfeitos com a experiência de aprendizagem. O 95% considerou que tinha adquirido novas habilidades de comunicação e colaboração ao estudar por meio virtual. Para o 76% facilitou-se o trabalho em equipe, assim como para o 84% melhorou a capacidade para aprender dos demais, interagindo entre outros. Conclusão: EpiDoc® utiliza uma plataforma ou mecanismo de comunicação baseado em tecnologias modernas por meio de Internet. Os resultados em geral confirmam que as novas tecnologias aplicadas ao processo de ensino da metodologia da pesquisa são bem recebidas por parte dos estudantes. Há uma atitude positiva em relação ao fato de incorporar esta modalidade em seus cursos regulares.Introduction: Epidoc® is a model for the transference of knowledge in the field or research methodology. It is based on the concept of collaboration strategies for learning (learning communities or communities of practice) by the joint effort among common interests of a professional group. The objective of this project is to develop a communication platform for the knowledge transference and developing of competences in a community which practices the Research Methodology in the health field. Methods: The communication platform was designed with a technology of ASP (Active Server Pages) interacting with a Microsoft SQL Server 2000 data base. For the evaluation phase a sample of 38 people was taken to answer an opinion questionnaire of 84 questions which include the different areas to evaluate such as the contents, the technology, the learning environment, the problems and the difficulties and also all the positive elements of the learning process. Results: The communication platform is divided in two zones, one public and one private and is available in three different languajes: English, Spanish and Portuguese. The platform contains the following modules: access control; library; courses administration; presentations; subscriptions for electronic distribution of educational materials; electronic and massive mail; Chat virtual rooms; discussion forums; documents management between users and mentors; implementation of evaluation test for the users; generation of certificates; metrics and activities reports. The evaluation was implemented with a sample of 38 students from a Clinical Epidemiology course. 94% of the students were satisfied or very satisfied by the learning experience. 95% considered that they had acquired new communication and collaboration abilities at studying by the virtual way. For 76% the group work was eased as for 84% noticed an improve capacity to learn form the others, interacting among others. Conclusion: EpiDoc uses a platform of communication based in modern technologies by theinternet. In general, the results confirm that the new technologies applied to the teaching process of research methodology are very welcomed by the students. They have a positive attitude toward the fact of incorporating this modality in their regular courses

Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial

Background: Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate. Methods: HERALD is a randomised, observer-blinded, placebo-controlled, phase 2b/3 clinical trial conducted in 47 centres in ten countries in Europe and Latin America. By use of an interactive web response system and stratification by country and age group (18–60 years and ≥61 years), adults with no history of virologically confirmed COVID-19 were randomly assigned (1:1) to receive intramuscularly either two 0·6 mL doses of CVnCoV containing 12 μg of mRNA or two 0·6 mL doses of 0·9% NaCl (placebo) on days 1 and 29. The primary efficacy endpoint was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose. For the primary endpoint, the trial was considered successful if the lower limit of the CI was greater than 30%. Key secondary endpoints were the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity by age group. Primary safety outcomes were solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events within 28 days after each dose in phase 2b participants, and serious adverse events and adverse events of special interest up to 1 year after the second dose in phase 2b and phase 3 participants. Here, we report data up to June 18, 2021. The study is registered at ClinicalTrials.gov, NCT04652102, and EudraCT, 2020–003998–22, and is ongoing. Findings: Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48·2 days (SE 0·2), 83 cases of COVID-19 occurred in the CVnCoV group (n=12 851) in 1735·29 person-years and 145 cases occurred in the placebo group (n=12 211) in 1569·87 person-years, resulting in an overall vaccine efficacy against symptomatic COVID-19 of 48·2% (95·826% CI 31·0–61·4; p=0·016). Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (95% CI 42·5–86·1; CVnCoV 12 cases in 1735·29 person-years, placebo 37 cases in 1569·87 person-years). In participants aged 18–60 years, vaccine efficacy against symptomatic disease was 52·5% (95% CI 36·2–64·8; CVnCoV 71 cases in 1591·47 person-years, placebo, 136 cases in 1449·23 person-years). Too few cases occurred in participants aged 61 years or older (CVnCoV 12, placebo nine) to allow meaningful assessment of vaccine efficacy. Solicited adverse events, which were mostly systemic, were more common in CVnCoV recipients (1933 [96·5%] of 2003) than in placebo recipients (1344 [67·9%] of 1978), with 542 (27·1%) CVnCoV recipients and 61 (3·1%) placebo recipients reporting grade 3 solicited adverse events. The most frequently reported local reaction after any dose in the CVnCoV group was injection-site pain (1678 [83·6%] of 2007), with 22 grade 3 reactions, and the most frequently reported systematic reactions were fatigue (1603 [80·0%] of 2003) and headache (1541 [76·9%] of 2003). 82 (0·4%) of 19 783 CVnCoV recipients reported 100 serious adverse events and 66 (0·3%) of 19 746 placebo recipients reported 76 serious adverse events. Eight serious adverse events in five CVnCoV recipients and two serious adverse events in two placebo recipients were considered vaccination-related. None of the fatal serious adverse events reported (eight in the CVnCoV group and six in the placebo group) were considered to be related to study vaccination. Adverse events of special interest were reported for 38 (0·2%) participants in the CVnCoV group and 31 (0·2%) participants in the placebo group. These events were considered to be related to the trial vaccine for 14 (<0·1%) participants in the CVnCoV group and for five (<0·1%) participants in the placebo group. Interpretation: CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile. Taking into account the changing environment, including the emergence of SARS-CoV-2 variants, and timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the development of next-generation vaccine candidates. Funding: German Federal Ministry of Education and Research and CureVac