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BACKGROUND AND AIM: Dengue is a viral febrile infectious disease characterized by mild symptoms that can progress to dengue hemorrhagic fever (DHF). Due to socioeconomic and environmental reasons, it is a significant public health problem in Brazil with high morbidity rates among children. The objective is to analyze the epidemiological behavior of dengue and DHF hospitalizations in Brazil and point out the importance of health surveillance. METHOD(S): Data were collected from the Sistema de Informacoes Hospitalares of the Brazilian Ministry of Health. The study population was children from zero to 14 years old diagnosed with classic dengue and/or DHF from January 2008 to November 2021 in Brazil. The variables analyzed were hospitalizations and deaths over the years, hospitalization time and expenses. RESULT(S): A total of 192,424 hospitalizations for dengue and DHF were reported, of which 95.3% were considered medical emergencies. Its epidemiological behavior has fluctuated over the years, with an increase of 162.0% between 2017 and 2019, followed by a decreasing trend starting in 2020. Despite the low mortality rate (0.24%), this scenario was responsible for $12,347,942.38 in expenses and a total of 652,552 hospitalization days. CONCLUSION(S): Dengue is responsible for a major socioeconomic impact on Brazilian's public health system since its severe cases require intensive care to avoid shock, organ failure and death. Due to COVID-19 pandemic and population's fear of contamination in medical facilities, underreporting of arboviruses cases was observed. Since early diagnosis and monitoring are predictors of good prognosis, it is crucial to encourage notification, epidemiological surveillance and sanitary hygiene measures.
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Objetivo: Relatar caso de Trombocitopenia Trombotica Imune induzida por Vacina (VITT) ocorrido na cidade de Uberaba - MG. Resultado: Paciente, 22 anos, admitida no dia 14/04/22 em Pronto Atendimento (PA) da cidade de Uberaba devido quadro de cefaleia, febre e plaquetopenia. Pela suspeita de dengue, foi internada em Unidade de Terapia Intensiva, onde realizou AngioTC de cranio, sem evidencia de tromboses ou sangramentos. Dado inicio de recuperacao plaquetaria e estabilidade clinica, recebeu alta hospitalar dois dias apos. Os testes laboratoriais para dengue foram negativos. Entretanto, retornou ao PA depois de 8 dias devido a rebaixamento do nivel de consciencia, com exame de imagem evidenciando isquemia em lobo parietal esquerdo com transformacao hemorragica. Propedeutica laboratorial mostrava plaquetopenia moderada, dimero D elevado (12.670) e hipofibrinogenemia. Dada a informacao sobre historico de vacinacao com Astrazeneca 10 dias antes de abertura do quadro, foi levantada suspeita de VITT e iniciada terapia com imunoglobulina humana e corticoide em dose imunossupressora, e solicitada pesquisa de anticorpos Antifator-4-Plaquetario (anti-F4P). A anticoagulacao foi contraindicada devido a gravidade do sangramento em sistema nervoso central e previsao de possivel abordagem cirurgica. Apesar da terapia instituida, paciente evoluiu com novas complicacoes tromboticas em outros sitios (pulmonar e membro inferior) e novas areas de isquemia em sistema nervoso central associado a sangramento, culminando no obito 6 dias apos a readmissao. Posteriormente, o resultado do anti-F4P foi liberado como reativo em altos titulos (IgG: 2996, IgM + IgA + IgG: 2631 sendo o valor de referencia menor que 0,4), preenchendo assim os criterios diagnosticos para VITT. Discussao: Durante a pandemia de COVID-19, em resposta ao crescente numero de casos e mortes, e ao consequente impacto economico e social resultante, vacinas foram desenvolvidas e administradas em campanhas de vacinacao no mundo inteiro. Neste contexto, efeitos colaterais raros associados a vacina comecaram a ser observados. Dentre eles, destaca-se a VITT, a qual e uma condicao rara e grave, descrita quase exclusivamente apos a AstraZeneca-Oxford e Johnson & Johnson, sem predominio entre os sexos, e com maior risco relatado em individuos mais jovens. O principal mecanismo fisiopatologico descrito, assim como ocorre na trombocitopenia induzida por Heparina (HIT), e o desenvolvimento de anticorpos contra o fator-4-plaquetario, porem a forma como a vacina induz esta resposta imunologica ainda nao e bem compreendida. Clinicamente apresenta-se como uma coagulopatia que se desenvolve 5 a 30 dias apos a vacinacao, com trombose venosa e/ou arterial, plaquetopenia, D-dimero elevado e hipofibrinogenemia, alem da presenca de anti-F4P. O tratamento assemelha-se ao de HIT, baseando-se em modulacao da resposta autoimune e anticoagulacao (opcoes sem heparina). A paciente descrita apresentou todos os criterios definidores de VITT. Conclusao: A VITT e uma entidade de identificacao recente, com poucos casos descritos em literatura, e, portanto, com fisiopatologia, clinica e arsenal terapeutico ainda em estudo. Os estudos evidenciam alta taxa de mortalidade, principalmente em pacientes que evoluem com complicacoes hemorragicas. A divulgacao de casos clinicos visa enriquecer o conhecimento disponivel sobre esta condicao e ressaltar a importancia da suspeicao precoce e instituicao de terapia direcionada. Copyright © 2022
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Introduction: The Portuguese government put into practice a vaccination plan soon after the approval of the first COVID-19 vaccine, prioritizing healthcare professionals (HCPs) and other population groups at risk. Objective(s): To characterize the case reports of adverse drug reactions (ADRs) associated with the administration of Comirnaty to HCPs in a Portuguese oncology hospital (IPO Coimbra). Method(s): This study was a nine-month prospective, observational study following a cohort event monitoring approach focused on signalling ADRs associated with the administration of Comirnaty to HCP in IPO Coimbra. The case reports of ADRs were sent to the Pharmacovigilance Unit of Coimbra (UFC) between 14/01/2021 and 13/10/2021. The population of HCP was characterized according to gender and age distribution. The seriousness of ADRs was assessed for each individual case in accordance with WHO criteria [1]. ADRs were coded with MedDRA version 24.0 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as ''expected'' or ''unexpected'' according to their description in the Summary of Product Characteristics (SmPC) of Comirnaty [2]. Result(s): A total of 816 HCPs were inoculated with at least one dose of Comirnaty-. The case reports of ADRs concerned 469 (57.5%) HCPs: 386 (82.3%) females;642 (78.7%) aged 30-59 years old. Of the 469 case reports, 24 (5%) were assessed as serious, 44 (9.4%) as unexpected, and 11 (2.3%) as both serious and unexpected. The 469 case reports contained a total of 1,955 ADRs. ''General disorders and administration site condition'' (n = 1,075;54,9%), such as vaccination site pain, chills and vaccination site swelling;''Musculoskeletal and connective tissue disorders'' (n = 373;19.1%), including myalgia and arthralgia;and ''Nervous system disorders'' (n = 250;12.8%), including headache, were the most frequently reported ADRs, which is in line with the SmPC of Comirnaty-. The 11 case reports classified as both serious and unexpected contained a total of 17 ADRs, including hyperhidrosis and paraesthesia. Conclusion(s): The results of this study bring value to the characterization of the safety profile of Comirnaty since the use of a cohort of individuals allows to estimate frequencies of ADRs in the real-world. Further, serious, and unexpected ADRs were identified. Importantly, this type of safety data was further included in the SmPC of the vaccine. In conclusion, the results are in favour of the positive benefitrisk ratio of Comirnaty-, and reinforce the importance of post-marketing pharmacovigilance to increase knowledge on drug safety.
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Introduction: To date, only two COVID-19 vaccines, Comirnaty and Spikevax, have received an extension of indication of use by European Medicines Agency (EMA) in 5-17 years old children/ adolescents. Due to the small sample size of pivotal trials in pediatrics, real-world evidence on the safety of those vaccines in the pediatric population is urgently required. Objective(s): (i) To investigate the safety of COVID-19 vaccines by measuring frequencies of solicited and serious adverse events following immunization (AEFIs) with the first and the second doses of vaccines through active surveillance and, (ii) to compare the results with the published clinicaltrials in children and adolescents. Method(s): In 5-17 years old vaccinees, and up to April 21, 2022, we explored the COVID-19 vaccine safety using prospectively collected data from the ''Covid Vaccine Monitor'' (CVM) project [1]. CVM comprises several safety assessment approaches amongst which an active surveillance project of COVID-19 vaccines in Europe through web-based baseline + 6 follow-up questionnaires filled by vaccinees (or their parents). We measured the frequency of local/systemic solicited, and serious adverse reactions following COVID-19 vaccination (first and second doses). The results were compared with findings of pivotal trials in children/adolescents. Result(s): Overall, 1,033 children/adolescents (5-11 years old: 32.9%;12-17 years old: 67.1%) who received a first/second dose of vaccine (mostly Comirnaty: 98.2%) were enrolled in the study. Of them, only 658 (63.7 %) filled baseline and at least one follow-up questionnaire and were included in the CVM analysis. Overall, 293 (44.5%) reported at least one AEFI following first dose of COVID-19 vaccine, with injection site pain being the most frequently reported local solicited AEFI (N = 192;29.2%) in both age groups. Fatigue was the most frequently reported systemic solicited AEFIs (N = 106;16.1%) in both age groups, followed by myalgia (N = 90;13.7%) and headache (N = 84;12.8%). Similar trend was observed after administering the second dose of COVID-19 vaccine. Conclusion(s): This study confirmed safety profile of COVID-19 vaccines in the pediatric population as already documented in the pivotal trials, with a high frequency of local solicited adverse events and an extremely low rate of serious adverse events.
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Introduction: The COVID-19 pandemic has had an impact on several sectors of the society. Whether it has disrupted drug safety monitoring is yet to be determined. Objective(s): To investigate whether the COVID-19 pandemic has had an impact on the proportions of spontaneous reports (SRs) of serious and unexpected adverse drug reactions (ADRs). Method(s): SRs received by the Coimbra Pharmacovigilance Unit (UFC) between January 2017 and December 2021 were included, except for those containing COVID-19 vaccines as suspected medicines. The SRs were categorized into two groups: pre-pandemic (2017-2019);and post-pandemic (2020-2021). The SRs were classified as serious or non-serious, and expected or unexpected, depending on the seriousness and expectedness of the suspected ADRs, according to the WHO criteria and the Summary of Product Characteristics [SmPC] of each suspected medicine, respectively [1,2]. To study the impact of the COVID-19 pandemic on the patterns of spontaneous reporting of suspected ADRs, two null hypotheses were proposed to test whether (i) the seriousness, and (ii) the expectedness were independent of the pandemic (i.e., if the pandemic has had no impact, then the proportions of SRs containing (i) serious and (ii) unexpected ADRs were expected to be the same in both periods). The qui-square test was used to test the hypotheses;p-values <0.001 were considered statistically significant. Microsoft Excel was used for the statistical analyses. Result(s): A total of 1,311 and 657 SRs were received in the prepandemic and post-pandemic periods, respectively. Of the 1,311 SRs received in the three pre-pandemic years, 1,012 (77%) were serious and 657 (13%) contained unexpected ADRs;of the 657 SR received during the two post-pandemic years, 434 (66%) were serious and 133 (20%) contained unexpected ADRs. The changes from pre- to postpandemic on both proportions of SRs containing serious (an absolute decrease of 11%;p = 0.01) or unexpected ADRs (an absolute increase of 7%;p = 0.01) were not statistically significant. Conclusion(s): The COVID-19 pandemic has had not a significant impact on the proportions of SRs of serious or unexpected ADRs in the Central Region of Portugal. Further research should be carried out in other pharmacovigilance databases to understand if the present conclusions are applicable to other geographic regions.
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Introduction: The Portuguese government put into practice a vaccination plan soon after the approval of the first COVID-19 vaccine, prioritizing healthcare professionals (HCPs) and other population groups at risk. Objective: To characterize the case reports of adverse drug reactions (ADRs) associated with the administration of Comirnaty to HCPs in a Portuguese oncology hospital (IPO Coimbra). Methods: This study was a nine-month prospective, observational study following a cohort event monitoring approach focused on signalling ADRs associated with the administration of Comirnaty to HCP in IPO Coimbra. The case reports of ADRs were sent to the Pharmacovigilance Unit of Coimbra (UFC) between 14/01/2021 and 13/10/2021. The population of HCP was characterized according to gender and age distribution. The seriousness of ADRs was assessed for each individual case in accordance with WHO criteria [1]. ADRs were coded with MedDRA version 24.0 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as expected or unexpected according to their description in the Summary of Product Characteristics (SmPC) of Comirnaty [2]. Results: A total of 816 HCPs were inoculated with at least one dose of Comirnaty. The case reports of ADRs concerned 469 (57.5%) HCPs: 386 (82.3%) females;642 (78.7%) aged 30-59 years old. Of the 469 case reports, 24 (5%) were assessed as serious, 44 (9.4%) as unexpected, and 11 (2.3%) as both serious and unexpected. The 469 case reports contained a total of 1,955 ADRs. "General disorders and administration site condition" (n = 1,075;54,9%), such as vaccination site pain, chills and vaccination site swelling;"Musculoskeletal and connective tissue disorders" (n = 373;19.1%), including myalgia and arthralgia;and "Nervous system disorders" (n = 250;12.8%), including headache, were the most frequently reported ADRs, which is in line with the SmPC of Comirnaty®. The 11 case reports classified as both serious and unexpected contained a total of 17 ADRs, including hyperhidrosis and paraesthesia. Conclusion: The results of this study bring value to the characterization of the safety profile of Comirnaty® since the use of a cohort of individuals allows to estimate frequencies of ADRs in the real-world. Further, serious, and unexpected ADRs were identified. Importantly, this type of safety data was further included in the SmPC of the vaccine. In conclusion, the results are in favour of the positive benefitrisk ratio of Comirnaty®, and reinforce the importance of post-marketing pharmacovigilance to increase knowledge on drug safety.
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Introduction: To date, only two COVID-19 vaccines, Comirnaty and Spikevax, have received an extension of indication of use by European Medicines Agency (EMA) in 5-17 years old children/adolescents. Due to the small sample size of pivotal trials in pediatrics, real-world evidence on the safety of those vaccines in the pediatric population is urgently required. Objective: (i) To investigate the safety of COVID-19 vaccines by measuring frequencies of solicited and serious adverse events following immunization (AEFIs) with the first and the second doses of vaccines through active surveillance and, (ii) to compare the results with the published clinicaltrials in children and adolescents. Methods: In 5-17 years old vaccinees, and up to April 21, 2022, we explored the COVID-19 vaccine safety using prospectively collected data from the "Covid Vaccine Monitor" (CVM) project [1]. CVM comprises several safety assessment approaches amongst which an active surveillance project of COVID-19 vaccines in Europe through web-based baseline + 6 follow-up questionnaires filled by vaccinees (or their parents). We measured the frequency of local/systemic solicited, and serious adverse reactions following COVID-19 vaccination (first and second doses). The results were compared with findings of pivotal trials in children/adolescents. Results: Overall, 1,033 children/adolescents (5-11 years old: 32.9%;12-17 years old: 67.1%) who received a first/second dose of vaccine (mostly Comirnaty: 98.2%) were enrolled in the study. Of them, only 658 (63.7 %) filled baseline and at least one follow-up questionnaire and were included in the CVM analysis. Overall, 293 (44.5%) reported at least one AEFI following first dose of COVID-19 vaccine, with injection site pain being the most frequently reported local solicited AEFI (N = 192;29.2%) in both age groups. Fatigue was the most frequently reported systemic solicited AEFIs (N = 106;16.1%) in both age groups, followed by myalgia (N = 90;13.7%) and headache (N = 84;12.8%). Similar trend was observed after administering the second dose of COVID-19 vaccine. Conclusion: This study confirmed safety profile of COVID-19 vaccines in the pediatric population as already documented in the pivotal trials, with a high frequency of local solicited adverse events and an extremely low rate of serious adverse events.
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Introduction: The COVID-19 pandemic has had an impact on several sectors of the society. Whether it has disrupted drug safety monitoring is yet to be determined. Objective: To investigate whether the COVID-19 pandemic has had an impact on the proportions of spontaneous reports (SRs) of serious and unexpected adverse drug reactions (ADRs). Methods: SRs received by the Coimbra Pharmacovigilance Unit (UFC) between January 2017 and December 2021 were included, except for those containing COVID-19 vaccines as suspected medicines. The SRs were categorized into two groups: pre-pandemic (2017-2019);and post-pandemic (2020-2021). The SRs were classified as serious or non-serious, and expected or unexpected, depending on the seriousness and expectedness of the suspected ADRs, according to the WHO criteria and the Summary of Product Characteristics [SmPC] of each suspected medicine, respectively [1,2]. To study the impact of the COVID-19 pandemic on the patterns of spontaneous reporting of suspected ADRs, two null hypotheses were proposed to test whether (i) the seriousness, and (ii) the expectedness were independent of the pandemic (i.e., if the pandemic has had no impact, then the proportions of SRs containing (i) serious and (ii) unexpected ADRs were expected to be the same in both periods). The qui-square test was used to test the hypotheses;p-values < 0.001 were considered statistically significant. Microsoft Excel® was used for the statistical analyses. Results: A total of 1,311 and 657 SRs were received in the prepandemic and post-pandemic periods, respectively. Of the 1,311 SRs received in the three pre-pandemic years, 1,012 (77%) were serious and 657 (13%) contained unexpected ADRs;of the 657 SR received during the two post-pandemic years, 434 (66%) were serious and 133 (20%) contained unexpected ADRs. The changes from pre- to postpandemic on both proportions of SRs containing serious (an absolute decrease of 11%;p = 0.01) or unexpected ADRs (an absolute increase of 7%;p = 0.01) were not statistically significant. Conclusion: The COVID-19 pandemic has had not a significant impact on the proportions of SRs of serious or unexpected ADRs in the Central Region of Portugal. Further research should be carried out in other pharmacovigilance databases to understand if the present conclusions are applicable to other geographic regions.
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The COVID-19 pandemic has profoundly impacted the Brazilian service sector. With the health crisis, challenges and changes in the business models of car dealerships are also intensified. Creativity is discussed by several conceptual approaches. From the point of view of neuroscience, it is a response to the human need of solving problems. It is within this premise that the present work aims to enhance value proposition for a business model centered on automobile e-commerce. This purpose unfolds in an exploratory research on approaches, methodologies, and tools of creativity, as well as the application of Cristiano Alves's creative framework in this business model. The analysis of the results signals improvements in solutions for car e-commerce. With this, it is concluded that collective creativity is efficient in the discovery of potentially innovative ideas. © 2022, IGI Global.
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Objective: The systemic anti-cancer therapy (SACT) work stream of the East of England Cancer alliance identified variation in SACT administration times as a potential area to counter the impact of Covid-19 capacity restrictions within chemotherapy day units. The aim is to assess the impact of reducing post infusion observation time of pertuzumab-trastuzumab on efficiency and safety. Methods: The recommendation from East of England Cancer Alliance was to adopt one hour observation post pertuzumab and one hour post trastuzumab for cycle 1, 30 min after each infusion for cycle 2 and 3 and a zero observation time thereafter for patients who have had no reaction. All patients administered IV pertuzumab-trastuzumab between October 2020 and May 2021 were identified. The number of patients experiencing hypersensitivity reactions with the original and reduced observation time was compared. The impact of reduced observation time on chair capacity was also calculated. Results: Of the 26 patients treated with the original observation time between October 2020 to January 2021, two patients reacted and received Hydrocortisone IV 100 mg and Chorphenamine IV 10 mg. Patients continued treatmnet at a slower rate. No patients discontinued treatment due to the reaction. Reactions included flushing, stomach pain, uncontrolled bladder and face swelling. Between February and May 2021,18 patients were treated with reduced observation times and 3 patients reacted. Reactions included hypertension, chills, vomiting and shivering. The total number of patients between the cohorts differs due to the conversion of some patients to Phesgo from April 2021. These patients were managed similarly to the previous cohort with added IV ondansetron and IV metoclopramide. No patient discontinued treatment following the reaction. Chair times savings were 5 h for cycle 1, 2 h for cycle 2 and 3, and 3 h from cycle 4 onwards. In total, 53 chair hours in the chemotherapy day unit were released between February to May 2021. Conclusion: The pressure on chemotherapy units has been exacerbated by staff absence, reduced capacity due to social distancing and use of PPE. Whilst the SPC for trastuzumab states patients should be observed for 6 h post first infusion and for 2 h post subsequent infusions, the implementation of reduced observation times post infusion of pertuzumab-trastuzumab did not impact on patient safety and encouragingly increased the capacity of the day unit by 53 h in four months.
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A Acreditação é a mais impactante estratégia de melhoria que prioriza a segurança e que busca o aprimoramento contínuo. O Programa QMentum Internacional teve início em novembro de 2019 com aplicação de visitas preparatórias, inicialmente presenciais, promovendo o desenvolvimento educacional em 08 Bancos de Sangue e mais de 140 agências transfusionais de 240 hospitais e clínicas, totalizando mais de 220 mil pacientes atendidos anualmente em 16 Estados brasileiros. A proposta desafiadora diante da amplitude do Grupo se tornaria ainda mais complexa, pois, com apenas três meses de projeto, tivemos o surgimento da pandemia do coronavírus. Mesmo diante das adversidades a Alta Gestão do Grupo entendeu a necessidade de fortalecer a Cultura de Segurança na Instituição. Objetivo: Descrever estratégias para obtenção da Certificação, bem como, a Cultura de Segurança, enraizada e cultivada em todas as esferas dos processos. Método: Utilizados os dados do projeto da Acreditação e da Pesquisa de Cultura de Segurança. Resultados: O Grupo conquistou a Certificação Internacional QMentum Diamond, o mais alto nível de excelência. Esse passo traz a consolidação da Cultura de Segurança Institucional além do nivelamento demonstrado nos resultados sistêmicos de excelência. Discussão: Após as visitas de diagnóstico, foram selecionadas as ROPs (Required Organizational Pratices), são práticas organizacionais obrigatórias respaldadas em evidências. Com as 14 ROPs, a Qualidade traçou o plano de ação para disseminar os conceitos e engajar os profissionais (cerca de 1700) com a proposta de assimilar que não teriam novas atividades, mas apenas uma forma nova de nomear as rotinas já executadas, solidificando a Cultura de Segurança. O planejamento conteve, por exemplo: 1. Vídeos Institucionais: de curta duração, vinculados por via whatsapp e e-mails, contendo exemplos de aplicação dos testes de conformidades e suas evidências, favorecendo assimilação das boas práticas. 2. Cartilha do Programa QMentum Internacional: distribuída de forma impressa e individual, contextualizando e correlacionando a identidade organizacional e planejamento estratégico do Grupo com o processo de Acreditação. 3. Auditorias Internas: o checklist desenvolvido especificamente para cada setor, com teste de conformidade de 75% por ROP, desta maneira, foram desenvolvidos crachás para os colaboradores, colecionarem os 14 bottons, diante da performance obtida gerando um clima competitivo, amistoso e emponderando os colaboradores como identificadores e condutores das melhorias. 4. Pesquisa de Cultura de Segurança: avalia as percepções dos profissionais sobre as práticas de segurança e o compromisso da gestão, bem como, a concretização desta como estratégia institucional, fortalecendo o clima organizacional, obtendo média de 87% de conformidade na primeira aplicação. O projeto foi realizado de forma robusta, com demais ações. Conclusão: Uma trajetória brilhante, com interação corporativa, focado nas diretrizes e padrões globais com consolidação da Cultura de Segurança, a Certificação apenas reflete as boas práticas vivenciadas todos os dias pelos colaboradores do Grupo GSH.
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O Grupo GSH, para garantir o cumprimento de sua missão: “Prover Soluções em Hemoterapia com Excelência, Segurança e Inovação”, adotou como estratégia a aquisição do Selo COVID FREE por meio da implantação e adequação de práticas preventivas para o enfrentamento do Coronavírus. O Grupo encontra-se atualmente em 16 Estados, com 06 Centros de Produção certificados com o Selo COVID FREE e mais de 120 Agências Transfusionais que prestam assistência hemoterápica para mais de 240 hospitais e clínicas. Diante do crescimento do Grupo, entende-se que a Equipe de Qualidade é de suma importância à medida que oferece suporte contínuo durante o processo de certificação e manutenção das diretrizes e boas práticas de gerenciamento de riscos e gestão. Objetivo: O principal objetivo deste artigo é demonstrar quantitativamente e qualitativamente os benefícios da implantação e acompanhamento das boas práticas preventivas para o enfrentamento do Coronavírus pela Certificação COVID FREE. Material e método: Para desenvolvimento deste artigo, utilizamos dados coletados da plataforma BE SOLUTIONS-COVID FREE, Sistema de Gestão da Qualidade AS – Strategic Adviser, treinamentos, Pesquisa de Cultura de Segurança/Clima Organizacional e Auditorias Internas realizadas pela equipe da Qualidade. Resultados: Após implantação da Certificação COVID FREE nos Centros de Produção, foi evidenciado mesmo durante os períodos mais críticos da Pandemia COVID-19 a manutenção dos níveis de satisfação dos doadores com média de 98, 33% e em relação aos pacientes a média foi de 99,72%. É importante ressaltar que para avaliar a satisfação dos colaboradores foi realizada uma Pesquisa de Cultura de Segurança/Clima Organizacional com média de satisfação de 93%. Discussão: No segundo semestre de 2021 foi iniciado o processo de implantação e adequação das boas práticas de segurança para o enfrentamento do Coronavírus nos Centros de Produção do Grupo GSH, conforme os padrões estabelecidos no Manual de Certificação COVID FREE. Durante a implantação seguimos as seguintes etapas: 1. Diagnóstico: Autoavaliação das unidades. 2. Implantação: Sensibilização dos colaboradores e adequação das práticas de segurança através do distanciamento físico, higienização e limpeza, utilização de equipamentos de proteção, monitoramento de saúde física e mental dos colaboradores, elaboração de informativos específicos de prevenção e controle, treinamentos, fortalecimento da comunicação efetiva elaboração de planos de contingência, dentre outros. Posteriormente foi realizado o upload das evidências, conforme requisitos do manual na Plataforma IBES Digital. 3. Certificação: Os avaliadores validaram as evidências, por meio da análise de documentos, entrevistas e fotos. Após avaliação emitiram o certificado aos Centros de Produção contemplados no escopo da Certificação. Conclusão: A implantação da Certificação foi de grande valia para o Grupo GSH, pois auxiliou na manutenção de um ambiente seguro conferindo credibilidade em relação as boas práticas de segurança na produção, operação e atendimento aos clientes. É importante salientar que o suporte da Equipe da Qualidade foi fundamental na disseminação e acompanhamento das diretrizes estabelecidas pela Certificação.
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It is well known that machine learning algorithms can support the classification of EEG data by using deep learning networks, especially convolutional neural networks [1-3]. In this paper, we propose a new method for automatic classification of movement disorders based on an open-access EEG dataset published by Anjun et al. in 2020 [4]. The dataset includes a total of 41 Parkinson's disease (PD) patients and 41 control subjects. Control participants were demographically matched for age and sex with PD patients and did not differ in any measurements of education or premorbid intelligence. Additionally, EEG recordings from OFF medication sessions for 27 PD patients were recorded in the practically defined OFF levodopa period (12 h after the last dose of dopaminergic medication). Resting state EEG recordings were gathered under both eyes-open and eyes-closed at a sampling rate of 500 Hz on a 64-channel system and eye blinks were removed [5]. In the first step of our machine learning process, a connectivity matrix is created using three different approaches based on Granger causality, Pearson correlation and Spearman correlation. In a second step, these matrices are fed into a convolutional neural network that is tuned using random search, hyperband and Bayesian optimization. We will show that this approach can provide very accurate classification results for the given EEG data sets. Comparison with the traditional method considering raw EEG data shows that our method is more accurate, highlighting the importance of network topology in describing brain data [6]. References: [1] J. C. Vasquez-Correa, T. Arias-Vergara, C. D. Rios-Urrego, M. Schuster, J. Rusz, J. R. Orozco-Arroyave, and E. N ̈oth, Convolutional neural networks and a transfer learning strategy to classify parkinson’s disease from speech in three different languages, in Iberoamerican Congress on Pattern Recognition(Springer, 2019) pp. 697–706. [2] T. D. Pham, A comprehensive study on classification of covid-19 on computed tomography with pretrained convolutional neural networks, Scientific reports10, 1 (2020). [3] O. Akbilgic, R. Kamaleswaran, A. Mohammed, G. W.Ross, K. Masaki, H. Petrovitch, C. M. Tanner, R. L. Davis, and S. M. Goldman, Electrocardiographic changes predate parkinson’s disease onset, Scientific reports 10, 1 (2020). [4] Narayanan lab, Data set https://narayanan.lab.uiowa.edu/article/datasets [5] M.F. Anjum, S. Dasgupta, R. Mudumbai, A. Singh, J. F. Cavanagh, N. S. Narayanan, Linear predictive coding distinguishes spectral EEG features of Parkinson's disease, Parkinsonism & Related Disorders, 79, 2020, pp. 79-85. [6] C. L. Alves, A. M. Pineda, K. Roster, C. Thielemann, and F. A. Rodrigues, EEG functional connectivity and deep learning for automatic diagnosis of brain disorders: Alzheimer’s disease and schizophrenia, arXiv preprintarXiv:2110.06140 (2021).
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Background/Introduction: The approval of COVID-19 vaccines has been based on fast clinical development programs leading to limited knowledge on safety data [1]. Unexpected adverse drug reactions (ADRs), including rare ADRs or delayed ADRs from long-term exposure, may occur [2]. Moreover pre-marketing clinical trials do not have power to detect all ADRs, thereby highlighting the need to analyse post-marketing spontaneous reports (SRs). Objective/Aim: To identify unexpected ADRs associated with COVID-19 vaccines spontaneously reported to the Regional Pharmacovigilance Unit of Coimbra in Portugal (UFC). Methods: SRs of ADRs associated with COVID-19 vaccines received by UFC between 30/12/2020 and 30/04/2021 were included. ADRs were coded with MedDRA®, v.24 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as "expected" or "unexpected" according to their description on the vaccines Summary of Product Characteristics (SmPC). Further, each unexpected ADR was classified as an important medical event (IME) according to the list from the European Medicines Agency (EMA). Results: A total of 771 SRs, of which 262 SRs (34%) contained a total of 420 unexpected ADRs were received. For Comirnaty®, out of 287 unexpected ADRs, 26 (9.1%) were IME. The most frequently reported IMEs were angioedema (n = 2;7.7%), bradycardia (n = 2;7.7%), death (n = 2;7.7%), deep vein thrombosis (n = 2;7.7%), ischaemic stroke (n = 2;7.7%), and seizure (n = 2;7.7%). The remaining ADRs (acute kidney injury, cardio-respiratory arrest, cerebrovascular accident, corneal opacity, haemorrhagic stroke, hypertensive crisis, laryngeal oedema, loss of consciousness, pneumonia, pulmonary oedema, sepsis, status epilepticus, tongue paralysis and upper gastrointestinal haemorrhage), had one report each (n=14;53.8%). Of the 121 unexpected ADRs reported for Vaxzevria®, 20 were IME (16.5%). The most frequently reported IMEs were ischaemic stroke (n = 5;25.0%), and conjunctival haemorrhage (n = 3;15.0%). The remaining ADRs (acute myocardial infarction, altered state of consciousness, angina pectoris, arrhythmia, death, guillain-Barre syndrome, hypothermia, mesenteric vein thrombosis, monoplegia, pericarditis, syncope and truncus coeliacus thrombosis), had one report each (n = 12;60.0%). Twelve unexpected ADRs were reported for the Moderna COVID-19 vaccine®, of which 4 IMEs (33.3%), corresponding to cerebrovascular accident (n = 1;25.0%), conjunctival haemorrhage (n = 1;25.0%), death (n = 1;25.0%) and retinal artery occlusion (n = 1;25.0%). Conclusion: A considerable proportion of SRs received by UFC contained unexpected ADRs, among which 11.9% were IMEs. These results highlight the value of post-marketing spontaneous reporting to identify unknown ADrs and to better characterize the safety profiles of newly approved COVID-19 vaccines, as well as their benefit/risk ratios.
ABSTRACT
The objective is to analyze the contributions of social media, in the format of lives, in health promotion in the context of physical distancing in the SARS-CoV-2 pandemic. This is an observational and bibliographic study of an exploratory analytical nature with a narrative approach, using data from streaming platforms and Google Trends from January to April 2020. Search for lives had a notable rise, especially between May and April, and these contribute for health promotion, mental health care, leisure, education, social relationships, entertainment, and emotional support as they articulate and permeate public policies associated with technologies. In addition, there is ample relevance regarding the social role they assume in encouraging donations. It is believed that these analyzes and information tend to cooperate with further investigations to better understand the contributions of digital technologies during the SARS-CoV-2 pandemic for people who have and/or are experiencing such experiences.
ABSTRACT
Background and Aims: Pituitary apoplexy (PA) is a rare clinical syndrome defined as the sudden hemorrhagic infarction of the pituitary gland, more frequently in a pre-existing tumor. Typical symptoms include sudden onset of headache, visual loss, diplopia, nausea, and hormonal deficiencies. Urgent or emergent surgical resection to decompress the mass is indicated when patients present with rapidly expanding mass lesions and severe visual loss. Methods and Results: We report the case of a 73-year-old man, ASA II, with PA and simultaneous assynthomatic SARS-CoV-2 infection, diagnosed on routine testing. The patient had a past surgical history of transphenoidal pituitary surgery and he presented with left eye amaurosis, bilateral eyelid ptosis, plegia of the extraocular muscles, headache and nausea. The pupils were minimally reactive with 3 mm diameter. Angio-TAC showed a expansive lesion in the pituitary fossa and sella expansion consistent with PA. He started corticosteroids and transsphenoidal resection was performed under general anesthesia with an oral endotracheal tube, with strict COVID-19 precautions. A lumbar spinal drain was placed. He was extubated at the end, uneventfully, made a full recovery and was discharged home. Conclusion: Due to rapidly expanding mass and progressive visual loss, neurosurgical treatment was required immediately. It's unclear whether the COVID-19 infection was a contributing factor in the apoplectic event, or if these events were coincidental and unrelated. Hemorrhagic complications of COVID-19 infection are beginning to be reported with several reports indicating increased risk for cerebrovascular hemorrhage. It is possible given the relatively fragile nature of the vasculature in the pituitary region that a coronavirus related infection could contribute to acute hemorrhagic infarction of the gland and related apoplexy although at this point this remains entirely speculative.
ABSTRACT
COVID-19 has represented a global challenge to health systems, expanding at an increasing rate of deaths. Methods to control the spread of the disease such as social isolation and tracing of case contacts have been used around the world. With the emergence of COVID-19, it was necessary to expand applications and adopt Telehealth technologies.
ABSTRACT
Rationale SARS-CoV-2 infected individuals elders have the highest hospitalization rates and represent >80% fatalities. However, most infected seniors remain asymptomatic and never progress to experience severe disease. Among those without symptoms, the rate of pre-symptomatic illness is unclear and potential predictors of progression are unknown. Our objective was to delineate the natural evolution of asymptomatic SARS-CoV-2 infection and identify determinants of progression to symptomatic illness. Methods We established a medical surveillance team monitoring 63 geriatric institutions in Buenos Aires between June and July 2020. When an index COVID-19 case emerged in one of these residencies, we tested all other eligible participants for SARS-CoV-2. Participating seniors were asymptomatic individuals ≥75 years of age, or between 65-74 years with ≥1 comorbidity. SARS-CoV-2 infected, asymptomatic elders were followed daily for 28 days by a medical team using pre-designed questionnaires. Disease was diagnosed when any COVID-19 manifestation occurred within 14 days of SARS-CoV-2 detection. SARS-CoV-2 load at enrollment and shedding on day 15, and antibody responses at the end of study participation were also studied. Results 113 asymptomatic SARS-CoV-2-infected elderly participated in the study. After 28 days of follow up, 75(66%) elders remained asymptomatic. In 38(34%) presymptomatic patients, median time to onset of symptoms was 3 days(IQR 5). 20/38(56%) pre-symptomatic patients developed hypoxemia, a presenting sign in 10/20(50%). Ten pre-symptomatic patients [26%;10/113(9%)] died(median day 14, IQR 12). Dementia was the only clinical risk factor associated with disease (OR 2.36(95%CI 1.05 to 5.29);P=.036;Table 1). PCR mean cycle threshold was similar in both groups at the time of enrollment. SARS-CoV-2 RT-PCR re-testing on day 15(IQR 1) was detectable in 61% of pre-symptomatic vs. 30% asymptomatic subjects(P=.012). Anti-S SARS-CoV-2 IgM and IgG assays on day 28 detected similar rates of antibody seropositivity in both groups (Table 1). Conclusion Our findings suggest that disease inception and disease progression may be driven by different pathogenic pathways. Dementia was the sole baseline difference potentially predicting progression to symptomatic disease in our study. Other comorbidities associated with progression from mild to severe symptoms did not affect the odds of experiencing pre-symptomatic illness. Evolution to symptomatic disease associated with longer viral shedding, suggesting that control of viral replication may influence symptom inception. In summary, dementia and persistent SARS-CoV-2 shedding associated with progression from asymptomatic to symptomatic infection in elders. These observations suggest that the mechanistic pathway to experiencing disease symptoms differs from the pathways determining severity in COVID-19.