The II Brazilian Guidelines for the pharmacological treatment of patients hospitalized with COVID-19 Joint Guidelines of the Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia and Sociedade Brasileira de Reumatologia.

OBJECTIVE: To update the recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. METHODS: Experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. RESULTS: Twenty-one recommendations were generated, including strong recommendations for the use of corticosteroids in patients using supplemental oxygen and conditional recommendations for the use of tocilizumab and baricitinib for patients on supplemental oxygen or on noninvasive ventilation and anticoagulants to prevent thromboembolism. Due to suspension of use authorization, it was not possible to make recommendations regarding the use of casirivimab + imdevimab. Strong recommendations against the use of azithromycin in patients without suspected bacterial infection, hydroxychloroquine, convalescent plasma, colchicine, and lopinavir + ritonavir and conditional recommendations against the use of ivermectin and remdesivir were made. CONCLUSION: New recommendations for the treatment of hospitalized patients with COVID-19 were generated, such as those for tocilizumab and baricitinib. Corticosteroids and prophylaxis for thromboembolism are still recommended, the latter with conditional recommendation. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and to promote resource economy.

The II Brazilian Guidelines for the pharmacological treatment of patients hospitalized with COVID-19 Joint Guidelines of the Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia and Sociedade Brasileira de Reumatologia / II Diretrizes Brasileiras para o tratamento farmacológico de pacientes hospitalizados com COVID-19 Diretriz conjunta da Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia e Sociedade Brasileira de Reumatologia

ABSTRACT Objective: To update the recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. Methods: Experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. Results: Twenty-one recommendations were generated, including strong recommendations for the use of corticosteroids in patients using supplemental oxygen and conditional recommendations for the use of tocilizumab and baricitinib for patients on supplemental oxygen or on noninvasive ventilation and anticoagulants to prevent thromboembolism. Due to suspension of use authorization, it was not possible to make recommendations regarding the use of casirivimab + imdevimab. Strong recommendations against the use of azithromycin in patients without suspected bacterial infection, hydroxychloroquine, convalescent plasma, colchicine, and lopinavir + ritonavir and conditional recommendations against the use of ivermectin and remdesivir were made. Conclusion: New recommendations for the treatment of hospitalized patients with COVID-19 were generated, such as those for tocilizumab and baricitinib. Corticosteroids and prophylaxis for thromboembolism are still recommended, the latter with conditional recommendation. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and to promote resource economy.

RESUMO Objetivo: Atualizar as recomendações para embasar as decisões para o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. Métodos: A elaboração desta diretriz foi feita por especialistas, incluindo representantes do Ministério da Saúde e metodologistas. O método utilizado para o desenvolvimento rápido de diretrizes baseou-se na adoção e/ou adaptação de diretrizes internacionais existentes (GRADE ADOLOPMENT) e contou com o apoio da plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. Resultados: Chegaram-se a 21 recomendações, incluindo recomendações fortes quanto ao uso de corticosteroides em pacientes em uso de oxigênio suplementar e recomendações condicionais para o uso de tocilizumabe e baricitinibe, em pacientes com oxigênio suplementar ou ventilação não invasiva, e de anticoagulantes, para prevenção de tromboembolismo. Devido à suspensão da autorização de uso, não foi possível fazer recomendações para o tratamento com casirivimabe + imdevimabe. Foram feitas recomendações fortes contra o uso de azitromicina em pacientes sem suspeita de infecção bacteriana, hidroxicloroquina, plasma convalescente, colchicina e lopinavir + ritonavir, além de recomendações condicionais contra o uso de ivermectina e rendesivir. Conclusão: Foram criadas novas recomendações para o tratamento de pacientes hospitalizados com COVID-19, como as recomendações de tocilizumabe e baricitinibe. Ainda são recomendados corticosteroides e profilaxia contra tromboembolismo, esta em caráter condicional. Vários medicamentos foram considerados ineficazes e não devem ser usados, no intuito de proporcionar o melhor tratamento segundo os princípios da medicina baseada em evidências e promover a economia de recursos.

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force.

OBJECTIVES: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR-The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. METHODS: The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review. RESULTS: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. CONCLUSIONS: The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force.

OBJECTIVES: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR-The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. METHODS: The joint Task Force consisted of 15 members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to 2 rounds of peer review. RESULTS: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. CONCLUSIONS: The guidance and the checklist contain a series of questions, grouped by 6 phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.

Brazilian Guidelines for the pharmacological treatment of patients hospitalized with COVID-19: Joint guideline of Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia, Sociedade Brasileira de Reumatologia. / Diretrizes Brasileiras para o tratamento farmacológico de pacientes hospitalizados com COVID-19: Diretriz conjunta da Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia e Sociedade Brasileira de Reumatologia.

OBJECTIVE: Several therapies are being used or proposed for COVID-19, and many lack appropriate evaluations of their effectiveness and safety. The purpose of this document is to develop recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. METHODS: A group of 27 experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. RESULTS: Sixteen recommendations were generated. They include strong recommendations for the use of corticosteroids in patients using supplemental oxygen, the use of anticoagulants at prophylactic doses to prevent thromboembolism and the nonuse of antibiotics in patients without suspected bacterial infection. It was not possible to make a recommendation regarding the use of tocilizumab in patients hospitalized with COVID-19 using oxygen due to uncertainties regarding the availability of and access to the drug. Strong recommendations against the use of hydroxychloroquine, convalescent plasma, colchicine, lopinavir + ritonavir and antibiotics in patients without suspected bacterial infection and also conditional recommendations against the use of casirivimab + imdevimab, ivermectin and rendesivir were made. CONCLUSION: To date, few therapies have proven effective in the treatment of hospitalized patients with COVID-19, and only corticosteroids and prophylaxis for thromboembolism are recommended. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and promote economical resource use.

OBJETIVOS: Há diversas terapias sendo utilizadas ou propostas para a COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é elaborar recomendações para subsidiar decisões sobre o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. MÉTODOS: Um grupo de 27 membros, formado por especialistas, representantes do Ministério da Saúde e metodologistas, integra essa diretriz. Foi utilizado o método de elaboração de diretrizes rápidas, tomando por base a adoção e/ou a adaptação de recomendações a partir de diretrizes internacionais existentes (GRADE ADOLOPMENT), apoiadas pela plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. RESULTADOS: Foram geradas 16 recomendações. Entre elas, estão recomendações fortes para o uso de corticosteroides em pacientes em uso de oxigênio suplementar, para o uso de anticoagulantes em doses de profilaxia para tromboembolismo e para não uso de antibacterianos nos pacientes sem suspeita de infecção bacteriana. Não foi possível fazer uma recomendação quanto à utilização do tocilizumabe em pacientes hospitalizados com COVID-19 em uso de oxigênio, pelas incertezas na disponibilidade e de acesso ao medicamento. Foi feita recomendação para não usar azitromicina, casirivimabe + imdevimabe, cloroquina, colchicina, hidroxicloroquina, ivermectina, lopinavir/ ritonavir, plasma convalescente e rendesivir. CONCLUSÃO: Até o momento, poucas terapias se provaram efetivas no tratamento do paciente hospitalizado com COVID-19, sendo recomendados apenas corticosteroides e profilaxia para tromboembolismo. Diversos medicamentos foram considerados ineficazes, devendo ser descartados, de forma a oferecer o melhor tratamento pelos princípios da medicina baseada em evidências e promover economia de recursos não eficazes.

Diretrizes Brasileiras para o tratamento farmacológico de pacientes hospitalizados com COVID-19: Diretriz conjunta da Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia e Sociedade Brasileira de Reumatologia / Brazilian Guidelines for the pharmacological treatment of patients hospitalized with COVID-19: Joint guideline of Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia, Sociedade Brasileira de Reumatologia

Há diversas terapias sendo utilizadas ou propostas para a COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é elaborar recomendações para subsidiar decisões sobre o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. Métodos: Um grupo de 27 membros, formado por especialistas, representantes do Ministério da Saúde e metodologistas, integra essa diretriz. Foi utilizado o método de elaboração de diretrizes rápidas, tomando por base a adoção e/ou a adaptação de recomendações a partir de diretrizes internacionais existentes (GRADE ADOLOPMENT), apoiadas pela plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. Resultados: Foram geradas 16 recomendações. Entre elas, estão recomendações fortes para o uso de corticosteroides em pacientes em uso de oxigênio suplementar, para o uso de anticoagulantes em doses de profilaxia para tromboembolismo e para não uso de antibacterianos nos pacientes sem suspeita de infecção bacteriana. Não foi possível fazer uma recomendação quanto à utilização do tocilizumabe em pacientes hospitalizados com COVID-19 em uso de oxigênio, pelas incertezas na disponibilidade e de acesso ao medicamento. Foi feita recomendação para não usar azitromicina, casirivimabe + imdevimabe, cloroquina, colchicina, hidroxicloroquina, ivermectina, lopinavir/ ritonavir, plasma convalescente e rendesivir. Conclusão: Até o momento, poucas terapias se provaram efetivas no tratamento do paciente hospitalizado com COVID-19, sendo recomendados apenas corticosteroides e profilaxia para tromboembolismo. Diversos medicamentos foram considerados ineficazes, devendo ser descartados, de forma a oferecer o melhor tratamento pelos princípios da medicina baseada em evidências e promover economia de recursos não eficazes.

Several therapies are being used or proposed for COVID-19, and many lack appropriate evaluations of their effectiveness and safety. The purpose of this document is to develop recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. Methods: A group of 27 experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. Results: Sixteen recommendations were generated. They include strong recommendations for the use of corticosteroids in patients using supplemental oxygen, the use of anticoagulants at prophylactic doses to prevent thromboembolism and the nonuse of antibiotics in patients without suspected bacterial infection. It was not possible to make a recommendation regarding the use of tocilizumab in patients hospitalized with COVID-19 using oxygen due to uncertainties regarding the availability of and access to the drug. Strong recommendations against the use of hydroxychloroquine, convalescent plasma, colchicine, lopinavir + ritonavir and antibiotics in patients without suspected bacterial infection and also conditional recommendations against the use of casirivimab + imdevimab, ivermectin and rendesivir were made. Conclusion: To date, few therapies have proven effective in the treatment of hospitalized patients with COVID-19, and only corticosteroids and prophylaxis for thromboembolism are recommended. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and promote economical resource use.

A Strategy to Improve Knowledge about Health Policies and Evidence Based Medicine for Federal Magistrates in Health Litigation.

Several countries maintain universal health coverage, which implies responsibility to organize delivery formats of healthcare services and products for citizens. In Brazil, the health system has a principle of universal access for more than 30 years, but many deficiencies remain and the country observes a day practice for those seeking judicial decisions to determine provision of healthcare.

Pharmacists' Educational Training and Professional Activities at the Municipal Level of the Brazilian National Health System

Abstract Brazilian pharmacists' education and training aims to prepare them for the various activities they will undertake during professional practice, especially in the national health system (SUS). By using an exploratory transversal study based on a validated questionnaire, we have characterized the educational and training background of pharmacists working in SUS municipal units in Ribeirão Preto, State of São Paulo (SP), Brazil, and the frequency with which these professionals carry out several activities. Pharmacists working in these municipal outpatient units (N=44) graduated between 1981 and 2014 (56.8% of them graduated from public state or federal institutions), are predominantly female (84%), and are aged 25-57 years; 34% of these pharmacists have a "Generalist" degree, and 90.9% attended postgraduate programs, mostly specialization (75%). All the pharmacists pointed out the need for continuing education. The frequency with which they carry out activities varies, but those involving direct contact with patients predominate. Consultations, therapeutic follow-up, case discussions, and health promotion activities take place only occasionally. We concluded that pharmacists who work in the municipality of Ribeirão Preto, SP, are very much involved with dispensing, but not with health education or pharmacotherapeutic follow-up, so investing in education and training in these areas is necessary.

Clinical, anatomopathological, and immunohistochemical findings of a transitional cell carcinoma from nasal cavity, frontal and ethmoidal sinus with meningoencephalic invasion in a dog.

Background: Primary neoplasms of the nasal cavity and sinuses are uncommon in domestic animals, most of which are of epithelial origin, being adenocarcinoma the most common tumor diagnosed in this region. Some malignant nasal cavity neoplasms may invade the brain causing clinical neurological signs, as well as purulent nasal secretion and epistaxis. Case Description: A case of neoplasm is reported in a 14-year-old pincher presenting dyspnea, epistaxis, and neurological alterations. Necropsy revealed the presence of a mass in the oral cavity vestibule, and another in the whole nasal cavity with invasion of the cribiform plate, meninges and brain. Squamous cells carcinoma was diagnosed in the oral cavity and transitional carcinoma in the nasal cavity. The immunohistochemistry confirmed that the brain infiltration was of the same origin as the nasal cavity neoplasm. Conclusion: The present report describes a rare case of transitional carcinoma of the nasal cavity as well as the frontal and ethmoidal sinuses with brain invasion, confirmed by immunohistochemistry. It is extremely important for veterinarians to include neoplasms in their differential diagnoses, when these animals show chronic respiratory signs and neurological alterations that do not improve with appropriate treatment, always associating with complementary exams, for correct diagnosis establishment and prognosis formulation.

Integrative Review of Managed Entry Agreements: Chances and Limitations.

BACKGROUND AND OBJECTIVE: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. METHODS: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. RESULTS: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. CONCLUSIONS: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Methicillin-Resistant Staphylococcus aureus CC398 in Purulent Lesions of Piglets and Fattening Pigs in Portugal.

Introduction: Methicillin-resistant Staphylococcus aureus (MRSA) is an important clinical problem. In 2005, a livestock-associated MRSA clone was described, named CC398, being mostly associated with pigs, and causing colonization and infection in pigs and in related humans. The prevalence of these strains in food-producing pigs raised concerns about the possibility of MRSA-CC398 being a foodborne pathogen. The objective of this study was to investigate the presence of S. aureus and MRSA in 141 carcasses of pigs at three slaughterhouses of Portugal, discarded from the food chain by signs of infection, and to characterize the recovered isolates. Methods: S. aureus isolates were identified by matrix-assisted laser desorption/ionization time-of-flight and they were typed (spa, CC398-clone, and SCCmec). The study of antibiotic resistance and virulence genes, and the detection of immune evasion cluster genes and prophages were performed by PCR and sequencing. Results: Twenty-eight S. aureus were obtained from 141 samples (one/sample, 19.9%), being 22 MRSA and 6 methicillin-susceptible S. aureus (MSSA). All MRSA strains were typed as CC398 and were ascribed to three spa types (t011, t108, and t1451). The SCCmec detected differed according to the spa types of MRSA isolates (SCCmecV: t011 and t108; SCCmecIVa: t1451). The MSSA strains were classified as spa-t1491-ST1-CC1. All the strains contained a wide range of antimicrobial resistance genes, the resistance to tetracycline being the prevalent one. In contrast, the strains contained only a few virulence genes. Among the 6 integrases of phages tested, three were detected: SΦ1, SΦ2, and SΦ7, with variations between MRSA and MSSA strains. Conclusions: MRSA-CC398 is not only a habitual pig colonizer but also an opportunistic pathogen in these animals, and must be controlled at the level of producers and slaughterhouses because of its impact on public health.

Qualidade de Vida de Pacientes Oncológicos em Cuidados Paliativos Domiciliares e Desafios da Prática Médica diante da Finitude da Vida / Quality of Life of Cancer Patients in Home Palliative Care and Challenges of Medical Practice Facing the Finitude of Life / Calidad de Vida de los Pacientes con Cáncer en Cuidados Paliativos en el Hogar y Desafíos de la Práctica Médica que Enfrentan la Finitud de la Vida

Introdução: Os cuidados paliativos (CP) despontam como importante abordagem terapêutica diante do avanço do câncer. Objetivo:Identificar os fatores que interferem na qualidade de vida (QV) de pacientes em CP domiciliares e discutir questões relacionadas à prática médica no cuidado em saúde. Método: Pesquisa quanti-qualitativa, transversal e descritiva, com participação de nove pacientes em acompanhamento domiciliar no Hospital Ophir Loyola (HOL), e utilização do Palliative Outcome Scale (POS), do Questionário de Perfil Pessoal do Paciente e do Questionário de Qualidade de Vida. Resultados: Todos os participantes foram diagnosticados há mais de um ano e estavam em CP há mais de seis meses, sendo que a maioria já havia realizado diferentes modalidades terapêuticas, destacando-se a quimioterapia. O principal local de tumor primário foi a mama e, entre os sintomas físicos apresentados, a presença de dor foi relatada pela maioria dos participantes. Categorias analíticas emergiram do tema QV, sendo a manutenção da saúde, o convívio familiar, o equilíbrio financeiro, a importância da fé e a esperança, a realização de atividades cotidianas e laborais e a manutenção da autonomia identificadas como variáveis que interferem positivamente na QV. As dificuldades socioeconômicas foram associadas a piores desempenhos no POS. Todos apresentaram uma avaliação positiva do trabalho desenvolvido pela equipe de CP. Conclusão: Agravos clínicos e sociais, com destaque para a dor e as limitações econômicas, são fatores que interferem na QV dos pacientes em atendimento domiciliar. Apesar dos avanços alcançados, a medicina ainda necessita priorizar a terminalidade da vida como parte indissociável da formação e prática médica.

Introduction: Palliative Care (PC) emerges as an important therapeutic approach in face of cancer progress. Objective: To identify the factors that affect the quality of life (QoL) of patients in home PC and discuss issues related to medical practice in health care. Method: Quantitative, qualitative, cross-sectional and descriptive study, involving 9 patients in home care at Ophir Loyola Hospital (HOL), using the Palliative Outcome Scale (POS), Patient Personal Profile Questionnaire and Quality of Life Questionnaire. Results: All the participants were diagnosed for over a year and had been in palliative care for more than six months, and most have already submitted to different therapeutic modalities, especially chemotherapy. Breast was the main site of primary tumor and among the physical symptoms presented, the presence of pain was reported by the majority of the participants. Analytical categories emerged from the theme quality of life, and the maintenance of health, family life, financial balance, importance of faith and hope, performance of daily and work activities and maintenance of autonomy were identified as variables that positively affect QoL. Socioeconomic difficulties were associated with worse performances in POS. All presented positive evaluation of the work done by the PC team. Conclusion: Clinical and social problems, especially pain and economic limitations are factors that interfere with the QoL of patients in home care. Despite the advances achieved, medicine still needs to prioritize the terminality of life as an inseparable part of medical education and practice.

Introducción: Los cuidados paliativos (PC) emergen como un enfoque terapéutico importante frente al progreso del cáncer. Objetivo: Identificar los factores que afectan la calidad de vida (QOL) de los pacientes con PC en el hogar y discutir temas relacionados con la práctica médica en la atención médica. Método: Estudio cuantitativo, cualitativo, transversal y descriptivo, que involucró a nueve pacientes en atención domiciliaria en el Hospital Ophir Loyola (HOL), utilizando el Palliative Outcome Scale(POS), el Cuestionario de perfil personal del paciente y el Cuestionario de Calidad de Vida. Resultados: Todos los participantes fueron diagnosticados durante más de un año y habían estado en PC durante más de seis meses, y la mayoría ya había realizado diferentes modalidades terapéuticas, especialmente quimioterapia. El sitio principal del tumor primario fue la mama y entre los síntomas físicos presentados, la mayoría de los participantes informaron la presencia de dolor. Las categorías analíticas surgieron del tema calidad de vida, y el mantenimiento de la salud, la vida familiar, el equilibrio financiero, la importancia de la fe y la esperanza, el desempeño de las actividades diarias y laborales y el mantenimiento de la autonomía se identificaron como variables que afectan positivamente la calidad de vida. Las dificultades socioeconómicas se asociaron con peores desempeños en POS. Todos tuvieron una evaluación positiva del trabajo realizado por el equipo de PC. Conclusión: Los problemas clínicos y sociales, especialmente el dolor y las limitaciones económicas, son factores que interfieren con la QOL de los pacientes en atención domiciliaria. A pesar de los avances logrados, la medicina aún necesita priorizar la terminación de la vida como una parte inseparable de la educación y práctica médica.

Relationship between the perceived social support and catastrophization in individuals with chronic knee pain / Relação entre suporte social percebido e catastrofização em indivíduos com dor crônica do joelho

ABSTRACT BACKGROUND AND OBJECTIVES: Catastrophization and social support influence health outcomes in people with chronic pain. However, there is still no consensus regarding the relationship between these factors, and the information available in what relates to chronic pain in the knee joint is even scarcer. The objective of this study was to describe and understand the relationship between the perceived social support and pain catastrophization in adults with chronic knee pain. METHODS: Sociodemographic data were collected, and the West Haven-Yale Multidimensional Pain Inventory and Pain Catastrophizing Scale were completed by the participants. The sample included 28 participants attending daycare institutions in Aveiro, Braga and Leiria districts (Portugal). RESULTS: Seventy-five percent of the participants presented clinically significant catastrophization, and 64.3% reported high perceived social support. There is a direct relationship between high catastrophization and frequent solicitations and distraction responses. Conversely, an inverse association between high catastrophization levels and infrequent negative responses was observed in the collected sample. CONCLUSION: Useful social support contributes to a maladaptive response to pain by increasing catastrophization levels, and the catastrophic response may be a way to ask for support. There is a direct association between the perceived social support and the catastrophization of chronic knee pain in the participants. However, the association between these variables was poor/low evidencing the need to consider other factors in the catastrophization study.

RESUMO JUSTIFICATIVA E OBJETIVOS: Tanto a catastrofização como o suporte social influenciam os resultados na saúde de indivíduos com dor crônica. Porém, não há consenso sobre a relação entre esses fatores, sendo escassa a informação direcionada à articulação do joelho. O objetivo deste estudo foi descrever e compreender a relação entre o suporte social percebido e a catastrofização da dor em idosos com dor crônica do joelho. MÉTODOS: Foi feita a coleta de dados sociodemográficos, em conjunto com o preenchimento dos instrumentos West Haven-Yale Multidimensional Pain Inventory e Pain Catastrophizing Scale pelos participantes. A amostra foi constituída por 28 participantes, institucionalizados em regime de centro de dia dos distritos de Aveiro, Braga e Leiria (Portugal). RESULTADOS: Setenta e cinco por cento dos participantes apresentaram catastrofização clinicamente significativa e 64,3% referiram alto suporte social percebido. Verificou-se uma relação diretamente proporcional entre a elevada catastrofização e as respostas solícitas e de distração frequentes. Contrariamente, existe uma associação inversamente proporcional entre o elevado nível de catastrofização e as respostas negativas pouco frequentes na amostra recolhida. CONCLUSÃO: O suporte social útil contribui para uma resposta desadaptativa à dor, pelo aumento dos níveis de catastrofização, podendo a resposta catastrófica constituir um meio para solicitar apoio. Denota-se uma associação diretamente proporcional entre o suporte social percebido e a catastrofização da dor crônica do joelho nos participantes. Contudo, a relação demonstrou ser pobre/baixa, evidenciando a necessidade de considerar outros fatores no estudo da catastrofização.

The Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil.

In Brazil, inclusion and exclusion of health technologies within the Unified Health System (SUS) is the responsibility of the National Committee for Health Technology Incorporation (CONITEC). A recent Cochrane systematic review demonstrated that intramuscular interferon beta 1a (IFN-ß-1a-IM) was inferior to the other beta interferons (IFN-ßs) for multiple sclerosis (MS). As a result, CONITEC commissioned an analysis to review possible disinvestment within SUS. The objective of this paper is to describe the disinvestment process for IFN-ß-1a-IM in Brazil. The first assessment comprised a literature review and mixed treatment comparison meta-analysis. The outcome of interest was the proportion of relapse-free patients in 2 years. This analysis confirmed the inferiority of IFN-ß-1a-IM. Following this, CONITEC recommended disinvestment, with the decision sent for public consultation. More than 3000 contributions were made on CONITEC's webpage, most of them against the preliminary decision. As a result, CONITEC commissioned a study to assess the effectiveness of IFN-ß-1a-IM among Brazilian patients in routine clinical care. The second assessment involved an 11-year follow-up of a non-concurrent cohort of 12,154 MS patients developed by deterministic-probabilistic linkage of SUS administrative databases. The real-world assessment further demonstrated that IFN-ß-1a-IM users had a statistically higher risk of treatment failure, defined as treatment switching or relapse treatment or death, with the assessment showing that IFN-ß-1a-IM was inferior to the other IFN-ßs and to glatiramer acetate in both direct and indirect analysis. In the drug ranking with 40,000 simulations, IFN-ß-1a-IM was the worst option, with a success rate of only 152/40,000. Following this, CONITEC decided to exclude the intramuscular presentation of IFN-ß from the current MS treatment guidelines, giving patients who are currently on this treatment the option of continuing until treatment failure. In conclusion, we believe this is the first example of this new disinvestment process in action, providing an exemplar for other treatments in Brazil as well as other countries.

pH control in the midgut of Aedesaegypti under different nutritional conditions.

Aedes aegypti is one of the most important disease vectors in the world. Because their gut is the first site of interaction with pathogens, it is important to understand A. aegypti gut physiology. In this study, we investigated the mechanisms of pH control in the midgut of A. aegypti females under different nutritional conditions. We found that unfed females have an acidic midgut (pH âˆ¼6). The midgut of unfed insects is actively maintained at pH 6 regardless of the ingestion of either alkaline or acidic buffered solutions. V-ATPases are responsible for acidification after ingestion of alkaline solutions. In blood-fed females, the abdominal midgut becomes alkaline (pH 7.54), and the luminal pH decreases slightly throughout blood digestion. Only ingested proteins were able to trigger this abrupt increase in abdominal pH. The ingestion of amino acids, even at high concentrations, did not induce alkalinisation. During blood digestion, the thoracic midgut remains acidic, becoming a suitable compartment for carbohydrate digestion, which is in accordance with the higher alpha-glucolytic activity detected in this compartment. Ingestion of blood releases alkalising hormones in the haemolymph, which induce alkalinisation in ex vivo preparations. This study shows that adult A. aegypti females have a very similar gut physiology to that previously described for Lutzomyia longipalpis It is likely that all haematophagous Nematocera exhibit the same type of physiological behaviour.

HEALTH TECHNOLOGY PERFORMANCE ASSESSMENT: REAL-WORLD EVIDENCE FOR PUBLIC HEALTHCARE SUSTAINABILITY.

OBJECTIVES: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health. METHODS: Our methods used include extensive literature review, refinement with experts across countries, and public consultation. RESULTS: A comprehensive guideline was developed, which has been adopted by the Brazilian government. CONCLUSION: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.

Morphophysiological study of digestive system litter-feeding termite Cornitermes cumulans (Kollar, 1832).

Termites are the major decomposers of lignocellulosic biomass on Earth and are commonly considered as biological reactor models for lignocellulose degradation. Despite their biotechnological potential, few studies have focused on the morphophysiological aspects of the termite digestive system. We therefore analyze the morphology, ultrastructure and gut luminal pH of the digestive system in workers of the litter-feeding termite Cornitermes cumulans (Blattodea: Termitidae). Their digestive system is composed of salivary glands and an alimentary canal with a pH ranging from neutral to alkaline. The salivary glands have an acinar structure and present cells with secretory characteristics. The alimentary canal is differentiated into the foregut, midgut, mixed segment and hindgut, which comprises the ileum (p1), enteric valve (p2), paunch (p3), colon (p4) and rectum (p5) segments. The foregut has a well-developed chewing system. The midgut possesses a tubular peritrophic membrane and two cell types: digestive cells with secretory and absorptive features and several regenerative cells in mitosis, both cell types being organized into regenerative crypts. The mixed segment exhibits cells rich in glycogen granules. Hindgut p1, p4 and p5 segments have flattened cells with a few apical invaginations related to mitochondria and a thick cuticular lining. Conversely, the hindgut p3 segment contains large cuboid cells with extensive apical invaginations associated with numerous mitochondria. These new insights into the morphophysiology of the digestive system of C. cumulans reveal that it mobilizes lignocellulose components as a nutritional source by means of a highly compartmentalized organization with specialized segments and complex microenvironments.

Diretriz metodológica para estudos de avaliação econômica de tecnologias em saúde no Brasil / Methodological guidelines for economic evaluation studies of health technologies in Brazil

Objetivos: Resumir os principais pontos da Diretriz de Avaliação Econômica em Saúde (AES) do Ministério da Saúde. Métodos: As diretrizes para AES no Brasil foram desenvolvidas por intermédio de múltiplas rodadas de trabalho iterativas por grupo multidisciplinar de especialistas em economia da saúde e foram submetidas à consulta pública. Resultados: O problema deve ser definido por meio de uma questão de pesquisa estruturada. O estudo pode ser baseado em dados primários ou em modelagem, em que o primeiro aumenta a validade interna dos resultados e o segundo, a capacidade de generalização do estudo. Quando o trabalho for baseado em modelagem e focado em doença crônica, o modelo de Markov pode ser usualmente empregado, quando não houver necessidades que apontem para simulação de eventos discretos (como competição dos indivíduos por recursos escassos) ou modelos de transmissão dinâmica (em vacinação e/ou doenças infecciosas com alta transmissão entre indivíduos). O horizonte temporal preferencial é o de tempo de vida, e a taxa de desconto padrão é de 5% para custo e efetividade. Os custos devem representar a perspectiva do Sistema Único de Saúde (SUS), podendo ser estimados por macrocusteio ou microcusteio. Sempre que possível, os resultados devem ser apresentados no formato de custo por ano de vida salvo ajustado para qualidade, para facilitar comparações com outros estudos. Análises de sensibilidade devem ser extensamente empregadas, de forma a avaliar o impacto da incerteza nos resultados produzidos. Conclusões: Espera-se que, com a padronização da metodologia proposta na Diretriz, a produção de AES no país tenha incremento na sua qualidade e reprodutibilidade.

Objectives: To summarize the main points from the Brazilian's Ministry of Health Economic Evaluations (HEE) guideline. Methods: The guideline was developed through multiple rounds of iterative work, conducted by a multidisciplinary team of specialists in health economics, and where submitted to public consultation. Results: The decision problem should be defined through a structured research question. The study can be either primary data or model-based; in the first case, there is greater internal validity, while the second generates a superior generalizability. When the study is model-based and focused on a chronic disease, a Markov model can be usually employed, except for situations that points towards the need of a discrete event simulation (such as competition of individuals for scarce resources) or a dynamic transition model (for example, vaccination models and infectious diseases with high transmission rates between individuals). The preferred time horizon is the lifetime one, and the default discount rate is 5% for both costs and effectiveness. Costs should represent the Unified Health System (SUS) perspective and can be estimated through either gross-costing or micro-costing. Results should be presented as costs per quality adjusted life years (QALYs) whenever possible, to facilitate comparison with other studies. Sensitivity analyses should be widely employed, in order to evaluate the impact of uncertainty in the results produced by the model. Conclusions: It is expected that, with the standardization proposed in this guideline, the HEE production in Brazil has gains in quality and reproducibility.

Beneficial effects of a pharmaceutical care program on outpatients with inflammatory bowel disease

This study aimed to evaluate the effects of aPharmaceutical Care (PC) program among outpatientswith Inflammatory bowel diseases (IBD) in an outpatientdepartment of a tertiary care teaching hospital in RibeiraoPreto, Brazil. Patients with IBD were randomizedinto two groups, one to receive PC procedures (PCG;N=18) and a control group (CG; N=17). Both groupswere followed for one year and compared at six (T6),and 12 (T12), months of study. Patients were assessedfor treatment compliance, knowledge about treatment,clinical colitis activity index, and quality of life (SF-36). In PCG patients, the number of adherent patientssignificantly increased from 28% to 72% (p<0.05), andin the percent score for patient knowledge increasedfrom 80% to 100% (p≤0.0001) from T0 to T12. Therewas a significant decrease in clinical activity indexesfrom T6 to T12 in PCG patients (median; range: 2.20;0.99­3.77 versus 1.90; 0.99­3.77; p=0.02), but not inthe CG group (1.69; 0.99­3.77 versus 1.69; 0.99­3.48).Quality of life questionnaire rvealed increased scoresfor mental health domain at T12 in both PCG (57.5versus 65.3; p=0.04) and CG (56.9 versus 67.0; p=0.01)groups. The PC program was associated with increasedcompliance, better mental health-related quality of life,and enhanced knowledge about treatment.(AU)