ABSTRACT
The coronavirus disease (COVID-19) pandemic has led to an unprecedented public health crisis. Insufficient testing continues to limit the effectiveness of the global response to the COVID-19 pandemic. Molecular testing methods such as reverse transcriptase polymerase chain reaction (RT-PCR) continue to be highly centralized and are a sub-optimal option for population surveillance. Rapid antigen tests (Ag-RDTs) offer multiple benefits including low costs, high flexibility to conduct tests in a wide variety of settings, and faster return of results. Self-test Ag-RDTs (STs) have gained approval in several markets and offer the possibility to expand testing, reaching at-risk populations. While STs have the potential to assist the COVID-19 response, test result integrity, reporting, and appropriate linkage to care continue to hinder the widespread implementation of self-testing programs. This protocol presents a mixed-methods pragmatic trial (ISRCTN91602092) to better understand the feasibility of self-testing as part of a contact tracing strategy within the Brazilian public health system. Approximately 604 close contacts of 150 index cases testing positive for COVID-19 will be enrolled. Index cases will be randomized for their close contacts to participate in either serial (daily) self-testing over a 10-day follow-up period or a more traditional approach to contact tracing with a professional Ag-RDT at one time point post-exposure. Usability workshops and focus group discussions will also be conducted. This study protocol presents a comprehensive plan to assess the effectiveness, operational feasibility, and stakeholder preferences of a serial self-testing strategy for contact tracing within the Brazilian public health system. Our results will contribute to better understanding of the feasibility of a self-testing strategy within the public sector. Potential risks and limitations are discussed. Our findings will have important implications as governments continue working to mitigate the impact of COVID-19, particularly in the context of where to direct limited resources for testing and healthcare infrastructure. Registration: This trial is registered at ISCTRN (ISRCTN91602092).
Subject(s)
COVID-19 , Humans , Brazil/epidemiology , Contact Tracing , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , Pandemics/prevention & control , Public Health , SARS-CoV-2 , Self-Testing , Pragmatic Clinical Trials as TopicABSTRACT
Resumo No Brasil, o acesso aos medicamentos do Componente Especializado da Assistência Farmacêutica, no âmbito do Sistema Único de Saúde, ocorre mediante preenchimento e entrega do termo de esclarecimento e responsabilidade nas farmácias especializadas. Estes termos visam a obtenção do consentimento informado do paciente no que diz respeito ao tratamento medicamentoso oferecido. O estudo avaliou-os à luz do referencial teórico da bioética de intervenção com ênfase na garantia da autonomia do paciente e na sua proteção como ente vulnerável. Embora haja dispositivos que resguardem sua privacidade e forneçam informações relevantes para seu empoderamento na relação com o médico, os termos carecem de medidas protetivas nos casos em que ocorrem efeitos indesejáveis. Cabe, portanto, ao Estado fortalecê-los para garantir verdadeira autonomia dos pacientes, balizar sua vulnerabilidade e assegurar medidas de proteção em casos de episódios adversos.
Abstract In Brazil, access to medicines of the Specialized Pharmaceutical Care Program, within the scope of the Brazilian Unified Health System, depends on filling out and delivering the Clarification and Responsibility Form at specialized pharmacies. These forms are intended to obtain the patient´s informed consent concerning the medication being offered. The study evaluated them in the light of the theoretical reference of intervention bioethics, with emphasis on guaranteeing patient autonomy and protection as a vulnerable entity. Though the forms studied consider patient privacy and provide them with information relevant to their empowerment in dealing with doctors, the term lacks enough protective measures in cases where undesirable effects occur. Therefore, it is a State responsibility to strengthen them to guarantee true autonomy for patients, to identify their vulnerability and to ensure protective measures in cases of adverse event.
Resumen En Brasil, el acceso a los medicamentos del Componente Especializado de la Asistencia Farmacéutica, en el ámbito del Sistema Único de Salud, tiene lugar mediante diligenciamiento y entrega del Formulario de Esclarecimiento y Responsabilidad en las farmacias especializadas. Estos documentos procuran la obtención del consentimiento informado del paciente respecto del tratamiento medicamentoso a ser ofrecido. Este estudio los evaluó a la luz del marco teórico de la bioética de intervención con énfasis en la garantía de la autonomía del paciente y en su protección como ente vulnerable. Aunque haya dispositivos que resguarden la privacidad del paciente y proporcionen informaciones relevantes para su empoderamiento en la relación con el médico, los formularios carecen de medidas de protección en los casos de ocurrencia de efectos indeseables. Le compete, por lo tanto, al Estado fortalecerlos para garantizar una verdadera autonomía de los pacientes, demarcar su vulnerabilidad, y asegurar medidas de protección en casos de episodios adversos.
Subject(s)
Bioethics , Personal Autonomy , Consent Forms , Health Vulnerability , Informed ConsentABSTRACT
This article explores the current situation regarding the importance of access to healthcare in relation to the genesis and context of bioethics developed in Brazil, a country in which healthcare is understood through the national constitution to be a universal right of its population. Since the onset of the development of Brazilian bioethics at the beginning of the 1990s, topics relating directly and indirectly to the field of public health have been a priority in the bioethics agenda. The article considers the socioeconomic context within which conflicts occur, an issue that has been addressed in other scientific articles on bioethics in Latin America. It presents the main conceptual bases of intervention bioethics, a critical approach that has been developed as a reference point in this region, with the aim of analyzing (bio)ethical issues and indicating solutions that relate specifically to the different forms of social exclusion that influence the health conditions and lives of people in Brazil, as well as in other peripheral countries in the Southern Hemisphere and of the world in general. The article calls attention to some of the problems and challenges that the Brazilian public health system has been facing. An international agenda of "universal health coverage" is one of the main global threats to implementing the universal right to healthcare as it has been understood in Brazil.
Subject(s)
Bioethics , Health Services Accessibility , Brazil , Human Rights , Public HealthABSTRACT
Resumen Este artículo nace de la necesidad de responder a la recurrente crítica que se hace a la bioética, sobre su falta de operatividad. Presenta y caracteriza los tres enfoques que han tratado de responder esta crítica: principialismo, casuística y narrativa. Discute la caracterización hecha de esos enfoques, especialmente en lo relativo al concepto de bioética que defienden. Finaliza, señalando la importancia de emprender una crítica a los citados enfoques, en el intento de ofrecer futuramente uno alternativo que responda a un concepto de bioética amplio, como el defendido por las bioéticas nacidas en los países periféricos.
Resumo Este artigo vem da necessidade de responder as recorrentes críticas feitas à bioética sobre a sua falta de operabilidade. Também apresenta e caracteriza três abordagens que tentaram respondê-las: principialismo, casuística e narrativa. Além disso, discute a caracterização dessas abordagens, especialmente no que diz respeito ao conceito de bioética que defendem, e de igual modo, finaliza indicando a importância da realização de uma crítica dessas abordagens citadas acima, com o intuito de oferecer futuramente, uma alternativa que responda a um conceito amplo de bioética como defendido pela bioética nascida em países periféricos.
Abstract This article is inspired by the need to respond to recurrent criticisms regarding the lack of operability of bioethics. It presents and characterizes three approaches that have tried to answer this criticism: principlism, casuistry and narrative. It also discusses the characterization of these approaches, especially in terms of the concepts of bioethics they defend. The article concludes by discussing the importance of carrying out a critique of such approaches, aimed at providing an alternative theory that responds to a broader concept of bioethics, as defended by the bioethics that has emerged from peripheral countries.
Subject(s)
Bioethics , Case Reports , Principle-Based Ethics , NarrationABSTRACT
As práticas regulatórias no campo da vigilância sanitária são indispensáveis. O objetivo deste estudo é mostrar, tomando como referência a Agência Nacional de Vigilância Sanitária, organismo referencial da vigilância sanitária no Brasil, que a bioética oferece aos organismos públicos uma série de ferramentas teóricas do campo da ética aplicada para o bom exercício e controle dessas práticas. Nesse intuito, o trabalho utiliza duas referências da bioética para o desenvolvimento de uma análise comparativa e de apoio às atividades regulatórias no campo da vigilância sanitária: a Declaração Universal sobre Bioética e Direitos Humanos da Unesco e a teoria da bioética de intervenção. Conclui-se que organismos e técnicos que trabalham com atividades de regulação podem aproveitar, em seu exercício profissional, os princípios e referenciais propostos pela bioética, especialmente aqueles relacionados à Declaração e à teoria de bioética da intervenção, esta última configurada pela observação e utilização dos princípios da prudência, precaução, proteção e prevenção.(AU)
Regulatory practices in the field of health surveillance are indispensable. The aim of this study is to show â taking the Brazilian National Surveillance Agency, governing body of sanitary surveillance in Brazil as a reference â that bioethics provides public bodies a series of theoretical tools from the field of applied ethics for the proper exercise and control of these practices. To that end, the work uses two references of bioethics for the development of a comparative and supportive analysis to regulatory activities in the field of health surveillance: the Universal Declaration on Bioethics and Human Rights of Unesco and the theory of intervention bioethics. We conclude that organizations and staff working with regulatory activities can take advantage of the principles and frameworks proposed by bioethics, especially those related to the Declaration and the theory of intervention bioethics, the latter being set by the observation and use of the principles of prudence, precaution, protection and prevention.(AU)
Subject(s)
Humans , Male , Female , Social Control, Formal , Health Surveillance , Bioethics , Public Health , Human RightsABSTRACT
Por meio da bioética narrativa, este artigo apresenta os resultados de estudo de narrativas de seis pessoas diretamente envolvidas na rotina da unidade de cuidados paliativos do Hospital de Apoio de Brasília. O objetivo foi contribuir para a investigação dos complexos problemas enfrentados pelos cuidados paliativos na prática profissional diária, com foco na relação entre espiritualidade e bioética. Foram realizadas entrevistas com profissionais, pacientes e familiares, buscando respostas à questão do sentido da vida e sua relação com o sofrimento. Conclui-se que a bioética narrativa aplicada aos cuidados paliativos pode oferecer importantes subsídios para elucidar as questões ligadas à compreensão da esfera espiritual, ao prover marcos analíticos voltados para o ser humano, que expressa, sente, diz e cria sentido no que é dito.
Through narrative bioethics, this article presents the results of a study of the narratives of six people directly involved in the routine of the palliative care unit at the Hospital de Apoio de Brasilia, with the aim of contributing to the study of the complex problems faced by palliative care in daily practice. Focusing on the relationship between spirituality and bioethics, interviews with professionals, patients and families were conducted, seeking answers to the question of the meaning of life and its relationship to suffering. It was concluded that narrative bioethics applied to palliative care can provide important input to clarify issues related to the understanding of the spiritual realm by providing analytical frameworks that take into account human beings which express, feel, say and make sense of what is said.
Por medio de la bioética narrativa, el presente artículo presenta los resultados del estudio de las narrativas de seis personas directamente involucradas en la rutina de la unidad de cuidados paliativos del Hospital de Apoyo de Brasilia, con el objetivo de contribuir al estudio de los complejos problemas enfrentados por los cuidados paliativos en la práctica profesional diaria. Enfocándose en la relación entre espiritualidad y bioética, se realizaron entrevistas con profesionales, pacientes y familiares, buscando respuestas a la cuestión del sentido de la vida y su relación con el sufrimiento. Se concluye que la bioética narrativa aplicada a los cuidados paliativos puede proporcionar importantes aportes para aclarar cuestiones relacionadas con la comprensión de la esfera espiritual, al proveer marcos analíticos que toman en cuenta al ser humano que expresa, siente, dice y crea sentido en lo que es dicho.
