Aspectos éticos e jurídicos dos exames complementares / Ethical and legal aspects of supplementary tests

Dentro do processo de decisão médica em cardiologia, em especial na doença arterial coronária, com a necessidade de avaliar o paciente individualmente dentro do binômio diagnóstico-prognóstico, estão incluídos os exames complementares não invasivos. Quando indicados nas populações classificadas como probabilidade pré-teste intermediária de doença, alcançam habitualmente sua máxima eficiência, mas envolvem riscos inerentes aos métodos empregados, que devem ser abordados no sentido de fornecer a máxima segurança ao paciente dentro da melhor relação custo-efetividade. No caso das provas de estresse físico como o teste ergo métrico (TE), a despeito de ser considerado um procedimento seguro, há relatos de eventos de natureza grave como infarto do miocárdio (lM) e morte, com estudos sugerindo de zero a seis mortes ou paradas cardíacas e dois a 10 IM por 10.000 testes realizados. Ressalta-se, no entanto, que as estimativas variam de modo significativo de acordo à prevalência e gravidade da doença cardíaca de base na população testada, sendo tais dados corroborados em diretrizes nacionais da especialidade. Destacados tais fatos, toma-se obrigatório o conhecimento pelo médico das implicações médico-legais do procedimento, abordadas nos Códigos de Proteção ao Consumidor, Civil Brasileiro e de Ética Médica e que são passíveis de aplicação. Há considerações adicionais quando exames complementares que empregam estresse físico, estímulo ou estresse farmacológico associam-se com a injeção de radiofármacos para o estudo da perfusão do miocárdio, como o tálio 201 ou isonitrilas (MIEI ou tetrofosmin) marcadas com tecnécio 99m, considerando-se a exposição à radiação e intercorrências possíveis relacionadas ao estresse, documentados em TCLE apropriado...

Within the cardiology medica I decision-rnaking, especially in coronary artery disease, and the need to evaluate the individual patient in binomial diagnosis-prognosis, as well as meet the conceptuation of incremental prognostic value, the complementary non-invasive examinations are included: when indicated in populations classified as intermediate pretest probability of illness they usually reach their maximum efficiency, but involve risks inherent in methods, which must be addressed in order to provide maximum safety to the patient within the best cost effectiveness ratio. In case of evidence of physical stress such as exercise testing (EXT), in spite of being considered a safe procedure, there are reports of serious nature, such as myocardial infarction (MI) and death, with studies suggesting from zero to six deaths or cardiac arrest and two to ten MI for 10.000 tests performed. It should be noted however, that estimates vary significantly according to the prevalence and the severity of heart disease based on the population tested, being such data supported by national specialty guidelines. Highlighted such facts, it becomes rnandatory the doctor's knowledge about the medical-legal implications of the procedure, consumer protection codes, Brazilian civil and medical ethics that can be applied. There are other considerations when additional tests that emply physical stress, stimulation or pharmacological stress associated with the injection of radio pharmaceuticals for the study of myocardiaI perfusion, as thallium 201 or isonitriles (MIBI or tetrofosrnin) labeled with technetium 99 m, considering the radiation exposure and possible complications related to stress, documented in appropriate free informed consent statement...

La obligación de informar al paciente: Cuestiones sobre el derecho a ser informado / The obligation to inform the patient: Issues on the right to be informed

This article aims to analyze, from a legal perspective, the boundaries of the obligation imposed on health care providers to inform the patient. This requirement originated and was developed as an ethical issue. However, with the newly approved law regulating the rights and duties of patients, the obligation to inform can be viewed from prisms and principles that differ from those governing medical ethics. With this purpose, we will focus on the comparative experience, which will allow us to evaluate the responsibility of health care providers when this duty is breached. We will try to answer the following questions: Which medical information must be informed to the patient? When should the doctor inform the patient? In which form should this information be provided?.

[The obligation to inform the patient: issues on the right to be informed]. / La obligación de informar al paciente: Cuestiones sobre el derecho a ser informado.

This article aims to analyze, from a legal perspective, the boundaries of the obligation imposed on health care providers to inform the patient. This requirement originated and was developed as an ethical issue. However, with the newly approved law regulating the rights and duties of patients, the obligation to inform can be viewed from prisms and principles that differ from those governing medical ethics. With this purpose, we will focus on the comparative experience, which will allow us to evaluate the responsibility of health care providers when this duty is breached. We will try to answer the following questions: Which medical information must be informed to the patient? When should the doctor inform the patient? In which form should this information be provided?.

Implicaciones éticas y jurídicas de los procedimientos invasivos en cardiología / Ethical and legal implications of invasive procedures in cardiology

La relación clínica entre el médico y el enfermo se ha modificado en los últimos 30 años. A ello han contribuido, entre otros, los nuevos modos de ejercer la medicina por parte de los profesionales sanitarios, y, en particular, de aplicar los avances tecnológicos. En el ámbito de la cardiología existen varios métodos invasivos de diagnóstico y tratamiento, los cuales presentan riesgos para la vida del paciente; por tanto, es necesario una adecuada información y la aplicación del consentimiento informado desde el punto de vista ético y judicial. En Cuba existen aún rezagos de la medicina paternalista, por lo cual la aplicación del consentimiento informado, que constituye mucho más que un documento que se anexa a la historia clínica antes de un estudio invasivo, no se aplica sistemáticamente en las instituciones de salud. En el presente artículo se realiza una revisión sobre los aspectos éticos y jurídicos del consentimiento informado como proceso con implicaciones fundamentalmente éticas, pero también jurídicas, y se sugiere un documento representativo para su aplicación en los servicios de Cardiología del país(AU)

Doctor-patient relationships have changed in the past 30 years. This has been due, among other factors, to the introduction of new forms of health care and in particular to the application of technological advances. In the field of cardiology, several invasive diagnostic procedures and treatments pose a risk to the life of patients. Therefore, in compliance with ethical and legal principles, adequate information and the application of informed consent are crucial. In Cuba some vestiges of medical paternalism have lived on till our days. As a result, informed consent, which is a lot more than a document attached to the medical record before the performance of an invasive study, is not systematically applied in health care institutions. The present paper is a review of the ethical and legal aspects of informed consent as a process with mainly ethical, but also legal implications. A representative document is proposed for the application of informed consent in the country's cardiology services(AU)

Documentos médicos / Medical documents

O artigo ressalta os aspectos jurídicos dos documentos médicos, privilegiando a sua vocação como meios de prova em processos judiciais. Procurase trazer uma abordagem prática da questão dos documentos médicos, com vistas ao exercício profissional cotidiano e sem que se pretenda minimizar a importância da investigação aprofundada da matéria, e muito menos desvalorizar a finalidade principal desses documentos que decorre da sua natureza médica. Os principais instrumentos que retratam os cuidados prestados ao paciente, quais sejam Prontuário Médico, Termo de Consentimento Informado, Atestados e Receituário, são comentados sob o enfoque legal, buscando-se apontar quais características lhe conferem legitimidade jurídica

This article emphasizes the legal aspects of medical documents, giving priority to their potential use as evidence in legal proceedings. It seeks to provide a practical approach to the issue of medical documents, which is addressed to everyday professional practice but has no intention of minimizing the importance of a thorough investigation of the matter, and much less underestimating the main purpose of these documents arising from its medical nature. The main instruments that reflect the care delivered to the patient, namely, Medical Chart, Informed Consent Form, Certificates and Prescriptions, are discussed under the legal point of view, aiming to point out which features grant them legal legitimacy

[Adolescents as research subjects and free informed consent: knowledge and opinion of researchers and adolescents]. / Adolescentes como voluntários de pesquisa e consentimento livre e esclarecido: conhecimento e opinião de pesquisadores e jovens.

This article presents the results of a study that evaluated the knowledge and opinions of researchers and adolescents that served as their research subjects on the legal norms that regulate the participation of the latter as research subjects, the capacity of adolescents to make autonomous decisions regarding participation, and the adolescent experience after agreeing to take part in a study. This was a qualitative study with a convenience sample, the size of which was defined by the criteria of informational redundancy. Interviews were conducted with three researchers who had used adolescents as research subjects and nine of these subjects. This number of interviews was sufficient to reach informational redundancy. Data was collected through recorded semi-structured interviews, with open questions. All the researchers were familiar with some legal document related to the participation of adolescents as subjects of research. On the other hand, the adolescents were surprised because they were not aware of the existence of such documents. However, they considered them necessary for their own protection. In general, researchers and adolescents believe that adolescents have the capacity to decide autonomously to participate as research subjects. The adolescents affirmed that they had decided to volunteer conscientiously.

Implementation of informed consent for a cystic fibrosis newborn screening program in France: low refusal rates for optional testing.

OBJECTIVES: The French Association for Neonatal Screening implemented cystic fibrosis neonatal screening (CF NBS) region by region in France, from the beginning of the year 2002 to early 2003. The program uses an immunoreactive trypsinogen/DNA testing algorithm on dried blood samples obtained at 3 days of age. Incorporation of DNA testing necessitated compliance with official regulations and French "bioethics" laws: the need for a written consent from the patient/guardian and specific circulation of the prescription, sample, and results. To fulfill these obligations, the Ethics and Genetics committee of the French Association for Neonatal Screening recommended that informed consent should be obtained for all neonates at birth by having the parents sign directly on the sampling paper. This study was designed to evaluate the effect of the educational efforts used to obtain informed consent on acceptance of CF NBS. STUDY DESIGN: Data from the screening center in Lille, France, were analyzed to determine the rate of refusal of CF NBS in the 18 months after initiation of the informed consent process. RESULTS: The number of refusals for CF NBS declined from 0.8% at the start of the program to 0.2% at the end of the first year of the new process for obtaining written consent. CONCLUSIONS: Efforts to inform parents and professionals resulted in a significant decrease in the number of refusals for CF NBS.

Reflexões teóricas acerca do termo de responsabilidade na prática da saúde / Theoretical reflections on the liability agreement in the health care practice

Este artigo pretende mostrar uma reflexão acerca do termo de responsabilidade assinado pelo paciente, quando de sua internação em uma instituição hospitalar, a partir de algumas idéias de autores que já abordaram a sua utilização na prática de saúde. A partir do questionamento para que serve o referido documento e quais suas implicações para o paciente e para a instituição, procura resgatar os determinantes de sua utilização levando em consideração a formação profissional, a realidade dos serviços de saúde e modelos de assistência adotados, a própria atuação dos profissionais da área e os direitos humanos.