Percepção sobre o cuidado à perda gestacional: estudo qualitativo com casais brasileiros / Perceptions on pregnancy loss care: a qualitative study with brazilian couples / Percepción sobre la atención a la pérdida del embarazo: estudio cualitativo con parejas brasileñas

Este artigo analisou a percepção e os sentimentos de casais sobre o atendimento recebido nos serviços de saúde acessados em função de perda gestacional (óbito fetal ante e intraparto). O convite para a pesquisa foi divulgado em mídias sociais (Instagram e Facebook). Dos 66 casais que contataram a equipe, 12 participaram do estudo, cuja coleta de dados ocorreu em 2018. Os casais responderam conjuntamente a uma ficha de dados sociodemográficos e uma entrevista semiestruturada, realizada presencialmente (n=4) ou por videochamada (n=8). Os dados foram gravados em áudio e posteriormente transcritos. A Análise Temática indutiva das entrevistas identificou cinco temas: sentimento de impotência, iatrogenia vivida nos serviços, falta de cuidado em saúde mental, não reconhecimento da perda como evento com consequências emocionais negativas, e características do bom atendimento. Os achados demonstraram situações de violência, comunicação deficitária, desvalorização das perdas precoces, falta de suporte para contato com o bebê falecido e rotinas pouco humanizadas, especialmente durante a internação após a perda. Para aprimorar a assistência às famílias enlutadas, sugere-se qualificação profissional, ampliação da visibilidade do tema entre diferentes atores e reorganização dos serviços, considerando uma diretriz clínica para atenção ao luto perinatal, com destaque para o fortalecimento da inserção de equipes de saúde mental no contexto hospitalar.(AU)

This study analyzed couples' perceptions and feelings about pregnancy loss care (ante and intrapartum fetal death). A research invitation was published on social media (Instagram and Facebook) and data collection took place in 2018. Of the 66 couples who contacted the research team, 12 participated in the study by filling a sociodemographic questionnaire and answering a semi-structured interview in person (n=04) or by video call (n=08). All interviews were audio recorded, transcribed, and examined by Inductive Thematic Analysis, which identified five themes: feelings of impotence, iatrogenic experiences in health services, lack of mental health care, not recognizing pregnancy loss as an emotionally overwhelming event, and aspects of good healthcare. Analysis showed experiences of violence, poor communication, devaluation of early losses, lack of support for contact with the deceased baby, and dehumanizing routines, especially during hospitalization after loss. Professional qualification, extended pregnancy loss visibility among different stakeholders, and reorganization of health services are needed to improve the care offered to grieving families, considering a clinical guideline for perinatal grief care with emphasis on strengthening the insertion of mental health teams in the hospital context.(AU)

Este estudio analizó las percepciones y sentimientos de parejas sobre la atención recibida en los servicios de salud a los que accedieron debido a la pérdida del embarazo (muerte fetal ante e intraparto). La invitación al estudio se publicó en las redes sociales (Instagram y Facebook). De las 66 parejas que se contactaron con el equipo, 12 participaron en el estudio, cuya recolección de datos se realizó en 2018. Las parejas respondieron un formulario de datos sociodemográficos y realizaron una entrevista semiestructurada presencialmente (n=4) o por videollamada (n=08). Los datos se grabaron en audio para su posterior transcripción. El análisis temático inductivo identificó cinco temas: Sentimiento de impotencia, experiencias iatrogénicas en los servicios, falta de atención a la salud mental, falta de reconocimiento de la pérdida como un evento con consecuencias emocionales negativas y características de buena atención. Los hallazgos evidenciaron situaciones de violencia, comunicación deficiente, desvalorización de las pérdidas tempranas, falta de apoyo para el contacto con el bebé fallecido y rutinas poco humanizadas, especialmente durante la hospitalización tras la pérdida. Para mejorar la atención a las familias en duelo, se sugiere capacitación profesional, ampliación de la visibilidad del tema entre los diferentes actores y reorganización de los servicios, teniendo en cuenta una guía clínica para la atención del duelo perinatal, enfocada en fortalecer la inserción de los equipos de salud mental en el contexto hospitalario.(AU)

Ethical issues in oncology practice: a qualitative study of stakeholders' experiences and expectations.

BACKGROUND: Clinical Ethics Support Services (CESS) have been established to support healthcare professionals in addressing ethically sensitive issues in clinical practice and, in many countries, they are under development. In the context of growing CESS, exploring how healthcare professionals experience and address clinical ethics issues in their daily practice represents a fundamental step to understand their potential needs. This is even more relevant in the context of extremely sensitive diseases, such as cancer. On this basis, we carried out a qualitative study conducting in-depth semi-structured interviews with stakeholders of a major comprehensive cancer centre in Italy, with the twofold aim of investigating what ethical issues arise in the context of clinical oncology and how they are addressed, as well as stakeholders' expectations about a potential CESS to be implemented within the Institution. METHODS: The study was conducted within the theoretical framework of Grounded Theory. Participants were healthcare professionals and other key stakeholders working within the cancer centre. The semi-structured interview aimed at exploring common ethical aspects of oncology, investigating stakeholders' professional experience in dealing with clinical ethics issues, their expectations and requests regarding ethics support services. Transcripts of the interviews were coded and analysed according to the principles of Grounded Theory. RESULTS: Twenty-one stakeholders were interviewed. Our analysis showed a wide consensus on the identification of ethically relevant issues, above all those concerning communication, end-of-life, and resource allocation. The absence of institutional tools or strategies to address and manage ethical issues at the patient bedside emerged, and this is reflected in the widespread request for their development in the future. The ideal support service should be fast and flexible in order to adapt to different needs and clinical cases. CONCLUSIONS: The interviewees showed a limited degree of 'ethical awareness': despite having reported many issues in clinical practice, they could hardly identify and describe the ethical aspects, while  complaining about a lack of ethical resources in their management. To build a truly effective support service, it therefore seems appropriate to take such context into consideration and address the emerged needs. Ethical sensitivity seems to be key and it becomes even more relevant in critical clinical areas, such as the therapeutic pathways of terminally ill patients.

Top Ten Tips Palliative Care Clinicians Should Know About Their Work's Intersection with Clinical Ethics.

Palliative care (PC) subspecialists and clinical ethics consultants often engage in parallel work, as both function primarily as interprofessional consultancy services called upon in complex clinical scenarios and challenging circumstances. Both practices utilize active listening, goals-based communication, conflict mediation or mitigation, and values explorations as care modalities. In this set of tips created by an interprofessional team of ethicists, intensivists, a surgeon, an attorney, and pediatric and adult PC nurses and physicians, we aim to describe some paradigmatic clinical challenges for which partnership may improve collaborative, comprehensive care.

A Pre-Doctoral Clinical Ethics Fellowship for Medical Students.

INTRODUCTION: Despite the need for trained physician ethicists, fellowships in clinical ethics are limited and primarily offered to those who have completed a graduate degree. The standardization of credentialing for clinical ethics consultants (CECs) and the restructuring of undergraduate medical education allow innovative models to train CECs that can provide an expanded opportunity for formal ethics training at an earlier stage. METHODS: At the University of Michigan Medical School we developed, implemented, and evaluated a pre-doctoral clinical ethics fellowship program from 2017 to 2019 for senior medical students, designed to meet established competencies for CECs. Consultation notes from the beginning and end of the fellowship program were randomly selected for each fellow and independently rated by two faculty ethicists who used the validated Ethics Consultation Quality Assessment Tool (ECQAT). Inter rater reliability and trends in scores over time were calculated. RESULTS: Three students successfully completed the fellowship at the University of Michigan Medical School, conducted at least 50 formal ethics consultations, and spent approximately 40 hours a week on service for a minimum of six months. All students finished the fellowship with teaching and policy development experience, first-authored peer-reviewed manuscripts, and national presentations. The fellows demonstrated improvement in their ECQAT overall holistic rating score; all ended their fellowship with a holistic score of adequate or above. There was 92 percent agreement between raters with respect to the acceptability of the fellows' ethics consult notes. Two fellows have taken and passed the Healthcare Ethics Consultant-Certification (HEC-C) exam offered by the American Society for Bioethics and Humanities (ASBH). CONCLUSIONS: Integration of a pre-doctoral fellowship model that meets professional certification standards for clinical ethics consultation creates an opportunity for medical students to become trained CECs early in their career.

Spiritual Care Providers as Full Partners in Whole-System Interventions.

In this commentary, I reflect on 12 stories from individuals who have had a near-death experience, and I describe how the ministry of the spiritual caregiver can aide patients who experience a near-death phenomenon. Spiritual care providers are trained to support patients and family members and promote a sense of peace and comfort. They offer affirmation while promoting a space for wondering. Spiritual health is an essential component of a whole-body system. The experiences of the 12 authors have much in common, but perhaps most surprising is the omission of any clergy or chaplains being called on despite many of the authors disclosing their NDE to physicians and nurses.

Closing the Medical Gap of Care for Patients Who Have Had a Near-Death Experience.

This commentary discusses the twelve stories in which patients tell what happened when they were hospitalized and they had a near-death experience. The stories display a consistent theme of the gap in medical and spiritual care they received, after the patient's near-death experience. This commentary explores the implications of this gap in care for these patients and the perceived medical professionals' bias that occurs after these experiences, which can contribute to long-term consequences such as isolation and rejection. Education in medical schools and continuing education can provide medical professionals with insights needed to support individuals with near-death experiences.

Comprehensive Quality Assessment in Clinical Ethics.

Scholars and professional organizations in bioethics describe various approaches to "quality assessment" in clinical ethics. Although much of this work represents significant contributions to the literature, it is not clear that there is a robust and shared understanding of what constitutes "quality" in clinical ethics, what activities should be measured when tracking clinical ethics work, and what metrics should be used when measuring those activities. Further, even the most robust quality assessment efforts to date are idiosyncratic, in that they represent evaluation of single activities or domains of clinical ethics activities, or a range of activities at a single hospital or healthcare system. Countering this trend, iin this article we propose a framework for moving beyond our current ways of understanding clinical ethics quality, toward comprehensive quality assessment. We first describe a way to conceptualize quality assessment as a process of measuring disparate, isolated work activities; then, we describe quality assessment in terms of tracking interconnected work activities holistically, across different levels of assessment. We conclude by inviting future efforts in quality improvement to adopt a comprehensive approach to quality assessment into their improvement practices, and offer recommendations for how the field might move in this direction.

Homeless, Ill, and Psychiatrically Complex: The Grueling Carousel of Cassandra Lee.

Ask any clinical ethics consultant, and they can tell you about their transformative cases. Some stick with us because all roads led nowhere. Cassandra Lee had a history of pulling out lines and tubes and a distaste of warming blankets. Her admission marked her thirtieth over the past year. Many of the challenges facing the hospital caring for her were not unique: significant psychiatric issues, prolonged nonadherence to medical advice, and end-of-life decision-making combined to create an ethically dense and vexing situation. Ms. Lee, like so many patients, was suffering because of system failures.

Challenges in the delivery of surgical care for head and neck cancer patients in the Hong Kong Special Administrative Region and China.

PURPOSE OF REVIEW: This article aims to explore the ethical dilemmas faced by head and neck surgeons in the Hong Kong Special Administrative Region (HKSAR) and China in the provision of safe, oncological sound and timely care for head and neck cancer patients. RECENT FINDINGS: There is no literature, in particular, in relation to the treatment of head and neck cancer patients and priority setting in head and neck surgery. However, through examining the healthcare provision and sociocultural backgrounds of the HKSAR and China, certain aspects, such as traditional Chinese medicine and medical guan xi (Seeking medical care for personal connections) have been shown to significantly influence the provision of care in China. Medical guan xi facilitates inequity and is problematic in developing a system based on justice, equity, nonmalfeasance and beneficence. In the HKSAR, resource limitations are related to the maldistribution of healthcare between the public and private sectors, resulting in significant time constraints for surgery and oncology care of patients. There is informal application of ethical frameworks for priority setting, however, these have neither been formally supported nor enforced from an administrative level that needs to be addressed. SUMMARY: In the HKSAR, there needs to be a strengthening of an ethical framework for priority setting to adhere to justice for our patients and healthcare providers in treating head and neck cancer patients. In China, priority setting is largely set by sociocultural practices that are endemic, in particular, medical guan xi that is inequitable and needs to be addressed to improve the doctor-patient relationship.

Spirituality in medical education: a concept analysis.

Spirituality in medical education is an abstract multifaceted concept, related to the healthcare system. As a significant dimension of health, the importance and promotion of this concept has received considerable attention all over the world. However, it is still an abstract concept and its use in different contexts leads to different perceptions, thereby causing challenges. In this regard, the study aimed to clarify the existing ambiguities of the concept of spirituality in medical education. Walker and Avant (Strategies for theory construction in nursing, Prentice Hall, Boston, 2011) concept analysis eight-step approach was used. After an extensive review of online national and international databases from 2000 to 2015, 180 articles and 3 books in English and Persian were retrieved for the purposes of the study. Analysis revealed that the defining attributes of spirituality in medical education are: teaching with all heart and soul, Life inspiring, ontological multidimensional connectedness, religious-secular spectrum, and socio-cultural intricacies. Moreover, innate wisdom, skillful treatment, transcendent education, and environmental requirements were antecedents to this concept, with the health of body and soul, intrapersonal development and elevation, and responsive treatment and education being its consequences. The defining attributes provided in this study can assist physicians, instructors, and professors to develop and implement evidence-based, health based and comprehensive education plans according to the guidelines of professional ethics and qualification of using spirituality in practice. The clarification of the noted concept facilitates further development of medical knowledge, research, and research instruments.

Health Professionals Perceived Concerns and Challenges in Providing Palliative and End-of-Life Care: A Qualitative Analysis.

BACKGROUND:: The Institute of Medicine identifies that quality palliative/end-of-life (EOL) care should be provided to patients with serious, life-limiting illnesses and their families by competently prepared health professionals. PURPOSE:: This study assessed perceived concerns of health professionals pertaining to the delivery of palliative/EOL care in the hospital setting. The specific aim was to determine thematic concerns in the delivery of palliative/EOL care which emerged from respondents' impressions of a memorable palliative/EOL patient experience. METHODS:: Interdisciplinary health professionals at a large academic health system in the Midwest were surveyed to reflect upon a memorable palliative/EOL life care patient situation (positive or negative). A Thematic Analysis approach was used to code qualitative responses to 4 open-ended questions and then extract themes and subthemes from the coded data. RESULTS:: Concerns identified by participants (N = 425) emerged around 7 themes including communication (97%), decision-making/care planning (75%), education needs (60%), EOL care (48%), ethics (24%), satisfaction with care (9%), and spiritual/cultural sensitivity (6%). CONCLUSION:: Challenges exist in the delivery of quality palliative/EOL care in the hospital setting which may be addressed through educational initiatives that focus on recognition of cultural influences on care preferences, improving communication between patients/families and providers, education about the differences between palliative and EOL care, and increased competency of health providers in having EOL/goals-of-care discussions. Health professionals must recognize the benefit of collaborative palliative care in order to meet patient and family needs holistically and comprehensively.

La bioética global: un puente dialógico-reflexivo entre la medicina convencional y la medicina integrativa / Global bioethics: a dialogic-reflexive bridge between conventional medicine and integrative medicine

El presente ensayo tiene como objetivo plantear una reflexión entre la Medicina Tradicional y Complementaria y la Medicina convencional mediada por la Bioética Global, en la cual el paciente, su salud y el restablecimiento será el eje central; dicha deliberación facilitará un diálogo entre ambas corrientes, porque aún no se ha dado un acuerdo visible, más allá de la polarización y defensa unilateral de cada una de ellas por parte de sus defensores y detractores

A relação subjetiva do cuidado: uma aproximação entre medicina e a psicanálise / The subjective relationship of care: an approach between medicine and psychoanalysis

O presente artigo trata da relação subjetiva entre o profissional da saúde e o paciente, no que se refere ao cuidado médico. A partir da visão do médico clínico Antonio Carlos Lopes, são analisadas as confluências e divergências desta relação entre a Medicina e a Psicanálise. (AU)

This article deals with the subjective relationship between the health professional and the patient regarding health care. From the perspective of the physician-clinician Antonio Carlos Lopes, the confluences and divergences of this relationship between medicine and psychoanalysis are analyzed. (AU)

What Should Physicians and Chaplains Do When a Patient Believes God Wants Him to Suffer?

When physicians encounter a patient who gives religious reasons for wanting to suffer, physicians should maintain their commitment to the patient's health while making room for religiously informed understandings of suffering and respecting the patient's authority to refuse medically indicated interventions. Respecting the patient can include challenging the patient's reasoning, and physicians can decline to participate in interventions that they believe contradict their professional commitments. Chaplains likewise should both support and possibly respectfully challenge a patient in instances that involve desire to suffer for religious reasons, and physicians should draw on chaplains' expertise in these situations to attend to the patient's spiritual concerns. Finally, conversations involving spiritual and existential suffering might include members of the patient's religious community when the patient is open to this option.

Why Are There So Few Ethics Consults in Children's Hospitals?

In most children's hospitals, there are very few ethics consultations, even though there are many ethically complex cases. We hypothesize that the reason for this may be that hospitals develop different mechanisms to address ethical issues and that many of these mechanisms are closer in spirit to the goals of the pioneers of clinical ethics than is the mechanism of a formal ethics consultation. To show how this is true, we first review the history of collaboration between philosophers and physicians about clinical dilemmas. Then, as a case-study, we describe the different venues that have developed at one children's hospital to address ethical issues. At our hospital, there are nine different venues in which ethical issues are regularly and explicitly addressed. They are (1) ethics committee meetings, (2) Nursing Ethics Forum, (3) ethics Brown Bag workshops, (4) PICU ethics rounds, (5) Grand Rounds, (6) NICU Comprehensive Care Rounds, (7) Palliative Care Team (PaCT) case conferences, (8) multidisciplinary consults in Fetal Health Center, and (9) ethics consultations. In our hospital, ethics consults account for only a tiny percentage of ethics discussions. We suspect that most hospitals have multiple and varied venues for ethics discussions. We hope this case study will stimulate research in other hospitals analyzing the various ways in which ethicists and ethics committees can build an ethical environment in hospitals. Such research might suggest that ethicists need to develop a different set of "core competencies" than the ones that are needed to do ethics consultations. Instead, they should focus on their skills in creating multiple "moral spaces" in which regular and ongoing discussion of ethical issues would take place. A successful ethicist would empower everyone in the hospital to speak up about the values that they believe are central to respectful, collaborative practice and patient care. Such a role is closer to what the first hospital philosophers set out to do than in the role of the typical hospital ethics consultant today.

Facilitating awareness of philosophy of science, ethics and communication through manual skills training in undergraduate education.

BACKGROUND: Professional health science education includes a common theoretical basis concerning the theory of science, ethics and communication. Former evaluations by first-year students of the bachelor physiotherapy program at Oslo and Akershus University College of Applied Sciences (HiOA) show that they find it hard to understand the relation between these particular topics and future professional practice. This challenge is the starting point for a pedagogical development project that aims to develop learning contexts that highlight the relevance of these theoretical concepts. AIM: The aim of the study is to explore and present findings on the value of using Sykegrep manual skills classes as an arena in which students can be encouraged to think about, reflect on and appreciate the role and value of the philosophical perspectives that inform their practice and contributes to practise knowledge. METHOD: A qualitative study with data collection through focus groups was performed and analyzed using thematic content analysis. Eighteen first-year undergraduate students, who had completed the manual skills course, participated in the study. FINDINGS: Analysis of the data yielded three categories of findings that can be associated with aspects of philosophy of science, ethics and communication. These are as follows: 1) preconceived understanding of physiotherapy; 2) body knowledge perspectives; and 3) relational aspects of interactions. Undergraduate students' understanding and experience of philosophy of science, ethics and communication may be facilitated by peer collaboration, reflection on intimacy and touch and the ethical aspects of interaction during manual skills training. CONCLUSION: Practical classes in Sykegrep provide a basis for students' discussions about the body as well as their experiences with the body in the collaborative learning context. The students' reflections on their expectations of manual skills in physiotherapy and experiences of touch and being touched can facilitate an awareness of philosophy of science, ethics and communication. IMPLICATIONS: Our study will be an incitement to further develop a manual skills teaching program that incorporates philosophy of science, ethics and communication in undergraduate education.

Islamic perspectives on clinical intervention near the end-of-life: We can but must we?

The ever-increasing technological advances of modern medicine have increased physicians' capacity to carry out a wide array of clinical interventions near the end-of-life. These new procedures have resulted in new "types" of living where a patient's cognitive functions are severely diminished although many physiological functions remain active. In this biomedical context, patients, surrogate decision-makers, and clinicians all struggle with decisions about what clinical interventions to pursue and when therapeutic intent should be replaced with palliative goals of care. For some patients and clinicians, religious teachings about the duty to seek medical care and the care of the dying offer ethical guidance when faced with such choices. Accordingly, this paper argues that traditional Sunni Islamic ethico-legal views on the obligation to seek medical care and Islamic theological concepts of human dignity (karamah) and inviolability (hurmah) provide the ethical grounds for non-intervention at the end-of-life and can help calibrate goals of care discussions for Muslim patients. In closing the paper highlights the pressing need to develop a holistic ethics of healthcare of the dying from an Islamic perspective that brings together multiple genres of the Islamic intellectual tradition so that it can meet the needs of the patients, clinicians and Muslim religious leaders interacting with the healthcare system.

WHY CLINICAL ETHICS? EXPERIENCE, DISCERNMENT AND THE ANAMNESIS OF MEANING AT THE BEDSIDE / ¿POR QUÉ LA ÉTICA CLÍNICA? LA EXPERIENCIA, EL DISCERNIMIENTO Y LA ANAMNESIS DEL SIGNIFICADO AL LADO DEL PACIENTE / POR QUE A ÉTICA CLÍNICA? A EXPERIÊNCIA, O DISCERNIMENTO E A ANAMNESE DO SIGNIFICADO AO LADO DO PACIENTE

The article asks about the function of clinical ethics. It does so by confronting the assumption that ethics is supposed to help in the solution of concrete problems, relying upon a defined set of principles and rules. The scientific character of such an approach to clinical ethics complements the very understanding of modern medicine as being increasingly scientific and technical; that is, as oriented toward the production of effects. The paper claims that, rather than sharing in the "suspension of meaning" pursued by medicine for the sake of scientific objectivity, the main task of clinical ethics consists of a retrieval, or "anamnesis," of the very questions medicine seems to suspend: the significance of illness and disease, of birth, suffering and death, and of the service to the ethos of generosity that sustains the healing professions. Also, the paper offers a cultural "etiology" of "the suspension of meaning" in ethics, and pleads for a moral reflection that begins with a free and open confrontation with clinical experience. Attending to the moral meaning of concrete situations, the paper argues that formal modes of logical argumentation are only derivative functions of the moral language and, thus, cannot exhaust the broad spectrum of ethical discourse in medicine.

El artículo pregunta acerca de la función de la ética clínica; lo hace mediante la confrontación del supuesto de que la ética debe ayudar a la solución de problemas concretos, a partir de una serie de principios y normas. El carácter científico de este tipo de enfoque de la ética clínica complementa la comprensión misma de la medicina moderna como un campo cada vez más científico y técnico; como orientado hacia la producción de efectos. En el artículo se afirma que, en lugar de compartir en la "suspensión de sentido", perseguido por la medicina en aras de la objetividad científica, la principal tarea de la ética clínica consiste en un sistema de recuperación, o "anamnesis", de las mismas preguntas que la medicina parece suspender: la importancia de la enfermedad y la patología, de nacimiento, el sufrimiento y la muerte, y del servicio al espíritu de generosidad que sustenta las profesiones de la salud. Además, el articulo ofrece una "etiología" cultural de "la suspensión de sentido" en la ética, y aboga por una reflexión moral que comienza con una confrontación libre y abierta con la experiencia clínica. Atendiendo el sentido moral de situaciones concretas, el artículo sostiene que los modos formales de argumentación lógica solo son funciones derivadas del lenguaje moral, y, por lo tanto, no pueden agotar el amplio espectro de discurso ético en la medicina.

Este artigo questiona acerca da função da ética clínica. Para isso, realiza uma confrontação do suposto de que a ética deve ajudar na solução de problemas concretos, baseada numa série definida de princípios e normas. O caráter científico desse tipo de enfoque da ética clínica complementa a compreensão em si da medicina moderna como um campo cada vez mais científico e técnico, isto é, orientado à produção de efeitos. Neste artigo, afirma-se que, em lugar de compartilhar na "suspensão de sentido" perseguido pela medicina em prol da objetividade científica, a principal tarefa da ética clínica consiste num sistema de recuperação ou anameses das mesmas perguntas que a medicina parece suspender: a importância da doença e da patologia, do nascimento, do sofrimento e da morte, e do serviço ao espírito de generosidade que sustenta as profissões da saúde. Além disso, o artigo oferece uma etiologia cultural da "suspensão de sentido" na ética e argumenta sobre uma reflexão moral que começa com uma confrontação livre e aberta com a experiência clínica. Atendendo ao sentido moral de situações concretas, o artigo sustenta que os modos formais de argumentação lógica somente são funções derivadas da linguagem moral e, portanto, não podem esgotar o amplo espectro de discurso ético na medicina.

Can the EVIDEM Framework Tackle Issues Raised by Evaluating Treatments for Rare Diseases: Analysis of Issues and Policies, and Context-Specific Adaptation.

BACKGROUND: The multiplicity of issues, including uncertainty and ethical dilemmas, and policies involved in appraising interventions for rare diseases suggests that multicriteria decision analysis (MCDA) based on a holistic definition of value is uniquely suited for this purpose. The objective of this study was to analyze and further develop a comprehensive MCDA framework (EVIDEM) to address rare disease issues and policies, while maintaining its applicability across disease areas. METHODS: Specific issues and policies for rare diseases were identified through literature review. Ethical and methodological foundations of the EVIDEM framework v3.0 were systematically analyzed from the perspective of these issues, and policies and modifications of the framework were performed accordingly to ensure their integration. RESULTS: Analysis showed that the framework integrates ethical dilemmas and issues inherent to appraising interventions for rare diseases but required further integration of specific aspects. Modification thus included the addition of subcriteria to further differentiate disease severity, disease-specific treatment outcomes, and economic consequences of interventions for rare diseases. Scoring scales were further developed to include negative scales for all comparative criteria. A methodology was established to incorporate context-specific population priorities and policies, such as those for rare diseases, into the quantitative part of the framework. This design allows making more explicit trade-offs between competing ethical positions of fairness (prioritization of those who are worst off), the goal of benefiting as many people as possible, the imperative to help, and wise use of knowledge and resources. It also allows addressing variability in institutional policies regarding prioritization of specific disease areas, in addition to existing uncertainty analysis available from EVIDEM. CONCLUSION: The adapted framework measures value in its widest sense, while being responsive to rare disease issues and policies. It provides an operationalizable platform to integrate values, competing ethical dilemmas, and uncertainty in appraising healthcare interventions.