Clinical Ethics Committee in an Oncological Research Hospital: two-years Report.

RESEARCH QUESTION AND AIM: Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC's implementation, to increase knowledge about CEC's implementation strategy. RESEARCH DESIGN: We collected quantitative data related to number and characteristics of CEC activities carried out from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC's development and implementation process. PARTICIPANTS AND RESEARCH CONTEXT: The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. ETHICAL CONSIDERATIONS: The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. FINDINGS: In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC's impact on clinical practice. CONCLUSION: Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially.

CURA-An Ethics Support Instrument for Nurses in Palliative Care. Feasibility and First Perceived Outcomes.

Evaluating the feasibility and first perceived outcomes of a newly developed clinical ethics support instrument called CURA. This instrument is tailored to the needs of nurses that provide palliative care and is intended to foster both moral competences and moral resilience. This study is a descriptive cross-sectional evaluation study. Respondents consisted of nurses and nurse assistants (n = 97) following a continuing education program (course participants) and colleagues of these course participants (n = 124). Two questionnaires with five-point Likert scales were used. The feasibility questionnaire was given to all respondents, the perceived outcomes questionnaire only to the course participants. Data collection took place over a period of six months. Respondents were predominantly positive on most items of the feasibility questionnaire. The steps of CURA are clearly described (84% of course participants agreed or strongly agreed, 94% of colleagues) and easy to apply (78-87%). The perceived outcomes showed that CURA helped respondents to reflect on moral challenges (71% (strongly) agreed), in perspective taking (67%), with being aware of moral challenges (63%) and in dealing with moral distress (54%). Respondents did experience organizational barriers: only half of the respondents (strongly) agreed that they could easily find time for using CURA. CURA is a feasible instrument for nurses and nurse assistants providing palliative care. However, reported difficulties in organizing and making time for reflections with CURA indicate organizational preconditions ought to be met in order to implement CURA in daily practice. Furthermore, these results indicate that CURA helps to build moral competences and fosters moral resilience.

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)

Research, education, ethics consultation: evaluating a Bioethics Unit in an Oncological Research Hospital.

BACKGROUND: This study aims to quantitatively and qualitatively evaluate the activities of a Bioethics Unit (BU) 5 years since its implementation (2016-2020). The BU is a research unit providing empirical research on ethical issues related to clinical practice, clinical ethics consultation, and ethical education for health care professionals (HPS). METHODS: We performed an explanatory, sequential, mixed-method, observational study, using the subsequent qualitative data to explain the initial quantitative findings. Quantitative data were collected from an internal database and analyzed by descriptive analysis. Qualitative evaluation was performed by semi-structured interviews with 18 HPs who were differently involved in the BU's activities and analyzed by framework analysis. RESULTS: Quantitative results showed an extensive increment of the number of BU research projects over the years and the number of work collaborations with other units and wards. Qualitative findings revealed four main themes, concerning: 1. the reasons for contacting the BU and the type of collaboration; 2. the role of the bioethicist; 3. the impact of BU activities on HPs, in terms of developing deeper and more mature thinking; 4. the need to extend ethics support to other settings. Overall, our results showed that performing both empirical bioethics research and more traditional clinical ethics activities at the same unit would produce an impetus to increase collaboration and spread an 'ethical culture' among local HPs. CONCLUSIONS: Our findings contribute to a growing body of literature on the models of clinical ethics support services and the role of empirical research in bioethics internationally. They also prepare the ground for the implementation of a multidisciplinary Clinical Ethics Committee (CEC) that aims to support the BU's ethics consultation service within the local context.

What outcomes of moral case deliberations are perceived important for healthcare professionals to handle moral challenges? A national cross-sectional study in paediatric oncology.

BACKGROUND: In paediatric oncology, healthcare professionals face moral challenges. Clinical ethics support services, such as moral case deliberation (MCD), aim to assist them in dealing with these challenges. Yet, healthcare professionals can have different expectations and goals related to clinical ethics support services. METHODS: In this study, the perceptions held by healthcare professionals (nursing assistants, registered nurses, physicians, and others) regarding the importance of possible outcomes of MCDs, prior to implementation of MCDs, were investigated. A multisite, cross-sectional, quantitative study was performed at all six Paediatric Oncology Centres in Sweden. Healthcare professionals answered the Euro-MCD instrument with 26 potential MCD outcomes using a scale from Not important (1) to Very important (4). Descriptive and comparative statistical analyses were carried out. RESULTS: All outcomes were rated high, i.e., between 3.12 and 3.78. More open communication, developing skills to analyse ethically difficult situations, better mutual understanding, and deciding on concrete actions were rated as most important. Understanding of ethical theories and critical examination of policies were rated less important. Most often nursing assistants rated higher and physicians lower than the other professions did. Women and participants without previous experience of MCDs perceived outcomes as more important. There were differences between centres as one centre had significantly higher, and one centre had significantly lower ratings compared to the others. CONCLUSION: It is clear that healthcare professionals want MCDs to improve teamwork and skills in order to analyse and manage ethically difficult situations. When comparing to previous research about important MCD outcomes, there were similarities in what healthcare professionals consider to be important when handling moral challenges regardless of country and potential differences in healthcare settings and systems, such as paediatric vs. adult care.

Disposition Decisions in Cases of Medical Complexity and Health Inequity.

The question of optimal disposition for children with complex medical and social circumstances has long challenged the well-intentioned clinician. The coronavirus disease 2019 pandemic created unique difficulties for patients, families, and health care providers, in addition to highlighting long-standing racial and socioeconomic inequities in health care. In pediatric hospitals, necessary public health measures such as visitor restrictions shifted many shared decision-making processes such as discharge planning from complicated to impossible. Here, we present the case of a medically complex adult (with a long-standing pediatric condition) whose surrogate decision-maker objected to discharge to a long-term care facility because of restrictions and risks associated with the coronavirus disease 2019 pandemic. We offer the commentary of experts in clinical ethics, intensive care, inpatient subacute care, and palliative care. Our discussion includes analysis of the ethical considerations involved in the case, concrete guidance on steps toward an ethically permissible discharge, and suggestions for how a health equity lens can improve communication and decision-making for families who are victims of systemic racism and economic discrimination.

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.

CURA: A clinical ethics support instrument for caregivers in palliative care.

This article presents an ethics support instrument for healthcare professionals called CURA. It is designed with a focus on and together with nurses and nurse assistants in palliative care. First, we shortly go into the background and the development study of the instrument. Next, we describe the four steps CURA prescribes for ethical reflection: (1) Concentrate, (2) Unrush, (3) Reflect, and (4) Act. In order to demonstrate how CURA can structure a moral reflection among caregivers, we discuss how a case was discussed with CURA at a psychogeriatric ward of an elderly care home. Furthermore, we go into some considerations regarding the use of the instrument in clinical practice. Finally, we focus on the need for further research on the effectiveness and implementation of CURA.

Participatory development of CURA, a clinical ethics support instrument for palliative care.

BACKGROUND: Existing clinical ethics support (CES) instruments are considered useful. However, users report obstacles in using them in daily practice. Including end users and other stakeholders in developing CES instruments might help to overcome these limitations. This study describes the development process of a new ethics support instrument called CURA, a low-threshold four-step instrument focused on nurses and nurse assistants working in palliative care. METHOD: We used a participatory development design. We worked together with stakeholders in a Community of Practice throughout the study. Potential end users (nurses and nurse assistants in palliative care) used CURA in several pilots and provided us with feedback which we used to improve CURA. RESULTS: We distinguished three phases in the development process. Phase one, Identifying Needs, focused on identifying stakeholder and end user needs and preferences, learning from existing CES instruments, their development and evaluation, and identify gaps. Phase two, Development, focused on designing, developing, refining and tailoring the instrument on the basis of iterative co-creation. Phase three, Dissemination, focused on implementation and dissemination. The instrument, CURA, is a four-step low-threshold instrument that fosters ethical reflection. CONCLUSIONS: Participatory development is a valuable approach for developing clinical ethics support instruments. Collaborating with end users and other stakeholders in our development study has helped to meet the needs and preferences of end users, to come up with strategies to refine the instrument in order to enhance its feasibility, and to overcome reported limitations of existing clinical ethics instruments.

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.

Interconsultas urológicas a un Servicio de Ética Clínica en un hospital de IV nivel / Urological Interconsultations to a Clinical Ethics Service in a Level-IV Hospital

Objetivo Los problemas éticos tienen una gran importancia en discusiones teóricas en la medicina, y este estudio tiene como objetivo caracterizar a los pacientes urológicos cuyos casos fueron motivos de consulta al Servicio de Ética Clínica (SEC) institucional de un hospital de IV nivel para comprender los dilemas éticos prevalentes en la práctica diaria de la urología y su abordaje. Materiales y Métodos Estudio descriptivo en el que se realizó una revisión retrospectiva de las historias clínicas de 20 pacientes urológicos interconsultados al SEC de un hospital de IV nivel. Se evaluó la frecuencia de las siguientes variables: diagnóstico, estadio funcional y clínico en el momento del diagnóstico, tiempo de evolución, tratamientos, y tipo de dilema ético motivo de la interconsulta. Resultados Desde enero de 2018, el SEC del Hospital Universitario San Ignacio ha respondido 1.123 interconsultas, y se vio un aumento significativo de las mismas en 2020 por razón de la pandemia de enfermedad por coronavirus 2019 (coronavirus disease 2019, COVID-19, en inglés). De estas interconsultas, solamente trece corresponden a pacientes con patología urológica de base, y siete, a compromiso urológico secundario. El diagnóstico más frecuente fue carcinoma de próstata en estadio IV, seguido de carcinoma urotelial avanzado. Predominó el tratamiento adecuado; solamente tres se diagnosticaron en ese momento, y no alcanzaron a recibir tratamiento. El principal dilema ético encontrado tuvo que ver con proporcionalidad al final de la vida, en dos casos, con respeto de la autonomía del paciente, incluida una solicitud de eutanasia. Conclusión El tamizaje establecido y los tratamientos efectivos tempranos se podrían reflejar en la baja frecuencia de situaciones clínicas extremas conducentes a la toma de decisiones al final de la vida, que serían dirigidas, entonces, ya sea a la reorientación del esfuerzo terapéutico, al plan de fin de vida, o a eutanasia.

Objective Ethical issues are extremely relevant in theoretical discussions in medicine, through the present article we intend to characterize patients with urologic conditions whose cases prompted consultations with the Clinical Ethics Service (CES) at a level-IV hospital in order to understand the prevalent ethical dilemmas encountered in the urological practice and their approach. Materials and Methods A descriptive study in which we performed a retrospective review of the clinical history of 20 urologic patients who were the subject of interconsultations with the CES of a level-IV hospital. We evaluated the frequency of the following variables: diagnosis, functional and clinical status at the time of the diagnosis, duration of disease evolution, and the type of ethical dilemma that prompted an interconsultation. Results Since January 2018, the CES at Hospital Universitario San Ignacio has received 1,123 interconsultation requests, and a significant increase in them has been observed due to the coronavirus disease 2019 (COVID-19) pandemic. Out of these interconsultations, only thirteen corresponded to patients with a urological diagnosis, and seven involved secondary urological compromise. The most frequent diagnosis was stage-IV prostate cancer, followed by advanced urothelial carcinoma. Proper treatment prevailed; only three cases were diagnosed at this stage, and they could not receive treatment. The main ethical dilemma involved treatment proportionality, in two cases, regarding patient autonomy, including one euthanasia request. Conclusion The established screening methods and effective early treatments are could lead to a low frequency of extreme clinical situations in which decision have to be made at the en

Barreras y factores facilitadores para la accesibilidad a lainterrupción legal del embarazo (ILE) en el subsistema privado y de la seguridad social de Argentina: análisis dela situación institucional en el Hospital Italiano de Buenos Aires / Barriers and facilitating factors for accessibility to legal interruption of pregnancy in Argentina's public health and private subsystem: analysis of the institutional situation at Hospital Italiano de Buenos Aires

Hasta diciembre de 2020, en Argentina el aborto era legal ante determinadas causales. Sin embargo, era común que la implementación de esta legislación se viera entorpecida. El objetivo de esta investigación fue identificar las barreras y los factores facilitadores para la accesibilidad a la interrupción legal de embarazo en una institución del subsistema privado y de la seguridad social. Se realizó una investigación con enfoque cualitativo con entrevistas a profesionales del equipo de salud involucrados en el circuito de atención de interrupción legal de embarazo del Hospital Italiano de Buenos Aires. Los resultados se organizan en cinco ejes temáticos que surgieron luego de un proceso de lectura, interpretación y discusión:1) ausencia de una política institucional explícita, 2) los componentes de la práctica (falta de registro en la historia clínica electrónica, desarrollo de circuitos paralelos para acceder a la medicación: misoprostol), 3) el marco jurídico legal y las causales (falta de leyes claras, diversas interpretaciones en lo que respecta al causal salud), 4) la objeción de conciencia y 5) los aspectos contextuales (movimiento feminista, el proyecto de ley desaprobado en el senado en 2018). A pesar de que el equipo de salud contaba con un marco legal claro, implementar una política institucional interna resulta sumamente necesario. (AU)

Up until December 2020, abortion was legal in Argentina on certain grounds. However, it was common for the implementation of this legislation to be hindered. The purpose of this research was to identify the barriers and facilitating factors for the accessibility to legal abortion in both private and public health care institutions. A qualitative research was carried out with interviews with health professionals involved in the health team at Hospital Italiano de Buenos Aires legal interruption of pregnancy care circuit. The results are organized into five thematic axes that emerged after a process of reading, interpreting and discussing: 1) the absence of an explicit institutional policy, 2) the components of the practice (lack of registration in the electronic health records, development of parallel circuits to access medication: misoprostol), 3) the legal framework and grounds (lack of clear laws, different interpretations regarding health grounds), 4) conscientious objection, and 5) contextual aspects (feminist movement, the bill disapproved in the Senate in 2018). Even though the health teamhad a clear legal framework in place, implementing an internal institutional policy is extremely necessary. (AU)

Clinical ethics case consultation in a university department of cardiology and intensive care: a descriptive evaluation of consultation protocols.

BACKGROUND: Clinical ethics case consultations (CECCs) provide a structured approach in situations of ethical uncertainty or conflicts. There have been increasing calls in recent years to assess the quality of CECCs by means of empirical research. This study provides detailed data of a descriptive quantitative and qualitative evaluation of a CECC service in a department of cardiology and intensive care at a German university hospital. METHODS: Semi-structured document analysis of CECCs was conducted in the period of November 1, 2018, to May 31, 2020. All documents were analysed by two researchers independently. RESULTS: Twenty-four CECCs were requested within the study period, of which most (n = 22; 92%) had been initiated by physicians of the department. The patients were an average of 79 years old (R: 43-96), and 14 (58%) patients were female. The median length of stay prior to request was 12.5 days (R: 1-65 days). The most frequent diagnoses (several diagnoses possible) were cardiology-related (n = 29), followed by sepsis (n = 11) and cancer (n = 6). Twenty patients lacked decisional capacity. The main reason for a CECC request was uncertainty about the balancing of potential benefit and harm related to the medically indicated treatment (n = 18). Further reasons included differing views regarding the best individual treatment option between health professionals and patients (n = 3) or between different team members (n = 3). Consensus between participants could be reached in 18 (75%) consultations. The implementation of a disease specific treatment intervention was recommended in five cases. Palliative care and limitation of further disease specific interventions was recommended in 12 cases. CONCLUSIONS: To the best of our knowledge, this is the first in-depth evaluation of a CECC service set up for an academic department of cardiology and intensive medical care. Patient characteristics and the issues deliberated during CECC provide a starting point for the development and testing of more tailored clinical ethics support services and research on CECC outcomes.

Percepción de médicos intensivistas de adultos sobre el aporte de la consultoría ético-clínica / Opinion about clinical ethics consultation among intensivist physicians

Background: Clinical ethics consultation services and their methods vary and they are seldom evaluated. Only one formal system of individual clinical ethics consultation has been reported in Chile, with a ten-year registry. Aim: To evaluate the opinion of intensivist physicians about the contribution of clinical ethics consultation. Material and Methods: An anonymous and voluntary questionnaire consulting their opinion about clinical ethics consultations was sent to 38 intensivist physicians. Results: The questionnaire was answered by 28 professionals. Eighty four percent of respondents considered that ethics consultation contributed to improve patients' quality of care, 92% responded that this practice helps in decisions about limitation of treatments or life support, and 96% expressed that it also was a positive support for patients and their relatives. Seventy two percent of respondents considered that ethics consultations enhanced their ethical sensibility, 76% that they improved their understanding of clinical ethics topics, and 72% declared that it decreased their stress in complex decision-making. Conclusions: Clinical ethics consultation provides a positive support for improvements in clinical decision-making and in the quality of patients' care.

Tumores de tronco encefálico: reflexión moral sobre la conducta quirúrgica / Brainstem tumors: moral reflection on surgery management / Tumores do tronco encefálico: reflexão moral sobre conduta cirúrgica

Resumen Los tumores de tronco encefálico representan alrededor del 10% al 20% de los tumores del sistema nervioso central en niños. El glioma intrínseco difuso es el más frecuente (80% de los casos) de este grupo de tumores, que se caracterizan por la mala evolución y una sobrevida corta. El diagnóstico se puede hacer por resonancia magnética (con espectroscopía) o por biopsia estereotáxica, un método controvertido, que permite el estudio inmunohistoquímico y molecular del tumor. La reflexión moral se focaliza en la indicación de biopsia para pacientes vulnerables y con mal pronóstico. Se analiza la cirugía desde el punto de vista ético, con base en el mejor interés del niño y en la actitud altruista del paciente y su familia.

Abstract Brainstem tumors represent about 10% to 20% of central nervous system tumors in children. Diffuse intrinsic glioma is the most frequent (80% of cases) in this group of tumors, characterized by poor prognosis and short survival. Diagnosis can be made by magnetic resonance (with spectroscopy) or by stereotactic biopsy, a controversial method that allows immunohistochemical and molecular study of the tumor. Moral reflection focuses on the indication of biopsy for vulnerable patients with a poor prognosis. Surgery is analyzed from an ethical point of view based on the best interests of the child and altruistic attitude of patient and family.

Resumo Os tumores de tronco encefálico representam cerca de 10% a 20% dos tumores do sistema nervoso central em crianças. O glioma intrínseco difuso é o mais frequente (80% dos casos) desse grupo de tumores, caracterizados pela má evolução e por uma curta sobrevida. O diagnóstico pode ser feito por ressonância magnética (com espectroscopia) ou por biópsia estereotáxica, um método controverso, que permite o estudo imunohistoquímico e molecular do tumor. A reflexão moral se concentra na indicação de biópsia para pacientes vulneráveis e com mau prognóstico. A cirurgia é analisada do ponto de vista ético com base no melhor interesse da criança e na atitude altruísta do paciente e da família.

Editorial: Artificial Intelligence (AI) in Clinical Medicine and the 2020 CONSORT-AI Study Guidelines.

Artificial intelligence (AI) in clinical medicine includes physical robotics and devices and virtual AI and machine learning. Concerns have been raised regarding ethical issues for the use of AI in surgery, including guidance for surgical decisions, patient confidentiality, and the need for support from controlled clinical trials to use these methods so that clinical guidelines can be developed. The most common applications for virtual AI include disease diagnosis, health monitoring and digital patient consultations, clinical training, patient data management, drug development, and personalized medicine. In September 2020, the CONSORT-A1 extension was developed with 14 additional items that should be reported for AI studies that include clear descriptions of the AI intervention, skills required, study setting, inputs and outputs of the AI intervention, analysis of errors, and the human and AI interactions. This Editorial aims to present current applications and challenges of AI in clinical medicine and the importance of the new 2020 CONSORT-AI study guidelines.

Evaluation of moral intelligence of healthcare professionals via the "Survey for Measuring Moral Intelligence in the Provision of Healthcare Services" / Evaluación de la inteligencia moral de profesionales de la salud a través de la "Encuesta para medir la inteligencia moral en la prestación de servicios de salud" / Avaliação da inteligência moral de professionais de saúde via "Levantamento para Medir a Inteligência Moral na Provisão de Serviços de Cuidados à Saúde"

Abstract: Moral intelligence -through which an individual makes mental evaluation before taking action about a decision- is important in individual-centered healthcare. Using Lawshe Method, we designed the "Survey for Measuring Moral Intelligence in the Provision of Healthcare Services" with "equality", "empathy", "moral intelligence", "justice", "tolerance", "self-control", and "politeness" dimensions (α=.966). Age of the population (physicians and nurses) was 36.44±9.52, consisting 517 (65.5%) women, 538 married participants, 653 employed in public hospitals, and 352 had work experience of 8 hours/day. Using dimensions of this survey as skills is expected to ensure due diligence about rights and dignity in healthcare services.

Resumen: La inteligencia moral, mediante la cual un individuo realiza una evaluación mental antes de tomar medidas sobre una decisión, es importante en la atención médica centrada en el individuo. Usando el método Lawshe, diseñamos la "Encuesta para medir la inteligencia moral en la provisión de servicios de salud" con dimensiones de "igualdad", "empatía", "inteligencia moral", "justicia", "tolerancia", "autocontrol" y "cortesía" (α=.966). La edad de la población (médicos y enfermeras) era de 36.44±9.52, que consistía en 517 (65,5%) mujeres, 538 participantes casados, 653 empleados en hospitales públicos y 352 tenían una experiencia laboral de 8 horas/día. Se espera que el uso de las dimensiones de esta encuesta como habilidades garantice la debida diligencia sobre los derechos y la dignidad en los servicios de atención médica.

Resumo: Inteligência moral -através da qual um individuo faz uma avaliação mental antes de agir frente a uma decisão- é importante em cuidados à saúde centrados na pessoa. Usando o Método Lawshe, nós elaboramos o "Levantamento para Medir a Inteligência Moral na Provisão de Serviços de Cuidados à Saúde" com as dimensões "igualdade", "empatia", "inteligência moral", "justiça", "tolerância", "autocontrole" e "polidez (α=.966). A idade da população (médicos e enfermeiras) foi 36.44±9.52 anos, consistindo de 517 (65.5%) mulheres, 538 participantes casados, 653 empregados em hospitais públicos e 352 tinham experiência de trabalho 8 horas/dia. Usando dimensões deste levantamento como habilidades, espera-se que garanta a devida presteza sobre direitos e dignidade em serviços de cuidados à saúde.

Reflection on the enactment and impact of safety laws for regenerative medicine in Japan.

Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM's origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavors to regulate SCBIs.