Descripción de la experiencia de un servicio de consultoría en ética clínica en el período 2019-2021 / Description of the experience of a clinical ethics consultation service from 2019-2021

Introducción La consultoría en ética clínica (CEC) es un modelo útil de asesoría ética, pero con escasa implantación en Europa. En el presente artículo se comparte la experiencia de uno de los primeros servicios de consultoría ética en España. Material y métodos Estudio observacional retrospectivo de todas las consultas recibidas por el servicio de CEC del Hospital Universitario de La Princesa (Madrid, España) entre el 1 de septiembre de 2019 y el 31 de agosto de 2021. Se analizaron variables demográficas, logísticas y éticas de los casos. Resultados Se analizaron 63 casos, en los que se identificaron un total de 124 conflictos éticos. El 41% (n=26) de las consultas eran de carácter urgente y el 38% (n=24), preferentes. La evaluación inicial se realizó en menos de 24horas en 50 casos (79%). El servicio que consultó con mayor frecuencia fue Medicina Intensiva (9; 14%). Los medios de contacto preferidos fueron el busca (36; 57%), el sistema electrónico de historia clínica (13; 21%) o la conversación directa con el equipo consultor (7; 11%). Los problemas éticos más comunes estaban relacionados con la adecuación de medidas terapéuticas (24; 19%), el rechazo del tratamiento (19; 15%), la comunicación con el paciente o su familia (29; 23%) o la competencia del paciente (13; 11%). Conclusiones Los servicios de CEC proporcionan una asistencia rápida y eficiente para la resolución de problemas éticos en la práctica habitual. Su implementación en España es factible (AU)

Introduction Clinical ethics consultation services (CEC) are useful model for ethical counselling, albeit with scarce implementation in European countries. This article shares the experience of one of the first ethics consultation services in Spain. Materials and methods This work is a retrospective, observational study of all consultations received by the CEC service at La Princesa University Hospital (Madrid, Spain) from September 1, 2019 to August 31, 2021. The demographic, logistic, and ethical variables of the cases were analyzed. Results A total of 63 cases were analyzed in which a total of 124 ethical conflicts were identified. Forty-one percent of the cases (n=26) were emergency consultations and 38% (n=24) were preferential inquiries. An initial evaluation was performed with 24hours in 50 cases (79%). The department that consulted most often was the Intensive Care Unit (9; 14%). The preferred contact methods were via pager (36; 57%), the electronic medical record system (13; 21%), or direct conversations with consulting team (7; 11%). The most common ethical conflicts were those related to the adequacy of treatment measures (24; 19%), refusal of treatment (19; 15%), communication with the patient or his/her family (29; 23%), or the patient's capacity (13; 11%). Conclusion CEC services provide quick, efficient assistance for resolving ethical problems in daily practice. Their implementation in Spain is feasible (AU)

"Tirando o jaleco": notas etnográficas sobre as práticas obstétricas em um hospital de ensino / "Taking off the lab coat": ethnographic notes on obstetric practices in a university hospital

Resumo O estudo teve como objetivo descrever e analisar aspectos do cotidiano da assistência ao parto em um hospital universitário no Sul do Brasil. A expressão "tirando o jaleco" serve como uma metáfora para iluminar o processo de conversão da enfermeira obstetra em pesquisadora em um ambiente hospitalar. Trata-se de uma de pesquisa qualitativa que lançou mão da perspectiva socioantropológica como referencial teórico e metodológico. Os resultados mostraram uma recorrente ausência de informações sobre condutas e decisões médicas dadas as mulheres, desconsiderando-as como sujeitos de direitos, a despeito do que preconiza a política de humanização do parto, revelando nuances do parto e do nascimento pautadas no modelo tecnocrático de assistência. Esse modelo de assistência vigente nos hospitais de ensino requer importantes mudanças através da incorporação de práticas com fundamentos científicos, da inclusão de enfermeiras obstetras e do respeito à mulher como protagonista deste evento.

Abstract The study aimed to describe and analyze everyday aspects of childbirth care in a university hospital in southern Brazil. The expression "taking off the coat" serves as a metaphor to illuminate the process of converting the obstetrician nurse into a researcher in a hospital environment. This is a qualitative research work that made use of the perspective socio-anthropology as a theoretical and methodological framework. The results showed a recurrent lack of information about medical conduct and decisions given to women, disregarding them as subjects of rights, despite what the policy of humanization of childbirth, revealing nuances of childbirth and birth based on the model assistance technocracy. This current care model in teaching hospitals requires important changes through the incorporation of practices with scientific foundations, the inclusion of obstetric nurses and respect for women as the protagonists of this event.

Sharing ICU Patient Data Responsibly Under the Society of Critical Care Medicine/European Society of Intensive Care Medicine Joint Data Science Collaboration: The Amsterdam University Medical Centers Database (AmsterdamUMCdb) Example.

OBJECTIVES: Critical care medicine is a natural environment for machine learning approaches to improve outcomes for critically ill patients as admissions to ICUs generate vast amounts of data. However, technical, legal, ethical, and privacy concerns have so far limited the critical care medicine community from making these data readily available. The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have identified ICU patient data sharing as one of the priorities under their Joint Data Science Collaboration. To encourage ICUs worldwide to share their patient data responsibly, we now describe the development and release of Amsterdam University Medical Centers Database (AmsterdamUMCdb), the first freely available critical care database in full compliance with privacy laws from both the United States and Europe, as an example of the feasibility of sharing complex critical care data. SETTING: University hospital ICU. SUBJECTS: Data from ICU patients admitted between 2003 and 2016. INTERVENTIONS: We used a risk-based deidentification strategy to maintain data utility while preserving privacy. In addition, we implemented contractual and governance processes, and a communication strategy. Patient organizations, supporting hospitals, and experts on ethics and privacy audited these processes and the database. MEASUREMENTS AND MAIN RESULTS: AmsterdamUMCdb contains approximately 1 billion clinical data points from 23,106 admissions of 20,109 patients. The privacy audit concluded that reidentification is not reasonably likely, and AmsterdamUMCdb can therefore be considered as anonymous information, both in the context of the U.S. Health Insurance Portability and Accountability Act and the European General Data Protection Regulation. The ethics audit concluded that responsible data sharing imposes minimal burden, whereas the potential benefit is tremendous. CONCLUSIONS: Technical, legal, ethical, and privacy challenges related to responsible data sharing can be addressed using a multidisciplinary approach. A risk-based deidentification strategy, that complies with both U.S. and European privacy regulations, should be the preferred approach to releasing ICU patient data. This supports the shared Society of Critical Care Medicine and European Society of Intensive Care Medicine vision to improve critical care outcomes through scientific inquiry of vast and combined ICU datasets.

Medical students' reflections on surgical educators' professionalism: Contextual nuances in the hidden curriculum.

INTRODUCTION: Surgical educators' professional behavior constitutes a hidden curriculum and impacts trainee's professional identity formation. This study explores the nuances of professional behaviors as observed in varying surgical settings. METHODS: 411 Transcripts originated from essays written by MS3 students during their surgical clerkship from 2010 to 2016 were collated. Employing a qualitative research methodology, we conducted a thematic analysis to uncover specific meaning emerging from medical student reflections' on surgical professionalism. RESULTS: In clinics, taking time and protecting patient privacy; in the OR, control over emotion during difficult situations and attention to learners; and in the inpatient setting, showing accountability above normal expected behavior were noted as professional. Similarly, unprofessional behaviors in these contexts paralleled lack of these attributes. CONCLUSIONS: Behaviors observed and the attributes of professionalism in the surgical learning environment have contextual nuances. These variations in professionalism can be utilized in deliberate development of professionalism in surgery.

Ghent University Hospital's protocol regarding the procedure concerning euthanasia and psychological suffering.

BACKGROUND: Notwithstanding fears of overly permissive approaches and related pleas to refuse euthanasia for psychological suffering, some Belgian hospitals have declared that such requests could be admissible. However, some of these hospitals have decided that such requests have to be managed and carried out outside their walls. MAIN TEXT: Ghent University Hospital has developed a written policy regarding requests for euthanasia for psychological suffering coming from patients from outside the hospital. The protocol stipulates several due care criteria that go beyond the requirements of the Belgian Euthanasia Law. For instance, the legally required first and second consulted physicians should all be psychiatrists and be affiliated with a psychiatry department of a Flemish university hospital. Moreover, euthanasia for psychological suffering can only be performed if the advices of these consulted physicians are positive. Importantly, preliminary reflection by the multidisciplinary Hospital Ethics Committee was introduced to discuss every request for euthanasia for psychological suffering coming from outside the hospital. CONCLUSION: In this way, the protocol supports psychiatrists faced with the complexities of assessing such requests, improves the quality of euthanasia practice by ensuring transparency and uniformity, and offers patients specialised support and guidance during their euthanasia procedure. Nevertheless, some concerns still remain (e.g. relating to possible unrealistic patient expectations and to the absence of aftercare for the bereaved or for patients whose requests have been refused).

Healthcare Data Analysis and Return of Investment for Patient Care: Challenges for a University Hospital / Análisis de datos sanitarios y retorno de la inversión para el cuidado de los pacientes: los retos para un hospital universitario / Anàlisi de dades sanitàries i retorn de la inversió per la cura dels pacients: els reptes per un hospital universitari

Ethical and scientific reasons sustain concerns when applying Big Data analytics in Healthcare. Patient’s data must be anonymized and must have enough quality. But the extreme variety of data and their multiple sources combined with many different stakeholders registering data in the Electronic Patient Record without a semantic standardization makes the process harder than in other business. Majority of patient’s data are in natural text or are only communicated verbally without a formal registration. To take a real benefit of the Healthcare data we must ensure their quality, high integrity, explicit meaning, context recording and complete anonymization. Three technologies must be of great help: Standardization for Semantic interoperability, Knowledge representation using Ontologies and advanced Natural Language Processing. Ethical conscience regarding confidentiality and ecological impact of ICTs must be empowered and practiced by individuals and organizations

La aplicación de la analítica de datos masivos en salud levanta preocupaciones éticas y científicas. Los datos de los pacientes deben ser anónimos y de calidad. Pero la gran variedad de datos, sus múltiples fuentes y los diferentes actores que registran datos en la historia clínica del paciente sin un estándar semántico, dificulta más el proceso que en otras áreas. La mayoría de los datos de los pacientes se dan en texto natural o se comunican sólo verbalmente, sin registro formal. Para beneficiarnos efectivamente de los datos de salud tenemos que asegurar su calidad, integridad, contenido explícito, contexto de registro y su completo anonimato. Existen tres tecnologías que pueden ser de gran ayuda: estandarización para la interoperabilidad semántica, representación del conocimiento usando ontologías y el procesamiento avanzado de lenguaje natural. La conciencia ética sobre la confidencialidad y el impacto ecológico de las tecnologías de información y comunicación (TIC) deben ser practicadas y potenciadas por los individuos y las organizaciones

L’aplicació de l’analítica de dades massives en salut aixeca preocupacions ètiques i científiques. Les dades dels pacients han de ser anònimes i de qualitat. Però la gran varietat de dades, les seves múltiples fonts i els diferents actors que enregistren dades en la història clínica del pacient sense un estàndard semàntic en dificulta el procés. La major part de les dades dels pacients es donen en text natural o es comuniquen només verbalment, sense cap registre formal. Per beneficiar-nos efectivament de les dades de salut hem d'assegurar la seva qualitat, integritat, contingut explícit, context de registre i anonimat. Existeixen tres tecnologies que poden ser de gran ajuda: estandardització per a la interoperabilitat semàntica, representació del coneixement usant ontologies i el processament avançat de llenguatge natural. La consciència ètica sobre la confidencialitat i l’impacte ecològic de les tecnologies d'informació i comunicació (TIC) han de ser practicats i potenciats tant pels individus com per les organitzacions

Visión integradora del pase de visita médico asistencial y docente en hospitales universitarios de Ecuador / Integrated vision of the clinical and educational round at Ecuador university hospitals

Introducción: El pase de visita docente asistencial en las instituciones docentes hospitalarias es complejo y hay que vencer diferentes objetivos en una misma actividad. Objetivo: Proponer un diseño a partir de concepciones pedagógicas actuales del pase de visita médico asistencial y docente en hospitales universitarios ecuatorianos. Material y Métodos: Se realizó una revisión de la bibliografía relacionada con los procesos pedagógicos de la educación en el trabajo en la formación médica. Se utilizaron los buscadores PubMed, Cochrane Library y Google académico, para identificar, seleccionar, estructurar y dar una visión sistémica del pase de visita médico docente-asistencial, proponiendo bases estructurales y metodológicas, partiendo de la experiencia cubana y directivas académicas propias de Ecuador. Desarrollo: El pase de visita docente- asistencial como forma de educación en el trabajo para obtener la excelencia debe de ser más integrador donde no solo se utilice el método clínico, sino el clínico y epidemiológico, y donde estén integrados objetivos gerenciales, se utilicen métodos pedagógicos constructivistas, concepciones del entorno salud-enfermedad del tipo holísticos, a través de estrategias de participación heurísticas. Conclusiones: La utilización de un modelo de actuación con fundamentos científicos, adecuadamente estructurado y basado en transformaciones pedagógicas cualitativas que se interrelacionen con los procesos asistenciales, gerenciales y donde el paciente sea evaluado integralmente, ofrece un enfoque más sistemático de esta actividad(AU)

Introduction: The educational and assistance round in the educational-hospital institutions is complex and it is necessary to overcome different goals in the same activity. Objective: To provide a design from current pedagogical conceptions of educational-medical rounds at Ecuadorian university hospitals. Material and Methods: It carried out review of the related bibliography with the pedagogic processes of education in the work of medical formation. Were used the searchers PubMed, Cochrane Library and Google scholar to know, select, built, analyze and give a systematic view of the educational and assistance round in Ecuador, proposing structural and methodological bases, starting from the Cubans experience and the own Ecuadorian academic directives. Development: Educational-medical rounds as educational method of labor to obtain excellence must be more inclusive not using only the clinical method, but also clinical and epidemiological method shall be included and where integrated management objectives must be joined, using pedagogical constructional methods, holistic health-disease environment through heuristic participation strategies.Conclusion: The use of a proceeding model on a scientific basis properly structured and based on qualitative educational transformations that interrelate with medical caretaking and management issues where patients are evaluated integrally, provides a systemic approach process to this activity(AU)

Evaluation of the work of hospital districts' research ethics committees in Finland.

The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area.

Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital.

BACKGROUND: Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis. RESULTS: Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01). CONCLUSIONS: The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC's ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials.

Clinical ethics and patient advocacy: the power of communication in health care.

In recent years, the rights of patients have assumed a more pivotal role in international discussion. Stricter laws on the protection of patients place greater priority on the perspective and the status of patients. The purpose of this study is to emphasize ethical aspects in communication, the role of patient advocates as contacts for the concerns and suggestions of patients, and how many problems of ethics disappear when communication is highlighted. We reviewed 680 documented cases of consultation in a 10-year period of patient advocates' activity at a big German university hospital with 1,300 beds. On the basis of this extensive material, the article will focus on the intersection of the advocate's work with the problems of patients in hospitals. Deficits in the level of communication between health care professionals and patients were frequently uncovered. Patients primarily complain about the lack of dialogue and empathy. Middle-aged patients consulted the patients' advocate disproportionately more often. Measured against this baseline, the group of 65 and older complained less frequently. Besides complaints the advocate was asked in more than one-third of all cases for information about medical matters, hospital regulations or administrative problems. Patients obviously see the advocate as a well-connected and ideally unbiased contact person for uncertainties concerning their malady or a potential stay in hospital. Those seeking help often set hope in the information given by the voluntary patient representative. It should be highly recommended for every German hospital to establish the position of a patient advocate. Furthermore, patients can profit from regular exchange between the advocate and the Ethics Committee, also, to help ensure that their rights are taken into account and implemented in an ethically desirable context.