RESUMEN
The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. METHODS: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. RESULTS: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. CONCLUSIONS: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects.
RESUMEN
La pandemia COVID-19 ha representado un reto hasta ahora desconocido para nuestro sistema sanitario. Una parte significativa de la gestión de la crisis y adaptación durante este periodo ha correspondido a los mandos de enfermería. Este artículo muestra las dificultades y los éxitos de esta gestión, así como las oportunidades futuras que estos cambios pueden suponer para la profesión enfermera. Se realizó una encuesta telemática de 17 preguntas a las responsables de gestionar la adaptación de los servicios hospitalarios a la pandemia COVID-19, mediante la reestructuración de diferentes áreas: la comunicación interna con participación en la toma de decisiones, la formación para la seguridad de los pacientes, la dotación de materiales, la dotación y rotación de los profesionales y la actualización de los protocolos. Mediante el análisis de una encuesta realizada por responsables de enfermería de diversos hospitales públicos y mutuas laborales situados en Cataluña, hemos podido identificar las principales dificultades surgidas y las decisiones tomadas en un tiempo record para poder adaptar nuestros hospitales a la pandemia, preservando la seguridad del personal y dar una respuesta profesional y humana a nuestros pacientes. La crisis sanitaria vivida representa un incentivo para consolidar logros y proponer cambios que afiancen los aciertos, realizar autocrítica de los errores y devolver así a la sociedad, mediante cambios estructurales, aquello que hayamos aprendido. Defender este cambio supone impulsar perspectivas valientes en la redefinición de las enfermeras del futuro
The COVID-19 pandemic has represented a hitherto unknown challenge for our healthcare system. A significant part of management and adaptation during this period has been the responsibility of middle management nursing staff. This article shows the difficulties and successes of this management, in addition to the future opportunities that these changes, if they are known how to take advantage of, may represent for the nursing profession. An online survey was carried out with 17 questions to those responsible for managing the adaptation of various hospital services to the COVID-19 pandemic, through the internal communication redesign, the participation in the decision making process, the education for the patient's safety and the management of personnel, systems and materials. Through the analysis of a survey carried out by nursing managers from various public hospitals and labour mutual societies located in Catalonia, we have been able to identify the main difficulties encountered and the decisions taken in record time to be able to adapt our hospitals to the pandemic, preserving the safety of the staff and give a professional and humane response to our patients. The lived health crisis represents an incentive to consolidate achievements and propose changes that strengthen the successes, carry out self-criticism of mistakes and thus return to society, through structural changes, what we have learned. Defending this paradigm shift means promoting courageous perspectives in redefining the nurses of the future
