RESUMEN
BACKGROUND: U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention. PURPOSE: Our goal is to elaborate on the updated 2013 U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States. METHODS: Review of the 2011 and updated FDA guidance document on exemption from informed consent. RESULTS: The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document. LIMITATIONS: The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that-guidelines. Therefore, they may not be followed as outlined in the guidance document within one's own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU. CONCLUSIONS: We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill.
Asunto(s)
Cuidados Críticos/ética , Enfermedad Crítica , Tratamiento de Urgencia/ética , Consentimiento Informado/ética , Selección de Paciente/ética , Sujetos de Investigación , Humanos , Unidades de Cuidados Intensivos , Obligaciones Morales , Seguridad del Paciente , Guías de Práctica Clínica como Asunto , Reproducibilidad de los Resultados , Proyectos de Investigación , Consentimiento por Terceros/ética , Resultado del Tratamiento , Estados Unidos , United States Food and Drug AdministrationRESUMEN
BACKGROUND: The development and validation of automated electronic medical record (EMR) search strategies are important for establishing the timing of mechanical ventilation initiation in the intensive care unit (ICU).Thus, we sought to develop and validate an automated EMR search algorithm (strategy) for time zero, the moment of mechanical ventilation initiation in the critically ill patient. METHODS: The EMR search algorithm was developed on the basis of several mechanical ventilation parameters, with the final parameter being positive end-expiratory pressure (PEEP), and was applied to a comprehensive institutional EMR database. The search algorithm was derived from a secondary retrospective analysis of a subset of 450 patients from a cohort of 2,684 patients admitted to a medical ICU and a surgical ICU from January 1, 2010, through December 31, 2011. It was then validated in an independent subset of 450 patients from the same period. The overall percent of agreement between our search algorithm and a comprehensive manual medical record review in the derivation and validation subsets, using peak inspiratory pressure (PIP) as the reference standard, was compared to assess timing of mechanical ventilation initiation. RESULTS: In the derivation subset, the automated electronic search strategy achieved an 87% (κ = 0.87) perfect agreement, with 94% agreement to within one minute. In validating this search algorithm, perfect agreement was found in 92% (κ = 0.92) of patients, with 99% agreement occurring within one minute. CONCLUSIONS: The use of an electronic search strategy resulted in highly accurate extraction of mechanical ventilation initiation in the ICU. The search algorithm of mechanical ventilation initiation is highly efficient and reliable and can facilitate both clinical research and patient care management in a timely manner.
Asunto(s)
Algoritmos , Registros Electrónicos de Salud/normas , Unidades de Cuidados Intensivos/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Respiración Artificial/normas , Adulto , Estudios de Factibilidad , Humanos , Respiración Artificial/métodos , Estudios Retrospectivos , Factores de TiempoAsunto(s)
Crioprotectores/efectos adversos , Dimetilsulfóxido/efectos adversos , Mieloma Múltiple/terapia , Trasplante de Células Madre de Sangre Periférica/efectos adversos , Complejos Prematuros Ventriculares/inducido químicamente , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bloqueo Atrioventricular/complicaciones , Bortezomib/administración & dosificación , Crioprotectores/farmacocinética , Dexametasona/administración & dosificación , Dimetilsulfóxido/farmacocinética , Electrocardiografía , Humanos , Soluciones Isotónicas/efectos adversos , Lenalidomida , Masculino , Melfalán/administración & dosificación , Mieloma Múltiple/tratamiento farmacológico , Talidomida/administración & dosificación , Talidomida/análogos & derivados , Trasplante AutólogoAsunto(s)
Ceguera/diagnóstico , Síndrome de Leucoencefalopatía Posterior/diagnóstico , Complicaciones Posoperatorias/diagnóstico , Anestesia General/efectos adversos , Ceguera/etiología , Humanos , Masculino , Persona de Mediana Edad , Síndrome de Leucoencefalopatía Posterior/complicaciones , Complicaciones Posoperatorias/etiologíaRESUMEN
BACKGROUND: Despite a demanding work environment, information on stress and burnout of critical care fellows is limited. OBJECTIVES: To assess 1) levels of burnout, perceived stress, and quality of life in critical care fellows, and 2) the impact of a brief stress management training on these outcomes. METHODS: In a tertiary care academic medical center, 58 critical care fellows of varying subspecialties and training levels were surveyed to assess baseline levels of stress and burnout. Twenty-one of the 58 critical care fellows who were in the first year of training at the time of this initial survey participated in a pre-test and 1-year post-test to determine the effects of a brief, 90-min stress management intervention. RESULTS: Based on responses (n=58) to the abbreviated Maslach Burnout Inventory, reported burnout was significantly lower in Asian fellows (p=0.04) and substantially higher among graduating fellows (versus new and transitioning fellows) (p=0.02). Among the intervention cohort, burnout did not significantly improve--though two-thirds of fellows reported using the interventional techniques to deal with stressful situations. Fellows who participated in the intervention rated the effectiveness of the course as 4 (IQR=3.75-5) using the 5-point Likert scale. CONCLUSIONS: In comparison with the new and transitioning trainees, burnout was highest among graduating critical care fellows. Although no significant improvements were found in first-year fellows' burnout scores following the single, 90-min training intervention, participants felt the training did provide them with tools to apply during stressful situations.
Asunto(s)
Agotamiento Profesional/epidemiología , Cuidados Críticos/psicología , Internado y Residencia , Calidad de Vida , Centros Médicos Académicos , Adulto , Factores de Edad , Agotamiento Profesional/psicología , Agotamiento Profesional/terapia , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Satisfacción Personal , Grupos Raciales , Factores SexualesRESUMEN
STUDY OBJECTIVE: To review national data on anesthesiology critical care medicine (ACCM) fellowship program enrollment and to describe a program that successfully recruited ACCM fellows and faculty at a single academic medical center. DESIGN: An incentive program known as the Mayo Clinic Scholar program, designed to recruit ACCM fellows and faculty, was reviewed. Interviews were conducted to assess the impact of the Mayo Clinic Scholar program. SETTING: Academic health center. MEASUREMENTS: ACCM fellowship program enrollment data were compared with similar data for critical care medicine fellowship programs in internal medicine, pulmonary medicine, pediatrics, and surgery.The results of a program to recruit ACCM fellows and faculty were reviewed. MAIN RESULTS: Only 89 of 147 (60.5%) ACCM fellowship positions available nationally were filled during the 2010-2011 academic year, and only 89 of the 896 (9.9%) critical care medicine fellows anticipated to graduate in 2011 were in ACCM programs. The Mayo Clinic ACCM fellowship enrolled 28 fellows from January 1, 2000 through July 1, 2010 (range 0-6 per yr). Ten of the 28 (35.7%) were United States medical graduates (USMGs) and 6 of the 10 (60.0%) USMGs who were graduates of the Mayo Clinic residency were appointed as Mayo Clinic Scholars. All 6 Mayo Clinic Scholars were retained as ACCM faculty. Only two of the 6 (33.3%) Mayo Clinic Scholars would have completed ACCM training without a Mayo Clinic Scholar appointment. All recommend ACCM training to others and plan to continue to practice ACCM. CONCLUSIONS: The Mayo Clinic Scholar program effectively recruited ACCM fellows and faculty in a single institution. Incentive-based programs should be considered to support the involvement of anesthesiologists in perioperative medicine.