Estrategia para fomentar la detección, manejo y reporte de eventos adversos en Ensayos Clínicos
Fecha
2014-06-25
Autores
García Alvarez, Neiby Bárbara
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Editor
Universidad Central "Marta Abreu" de Las Villas
Resumen
Los Ensayos Clínicos constituyen una oportunidad casi única para establecer la eficacia de un determinado producto, así como, la frecuencia y severidad con que se presentan los Eventos Adversos. Con el objetivo de caracterizar los elementos estructura y proceso en el sistema detección, manejo y reporte de eventos adversos en los ensayos clínicos, se realizó una investigación en Sistemas y Servicios de Salud con enfoque sistémico, de tipo observacional descriptivo, de corte transverso. El contexto espacial fue el Hospital Universitario “Dr. Celestino Hernández Robau” de Santa Clara, en el periodo de enero-mayo de 2014 utilizándose la planificación estratégica como guía metodológica. La muestra estuvo conformada por los investigadores clínicos y los ensayos monitorizados por el CENCEC. La caracterización evidenció una estructura medianamente adecuada al resultar parcialmente disponible la documentación y los recursos humanos, al ser parcialmente suficientes los recursos materiales y referir altas necesidades de conocimiento más del 64% de los profesionales; el proceso se consideró parcialmente adecuado al constatar que el procedimiento de la identificación de necesidades de aprendizaje fue medianamente adecuado, la calidad de las evoluciones médica no adecuadas, las evoluciones de enfermería adecuadas, la calidad de la notificación y los reportes medianamente adecuados. Para dar solución a esta problemática y teniendo en cuenta los resultados se elaboró una estrategia de intervención para fomentar la detección, manejo y reporte de los eventos adversos la cual fue valorada por los expertos de muy adecuada.
Clinical trials are an almost unique opportunity to establish the efficacy of a given product, as well as the frequency and severity of Adverse Events that occur. In order to characterize the structure and process elements in the detection, management and reporting of adverse events in clinical trials system, research in Health Systems and Services systemic approach, descriptive observational, transverse cut was made. The spatial context was the Hospital Universitario "Dr. Celestino Hernández Robau "Santa Clara, in the period January to May 2014 used strategic planning as a methodological guide. The sample consisted of clinical investigators and monitored by the CENCEC trials. The characterization showed a moderately adequate structure to be partially available documentation and human resources, to be partially sufficient material resources and refer high needs knowledge over 64% of professionals; the process is considered partially adequate finding that the process of identifying learning needs was fairly adequate, the quality of medical developments inadequate, the evolution of nursing adequate, quality of reporting and reporting moderately suitable. To solve this problem and the results considering an intervention strategy was developed to promote the detection, management and reporting of adverse events which was valued by experts very appropriate.
Clinical trials are an almost unique opportunity to establish the efficacy of a given product, as well as the frequency and severity of Adverse Events that occur. In order to characterize the structure and process elements in the detection, management and reporting of adverse events in clinical trials system, research in Health Systems and Services systemic approach, descriptive observational, transverse cut was made. The spatial context was the Hospital Universitario "Dr. Celestino Hernández Robau "Santa Clara, in the period January to May 2014 used strategic planning as a methodological guide. The sample consisted of clinical investigators and monitored by the CENCEC trials. The characterization showed a moderately adequate structure to be partially available documentation and human resources, to be partially sufficient material resources and refer high needs knowledge over 64% of professionals; the process is considered partially adequate finding that the process of identifying learning needs was fairly adequate, the quality of medical developments inadequate, the evolution of nursing adequate, quality of reporting and reporting moderately suitable. To solve this problem and the results considering an intervention strategy was developed to promote the detection, management and reporting of adverse events which was valued by experts very appropriate.
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Ensayos Clínicos como Asunto, Clinical Trials as Topic, Sistemas y Servicios de Salud, Hospital Universitario “Dr. Celestino Hernández Robau”, Santa Clara, Eventos Adversos., Buenas Prácticas de Laboratorio Clínico