Article information
Resumen
Introducción
El delírium es una alteración aguda de la conciencia y la cognición que ha empezado a manejarse con antipsicóticos atípicos (AA). Debido a que las facultades mentales, por definición, se ven afectadas, los estudios en esta población generan dilemas éticos respecto a la participación voluntaria de los pacientes y su estado de vulnerabilidad.
ObjetivoValorar si los estudios realizados con AA para el tratamiento del delírium obtuvieron una aprobación por un comité de ética en investigación en seres humanos (CEISH), si hubo aplicación de un consentimiento informado (CI), si este era verbal o escrito y quién dio la aprobación para la participación en el protocolo.
DiseñoRevisión sistemática en MedLine de los estudios de delírium que emplearon quetiapina y olanzapina y valoración de la existencia de aprobación por un CEISH y de la aplicación de un CI.
ResultadosSe detectaron 11 estudios (6 de quetiapina y 5 de olanzapina), de los cuales 5 contaron con la aprobación del protocolo por un CEISH.
ConclusionesLa mayoría de los estudios para el tratamiento del delírium no fueron sometidos a su aprobación por parte de un CEISH ni obtuvieron (de forma exclusiva) el CI de participación por parte del apoderado legal del paciente. Es fundamental que los futuros estudios de antipsicóticos y otros fármacos cuenten con la aprobación del protocolo por parte de un CEISH y de la firma del CI por parte del representante legal del paciente.
Palabras clave:
Delírium
quetiapina
olanzapina
consentimiento informado
comités de ética
Abstract
Introduction
Delirium is an acute alteration of consciousness and cognition. Atypical antipsychotics (AA) have recently become a main part of its treatment. Studies in this population generate a series of ethical dilemmas concerning the voluntary participation of patients and their state of vulnerability since their mental faculties are, by definition, compromised.
ObjectiveTo assess whether studies with AA for the treatment of delirium obtained an approval by an ethics committee on human research (ECHR), if an informed consent (IC) was obtained, whether the IC was verbal or written, and who gave the approval to participate.
MethodSystematic review of Medline for studies of delirium where quetiapine and olanzapine were the main treatment, assessing the existence of an ECHR approval and implementation of an IC.
Results11 studies were identified (6 of quetiapine and 5 of olanzapine). 5 had an ECHR approval.
ConclusionsMost studies examining the treatment of delirium with quetiapine or olanzapine were not subject to approval by an ECHR and most of them did not obtain an IC from the patient's legal guardian. It is essential that future studies of antipsychotics and other drugs for the treatment of delirium have the protocol approved by an ECHR and a written IC signed by the patient's legal representative, since by definition delirium is a condition that compromises superior mental processes.
Key words:
Delirium
quetiapine
olanzapine
informed consent
ethicscommittees
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Conflictos de interés: El autor manifiesta que no tiene conflictos de interés en este artículo.
Copyright © 2012. Asociación Colombiana de Psiquiatría
