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Elementos Estándar en Estudios de Eventos Adversos y Errores Médicos: la declaración SESAME
Richard T Griffey1, Maria Unbeck2,3, David C Stockwell4
1Department of Emergency Medicine, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA griffeyr@wustl.edu.
BMJ quality & safety
|January 23, 2026
Resumen
La notificación de eventos adversos en la atención médica es inconsistente. La nueva guía Elementos Estándar en Estudios de Eventos Adversos y Errores Médicos (SESAME) ofrece una lista de verificación de 44 elementos para mejorar la calidad de la notificación y la seguridad del paciente.
Área de la Ciencia:
- Investigación en atención médica
- Seguridad del paciente
- Notificación de errores médicos
Sus antecedentes:
- Se ha observado una variabilidad constante y lagunas en la notificación de eventos adversos en estudios de atención médica.
- Los detalles incompletos de la notificación (diseño del estudio, conducción, metodología, definiciones) dificultan la interpretación, evaluación y reproducibilidad.
- Estas deficiencias limitan el impacto de los estudios en las iniciativas de seguridad del paciente y las políticas.
Objetivo del estudio:
- Abordar los desafíos en la calidad de la notificación de eventos adversos.
- Introducir una guía de notificación estandarizada para estudios sobre daño al paciente.
Principales métodos:
- Desarrollo de la guía SESAME (Standard Elements in Studies of Adverse Events and Medical Error).
- Se creó una lista de verificación de 44 elementos a través de un proceso de consenso de 2 años.
- Un panel internacional multidisciplinario guió el desarrollo, adhiriéndose a los estándares de la Red para Mejorar la Calidad y Transparencia de la Investigación en Salud (Enhancing the QUAlity and Transparency Of Health Research Network).
Principales resultados:
- La guía SESAME, una lista de verificación de 44 elementos, ha sido desarrollada.
- Su objetivo es apoyar la notificación integral y estandarizada en estudios de daño al paciente.
- La guía se creó a través de un proceso de consenso.
Conclusiones:
- La guía SESAME proporciona un marco para mejorar la calidad y estandarización de la notificación de eventos adversos.
- Se espera que la mejora de la notificación facilite una mejor interpretación, evaluación crítica y reproducibilidad de los hallazgos.
- Esta iniciativa tiene como objetivo fortalecer el impacto de la investigación sobre seguridad del paciente en las políticas y la práctica.
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