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Evaluación de la Integridad Ética de los Estudios de Mejora de la Calidad [AEGIS]: un estudio de métodos mixtos

Matthew J Leach^1,2, Vanesa Bochkezanian², Alexa McArthur²

¹Faculty of Health and Community Services, TAFE SA, Adelaide, SA, Australia.

JBI evidence implementation

|December 23, 2025

Resumen

Este estudio desarrolló la herramienta de Evaluación de la Integridad Ética de los Estudios de Mejora de la Calidad (AEGIS) para evaluar los estándares éticos en las iniciativas de mejora de la calidad. La herramienta AEGIS demuestra una buena fiabilidad y utilidad para evaluar la conducta ética en la atención sanitaria.

Área de la Ciencia:

Ética Sanitaria
Investigación de Mejora de la Calidad
Metodología de Investigación

Sus antecedentes:

Las iniciativas de mejora de la calidad (MC) son cruciales para mejorar la calidad de la atención sanitaria.
Sin embargo, la integridad ética de las iniciativas de MC a menudo carece de la atención y evaluación suficientes.
Se necesita una herramienta estandarizada para evaluar las dimensiones éticas de los estudios de MC.

Objetivo del estudio:

Desarrollar y evaluar psicométricamente la herramienta de Evaluación de la Integridad Ética de los Estudios de Mejora de la Calidad (AEGIS).
Operacionalizar criterios clave para evaluar la integridad ética de la investigación de mejora de la calidad.
Proporcionar un instrumento fiable para la revisión ética de proyectos de MC.

Principales métodos:

Se empleó un diseño secuencial de métodos mixtos de cuatro fases.
Fases I y II: Estudio de mapeo sistemático para identificar y mapear criterios preliminares contra directrices éticas internacionales.
Fase III: Estudio e-Delphi para el consenso sobre los criterios AEGIS.
Fase IV: Evaluación psicométrica de la utilidad y fiabilidad de la herramienta AEGIS.

Principales resultados:

La Fase I identificó 23 criterios preliminares, mapeados contra 18 directrices éticas.
El estudio e-Delphi logró consenso sobre 18 criterios AEGIS transformados (>70% de acuerdo).
La evaluación psicométrica mostró buena consistencia interna (α=0.734), moderada fiabilidad interevaluador (κ=0.481) y buena utilidad.

Conclusiones:

La herramienta AEGIS de 18 ítems posee una excelente validez aparente y de contenido.
La herramienta AEGIS demuestra una buena consistencia interna, utilidad y amplia relevancia internacional.
AEGIS es un instrumento valioso para mejorar la conducta y la integridad ética de los proyectos de MC.

Palabras clave:

auditoría clínica revisión ética ética aseguramiento de la calidad mejora de la calidad

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