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Información de ensayos aleatorizados factoriales: extensión de la declaración de CONSORT 2010
Brennan C Kahan1, Sophie S Hall2, Elaine M Beller3
1MRC Clinical Trials Unit at UCL, London, United Kingdom.
JAMA
|December 5, 2023
Resumen
La notificación de ensayos aleatorizados factoriales se ha mejorado con una nueva extensión de CONSORT. Esta guía mejora la transparencia y la comprensión de los diseños complejos de ensayos, garantizando una mejor evaluación crítica de los resultados.
Área de la Ciencia:
- Metodología de los ensayos clínicos
- Normas de información sobre la investigación en el ámbito de la salud
Sus antecedentes:
- El informe transparente de los ensayos aleatorizados es crucial para la evaluación crítica.
- Los ensayos factoriales, que evalúan múltiples intervenciones simultáneamente, tienen necesidades de información únicas.
- Las prácticas actuales de presentación de informes para ensayos factoriales no son óptimas.
Objetivo del estudio:
- Desarrollar una extensión basada en el consenso de la Declaración de las Normas Consolidadas de Información de Ensayos (CONSORT) 2010, específicamente para ensayos factoriales.
Principales métodos:
- Se realizó una revisión del alcance de los artículos metodológicos.
- Se realizó una encuesta Delphi de 3 rondas en la que participaron 104 panelistas de 14 países.
- Una reunión de consenso híbrido con 15 panelistas finalizó la lista de verificación de informes.
Principales resultados:
- La extensión CONSORT modifica 16 elementos existentes y añade 1 nuevo elemento a la lista de verificación CONSORT 2010.
- Las recomendaciones clave incluyen la presentación de informes sobre la justificación del diseño factorial, la identificación de los principales grupos de comparación y la presentación de informes sobre los efectos de la interacción.
Conclusiones:
- Esta extensión de CONSORT proporciona una guía esencial para la notificación de ensayos aleatorios factoriales.
- La extensión tiene por objeto mejorar la transparencia y facilitar una mayor comprensión de estos complejos diseños de ensayos.
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