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Una estrategia de aleatorización para un ensayo controlado aleatorizado por clúster con disponibilidad variable de

Sheau-Chiann Chen¹, Heidi Chen¹, Rafael Paez²

¹Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.

Contemporary clinical trials

|August 30, 2025

Resumen

Este estudio optimizó los ensayos de broncoscopia de diagnóstico mediante la estratificación de las asignaciones de la sala de operaciones. Un nuevo método de aleatorización redujo significativamente el desequilibrio de asignación de pacientes, mejorando la asignación de recursos para las comparaciones de resultados clínicos.

Área de la Ciencia:

Metodología de la investigación médica
Pulmonología
Diseño del ensayo clínico

Sus antecedentes:

La comparación de plataformas de broncoscopia de diagnóstico requiere diseños de ensayo robustos.
Las limitaciones de recursos en las salas de operaciones (OR) y el equipo pueden desafiar la aleatorización del paciente.
Los ensayos controlados aleatorizados en clúster (cRCTs) son adecuados para comparaciones pragmáticas, pero requieren estrategias de asignación cuidadosas.

Objetivo del estudio:

Para comparar los resultados clínicos de dos enfoques de broncoscopia de diagnóstico (plataforma A y plataforma B).
Desarrollar y evaluar una estrategia de aleatorización eficaz para un ensayo controlado aleatorizado en clúster (cRCT) teniendo en cuenta las limitaciones de recursos.
Para minimizar el desequilibrio de asignación de pacientes entre las dos plataformas.

Principales métodos:

Se diseñó un cRCT de centro único, abierto, pragmático y sin inferioridad.
Las agrupaciones se definieron como días de sala de operaciones (OR).
Un método de aleatorización de bloques permutados, estratificado por disponibilidad de OR, fue simulado y evaluado para el equilibrio de asignación.

Principales resultados:

La estratificación por disponibilidad de OR redujo significativamente el desequilibrio de asignación (desequilibrio medio = -0.006, SD = 0.690) en comparación con la estratificación por días laborables (desequilibrio medio = 0.044, SD = 1.110).
El método propuesto minimizó efectivamente la diferencia en la inscripción de pacientes entre la Plataforma A y la Plataforma B.
La estrategia optimizó la asignación de recursos limitados de la plataforma de quirófano y broncoscopia.

Conclusiones:

Un método de aleatorización de bloques permutados estratificado por disponibilidad de OR es una estrategia efectiva para los cRCT con limitaciones de recursos.
Este diseño innovador mejora el equilibrio de las asignaciones de pacientes en ensayos de broncoscopia de diagnóstico.
Los hallazgos apoyan una asignación de recursos optimizada y comparaciones confiables de resultados clínicos en ensayos pragmáticos.

Palabras clave:

Tamaño del bloque El grupo Aleatorización de bloques permutados La aleatorización simple Estratificación

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