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Ensayos clínicos aleatorios con el tratamiento preferido por el clínico
1Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892.
Lancet (London, England)
|January 19, 1991
Resumen
Los ensayos clínicos aleatorizados estándar pueden no ser adecuados para situaciones en las que los médicos prefieren un tratamiento específico. Un enfoque alternativo sugiere aleatorizar a los pacientes sólo cuando no hay
Área de la Ciencia:
- Metodología de ensayos clínicos Metodología de ensayos clínicos.
- Ética médica y ética médica.
- La atención centrada en el paciente.
Sus antecedentes:
- Los ensayos clínicos aleatorizados estándar (ECA) pueden ser subóptimos cuando los médicos tienen fuertes preferencias de tratamiento o creencias sobre la superioridad.
- El sesgo clínico puede influir en el diseño del ensayo y los resultados de los pacientes en los ECA tradicionales.
Objetivo del estudio:
- Proponer un diseño de ensayo alternativo para situaciones con preferencias de tratamiento clínico.
- Asegurar que la asignación de pacientes se alinea con el juicio clínico cuando existe un desacuerdo.
Principales métodos:
- La asignación aleatoria de pacientes al tratamiento se sugiere solo cuando surge un desacuerdo clínico sobre la mejor opción.
- Los pacientes son entonces asignados a un clínico que apoya el régimen de tratamiento asignado.
Principales resultados:
- Este enfoque modificado aborda escenarios en los que los ECA estándar pueden ser inapropiados debido a la experiencia o preferencia del clínico.
- Su objetivo es integrar el juicio clínico en el proceso de aleatorización.
Conclusiones:
- El diseño propuesto ofrece una solución potencial para mejorar la aplicabilidad de los ensayos clínicos en la práctica.
- Busca equilibrar la aleatorización con la toma de decisiones clínicas individualizadas.
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