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Ensayos clínicos aleatorizados en pacientes individuales durante un período de 2 años
E B Larson1, A J Ellsworth, J Oas
1Department of Medicine, School of Medicine, University of Washington, Seattle.
JAMA
|December 8, 1993
Resumen
Los ensayos con un solo paciente (SPT) son factibles y rentables, proporcionando datos valiosos para guiar las decisiones de tratamiento de enfermedades crónicas. Estos SPT formales mejoran la precisión terapéutica y la confianza del clínico.
Área de la Ciencia:
- Metodología de la investigación clínica.
- Farmacoeconomía La farmacoeconomía es la economía de las drogas.
- La medicina basada en la evidencia es la medicina basada en la evidencia.
Sus antecedentes:
- Los ensayos con un solo paciente (SPT) ofrecen un enfoque personalizado para la evaluación del tratamiento.
- La evaluación de la viabilidad y el impacto de un servicio formal de SPT es crucial para optimizar la atención al paciente.
Objetivo del estudio:
- Evaluar la viabilidad de la implementación de un servicio de ensayo con un solo paciente (SPT, por sus siglas en inglés).
- Determinar la influencia de los SPT formales en la precisión terapéutica y la toma de decisiones clínicas.
Principales métodos:
- Un estudio descriptivo y evaluativo de SPTs realizado durante dos años (1988-1990).
- Los ensayos fueron diseñados en doble ciego, aleatorizados, múltiples diseños de cruce con asignación aleatoria y evaluación explícita de resultados.
- Los niveles de confianza del paciente y el médico se midieron utilizando escalas analógicas visuales previas y posteriores al ensayo.
Principales resultados:
- De los 34 SPT completados, 17 dieron resultados definitivos. El tratamiento se continuó o se inició en 16 ensayos basados en resultados positivos.
- El tratamiento se interrumpió o no se inició en 18 ensayos debido a ineficacia, daño o equivalencia.
- La confianza de los médicos aumentó o disminuyó en función de los resultados del ensayo, mientras que la mayoría de los pacientes no informaron ningún cambio; el servicio fue calificado como muy útil.
Conclusiones:
- Un servicio de ensayo con un solo paciente (SPT) es factible, con costos comparables a los servicios convencionales.
- Los SPT mejoran la confianza del clínico y la precisión terapéutica, particularmente para valores de tratamiento inciertos en enfermedades crónicas.
- Los SPT formales pueden guiar eficazmente las decisiones de tratamiento posteriores cuando existe incertidumbre con respecto a la eficacia o seguridad del tratamiento.
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