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Dominios de resultados centrales para la enfermedad pulmonar del complejo Mycobacterium avium: un estudio MACCOR
Cara D Varley1,2, Sarah A R Siegel2, Naomi A DeBacker2
1Oregon Health and Science University, School of Medicine, Portland, OR, USA.
ERJ open research
|December 24, 2025
Resumen
Los investigadores establecieron dominios de resultados centrales para ensayos clínicos de enfermedad pulmonar del complejo Mycobacterium avium (MAC-PD). Este consenso mejorará la investigación y la evaluación del tratamiento para esta afección pulmonar crónica.
Área de la Ciencia:
- Medicina Pulmonar
- Diseño de Ensayos Clínicos
- Resultados Informados por el Paciente
Sus antecedentes:
- La enfermedad pulmonar del complejo Mycobacterium avium (MAC-PD) es una afección inflamatoria crónica con un impacto significativo en el paciente.
- Las medidas de resultado actuales en los ensayos de MAC-PD a menudo son inadecuadas para reflejar los efectos de la enfermedad y el tratamiento.
- Existe la necesidad de dominios de resultados estandarizados en la investigación de MAC-PD.
Objetivo del estudio:
- Establecer un conjunto de dominios de resultados centrales (COD) basado en el consenso internacional para ensayos clínicos de MAC-PD.
- Desarrollar un marco para la evaluación de MAC-PD que refleje mejor la experiencia del paciente y la carga de la enfermedad.
- Guiar la investigación futura en el desarrollo de instrumentos de medición apropiados para MAC-PD.
Principales métodos:
- Se empleó una metodología de consenso Delphi modificada.
- Participaron partes interesadas internacionales, incluidos pacientes, médicos e investigadores, en un proceso Delphi electrónico.
- Los participantes calificaron la importancia de los dominios de resultados preliminares para alcanzar un consenso.
Principales resultados:
- 306 participantes de 17 países participaron en el proceso de consenso.
- Nueve dominios de resultados centrales cumplieron los criterios de inclusión después de múltiples rondas de consenso.
- Los dominios incluidos cubren síntomas, microbiología, efectos secundarios del tratamiento, imágenes, función física, carga del tratamiento, vitalidad, recurrencia y biomarcadores.
Conclusiones:
- Los dominios de resultados centrales identificados proporcionan una base para el diseño de ensayos clínicos de MAC-PD.
- Estos dominios facilitarán el desarrollo de medidas compuestas para la actividad de la enfermedad.
- La difusión de estos COD ayudará a priorizar la investigación de instrumentos de medición en MAC-PD.
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