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La declaración de CONSORT: recomendaciones revisadas para mejorar la calidad de los informes de ensayos aleatorios de
D Moher1, K F Schulz, D G Altman
1University of Ottawa, Thomas C Chalmers Centre for Systematic Reviews, Ottawa, Ontario, Canada.
Lancet (London, England)
|April 27, 2001
Resumen
La mejora de los informes de ensayos controlados aleatorios (ECA) es crucial para comprender la validez del estudio. La declaración revisada de CONSORT ofrece una lista de verificación y un diagrama de flujo para mejorar la transparencia y la interpretación de los resultados de los ECA.
Área de la Ciencia:
- Los ensayos clínicos son ensayos clínicos.
- Metodología de la investigación médica Metodología de la investigación médica.
- La medicina basada en la evidencia.
Sus antecedentes:
- La interpretación precisa de los ensayos controlados aleatorios (ECA) requiere comprender su diseño, conducta, análisis y resultados.
- A pesar de los esfuerzos educativos, la calidad de los informes de los ECA sigue siendo subóptima.
- La declaración original de CONSORT (Estándares consolidados de informes de ensayos) se desarrolló para mejorar los informes de ECA.
Objetivo del estudio:
- Presentar una declaración revisada de CONSORT que incorpore nuevas pruebas y aborde las críticas al original.
- Mejorar la transparencia y la claridad de los informes de los ECA.
- Permitir a los lectores evaluar mejor la validez y relevancia de los hallazgos de los ensayos clínicos.
Principales métodos:
- Desarrollo de una lista de verificación revisada de CONSORT con 22 puntos.
- Inclusión de elementos críticos para juzgar el sesgo del efecto del tratamiento y la confiabilidad de los hallazgos.
- Revisión del diagrama de flujo de CONSORT para ilustrar la progresión de los participantes a través de las cuatro etapas del ensayo (inscripción, asignación, seguimiento, análisis).
Principales resultados:
- La lista de verificación revisada incluye elementos esenciales para la transparencia de los informes de los ECA.
- El diagrama de flujo actualizado muestra explícitamente el número de participantes en el análisis de datos primarios.
- La declaración revisada de CONSORT tiene como objetivo mejorar la comprensión de la conducta de los ECA y la evaluación de los resultados.
Conclusiones:
- La declaración revisada de CONSORT proporciona un marco integral para mejorar la presentación de informes de ECA.
- La mayor transparencia a través de la lista de verificación y el diagrama de flujo de CONSORT facilita la evaluación crítica de los resultados de los ensayos.
- El cumplimiento de las directrices de CONSORT es esencial para garantizar la fiabilidad y la interpretabilidad de la evidencia de ensayos clínicos.
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