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Información e interpretación de ensayos controlados aleatorios con resultados estadísticamente no significativos para
Isabelle Boutron1, Susan Dutton, Philippe Ravaud
1Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom. isabelle.boutron@htd.aphp.fr
JAMA
|May 27, 2010
Resumen
Los autores con frecuencia distorsionan los hallazgos en los ensayos controlados aleatorios (ECA) publicados con resultados no significativos. Este "giro" engaña a los lectores sobre la efectividad del tratamiento, impactando la medicina basada en la evidencia.
Área de la Ciencia:
- Investigaciones médicas informes de investigación médica.
- Análisis de ensayos clínicos análisis de ensayos clínicos.
- Integridad de la publicación científica integridad de la publicación científica
Sus antecedentes:
- Los resultados de ensayos publicados pueden ser mal interpretados debido al sesgo del autor.
- Comprender el "spin" es crucial para una interpretación científica precisa.
Objetivo del estudio:
- Determinar la prevalencia y la naturaleza del "spin" en ensayos controlados aleatorios (ECA).
- Investigar cómo los autores presentan resultados primarios estadísticamente no significativos.
Principales métodos:
- Buscado MEDLINE a través de PubMed para ECA publicados en diciembre de 2006.
- Se incluyeron ECA de grupos paralelos con resultados primarios estadísticamente no significativos (P > o = .05).
- Dos revisores evaluaron 72 artículos elegibles utilizando un formulario estandarizado.
Principales resultados:
- "Spin" estaba presente en el 18% de los títulos, el 37,5% de los resultados abstractos y el 58,3% de las conclusiones abstractas.
- Las secciones de texto principal también mostraron "spin": 29.2% en Resultados, 43.1% en Discusión y 50% en Conclusiones.
- Más del 40% de los informes exhibieron "spin" en al menos dos secciones de texto principales.
Conclusiones:
- La presentación de informes e interpretación de los hallazgos en ECA con resultados primarios no significativos a menudo son inconsistentes con los resultados reales.
- Este "giro" frecuente puede engañar a los lectores y afectar la toma de decisiones clínicas.
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