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Disparidad entre la significación estadística y la importancia clínica en ensayos controlados aleatorios publicados:

Tonya Marianne Esterhuizen¹, Lawrence Mbuagbaw^2,3,4,5, Nadia Rehman³

¹Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, Western Cape, South Africa tonyae@sun.ac.za.

|August 25, 2025

Resumen

Una parte significativa de los ensayos controlados aleatorios (ECA) muestra una disparidad entre la significación estadística y la importancia clínica. Esto pone de relieve la necesidad de considerar la relevancia clínica al interpretar los resultados de los ensayos para una mejor investigación médica.

Área de la Ciencia:

Metodología de los ensayos clínicos
La medicina basada en la evidencia
Estadísticas biológicas

Sus antecedentes:

La interpretación de los ensayos controlados aleatorios (ECA) requiere evaluar tanto la significación estadística como la importancia clínica.
Existe una posible disparidad entre estas dos medidas, lo que afecta a la fiabilidad de los resultados de la investigación.

Objetivo del estudio:

Estimar el grado de disparidad entre la significación estadística y la importancia clínica en los ECA publicados.
Identificar los factores asociados con esta disparidad de importancia estadística y clínica.

Principales métodos:

Un estudio metodológico analizó 500 ECA de dos brazos, fase tres, de superioridad en intervenciones de salud humana publicadas entre 2018-2022.
La importancia clínica se determinó comparando el valor delta especificado o la diferencia mínima clínicamente importante con el tamaño del efecto.
La regresión logística multinomial exploró los factores asociados con la significancia estadística y las disparidades de importancia clínica (SS+CI- y SS-CI+).

Principales resultados:

La información para clasificar la importancia clínica no estaba disponible para el 38,4% de los ensayos.
La disparidad general se observó en el 20,5% de los 308 ensayos restantes.
La disparidad estadísticamente significativa pero no clínicamente importante (SS+CI-) se produjo en el 10,3% de los ensayos, mientras que la disparidad estadísticamente no significativa pero clínicamente importante (SS-CI+) se produjo en el 29,5%.

Conclusiones:

Hasta el 20% de los ECA pueden presentar una disparidad entre la significación estadística y la importancia clínica.
Hace hincapié en la necesidad de considerar la importancia clínica junto con la significación estadística en la interpretación del ensayo.
Recomienda el cumplimiento estricto de las directrices de notificación para mejorar la claridad y la fiabilidad de los ECA.

Palabras clave:

Relevancia clínica Ensayos controlados aleatorios Diseño de la investigación Estadísticas y métodos de investigación

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