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Diseño de Ensayos Controlados por Grupos: Una Guía Práctica para Investigadores

Kendra Davis-Plourde1, Xiaoying Yu2, Jeanne A Teresi3,4

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Para evaluar la eficacia de la intervención, los investigadores deben priorizar la aleatorización individual y los diseños de ensayos paralelos. Este comentario proporciona orientación sobre la selección de diseños apropiados de ensayos controlados aleatorios por grupos, incluidos los complejos como la cuña escalonada.

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ensayos controlados aleatorios por gruposdiseños cruzadoscorrelación intragrupodiseños paralelosdiseño de ensayo controlado aleatoriocuña escalonada

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Área de la Ciencia:

  • Metodología de Ensayos Clínicos
  • Bioestadística
  • Epidemiología

Sus antecedentes:

  • Los ensayos controlados aleatorios por grupos son cada vez más populares, pero se necesitan directrices claras para seleccionar el mejor diseño, especialmente los complejos como la cuña escalonada.
  • Los investigadores requieren orientación práctica sobre la elección entre ensayos controlados aleatorios individuales y ensayos controlados aleatorios por grupos.
  • Este comentario aborda ideas erróneas y proporciona recomendaciones para la selección del diseño del ensayo.

Objetivo del estudio:

  • Proporcionar orientación sobre la selección de diseños apropiados de ensayos controlados aleatorios.
  • Aclarar el uso de la aleatorización por grupos y los diseños cruzados, incluida la cuña escalonada.
  • Ofrecer recomendaciones prácticas para investigadores de todos los niveles estadísticos.

Principales métodos:

  • El comentario aborda ideas erróneas sobre la aleatorización por grupos y los diseños cruzados.
  • Se analiza el coeficiente de correlación intragrupo y su impacto en el tamaño de la muestra.
  • Se proporcionan un diagrama de flujo y tablas de definiciones y consideraciones de diseño para ayudar a los investigadores.

Principales resultados:

  • El comentario ofrece recomendaciones prácticas para la selección de diseños de ensayos.
  • Se presenta un diagrama de flujo para ayudar a los investigadores a identificar diseños adecuados.
  • Se incluyen definiciones estadísticas y consideraciones para diseños complejos.

Conclusiones:

  • Los investigadores deben priorizar la aleatorización individual y los diseños de ensayos paralelos para evaluar la eficacia o efectividad de la intervención.
  • Esta guía tiene como objetivo apoyar la toma de decisiones informadas en el diseño del ensayo.
  • La consulta eficaz con un estadístico es crucial durante la fase de diseño.