Rompiendo el efecto ‘‘techo de cristal’’ en la generación de evidencia clínica de alto nivel en ortopedia y traumatología
DOI:
https://doi.org/10.1016/j.rccot.2022.10.003Palabras clave:
ensayo controlado aleatorizado, protocolo de ensayo clínico, diseño de investigaciones epidemiológicas, estudios de cohortes, estadísticasResumen
Introducción: En los estudios clínicos relacionados con problemas ortopédicos comunes y lesiones traumáticas, los métodos de aleatorización son difíciles de orquestar. La falta de evidencia clínica de alto nivel que tomen como fuente estudios prospectivos, aleatorizados y doble ciego, se cita a menudo como una razón principal para rechazar los avances terapéuticos propuestos en cirugía ortopédica.
Materiales y métodos: Este documento de opinión resume las limitaciones de los ensayos clínicos en las subespecialidades quirúrgicas. Se presente un consenso acerca de cómo el cirujano ortopédico en ejercicio puede producir evidencia clínica de alta calidad y de esta forma realizar cambios en sus protocolos de práctica clínica.
Resultados: Esta revisión de la literatura reveló que las clasificaciones del nivel de evidencia varían entre las subespecialidades quirúrgicas. La investigación en la ortopedia y traumatología se dirige principalmente al diagnóstico, el tratamiento preferido y el análisis de decisiones económicas, mientras que otras clasificaciones de pronóstico son preferidas en otras áreas, como cirugía plástica. En ortopedia, los estudios doble ciego controlados son raros y, a menudo, pocos prácticos o, incluso, pocos éticos. El cruzamiento entre ensayos quirúrgicos aleatorios de grupos de estudio es más común. Otras dificultades en los ensayos quirúrgicos van desde: la falta de apoyo organizativo y financiero, aprobación institucional o comité de ética y requisitos de registro para los ensayos clínicos, y hasta tiempo insuficiente por fuera de un programa clínico, ya ocupado para dedicarle a esta laboriosa tarea no compensada.
Conclusión: La cirugía ortopédica es una subespecialidad basada en la experiencia y la habilidad. Muchas innovaciones comienzan con cirujanos emprendedores reportando informes de opiniones o estudios de cohortes retrospectivos, muchos de los cuales tienen sesgo. Los estudios de cohortes observacionales prospectivos con resultados consistentes pueden ofrecer evidencia clínica de mayor grado que los ensayos aleatorios mal ejecutados.
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