Clasificación de los desenlaces en los ensayos clínicos

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Daniela Hincapié Tabares
Vanessa Pérez Carrillo
Jorge Hernando Donado Gómez

Resumen

El ensayo clínico controlado aleatorizado (ECA) es un experimento planificado, controlado y prospectivo, en el que una o más intervenciones son asignadas a participantes humanos, con el fin de evaluar los efectos sobre los resultados relacionados con la salud, como la eficacia y seguridad de tratamientos, procedimientos o ayudas diagnósticas para diferentes enfermedades. En los ECA se pueden medir diferentes desenlaces, ya sean clínicos, relacionados con el paciente o económicos. Un desenlace es un evento clínico, médico, quirúrgico o de cualquier índole, que busca medir la efectividad y seguridad del tratamiento o intervención que se desea evaluar en un ensayo clínico. La elección de uno o más dependerá de la naturaleza del estudio y de la pregunta que se desea responder. Así mismo, el uso de una amplia gama de ellos tiende a ser más informativo que la medida de uno solo, por lo que es importante reconocer cada uno de estos, para definir su correcta implementación en el ámbito de la investigación. Este estudio tiene como objetivo principal describir los diferentes tipos de desenlaces, los cuales se clasifican en nueve categorías: 1. Eficacia y seguridad; 2. Primario, coprimario, secundario y terciario; 3. Simple y compuesto;


4. Positivo y negativo; 5. Clínicamente significativo y subrogado; 6. Objetivo y subjetivo; 7. Medidas únicas, repetidas y conteos (sucesos); 8. Dicotómico y continuo; y 9. Tiempo fijo y tiempo calendario.

Palabras clave:
clinical trial, efficacy, measures of association, exposure, risk or outcome ensayo clínico, eficacia, medidas de asociación, exposición, riesgo o desenlace ensaio clínico, eficácia, medidas de associação, exposição, risco ou desenlace

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