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Impacto de las preferencias de intervención del participante y el médico en los ensayos aleatorizados: una revisión

Michael King¹, Irwin Nazareth, Fiona Lampe

¹Department of Mental Health Sciences, Royal Free and University College Medical School, Royal Free Campus, London, England. m.king@medsch.ucl.ac.uk

|March 3, 2005

Resumen

Las preferencias de los pacientes afectan la participación en los ensayos, pero muestran un efecto mínimo en la validez de los resultados de los ensayos controlados aleatorios. Comprender la elección del paciente es clave para una investigación clínica efectiva.

Área de la Ciencia:

La medicina clínica es la medicina clínica.
Metodología de la investigación médica Metodología de la investigación médica.
La bioestadística es la bioestadística.

Sus antecedentes:

La aleatorización es el estándar de oro para las estimaciones imparciales de la eficacia de los ensayos clínicos.
Las preferencias del paciente pueden influir en el reclutamiento del ensayo (validez externa) y los resultados (validez interna).

Objetivo del estudio:

Determinar el impacto de las preferencias de los pacientes en el reclutamiento para ensayos clínicos.
Evaluar el efecto de las preferencias del paciente en la validez interna de los resultados de los ensayos.

Principales métodos:

Revisión sistemática de ensayos aleatorizados y cohortes publicados entre 1966 y 2004.
Se han realizado búsquedas en varias bases de datos (MEDLINE, EMBASE, PsycINFO, etc.) y revistas revisadas a mano.
Datos extraídos sobre el diseño del estudio, la medición de las preferencias, el reclutamiento, el desgaste y los resultados.

Principales resultados:

Las preferencias del paciente influyeron en la negativa a participar en la aleatorización.
Hay poca evidencia de sesgo en las características de los participantes que aceptaron la aleatorización.
Las diferencias en los resultados entre los grupos aleatorizados y los grupos de preferencia fueron generalmente pequeñas, especialmente en ensayos más grandes.

Conclusiones:

Las preferencias de los pacientes influyen significativamente en la participación en ensayos aleatorizados.
Hay pruebas limitadas de que las preferencias afectan sustancialmente la validez interna de los ensayos aleatorizados.

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