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Desarrollo de directrices basadas en la evidencia para describir los beneficios y los daños potenciales en los
Jeremy Howick1,2, Martina Svobodova1, Shaun Treweek3
1Centre for Trials Research, Cardiff University, Cardiff, UK.
Health technology assessment (Winchester, England)
|August 23, 2025
Resumen
Se desarrollaron siete principios para mejorar la presentación de la información de los ensayos clínicos, con el objetivo de reducir el daño y el desperdicio de la investigación. Estas directrices mejoran los folletos informativos para pacientes, promoviendo prácticas de ensayos éticos y una comunicación más clara de los beneficios y riesgos.
Área de la Ciencia:
- Ensayos clínicos
- Hojas de información para el paciente
- Consentimiento informado
Sus antecedentes:
- La información inconsistente en los prospectos de ensayos con pacientes puede conducir a daños nocebo, desperdicio de investigación y preocupaciones éticas.
- La comunicación más clara de los beneficios y daños potenciales es crucial para la conducta ética de los ensayos clínicos.
Objetivo del estudio:
- Desarrollar principios informados para las partes interesadas para describir los beneficios y los daños de las intervenciones de ensayo en los folletos informativos para pacientes.
- Probar la viabilidad de estos principios para mejorar el reclutamiento en ensayos y las tasas de eventos adversos.
- Crear y difundir orientaciones para la aplicación de estos principios.
Principales métodos:
- Un enfoque de métodos mixtos que incluya una encuesta de Delphi modificada y una reunión de consenso para establecer principios.
- Principios de ensayo mediante la transformación de los prospectos de información para el paciente existentes en "prospectos de información para el paciente basados en principios".
- Utilización de la infraestructura de estudios dentro de un ensayo (SWAT) para evaluar el impacto en el reclutamiento y los eventos adversos.
Principales resultados:
- Se acordaron siete principios de consenso para presentar los beneficios y los daños del ensayo.
- Se elaboraron folletos de información para pacientes basados en principios para cinco ensayos de huéspedes.
- Se publicó un protocolo para un metanálisis de SWAT para sintetizar los resultados.
Conclusiones:
- Se establecieron siete principios para armonizar la comunicación de los beneficios y daños de los ensayos.
- Se espera que estos principios reduzcan el desperdicio de investigación y el daño inducido por la información.
- La aplicación de estos principios puede mejorar la ética de los ensayos clínicos.
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