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- W4288773087 abstract "The level of comprehension on the information provided in the process of the informed consent can provide a free and voluntary decision. The comprehension and satisfaction of the participants affect their adherence to clinical trials. The objective of the study was to analyze the level of satisfaction of the subjects with the informed consent process as well as with their participation in clinical trials. A total of 3115 out of 3404 surveys received were included, from 362 protocols (with a similar number of investigators), conducted in different Argentinian provinces. Overall, 91% of the people classified the received information as rather good or excellent, and 95% replied that all of their doubts were cleared up. In the surveys, 97% expressed their willingness to participate in future studies, and 98% would recommend participating in clinical trials to others. The satisfaction score with participation in the study was associated, independently of age and socioeconomic level, with the desire to participate in a clinical trial again (OR 13.6: 95% CI: 4.7-39.1, p < 0.001) and with the recommendation to participate given to others (OR 16.7: 95% CI: 4.4-63.4, p < 0.001). In this sample from Argentina, there was a high degree of satisfaction both with the process of obtaining informed consent and with participation in clinical trials, regardless of age and socioeconomic status.El grado de comprensión de la información brindada en el proceso de consentimiento informado permite tomar una decisión libre y voluntaria. La comprensión y satisfacción de los participantes impactan sobre la adherencia a los ensayos clínicos. El objetivo de este estudio observacional fue analizar el grado de satisfacción de los sujetos con el proceso de consentimiento informado y con la participación en un ensayo clínico. Se incluyeron 3115 de 3404 encuestas recibidas, de 362 protocolos (y similar cantidad de investigadores) realizados en diversas provincias de la Argentina. El 91% de las personas clasificó la información recibida como muy buena o excelente y el 95% contestó que todas sus dudas fueron aclaradas. El 97% expresó su voluntad de volver a participar en estudios futuros y el 98% recomendaría a otras personas participar en ensayos clínicos. El puntaje de satisfacción con la participación en el estudio se asoció, en forma independiente de la edad y del nivel socioeconómico, con el deseo de volver a participar en un ensayo clínico (OR 13.6: IC95%: 4.7-39.1, p < 0.001) y con la recomendación a un tercero para que también participe (OR 16.7: IC95%: 4.4-63.4, p < 0.001). En esta muestra de la Argentina existe alto grado de satisfacción tanto con el proceso de toma de consentimiento informado como con la participación en los ensayos clínicos, en forma independiente de la edad y del nivel socioeconómico." @default.
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- W4288773087 date "2022-01-01" @default.
- W4288773087 modified "2023-09-28" @default.
- W4288773087 title "[Degree of satisfaction with the informed consent process and participation in clinical trials. A 3400 patients' study]." @default.
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