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- W1748064240 abstract "e17500 Background: Informed consent process is the key-element of the ethical considerations of clinical trials. Several reports have shown that even having been through this process, enrolled patients misunderstand the modalities and goals of randomized clinical trials (RCT). The purpose of this study is to compare individuals’ objective understanding about RCT between patients already included (cases) and patients treated under standard care who have never received information about clinical trials (controls). Methods: We submitted a standardized questionnaire to both populations to explore the objective understanding of RCT. This questionnaire includes 10 ended-questions (q) exploring: understanding of underlying legislation (3 q), understanding of conditions of study withdrawal (3 q), understanding of randomization (2 q) and understanding of uncertainty (2 q). Results: 75 cases and 107 controls were included in the present study. Three questions are associated with a rate of good responses close to 70% in both populations: anonymity of collected data (66% in controls vs 81% in cases), existence of legislation protecting patients (73% vs 76%) and right to withdraw in case of toxicity (73% vs 82%). Understanding of cases is statistically better (p < 0.05) for 6 other questions: physicians duty to tell everything about the trial (44% vs 68%), right to withdraw from the study without giving any reason (38% vs 73%), withdrawing does not jeopardies the quality of further care (40% vs 71%), all the patients do not receive the same treatment (56% vs 73%), allocation at random (12% vs 52%) and uncertainty about benefits (20% vs 38%). At last, the rate of correct responses is similar and very low for the question exploring the uncertainty about toxicity (43% vs 44%). Conclusions: Informed consent actually improves enrolled patients’ understanding of RCT. Nevertheless, additional efforts should be made to increase the quality of the transmission of information about randomization and uncertainty. [Table: see text]" @default.
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- W1748064240 date "2009-05-20" @default.
- W1748064240 modified "2023-10-07" @default.
- W1748064240 title "Objective measure of patients’ understanding of their role in a randomized trial: A multicenter case-control study" @default.
- W1748064240 doi "https://doi.org/10.1200/jco.2009.27.15_suppl.e17500" @default.
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