癌症患者是否完全理解参与临床试验的相关情况？一项评估知情同意和患者期望的试点研究。
Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations.
作者信息
Wray Ricardo J, Stryker Jo Ellen, Winer Eric, Demetri George, Emmons Karen M
机构信息
Department of Community Health, Saint Louis University School of Public Health, St. Louis, MO 63104, USA.
出版信息
J Cancer Educ. 2007 Spring;22(1):21-4. doi: 10.1007/BF03174370.
BACKGROUND
Accepted practices of informed consent often result in suboptimal patient understanding of research studies.
METHODS
This pilot study aimed to assess trial-specific tailored materials, compared to a widely used generic booklet about clinical trials, randomly assigned to 118 candidates for cancer clinical trials. Study outcomes were: satisfaction with decision-making; satisfaction with materials; and subjective understanding of the clinical trial.
RESULTS
There were no major differences between groups. Participants rated tailored materials higher as a useful reference.
CONCLUSIONS
Trial-specific materials hold utility for reference during clinical trials. Studies of informed consent are feasible, although important factors limit research.
背景
知情同意的常规做法常常导致患者对研究的理解不够理想。
方法
本试点研究旨在评估针对特定试验量身定制的材料，将其与一本广泛使用的关于临床试验的通用手册进行比较，随机分配给118名癌症临床试验候选人。研究结果包括：对决策的满意度；对材料的满意度；以及对临床试验的主观理解。
结果
两组之间没有重大差异。参与者对量身定制的材料评价更高，认为其是有用的参考资料。
结论
针对特定试验的材料在临床试验期间具有参考价值。尽管有重要因素限制研究，但关于知情同意的研究是可行的。
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