Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations
Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations
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DOI：
10.1007/bf03174370
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发表时间：
2007-03-01
影响因子：
1.6
通讯作者：
Demetri, George
中科院分区：
文献类型：
--
作者：
Wray, Ricardo J.;Stryker, Jo Ellen;Demetri, George
背景知情同意的公认做法往往导致患者对研究的理解不够理想。方法.这项试点研究旨在评估试验特定的定制材料，与广泛使用的关于临床试验的通用手册相比，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。结果组间无重大差异。参与者认为量身定制的材料更有参考价值。结论.试验专用材料可用于临床试验期间的参考。对知情同意的研究是可行的，尽管一些重要因素限制了研究。
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.