Cancer clinical trial participants' assessment of risk and benefit.
Cancer clinical trial participants' assessment of risk and benefit.
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DOI：
10.1080/23294515.2015.1034381
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发表时间：
2016
影响因子：
--
通讯作者：
Grady C
中科院分区：
文献类型：
--
作者：
Ulrich CM;Ratcliffe SJ;Wallen GR;Zhou QP;Knafl K;Grady C
本文的目的是检查癌症临床试验参与者在入组前评估参与研究的益处和风险的程度。110名肿瘤学研究参与者参加了东北一家大型癌症中心的癌症临床研究，他们对癌症临床试验的看法进行了自我管理的问卷调查。在参与者中，51.6%的人表示他们没有直接评估益处或风险。受教育程度、年龄、就业、治疗方案、保险和精神宗教信仰与参与者是否评估风险和收益显著相关。那些感觉信息充分的人比那些感觉信息不充分的人更有可能在入组时评估获益和风险（优势比[OR] = 3.92, p = 0.014）；在那些没有评估风险和收益的人中，21%的人在入组时没有得到充分的信息（p = .001）。那些同意临床试验有助于支付医疗费用的人，不评估风险和收益的几率几乎是不同意的人的三倍。我们的研究有重要的意义,可以让人们了解评估风险和收益的作用在癌症患者的研究参与决策和要求进一步理解为什么参与者没有评估的信息被认为是自主决策的必要条件。
The purpose of this article is to examine the extent to which cancer clinical trial participants assess the benefits and risks of research participation before enrollment. One hundred and ten oncology research participants enrolled in cancer clinical research in a large Northeastern cancer center responded to a self-administered questionnaire on perceptions about cancer clinical trials. Of the participants, 51.6% reported they did not directly assess the benefits or risks. Educational level, age, employment, treatment options, insurance, and spiritual–religious beliefs were significantly associated with whether participants assessed risk and benefits. Those who felt well informed were more likely to have assessed the benefits and risks at enrollment than those who did not feel well informed (odds ratio [OR] = 3.92, p = .014); of those who did not assess the risks and benefits, 21% did not feel well informed at enrollment (p = .001). Those who agreed that the clinical trial helped pay the costs of the care had nearly three times the odds of not assessing risks and benefits compared to those who disagreed. Our findings have important implications for understanding the role of assessing risks and benefits in the research participation decisions of patients with cancer and call for further understanding of why participants are not assessing information believed to be essential for autonomous informed decisions.