Levels of knowledge and perceived understanding among participants in cancer clinical trials - factors related to the informed consent procedure
Levels of knowledge and perceived understanding among participants in cancer clinical trials - factors related to the informed consent procedure
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DOI：
10.1177/1740774510384516
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发表时间：
2011-02-01
期刊：
影响因子：
2.7
通讯作者：
Wilking, Nils
中科院分区：
文献类型：
--
作者：
Bergenmar, Mia;Johansson, Hemming;Wilking, Nils
根据国际和国家指南和法律，参与癌症临床试验的患者的知情同意是强制性的。不足的知识和理解的试验参与者已被报道在几个study.Purpose-本研究的目的是调查的重要因素的知识和理解癌症临床试验之间的trial participants.Methods所有患者同意的第二阶段或第三阶段的临床试验在1年内被邀请（n = 325）。知识和感知的理解的数据收集的问卷，知情同意的质量。结果基于268例患者（82%）的数据。知识和感知的理解以及临床，社会经济因素和相关的因素之间的关联进行了tested.Results在多变量分析中没有统计学显着的关联发现知识和任何因素之间。在他们决定参加之前报告试验信息时间较长的患者，那些发现容易做出决定的患者，以及报告使用其他信息来源的患者具有统计学显著性较高的感知理解。没有发现任何临床因素的知识或感知理解的平均得分差异（年龄、性别、诊断组、试验阶段）、社会经济因素（教育、婚姻状况），以及与知情同意程序相关的下列因素;亲属或护士在场了解有关试验的信息或以前参加过临床试验。结论需要制定提高患者知识水平的策略，以提高癌症临床试验参与者对知情同意要求的满足程度。临床试验2011; 8：77-84。http：//ctj.sagepub.com.
Background An informed consent from patients participating in cancer clinical trials is mandatory according to international and national guidelines and laws. Insufficient knowledge and understanding by trial participants have been reported in several studies.Purpose The aims of this study were to investigate factors of importance for knowledge and understanding about cancer clinical trials among trial participants.Methods All patients consenting to a phase II or III clinical trial during 1 year were invited (n = 325). Data on knowledge and perceived understanding were collected by a questionnaire, Quality of Informed Consent. Results are based on data from 268 patients (82%). Associations between knowledge and perceived understanding as well as clinical, socio-economic factors, and factors related to the informed consent procedure were tested.Results In the multivariate analysis no statistically significant associations were found between knowledge and any of the factors. Patients who reported longer time for trial information before their decision to participate, those who found the decision easy to take, and patients who reported use of other information sources had statistically significant higher perceived understanding. No differences in mean scores for knowledge or perceived understanding were found for any of the clinical factors (age, gender, diagnostic group, trial phase), socio-economic factors (education, marital status), and the following factors related to the informed consent procedure; presence of relative or nurse at information about the trial or previous participation in clinical trials.Limitations No study specific questions were included due to the number of trials (n = 35).Conclusion Strategies to increase patients' knowledge needs to be elaborated in order to improve the fulfilment of the requirements of informed consent in participants in cancer clinical trials. Clinical Trials 2011; 8: 77-84. http:// ctj.sagepub.com.