Sanchini Virginia, Reni Michele, Calori Giliola, Riva Elisabetta, Reichlin Massimo
SEMM - European School of Molecular Medicine, Milan, Italy.
J Med Ethics. 2014 Apr;40(4):269-75. doi: 10.1136/medethics-2012-101115. Epub 2013 May 31.
We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.
2011年3月至7月期间，我们在米兰的圣拉斐尔科学研究所，对77名先前参加过随机II期或III期临床试验的癌症患者对知情同意书的理解情况进行了探究。我们让参与者填写一份专门设计的问卷，并对他们的回答进行分析。62%的患者理解他们所参与试验的目的和性质；44%的患者理解研究程序，40%的患者正确列出了至少一项与参与试验相关的主要风险或并发症。我们确定了与知情同意理解相关的三个因素：年龄、教育程度以及肿瘤类型/研究者团队。我们提出了几种在获取知情同意方面可能的改进方法，这将提高患者的认知度，以及临床试验的有效性和效果。
