Participation in clinical trials as viewed by the patient:: Understanding cultural and emotional aspects which influence choice
Participation in clinical trials as viewed by the patient:: Understanding cultural and emotional aspects which influence choice
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DOI：
10.1159/000151365
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发表时间：
2008-01-01
期刊：
影响因子：
3.5
通讯作者：
Nole, Franco
中科院分区：
文献类型：
--
作者：
Catania, Chiara;De Pas, Tommaso;Nole, Franco
背景：被邀请参加临床试验的患者可能会唤起一个原型，他们可以根据这个原型做出坚持参与的决定，而不是基于研究本身。方法：编制一份包含17个项目的多项选择问卷，对102名从未参加过试验的讲意大利语的晚期肺癌或乳腺癌患者进行测试。结果：所有患者均进行了问卷调查。85%的人对参与试验持肯定态度。人口统计学因素不影响患者参与的意愿。接受参与的理由包括对研究人员(76%)或研究所()的信任，以及希望获得新的治愈机会(78%)。少数人(31%)担心潜在的利益冲突(31%)或认为自己是“豚鼠”(36%)，并担心医生对推进自己的研究感兴趣，尽管有更有效的药物可用(28%)。50%的人害怕接受一种鲜为人知的药物，76%的人认为对拟议治疗的毒性/安全性的彻底解释帮助他们做出了决定。结论：问卷捕捉到了一些偏见、恐惧和一些希望。了解这些细节将改善患者信息，引导患者更有意识地决定是否参与临床试验。版权所有(C)2008 S.Karger AG，巴塞尔。
Background: Patients invited to take part in a clinical trial may evoke an archetype on which they may base their decision of adherence to participation, instead of on the study itself. Methods: A 17-item, multiple choice questionnaire was developed, tested and then administered to 102 Italian-speaking patients with advanced lung or breast cancers who had never been exposed to participation in a trial. Results: The questionnaire was answered by all patients. Eighty-five percent were positive about trial participation. Demographic factors did not influence patients' willingness to participate. Trust in the investigator (76%) or in the institute (64%) and hope of receiving a new chance for cure (78%) were cited as reasons to accept participation. A minority was concerned by potential conflicts of interest (31%) or the thought of being 'guinea pigs' (36%), and feared that doctors were interested in advancing their own research, even though there were more efficient drugs available (28%). Fifty percent feared receiving a little-known medicine, and 76% considered that a thorough explanation of toxicity/safety of the proposed treatment helped them decide. Conclusion: Several prejudices, fears and some hopes have been captured by the questionnaire. Understanding such specifics will improve patient information leading patients to a more conscious motivation in deciding whether to participate in a clinical trial. Copyright (c) 2008 S. Karger AG, Basel.