Maastricht University, School CAPHRI, Department of Health, Ethics, and Society, P.O. Box 616, 6200 MD Maastricht, The Netherlands.
Maastricht University, School CAPHRI, Department of Health, Ethics, and Society, P.O. Box 616, 6200 MD Maastricht, The Netherlands.
Soc Sci Med. 2014 Mar;104:116-23. doi: 10.1016/j.socscimed.2013.12.011. Epub 2013 Dec 18.
The purpose of this study was to gain insight into the experiences and dynamics of the involvement of research participants in a randomized clinical trial for nicotine vaccination. Participants received an experimental nicotine vaccine or a placebo, in addition to quit smoking medication and counseling. The longitudinal design of this qualitative study allowed us to follow people from their first visit to the trial location until the unblinding of their treatment with either verum or placebo vaccine. The empirical data consisted of 49 semi-structured, in-depth interviews, field notes and memos, and trial documents collected in the Netherlands between 2010 and 2012. Participants' expectations and experiences of the innovative nicotine vaccine were characterized by ambivalence: Although they complied with the research design, throughout the study they tinkered with discourses, objects, and activities to make them serve their individual goals. They made the concepts of nicotine vaccination and placebo treatment meaningful for quitting, reshaped the meaning of research tests and obligatory visits to serve their own personal goals, and introduced a new element into the trial by creating space to discuss problems that might endanger the quit attempt. In short, the participants constructed the clinical study for nicotine vaccination as their own personal lifestyle change project.
本研究旨在深入了解研究参与者参与尼古丁疫苗随机临床试验的经验和动态。参与者除了接受戒烟药物和咨询外，还接受了实验性尼古丁疫苗或安慰剂。这项定性研究的纵向设计使我们能够从参与者首次访问试验地点开始跟踪他们，直到他们的治疗方案（无论是真疫苗还是安慰剂疫苗）揭盲。实证数据包括 2010 年至 2012 年在荷兰收集的 49 次半结构化深入访谈、实地笔记和备忘录以及试验文件。参与者对创新型尼古丁疫苗的期望和体验表现出矛盾心理：尽管他们遵守了研究设计，但在整个研究过程中，他们对话语、对象和活动进行了调整，以使它们服务于自己的个人目标。他们使尼古丁疫苗接种和安慰剂治疗的概念对戒烟有意义，重塑了研究测试和强制性就诊的意义，以服务于自己的个人目标，并通过创造讨论可能危及戒烟尝试的问题的空间，为试验引入了一个新元素。简而言之，参与者将尼古丁疫苗的临床研究构建为他们自己的个人生活方式改变项目。
