METHODS: Thematic analysis of open-ended, semi-structured interviews with eight people who participated in an inpatient clinical trial of lisdexamfetamine for acute methamphetamine withdrawal. Interviews were conducted between days 3 and 6 of admission to an inner-city Sydney hospital.
RESULTS: Participants described how research procedures, the research setting, and the investigational product affected their experiences while enrolled in a clinical trial. Of particular importance to participants were transparent and low burden trial procedures, a welcoming trial environment, trusting relationships and effective communication, which were linked with the participants\' subsequent decision to remain enrolled in the trial.
CONCLUSIONS: The experiences of participants in this clinical trial can be distilled into four meta-themes: agency, caring-trust, safety, and communication. Participants spontaneously linked these experiences with a capacity to remain enrolled in the study. By considering the experiences of trial participants in clinical trial design, researchers can improve the experiences of future trial participants and facilitate their choice to remain enrolled in clinical trials.
方法:开放式主题分析,对8人进行了半结构化访谈,这些人参与了利德西非他明用于急性甲基苯丙胺戒断的住院临床试验。面试是在悉尼市中心医院入院的第3天至第6天进行的。
结果:参与者描述了研究程序,研究环境,研究产品影响了他们在参加临床试验时的经历。对参与者特别重要的是透明和低负担的审判程序,一个受欢迎的试验环境,信任关系和有效的沟通,这与参与者随后决定继续参加试验有关.
结论:这项临床试验参与者的经验可以归纳为四个元主题:机构,关怀信任,安全,和沟通。参与者自发地将这些经历与继续参与研究的能力联系起来。通过考虑临床试验设计中试验参与者的经验,研究人员可以改善未来试验参与者的体验,并帮助他们选择继续参加临床试验.