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参与者在临床试验中被告知安慰剂分配后的体验。

Participants' experiences of being debriefed to placebo allocation in a clinical trial.

机构信息

Psychology, Faculty of Human and Social Sciences, University of Southampton, Southampton, United Kingdom.

出版信息

Qual Health Res. 2012 Aug;22(8):1138-49. doi: 10.1177/1049732312448544. Epub 2012 Jun 6.

Abstract

Participants in placebo-controlled clinical trials give informed consent to be randomized to verum or placebo. However, researchers rarely tell participants which treatment they actually received. We interviewed 4 participants in a trial of acupuncture for irritable bowel syndrome before, during, and after they received a course of placebo treatments over 6 weeks. During the final interview, we informed participants that they had received a course of placebo treatments. We used an idiographic phenomenological approach based on the Sheffield School to describe each participant's experiences of being blinded to and then debriefed to placebo allocation. The participants' experiences of blinding and debriefing were embodied, related to their goals in undertaking the study, and social (e.g., embedded in trusting and valued relationships with acupuncturists). We suggest ways in which debriefing to placebo allocation can be managed sensitively to facilitate positive outcomes for participants.

摘要

参加安慰剂对照临床试验的患者在知情同意的情况下被随机分配到真药组或安慰剂组。然而,研究人员很少告诉患者他们实际接受了哪种治疗。我们在一项针灸治疗肠易激综合征的试验中,在患者接受 6 周的安慰剂治疗前后对 4 名患者进行了访谈。在最后一次访谈中,我们告知患者他们接受了一疗程的安慰剂治疗。我们使用基于谢菲尔德学派的具象现象学方法,描述了每个参与者在被蒙蔽和接受安慰剂分配情况说明时的体验。参与者对蒙蔽和情况说明的体验是具体的,与他们参与研究的目标有关,并且与社会有关(例如,与针灸师的信任和有价值的关系有关)。我们提出了一些方法,可以敏感地处理安慰剂分配情况说明,为参与者带来积极的结果。

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