Reactions to treatment debriefing among the participants of a placebo controlled trial.
Reactions to treatment debriefing among the participants of a placebo controlled trial.
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DOI：
10.1186/1472-6963-5-30
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发表时间：
2005-04-22
影响因子：
2.8
通讯作者：
Kleijnen J
中科院分区：
文献类型：
--
作者：
Di Blasi Z;Crawford F;Bradley C;Kleijnen J
相当大比例的试验参与者对安慰剂的各种条件有反应。尽管这些试验的共同实施和对知情同意的高度重视，但对在试验结束时告知参与者其个体治疗分配的情况知之甚少。本研究旨在通过探索安慰剂对照随机临床试验（RCT）参与者的治疗信念和对治疗分配反馈的反应来解决文献中的这一差距。使用半结构化问卷调查试验参与者，包括封闭式和开放式问题，通过电话访谈和邮寄问卷进行管理。试验参与者入组了一项双盲安慰剂对照RCT，评价皮质类固醇治疗足跟痛的有效性（ISRCTN 36539116）。试验已经结束，参与者对治疗分配保持盲态。我们评估了治疗期望、希望了解治疗分配的参与者百分比、他们的猜测能力和对汇报的反应。46名（73%）可联系的参与者对我们的调查做出了回应。42例合格（4例双侧疾病受试者被排除，因为他们接受了两种治疗）。大多数（79%）参与者在接受治疗之前没有任何期望，但许多人“希望”有帮助。没有高期望的原因包括他们护理的实验性质和他们可能得到安慰剂的可能性。参与者充满希望，因为他们的痛苦是如此严重，因为他们信任的工作人员和服务。大多数人（83%）希望了解他们的治疗分配和研究结果。超过一半（55%）的人说他们无法猜测他们被随机分配到哪种治疗，许多试图猜测的人都是错误的。对治疗报告的反应通常是积极的，包括安慰剂应答者。我们的研究表明，大多数试验参与者希望了解他们的治疗分配和试验结果。需要进一步的研究来制定希望和期望的衡量标准，并严格评估前瞻性汇报的效果。
A significant proportion of trial participants respond to placebos for a variety of conditions. Despite the common conduct of these trials and the strong emphasis placed on informed consent, very little is known about informing participants about their individual treatment allocation at trial closure. This study aims to address this gap in the literature by exploring treatment beliefs and reactions to feedback about treatment allocation in the participants of a placebo-controlled randomized clinical trial (RCT). Survey of trial participants using a semi-structured questionnaire including close and open-ended questions administered as telephone interviews and postal questionnaires. Trial participants were enrolled in a double-blind placebo-controlled RCT evaluating the effectiveness of corticosteroid for heel pain (ISRCTN36539116). The trial had closed and participants remained blind to treatment allocation. We assessed treatment expectations, the percentage of participants who wanted to be informed about their treatment allocation, their ability to guess and reactions to debriefing. Forty-six (73%) contactable participants responded to our survey. Forty-two were eligible (four participants with bilateral disease were excluded as they had received both treatments). Most (79%) participants did not have any expectations prior to receiving treatment, but many 'hoped' that something would help. Reasons for not having high expectations included the experimental nature of their care and possibility that they may get a placebo. Participants were hopeful because their pain was so severe and because they trusted the staff and services. Most (83%) wanted to be informed about their treatment allocation and study results. Over half (55%) said they could not guess which treatment they had been randomized to, and many of those who attempted a guess were incorrect. Reactions to treatment debriefing were generally positive, including in placebo responders. Our study suggests that most trial participants want to be informed about their treatment allocation and trial results. Further research is required to develop measure of hope and expectancy and to rigorously evaluate the effects of debriefing prospectively.
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影响因子：
5.5
作者：
Crawford, F;Atkins, D;Edwards, J
通讯作者：
Edwards, J
影响因子：
5.5
作者：
Atkins, D;Crawford, F;Lambert, M
通讯作者：
Lambert, M
DOI：
10.1111/j.1365-2753.2004.00512.x
发表时间：
2005-02-01
影响因子：
2.4
作者：
Stone, DA;Kerr, CE;Kaptchuk, TJ
通讯作者：
Kaptchuk, TJ
影响因子：
17.7
作者：
Leuchter, AF;Cook, IA;Abrams, M
通讯作者：
Abrams, M
影响因子：
2.2
作者：
Michels, KB;Rothman, KJ
通讯作者：
Rothman, KJ