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为了让试验参与者在知情同意的情况下了解安慰剂效应,他们需要知道什么:一项针对腰痛患者现有知识的调查。

What trial participants need to be told about placebo effects to give informed consent: a survey to establish existing knowledge among patients with back pain.

机构信息

Royal London Hospital for Integrated Medicine, London, UK.

Department of Psychology, University of Southampton, Southampton, UK.

出版信息

J Med Ethics. 2017 Dec;43(12):867-870. doi: 10.1136/medethics-2016-103964. Epub 2017 Jun 29.

Abstract

INTRODUCTION

Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients' baseline (ie, pretrial recruitment) levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain.

DESIGN

A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of receiving placebos.

SETTING

Participants recruited from community settings completed the study online.

RESULTS

210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly (SD=2.35). However, few participants correctly answered questions about the nocebo effect (31.9% correct) and the impact of the colour of a placebo pill (55.2% correct).

CONCLUSIONS

The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects.

摘要

简介

为了确保安慰剂对照临床试验的同意书充分告知患者有关安慰剂及其可能效果的信息,患者需要准确了解安慰剂。然而,以前的研究很少探讨患者在试验前招募时对安慰剂的理解和认识的基线水平。本项在线调查旨在评估有背痛病史患者对安慰剂的了解程度。

设计

我们构建了一个包含 15 个问题的问卷来衡量对安慰剂的了解程度。其他问题评估了社会人口统计学特征、背痛的持续时间和严重程度以及接受安慰剂的既往经历。

设置

从社区环境中招募的参与者在线完成了这项研究。

结果

共有 210 名参与者完成了问卷。86.7%的人在过去 6 个月内有背痛,44.3%的人目前有背痛。4.3%的人曾接受过安慰剂干预作为临床试验的一部分,68.1%的人以前读过或听过有关安慰剂的信息。整体上对安慰剂的了解程度较高,参与者平均正确回答了 15 个关于安慰剂问题中的 12.07 个(标准差=2.35)。然而,很少有参与者正确回答了关于反安慰剂效应(31.9%正确)和安慰剂丸颜色影响的问题(55.2%正确)。

结论

研究结果确定了对安慰剂了解方面的一些关键差距。特别是对反安慰剂效应缺乏了解,这对试验参与者的知情同意产生了影响。研究伦理委员会和研究人员应优先考虑修改知情同意程序,以纳入安慰剂组参与者可能会出现不良副作用的事实。

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