Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials
Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials
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DOI：
10.1186/s13063-020-04591-w
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发表时间：
2020-07-17
期刊：
影响因子：
2.5
通讯作者：
Hood, Kerenza
中科院分区：
文献类型：
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作者：
Kirby, Nigel;Shepherd, Victoria;Hood, Kerenza
研究背景临床试验参与者所经历的Nocbo效应(“负性安慰剂”效应)可能源于潜在的疾病，或通过在参与者信息传单(或其他地方)中关于副作用的交流而产生。错误地将NOCEBO效应归因于药物干预可能会导致参与者经历有害的NOCEBO效应，并可能导致不良反应报告的失真。然而，关于潜在副作用的信息是如何提供给试验参与者的，人们知之甚少。越来越多的人担心，在临床试验中，在参与者信息传单(PIL)中向患者描述潜在副作用的方式本身可能会通过增加焦虑、依从性差或诱导副作用本身而造成伤害。在这项研究中，我们旨在探索这些担忧，并确定在试验中使用的研究用医药产品的潜在副作用是如何以书面信息呈现给潜在参与者的。方法从国际标准随机对照试验号码(ISRCTN)临床试验登记(世界卫生组织国际临床试验登记平台(ICTRP)的主要登记)中确定试验。符合条件的研究是在英国进行的成人研究药物(IMP)的安慰剂对照临床试验。我们使用Flesch阅读轻松度量表、Gunning-Fog指数和Flesch-Kincaid等级来评估可读性。从PILS中提取的数据被分成8个预定义的定性主题，以便在NVivo11中进行分析。结果根据Flesch阅读轻松度量表，大多数患者信息传单被评为“相当难读”或“难读”。所有的研究都提供了关于不良事件的信息，而只有三分之一的研究提供了关于干预益处的信息。在出现干预或研究益处的地方，通常是在不良事件之后(21/33，%)。讨论参与者的信息传单在易读性方面得分较低，与不利影响有关的内容多于任何潜在的有益影响。不良事件的呈现方式在其可能性和严重性以及提供的详细程度和数量方面是不同的。相比之下，干预和/或研究的潜在益处较少用较短的文本描述，而且只在有关危害的信息之后描述。
Background Nocebo effects ('negative placebo' effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). Misattributing nocebo effects to the medicinal intervention can lead to participants experiencing harmful nocebo effects and may result in distortion of adverse effect reporting. However, little is known about how information on potential side effects is provided to trial participants. There is increasing concern that the way in which potential side effects in clinical trials are described to patients in participant information leaflets (PIL) can in itself cause harm by either increased anxiety, poor adherence or inducing the side effect itself. In this study, we aimed to explore these concerns and identify the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants. Methods Trials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry (a primary registry of the WHO International Clinical Trials Registry Platform (ICTRP)). Eligible studies were placebo-controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11. Results Most of the patient information leaflets were ranked as 'fairly difficult to read' or 'difficult to read' according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33, 64%). Discussion Participant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. By comparison, potential benefits from the intervention and/or study were described less often, by shorter text, and only after information about harms.