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首页> 外文期刊>JMIR Research Protocols >Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website
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Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website

机译：告知患者安慰剂的作用：使用证据，理论和定性方法开发新网站

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Background According to established ethical principles and guidelines, patients in clinical trials should be fully informed about the interventions they might receive. However, information about placebo-controlled clinical trials typically focuses on the new intervention being tested and provides limited and at times misleading information about placebos. Objective We aimed to create an informative, scientifically accurate, and engaging website that could be used to improve understanding of placebo effects among patients who might be considering taking part in a placebo-controlled clinical trial. Methods Our approach drew on evidence-, theory-, and person-based intervention development. We used existing evidence and theory about placebo effects to develop content that was scientifically accurate. We used existing evidence and theory of health behavior to ensure our content would be communicated persuasively, to an audience who might currently be ignorant or misinformed about placebo effects. A qualitative ‘think aloud’ study was conducted in which 10 participants viewed prototypes of the website and spoke their thoughts out loud in the presence of a researcher. Results The website provides information about 10 key topics and uses text, evidence summaries, quizzes, audio clips of patients’ stories, and a short film to convey key messages. Comments from participants in the think aloud study highlighted occasional misunderstandings and off-putting/confusing features. These were addressed by modifying elements of content, style, and navigation to improve participants’ experiences of using the website. Conclusions We have developed an evidence-based website that incorporates theory-based techniques to inform members of the public about placebos and placebo effects. Qualitative research ensured our website was engaging and convincing for our target audience who might not perceive a need to learn about placebo effects. Before using the website in clinical trials, it is necessary to test its effects on key outcomes including patients’ knowledge and capacity for making informed choices about placebos.
机译：背景技术根据既定的道德原则和准则，应充分告知临床试验患者可能接受的干预措施。但是，有关安慰剂对照临床试验的信息通常集中在正在测试的新干预措施上，并提供有关安慰剂的有限且有时会引起误解的信息。目的我们的目标是创建一个信息丰富，科学准确且引人入胜的网站，该网站可用于增进可能正在考虑参加安慰剂对照临床试验的患者对安慰剂作用的了解。方法我们的方法基于证据，理论和基于人的干预开发。我们使用有关安慰剂作用的现有证据和理论来开发科学上准确的内容。我们使用现有的证据和健康行为理论来确保我们的内容能被有说服力的传达给目前可能对安慰剂作用无知或误解的听众。进行了定性的“大声思考”研究，其中10位参与者查看了网站的原型，并在研究员在场的情况下大声说出了自己的想法。结果该网站提供有关10个关键主题的信息，并使用文本，证据摘要，测验，患者故事的音频剪辑和短片来传达关键信息。大声思考研究参与者的评论强调了偶尔的误解和令人反感/令人困惑的功能。通过修改内容，样式和导航元素来改善这些问题，以改善参与者使用网站的体验。结论我们已经建立了一个基于证据的网站，该网站结合了基于理论的技术，以向公众介绍安慰剂和安慰剂的作用。定性研究确保我们的网站吸引并说服了目标受众，使他们可能没有必要了解安慰剂的作用。在临床试验中使用该网站之前，有必要测试其对关键结局的影响，包括患者的知识和做出有关安慰剂的明智选择的能力。

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