Preventive misconception - Its nature, presence, and ethical implications for research
Preventive misconception - Its nature, presence, and ethical implications for research
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DOI：
10.1016/j.amepre.2007.01.007
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发表时间：
2007-05-01
影响因子：
5.5
通讯作者：
Sugarman, Jeremy
中科院分区：
文献类型：
--
作者：
Simon, Alan E.;Wu, Albert W.;Sugarman, Jeremy
背景：预防性试验的伦理方面，因为它们不同于治疗性试验，还没有得到充分的探讨。本文旨在定义和证明“预防性误解”（PM）的存在，这是一种误解，即预防性试验中的研究参与者“高估了参加预防性干预试验所提供的个人保护的概率或水平”。“方法：一个评级工具的开发，以评估PM，使用2000年8月至2002年7月之间收集的数据作为一个全国性的研究的一部分，在一个带状疱疹疫苗试验的知情同意的质量。在2005-2006年期间，两对评分员评估了50名参与者对参与者同意参加带状疱疹试验后提出的问题的回答。两对评分员评价了PM的存在和类型的反应。每对评分者对他们的回答进行评判，并评估评分者间的信度。（CI：20.7%-45.9%）的参与者显示PM证据（kappa=0.71，CI：0.52-0.90）; 12%（CI：5.2%-24.2%）的受试者低估了接受安慰剂的可能性（kappa=0.53，CI：0.24-0.83）; 24%（CI：14.2%-37.6%）高估了实验干预的可能个人有效性结论：本研究对预防性误解的概念进行了新的描述，并在预防性试验中证实了其存在。研究参与者可能高估了他们通过参加预防试验所获得的保护，这对研究提出了伦理挑战。
Background: Ethical aspects of prevention trials, as they differ from therapeutic trials, have not been fully explored. This article aims to define and demonstrate the existence of "preventive misconception" (PM), a misunderstanding in which research participants in prevention trials make an "overestimate in probability or level of personal protection that is afforded by being enrolled in a trial of a preventive intervention."Methods: A rating tool was developed to evaluate PM, using data collected between August 2000 and July 2002 as part of a nationwide study of the quality of informed consent in a trial of a shingles vaccine. During 2005-2006, two pair of raters assessed the responses of 50 participants to questions asked after the participants had given consent to participate in the shingles trial. Two pair of raters evaluated the response for the presence and type of PM. Each pair of raters adjudicated their responses and inter-rater reliability was assessed.Results: Adjudicated pairs of raters agreed that 32% (CI: 20.7%-45.9%) of participants showed evidence of PM (kappa=0.71, CI: 0.52-0.90); that 12% (CI: 5.2%-24.2%) of participants underestimated the probability of receiving placebo (kappa=0.53, CI: 0.24-0.83); and that 24% (CI: 14.2%-37.6%) overestimated the likely personal effectiveness of the experimental intervention (kappa=0.42, CI: 0.08-0.76).Conclusions: This study newly describes the concept of preventive misconception and empirically demonstrates its existence in trials of prevention. Study participants may overestimate the protection that they receive by being enrolled in a trial of prevention, which poses, ethical challenges for research.