Therapeutic misconception in early phase gene transfer trials
Therapeutic misconception in early phase gene transfer trials
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DOI：
10.1016/j.socscimed.2005.05.022
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发表时间：
2006-01-01
影响因子：
5.4
通讯作者：
Nelson, DK
中科院分区：
文献类型：
--
作者：
Henderson, GE;Easter, MM;Nelson, DK
早期临床试验中的许多受试者期望以某种方式从研究干预中获益。无论证据如何，人们都希望自己的病情得到改善，这是可以理解的。然而，对医疗获益的不合理期望可能反映了知情同意方面的问题：研究者可能没有明确披露早期实验干预不太可能或不可能带来直接医疗获益，或者受试者可能没有意识到治疗和研究之间的差异。本文介绍了最近对研究人员和受试者的采访结果，以及对早期基因转移研究（一种通常被称为“基因治疗”的尖端技术）中同意书的分析。我们使用三个变量来构建治疗误解TM的复合测量，挖掘关于早期研究目的的误解以及这些试验中直接医疗益处的潜力。我们的多变量模型证明了受试者和研究水平因素作为TM指数预测因子的重要性：教育、疾病类型和研究人员关于获益可能性的沟通。我们希望这项工作将深化如何定义和测量TM的讨论，并细化与受试者TM相关的因素的规范。(c)2005爱思唯尔有限公司保留所有权利。
Many subjects in early phase clinical trials expect to benefit in some way from the research intervention. It is understandable that people hope for improvement in their condition, no matter what the evidence. Yet unreasonable expectation of medical benefit may reflect problems with informed consent: Investigators may not disclose clearly that direct medical benefit from an early phase experimental intervention is unlikely or impossible, or subjects may not appreciate the differences between treatment and research. This paper presents findings from recent interviews with researchers and subjects and analysis of consent forms in early phase gene transfer research, a cutting-edge technology often called 'gene therapy. We use three variables to construct a composite measure of therapeutic misconception TM, tapping misconceptions about the purposes of early phase research and the potential for direct medical benefit in these trials. Our multivariate model demonstrates the importance of both subject- and study-level factors as predictors of this TM index: education, disease type, and communication by study personnel about the likelihood of benefit. We hope that this work will deepen the discussion of how to define and measure TM, and refine the specification of factors that are related to subjects' TM. (c) 2005 Elsevier Ltd. All rights reserved.