The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials.
The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials.
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DOI：
10.1002/cncr.25201
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发表时间：
2010-08-01
期刊：
影响因子：
6.2
通讯作者：
Weinfurt, Kevin P.
中科院分区：
文献类型：
--
作者：
Sulmasy, Daniel P.;Astrow, Alan B.;He, M. Kai;Seils, Damon M.;Meropol, Neal J.;Micco, Ellyn;Weinfurt, Kevin P.
患者对参与早期试验的治疗获益机会的估计大大超过了历史数据。伦理学家担心这种“治疗误判”会破坏知情同意的有效性。我们采访了45名参加I期或II期肿瘤学试验的患者，了解他们对治疗益处的期望以及他们期望这些期望的原因。我们采用了现象学，定性的方法与一个主要的编码器，以确定紧急的主题，验证了2个独立的编码器。治疗获益的中位预期从50%到80%不等，这取决于问题的提问方式。理由普遍唤起希望和乐观，27/45的参与者使用了其中一个词。出现了三大主题：（1）乐观主义是行为的，也就是说，积极的思想和表达可以增加受益的机会;（2）与癌症作斗争;（3）对上帝、科学或两者的信仰。许多参与者描述了一种鼓励和期望乐观的文化，因此试验招募成为反映这种期望的一种方式。许多人报告说，他们被告知很少有患者会受益，似乎理解临床研究的不确定性，但表达了很高的预期个人治疗益处。更痛苦的参与者不太可能为他们的期望援引表演理由（50%对84%; P = 0.04）。高预期治疗获益的表达与报告知识关系不大，与表达乐观关系更大。这些结果对于理解如何在早期临床试验中获得参与者的有效同意具有重要意义。
Patients’ estimates of their chances of therapeutic benefit from participation in early-phase trials greatly exceed historical data. Ethicists worry that this “therapeutic misestimation” undermines the validity of informed consent. We interviewed 45 patients enrolled in phase I or II oncology trials about their expectations of therapeutic benefit and their reasons for those expectations. We employed a phenomenological, qualitative approach with one primary coder to identify emergent themes, verified by 2 independent coders. Median expectations of therapeutic benefit varied from 50% to 80%, depending on how the question was asked. Justifications universally invoked hope and optimism, and 27/45 participants used one of these words. Three major themes emerged: (1) optimism as performative, that is, the notion that positive thoughts and expressions improve chances of benefit; (2) fighting cancer as a battle; and (3) faith in God, science, or both. Many participants described a culture in which optimism was encouraged and expected, such that trial enrollment became a way of reflecting this expectation. Many reported they had been told few patients would benefit and appeared to understand the uncertainties of clinical research, yet expressed high expected personal therapeutic benefit. More distressed participants were less likely to invoke performative justifications for their expectations (50% vs 84%; P = .04). Expressions of high expected therapeutic benefit had little to do with reporting knowledge and more to do with expressing optimism. These results have implications for understanding how to obtain valid consent from participants in early-phase clinical trials.
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