Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, USA
J Med Ethics. 2020 Mar;46(3):172-177. doi: 10.1136/medethics-2019-105377. Epub 2019 Aug 31.
Researchers worry that patients in early-phase research experience unrealistic optimism about benefits and risks of participation. The standard measure of unrealistic optimism is the Comparative Risk/Benefit Assessment (CRBA) questionnaire, which asks people to estimate their chances of an outcome relative to others in similar situations. Such a comparative framework may not be a natural way for research participants to think about their chances.
To examine how people interpret questions measuring unrealistic optimism and how their interpretations are associated with their responses.
Using an early-phase cancer trial vignette, we administered the CRBA to 297 adults from the general public. They estimated their comparative chances of risk and benefit (7-point scale: -3 less likely to +3 more likely), then provided rationales for their estimates.
For both CRBA benefit and risk questions, about 50% of respondents chose 0 (the 'correct' response of 'average likelihood'), and 50% chose a non-0 response. Respondents' rationales for their estimates showed that overall only about 40%-44% gave comparative rationales, indicating that they interpreted the CRBA as intended. 68.7% of respondents who gave the 'correct' 0 rating gave comparative rationales, whereas only 11.6% of respondents who gave non-0 ratings did so. A similar trend was seen for chances of risk (p<0.001 for both).
Research participants may not understand comparative benefit and risk questions as intended; attributions of unrealistic optimism may require additional evidence that the respondents' estimates are intended to be comparative.
研究人员担心处于研究早期阶段的患者对参与的获益和风险会产生不切实际的乐观。不切实际乐观的标准衡量方法是相对获益/风险评估（CRBA）问卷，该问卷要求人们估计自己相对于类似情况下其他人的结果的机会。这样的比较框架可能不是研究参与者思考自己机会的自然方式。
研究人们如何解释衡量不切实际乐观的问题，以及他们的解释如何与其反应相关联。
使用早期癌症试验的虚构案例，我们向 297 名来自普通公众的成年人施测了 CRBA。他们估计了自己的风险和获益的相对机会（7 分制：-3 表示不太可能，+3 表示更有可能），然后为他们的估计提供了理由。
对于 CRBA 的获益和风险问题，大约有 50%的受访者选择 0（“正确”的平均可能性反应），而 50%选择了非 0 反应。受访者对其估计的理由表明，总体而言，只有约 40%-44%给出了比较性的理由，表明他们按照预期解释了 CRBA。68.7%给出“正确”0 评级的受访者给出了比较性的理由，而只有 11.6%给出非 0 评级的受访者给出了比较性的理由。对于风险的机会，也出现了类似的趋势（两者均 p<0.001）。
研究参与者可能没有按照预期理解相对获益和风险问题；不切实际的乐观归因可能需要额外的证据来证明受访者的估计是有比较性的。
