早期肿瘤学试验中的性格乐观与治疗期望
Dispositional optimism and therapeutic expectations in early-phase oncology trials.
作者信息
Jansen Lynn A, Mahadevan Daruka, Appelbaum Paul S, Klein William M P, Weinstein Neil D, Mori Motomi, Daffé Racky, Sulmasy Daniel P
机构信息
Madeline Brill Nelson Chair in Ethics Education, Center for Ethics in Health Care, Oregon Health & Science University, Portland, Oregon.
Professor of Medicine, University of Arizona Cancer Center.
出版信息
Cancer. 2016 Apr 15;122(8):1238-46. doi: 10.1002/cncr.29908. Epub 2016 Feb 16.
BACKGROUND
Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early-phase oncology trials. However, optimism is not a unitary construct; it also can be defined as a general disposition, or what is called dispositional optimism. The authors assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. The authors also assessed how dispositional optimism related to unrealistic optimism.
METHODS
Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception.
RESULTS
Dispositional optimism was found to be significantly associated with higher expectations for personal therapeutic benefit (Spearman rank correlation coefficient [r], 0.333; P<.0001), but was not associated with the therapeutic misconception (Spearman r, -0.075; P = .329). Dispositional optimism was found to be weakly associated with unrealistic optimism (Spearman r, 0.215; P = .005). On multivariate analysis, both dispositional optimism (P = .02) and unrealistic optimism (P<.0001) were found to be independently associated with high expectations for personal therapeutic benefit. Unrealistic optimism (P = .0001), but not dispositional optimism, was found to be independently associated with the therapeutic misconception.
CONCLUSIONS
High expectations for therapeutic benefit among patient-subjects in early-phase oncology trials should not be assumed to result from misunderstanding of specific information regarding the trials. The data from the current study indicate that these expectations are associated with either a dispositionally positive outlook on life or biased expectations concerning specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early-phase oncology research.
背景
先前的研究已将不切实际的乐观主义确定为一种偏差,这种偏差可能会损害肿瘤学早期试验中患者受试者的知情同意。然而,乐观并非单一的概念;它也可被定义为一种总体倾向,即所谓的特质性乐观。作者评估了特质性乐观是否与这些试验中患者受试者报告的对个人治疗益处的高期望相关,但与治疗错误观念无关。作者还评估了特质性乐观与不切实际的乐观主义之间的关系。
方法
患者受试者完成了旨在测量对治疗益处的期望、特质性乐观、不切实际的乐观主义和治疗错误观念的问卷。
结果
发现特质性乐观与对个人治疗益处的更高期望显著相关(斯皮尔曼等级相关系数[r],0.333;P<0.0001),但与治疗错误观念无关(斯皮尔曼r,-0.075;P = 0.329)。发现特质性乐观与不切实际的乐观主义弱相关(斯皮尔曼r,0.215;P = 0.005)。在多变量分析中,发现特质性乐观(P = 0.02)和不切实际的乐观主义(P<0.0001)均与对个人治疗益处的高期望独立相关。发现不切实际的乐观主义(P = 0.0001)而非特质性乐观与治疗错误观念独立相关。
结论
不应假定肿瘤学早期试验中患者受试者对治疗益处的高期望是由于对试验具体信息的误解所致。当前研究的数据表明,这些期望与对生活的特质性积极看法或对试验参与特定方面的偏差期望有关。并非所有乐观表现都是相同的,不同类型的乐观可能对肿瘤学早期研究中的知情同意产生不同后果。