Research Participants' High Expectations of Benefit in Early-Phase Oncology Trials: Are We Asking the Right Question?
Research Participants' High Expectations of Benefit in Early-Phase Oncology Trials: Are We Asking the Right Question?
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DOI：
10.1200/jco.2011.40.6587
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发表时间：
2012-12-10
影响因子：
45.3
通讯作者：
Meropol, Neal J.
中科院分区：
文献类型：
--
作者：
Weinfurt, Kevin P.;Seils, Damon M.;Meropol, Neal J.
PurposeTo确定患者的期望是否受益于早期肿瘤学试验取决于患者如何查询，并探讨是否与患者的characteristics.Patients和MethodsParticipants的期望是171例患者在美国的I期或II期肿瘤学试验。在提供试验的知情同意书后，但在接受研究性治疗之前，参与者回答了有关预期获益的问题。我们将参与者随机分配到三组中的一组，对应于三个关于期望的查询：频率类型，信念类型或两者兼而有之。主要结果是不同问题类型的期望差异，以及期望与人口统计学特征，算术，性格乐观，宗教/精神，对研究的理解和其他措施的相关程度。（64.4/100）高于联合组（51.6; P = .01）和频率型组（43.1; P < .001）。组合和频率组的平均期望值无显著差异（P = .06）。信念型期望与对非定量信息的偏好有关（r = -0.19; 95%CI，-0.19至-0.36），研究知识（r = -0.21; 95%CI，-0.38至-0.03）、性格乐观（r = 0.20; 95%CI，0.01至0.37）和灵性（r = 0.22; 95%CI，0.03至0.38）。频率型预期与临床研究知识相关（r = -0.27; 95%CI，-0.27 to -0.51）。ConclusionIn early-phase oncology trials，patients' reported expectations of benefit different during the patients were questioned and were associated with patient characteristics.这些发现对如何获得和评估知情同意具有影响。J Clin Oncol 30：4396-4400. (C)2012年美国临床肿瘤学会
PurposeTo determine whether patients' expectations of benefit in early-phase oncology trials depend on how patients are queried and to explore whether expectations are associated with patient characteristics.Patients and MethodsParticipants were 171 patients in phase I or II oncology trials in the United States. After providing informed consent for a trial but before receiving the investigational therapy, participants answered questions about expectations of benefit. We randomly assigned participants to one of three groups corresponding to three queries about expectations: frequency type, belief type, or both. Main outcomes were differences in expectations by question type and the extent to which expectations were associated with demographic characteristics, numeracy, dispositional optimism, religiousness/spirituality, understanding of research, and other measures.ResultsThe belief-type group had a higher mean expectation of benefit (64.4 of 100) than the combination group (51.6; P = .01) and the frequency-type group (43.1; P < .001). Mean expectations in the combination and frequency groups were not significantly different (P = .06). Belief-type expectations were associated with a preference for nonquantitative information (r = -0.19; 95% CI, -0.19 to -0.36), knowledge about research (r = -0.21; 95% CI, -0.38 to -0.03), dispositional optimism (r = 0.20; 95% CI, 0.01 to 0.37), and spirituality (r = 0.22; 95% CI, 0.03 to 0.38). Frequency-type expectations were associated with knowledge about clinical research (r = -0.27; 95% CI, -0.27 to -0.51).ConclusionIn early-phase oncology trials, patients' reported expectations of benefit differed according to how patients were queried and were associated with patient characteristics. These findings have implications for how informed consent is obtained and assessed. J Clin Oncol 30: 4396-4400. (C) 2012 by American Society of Clinical Oncology