Duke University, Durham, NC 27715, USA.
J Clin Oncol. 2012 Dec 10;30(35):4396-400. doi: 10.1200/JCO.2011.40.6587. Epub 2012 Oct 22.
To 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.
Participants 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.
The 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).
In 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.
确定患者对早期肿瘤试验获益的期望是否取决于患者的提问方式，并探讨这些期望是否与患者特征相关。
本研究在美国进行的 I 期或 II 期肿瘤试验中纳入了 171 名患者。在签署知情同意书参与试验但尚未接受试验性治疗之前，参与者回答了关于获益期望的问题。我们将参与者随机分配到三个问题组之一，对应三种询问期望的方式：频率类型、信念类型或两者兼而有之。主要结局是不同问题类型之间的期望差异，以及期望与人口统计学特征、计算能力、倾向性乐观、宗教/精神信仰、对研究的理解以及其他措施的相关性。
信念类型组的平均获益期望（64.4 分[100 分制]）高于组合组（51.6；P=0.01）和频率类型组（43.1；P<0.001）。组合组和频率组的平均期望没有显著差异（P=0.06）。信念类型的期望与对非定量信息的偏好（r=-0.19；95%CI，-0.19 至-0.36）、对研究的了解（r=-0.21；95%CI，-0.38 至-0.03）、倾向性乐观（r=0.20；95%CI，0.01 至 0.37）和精神信仰（r=0.22；95%CI，0.03 至 0.38）相关。频率类型的期望与对临床研究的了解相关（r=-0.27；95%CI，-0.27 至-0.51）。
在早期肿瘤试验中，患者报告的获益期望因提问方式而异，并且与患者特征相关。这些发现对如何获得和评估知情同意具有影响。
