Weinfurt Kevin P, Castel Liana D, Li Yun, Sulmasy Daniel P, Balshem Andrew M, Benson Al B, Burnett Caroline B, Gaskin Darrell J, Marshall John L, Slater Elyse F, Schulman Kevin A, Meropol Neal J
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27715, USA.
Cancer. 2003 Jul 1;98(1):166-75. doi: 10.1002/cncr.11483.
Patients in Phase I clinical trials sometimes report high expectations regarding the benefit of treatment. The authors examined a range of patient characteristics to determine which factors were associated with greater expectations of benefit from Phase I trials.
Participants were adult patients with cancer who had been offered participation in Phase I studies and had decided to participate. Patients completed interviewer-administered surveys before initiation of treatment. Physicians assessed Eastern Cooperative Oncology Group performance status for each patient. Statistical analyses (Pearson product moment correlation and t tests) used multiple imputation to account for missing data.
Overall, 593 patients who were offered participation in Phase I trials were contacted, and 328 patients agreed to participate in a study of decision making by cancer patients. Of these, 260 patients (79%) enrolled in a Phase I trial. Patients' expectations regarding the chance that their disease would be controlled with experimental therapy were unrelated to age, gender, living situation, education level, or functional status. Expectations were correlated positively with beliefs about the benefit of standard therapy and the maximum benefit patients may experience from experimental therapy. Greater expectations of benefit were associated with better health-related quality of life, stronger religious faith, optimism, relative health stock, monetary risk seeking, and poorer numeracy.
Expectations expressed as beliefs in personal outcomes may be related more to quality of life and personality variables than to patients' knowledge or functional status. Whether such expectations are accurate reflections of knowledge has important implications for evaluating the informed consent process.
I期临床试验中的患者有时会对治疗益处抱有很高期望。作者研究了一系列患者特征，以确定哪些因素与对I期试验更大的益处期望相关。
参与者为成年癌症患者，他们被邀请参加I期研究并决定参与。患者在开始治疗前完成由访谈者实施的调查。医生评估每位患者的东部肿瘤协作组体能状态。统计分析（Pearson积矩相关和t检验）使用多重填补法处理缺失数据。
总体而言，联系了593名被邀请参加I期试验的患者，328名患者同意参与一项关于癌症患者决策的研究。其中，260名患者（79%）参加了I期试验。患者对其疾病通过实验性治疗得到控制的可能性的期望与年龄、性别、生活状况、教育水平或功能状态无关。期望与对标准治疗益处的信念以及患者从实验性治疗中可能获得的最大益处呈正相关。对益处的更高期望与更好的健康相关生活质量、更强的宗教信仰、乐观情绪、相对健康状况、金钱风险寻求和较差的数字运算能力相关。
以对个人结果的信念表达的期望可能更多地与生活质量和个性变量有关，而非与患者的知识或功能状态有关。这些期望是否准确反映知识对评估知情同意过程具有重要意义。
