Understanding Patient Expectations of Treatment Outcomes

描述（由申请人提供）：知情同意过程的关键是患者对其治疗方案相关信息的理解。我们以前的工作和其他人的工作引起了人们对这一进程是否充分的关注。在早期的一项由美国国家癌症研究所资助的研究中，我们发现参与早期肿瘤学试验的患者经常报告对实验性治疗的益处有很高的期望。如果这些高期望反映了对治疗性质的错误信念，那么他们就会使患者的同意无效。然而，从现有的证据来看，还不清楚患者是否在每次表达对获益的高期望时都表现出对治疗的错误认识。也许患者对获益的高期望反映了对概率的不同解释和/或表达治疗期望的不同动机。如果不了解患者期望获益的含义，就不能得出结论说知情同意程序未能确保患者的理解。本提案的目的是更好地理解患者在知情同意过程中报告的治疗结果预期的含义。为了实现这一目标，我们将追求3个具体目标：（1）确定参与I期和II期研究的患者如何理解有关其治疗结局预期的问题。研究1将通过对患者的认知访谈来实现这一目标。(2)确定患者对治疗结果的估计如何取决于患者如何被要求提供估计。研究2将使用一种实验设计来解决这一目标，在这种设计中，患者被询问他们的期望的方式将被操纵。(3)描述与治疗结果相关的更高期望相关的患者特征。这一目标将在研究2的背景下通过使用访谈者管理的调查评估不同的患者特征来解决。拟议研究的结果将有助于确定患者对治疗期望的报告是否以及何时表明知情同意过程失败。这些结果也将适用于正在考虑治疗危及生命的疾病的患者。

DESCRIPTION (provided by applicant): The crux of the informed consent process is patients' understanding of pertinent information about their treatment options. Our previous work and that of others has raised concerns about the adequacy of this process. In an earlier NCI-funded study, we found that patients who were offered participation in early phase oncology trials frequently reported high expectations about the benefit of an experimental therapy. If these high expectations reflect false beliefs about the nature of treatment, then they invalidate the patient's consent. It is unclear from the available evidence, however, whether patients are demonstrating faulty knowledge about a treatment every time they express high expectations of benefit. Perhaps patients' high expectations of benefit reflect a different interpretation of probability and/or a different motivation for expressing treatment expectations. Without knowing the meaning of patients' expectations of benefit, one cannot conclude that the informed consent process has failed to ensure the patients' understanding. The objective of this proposal is to better understand the meaning of patients' reported expectations regarding treatment outcomes in the informed consent process. To accomplish this objective, we will pursue 3 Specific Aims: (1) To determine how patients who are offered participation in phase I and II studies understand questions regarding their expectations of treatment outcomes. Study 1 will address this aim using cognitive interviews of patients. (2) To determine how patients' estimates of treatment outcomes depend upon how the patients are asked to provide the estimates. Study 2 will address this aim using an experimental design in which the way patients are queried about their expectations will be manipulated. (3) To describe patient characteristics that are associated with higher expectations regarding treatment outcomes. This aim will be addressed in the context of Study 2 by assessing different patient characteristics using an interviewer-administered survey. Findings from the proposed research will help to determine if and when patients' reports of treatment expectations indicate a failure of the informed consent process. The results will also be applicable to a broad array of patients who are considering treatment options for life threatening diseases.