Understanding Patient Expectations of Treatment Outcomes

了解患者对治疗结果的期望

• 批准号: 6867716
• 负责人: Kevin P Weinfurt
• 金额: $ 38.31万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-03-09 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6867716
• 关键词: behavioral /social science research tag; clinical research; data collection methodology /evaluation; decision making; expectancy; experimental designs; health education; human subject; information system analysis; informed consent; interview; outcomes research; patient care; patient care personnel relations; questionnaires

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.

描述(由申请人提供)：知情同意程序的关键是患者对有关其治疗选择的相关信息的理解。我们以前的工作和其他人的工作引起了人们对这一进程的充分性的关切。在NCI资助的一项早期研究中，我们发现，被提供参与早期肿瘤学试验的患者经常报告对实验性治疗的好处有很高的期望。如果这些过高的期望反映了对治疗性质的错误信念，那么它们就会使患者的同意无效。然而，从现有的证据中尚不清楚，患者是否在每次表达对收益的高期望时，都表现出对治疗的错误认识。也许患者对受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。如果不知道患者对利益的期望的含义，就不能得出知情同意程序未能确保患者理解的结论。这项建议的目的是更好地理解患者在知情同意过程中报告的对治疗结果的期望的含义。为了实现这一目标，我们将追求3个具体目标：(1)确定参与第一阶段和第二阶段研究的患者如何理解有关他们对治疗结果的期望的问题。研究1将通过对患者的认知访谈来解决这一目标。(2)确定病人对治疗结果的估计如何取决于病人被要求提供估计的方式。研究2将使用一种实验设计来解决这一目标，在实验设计中，将操纵询问患者期望的方式。(3)描述与对治疗结果的更高期望相关的患者特征。这一目标将在研究2的背景下通过使用面试者管理的调查来评估不同的患者特征来实现。拟议研究的结果将有助于确定患者对治疗预期的报告是否以及何时表明知情同意程序失败。这一结果也将适用于广泛的患者，他们正在考虑威胁生命的疾病的治疗方案。