Measuring Patient Expectations for CAM Therapies

描述（由申请人提供）：许多临床医生和研究人员认为，期望特定治疗能够缓解症状的患者更有可能从该治疗中受益。然而，对评估补充和替代医学（CAM）治疗慢性背痛的临床试验数据的分析并没有一致地发现治疗前的预期可以预测更好的结果。由于缺乏关于患者期望如何影响治疗结果的适当概念模型，以及缺乏用于捕获患者期望的有效问卷，对这些相互矛盾的结果的解释变得复杂。为了帮助进一步了解期望与治疗结果之间的关系，本申请建议系统地开发和验证一份问卷，以评估患者对慢性背痛的CAM治疗的期望。这个三期项目的第一阶段将侧重于全面了解治疗预期概念背后的问题。这将包括进行访谈，以收集有关背痛患者以及背痛常用的四种CAM疗法（针灸、脊椎指压疗法、按摩、瑜伽）提供者的期望的定性信息。将使用严格的定性研究方法来分析访谈数据，以确定与期望发展相关的关键概念域。然后，这些分析的结果将用于创建一个概念模型，说明患者对治疗成功的期望在治疗开始后是如何发展和变化的。第二阶段的活动将侧重于开发一份问卷来评估患者的期望，第三阶段将测试问卷的心理测量特性（例如，信度和效度）。问卷将在不同的临床和研究人群中进行测试。该项目预计将产生一份心理测量学上健全的问卷，可用于CAM和传统研究界，以衡量慢性背痛非药物治疗临床试验中患者对治疗结果期望的重要性。开发一个概念模型来理解患者期望与治疗结果之间的关系，并创建一个有效和可靠的问卷来评估患者的期望，将为未来研究情境效应如何影响治疗结果提供有价值的工具。这样的研究有可能提高对如何最有效地将随机疗效试验结果转化为临床实践的理解。

DESCRIPTION (provided by applicant): Many clinicians and researchers believe that patients who expect that a specific treatment will relieve their symptoms will be more likely to benefit from that treatment. However, analyses of data from clinical trials evaluating complementary and alternative medicine (CAM) treatments for chronic back pain have not consistently found pre-treatment expectations to be predictive of superior outcomes. Interpretation of these conflicting results has been complicated by the absence of an adequate conceptual model of how patient expectations might affect treatment outcomes and the lack of a validated questionnaire for capturing patient expectations. To help advance understanding of the relationship between expectations and treatment outcomes, this application proposes to systematically develop and validate a questionnaire to assess patient expectations of CAM therapies for chronic back pain. Phase I of this 3-phase project will focus on gaining a comprehensive understanding of the issues underlying the concept of treatment expectations. This will involve conducting interviews to collect qualitative information about expectations from patients with back pain as well as from providers of four CAM therapies commonly used for back pain (acupuncture, chiropractic, massage, yoga). Rigorous qualitative research methods will be used to analyze this interview data in order to identify key conceptual domains associated with the development of expectations. The results of these analyses will then be used to create a conceptual model about how patient expectations of treatment success develop and change after initiation of treatment. Phase II activities will focus on developing a questionnaire to assess patient expectations and Phase III will feature testing the psychometric properties of the questionnaire (e.g., reliability and validity). The questionnaire will be tested in diverse clinical and research populations. This project is expected to result in the creation of a psychometrically sound questionnaire that can be used by the CAM and conventional research communities to measure the importance of patient expectations of treatment outcomes in clinical trials of non-pharmacologic treatments for chronic back pain. Development of a conceptual model for understanding the relationship between patient expectations and treatment outcomes and creation of a valid and reliable questionnaire for assessing patient expectations will provide valuable tools for future research on how context effects influence treatment outcomes. Such research has the potential to improve understanding of how to most effectively translate the results of randomized efficacy trials into clinical practice.