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中文摘要
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描述(申请人提供):许多临床医生和研究人员认为,期望特定治疗将缓解其症状的患者将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的数据分析并未始终如一地发现治疗前的期望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充分概念模型,以及缺乏用于获取患者期望的有效问卷,这些相互矛盾的结果的解释变得复杂。为了帮助加深对期望和治疗结果之间关系的理解,本应用程序建议系统地开发和验证一份问卷,以评估患者对治疗慢性背痛的CAM疗法的期望。这个分3个阶段的项目的第一阶段将侧重于全面了解治疗期望概念背后的问题。这将包括进行访谈,收集背痛患者以及四种常用的治疗背痛的CAM疗法(针灸、脊椎按摩、按摩、瑜伽)提供者的期望的定性信息。我们将使用严谨的定性研究方法对访谈数据进行分析,以确定与期望发展相关的关键概念领域。这些分析的结果将被用来创建一个概念模型,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,以评估患者的期望,第三阶段将测试问卷的心理测量学特性(例如,可靠性和有效性)。该问卷将在不同的临床和研究人群中进行测试。这一项目预计将产生一个心理测量学上合理的问卷,可供CAM和传统研究团体使用,以衡量患者对治疗结果的期望在慢性背痛非药物治疗临床试验中的重要性。开发一个概念模型来了解患者期望和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期望,这将为未来关于背景效应如何影响治疗结果的研究提供宝贵的工具。这样的研究有可能提高对如何最有效地将随机疗效试验的结果转化为临床实践的理解。
英文摘要
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.
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