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中文摘要
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描述(由申请人提供):许多临床医生和研究人员认为,预期特定治疗将缓解其症状的患者更有可能从该治疗中获益。然而,临床试验的数据分析评价补充和替代医学(CAM)治疗慢性背痛并没有一致地发现治疗前的预期是预测上级的结果。这些相互矛盾的结果的解释已经复杂的缺乏一个足够的概念模型,患者的期望可能会影响治疗结果和缺乏一个有效的问卷调查,以捕捉患者的期望。为了帮助进一步了解期望和治疗结果之间的关系,本申请提出系统地开发和验证问卷,以评估慢性背痛患者对CAM治疗的期望。这个三阶段项目的第一阶段将侧重于全面了解治疗期望概念的基础问题。这将涉及进行访谈,以收集有关背痛患者期望的定性信息,以及通常用于背痛的四种CAM疗法(针灸,脊椎按摩,按摩,瑜伽)的提供者。严格的定性研究方法将被用来分析这些访谈数据,以确定与发展的期望相关的关键概念域。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开始治疗后如何发展和变化。第二阶段的活动将侧重于制定一份问卷,以评估患者的期望,第三阶段的特点是测试问卷的心理测量特性(例如,信度和效度)。该问卷将在不同的临床和研究人群中进行测试。该项目预计将导致创建一个心理测量的声音问卷,可用于CAM和传统的研究社区,以衡量慢性背痛的非药物治疗的临床试验中的治疗结果的患者期望的重要性。发展一个概念模型,了解患者的期望和治疗结果之间的关系,并创建一个有效的和可靠的问卷调查,以评估患者的期望,将提供有价值的工具,为未来的研究背景如何影响治疗结果。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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