The Healing Context in CAM: Instrument Development and Initial Validation

描述(由申请人提供)：这项研究的总体目标是开发和测试一种有效的自我报告工具，以衡量与CAM相关的背景因素在康复中的重要作用。这些治愈因素，可能包括患者的信念和期望，对患者-提供者关系的看法，以及治疗的其他环境方面，无疑是复杂的，通常没有在试验中得到解决。然而，治愈的背景可能在很大程度上解释了人们所说的“安慰剂”。直到最近，研究人员才意识到，在试验和临床环境中，安慰剂效应的“黑匣子”值得理解和加强。解决复杂问题的最佳方法是仔细而准确的方法论。我们的项目与NIH路线图倡议--患者报告结果测量信息系统(PROIS)协同工作，并将使用PROMIS严格的仪器开发和验证方法。第一步是开发和提炼题库。建立一个项目库可以评估治疗中的背景因素，最初的步骤包括a)汇编和评估现有工具和相关问题，b)咨询专家，c)与参与CAM和常规医学干预的个人组成重点小组，以及d)项目编辑和改进。工具开发的下一步将涉及对1200人(来自一家CAM诊所和传统初级保健机构的1000名成年人和200名当地患者的互联网样本)进行修订题库管理，并使用项目反应理论和经典测试理论对项目进行校准。这将产生一个计算机化的适应性测试版本的仪器，以及一个静态的简短形式，这两个都最大限度地增加信息，同时最大限度地减少患者的负担。在这个项目中开发的工具将被称为治愈遭遇和态度列表(Hear)。该项目的最后阶段将涉及对Hear进行初步验证研究。我们将评估该工具在200名慢性下腰痛患者样本中的收敛、判别和预测有效性。其中100人将是参加脊椎按摩手法或基于正念的压力减轻的CAM患者。100名将是参加物理治疗的传统医学患者。我们将实施CAT版本的Heave仪器，以及治疗预期、对治疗提供者的信心、心理社会功能以及CLBP疼痛和残疾的治疗结果衡量的传统衡量标准。对于收敛效度，Hear预计将与类似结构的测量显示出中等到较大的相关性。治疗被期望与一般心理社会功能的自我报告测量适度相关，以支持区分效度。最后，治愈评分应该在治疗结果的差异中占很大比例，支持预测有效性。该项目将通过提供一种工具来衡量患者提供者和治疗环境的各个方面，从而直接影响干预试验的方法学，这些方面可能对健康和福祉做出重大贡献。 公共卫生相关性：该项目将使用现代测试开发方法，创建一种工具来测量患者在CAM治疗中对愈合环境的感知。评估康复背景方面的患者报告措施，如信念、对患者-提供者关系的看法，以及整体康复环境的其他方面，将促进CAM研究，阐明未被充分研究的现象，如“安慰剂”，并最终可能有助于总体研究试验设计的改善。

DESCRIPTION (provided by applicant): The overall objective of this study is to develop and test an efficient self-report instrument to measure CAM- relevant contextual factors important in healing. Such healing factors, which may include patients' beliefs and expectancies, perceptions of the patient-provider relationship, and other environmental aspects of healing, are undoubtedly complex and have typically not been addressed in trials. However, the healing context may account for much of what is known as 'placebo.' Only recently have investigators entertained the idea that the 'black box' of the placebo effect is worth understanding and enhancing in trials and in clinical settings. The best approach to a complex issue is careful and precise methodology. Our project is synergistic with the NIH Roadmap initiative, Patient Reported Outcomes Measurement Information System (PROMIS), and will use the rigorous instrument development and validation methodology of PROMIS. The first step is to develop and refine an item bank. Initial steps in developing a bank of items that may assess contextual factors in healing include a) compilation and evaluation of existing instruments and relevant questions, b) consultation with experts, and c) focus groups with individuals who participate in CAM and conventional medicine interventions, and d) item editing and refinement. The next step of instrument development will involve administering the revised item bank to 1200 persons (an internet sample of 1000 adults and 200 local patients of a CAM clinic and a conventional primary care setting) and calibrating the items using item response theory and classical test theory. This will result in a computerized adaptive testing version of the instrument, as well as a static short form, both of which maximize information while minimizing patient burden. The instrument developed in this project will be called the Healing Encounters and Attitudes List (HEAL). The final phase of the project will involve conducting initial validation studies of the HEAL. We will evaluate the convergent, discriminant, and predictive validity of the instrument in a sample of 200 patients with chronic low back pain. One hundred of these will be CAM patients participating in chiropractic manipulation or mindfulness-based stress reduction. One hundred will be conventional medicine patients who are participating in physical therapy. We will administer the CAT version of the HEAL instrument as well as conventional measures of treatment expectancy, confidence in treatment provider, psychosocial functioning, and treatment outcome measures of CLBP pain and disability. For convergent validity, the HEAL is expected to display moderate to large correlations with measures of similar constructs. The HEAL is expected to correlate modestly with self-report measures of general psychosocial functioning, in support of discriminant validity. Finally, HEAL score should account for a significant proportion of the variance in treatment outcome, supporting predictive validity. The project will directly impact methodology of intervention trials by providing a tool to measure aspects of patient-provider and treatment environment that may contribute substantially to health and well being. PUBLIC HEALTH RELEVANCE: Using modern test development methods, this project will create an instrument to measure the patient's perception of the healing context in CAM treatments. A patient-report measure to assess aspects of the healing context such as beliefs, perceptions of the patient-provider relationship, and other aspects of the overall healing environment will advance CAM research, shed light on under-studied phenomena such as 'placebo,' and may ultimately contribute to improvement in research trial design in general.