The Healing Context in CAM: Instrument Development and Initial Validation

描述（由申请人提供）：本研究的总体目标是开发和测试一种有效的自我报告工具，以测量愈合中重要的CAM相关背景因素。这些愈合因素，其中可能包括患者的信念和期望，患者-提供者关系的看法，以及愈合的其他环境方面，无疑是复杂的，通常没有在试验中得到解决。然而，治疗环境可能是所谓的“安慰剂”的主要原因。直到最近，研究人员才接受了这样一种观点，即安慰剂效应的“黑匣子”值得在试验和临床环境中理解和加强。处理复杂问题的最佳方法是谨慎而精确的方法。我们的项目是协同与NIH路线图倡议，患者报告的结果测量信息系统（PROMIS），并将使用严格的仪器开发和验证方法的PROMIS。第一步是开发和完善一个试题库。开发一个可以评估愈合中背景因素的项目库的初始步骤包括：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和传统医学干预的个人进行焦点小组讨论，d）项目编辑和细化。仪器开发的下一步将涉及管理修订后的项目银行1200人（互联网样本的1000名成年人和200名当地患者的CAM诊所和传统的初级保健设置）和校准的项目使用项目反应理论和经典的测试理论。这将导致仪器的计算机化自适应测试版本，以及静态简短形式，两者都最大限度地增加信息，同时最大限度地减少患者负担。在这个项目中开发的工具将被称为愈合遭遇和态度列表（HEAL）。该项目的最后阶段将涉及对HEAL进行初步验证研究。我们将在200例慢性腰痛患者的样本中评估该工具的收敛性、判别性和预测有效性。其中100人将是CAM患者，他们将参与脊椎按摩或基于正念的减压。100名将是参加物理治疗的传统医学患者。我们将管理CAT版本的HEAL仪器以及治疗预期的常规措施，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措施。对于收敛效度，预计HEAL将显示与类似结构的测量值的中度至较大的相关性。预计HEAL与一般心理社会功能的自我报告测量值适度相关，以支持判别有效性。最后，HEAL评分应占治疗结果方差的显著比例，支持预测有效性。该项目将通过提供一种工具来衡量可能对健康和福祉有重大贡献的患者-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。 公共卫生相关性：使用现代测试开发方法，该项目将创建一个工具来测量患者对CAM治疗中愈合环境的感知。一个病人报告的措施，以评估方面的愈合情况，如信仰，病人与供应商的关系的看法，以及其他方面的整体愈合环境将推进CAM研究，阐明研究不足的现象，如“安慰剂”，并可能最终有助于改善研究试验设计一般。

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.