The Healing Context in CAM: Instrument Development and Initial Validation

CAM 中的治疗环境：仪器开发和初步验证

• 批准号: 8145328
• 负责人: CAROL MARIE GRECO
• 金额: $ 44.59万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8145328
• 关键词: Accounting; Address; Adult; Area; Attitude; Belief; Boxing; Caring; Chiropractic manipulation; Chronic low back pain; Clinic; Clinical; Clinical Trials Design; Complementary and alternative medicine; Complex; Consultations; Curiosities; Device or Instrument Development; Environment; Evaluation; Expectancy; Focus Groups; Healed; Health; Health Personnel; Individual; Information Systems; Integrative Medicine; Internal Medicine; Internet; Intervention; Intervention Trial; Light; Measurement; Measures; Medical center; Medicine; Methodology; Outcome; Outcome Measure; Outpatients; Pain; Patient Outcomes Assessments; Patient Self-Report; Patients; Perception; Persons; Phase; Physical therapy; Placebo Control; Placebo Effect; Placebos; Price; Provider; Published Comment; Questionnaires; Reporting; Research; Research Personnel; Sampling; Services; Symptoms; Testing; Time; Treatment Efficacy; Treatment outcome; United States National Institutes of Health; Universities; Validation; base; computerized; contextual factors; control trial; conventional therapy; disability; efficacy trial; healing; instrument; method development; mindfulness-based stress reduction; primary care setting; psychosocial; public health relevance; response; theories; tool; validation studies

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.

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，以测量对康复很重要的 CAM 相关背景因素。这些治疗因素可能包括患者的信念和期望、对医患关系的看法以及治疗的其他环境方面，这些因素无疑是复杂的，并且通常在试验中没有得到解决。然而，治疗背景可能在很大程度上解释了所谓的“安慰剂”。直到最近，研究人员才意识到安慰剂效应的“黑匣子”值得在试验和临床环境中理解和加强。解决复杂问题的最佳方法是仔细而精确的方法。我们的项目与 NIH 路线图倡议、患者报告结果测量信息系统 (PROMIS) 具有协同作用，并将使用 PROMIS 严格的仪器开发和验证方法。第一步是开发和完善项目库。开发可评估康复背景因素的项目库的初步步骤包括：a）现有工具和相关问题的汇编和评估，b）与专家的协商，以及c）与参与 CAM 和传统医学干预措施的个人进行焦点小组， d) 项目编辑和细化。仪器开发的下一步将涉及对 1200 人（1000 名成人和 CAM 诊所和传统初级保健机构的 200 名当地患者的互联网样本）管理修订后的项目库，并使用项目反应理论和经典测试理论校准项目。这将产生该仪器的计算机化自适应测试版本以及静态简表，这两者都可以最大化信息，同时最小化患者负担。该项目开发的工具将被称为治愈遭遇和态度清单（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 名慢性腰痛患者的样本中评估该仪器的收敛、判别和预测有效性。其中 100 名将是参与脊椎按摩疗法或基于正念减压的 CAM 患者。一百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 工具以及治疗预期、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测量的常规测量。对于收敛效度，HEAL 预计将与类似结构的测量显示出中等至较大的相关性。 HEAL 预计将与一般心理社会功能的自我报告测量适度相关，以支持区分有效性。最后，HEAL 评分应能解释治疗结果差异的很大一部分，支持预测的有效性。该项目将通过提供一种工具来衡量可能对健康和福祉做出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。 公共健康相关性：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对 CAM 治疗中康复环境的感知。患者报告措施用于评估治疗背景的各个方面，例如信念、患者与提供者关系的看法以及整体治疗环境的其他方面，将推进 CAM 研究，揭示诸如“安慰剂”等尚未充分研究的现象。并最终可能有助于改善总体研究试验设计。