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: 8541700
• 负责人: CAROL MARIE GRECO
• 金额: $ 42.36万
• 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/8541700
• 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）：本研究的总体目的是开发和测试有效的自我报告工具，以测量与康复重要的相关背景因素。这种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康复的其他环境方面无疑是复杂的，通常在试验中没有解决。但是，治愈环境可能解释了所谓的“安慰剂”。直到最近，调查人员才阐明了安慰剂效应的“黑匣子”值得在试验和临床环境中理解和增强的想法。解决复杂问题的最佳方法是谨慎而精确的方法。我们的项目与NIH路线图计划，患者报告的结果测量信息系统（PROMIS）是协同的，并将使用严格的仪器开发和Promis的验证方法。第一步是开发和完善项目库。开发一组可能评估康复背景因素的项目的初步步骤包括a）汇编和评估现有工具和相关问题，b）与专家进行磋商，c）与参加CAM和常规医学干预措施的个人焦点小组，以及d）项目编辑和完善。仪器开发的下一步将涉及将修订的物品库管理至1200人（1000名成人的互联网样本和200个CAM诊所的本地患者和常规的初级保健设置），并使用项目响应理论和经典测试理论对项目进行校准。这将导致该仪器的计算机自适应测试版本以及静态的简短形式，两者都可以最大程度地提高信息，同时最大程度地减少患者负担。该项目中开发的仪器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治疗的初步验证研究。我们将在200例慢性下背痛患者的样本中评估该仪器的收敛性，判别和预测有效性。其中一百个将是参加脊椎按摩治疗或基于正念的压力减轻的CAM患者。一百个将是参加物理治疗的常规医学患者。我们将管理CAT版本的Heal仪器以及治疗预期，对治疗提供者的信心，社会心理功能以及CLBP疼痛和残疾的治疗结果度量的常规度量。对于收敛有效性，预计愈合将与相似构造的度量显示中等至较大的相关性。预计治疗将与一般的社会心理功能的自我报告量度相关，以支持判别有效性。最后，治疗评分应考虑治疗结果方差的很大比例，从而支持预测有效性。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，直接影响干预试验的方法，这些工具可能对健康和健康产生重大贡献。 公共卫生相关性：使用现代测试开发方法，该项目将创建一种工具，以衡量患者对CAM治疗中治愈环境的看法。一项评估康复背景方面的患者报告措施，例如信念，对患者 - 培训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，阐明诸如“安慰剂”等研究不足的现象，并最终可能有助于改善一般研究试验设计。