An Instrument to Assess the Functional Impact of Chronic Pain

评估慢性疼痛功能影响的工具

• 批准号: 10436545
• 负责人: Brian R Clark
• 金额: $ 72.54万
• 依托单位: BARRON ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10436545
• 关键词: Activities of Daily Living; Assessment tool; Biometry; Clinical Research; Clinical Trials; Communication; Complement; Complex; Computer software; Computerized Medical Record; Custom; Data; Dementia; Devices; Effectiveness; Evaluation; Freedom; Grant; Health Care Costs; Heart Diseases; Heart Rate; Individual; Intervention; Language; Letters; Life; Literature; Malignant Neoplasms; Measurement; Measures; Methodology; Methods; Modeling; Motion; Nature; Opioid; Pain; Pain Measurement; Pain intensity; Pain management; Pathology; Patient Outcomes Assessments; Patient Self-Report; Patients; Pharmaceutical Preparations; Phase; Physical Function; Physiological; Primary Health Care; Process; Property; Psychometrics; Quality of life; Reporting; Research; Rotation; Skin; Small Business Innovation Research Grant; Statistical Models; Surface; System; Technology; Temperature; Translations; Treatment Efficacy; Work; Workers' Compensation; Wrist; analytical method; base; chronic pain; chronic pain management; chronic pain patient; clinical pain; cohort; cost; design; disability; effective therapy; experience; functional disability; heart rate variability; improved; improved outcome; innovation; instrument; kinematics; light weight; novel; phase 2 testing; profiles in patients; prototype; response; sensor technology; theories; tool; trait; usability

Project Summary/Abstract Evaluation and treatment for chronic pain are major contributors to rising healthcare costs. Although accurate assessment of pain and function is the cornerstone to successful chronic pain management, systematic, objective assessment of the functional impact of pain remains exceptionally challenging in practice. The intricate nature of chronic pain demands a comprehensive, multi-mode assessment methodology that combines subjective Patient Reported Outcomes (PROs) with objective data. There is significant potential to reduce the costs associated with chronic pain and simultaneously improve outcomes by leveraging novel, cutting-edge sensing technology and analytical methods to provide new pain assessment and treatment evaluation information. The proposed Fast Track SBIR effort will develop and validate the reliable, low-cost KnowPain instrument. KnowPain will objectively and quantitatively assess the functional impact of chronic pain (FIP) using measures derived from six degrees-of-freedom (6-DOF) motion, heart rate, skin surface temperature, and skin conductivity collected via a specially designed, ergonomic wrist-worn biometric sensing instrument. The new assessment instrument will apply advanced psychometric methods to both physiologic and kinematic data to provide precise scores for functional impairment due to chronic pain. The validated instrument will be a fully-automated, stand-alone product available to clinicians assessing and treating chronic pain in a variety of settings. The KnowPain instrument will be worn by the patient for a period of up to one week, after which collected data will automatically be uploaded and processed by the system's custom software using Multidimensional Item Response Theory models. The assessment results will be presented to the clinician in an easy-to-understand report and will include longitudinal results, confidence estimates, and normative data to enable comparisons both within and between patients. The system will include provision to interface with electronic medical records (EMRs). Accurate functional assessment is a crucial component in the effective treatment of chronic pain. The proposed approach will supplement existing methods for assessing patient function (e.g., PROs) by providing novel and highly complementary information for a more complete (and often unobserved) picture of the impact of chronic pain on patient function. KnowPain measures will provide important data on the practical consequences of pain and on treatment efficacy. The impact of chronic pain on daily life is a primary concern for patients; patients assign great value to pain interventions that improve their ability to participate in normal daily activities. The proposed KnowPain system will provide currently unavailable objective data to facilitate informed and effective pain management decisions, leading to: (1) reduced functional impairment, increased mobility, and improved quality-of-life; (2) de-emphasis on medications, particularly opioids; and (3) reduced disability and associated healthcare costs, including worker's compensation.

项目总结/摘要 慢性疼痛的评估和治疗是医疗保健成本上升的主要原因。虽然准确 疼痛和功能的评估是成功的慢性疼痛管理的基石，系统，客观 疼痛的功能影响的评估在实践中仍然非常具有挑战性。的性质复杂 慢性疼痛需要一种综合的、多模式的评估方法， 报告结局（PRO）和客观数据。降低相关费用的潜力很大 并同时通过利用新颖的尖端传感技术来改善结果 和分析方法，以提供新的疼痛评估和治疗评价信息。 拟议的快速跟踪SBIR工作将开发和验证可靠、低成本的KnowPain仪器。 KnowPain将客观和定量地评估慢性疼痛（FIP）的功能影响， 从六自由度（6-DOF）运动、心率、皮肤表面温度和皮肤电导率导出 通过一个特别设计的，符合人体工程学的腕戴式生物传感仪器收集。新的考核 仪器将对生理学和运动学数据应用先进心理测量方法， 由于慢性疼痛导致的功能损害的评分。经过验证的仪器将是一台全自动的， 独立产品，可供临床医生在各种环境中评估和治疗慢性疼痛。 患者将佩戴KnowPain仪器长达一周，之后收集 数据将自动上传并由系统的定制软件使用多维项目进行处理 反应理论模型评估结果将以易于理解的方式呈现给临床医生。 报告将包括纵向结果、置信度估计和规范性数据，以便进行比较 在患者体内和患者之间。该系统将包括与电子病历接口的规定 （电子病历）。 准确的功能评估是有效治疗慢性疼痛的关键组成部分。的 所提出的方法将补充用于评估患者功能的现有方法（例如，通过提供 新的和高度互补的信息，以更完整的（往往是未观察到的）的影响图片， 慢性疼痛对患者功能的影响KnowPain测量将提供有关实际后果的重要数据 疼痛和治疗效果。慢性疼痛对日常生活的影响是患者最关心的问题; 患者非常重视疼痛干预，因为疼痛干预可以提高他们参与正常日常活动的能力。 拟议的KnowPain系统将提供目前不可用的客观数据，以促进知情和 有效的疼痛管理决策，导致：（1）减少功能障碍，增加活动性， 改善生活质量;（2）减少对药物的依赖，特别是阿片类药物;（3）减少残疾， 相关的医疗费用，包括工人的赔偿。