Developing Shorter Joint-Specific Patient-Reported Outcome Measures to Enhance Clinical Use in Total Joint Replacement

 描述（由申请人提供）：全关节置换术（TJR）是最常见的医疗保险外科手术之一，在年轻患者中也在增加。由于TJR是为了恢复功能和减少疼痛和其他症状，患者报告的结果（PRO）数据对于患者和临床医生来说非常重要，可以告知TJR的需求和时间以及评估TJR结果。然而，目前在TJR研究中使用的关节专用PRO工具对于临床护理中的常规使用来说太长。该项目将开发两种关节特异性PRO指标的简短版本，即42项膝关节损伤和骨关节炎结局评分（KOOS）和40项髋关节功能障碍骨关节炎结局评分（HOOS）;最近医疗保险和医疗补助服务中心（CMS）技术专家小组评估TJR结局时建议在基于性能的测量系统中考虑这两种工具。具体而言，本研究的目的是：（1）选择固定长度的KOOS简表，比较简表和传统简表的效度和反应度（原始）KOOS量表，并准备人行横道，以等同于短和遗留KOOS分数;和（2）选择固定长度HOOS简短表格的项目，比较简短和传统HOOS量表的有效性和反应性，并准备一个人行横道，以等同于短期和传统的HOOS分数。数据将来自AHRQ申办的TJR（FORCE-TJR）研究登记的功能和结局比较有效性研究，该研究已成功收集了来自美国150名不同骨科医生的25，000多名患者的PRO。将分析从FORCE-TJR数据库中随机抽取的N= 1，200例全膝关节置换术和N= 1，200例全髋关节置换术患者的TJR前后数据。KOOS和HOOS分别测量四个关节特异性领域：功能，疼痛，其他症状和生活质量（QOL）。 这项研究的目标是开发简短的形式，大约是三分之一的遗产文书，但衡量所有四个领域。多个标准，包括内容代表性，经验数据，临床医生和患者输入，将被考虑在选择项目的简短形式由一个团队，其中包括研究人员在开发简短的形式从较长的PRO工具，主要研究者（PI）的FORCE-TJR研究补助金，（作为顾问）KOOS和HOOS的开发者，以及FORCE-TJR指导委员会的外科医生和患者成员。广泛使用的心理测量方法，如项目反应理论建模和真实数据计算机自适应测试（CAT）模拟，这是成功地用于PROMIS和其他PRO测量举措，将被应用于提供经验数据，用于通知项目选择。将利用各种横截面和纵向测试来比较简短形式和传统KOOS和HOOS量表的有效性和反应性。将编制便于用户使用的文件和人行横道，以使简表和遗留文书上的量表分数相等。本项目完成后，将向TJR患者提供简短的关节专用PRO工具，以更好地告知临床护理决策和结局。

 DESCRIPTION (provided by applicant): Total joint replacement (TJR) is among the most common Medicare surgical procedures and is increasing among younger patients as well. Because TJR is performed to restore function and to reduce pain and other symptoms, patient-reported outcome (PRO) data is important for patients and clinicians in informing the need for and timing of TJR and in evaluating TJR outcomes. However, joint-specific PRO instruments currently used in TJR research are too long for routine use in clinical care. This project will develop short versions of two joint-specific PRO measures, the 42-item Knee Injury and Osteoarthritis Outcome Score (KOOS) and the 40-item Hip Dysfunction Osteoarthritis Outcome Score (HOOS); a recent Centers for Medicare and Medicaid Services (CMS) Technical Expert Panel on evaluating TJR outcomes recommended consideration of both instruments in performance-based measurement systems. Specifically, the aims of this research are to: (1) Select items for a fixed-length KOOS short form, compare the validity and responsiveness of short and legacy (original) KOOS scales, and prepare a crosswalk to equate short and legacy KOOS scores; and (2) Select items for a fixed-length HOOS short form, compare the validity and responsiveness of short and legacy HOOS scales, and prepare a crosswalk to equate short and legacy HOOS scores. Data will come from the AHRQ-sponsored Function and Outcomes Research for Comparative Effectiveness in TJR (FORCE-TJR) research registry, which has successfully collected PROs from more than 25,000 patients of 150 diverse orthopedic surgeons throughout the US. Pre- and post-TJR data from N=1,200 total knee and N=1,200 total hip replacement patients randomly drawn from the FORCE-TJR database will be analyzed. KOOS and HOOS each measure four joint-specific domains: function, pain, other symptoms and quality of life (QOL). The goal of this research is to develop short forms that are approximately one-third as long as the legacy instruments but which measure all four domains. Multiple criteria, including content representation, empirical data, and clinician and patient inpu, will be considered in selecting items for the short forms by a team that includes researchers with considerable experience in developing short forms from longer PRO instruments, the Principal Investigator (PI) of the FORCE-TJR research grant, and (as advisors) the developer of the KOOS and the HOOS, and surgeon and patient members of the FORCE-TJR Steering Committee. Widely-used psychometric methods such as item response theory modeling and real-data computerized adaptive test (CAT) simulations, which were successfully used in PROMIS and other PRO measurement initiatives, will be applied to provide empirical data used to inform item selection. A variety of cross-sectional and longitudinal tests will be utilized to compare the validity and responsiveness of the short form and legacy KOOS and HOOS scales. User-friendly documentation and crosswalks to equate scale scores on the short forms and legacy instruments will be prepared. Upon completion of this project, brief joint-specific PRO instruments will be available for administration to TJR patients to better inform clinical care decisions and outcomes.