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的实施是为了恢复功能，减轻疼痛和其他症状，患者报告的结果(PRO)数据对于患者和临床医生在告知TJR的必要性和时机以及评估TJR结果方面非常重要。然而，目前在TJR研究中使用的关节特异性PRO器械太长，不能在临床护理中常规使用。该项目将开发两个关节专用PRO指标的简短版本，即42项膝关节损伤和骨关节炎结果评分(KOS)和40项髋关节功能障碍骨关节炎结果评分(HOS)；最近医疗保险和医疗补助服务中心(CMS)评估TJR结果的技术专家小组建议在基于绩效的测量系统中考虑这两种工具。具体地说，本研究的目的是：(1)为固定长度的Koos短表格选择条目，比较短的和传统的(原始)Koos量表的有效性和响应性，并准备一个人行横道，以等同短的和传统的Koos分数；(2)选择固定长度的Hoos短表格的条目，比较短的和传统的Hoos量表的有效性和响应性，并准备一个人行横道，以等同短的和传统的Hoos分数。数据将来自AHRQ赞助的TJR(FORCE-TJR)研究登记中比较有效性的功能和结果研究，该研究已经成功地从全美150名不同整形外科医生的25,000多名患者中收集了专业人员。将分析从FORCE-TJR数据库中随机抽取的N=1,200个全膝关节和N=1,200个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定的领域：功能、疼痛、其他症状和生活质量(QOL)。这项研究的目标是开发出长度约为传统工具的三分之一但测量所有四个领域的简短表格。在为短表格选择项目时，将考虑多个标准，包括内容表述、经验数据和临床医生和患者INPU，团队成员包括在从较长的PRO器械开发短表格方面具有丰富经验的研究人员、FORCE-TJR研究拨款的首席调查员(PI)和(作为顾问)KoO和HOO的开发商，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学方法，如项目反应理论建模和真实数据计算机化自适应测验(CAT)模拟，将被成功地用于PROIS和其他PRO测量举措，以提供用于指导项目选择的经验数据。将利用各种横截面和纵向测试来比较简式和传统的Koos和Hoos量表的有效性和反应性。将准备便于用户使用的文件和人行横道，以使缩写表格和传统工具上的比例尺分数相等。该项目完成后，将向TJR患者提供简短的联合专用PRO仪器，以便更好地为临床护理决策和结果提供信息。

 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.