Knee CAT Study - Validity of PROMIS Pain Interference and Physical Function CATs

描述（由申请人提供）：前交叉韧带（ACL）损伤，半月板撕裂和骨关节炎（OA）是影响膝关节的常见疾病，导致严重疼痛和身体功能限制。评估患者对疼痛和身体功能的感知对于测量这些疾病对膝关节的影响以及旨在改善这些疾病的干预措施的有效性和疗效非常重要。传统上，对患者报告的疼痛和身体功能的评估使用了各种患者报告的结果（PRO）措施，这些措施是使用与经典测试理论相一致的方法开发的，结果是对所有个体进行了一套固定的项目，而不管这些项目是否适合特定个体。测试理论的进步，即项目反应理论（IRT），使计算机自适应测试（CAT）成为现实。在CAT中，为个人量身定制的项目被管理，以更有效和准确地确定个人的状态。患者报告结果测量信息系统（PROMIS）是美国国立卫生研究院的路线图倡议，它创建了校准的物项库，允许CAT用于健康的多个维度，包括疼痛干扰和身体功能。对于包括前交叉韧带损伤、半月板撕裂或OA在内的各种常见膝关节疾病患者，疼痛干扰和身体功能cat的解释和使用需要进一步的研究来提供有效性证据。本申请的总体目的是在4个正在进行的涉及前交叉韧带损伤、半月板撕裂或OA患者的临床研究背景下，为PROMIS疼痛干扰和身体功能物项库和cat的解释和使用提供证据。本应用程序的具体目的是：1)评估疼痛干扰和身体功能项目库中项目的适当性；2)为疼痛干扰和身体功能cat的解释和使用提供证据；3)研究差异项目功能（DIF）和4)确定使用PROMIS疼痛干扰和物理功能cat与传统固定长度膝关节PRO测量相比所获得的效率。来自父母研究的多达50名受试者将参加认知访谈，以确定项目的清晰度和相关性，并确定领域内容覆盖的任何空白。将对来自父母研究的多达600名个体进行纵向跟踪，以确定测试再测试的可靠性、反应性和患者可接受的症状状态。项目回答将被探讨，以确定DIF的潜在来源，包括年龄、性别和膝关节状况类型。将通过比较管理时间以及CAT与固定长度遗留PRO措施的可靠性和响应性来评估效率。本研究的结果将为PROMIS疼痛干扰、身体功能物项库和cat在各种常见膝关节疾病（包括前交叉韧带损伤、半月板撕裂或OA）患者中的解释和使用提供有效性证据。

DESCRIPTION (provided by applicant): Anterior cruciate ligament (ACL) injuries, meniscus tears and osteoarthritis (OA) are common conditions affecting the knee that lead to substantial pain and limitations in physical function. Assessment of the patient's perception of pain and physical function are important to measure the impact of these conditions affecting the knee as well as the effectiveness and efficacy of interventions aimed at ameliorating these conditions. Assessment of patient-reported pain and physical function has traditionally made use of a variety of patient-reported outcome (PRO) measures that were developed using methods consistent with classical test theory, resulting in a fixed set of items administered to all individuals regardless of the appropriateness of the items for a specific individual. Advances in test theory, namely item response theory (IRT), have made computer adaptive testing (CAT) a reality. In CAT, items tailored to the individual are administered to more efficiently and precisel determine the status of an individual. The Patient-Reported Outcome Measurement Information System (PROMIS), which is an NIH Roadmap Initiative, has created calibrated item banks to permit CAT for multiple dimensions of health, including pain interference and physical function. Further research is needed to provide validity evidence for interpretation and use of the pain interference and physical function CATs for patients with a variety of common knee conditions including ACL injuries, meniscus tears or OA. The overall purpose of this application is to provide evidence to support the interpretation and use of the PROMIS pain interference and physical function item banks and CATs within the context of 4 ongoing clinical studies involving individuals with an ACL injury, meniscus tear or OA. The specific aims of this application are to: 1) evaluate the appropriateness of the items in the pain interference and physical function item banks; 2) provide evidence for interpretation and use of the pain interference and physical function CATs; 3) investigate differential item function (DIF) and 4) determine the efficiencies gained by use of the PROMIS pain interference and physical function CATs in comparison to legacy fixed-length PRO measures for the knee. Up to 50 subjects from the parent studies will participate in cognitive interviews to determine the clarity and relevance of the items and to identify any gaps in domain content coverage. Up to 600 individuals from the parent studies will be followed longitudinally to determine test re-test reliability, responsiveness and the patient acceptable symptom state. Item responses will be explored to identify potential sources of DIF including age, gender and type of knee condition. Efficiency will be assessed by comparing time for administration as well as reliability and responsiveness of the CAT versus the fixed-length legacy PRO measures. The results of this study will provide validity evidence to support interpretation and use of the PROMIS pain interference and physical function item banks and CATs in individuals with a variety of common knee conditions including ACL injury, meniscus tear or OA.