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

描述（由申请人提供）：前十字韧带 (ACL) 损伤、半月板撕裂和骨关节炎 (OA) 是影响膝盖的常见病症，会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衡量这些影响膝盖的病症的影响以及旨在改善这些病症的干预措施的有效性和功效非常重要。传统上，对患者报告的疼痛和身体功能的评估使用各种患者报告的结果（PRO）测量，这些测量是使用与经典测试理论一致的方法开发的，从而导致对所有个体进行一组固定的项目，无论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，管理针对个人量身定制的项目，以更有效、更精确地确定个人的状态。患者报告结果测量信息系统 (PROMIS) 是 NIH 路线图倡议，它创建了校准项目库，以允许 CAT 用于健康的多个维度，包括疼痛干扰和身体功能。需要进一步的研究来为患有各种常见膝关节疾病（包括 ACL 损伤、半月板撕裂或 OA）的患者解释和使用疼痛干扰和身体功能 CAT 提供有效证据。本申请的总体目的是在涉及 ACL 损伤、半月板撕裂或 OA 个体的 4 项正在进行的临床研究的背景下，提供证据支持 PROMIS 疼痛干扰和身体功能项目库和 CAT 的解释和使用。本应用的具体目的是： 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) 研究差分项目功能 (DIF)，4) 确定与传统的膝关节固定长度 PRO 测量相比，使用 PROMIS 疼痛干扰和身体功能 CAT 获得的效率。来自家长研究的最多 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，并找出领域内容覆盖范围内的任何差距。将纵向跟踪来自母研究的多达 600 名个体，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。将探讨项目反应以确定 DIF 的潜在来源，包括年龄、性别和膝盖状况类型。将通过比较 CAT 的管理时间以及可靠性和响应能力与固定长度的传统 PRO 措施来评估效率。这项研究的结果将提供有效的证据，以支持对患有各种常见膝关节疾病（包括 ACL 损伤、半月板撕裂或 OA）的个体解释和使用 PROMIS 疼痛干扰和身体功能项目库和 CAT。

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.