Reliability and Responsiveness of PROMIS tools in Orthopaedic Trauma Patients

描述(由申请人提供)：尽管在过去20年中肢体创伤的治疗有了很大的改善，但这些损伤往往会给原本健康的年轻人带来重大的长期后果，因为他们还有很多年的潜在生产力。骨科肢体损伤每年导致近70万人住院治疗， 仅生产力损失就占了近200亿美元。临床疗效评估是 对于确定骨科创伤患者的最佳治疗方案至关重要。然而，创伤结局测量中的关键障碍阻碍了这一领域的研究。这些因素包括创伤的多因素性质，结果取决于时间，以及创伤往往挑战年轻和活跃的个人；需要在所有功能状态下采取可靠的措施。PROMIS题库可以通过计算机自适应测试或CATS来应对这些挑战。CATS提供了既短又精确的测量方法，使跨多个领域的测量成为可能。猫还可以延长个别域名的上限和下限，潜在地增强响应能力。然而，PROMIS题库和工具尚未在骨科创伤患者中进行可靠性、有效性和响应性的充分测试，特别是在骨科创伤临床试验的背景下。拟议的项目旨在通过检查PROMIS工具在这一人群和环境中的测量特性来解决这些问题。总体战略将是利用大型骨科创伤临床试验财团--主要肢体创伤研究财团(METRC)的现有基础设施。我们建议进行一组子研究，在早期登记阶段将PROMIS数据收集添加到三个临床试验中。这些研究在接下来的三年里增加了近2000名参与者，非常适合拟议的项目，因为他们将纵向收集对这一人群至关重要的五个关键领域的数据：身体功能、情绪困扰-抑郁、情绪痛苦-焦虑、疼痛影响以及参与社会角色和活动的能力。具体来说，我们建议：(1) 研究PROMIS工具在Metrc数据收集基础设施中的整合；(2)检查现有PROMIS域在骨科创伤患者中的响应性；以及(3)检查现有PROMIS猫和题库在骨科创伤患者中的测量特性。 公共卫生相关性：PROMIS题库和工具尚未在骨科创伤患者中得到充分验证，也没有在骨科创伤临床试验的背景下评估它们的反应性。拟议的项目旨在通过检查PROMIS工具在这一人群和环境中的测量特性来解决这些问题。总体战略将是利用大型骨科创伤临床试验财团--主要肢体创伤研究财团(METRC)的现有基础设施。我们建议进行一组子研究，在早期登记阶段将PROMIS数据收集添加到三个临床试验中。

DESCRIPTION (provided by applicant): Despite substantial improvements in care made over the last two decades for limb trauma, these injuries often result in significant long-term consequences for previously healthy young individuals with many years remaining of potentially productive life. Orthopaedic limb injuries result in nearly 700,000 hospitalizations each year, and account for nearly $20 billion in productivity losses alone. Clinical effectiveness evaluations are essential for identifying the optimal treatment for orthopaedic trauma patients. However, key barriers in trauma outcomes measurement have hampered research in this field. These include the multi-factorial nature of trauma, the fact that outcomes are time dependent, and the fact that trauma challenges often young and active individuals; requiring measures that are reliable across the full range of functional status. PROMIS item banks can address these challenges through computer-adaptive tests or CATs. CATs offer measures that are both short and precise, making measurement feasible across multiple domains. CATs can also extend the ceiling and floor of individual domains, potentially enhancing responsiveness. However, the PROMIS item banks and tools have not been fully tested among orthopaedic trauma patients for reliability, validity and responsiveness, especially in the context of orthopaedic trauma clinical trials. The proposed project aims to address these problems by examining the measurement properties of PROMIS tools in this population and setting. The overall strategy will be to leverage the existing infrastructure of a large orthopaedic trauma clinical trials consortium, the Major Extremity Trauma Research Consortium (METRC). We propose to conduct a set of sub-studies, adding PROMIS data collection to three clinical trials in early enrollment stages. These studies add up nearly 2000 participants over the next three years, and are well suited for the proposed project because they will collect data longitudinally across five key domains of importance for this population: Physical Function, Emotional Distress-Depression, Emotional Distress-Anxiety, Pain Impact, and Ability to Participate in Social Roles and Activities. Specifically, we propose to: (1) Study the integration of the PROMIS tools within the data collection infrastructure of METRC; (2) Examine the responsiveness of existing PROMIS domains in patients with orthopaedic trauma; and (3) Examine the measurement properties of existing PROMIS CATs and item banks in patients with orthopaedic trauma. PUBLIC HEALTH RELEVANCE: PROMIS item banks and tools have not been fully validated among orthopaedic trauma patients, nor has their responsiveness been evaluated in the context of orthopaedic trauma clinical trials. The proposed project aims to address these problems by examining the measurement properties of PROMIS tools in this population and setting. The overall strategy will be to leverage the existing infrastructure of a large orthopaedic trauma clinical trials consortium, the Major Extremity Trauma Research Consortium (METRC). We propose to conduct a set of sub-studies, adding PROMIS data collection to three clinical trials in early enrollment stages.