Reliability and Responsiveness of PROMIS tools in Orthopaedic Trauma Patients

描述（由申请人提供）：尽管在过去的二十年里，肢体创伤的护理有了很大的改善，但这些损伤通常会对以前健康的年轻人造成严重的长期后果，这些年轻人可能还有许多年的生产生活。矫形肢体损伤导致每年近70万人住院， 仅生产力损失就将近200亿美元。临床有效性评价是 对于确定骨科创伤患者的最佳治疗至关重要。然而，创伤结果测量的关键障碍阻碍了这一领域的研究。这些包括创伤的多因素性质，结果是时间依赖性的事实，以及创伤通常挑战年轻和活跃的个体的事实;需要在整个功能状态范围内可靠的措施。PROMIS试题库可以通过计算机自适应测试或CAT来应对这些挑战。CAT提供了既简短又精确的测量方法，使得跨多个领域的测量变得可行。CAT还可以扩展各个域的上限和下限，从而潜在地增强响应能力。然而，PROMIS项目库和工具尚未在骨科创伤患者中进行充分的可靠性，有效性和反应性测试，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审查PROMIS工具在这一人群和环境中的测量特性来解决这些问题。总体战略将是利用现有的基础设施的一个大型骨科创伤临床试验联盟，重大创伤研究联盟（METRC）。我们建议进行一系列子研究，在早期招募阶段将PROMIS数据收集添加到三项临床试验中。这些研究在未来三年内增加了近2000名参与者，非常适合拟议的项目，因为它们将纵向收集该人群五个重要领域的数据：身体功能，情绪困扰-抑郁，情绪困扰-焦虑，疼痛影响和参与社会角色和活动的能力。具体而言，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）检查骨科创伤患者现有PROMIS域的响应性;（3）检查骨科创伤患者现有PROMIS CAT和项目库的测量特性。 公共卫生相关性：PROMIS项目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对其反应性进行评估。拟议的项目旨在通过审查PROMIS工具在这一人群和环境中的测量特性来解决这些问题。总体战略将是利用现有的基础设施的一个大型骨科创伤临床试验联盟，重大创伤研究联盟（METRC）。我们建议进行一系列子研究，在早期招募阶段将PROMIS数据收集添加到三项临床试验中。

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.