Reliability and Responsiveness of PROMIS tools in Orthopaedic Trauma Patients

PROMIS 工具在骨科创伤患者中的可靠性和响应性

• 批准号: 8707830
• 负责人: Renan C Castillo
• 金额: $ 35.72万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-13 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8707830
• 关键词: Accounting; Address; Afghanistan; Anxiety; Attention; Caring; Clinic; Clinical; Clinical Trials; Clinical effectiveness; Computers; Data; Data Collection; Data Quality; Devices; Enrollment; Evaluation; Failure; Floor; Follow-Up Studies; Funding; General Population; Hospitalization; Individual; Infection; Injury; Intervention; Interview; Iraq; Life; Limb structure; Measurement; Measures; Mental Depression; Military Personnel; Nature; Orthopedics; Outcome; Pain; Participant; Patients; Physical Function; Population; Process; Property; Recovery; Research; Research Infrastructure; Respondent; Role; Services; Staging; Surgical Flaps; System; Technology; Testing; Time; Trauma; Trauma Research; United States National Institutes of Health; Validity and Reliability; Variant; War; base; electronic data; emotional distress; experience; functional status; limb injury; member; productivity loss; psychosocial; response; tool; trauma centers; treatment effect

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.

描述（由申请人提供）：尽管在过去的二十年里，肢体创伤的护理取得了显着的进步，但这些伤害往往会给以前健康、还有很多年的潜在生产能力的年轻人带来严重的长期后果。每年因骨科肢体损伤导致近 70 万人住院， 仅生产力损失一项就造成了近 200 亿美元的损失。临床有效性评估是 对于确定骨科创伤患者的最佳治疗至关重要。然而，创伤结果测量的主要障碍阻碍了该领域的研究。其中包括创伤的多因素性质、结果取决于时间的事实，以及创伤通常对年轻和活跃的个人提出的挑战；需要在整个功能状态下都可靠的措施。 PROMIS 题库可以通过计算机自适应测试或 CAT 来应对这些挑战。 CAT 提供的测量既简短又精确，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，从而有可能增强响应能力。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、有效性和响应性测试，特别是在骨科创伤临床试验中。拟议项目旨在通过检查 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联盟——主要肢体创伤研究联盟 (METRC) 的现有基础设施。我们建议开展一系列子研究，将 PROMIS 数据收集添加到早期入组阶段的三项临床试验中。这些研究在未来三年内共有近 2000 名参与者，非常适合拟议的项目，因为它们将纵向收集对该人群重要的五个关键领域的数据：身体机能、情绪困扰-抑郁、情绪困扰-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） 研究将 PROMIS 工具集成到 METRC 数据收集基础设施中； (2) 检查现有 PROMIS 域对骨科创伤患者的反应性； (3) 检查现有 PROMIS CAT 和项目库对骨科创伤患者的测量特性。