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

基本信息

批准号：
8457694
负责人：
Renan C Castillo
金额：
$ 36.45万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
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/8457694
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

项目摘要

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.

描述（由申请人提供）：尽管过去二十年来针对肢体创伤的护理有了很大的改善，但这些伤害通常会给以前健康的年轻人带来重大的长期后果，而这些年轻人剩下多年的生产力。骨科肢体受伤每年导致近700,000次住院仅将近200亿美元的生产力损失占。临床有效性评估是确定骨科创伤患者的最佳治疗至关重要。但是，创伤结果测量的关键障碍阻碍了该领域的研究。其中包括创伤的多因素性质，结果是时间依赖的事实，以及创伤挑战通常是年轻和活跃的个体的事实。需要在全部功能状态范围内可靠的措施。 Promis物品库可以通过计算机自适应测试或猫解决这些挑战。猫提供既短而精确又精确的措施，使得在多个领域可行。猫还可以扩展单个领域的天花板和地板，从而有可能增强反应性。但是，在骨科创伤患者中尚未对Promis物品库和工具进行全面测试，以确保可靠性，有效性和反应性，尤其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该人群和环境中的Promis工具的测量属性来解决这些问题。总体策略将是利用大型骨科创伤临床试验联盟（主要肢体创伤联盟（METRC））的现有基础设施。我们建议进行一系列子研究，并在早期入学阶段为三个临床试验增加了Promis数据收集。这些研究在未来三年中总计近2000名参与者，并且非常适合该项目，因为它们将在对该人群的重要性，身体机能，情绪困扰抑郁，情绪困扰，疼痛，疼痛和参与社会角色和活动的能力上纵向收集数据。具体来说，我们建议：（1）研究Promis工具在METRC的数据收集基础架构中的集成；（2）检查骨科创伤患者现有Promis域的反应性；（3）检查骨科创伤患者现有的Promis猫和物品库的测量特性。公共卫生相关性：Promis物品银行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其反应能力。拟议的项目旨在通过检查该人群和环境中的Promis工具的测量属性来解决这些问题。总体策略将是利用大型骨科创伤临床试验联盟（主要肢体创伤联盟（METRC））的现有基础设施。我们建议进行一系列子研究，并在早期入学阶段为三个临床试验增加了Promis数据收集。