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.
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.
