Multi-Institutional IMPACT Validation

Background: Maxillofacial trauma literature is dominated by objective and physician-rated outcomes, leaving a paucity of patient-reported outcome (PRO) research. In fact, no PRO measure (PROM) has ever been validated in this population, posing a tremendous barrier to our understanding of the patient experience. This project will overcome this barrier by validating a novel PROM designed by our research group: The Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT). The IMPACT is the first PROM designed for maxillofacial trauma, providing novel insight into the patient experience. In its current form, it is a 4-module survey instrument: one general module for all patients (IMPACT-G) and 3 modules specific to fractures of the nasal (IMPACT-N), orbital (IMPACT-O), and/or jaw (IMPACT-J) regions. Each module takes 2-5 minutes to complete for a total of 2-20 minutes, depending on the injury.

Objectives: This study will be a multi-institutional field test to determine the validity and reliability of using the IMPACT for measuring QOL in patients suffering maxillofacial trauma. The hypothesis is that each IMPACT module and subscale will significantly and at least moderately correlate with the 15D, an established general QOL survey instrument.

Methods: Patients with maxillofacial trauma presenting for routine follow-up within one year from their injury will be invited to complete the IMPACT and the 15D survey. Patients who completed an initial survey and return within one month will be invited to complete a second follow-up survey. The scores be tested for validity and reliability using multivariable linear regression, Pearson's r, Cronbach alpha, and test-retest reliability. The sensitivity to change and minimally clinically important difference (MCID) will also be calculated.

Impact: Validation of the first PROM for maxillofacial trauma is anticipated to have a significant and lasting impact in the field of maxillofacial trauma. This will allow researchers and clinicians to better understand the patient experience and make management recommendations accordingly. Integrating the IMPACT into future studies may revolutionize the field by providing novel evidence for controversial topics such as maxillomandibular fixation techniques, surgical approaches, adjunctive therapies, and more.

• Reliability: Covariance of each item in the IMPACT modules and subscales [Срок оценки: When the initial survey is completed (within 12 months of the injury).]
• Sensitivity to Change: Change in IMPACT scores over the treatment course. [Срок оценки: At the completion of the second survey.]
• Sensitivity to Change: Change in IMPACT scores over the treatment course. [Срок оценки: Baseline (at recruitement, Day 0) and at 4 weeks.]
• Minimally Clinically Important Difference (MCID) [Срок оценки: When the initial survey is completed (within 12 months of the injury).]