Measuring the IMPACT: Pilot Validation of a Novel Patient-Reported Outcome Measure for Craniomaxillofacial Trauma

Background: There is a paucity of validated, patient-reported outcome measures for quality-of-life (QOL) in craniomaxillofacial (CMF) trauma. Objective: To determine whether the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT) independently measures QOL in patients presenting for routine follow-up within 3 months of injury by comparing with the 15-Dimension QOL survey (15D). Methods: A mixed-methods, pilot validation was performed via literature review, expert opinion, patient interviews, and prospective survey collection. Criterion validity was determined by multivariable adjusted correlation coefficients (B) between IMPACT and 15D scores. Reliability was assessed by Cronbach's alpha (A). Results: General (IMPACT-G), Nasal (IMPACT-N), Orbit (IMPACT-O), and Jaw (IMPACT-J) modules were developed. Domains include overall satisfaction, facial function, facial appearance, psychosocial function, general symptoms, and pain. Validation was performed in 53 patients with CMF trauma who had mandible (n = 27, 50.1%), nasal (n = 10, 18.9%), zygomaticomaxillary complex (n = 7, 13.2%), Le Fort (n = 6, 11.3%), and/or other fracture patterns. IMPACT scores independently predicted QOL (B > |0.4|; p 0.8; p < 0.05). Conclusions: The IMPACT was developed to measure QOL in patients suffering CMF trauma, and results from this initial validation study warrant expansion to a larger, diversified cohort.