Multi-Institutional SMASH-Q Validation

• Conditions: Facial Injuries; Mandible Fracture; Le Fort; Zygomaticomaxillary Complex Fracture; Nasal Fracture; Orbital Fractures; Zygoma Fracture; Orbital Floor Fracture; Facial Laceration

• Registration Number: NCT06850857
• Lead Sponsor: University of Tennessee

Brief Summary

The goal of this observational study is to validate a novel patient-reported outcome measure (PROM) for patients suffering maxillofacial trauma: The Survey for Maxillofacial Trauma and Soft Tissue Healing (SMASH-Q). The primary question is:

Are the SMASH-Q modules valid and reliable measures to study quality-of-life (QOL) in patients with maxillofacial trauma?

Patients presenting for routine clinic follow-up for maxillofacial trauma will be invited to complete the SMASH-Q in addition to the 15 Dimension (15D) QOL survey as a control.

Detailed Description

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 Survey for Maxillofacial Trauma and Soft Tissue Healing (SMASH-Q). The SMASH-Q 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 (SMASH) and 3 modules specific to fractures of the nasal (N-SMASH), orbital (O-SMASH), and/or jaw (J-SMASH) 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 SMASH-Q for measuring QOL in patients suffering maxillofacial trauma. The hypothesis is that each SMASH-Q 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 SMASH-Q 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 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 SMASH-Q 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Study Start: 2025-03-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Diagnosis of maxillofacial trauma (fracture of any facial bone[s] and/or soft tissue injury) within 12 months of recruitment date.

Exclusion Criteria

1. Patients presenting to clinic for reasons not related to maxillofacial trauma.
2. Patients with isolated fractures of the cranium or teeth.
3. Patients who cannot read, write, and/or speak English.
4. Patients who are unable to provide informed consent for themselves (including those who are under 18 years old, incapacitated, intoxicated, or cognitively impaired with a legal guardian)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Criterion validity: Correlation of SMASH-Q modules with the 15D QOL control survey	When the initial survey is completed (within 12 months of the injury).	Criterion validity will primarily be determined by calculating the correlation between each of the SMASH-Q module total scores and the 15D QOL control survey via Pearson's r, controlling for independent variables that influence survey scores.

Secondary Outcome Measures

Name	Time	Method
Reliability: Covariance of each item in the SMASH-Q modules and subscales	When the initial survey is completed (within 12 months of the injury).	The reliability of each module and subscale will be measured via Cronbach alpha's measurement of internal consistency,
Reliability: Test-Rest Reliability of SMASH-Q scores	At the completion of the second survey (within 4 weeks of the initial survey).	The reliability will also be evaluated by comparing consecutive SMASH-Q module and subscale scores for patients who completed the survey two times. Only those returning within 4 weeks of completing the initial survey will be included.
Minimally Clinically Important Difference (MCID)	When the initial survey is completed (within 12 months of the injury).	The MCID will be calculated for each SMASH-Q module and subscale via an anchor-based approach, using a single global question designed to comprehensively assess how the patient feels regarding their facial injury.

Trial Locations

Locations (3)

University of California, Davis; 🇺🇸 Sacramento, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States