Multi-Institutional Validation of the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Criterion validity: Correlation of IMPACT modules with the 15D QOL control survey
研究概览
简要总结
The goal of this observational study is to validate a novel patient-reported outcome measure (PROM) for patients suffering maxillofacial trauma: The Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT). The primary question is:
Are the IMPACT 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 IMPACT in addition to the 15 Dimension (15D) QOL survey as a control.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of maxillofacial trauma (fracture of any facial bone[s] and/or soft tissue injury) within 12 months of recruitment date.
排除标准
- •Patients presenting to clinic for reasons not related to maxillofacial trauma.
- •Patients with isolated fractures of the cranium or teeth.
- •Patients who cannot read, write, and/or speak English.
- •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)
结局指标
主要结局
Criterion validity: Correlation of IMPACT modules with the 15D QOL control survey
时间窗: 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 IMPACT module total scores and the 15D QOL control survey via Pearson's r, controlling for independent variables that influence survey scores.
次要结局
- Reliability: Covariance of each item in the IMPACT modules and subscales(When the initial survey is completed (within 12 months of the injury).)
- Sensitivity to Change: Change in IMPACT scores over the treatment course.(Baseline (at recruitement, Day 0) and at 4 weeks.)
- Minimally Clinically Important Difference (MCID)(When the initial survey is completed (within 12 months of the injury).)