Development and preliminary validation of the Lip Reanimation Outcomes Questionnaire

Abstract

OBJECTIVE: Lip paralysis is associated with eating, speaking, and appearance impairments. The lip reanimation outcome questionnaire is designed to assess these functional impairments after lip reanimation. STUDY DESIGN: Cross-sectional validation study. SETTING: Tertiary care academic center. SUBJECTS AND METHODS: Patients who underwent lip reanimation and control subjects. A disease-specific instrument was created by systematic literature review and expert opinion. The 15-item patient completed subscale was administered to 20 lip reanimation patients. Photographs of 19 patients and three control subjects were taken in four poses and rated by six raters (2 surgeons, 2 residents, and 2 novices) by the use of a external rater subscale, and reliability was determined by the use of intraclass correlation coefficients (ICC). Content and construct validity were assessed. RESULTS: Internal consistency (ICC range 0.813-0.915 for each domain), test—retest reliability (ICC range 0.616-0.981 for each item) for the patient completed subscale, and interrater (ICC = 0.852) and interlevel reliability (ICC = 0.929) for the external rater subscale were substantial to excellent. The content validity index was 0.87. Construct validity was demonstrated by poorer scores in patients with transected nerves versus intact nerves for appearance ( P = 0.04) and oral competence ( P = 0.011). Photographs of control patients had lower asymmetry scores ( P < 0.001), and the instrument detected greater asymmetry in patients with progressively more exaggerated smile ( P < 0.001). CONCLUSION: The lip reanimation outcome questionnaire has promising reliability and validity in this preliminary study, but additional psychometric testing with larger samples is required before the survey can be recommended for clinical use. © 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. All rights reserved.