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Objective 1) Define the minimal clinically important difference (MCID) of the Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) instrument, and 2) test for change in quality of life after VPI surgery. Study Design Prospective observational cohort. Setting VPI clinic at a tertiary pediatric medical center. Subjects and Methods Children with VPI and their parents completed the VELO instrument (higher score is better quality of life) at enrollment and then underwent VPI surgery (Furlow palatoplasty or sphincter pharyngoplasty, n=32), other treatments (obturator or oronasal fistula repair, n=7), or no treatment (n=18). They completed the VELO instrument again and an instrument of global rating of change in quality of life at one year. MCID was anchored to the global change instrument scores corresponding to “a little” or “somewhat” better. Within-group (paired t-test) and between-group (Student’s t-test) changes in VELO were tested for the VPI surgery and no treatment groups. The association between treatment group and VELO change was tested with multivariate linear regression, adjusting for confounders. Results Follow up was obtained on 37/57 (65%) of patients. The mean (SD) VELO change scores corresponding to the MCID anchor was 15 (13). The VELO score improved significantly more in the VPI surgery group (change 22 [15]), p<0.001) than in the no-treatment group (change 9 [12], p=0.04), after adjusting for confounders (p=0.007 between groups). Conclusion VPI surgery using the Furlow palatoplasty or sphincter pharyngoplasty improves VPI specific quality-of-life, and the improvement is clinically important.

Objective Test the Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) instrument for validity, reliability and responsiveness. Study Design Observational cohort Setting Academic tertiary medical center Subjects Children with VPI (n=59) and their parents (n=84) were prospectively enrolled from a pediatric VPI clinic. Methods Pediatric speech language pathologists diagnosed VPI using perceptual speech analysis and rated VPI severity and speech intelligibility deficit (each as minimal, mild, moderate or severe). All parents and youth 8+ years old (n=24) completed the VELO instrument and other quality-of-life questionnaires at baseline; the first 40 subjects completed the VELO instrument again two-weeks later. Treatments included Furlow palatoplasty (n=20), sphincter pharyngoplasty (n=14) or an obturator (n=2), and 29/36 (81%) subjects completed the questionnaires three months post-treatment. VELO was tested with correlations for criterion validity against VPI severity, construct validity against speech intelligibility and velopharyngeal gap size, and concurrent validity against other quality-of-life measures (r>0.40 demonstrating validity); for test-retest reliability using intraclass correlation (>0.6 demonstrating reliability); and for responsiveness with the 3-month post-treatment measure using the paired t-test. Results Parental responses are reported; youth responses showed similar results. The VELO instrument did not meet criterion validity (r=−0.18, p=0.10), or functional construct validity (r=−0.37, p=0.001), but did meet anatomic construct and concurrent validity (each r>0.50, p<0.01). VELO scores demonstrated excellent test-retest reliability (r=0.85, p<0.001) and responsiveness (baseline 54+/−14 to post-treatment 70+/−18, p<0.001). Conclusion VELO provides a VPI specific quality-of-life instrument that demonstrates concurrent validity, test-retest reliability, and responsiveness to change in quality-of-life with treatment.

Objectives/Hypothesis: To translate the Velopharyngeal Insufficiency Effects on Life Outcomes (VELO) instrument into Chinese and test its psychometric properties.Study Design: Quality of life instrument translation and validation. Methods: The original English version of the VELO instrument was translated into Mandarin, back-translated, and adapted among the Chinese population, based on the standardized guidelines for the cross-culture adaption process. Velopharyngeal insufficiency (VPI) patients were identified by a professional speech and language pathologist. Internal reliability of the VELO instrument was assessed by the Cronbach's α coefficient. Discriminant validity was tested by the Mann-Whitney U test. Construct validity was assessed by factor analysis.Results: A total of 113 patients with VPI and 72 parents of the patients were enrolled. The mean age of the VPI patients was 14.8 years. Internal reliability was excellent; Cronbach's α coefficients were 0.92 and 0.94 for VPI patients and their parents, respectively. The Chinese VELO discriminated well between the VPI group and the controls, with a mean (standard deviation) score that was significantly lower for the VPI group (74.8 [25.7]) than the control group (98.0 [15.9]) (P < .001). The total scores and scores in the emotional domain or perception domain showed differences between VPI patients and their parents. Similar to the original study, the factor loading after rotation followed hypothesized domains largely, in spite of items from several domains loaded on the same factor.Conclusions: The translated Chinese version of the VELO instrument demonstrated an acceptable reliability, discriminant validity, and construct validity. These psychometric properties suggested theoretical evidence for the further use of the VELO instrument among Chinese patients with VPI.