Ecuadorian Spanish translation and validation of the VELO quality of life instrument.

OBJECTIVES: Adapt the Spanish translation of VPI Effects on Life Outcome (VELO) instrument into Ecuadorian Spanish; test the resulting instrument for reliability and validity. METHODS: A cross-sectional, prospective design, set at a humanitarian mission within a community hospital. Linguistic validation: native Ecuadorian-Spanish speakers modified the Spanish VELO to Ecuadorian Spanish. Cognitive interviews were conducted with children with cleft palate (CP) and their parents (n = 50), guiding instrument modifications. An expert panel reviewed changes, resulting in the VELO-Ecuadorian dialect (VELO-Ec). INSTRUMENT ASSESSMENT: 88 participants with CP (88 parents, 46 children) and 33 non-cleft controls (33 adult, 11 children) completed the VELO-Ec, Spanish-Pediatric Voice Handicap Index (pVHI), and Spanish-Intelligibility in Context Scale (ICS). Internal consistency was assessed with Cronbach's alpha; test-retest reliability was assessed by calculating the intraclass correlation coefficient (ICC); standard error of measurement (SEM) was calculated. Concurrent validity was assessed with Pearson correlations of VELO-Ec with pVHI and ICS. Discriminant validity assessment used an established ICS cutoff. Construct validity was assessed by grouping patients by parent report of hypernasality and early vs. late cleft repair (>24 months) using the Wilcoxon Rank-Sum test. RESULTS: VELO-Ec showed excellent internal consistency (alpha 0.96) and test-retest reliability (ICC = 0.85, 95% CI 0.68-0.93, SEM 5.71). It had strong concurrent validity, correlating with ICS (r = 0.75, p < 0.001) and pVHI (r = -0.79, p < 0.001). Discriminant validity was strong with better VELO-Ec scores among subjects with normal vs. abnormal ICS score (median 95 & 61, p < 0.001). Strong construct validity was identified: those with parent-reported hypernasality had worse VELO-Ec scores than those without (median 59 & 75, p < 0.001). Those with repair before or after 24 months had similar VELO-Ec scores (p = 0.882). CONCLUSION: The VELO-Ec is a valid and reliable measure of VPI-related quality of life, useful to clinicians and researchers treating Ecuadorian CP patients, especially in areas with limited resources such as on humanitarian missions.

Spanish Linguistic Validation of the Velopharyngeal Insufficiency Effects on Life Outcomes: VELO-Spanish.

BACKGROUND: Quality of life (QOL) assessments are useful tools that measure a patient's health status and monitor patient-reported outcome measures. This study highlights the process of linguistic validation of a QOL assessment to serve Spanish-speaking families and ultimately help decrease language barriers in the treatment of velopharyngeal insufficiency (VPI). METHODS: The standardized linguistic validation process included forward and backward translation, reconciliation, and cognitive interviews with patients and families. Preliminary instrument test-retest measurement was assessed. Eligibility for cognitive interviews included families with familiarity of velopharyngeal insufficiency. Exclusion criteria included illiteracy and parent and child respondents who do not speak Spanish. Reliability was tested by intraclass correlation (ICC) on VPI Effects on Life Outcomes (VELO)-Spanish instruments completion on 2 measurements from the medical record. RESULTS: The instrument was optimized through a standardized forward and backward translation process. Further problematic language was identified during cognitive interviews with families and their children. In the second interview, only minimal changes were needed. Twenty-one patients (8 males and 13 females) were included. Mean (SD) age was 8.0 (5.3) years (range, 3-21 years). The mean (SD) Velo-Spanish score was 65 (22.1); range 32.7-100. The VELO-Spanish instrument demonstrated excellent test-retest reliability [ICC = 0.91; n = 21 and internal consistency (α = 0.96)]. CONCLUSIONS: The Spanish VELO has been developed and refined for use in Spanish-speaking populations as a VPI-specific QOL instrument. The linguistic validation process including cognitive interviews and initial reliability testing. The instrument may improve the understanding of patient-reported outcomes and potential disparities from linguistic and cultural barriers in VPI treatment.

Revision rates and speech outcomes following pharyngeal flap surgery for velopharyngeal insufficiency.

IMPORTANCE: Velopharyngeal insufficiency in children with cleft palate (and other causes) contributes to difficulty with communication and quality of life. The pharyngeal flap is a workhorse to address hypernasality and nasal air escape. However, there is a paucity of literature on the characteristics of cases that require revision. OBJECTIVE: To measure the revision rate of pharyngeal flaps, compare the preperceptual and postperceptual speech scores, and identify the characteristics of those patients who required revision. DESIGN, SETTING, AND PARTICIPANTS: A retrospective medical record review was completed for patients who underwent pharyngeal flap surgery from June 1, 2008, through January 31, 2013, at a tertiary academic center. MAIN OUTCOMES AND MEASURES: Perceptual speech analyses and surgical revision rates. Perceptual speech patterns before and after surgery were compared using nasal air emission and resonance scores. The association between requiring revision surgery and covariates was analyzed using multivariable mixed-effects logistic regression. RESULTS: Sixty-one patients were identified, including 24 boys (39%) and 37 girls (61%). The mean (SD) patient age at the time of pharyngeal flap surgery was 8.2 (6.8) years (range, 3-55 years). Velopharyngeal insufficiency was associated with cleft palate in 51 patients (84%), and 17 patients (28%) had a syndrome. The mean (SD) time to surgery after the speech evaluation was 225 (229) days (range, 14-1341 days). The mean (SD) nasal air emission scores decreased by -1.1 (2.0 [1.1] preoperatively to 0.8 [1.1] postoperatively). The mean (SD) resonance score decreased by -1.5 (2.4 [1.1] preoperatively to 0.9 [1.1] postoperatively; P < .001). Flaps were revised in 12 patients (20%), including port revision in 9, complete flap revision in 2, and flap takedown in 1. The only covariate that was significantly associated with revision rates was increased age at surgery, which was associated with a higher probability of revision surgery (odds ratio, 1.31; 95% CI, 1.03-1.66; P = .04). CONCLUSIONS AND RELEVANCE: Pharyngeal flap surgery, when appropriately selected, was effective at improving speech with a revision rate of 20%, which is comparable to previously published studies. Increased age at the time of the pharyngeal flap surgery was associated with an increased need for revision surgery, supporting evidence that cleft centers should encourage early childhood speech evaluations with consistent documentation and prompt treatment. LEVEL OF EVIDENCE: 3.