RESUMO
OBJECTIVES: To translate and cross-culturally adapt the 12-item reflux symptom score (RSS-12) to European Portuguese (EP) and determine its clinimetric properties for symptomatic individuals with laryngopharyngeal reflux (LPR). STUDY DESIGN: Multinational cross-sectional cohort study. METHODS: The English RSS-12 was cross-culturally adapted according to the recommendations of the international guidelines. The validation study included the completion of the RSS-12, reflux symptom index, and voice handicap index by symptomatic and asymptomatic subjects with LPR. The RSS-12 was completed a second time by symptomatic subjects. Nine clinimetric properties were analyzed according to the international guidelines for validation of patient-reported outcome measures. RESULTS: The EP RSS-12 is equivalent to the English version (content, depth, and scoring). A total of 155 adults (84 with LPR symptoms) aged 21-78 years participated in the validation study. Statistical analyses revealed high internal consistency (Cronbach alpha >0.90), high test-retest reliability (intraclass correlation coefficient > 0.70, P < 0.001), low measurement error (Standard measure error of 5.21 for RSS and 1.59 for quality of life), good content validity (omission data <1% and item-total correlations > 0.652), good construct validity (61.9% of the total item variance with moderate item loadings), strong concurrent validity with reflux symptom index (rp = 0.772, P < 0.001) and moderate validity with voice handicap index (rp = 0.531, P < 0.001), and significantly known-groups validity (P < 0.001). The EP RSS-12 showed cross-cultural validity with French and Persian versions and high predictive validity with a cut-off value >8 for a sensitivity of 91.7% and a specificity of 91.5%. CONCLUSIONS: The EP RSS-12 retained the features of the English version and is a reliable and valid patient-reported outcome measure for EP individuals with LPR in the study.
RESUMO
OBJECTIVES: To determine reliability and validity of the European Portuguese pVHI version (pVHI-EP). STUDY DESIGN: Cross-sectional design. METHODS: The pVHI-EP and the talkative and global voice assessment scales were administered to the caregivers of children aged from 3 to 16 years old with and without dysphonia. Reliability (internal consistency and test-retest) was analyzed. The validity analyses performed were: (1) content validity by analyzing the percentage of missing data; (2) construct validity with intraclass correlation coefficients among pVHI-EP domains and overall score; (3) concurrent validity was conducted between pVHI-EP, the caregivers' judgment of the child's voice severity on a visual analog scale and the Speech-Language Pathologist perceptual voice assessment; (4) known-groups validity between children with and without dysphonia, and (5) predictive validity by calculating receiver operating characteristics, sensitivity and specificity and determining cut-off points. RESULTS: A total of 283 children (61.5% boys, mean age 8.3 years) participated in the study. The pVHI-EP showed an excellent internal consistency for the pVHI-EP total data. Strong to moderate test-retest reliability confirms pVHI-EP reproducibility. Excellent to good intraclass correlation coefficients between the pVHI-EP overall and the domains confirms its construct validity. Weak to moderate concurrent validity with visual analog scale and Speech-Language Pathologist perceptual voice assessment was confirmed. The pVHI-EP significantly distinguished two groups of different voice conditions. A cut-off point of 10.5 with 95.9% sensitivity and 92.5% specificity was determined for the overall score of the pVHI-EP. CONCLUSIONS: The pVHI-EP is a reliable and valid caregiver voice outcome tool for EP children with dysphonia.
