RESUMEN
OBJECTIVES: The objective of this study was to establish normative data and cut-off scores for the Children Voice Handicap Index-10 (CVHI-10) and the Children Voice Handicap Index-10 for Parents (CVHI-10-P) METHODS: For normative data, CVHI-10 and CVHI-10-P questionnaires originally developed in the Italian language were completed by 201 children without dysphonia and with no history of voice disorders, and by 1 of their parents. The results were analyzed for mean, standard deviation (SD), and standard error of the mean (SEM) for both questionnaires. For cut-off values determination, data from 49 dysphonic children and from 1 of their parents were also used. This analysis was based on the sensitivity and specificity indicators of the questionnaires using the "receiver operating characteristic" (ROC) curve. RESULTS: Analysis of the questionnaires related to healthy children revealed a mean of 0.26 (SD 0.74; SEM 0.06) for CVHI-10 and a mean of 0.15 (SD 0.49; SEM 0.04) for CVHI-10-P for the normative values. ROC curve analysis allowed us to establish the cut-off scores of 2.5 for CVHI-10 and 1.5 for CVHI-10-P. CONCLUSIONS: This study offers normative data for CVHI-10 and CVHI-10-P and provides cut-off values for both questionnaires to distinguish healthy and pathologic responders.
RESUMEN
OBJECTIVES/HYPOTHESIS: The Children's Voice Handicap Index-10 (CVHI-10) was introduced as a tool for self-assessment of children's dysphonia. However, in the management of children with voice disorders, both parents' and children's perspectives play an important role. Because a self-tool including both a children's and a parents' version does not exist yet, the aim of the study was to develop and validate an assessment tool which parallels the CVHI-10 for parents to assess the level of voice handicap in their child's voice. STUDY DESIGN: Observational, prospective, cross-sectional study. METHODS: To develop a CVHI-10 for parents, called "CVHI-10-P", the CVHI-10 items were adapted to reflect parents' responses about their child. Fifty-five children aged 7-12 years completed the CVHI-10, whereas their parents completed the CVHI-10-P. Each child's voice was also perceptually assessed by an otolaryngologist using the Grade Breathness Roughness (GRB) scale. Fifty-one of the 55 children underwent voice therapy (VT) and were assessed afterward using the GRB, CVHI-10, and CVHI-10-P. RESULTS: CVHI-10-P internal consistency was satisfactory (Cronbach alpha = .78). Correlation between CVHI-10-P and CVHI-10 was moderate (r = 0.37). CVHI-10-P total scores were lower than CVHI-10 scores in most of the cases. Single-item mean scores were always lower in CVHI-10-P compared with CVHI-10, with the exception of the only one item of the CVHI-10-P that directly involves the parent's experience (item 10). Data gained from one tool are not directly related to the other, suggesting that these two tools appraise the child's voice handicap from different perspectives. The overall perceptual assessment scores of the 51 children after VT significantly improved. There was a statistically significant reduction of the total scores and for each item in CVHI-10 and CVHI-10-P after VT. These data support the adoption of the CVHI-10-P as an assessment tool and an outcome measure for management of children's voice disorders. CONCLUSIONS: CVHI-10-P is a valid tool to appraise parents' perspective of their child's voice disorder. The use of the CVHI-10 and the CVHI-10-P is recommended for objectively determining the level of voice handicap in children by parents and child.
Asunto(s)
Evaluación de la Discapacidad , Padres/psicología , Encuestas y Cuestionarios , Trastornos de la Voz/diagnóstico , Calidad de la Voz , Factores de Edad , Niño , Estudios Transversales , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Valor Predictivo de las Pruebas , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Medición de la Producción del Habla , Trastornos de la Voz/fisiopatología , Trastornos de la Voz/terapia , Entrenamiento de la VozRESUMEN
OBJECTIVES/HYPOTHESIS: To develop and validate the self-administered Voice Handicap Index-10 for children (CVHI-10) in Italian and evaluate its internal consistency and reliability in normal and disordered children's voices. STUDY DESIGN: Cross-sectional survey study. METHODS: CVHI-10 was developed after a series of individual interviews with 20 children, aged 8-14 years to discuss the phrasing and wording of the original VHI-10. Subsequently, 66 dysphonic children (group 1) provided input to test internal consistency, external validity, and clinical validity. The voices of group 1 children were rated using the grade, roughness, and breathiness parameters of the grade, roughness, breathiness, asthenia, strain (GRBAS) scale. The test-retest results of 30 children (group 2) who successfully underwent voice treatment were also analyzed for test-retest reliability and responsiveness to treatment. Children of group 2 completed CVHI-10 twice, with an interval of 2 weeks. Additionally, 40 children without voice disorders (group 3) were included as a control group to obtain clinical validity. Each child included in the study completed CVHI-10 autonomously. RESULTS: Internal consistency measured with the Cronbach α coefficient was .85; test-retest reliability was 0.84. CVHI-10 positively correlated with G (r=0.62) and B (r=0.34) parameters of the GRBAS scale on Spearman rho test. The mean CVHI-10 score for group 2 was 12.4±2.8 before treatment and 3.6±1.6 after treatment; the difference was significant using the Wilcoxon sign test (P=0.0001). The difference between CVHI-10 scores in groups 1 and 3 was significant using the Mann-Whitney U test (P=0.0001). CONCLUSIONS: CVHI-10 is easily administered, highly reproducible, exhibits good clinical validity, and responsiveness to treatment.
Asunto(s)
Evaluación de la Discapacidad , Disfonía/diagnóstico , Encuestas y Cuestionarios , Calidad de la Voz , Adolescente , Factores de Edad , Estudios de Casos y Controles , Niño , Comprensión , Estudios Transversales , Disfonía/fisiopatología , Femenino , Humanos , Italia , Lenguaje , Masculino , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Psicometría , Reproducibilidad de los Resultados , Índice de Severidad de la EnfermedadRESUMEN
In vitro biorelevant dissolution tests enabling the prediction of in vivo performance of an oral modified-release (MR) dosage form were developed in this study. In vitro dissolution of MR diclofenac sodium pellets containing 100mg active ingredient was evaluated under simulated pre- and postprandial conditions using USP Apparatus 3 (reciprocating cylinder, Bio-Dis) and 4 (flow-through cell) and results compared with compendial methods using USP Apparatus 1 (basket) and 2 (paddle). In vivo, the effects of food on the absorption of diclofenac sodium from the pellet dosage form were investigated by administering the product to 16 healthy volunteers pre- and postprandially in a crossover-design study. The in vitro results were compared with the in vivo data by means of Level A in vitro-in vivo correlation (IVIVC) and Weibull distribution analysis. The compendial dissolution tests were not able to predict food effects. The biorelevant dissolution tests predicted correctly that the release (and hence absorption) of diclofenac sodium would be slower in the fed state than in the fasted state. No significant differences in extent of absorption due to changes in extent of release were predicted or observed. The results demonstrate good correlations between in vitro drug release and in vivo drug absorption in both pre- and postprandial states using the biorelevant dissolution test methods.