Normative Values for the Children Voice Handicap Index-10 (CVHI-10) and for the Children Voice Handicap Index-10 for Parents (CVHI-10-P).

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.

Development and Validation of the Children's Voice Handicap Index-10 for Parents.

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.

Development and validation of the children's voice handicap index-10 (CVHI-10).

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.

Application of biorelevant dissolution tests to the prediction of in vivo performance of diclofenac sodium from an oral modified-release pellet dosage form.

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.