Italian version of Qualiveen-30: cultural adaptation of a neurogenic urinary disorder-specific instrument

Abstract

Purpose: Qualiveen-30 is a neurological urinary disorder (UD)-specific health-related quality of life (HRQL) instrument, recommended in the European Association of Urology guideline 2008. The objective is to complete the cultural adaptation of Qualiveen-30 into Italian.

Materials and methods: One hundred and twenty eight Italian-speaking spinal cord injury (SCI) patients completed Qualiveen-30 and the SF-12 physical and mental component (PC and MC) at enrollment and 4 weeks later. At follow-up, patients also made global ratings of change (GRC) in urinary HRQL (GRC).

Results: Qualiveen-30 proved reliable (intraclass correlation coefficients of four domains: 0.77-0.90). Correlations with SF-12 and GRC were generally consistent with our a priori predictions. Qualiveen-30 domains showed weak-to-moderate cross-sectional correlations with SF-12 scores (0.31-0.45 PC and 0.28-0.45 MC). Correlations between changes in Qualiveen-30 scores and in SF-12-PC scores were weak or absent. Correlations between changes in Qualiveen-30 scores and in SF-12-MC scores were weak to moderate (0.25-0.38). Relationships between change in Qualiveen-30 and GRC were moderate to strong (0.48-0.56). The responsiveness was excellent, similar to the original form (SMR: 1.76-2.31). Minimally important difference values in the four domains varied from 0.34 to 0.47.

Conclusions: Italian Qualiveen-30 is a reliable, valid, and responsive measure of UD-related HRQL in SPI patients. Investigators can be confident of the Qualiveen-30 questionnaire's ability in distinguishing between patients in a cross-sectional survey, as well as in measuring within-subject changes over time in clinical trials in French, English, and Italian.