Introduction: There exists a need to assess the impact of urinary disorders (UD) on spinal cord injury (SCI) patients’ health-related quality of life. Qualiveen is a specific health-related quality of life (HRQL) questionnaire for UD in neurologic conditions such as multiple sclerosis (MS) and SCI patients. Its long version (30 items) as well as its short form (SF-Qualiveen with 8 items) have proved reliable, valid, and responsive in French-speaking and English-speaking MS and SCI patients with UD.
Aim of the Study: To assess cross-sectional and longitudinal construct validity, reliability, and responsiveness of the Italian versions of Qualiveen in the spinal cord injury population.
Patients and Methods: One hundred and twenty-one Italian-speaking outpatients who, at enrollment, were classified as “stable” if they had no UD requiring change in medicine or “anticipated improvement” if they had troubling UD that mandated intensified treatment. All patients completed Qualiveen, the SF-12 questionnaire and urinary function assessments, at enrolment and 2 to 10 weeks later. At the second visit, patients also made global ratings of change in urinary HRQL (GRC). We tested predictions about the relationships between changes in other questionnaires (SF-12, urinary function assessments, and GRC) and changes in the Qualiveen domains. Test-retest reliablity was analyzed by intraclass correlation coefficients for each Qualiveen domain. A paired test in the anticipated improvement group comparing scores before and after the intervention, and the magnitude of the standardized response mean (SRM), provided measures of responsiveness.
Results: Correlations of the SF-Qualiveen with its original form were high (R = 0.86 to 0.90). Correlations with other measures were consistent with our a priori predictions for the SF12 Physical Component (PC) and SF12 Mental Component (MC) scores and GRC. Both versions of Qualiveen showed weak-to-moderate cross-sectional correlations with SF-12 Scores (0.31 to 0.45 and 0.28 to 0.45, respectively). Correlations between changes in Qualiveen scores and changes in SF-12 PC scores were weak or absent. Correlations between changes in Qualiveen scores and changes in SF-12 MC scores were weak to moderate (0.25 to 0.38). Relationships between change in Qualiveen and change in GRC were moderate to strong (0.48 to 0.56) . The urinary function assessments were neither correlated with Qualiveen scores, nor with the SF-12 scores, suggesting lack of validity of urinary function assessments. Both Qualiveen versions proved reliable (intraclass correlation coefficients 0.77 to 0.90). The short-version responsiveness was similar to the long form (standardized response means between 1.76 to 2.31).
Conclusions: The SF-Qualiveen has excellent measurement properties, similar to those of its long form. The new instrument is likely to perform well in the clinical and research context. The Italian version showed similar measurement properties of the original French and English version.
KEYWORDS: Spinal cord injury, neurogenic bladder dysfunction, quality of life, Qualiveen