Qualiveen: A Urinary Disorder−Specific Instrument for Use in Clinical Trials in Multiple Sclerosis

OBJECTIVE: To examine the longitudinal construct validity and the responsiveness of the English and French versions of Qualiveen in multiple sclerosis (MS) patients with urinary disorders. DESIGN: Cohort study. SETTING: MS clinics and departments of rehabilitation in Canada and France. PARTICIPANTS: One hundred eighty English-speaking and French-speaking outpatients who, at enrollment, were classified as "stable" if they had no urinary disorders requiring change in medicine, or "anticipated improvement" if they had troubling urinary disorders that mandated intensified treatment. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We tested predictions about the relation between changes in other questionnaires (Multiple Sclerosis Quality of Life-54 questionnaire or its French version, the SEP-59, and a global rating of change) and changes in the Qualiveen domains. A paired t 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: Consistent with a priori predictions (weighted kappa=.71), changes in Qualiveen score correlated with changes in other questionnaires. All Qualiveen domains detected changes in patients in the anticipated improvement group (P<.001) and differentiated these patients from "stable" patients (P<.001);all SRMs were large (>.75). CONCLUSIONS: Valid and responsive, both English and French versions are useful for MS studies into urinary disorders.