Quality of life in spinal cord injury patients with urinary difficulties - Development and validation of qualiveen

Background: Quality of life (QoL) may be severely affected in patients with spinal cord injury (SCI) and resulting urinary difficulties (UD). There is, however, a need for instruments capable of measuring QoL in these patients. The aim of this study was to develop and validate a questionnaire suitable for use in SCI patients with urinary disorders. Methods: Following patient interviews, a questionnaire was developed in French that was subjected to item reduction and cross-sectional validation. The resulting Qualiveen (Qualiveen is a pending registration trade mark of Coloplast A/S, DK-3050 Humlebaek, Denmark) questionnaire underwent multi-trait and principal component analysis and the test-retest reliability of the questionnaire was examined in stable patients. Results: Patient interviews identified 257 concepts relevant to SCI patients with urinary disorders. Item reduction led to a 30-item questionnaire, which was psychometrically validated in 281 SCI patients with UD. The median age of patients was 41 years, 78% were male and the majority were paraplegic (55%). The construct and clinical validity of the Qualiveen was confirmed, as well as its reliability in patients whose condition was stable over a 15-day period. Patients confirmed that it was easy to understand, complete and comprehensive. Conclusions: The Qualiveen is a reliable and psychometrically validated instrument that may be used to measure the QoL of SCI patients with UD. Copyright (C) 2001 S. Karger AG, Basel.