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 patient s. The aim of this study was to develop and validate a questionnaire suitab le for use in SCI patients with urinary disorders. Methods: Following patient interviews, a questionnaire was developed in Fre nch that was subjected to item reduction and cross-sectional validation. Th e resulting Qualiveen (Qualiveen is a pending registration trade mark of Co loplast A/S, DK-3050 Humlebaek, Denmark) questionnaire underwent multi-trai t and principal component analysis and the test-retest reliability of the q uestionnaire was examined in stable patients. Results: Patient interviews identified 257 concepts relevant to SCI patient s with urinary disorders. Item reduction led to a 30-item questionnaire, wh ich was psychometrically validated in 281 SCI patients with UD. The median age of patients was 41 years, 78% were male and the majority were paraplegi c (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 ins trument that may be used to measure the QoL of SCI patients with UD. Copyri ght (C) 2001 S. Karger AG, Basel.