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

Abstract

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. 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. 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. The Qualiveen is a reliable and psychometrically validated instrument that may be used to measure the QoL of SCI patients with UD.