An instrument for measuring health-related quality of life in patients with Deep Venous Thrombosis (DVT): development an
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An instrument for measuring health-related quality of life in patients with Deep Venous Thrombosis (DVT): development and validation of Deep Venous Thrombosis Quality of Life (DVTQOL) questionnaire Ewa Hedner*1, Jonas Carlsson2, Károly R Kulich2, Lennart Stigendal3, Anders Ingelgård2 and Ingela Wiklund2 Address: 1Experimental Medicine, AstraZeneca, R&D, SE-431 83 Mölndal, Sweden, 2Clinical Science, AstraZeneca, R&D, Mölndal, Sweden and 3Section for Coagulation Disorders, Department of Internal Medicine, Sahlgrenska University Hospital, Göteborg, Sweden Email: Ewa Hedner* - [email protected]; Jonas Carlsson - [email protected]; Károly R Kulich - [email protected]; Lennart Stigendal - [email protected]; Anders Ingelgård - [email protected]; Ingela Wiklund - [email protected] * Corresponding author
Published: 23 June 2004 Health and Quality of Life Outcomes 2004, 2:30
doi:10.1186/1477-7525-2-30
Received: 08 March 2004 Accepted: 23 June 2004
This article is available from: http://www.hqlo.com/content/2/1/30 © 2004 Hedner et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.
Deep Venous ThrombosesHealth-related Quality of LifePsychometric evaluation
Abstract Background: Few studies have evaluated patient-reported outcomes in connection with a primary event of deep venous thrombosis, partly due to a lack of disease-specific measures. The aim here was to develop a disease-specific health-related quality of life (HRQL) measure, the deep venous thrombosis quality of life questionnaire (DVTQOL), for patients with recent exposition and treatment of proximal deep venous thrombosis. Methods: A total of 121 consecutive outpatients (50 % males; mean age 61.2 ± 14 years) treated with warfarin (Waran®) for symptomatic proximal deep venous thrombosis were included in the study. Patients completed the SF-36, EQ-5D and the pilot version of the DVTQOL. Results: Items having: high ceiling and floor effect, items with lower factor loadings than 0.50 and items loading in several factors were removed from the pilot version of DVTQOL. In addition, overlapping and redundant items identified by the Rasch analysis were excluded. The final DVTQOL questionnaire consists of 29 items composing six dimensions depicting problems with: emotional distress; symptoms (e.g. pain, swollen ankles, cramp, bruising); limitation in physical activity; hassle with coagulation monitoring; sleep disturbance; and dietary problems. The internal consistency reliability was high (alpha value ranged from 0.79 to 0.93). The relevant domains of the SF-36 and EQ-5D significantly correlated with DVTQOL, thereby confirming its construct validity. Conclusions: The DVTQOL is a short and user-friendly instrument with good reliability and validity. Its test-retest reliability and responsiveness
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