Abstract
BackgroundFew 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.MethodsA 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.ResultsItems 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.ConclusionsThe DVTQOL is a short and user-friendly instrument with good reliability and validity. Its test-retest reliability and responsiveness to change in clinical trials, however, must be explored.
Highlights
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
Patients report problems with functioning, low levels of energy, sleep disturbance, pain and limitations in physical mobility that were evaluated by the Nottingham Health Profile (NHP)
In contrast to previous measures, the deep venous thrombosis quality of life questionnaire (DVTQOL) focuses on the early symptoms and problems related to anticoagulation management that patients have after a recent deep venous thrombosis (DVT) event
Summary
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. In a long-term outcomes study of DVT, it was shown that symptoms in the leg, such as pain, swelling, ulceration and discoloration, affected patients' perception of HRQL as measured by the Short Form Health Survey (SF-36) [6,7]. There are a number of characteristics of current oral anticoagulation therapies that can potentially induce dissatisfaction and reduce HRQL. Among these are the necessity for frequent doctor visits for regular blood testing, lifestyle limitations, including restrictions on diet and activities, and possible worry about bleedings. The practical and psychological demand of such therapy has negative effects on patients' perceptions of their HRQL[8,9]
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