The VEINES-QOL/Sym Questionnaire Is a Valid and Reliable Measure of Quality of Life in Patients with Deep Venous Thrombosis.

Objectives: To assess the validity and reliability of VEINES-QOL/Sym, a patient-reported questionnaire, for the evaluation of quality of life and symptoms in patients with deep venous thrombosis.

Study design: Psychometric study within the Venous Thrombosis Outcomes (VETO) Study, a Canadian multicenter prospective cohort study of long term outcomes after venous thrombosis.

Subjects: 359 English and French-speaking patients with deep vein thrombosis consecutively recruited at seven hospitals in the province of Quebec, Canada.

Outcome measures: The 26-item VEINES-QOL/Sym is a patient-reported questionnaire that we originally developed and validated for use in patients with chronic venous disorders of the leg (J Vasc Surg 2003). VEINES-QOL/Sym generates separate summary scores for symptoms and quality of life. We performed a comprehensive psychometric evaluation of the acceptability, reliability, validity and responsiveness of VEINES-QOL/Sym in the VETO study population, all of whom had objectively diagnosed symptomatic deep venous thrombosis (mean age 56 years; 50% male; 67% outpatients; 55% proximal DVT).

Results: Criterion-standard psychometric tests confirmed the acceptability (missing data, item endorsement frequencies, floor and ceiling effects), reliability (internal consistency, item-total and inter-item correlations, test-retest), validity (content, construct, convergent, discriminant, known groups) and responsiveness to clinical change of the VEINES-QOL/Sym.

Conclusions: Our results indicate that VEINES-QOL/Sym is a practical, valid and reliable measure of quality of life and symptoms in patients with deep venous thrombosis. VEINES-QOL/Sym provides a rigorous tool to allow more comprehensive evaluation of patient outcomes in clinical trials and epidemiological studies of patients with deep venous thrombosis.