A Health-Related Quality of Life Measure in Patients with Deep Vein Thrombosis: A Validation Study
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Drug Information J o u m l , Vol. 33, pp. 1173-1187, 1999 Printed in the USA.All rights reserved.
A HEALTH-RELATED QUALITY OF LIFE MEASURE IN PATIENTS WITH DEEP VEIN THROMBOSIS: A VALIDATION STUDY* SUSAND. MATHIAS,MPH Senior Director, Quality of Life Research, Lewin-TAG, Inc., San Francisco, California
LEEANNPREBIL Associate, Lewin-TAG, Inc., San Francisco, California
CARYNG. PUTERMAN Manager, Health Outcomes Research, Abbott Laboratories, Abbot Park, Illinois
JOSEPHJ. CHMIEL,PHD Director of Epidemiologic Statistics, Abbott Laboratories, Abbot Park, Illinois
RICHARDC. THROM Clinical Research Coordinator, School of Medicine, Temple University, Philadelphia, Pennsylvania
ANTHONYJ. COMEROTA, MD, FACS Professor of Surgery and Chief of Vascular Surgery, School of Medicine, Temple University, Philadelphia, Pennsylvania
This study was conducted to test the psychometric properties of a newly developed healthrelated quality of life (HRQOL) questionnaire. One hundred eleven individuals identified through a registry and medical records who experienced an acute iliofemoral deep vein thrombosis (DVT)more than six months ago completed the questionnaire (containing the Health Utilities Index and Short Form-12,and DVT-specijk scales). Respondents were primarily female, Caucasian, and married with an average age of 54 years. Internalconsistency reliability was acceptable (Cronbach ’s alpha: 0.6eO.95).Interscale correlations were as expected. In general, patients with no symptoms reported the highest functioning, those with severe symptoms the lowest, and those with moderate symptoms reported values between the two. Guyattk statistic values for the majority of scales were t 10.201, demonstrating acceptable responsiveness to change. Psychometric testing indicated that the measure is reliable, valid, and responsive in this group. Future research will focus on further evaluating its use in studies of patients receiving different therapies for acute DVT Key Words: Venous thrombosis; Health-related quality of life; Questionnaire; Functioning and well-being; Validation *This study was supported by Abbott Laboratories. Preliminary results of this study were presented at the DIA Fifth Annual “Symposium of Contributed Papers on Quality of Life Evaluation,” April 6-7, 1998, Hilton Head, South Carolina. Reprint address: Susan D. Mathias, MPH, Lewin-TAG, Inc., 490 Second Street, Suite 201, San Francisco, CA 94 107. E-mail: [email protected].
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S. D. Mathias, L. A. Prebil, C. G. Putterman, J . J. Chmiel, R. C. Throm, and A. J . Comerota
INTRODUCTION
acute DVT (9,10,11), very few have examined the health-related quality of life ACUTE ILIOFEMORAL DEEP vein throm- (HRQOL) of patients with DVT or patients bosis, the sudden onset of a blood clot that receiving treatment for DVT. Beyth et al. forms in the iliofemoral veins resulting in (2) administered a questionnaire containing obstruction of venous flow, is a condition three subscales of the SF-36, items to assess associated with significant morbidity and the severity of symptom
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