Responsiveness of the electronic touch screen WOMAC 3.1 OA Index in a short term clinical trial with rofecoxib

Background: The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a self-administered validated questionnaire for patients with osteoarthritis (OA) of the hip or knee. The electronic touch screen version of the WOMAC (e-WOMAC) has been previously shown to be highly correlated with the original paper format. However, whether the e-WOMAC would be suitable for monitoring the effects of drug treatment is unknown. Aim: To validate the longitudinal use of the e-WOMAC questionnaire and its ability to detect changes in WOMAC-scores induced by drug treatment in outpatient care. Methods: Fifty-three outpatients, men and women (mean age: 64 years; SD +/- 9.5), with symptomatic osteoarthritis of hip or knee were included in an open label study with rofecoxib. At three visits over 3 weeks, responsiveness of the WOMAC 3.1 regarding the three subscales, pain, stiffness and function, were compared for the original paper format and the computer touch screen format (QUALITOUCH((R))) using a Likert scale. WOMAC scores were transformed to the 0-100 scale. ANOVA for repeated measures was used for analysis and effect sizes by subscale were compared for both formats. Results: Responsiveness for all three subscales was similar between formats. In both formats, pain and stiffness were significantly reduced with rofecoxib as early as 7 days, while functional ability was significantly increased (P < 0.01 for all aggregate subscale scores) with continuing improvement until the end of study. The effect sizes by subscale between Day 1 and 21 were not statistically different between the paper and the electronic version of the questionnaire and showed similar clinically meaningful improvements in WOMAC scores over 3 weeks. Conclusion: In this longitudinal intervention study, the e-WOMAC OA Index 3.1 showed similar responsiveness in detecting clinically meaningful changes than the original paper format. (C) 2004 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.