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Journal of Preventive Medicine and Public Health 2004;37(4): 381-389.
Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method.
Hoi Jeong Lim, Yooni Kim, Young Bok Jung, Sang Cheol Seong, Jin Hwan Ahn, Kwon Jae Roh, Jung Man Kim, Byung Joo Park
1Department of Preventive Medicine, Seoul National University, Korea. bjpark@snu.ac.kr
2Institute of Radiation Effect & Epidemiology, Medical Research Center, Seoul National University, Korea.
3Department of Orthopaedic Surgery, Chung-Ang University, Korea.
4Department of Orthopaedic Surgery, Seoul National University, Korea.
5Department of Orthopaedic Surgery, Sungkyunkwan University and Samsung Medical Center, Korea.
6Department of Orthopaedic Surgery, Ewha Woman's University Hospital, Korea.
7Department of Orthopaedic Surgery, The Catholic University of Korea, Korea.
8Clinical Trial Center, Clinical Research Institute, Seoul National University Hospital, Korea.
OBJECTIVE : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. METHODS: A randomized, double-blind, active comparator controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent (or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. RESULTS: While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT: aOR=1.37, 95% CI= (0.8200, 2.26), PP: aOR=1.47, 95% CI= (0.73, 2.95) ). The goodness-off it statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. CONCLUSIONS: Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.
Key words: VAS pain score; GEE; Goodness-of-fit test for GEE; Osteoarthritis; Clinical Trial
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