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Clinical Trial
- 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
- J Prev Med Public Health. 2004;37(4):381-389. Published online November 30, 2014
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- 201 Download
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Abstract
PDF - 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. -
SummaryOriginal Article
- Correlation of Fit Factors for Respirators and Anthropometric Dimension.
- Don Hee Han
- Korean J Prev Med. 1998;31(3):440-448.
- 1,860 View
- 46 Download
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Abstract
PDF
- In many developed countries, for example, USA, respirator fit testing is required before entering specific work environment to ensure that the respirator worn satisfies a minimum of fit and that the user knows when the respirator fits properly. Unfortunately because we have not fit test regulation in Korea, a lot of workers wearing respirators may be potentially exposed to hazards. This study was conducted to evaluate the fitting performance for respirators and correlation fit factors with facial dimensions of wearers. 110 subjects (70 males, 40 females) were fit tested for three quarter masks, i.e., two domestic-made Mask Z, and Y and one foreign-made Mask T using PortaCount 8020. A facial dimension survey of the same subjects was conducted to develop a facial dimension grids for correlation fit factors with facial dimension parameters. A facial dimension grid was developed on the basis of face length and lip length for quarter masks. The results obtained were as follows: 1. Fit factors of Mask T were much higher than those of Masks Z, and Y. 2. Males were fitted more properly than females. 3. Male in box "f" of grid would be adequately fitted Mask Y and male in box "b", "e", "f", "h" of grid would be sufficiently fitted Mask T. Female in box "h" of grid may have a good fitting performance for both Mask Y, and T. But subjects in all boxes of grid would be inadequately fitted Mask Z.
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Summary
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