- Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method.
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Hoi Jeong Lim, Yooni Kim, Young Bok Jung, Sang Cheol Seong, Jin Hwan Ahn, Kwon Jae Roh, Jung Man Kim, Byung Joo Park
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J Prev Med Public Health. 2004;37(4):381-389. Published online November 30, 2014
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: 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.
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- Nonsteroidal Anti-inflammatory Drugs Utilization Patterns among the Elderly with Osteoarthritis at Primary Ambulatory Care Units in Busan Metropolitan City, Korea.
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Nam Kyong Choi, Yooni Kim, Seung Mi Lee, Byung Joo Park
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J Prev Med Public Health. 2004;37(2):150-156.
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- OBJECTIONS: To investigate the utilization patterns of non-steroidal anti-inflammatory drugs (NSAIDs) among the elderly with osteoarthritis (OA) undergoing primary ambulatory care in Busan metropolitan city, Korea. METHODS: OA patients, aged 65 years and over, were identified from the Korean National Health Insurance Review Agency drug prescription database. The subjects had at least one episode of claim for OA (ICD-10-CM: M15-M19) between August 1, 2000 and February 28, 2002. Trends in the determinations of NSAIDs utilization were identified using chi-squared tests for trend. RESULTS: There were 47, 711 osteoarthritic patients. The total number of visits by these patients was 177, 443, with a total frequency for NSAID prescriptions of 214, 952. Seventy-nine percent of the OA patients were female. NSAIDs were prescribed on 133, 284 visits (75.1%) and the proportion of prescriptions was significantly increased with age. Only the proportion of visit when NSAIDs were prescribed decreased, from 65.1 to 43.5%, during the study period (p< 0.001). However, the proportion of combined treatments with anti-ulcer drugs was increased. The use of NSAIDs injections was decreased. Of the individual NSAIDs, diclofenac (28.7% of total frequency of NSAID prescriptions), piroxicam (15.0%) and talniflumate (8.7%), were the most frequently prescribed. Among the NSAIDs prescribed OA visits, 45.7% used two or more NSAIDs. CONCLUSION: The total proportion of NSAIDs prescribed to the osteoarthritic patients was higher than in other studies. The decline in the use of NSAIDs during the study period, and the frequent selection of safer medications, such as combination therapy with anti-ulcer drug, may reflect the risk awareness of the use of NSAIDs.
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- Physical Activity and Hip Fracture in Elderly People: A Cohort Study in Korea.
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Kyung Eun Youn, Seung Mi Lee, Yooni Kim, Byung Joo Park
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Korean J Prev Med. 2002;35(4):351-358.
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To evaluate the relationship between physical activity and the risk of hip fracture in the elderly Korean people. METHODS: The study population was a Physical Activity Subcohort (n=8,908) extracted from the Korean Elderly Pharmacoepidemiological Cohort (KEPEC). Physical activity information was obtained from a mailed questionnaire surveys. The outcome data was collected from claims data gathered between Jan. 1993 and Dec. 1998. A hospital survey relating to potential cases was conducted to confirm the final diagnoses. The abstracted data was reviewed by a medical doctor before the final diagnoses were confirmed. A mailing questionnaire survey was performed to obtain information on potentially confounding variables, including alcohol intake, smoking habits, weight, height and postmenopausal duration. There were 79 confirmed cases hospitalized due to hip fractures between Jan. 1993 and Dec. 1998. Relative risk of physical activity scores on the hip fracture, and their 95% confidence intervals, were estimated by a Cox's proportional hazard model using SAS for Windows ver. 6.12. RESUJLTS: Compared to the reference group, the adjusted relative risk of hip fracture associated with the most physical active category; after controlling for age, weight and alcohol intake in the males, and for weight, alcohol intake and postmenopausal duration in the females, were 1.04 (95% CI=0.35-3.06) and 0.44 (95% CI=0.26-0.77), respectively. CONCLUSIONS: Physical activity may protect elderly women from hip fracture.
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- Reproductive History and Hip Fracture in the Elderly Women in Korea: A Cohort Study.
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Seung Mi Lee, Yooni Kim, Koung Eun Youn, Byung Joo Park
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Korean J Prev Med. 2002;35(4):305-312.
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The reproductive history of women has been suggested to have a possible influence on the risk of osteoporotic fractures. The purpose of this study was to assess the association between reproductive history and hip fractures in the elderly women. METHODS: The study subjects were drawn from women members of the Korean Elderly Pharmacoepidemiologic Cohort (KEPEC), aged 65 years or over, whose reproductive histories were available, and who were beneficiaries of the Korea Medical Insurance Corporation (KMIC) in 1993 and lived in Busan city, Korea. The information on reproductive histories, and possible confounders, were collected from mailed questionnaires. Potential hip fracture cases were collected from the claims data obtained between 1993 and 1998, with a hospital survey conducted to confirm the final diagnoses. Rate ratios and their 95% confidence intervals, were calculated using a Cox's proportional hazard model. RESUJLTS: Following up 5,219 women for 6 years, 51 cases were confirmed with hip fractures. When adjusted for age, weight and physical activity, the rate ratio of hip fractures in women who had given birth three or more times was 0.56 (95% CI: 0.25 - 1.25), compared with those who had given birth two or less times. When adjusted for age, number of births, weight and physical activity, the rate ratio in women who first gave birth when younger than 22 years was 0.60 (95% CI: 0.34 - 1.08) compared with those who had giving birth at 22 years or older. CONCLUSIONS: According to these findings, an early age when first giving birth might decrease the risk of hip fractures in elderly Korean women.
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- H2 Receptor Antagonists and Gastric Cancer in the Elderly: A Nested Case-Control Study.
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Yooni Kim, Dae Seog Heo, Seung Mi Lee, Kyoung Eun Youn, Hye Won Koo, Jong Myon Bae, Byoung Joo Park
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Korean J Prev Med. 2002;35(3):245-254.
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To test if the intake of H2 receptor antagonists (H2-RAs) increases the risk of gastric cancer in the elderly. METHODS: The source population for this study was drawn from the responders to a questionnaire survey administered to the Korea Elderly Pharmacoepidemiological Cohort (KEPEC), who were beneficiaries of the Korean Medical Insurance Corporation, were at least 65 years old, and residing in Busan in 1993. The information on H2-RAs exposure was obtained from a drug prescription database compiled between Jan. 1993 and Dec. 1994. The cases consisted of 76 gastric cancer patients, as confirmed from the KMIC claims data, the National Cancer Registry and the Busan Cancer Registry. The follow-up period was from Jan. 1993 to Dec. 1998. Cancer free controls were randomly selected by 1:4 individual matching, which took in to consideration the year of birth and gender. Information on confounders was collected by a mail questionnaire survey. The odds ratios, and their 95% confidence intervals, were calculated using a conditional logistic regression model. RESULTS: After adjusting for a history of gastric ulcer symptoms, medication history, and body mass index, the adjusted OR (aOR) was 4.6 (95% CI=1.72-12.49). The odds ratio of long term use (more than 7 days) was 2.3 (95% CI=1.07-4.82). The odds ratio of short term use was 4.6 (95% CI=1.26-16.50). The odds ratio of parenteral use was 4.4 (95% CI=1.16-17.05) and combination use between the oral and parenteral routes (aOR, 16.8; 95% CI=1.21-233.24) had the high risk of gastric cancer. The aOR of cimetidine was 1.7 (95% CI=1.04-2.95). The aOR of ranitidine was 2.0 (95% CI=1.21-3.40). The aOR of famotidine was 1.7 (95% CI=0.98-2.80). CONCLUSION: The intake of H2-RAs might increase the risk of gastric cancer through achlorhydria in the elderly.
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KSPM
