Journal of Preventive Medicine and Public Health

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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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.; Summary

Original Article

Impact of Individual and Combined Health Behaviors on All Causes of Premature Mortality Among Middle Aged Men in Korea: The Seoul Male Cohort Study: Chul Woo Rhee, Ji Young Kim, Byung Joo Park, Zhong Min Li, Yoon-Ok Ahn; J Prev Med Public Health. 2012;45(1):14-20. Published online January 31, 2012; DOI: https://doi.org/10.3961/jpmph.2012.45.1.14

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Abstract PDF

Objectives

The aim of this study was to evaluate and quantify the risk of both individual and combined health behaviors on premature mortality in middle aged men in Korea.

Methods

In total, 14 533 male subjects 40 to 59 years of age were recruited. At enrollment, subjects completed a baseline questionnaire, which included information about socio-demographic factors, past medical history, and life style. During the follow-up period from 1993 to 2008, we identified 990 all-cause premature deaths using national death certificates. A Cox proportional hazard regression model was used to estimate the hazard ratio (HR) of each health risk behavior, which included smoking, drinking, physical inactivity, and lack of sleep hours. Using the Cox model, each health behavior was assigned a risk score proportional to its regression coefficient value. Health risk scores were calculated for each patient and the HR of all-cause premature mortality was calculated according to risk score.

Results

Current smoking and drinking, high body mass index, less sleep hours, and less education were significantly associated with all-cause premature mortality, while regular exercise was associated with a reduced risk. When combined by health risk score, there was a strong trend for increased mortality risk with increased score (p-trend < 0.01). When compared with the 1-9 score group, HRs of the 10-19 and 20-28 score groups were 2.58 (95% confidence intervals [CIs], 2.19 to 3.03) and 7.09 (95% CIs, 5.21 to 9.66), respectively.

Conclusions

Modifiable risk factors, such as smoking, drinking, and regular exercise, have considerable impact on premature mortality and should be assessed in combination.

Summary

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English Abstracts

The Risk of Fracture with Taking Alpha Blockers for Treating Benign Prostatic Hyperplasia.: Joongyub Lee, Nam Kyoung Choi, Sun Young Jung, Ye Jee Kim, Jong Mi Seong, Seung June Oh, Byung Joo Park; J Prev Med Public Health. 2009;42(3):165-170.; DOI: https://doi.org/10.3961/jpmph.2009.42.3.165

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Abstract PDF

OBJECTIVES
We evaluated the risk of fracture associated with hypotension-related adverse drug reaction caused by taking alpha blockers to treat benign prostatic hyperplasia (BPH). METHODS: We used the Health Insurance Review and Assessment Service database from January 1st 2005 to June 30th 2006 for this study. The male patients with BPH and who had a prescription for alpha blockers following any fractures were defined as the cases. We set the 20 day long hazard period prior to the index date and the four control periods whose lengths were same with hazard period. After 1:4 matching of the hazard and control periods, conditional logistic regression was used to calculate the odds ratios for the risk of fractures as related to the alpha blocker exposure. RESULTS: Doxazosin and tamsulosin showed the increased risk of fractures, whereas terazosin did not. After stratification using the defined daily doses, a protective effect was shown for the patients who took terazosin at the doses lower than 0.4 DDD and the hazardous effect at the doses higher than or equal to 0.4 DDD. There was no significant difference for the risk of patients taking tamsulosin at the doses higher than 1.0 DDD but there was a statistically significant increase in the risk at the doses higher than or equal to 1.0 DDD. CONCLUSIONS: Alpha blockers for BPH may increase the risk of fracture in elderly patients who have comorbidities and take the concomitant medications. Alpha blockers need to be prescribed with caution, although some have high prostate specificity.

Summary

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Risk for Hip Fracture due to Alpha Blocker Treatment in Korean Women: National Health Insurance Database Study
Gi H. SEO, Sung R. SHIM, Hwan W. LEE, Jin H. KIM, Dong‐Il CHUN, Hyun J. KIM, Hyun Y. LEE, Jae H. KIM
LUTS: Lower Urinary Tract Symptoms.2018; 10(2): 175. CrossRef
Risk of hip/femur fractures during the initiation period of α‐adrenoceptor blocker therapy among elderly males: a self‐controlled case series study
Chao‐Lun Lai, Raymond Nien‐Chen Kuo, Ho‐Min Chen, Ming‐Fong Chen, Kinwei Arnold Chan, Mei‐Shu Lai
British Journal of Clinical Pharmacology.2015; 80(5): 1208. CrossRef
The Association of Alpha-Blockers and 5-Alpha Reductase Inhibitors in Benign Prostatic Hyperplasia With Fractures
Sian Yik Lim, Pavis Laengvejkal, Ragesh Panikkath, Kenneth Nugent
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Cohort Study on the Association between Alcohol Consumption and the Risk of Colorectal Cancer in the Korean Elderly.: Hoi Jeong Lim, Byung Joo Park; J Prev Med Public Health. 2008;41(1):23-29.; DOI: https://doi.org/10.3961/jpmph.2008.41.1.23

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Abstract PDF

OBJECTIVES
We examined the association between alcohol consumption and incidence of colorectal cancer in elderly Koreans. METHODS: The cohort members (n=14,304) consisted of 4,834 males and 9,470 females derived from the Korea Elderly Pharmacoepidemiologic Cohort (KEPEC), a population-based dynamic cohort. They were aged 65 years old or older and lived in Busan between 1993-1998; they were beneficiaries of the Korean Medical Insurance Corporation (KMIC). Baseline information was surveyed by a self-administered, mailed questionnaire. This study population was restricted to 14,304 participants who reported alcohol drinking habits on the questionnaire and had not been diagnosed with colorectal cancer at baseline. The adjusted hazard ratios (aHR) of status, type, frequency and daily average amount of alcohol consumption were computed with Cox's proportional hazard model, with the never-drinkers as a reference group and controlling for age and gender. RESULTS: After 4.82 person-years of mean follow-up 112 cases of colorectal cancer occurred. The incidence densities of colorectal cancer were 161 (95% CI=123-200) for never-drinkers, 219 (95% CI=125-339) for ex-drinkers, and 137 (95% CI=84-189) for current-drinkers per 100,000 person-year. The status, type, frequency, and daily average amount of alcohol consumption were not significantly related to the incidence of colorectal cancer after controlling for age and gender. CONCLSIONS: There was no significant association between alcohol consumption and colorectal cancer among elderly people after controlling for age and gender.

Summary

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Body Mass Index and Risk of Hemorrhagic Stroke in Korean Adults: Case-control Study.: Seon Ha Kim, Yong Seok Lee, Seung Mi Lee, Byung Woo Yoon, Byung Joo Park; J Prev Med Public Health. 2007;40(4):313-320.; DOI: https://doi.org/10.3961/jpmph.2007.40.4.313

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Abstract PDF

OBJECTIVES
To evaluate the association between body mass index (BMI) and hemorrhagic stroke. METHODS: A case-control study was conducted on 2,712 persons (904 cases, 904 hospital controls, and 904 community controls) participating in an Acute Brain Bleeding Analysis study from October 2002 to March 2004. Two controls for each case were matched according to age and gender. The information was obtained by trained interviewers using standardized questionnaire. A conditional logistic regression model was used to estimate the association between BMI and the frequency of having a hemorrhagic stroke. RESULTS: Obese men (25.0 < or = BMI < 30.0 kg/m2) had an odds ratios (OR) of 1.39 (95% CI 1.03 to 1.87) a hemorrhagic stroke, compared to men with a normal BMI (18.5 to 24.9 kg/m2). Conversely, women with lower BMI had a higher risk of having hemorrhagic stroke. With respect to subtypes of hemorrahagic stroke, we observed about a three-fold increase in the risk of intracerebral hemorrhage (ICH) in the highly obese group. However, these trends were not significant in patients with subarachnoid hemorrhages. CONCLUSIONS: Obesity was identified as one of the risk factors in hemorrhagic stroke, in particular ICH. Conversely, in women, a lean body weight increases the risk of hemorrhagic stroke. Consequently, managing one\s weight is essential to reduce the risks of hemorrhagic stroke.

Summary

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Review

Adverse Drug Reaction Surveillance System in Korea.: Nam Kyong Choi, Byung Joo Park; J Prev Med Public Health. 2007;40(4):278-284.; DOI: https://doi.org/10.3961/jpmph.2007.40.4.278

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Abstract PDF

Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

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Original Articles

Physical Activity and Hip Fracture in Elderly People: A Cohort Study in Korea.: Kyung Eun Youn, Seung Mi Lee, Yooni Kim, Byung Joo Park; Korean J Prev Med. 2002;35(4):351-358.

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Abstract PDF: OBJECTIVE
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.; Summary

Reproductive History and Hip Fracture in the Elderly Women in Korea: A Cohort Study.: Seung Mi Lee, Yooni Kim, Koung Eun Youn, Byung Joo Park; Korean J Prev Med. 2002;35(4):305-312.

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Abstract PDF: OBJECTIVES
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.; Summary

An Approach to Survey Data with Nonresponse: Evaluation of KEPEC Data with BMI.: Jieun Baek, Weechang Kang, Youngjo Lee, Byung Joo Park; Korean J Prev Med. 2002;35(2):136-140.

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Abstract PDF: OBJECTIVES
A common problem with analyzing survey data involves incomplete data with either a nonresponse or missing data. The mail questionnaire survey conducted for collecting lifestyle variables on the members of the Korean Elderly Phamacoepidemiologic Cohort(KEPEC) in 1996 contains some nonresponse or missing data. The proper statistical method was applied to evaluate the missing pattern of a specific KEPEC data, which had no missing data in the independent variable and missing data in the response variable, BMI. METHODS: The number of study subjects was 8,689 elderly people. Initially, the BMI and significant variables that influenced the BMI were categorized. After fitting the log-linear model, the probabilities of the people on each category were estimated. The EM algorithm was implemented using a log-linear model to determine the missing mechanism causing the nonresponse. RESULTS: Age, smoking status, and a preference of spicy hot food were chosen as variables that influenced the BMI. As a result of fitting the nonignorable and ignorable nonresponse log-linear model considering these variables, the difference in the deviance in these two models was 0.0034(df=1). CONCLUSION: There is a lot of risk if an inference regarding the variables and large samples is made without considering the pattern of missing data. On the basis of these results, the missing data occurring in the BMI is the ignorable nonresponse. Therefore, when analyzing the BMI in KEPEC data, the inference can be made about the data without considering the missing data.; Summary

Drug Utilization Review of Antiulcerative Agents in Korean Elderly Inpatients.: Wonsik Lee, Seung Mi Lee, Hye Won Koo, Byung Joo Park; Korean J Prev Med. 2002;35(1):41-48.

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Abstract PDF: OBJECTIVES
To review the drug prescription pattern of antiulcerative agents for elderly inpatients. METHODS: The study population comprised inpatients of community hospitals who were members of the Korean Elderly Pharmacoepidemiologic Cohort (KEPEC), aged 65 years or over, beneficiaries of the Korea Medical Insurance Corporation (KMIC) and residing in Busan city in 1993. The drug prescription information was collected from the claims data of hospitals where the cohort members received medical care between January 1993 and December 1994. The information included personal identification, age, gender, diagnosis, drug dosage, date of hospital admission and name of medical institutions where the study subjects received drug prescriptions. The data analysis produced outcomes in terms of distribution of antiulcerative agents by class and by medical institution and trend of relative prescription. Analysis was also performed in terms of combined prescriptions of antiulceratives and drugs that could induce risk from drug interaction with antiulceratives. RESULTS: The number of patients prescribed antiulcerative agents was 1,059 (64.9%) male and 1,724 (65.5%) female among the total inpatients. An antacid and composite agent was the most frequently prescribed antiulcerative agent (70.8%), followed by H2 antagonist (16.0%). Among the potential drugs that could induce risk from drug interaction with the antiulcerative agents, diazepam was the most frequently prescribed. The proportion of diazepam co-prescription was 22.5% of the total cimetidine prescriptions and 14.5% of the total omeprazole prescriptions. CONCLUSIONS: Antiulcerative drugs were frequently prescribed in the elderly inpatients. The adverse drug reaction could possibly be due to drug interaction. The study results could be used as fundamental data for further drug utilization review of antiulcerative agents.; Summary

Comparison of Efficiency between Individual Randomization and Cluster Randomization in the Field Trial.: Hye Won Koo, Min Jeong Kwak, Youngjo Lee, Byung Joo Park; Korean J Prev Med. 2000;33(1):51-55.

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Abstract PDF: OBJECTIVES
In large-scale field trials, randomization by cluster is frequently used because of the administrative convenience, a desire to reduce the effect of treatment contamination, and the need to avoid ethical issues that might otherwise arise. Cluster randomization trials are experiments in which intact social unit, e.g., families, schools, cities, rather than independent individuals are randomly allocated to intervention groups. The positive correlation among responses of subjects from the same cluster is in matter in cluster randomization. This thesis is to compare the results of three randomization methods by standard error of estimator of treatment effect. METHODS: We simulated cholesterol data varing the size of the cluster and the level of the correlation in clusters and analyzed the effect of cholesterol-lowering agent. RESULTS: In intra-cluster randomization the standard error of the estimator of treatment effect is smallest relative to that in inter-cluster randomization and that in individual randomization. CONCLUSIONS: Intra-cluster randomization is the most efficient in its standard error of estimator of treatment effect but other factor should be considered when selecting a specific randomization method.; Summary

Reliability for Multiple Reviewers by using Loglinear Models.: Byung Joo Park, Sung Im Lee, Young Jo Lee, Dong Hyun Kim, Ho Jang Kwon, Jong Myon Bae, Myung Hee Shin, Mi Na Ha, Sang Whan Han; Korean J Prev Med. 1997;30(4):719-728.

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Abstract PDF: To guarantee the inter-reviewer reliability is very important in evaluating the quality of large number of clinical research papers by multiple reviewers. We cannot find reports on statistical methods for evaluating reliability for multiple raters in clinical research field. The purpose of this paper is to introduce the statistical methods focused on kappa statistic and five kinds of loglinear models for, which can be applied when evaluating the reliability of multiple raters. We have applied these methods to the result of a project, in which seven reviewers have evaluated the quality of 33 papers with regard to four aspects of paper contents including study hypothesis, study design, study population, study method, data analysis and interpretation. Among the five loglinear models including Symmetry model, Conditional symmetry model, Quasi-symmetry model, Independence model, and Quasi-independence model, Quasi-symmetry model shows the best model of fitting. And the level of reliability among seven reviewers revealed to be acceptable as meaningful.; Summary

Nationwide Incidence Estimation of Uterine Cervix Cancer among Korean Women.: Byung Joo Park, Moo Song Lee, Yoon Ok Ahn, Young Min Choi, Yeong Su Ju, Keun Young Yoo, Hun Kim, Ha Seung Yew, Tae Soo Park; Korean J Prev Med. 1996;29(4):843-852.

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Abstract PDF: To estimate the incidence of uterine cervix cancer among Korean women, we have conducted a study using the claim data on the beneficiaries of Korea Medical Insurance Corporation(KMIC). All medical records of the potential cases with diagnosis of ICD-9 180, 181, 182, 199, 219, 233 in the claims sent by medical care institutions in the whole country to the KMIC from January 1988 to December 1989, were abstracted and Gynecology specialist reviewed the records to identify the new cases of uterine cervix cancer among the potential cases during the corresponding period. Using these data, the incidence of uterine cervix cancer among Korean women was estimated as of July 1, 1988 to June 30, 1989. The crude rate was estimated to be 17.34(95% CI: 16.76~17.92) per 100,000 and the cumulative rates for the ages 0~64 and 0~74 were 1.7% and 2.2%, respectively. The age-adjusted rate for the world population was 19.93 per 100,000 which was higher than those of other Asian countries including China and Japan in 1983~1987. The truncated rate for ages 35~64 was 52.05 per 100,000 which was one of the highest in the world. With increasing age, the incidence rate increased to 78.11 per 100,000 in women aged 55~59 years, then it decreased in the older groups. This finding suggests that detecting rate of uterine cervix cancer may decrease in women aged 60 years or older due to detecting rate of uterine cervix cancer may decrease in women aged 60 years or older due to inadequate medical care seeking behavior. In the geographical area, the SIR of Jeju province was significantly low but it might be due to statistical unstability by small case numbers.; Summary

Association of Liver Dysfunction with Self-Medication History in Korean Healthy Male Adults.: Jong Myon Bae, Byung Joo Park, Moo Song Lee, Dong Hyun Kim, Myung Hee Shin, Yoon Ok Ahn; Korean J Prev Med. 1996;29(4):801-814.

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Abstract PDF: BACKGROUND
Korean people could abuse healthy foods as well as medications, which might cause serious side effects. The aim of this study was elucidating liver dysfunction due to the self-medications of hepatotonics, healthy foods and herb medications by nested case-control study. METHODS: Study subjects were drawn from male members of seoul Cohort Study who were recruited by self-administered structured questionnaire survey through mailing to the healthy men between the age of 40 and 59 years through the program of biennial health check-up offered by Korea Medical Insurance Corporation(KMIC). The liver dysfunction was defined as the level of serum AST and ALT above 40 IU/L and increased in more than one hundred per-cent during the 2 year follow-up period. To estimate the odds ratio between self-medication and liver dysfunction after controlling for potential confounders, logistic regression was performed. RESULTS: During the follow-up period, 30 members were identified to fit into case criteria and 2,625 members were selected as control. In logistic regression analyses, history of healthy foods intake, age under 45 years, obesity, and habit of regular exercise were significantly associated with liver dysfunction. The following factors exhibited no statistical significance: intake of hepatotonics, of herb medicine; history of disease in family, of operation, and of radiologic examination; smoking habits and drinking amounts. CONCLUSION: The significant association between the intake of healthy foods and the liver dysfunction illustrates that chronically optional overuse of healthy foods might bring to hazards to health. As the increasing trend of the size of purchasing healthy foods in Korea, pharmacoepidemiologic studies evaluating the safety and efficacy of the widely used healthy foods should be performed in the near future.; Summary

Survey Methods on Cancer Epidemic.: Byung Joo Park, Jong Myon Bae, Yoon Ok Ahn, Keun Young Yoo; Korean J Prev Med. 1994;27(3):411-424.

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Abstract PDF: The survey methods for confirming the epidemicity and identifying the possible causes of the cancer epidemic can be different from those for infectious diseases. The procedure for confirming whether the outbreak is epidemic or not is quite different. Household survey for identifying cancer cases and residents actually living at the area should be done. Hospital survey for medical record review should be performed to identify all cancer cases among the residents of the outbreak area and confirming the final diagnoses of the cancer cases. Comparing the level of cancer incidence or mortality with other areas can be done by using poison distribution, or calculating SIR (standard Incidence Ratio) from cumulative incidence rates. Case-control study can be conducted to identify the etiologic factors of the cancer epidemic and to establish strategy for preventing further recurrence of the outbreak.; Summary

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