• Communications for Statistical Applications and Methods
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• 제26권2호
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• pp.163-173
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• 2019

Simon's two-stage designs are frequently used in phase II single-arm trials for efficacy studies. A concern of safety studies is too many patients who experience an adverse event. We show that Simon's two-stage designs for efficacy studies can be similarly used to design a two-stage safety study by modifying some of the design parameters. Given the type I and II error rates and the proportion of adverse events experienced in the first stage cohort, we prescribe a procedure whether to terminate the trial or proceed with a stage 2 trial by recruiting additional patients. We study the relationship between a two-stage design with a safety endpoint and an efficacy endpoint as well as use simulation studies to ascertain their properties. We provide a real-life application and a free R package gen2stage to facilitate direct use of two-stage designs in a safety study.

• Environmental Analysis Health and Toxicology
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• 제30권
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• pp.10.1-10.14
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• 2015

Recent cohort studies have relied on exposure prediction models to estimate individual-level air pollution concentrations because individual air pollution measurements are not available for cohort locations. For such prediction models, geographic variables related to pollution sources are important inputs. We demonstrated the computation process of geographic variables mostly recorded in 2010 at regulatory air pollution monitoring sites in South Korea. On the basis of previous studies, we finalized a list of 313 geographic variables related to air pollution sources in eight categories including traffic, demographic characteristics, land use, transportation facilities, physical geography, emissions, vegetation, and altitude. We then obtained data from different sources such as the Statistics Geographic Information Service and Korean Transport Database. After integrating all available data to a single database by matching coordinate systems and converting non-spatial data to spatial data, we computed geographic variables at 294 regulatory monitoring sites in South Korea. The data integration and variable computation were performed by using ArcGIS version 10.2 (ESRI Inc., Redlands, CA, USA). For traffic, we computed the distances to the nearest roads and the sums of road lengths within different sizes of circular buffers. In addition, we calculated the numbers of residents, households, housing buildings, companies, and employees within the buffers. The percentages of areas for different types of land use compared to total areas were calculated within the buffers. For transportation facilities and physical geography, we computed the distances to the closest public transportation depots and the boundary lines. The vegetation index and altitude were estimated at a given location by using satellite data. The summary statistics of geographic variables in Seoul across monitoring sites showed different patterns between urban background and urban roadside sites. This study provided practical knowledge on the computation process of geographic variables in South Korea, which will improve air pollution prediction models and contribute to subsequent health analyses.

• 근관절건강학회지
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• 제27권3호
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• pp.219-228
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• 2020

Purpose: This study was a comparative analysis of stroke-related factors between recurrent patients and non-recurrent patients. Methods: A retrospective cohort study design was used, and data were collected from March 2020 to April 2020 using electronic medical records. 244 patients (221 first-timers and 23 recurrent) were included in this study. Results: The stroke recurrence rate in 5 years was 9.4%, the readmission rate was 39.3%, and the mortality rate was 2.0%. The number of patients hospitalized for stroke was greater among men than among women. Of the patients, 60.7% had an underlying disease. With regard to daily life abilities, over 70% of participants needed more than moderate dependence and about 40% of participants had more than mild cognitive impairment. More than 50% were moved to wheelchairs or stretcher cars. The difference in the stroke readmission rate between recurrent and non-recurrent patients was statistically significant. Conclusions: Based on our findings, a program to prevent recurrence of stroke should be developed to considering age, ability of daily living, place of discharge, gait ability at discharge, and place of discharge.

• Safety and Health at Work
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• 제14권3호
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• pp.279-286
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• 2023

Background: This study aimed to evaluate the association between exposure to occupational hazards and the metabolic syndrome. A secondary objective was to analyze the additive and multiplicative effects of exposure to risk factors. Methods: This retrospective cohort was based on 31,615 health examinees at the Pusan National University Yangsan Hospital in Republic of Korea from 2012-2021. Demographic and behavior-related risk factors were treated as confounding factors, whereas three physical factors, 19 organic solvents and aerosols, and 13 metals and dust were considered occupational risk factors. Time-dependent Cox regression analysis was used to calculate hazard ratios. Results: The risk of metabolic syndrome was significantly higher in night shift workers (hazard ratio = 1.45: 95% confidence interval = 1.36-1.54) and workers who were exposed to noise (1.15:1.07-1.24). Exposure to some other risk factors was also significantly associated with a higher risk of metabolic syndrome. They were dimethylformamide, acetonitrile, trichloroethylene, xylene, styrene, toluene, dichloromethane, copper, antimony, lead, copper, iron, welding fume, and manganese. Among the 28 significant pairs, 19 exhibited both positive additive and multiplicative effects. Conclusions: Exposure to single or combined occupational risk factors may increase the risk of developing metabolic syndrome. Working conditions should be monitored and improved to reduce exposure to occupational hazards and prevent the development of the metabolic syndrome.

• Genomics & Informatics
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• 제12권4호
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• pp.236-239
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• 2014

The genetic regulation of glucose and insulin levels might be modified by adiposity. With regard to the genetic factors that are altered by adiposity, a large meta-analysis on the interactions between genetic variants and body mass index with regard to fasting glucose and insulin levels was reported by the Meta-Analyses of Glucose- and Insulin-related trait Consortium (MAGIC), based on European ancestry. Because no replication study has been performed in other ethnic groups, we first examined the link between reported single-nucleotide polymorphisms (SNPs) and fasting glucose and insulin levels in a large Korean cohort (Korean Genome and Epidemiology Study cohort [KoGES], n = 5,814). The MAGIC study reported 7 novel SNPs for fasting glucose levels and 6 novel SNPs for fasting insulin levels. In this study, we attempted to replicate the association of 5 SNPs with fasting glucose levels and 5 SNPs with fasting insulin levels. One SNP (rs2293941) in PDX1 was identified as a significant obesity-modifiable factor in Koreans. Our results indicate that the novel loci that were identified by MAGIC are poorly replicated in other ethnic groups, although we do not know why.

• Childhood Kidney Diseases
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• 제27권2호
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• pp.111-116
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• 2023

Purpose: This article was to investigate the association between urinary tract infections (UTIs) and high weight status in infancy. Methods: We conducted a nationwide matched cohort study from January 2018 to December 2020 using data from the Korean National Health Insurance System and the Korean National Health Screening Program for Infants and Children. We analyzed the association between UTI diagnosis codes and high weight status (which was defined as being in the 90th percentile or higher of weight-for-age). Results: We found that 22.8% of infants with UTIs exhibited high weight status, compared to 20.0% of non-UTI infants (P<0.001). Per our multivariable analyses, the adjusted odds ratio for high weight status was 1.09 (95% confidence interval, 1.06-1.13). Conclusions: UTI in the first 12 months of life was associated with a weight-for-age percentile of ≥90. Our findings corroborate those of previous single-center studies and emphasize the importance of careful monitoring for this at-risk group.

• Journal of Gastric Cancer
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• 제15권3호
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• pp.167-175
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• 2015

Purpose: Although several studies report risk factors for anastomotic leakage after gastrectomy for gastric cancer, they have yielded conflicting results. The present retrospective cohort study was performed to identify risk factors that are consistently associated with anastomotic leakage after gastrectomy for stomach cancer. Materials and Methods: All consecutive patients who underwent gastrectomy at a single gastric surgical unit between May 2003 and December 2012 were identified retrospectively. The associations between anastomotic leakage and 23 variables related to patient history, diagnosis, and surgery were assessed and analyzed with logistic regression. Results: In total, 3,827 patients were included. The rate of anastomotic leakage was 1.88% (72/3,827). Multiple regression analysis showed that male sex (P=0.001), preoperative/intraoperative transfusion (P<0.001), presence of cardiovascular disease (P=0.023), and tumor location (P<0.001) were predictive of anastomotic leakage. Patients with and without leakage did not differ significantly in terms of their 5-year survival: 97.6 vs. 109.5 months (P=0.076). Conclusions: Male sex, cardiovascular disease, perioperative transfusion, and tumor location in the upper third of the stomach were associated with an increased risk of anastomotic leakage. Although several studies have reported that an anastomotic complication has a negative impact on long-term survival, this association was not observed in the present study.

• Journal of Gastric Cancer
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• 제22권4호
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• pp.408-417
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• 2022

Purpose: Treatment options are limited after the failure of first-and second-line treatments in patients with HER2⁺ metastatic gastric cancer (mGC). The present study aimed to explore the efficacy, safety, and prognostic factors of apatinib efficacy as a third-line therapy for patients with human epithelial growth factor receptor 2-positive (HER2⁺) mGC. Materials and Methods: A total of 59 HER2⁺ mGC patients who received apatinib as third-line therapy were retrospectively enrolled in this two-center, single-arm, cohort study; the clinical response, survival data, and adverse events were retrieved. Results: The median progression-free survival (PFS) was 5.2 months (95% confidence interval [CI], 3.9-6.5), and the median overall survival (OS) was 8.2 months (95% CI, 6.6-9.8) Furthermore, forward stepwise multivariate Cox regression analysis showed that a higher Eastern Cooperative Oncology Group performance status score and multiple metastases were independently correlated with decreased PFS and OS (both P<0.05). The main adverse events were leukopenia (45.8%), hypertension (44.1%), thrombocytopenia (39.0%), hand-foot syndrome (37.3%), and elevated transaminase (33.9%). Grade 3 adverse events mainly included hypertension (5.1%) and neutropenia (5.1%); grade 4 adverse events did not occur. Conclusions: Apatinib is efficient and well tolerated in patients with HER2⁺ mGC as a third-line treatment, suggesting that it may be a candidate of choice for these patients.

• The Journal of Advanced Prosthodontics
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• 제2권2호
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• pp.54-57
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• 2010

PURPOSE. The aim of this study was to evaluate the periodontal and prosthodontic complications of multiple freestanding implants in the posterior jaws for up to 1 year of function. MATERIALS AND METHODS. Eight patients received 20 implants posterior to canines. Two or more implants were consecutively inserted to each patient. Single crowns were delivered onto the implants. Marginal bone loss, implant mobility, probing depth, and screw loosening were examined to evaluate the clinical success of such restorations for maximum 1 year of functional loading. RESULTS. All the implants performed well during the observation period. Neither periodontal nor prosthodontic complications were found except a slight porcelain chipping. While the marginal bone level was on average 0.09 mm lower around the implant after 6 months of loading, it was 0.15 mm higher after 1 year. CONCLUSION. Within the limits of this investigation, separate single-tooth implant restorations to replace consecutive missing teeth may clinically function well in the posterior jaw.

• Genomics & Informatics
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• 제12권4호
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• pp.216-224
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• 2014

Gastritis is a common but a serious disease with a potential risk of developing carcinoma. Helicobacter pylori infection is reported as the most common cause of gastritis, but other genetic and genomic factors exist, especially single-nucleotide polymorphisms (SNPs). Association studies between SNPs and gastritis disease are important, but results on epistatic interactions from multiple SNPs are rarely found in previous genome-wide association (GWA) studies. In this study, we performed computational GWA case-control studies for gastritis in Korea Associated Resource (KARE) data. By transforming the resulting SNP epistasis network into a gene-gene epistasis network, we also identified potential gene-gene interaction factors that affect the susceptibility to gastritis.