• Title/Summary/Keyword: real cohort

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Cancer Risk in Patients with Type 2 Diabetes on Antidiabetic Monotherapy: A Population Based Cohort Study Using National Insurance Health Service Database (혈당강하제 단독요법 투여 당뇨병환자에서 암발생률 평가: 후향적 코호트 연구)

  • Jung, Han Yeong;Lee, Sukhyang
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.3
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    • pp.186-192
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    • 2019
  • Background: Diabetes is associated with cancer risk in the aging population. Observational studies have indicated the beneficial effects of metformin against breast cancer, making studies on the anticancer potential of antidiabetic drugs worthwhile. This study investigated cancer incidence in patients on antidiabetic monotherapy. Methods: Using National Health Insurance Service data (2002-2013), a retrospective cohort study that included type 2 diabetes mellitus (T2DM) patients was conducted. Study subjects were enrolled if they were ${\geq}30$ years old, on monotherapy for diabetes, and cancer-free. They were followed up for cancer occurrence or death, until December 31st, 2013. A Cox proportional hazard model analysis was conducted between metformin and sulfonylurea (including meglitinide) users, to determine cancer risk, with adjustment for age, gender, comorbidity index, dyslipidemia, hypertension, and T2DM duration. Results: The number of antidiabetic monotherapy-treated T2DM patients without a history of cancer was 9,554 (metformin, n = 5,825; sulfonylurea, n = 3,225; others, n = 504). During the follow-up period (mean, 2.04; IQR, 3.18 years), the cancer incidence rate was 5.48/100 and 5.45/100 patient-years for metformin and sulfonylurea, respectively. The hazard ratio (HR) for risk of cancer incidence in the metformin group was 0.74 (95% confidence interval [CI], 0.66-0.83; p < 0.0001), compared with sulfonylurea. Additionally, the HRs for risks of lung, liver, and stomach cancer were respectively 0.46 (95% CI, 0.31-0.66; p < 0.0001), 0.41 (95% CI, 0.31-0.54; p < 0.0001), and 0.51 (95% CI, 0.35-0.73; p = 0.0003). Conclusion: Antidiabetic therapy with metformin reduces cancer risk by 26%, specifically for lung, liver, and stomach cancer.

Correlation between Telomere Length and Chronic Obstructive Pulmonary Disease-Related Phenotypes: Results from the Chronic Obstructive Pulmonary Disease in Dusty Areas (CODA) Cohort

  • Moon, Da Hye;Kim, Jeeyoung;Lim, Myoung Nam;Bak, So Hyen;Kim, Woo Jin
    • Tuberculosis and Respiratory Diseases
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    • v.84 no.3
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    • pp.188-199
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    • 2021
  • Background: Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease with increased prevalence in the elderly. Telomeres are repetitive DNA sequences found at the end of the chromosome, which progressively shorten as cells divide. Telomere length is known to be a molecular marker of aging. This study aimed to assess the relationship between telomere length and the risk of COPD, lung function, respiratory symptoms, and emphysema index in Chronic Obstructive Pulmonary Disease in Dusty Areas (CODA) cohort. Methods: We extracted DNA from the peripheral blood samples of 446 participants, including 285 COPD patients and 161 control participants. We measured absolute telomere length using quantitative real-time polymerase chain reaction. All participants underwent spirometry and quantitative computed tomography scan. Questionnaires assessing respiratory symptoms and the COPD Assessment Test was filled by all the participants. Results: The mean age of participants at the baseline visit was 72.5±7.1 years. Males accounted for 72% (321 participants) of the all participants. The mean telomere length was lower in the COPD group compared to the non-COPD group (COPD, 16.81±13.90 kb; non-COPD, 21.97±14.43 kb). In COPD patients, 112 (75.7%) were distributed as tertile 1 (shortest), 91 (61.1%) as tertile 2 and 82 (55%) as tertile 3 (longest). We did not find significant associations between telomere length and lung function, exacerbation, airway wall thickness, and emphysema index after adjusting for sex, age, and smoking status. Conclusion: In this study, the relationship between various COPD phenotypes and telomere length was analyzed, but no significant statistical associations were shown.

Estimation of Conditional Kendall's Tau for Bivariate Interval Censored Data

  • Kim, Yang-Jin
    • Communications for Statistical Applications and Methods
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    • v.22 no.6
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    • pp.599-604
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    • 2015
  • Kendall's tau statistic has been applied to test an association of bivariate random variables. However, incomplete bivariate data with a truncation and a censoring results in incomparable or unorderable pairs. With such a partial information, Tsai (1990) suggested a conditional tau statistic and a test procedure for a quasi independence that was extended to more diverse cases such as double truncation and a semi-competing risk data. In this paper, we also employed a conditional tau statistic to estimate an association of bivariate interval censored data. The suggested method shows a better result in simulation studies than Betensky and Finkelstein's multiple imputation method except a case in cases with strong associations. The association of incubation time and infection time from an AIDS cohort study is estimated as a real data example.

A GENERAL UNIQUENESS RESULT OF AN ENDEMIC STATE FOR AN EPIDEMIC MODEL WITH EXTERNAL FORCE OF INFECTION

  • Cha, Young-Joon
    • Communications of the Korean Mathematical Society
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    • v.22 no.4
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    • pp.597-608
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    • 2007
  • We present a general uniqueness result of an endemic state for an S-I-R model with external force of infection. We reduce the problem of finding non-trivial steady state solutions to that of finding zeros of a real function of one variable so that we can easily prove the uniqueness of an endemic state. We introduce an assumption which was usually used to show stability of a non-trivial steady state. It turns out that such an assumption adopted from a stability analysis is crucial for proving the uniqueness as well, and the assumption holds for almost all cases in our model.

Regression analysis of interval censored competing risk data using a pseudo-value approach

  • Kim, Sooyeon;Kim, Yang-Jin
    • Communications for Statistical Applications and Methods
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    • v.23 no.6
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    • pp.555-562
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    • 2016
  • Interval censored data often occur in an observational study where the subject is followed periodically. Instead of observing an exact failure time, two inspection times that include it are available. There are several methods to analyze interval censored failure time data (Sun, 2006). However, in the presence of competing risks, few methods have been suggested to estimate covariate effect on interval censored competing risk data. A sub-distribution hazard model is a commonly used regression model because it has one-to-one correspondence with a cumulative incidence function. Alternatively, Klein and Andersen (2005) proposed a pseudo-value approach that directly uses the cumulative incidence function. In this paper, we consider an extension of the pseudo-value approach into the interval censored data to estimate regression coefficients. The pseudo-values generated from the estimated cumulative incidence function then become response variables in a generalized estimating equation. Simulation studies show that the suggested method performs well in several situations and an HIV-AIDS cohort study is analyzed as a real data example.

Phase II two-stage single-arm clinical trials for testing toxicity levels

  • Kim, Seongho;Wong, Weng Kee
    • Communications for Statistical Applications and Methods
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    • v.26 no.2
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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.

Key Principles of Clinical Validation, Device Approval, and Insurance Coverage Decisions of Artificial Intelligence

  • Seong Ho Park;Jaesoon Choi;Jeong-Sik Byeon
    • Korean Journal of Radiology
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    • v.22 no.3
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    • pp.442-453
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    • 2021
  • Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.

Long-Term Efficacy of Anti-Tumor Necrosis Factor Agents in Pediatric Luminal Crohn's Disease: A Systematic Review of Real-World Evidence Studies

  • Rheenen, Hanna van;Rheenen, Patrick Ferry van
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.2
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    • pp.121-131
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    • 2020
  • Purpose: To determine the long-term efficacy of the anti-tumor necrosis factor (TNF) agents, infliximab (IFX) and adalimumab (ADA), in pediatric luminal Crohn's disease (CD) by performing a systematic literature review. Methods: An electronic search was performed in Medline, Embase, and the Cochrane Library from inception to September 26, 2019. Eligible studies were cohort studies with observation periods that exceeded 1 year. Studies that reported time-to-event analyses were included. Events were defined as discontinuation of anti-TNF therapy for secondary loss of response. We extracted the probabilities of continuing anti-TNF therapy 1, 2, and 3 years after initiation. Results: In total, 2,464 papers were screened, 94 were selected for full text review, and 13 studies (11 on IFX, 2 on ADA) met our eligibility criteria for inclusion. After 1 year, 83-97% of patients were still receiving IFX therapy. After 2 and 3 years the probability of continuing IFX therapy decreased to 67-91% and 61-85%, respectively. In total, 5 of the 11 studies subgrouped by concomitant medication consistently showed that the probabilities of continuing IFX therapy in patients with prolonged immunomodulator use were higher than those in patients on IFX monotherapy. Conclusion: This review of real-world evidence studies confirms the long-term therapeutic benefit of IFX therapy in diverse cohorts of children with luminal CD. Moreover, it supports the view that combination therapy with an immunomodulator prolongs the durability of IFX therapy in patients who previously failed to recover following first-line therapy. The limited number of time-to-event studies in patients on ADA prevented us from drawing definite conclusions about its long-term efficacy.

Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System

  • Soonil Kwon;Eue-Keun Choi;So-Ryoung Lee;Seil Oh;Hee-Seok Song;Young-Shin Lee;Sang-Jin Han;Hong Euy Lim
    • Korean Circulation Journal
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    • v.54 no.3
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    • pp.140-153
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    • 2024
  • Background and Objectives: Although a single-lead electrocardiogram (ECG) patch may provide advantages for detecting arrhythmias in outpatient settings owing to user convenience, its comparative effectiveness for real-time telemonitoring in inpatient settings remains unclear. We aimed to compare a novel telemonitoring system using a single-lead ECG patch with a conventional telemonitoring system in an inpatient setting. Methods: This was a single-center, prospective cohort study. Patients admitted to the cardiology unit for arrhythmia treatment who required a wireless ECG telemonitoring system were enrolled. A single-lead ECG patch and conventional telemetry were applied simultaneously in hospitalized patients for over 24 hours for real-time telemonitoring. The basic ECG parameters, arrhythmia episodes, and signal loss or noise were compared between the 2 systems. Results: Eighty participants (mean age 62±10 years, 76.3% male) were enrolled. The three most common indications for ECG telemonitoring were atrial fibrillation (66.3%), sick sinus syndrome (12.5%), and atrioventricular block (10.0%). The intra-class correlation coefficients for detecting the number of total beats, atrial and ventricular premature complexes, maximal, average, and minimal heart rates, and pauses were all over 0.9 with p values for reliability <0.001. Compared to a conventional system, a novel system demonstrated significantly lower signal noise (median 0.3% [0.1-1.6%] vs. 2.4% [1.4-3.7%], p<0.001) and fewer episodes of signal loss (median 22 [2-53] vs. 64 [22-112] episodes, p=0.002). Conclusions: The novel telemonitoring system using a single-lead ECG patch offers performance comparable to that of a conventional system while significantly reducing signal loss and noise.

The Effects of Self-esteem, Shopping Motivations, and Shopping Tendencies on the Clothing Purchase Behavior of the MZ Generation (MZ세대의 자아존중감, 쇼핑동기 및 쇼핑성향이 의복구매행동에 미치는 영향)

  • Lee, Myeong-Jin;Lee, Min-Ji;Kim, Hye-Kyung
    • The Journal of the Korea Contents Association
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    • v.22 no.9
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    • pp.308-321
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    • 2022
  • The purpose of this study is to understand how self-esteem, shopping motivations, and shopping tendencies affect the clothing purchase behavior of the so-called "MZ generation," a cohort that includes both millenials and Generation Z and exerts significant influence in various areas. The results of this study can be summarized as follows: First, it was found that extrinsic purchase motivations (purchased made due to the influence of other people), trend-seeking shopping tendencies, and pleasure-seeking shopping tendencies had a positive and significant effect on personal needs among the sub-factors of clothing purchase behavior of the MZ generation. Second, it was found that the MZ real purchase shopping motivations, trend-seeking shopping tendencies, pleasure-seeking shopping tendencies, and convenience-seeking shopping tendencies had a positive and significant effect on actual needs among the sub-factors of clothing purchase behavior among the MZ generation. Third, it was found that social self-esteem, extrinsic purchase motivations, and convenience-seeking shopping tendencies had a positive and significant effect on clothing marketing strategies among the sub-factors of clothing purchase behavior of the MZ generation. On the other hand, personal self-esteem was found to negatively affect the marketing strategies of clothing purchase behavior. In other words, the expectation that the MZ generation would buy clothes in accordance with their individual preferences and beliefs was not supported by the findings of this study. It would appear that the beliefs and behaviors of the digitally savvy MZ generation are changed by the fashion trend-related information they readily access when purchasing clothing. From the above research results, it can be concluded that there many variables that influence the clothing purchase behavior of the MZ generation and it is thus necessary to consider this cohort a new consumer segment and establish marketing strategies accordingly.