• Journal of Preventive Medicine and Public Health
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• v.40 no.2
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• pp.122-129
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• 2007

During the last decade, genomic cohort study has been developed in many countries by linking health data and genetic data in stored samples. Genomic cohort study is expected to find key genetic components that contribute to common diseases, thereby promising great advance in genome medicine. While many countries endeavor to build biobank systems, biobank-based genome research has raised important ethical concerns including genetic privacy, confidentiality, discrimination, and informed consent. Informed consent for biobank poses an important question: whether true informed consent is possible in population-based genomic cohort research where the nature of future studies is unforeseeable when consent is obtained. Due to the sensitive character of genetic information, protecting privacy and keeping confidentiality become important topics. To minimize ethical problems and achieve scientific goals to its maximum degree, each country strives to build population-based genomic cohort research project, by organizing public consultation, trying public and expert consensus in research, and providing safeguards to protect privacy and confidentiality.

• Journal of Preventive Medicine and Public Health
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• v.55 no.5
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• pp.464-474
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• 2022

Objectives: We introduced the cohort studies included in the Korean Cohort Consortium (KCC), focusing on large-scale cohort studies established in Korea with a prolonged follow-up period. Moreover, we also provided projections of the follow-up and estimates of the sample size that would be necessary for big-data analyses based on pooling established cohort studies, including population-based genomic studies. Methods: We mainly focused on the characteristics of individual cohort studies from the KCC. We developed "PROFAN", a Shiny application for projecting the follow-up period to achieve a certain number of cases when pooling established cohort studies. As examples, we projected the follow-up periods for 5000 cases of gastric cancer, 2500 cases of prostate and breast cancer, and 500 cases of non-Hodgkin lymphoma. The sample sizes for sequencing-based analyses based on a 1:1 case-control study were also calculated. Results: The KCC consisted of 8 individual cohort studies, of which 3 were community-based and 5 were health screening-based cohorts. The population-based cohort studies were mainly organized by Korean government agencies and research institutes. The projected follow-up period was at least 10 years to achieve 5000 cases based on a cohort of 0.5 million participants. The mean of the minimum to maximum sample sizes for performing sequencing analyses was 5917-72 102. Conclusions: We propose an approach to establish a large-scale consortium based on the standardization and harmonization of existing cohort studies to obtain adequate statistical power with a sufficient sample size to analyze high-risk groups or rare cancer subtypes.

• Annals of Geriatric Medicine and Research
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• v.20 no.3
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• pp.114-117
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• 2016

A research project, the "Construction of Frailty Cohort for Elderly and Intervention Study," funded by the Ministry of Health and Welfare, has been ongoing since December 2015. The Korean Frailty and Aging Cohort Study (KFACS) aims to identify risk factors for adverse outcomes associated with frailty in community-dwelling older adults, as well as means of prevention. KFACS is a multicenter, longitudinal study, with the baseline survey being conducted in 2016-2017. The sample (n=3,000) consists of those aged 70-84 years, stratified by age and gender, recruited from urban and rural regions nationwide. An in-person interview and health examination are performed every 2 years. This project is also conducting many intervention studies. Project interventions focus on nutrition and exercise. The nutritional intervention study compares the effects of 1.2 g/kg versus 1.5 g/kg daily protein intake on sarcopenia and frailty in older Koreans. The exercise trial examines the effectiveness of an information and communication technology-based program in preventing or reducing frailty.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.8
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• pp.4667-4669
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• 2013

We evaluated cigarette smoking as a risk factor for prostate cancer in a prospective, population-based cohort study. The subjects were 14,450 males among the participants in the Seoul Male Cancer Cohort Study who had at least 1-year follow-up. They were followed up between 1993 and 2008. During the 16-year follow-up period, 87 cases of prostate cancer occurred over the 207,326 person-years of the study. The age-adjusted relative risks of past and current smokers at entry were 0.60 (95%CI: 0.34-1.06) and 0.70 (95%CI: 0.43-1.13), respectively, suggesting that cigarette smoking may not be a risk factor for prostate cancer. The relationship between prostate cancer and other modifiable factors, such as Westernized diet, should be studied with the goal of establishing prevention programs for prostate cancer.

• Journal of Cancer Prevention
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• v.23 no.4
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• pp.183-190
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• 2018

Background: As the number of big-cohort studies increases, validation becomes increasingly more important. We aimed to validate administrative database categorized as colorectal cancer (CRC) by the International Classification of Disease (ICD) 10th code. Methods: Big-cohort was collected from Clinical Data Warehouse using ICD 10th codes from May 1, 2003 to November 30, 2016 at Seoul National University Bundang Hospital. The patients in the study group had been diagnosed with cancer and were recorded in the ICD 10th code of CRC by the National Health Insurance Service. Subjects with codes of inflammatory bowel disease or tuberculosis colitis were selected for the control group. For the accuracy of registered CRC codes (C18-21), the chart, imaging results, and pathologic findings were examined by two reviewers. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for CRC were calculated. Results: A total of 6,780 subjects with CRC and 1,899 control subjects were enrolled. Of these patients, 22 subjects did not have evidence of CRC by colonoscopy, computed tomography, magnetic resonance imaging, or positron emission tomography. The sensitivity and specificity of hospitalization data for identifying CRC were 100.00% and 98.86%, respectively. PPV and NPV were 99.68% and 100.00%, respectively. Conclusions: The big-cohort database using the ICD 10th code for CRC appears to be accurate.

• Journal of Preventive Medicine and Public Health
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• v.43 no.6
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• pp.543-548
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• 2010

Objectives: The objective of this study was to calculate sample size and power in an ongoing cohort, Korea radiation effect and epidemiology cohort (KREEC). Method: Sample size calculation was performed using PASS 2002 based on Cox regression and Poisson regression models. Person-year was calculated by using data from '1993-1997 Total cancer incidence by sex and age, Seoul' and Korean statistical informative service. Results: With the assumption of relative risk=1.3, exposure:non-exposure=1:2 and power=0.8, sample size calculation was 405 events based on a Cox regression model. When the relative risk was assumed to be 1.5 then number of events was 170. Based on a Poisson regression model, relative risk=1.3, exposure:non-exposure=1:2 and power=0.8 rendered 385 events. Relative risk of 1.5 resulted in a total of 157 events. We calculated person-years (PY) with event numbers and cancer incidence rate in the nonexposure group. Based on a Cox regression model, with relative risk=1.3, exposure:non-exposure=1:2 and power=0.8, 136 245PY was needed to secure the power. In a Poisson regression model, with relative risk=1.3, exposure:non-exposure=1:2 and power=0.8, person-year needed was 129517PY. A total of 1939 cases were identified in KREEC until December 2007. Conclusions: A retrospective power calculation in an ongoing study might be biased by the data. Prospective power calculation should be carried out based on various assumptions prior to the study.

• Journal of Preventive Medicine and Public Health
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• v.55 no.4
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• pp.313-320
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• 2022

The KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) was launched in 2011 with the support of the Korea Disease Control and Prevention Agency. The study was designed with the aim of exploring the various clinical features and characteristics of chronic kidney disease (CKD) in Koreans, and elucidating the risk factors for CKD progression and adverse outcomes of CKD. For the cohort study, nephrologists at 9 tertiary university-affiliated hospitals participated in patient recruitment and follow-up. Biostatisticians and epidemiologists also participated in the basic design and structuring of the study. From 2011 until 2016, the KNOW-CKD Phase I recruited 2238 adult patients with CKD from stages G1 to G5, who were not receiving renal replacement therapy. The KNOW-CKD Phase II recruitment was started in 2019, with an enrollment target of 1500 subjects, focused on diabetic nephropathy and hypertensive kidney diseases in patients with reduced kidney function who are presumed to be at a higher risk of adverse outcomes. As of 2021, the KNOW-CKD investigators have published articles in the fields of socioeconomics, quality of life, nutrition, physical activity, renal progression, cardiovascular disease and outcomes, anemia, mineral bone disease, serum and urine biomarkers, and international and inter-ethnic comparisons. The KNOW-CKD researchers will elaborate a prediction model for various outcomes of CKD such as the development of end-stage kidney disease, major adverse cardiovascular events, and death.

• Journal of Preventive Medicine and Public Health
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• v.51 no.6
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• pp.281-288
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• 2018

Objectives: We investigated the association between cholecystectomy or appendectomy and the subsequent risk of colorectal cancer (CRC) in the Korean population. Methods: A retrospective cohort study was conducted with the National Health Insurance Service-National Sample Cohort of Korea; this sample was followed up from January 1, 2002, until the date of CRC incidence, loss to follow-up, or December 31, 2015. The exposure status of cholecystectomy and appendectomy was treated as a time-varying covariate. The calculated risk of CRC was stratified by follow-up period, and the association between these surgical procedures and CRC was investigated by a Cox regression model applying appropriate lag periods. Results: A total of 707 663 individuals were identified for analysis. The study population was followed up for an average of 13.66 years, and 4324 CRC cases were identified. The hazard ratio (HR) of CRC was elevated in the first year after cholecystectomy (HR, 1.71; 95% confidence interval [CI], 1.01 to 2.89) and in the first year and 2-3 years after appendectomy (HR, 4.22; 95% CI, 2.87 to 6.20; HR, 2.34; 95% CI, 1.36 to 4.03, respectively). The HRs of CRC after applying 1 year of lag after cholecystectomy and 3 years of lag after appendectomy were 0.80 (95% CI, 0.57 to 1.13) and 0.77 (95% CI, 0.51 to 1.16), respectively. Conclusions: The risk of CRC increased in the first year after cholecystectomy and appendectomy, implying the possibility of bias. When appropriate lag periods after surgery were applied, no association was found between cholecystectomy or appendectomy and CRC.

• Journal of Preventive Medicine and Public Health
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• v.40 no.4
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• pp.321-328
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• 2007

Objectives : The aim of this study was to evaluate the roles of cigarette smoking, alcohol consumption, tuberculosis, and their interactions in the risk of lung cancer in a Korean cohort. Methods : The study subjects comprised 13,150 males and females aged above 20 years old. During the follow up period from 1993 to 2002, 79 lung cancer cases were identified by the central cancer registry and the national death certificate database. Information on cigarette smoking, alcohol consumption and the history of physician-diagnosed tuberculosis was obtained by interview. Indirect chest X-ray findings were also evaluated to ascertain tuberculosis cases. Cox proportional hazard models were used to estimate relative risks (RR) and 95% confidence intervals (CI) after adjusting for age and gender. Results : Cigarette smoking was statistically significantly associated with an increased risk of lung cancer [for current smokers, RR = 2.33 (95% CI = 1.23 - 4.42) compared to non-smokers]. After further adjustment for cigarette smoking, both alcohol consumption and tuberculosis showed no statistically significant association with the risk of lung cancer [for current drinkers, RR = 0.80 (95% CI = 0.48 - 1.33) compared to non-drinkers] [for tuberculosis cases, RR = 1.17 (95% CI = 0.58 - 2.36) compared to non-cases]. There was no statistically significant interaction between cigarette smoking and alcohol consumption (p-interaction = 0.38), or cigarette smoking and tuberculosis (p-interaction = 0.74). Conclusions : Although cigarette smoking was confirmed as a risk factor of lung cancer in this cohort study, this study suggests that alcohol consumption and tuberculosis may not be associated with the risk of lung cancer.

• Journal of Preventive Medicine and Public Health
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• v.40 no.2
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• pp.95-101
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• 2007

Focusing on complex diseases of public health significance, strategic issues regarding the on-going Korean Genome Cohort were reviewed: target size and diseases, measurements, study design issues, and follow-up strategy of the cohort. Considering the epidemiologic characteristics of Korean population as well as strengths and drawbacks of current research environment, we tried to tailor the experience of other existing cohorts into proposals for this Korean study. Currently 100,000 individuals have been participating the new Genome Cohort in Korea. Target size of de novo collection is recommended to be set as between 300,000 to 500,000. This target size would allow acceptable power to detect genetic and environmental factors of moderate effect size and possible interactions between them. Family units and/or special subgroups are recommended to parallel main body of adult individuals to increase the overall efficiency of the study. Given that response rate to the conventional re-contact method may not be satisfactory, successful follow-up is the main key to the achievement of the Korean Genome Cohort. Access to the central database such as National Health Insurance data can provide enormous potential for near-complete case detection. Efforts to build consensus amongst scientists from broad fields and stakeholders are crucial to unleash the centralized database as well as to refine the commitment of this national project.