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.
Extended follow-up of Hodgkin lymphoma (HL) survivors indicates that these patients are at high risk of secondary malignant neoplasms (SMNs) contributing to increased morbidity and mortality. This study examined the characteristics of HL survivors who developed SMNs with the aim to report any correlation with radiotherapy (RT) dose. In this retrospective multi-center cohort study of HL patients treated between 1990 and 2011 at three major teaching hospitals in Lebanon, classification was into two groups including those treated with combined modality (RT and chemotherapy-CHT) and those treated with CHT alone. Approval from the University Institutional Review Board (IRB) was obtained. Of the 112 patients evaluated, 52.7% (59) received the combined modality while 47.3% (53) received CHT alone. There were 6 cases of SMNs in the combined modality cohort and 5 cases in the CHT cohort. The mean RT dose in the combined modality cohort was 34.5 Gray (Gy) ($SD{\pm}5.3$). A statistically significant increase (1.5 fold) in the risk of developing SMNs was observed among patients who received a dose higher than 41 Gy compared to a dose between 20 to 30 Gy (OR= 1.5; 95% confidence interval= 0.674 to 3.339, p=0.012). The risk of SMNs was not significantly higher among patients who received extended field compared to involved field RT (p=0.964). This study showed that the risk of developing SMNs is higher among patients treated with RT dose greater than 31 Gy, independent of the RT type used.
Background: Differentiated thyroid cancer is the most common endocrine malignancy with a generally good prognosis. Knowing long-term outcomes of each patient helps management planning. The study was conducted to develop and validate a clinical prognostic score for predicting disease remission in patients with differentiated thyroid cancer based on patient, tumor and treatment factors. Materials and Methods: A retrospective cohort study of 1,217 differentiated thyroid cancer patients from two tertiary-care hospitals in the Northeast of Thailand was performed. Associations between potential clinical prognostic factors and remission were tested by Cox proportional-hazards analysis in 852 patients (development cohort). The prediction score was created by summation of score points weighted from regression coefficients of independent prognostic factors. Risks of disease remission were estimated and the derived score was then validated in the remaining 365 patients (validation cohort). Results: During the median follow-up time of 58 months, 648 (76.1%) patients in the development cohort had disease remission. Five independent prognostic factors were identified with corresponding score points: duration from thyroid surgery to $^{131}I$ treatment (0.721), distant metastasis at initial diagnosis (0.801), postoperative serum thyroglobulin level (0.535), anti-thyroglobulin antibodies positivity (0.546), and adequacy of serum TSH suppression (0.293). The total risk score for each patient was calculated and three categories of remission probability were proposed: ${\leq}1.628$ points (low risk, 83% remission), 1.629-1.816 points (intermediate risk, 87% remission), and ${\geq}1.817$ points (high risk, 93% remission). The concordance (C-index) was 0.761 (95% CI 0.754-0.767). Conclusions: The clinical prognostic scoring model developed to quantify the probability of disease remission can serve as a useful tool in personalized decision making regarding treatment in differentiated thyroid cancer patients.
Roh, Simon;Iannettoni, Mark D.;Keech, John;Arshava, Evgeny V.;Swatek, Anthony;Zimmerman, Miriam B.;Weigel, Ronald J.;Parekh, Kalpaj R.
Journal of Chest Surgery
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제52권1호
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pp.1-8
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2019
Background: Neoadjuvant chemoradiation therapy (nCRT) has become the standard of care for esophageal cancer patients prior to esophagectomy. However, the optimal timing for surgery after completion of nCRT remains unclear. Methods: A retrospective review was performed of patients who underwent esophagectomy with cervical anastomosis for esophageal cancer at a single institution between January 2000 and June 2015. Patients were categorized into 3 cohorts: those who did not receive nCRT prior to esophagectomy (no nCRT), those who underwent esophagectomy within 35 days after nCRT (${\leq}35d$), and those who underwent esophagectomy more than 35 days after nCRT (>35d). Results: A total of 366 esophagectomies were performed during the study period, and 348 patients met the inclusion criteria. Anastomotic leaks occurred in 11.8% of all patients included in the study (41 of 348). Within each cohort, anastomotic leaks were detected in 14.7% of patients (17 of 116) in the no nCRT cohort, 7.3% (13 of 177) in the ${\leq}35d$ cohort, and 20.0% (11 of 55) in the >35d cohort (p=0.020). Significant differences in the occurrence of anastomotic leaks were observed between the no nCRT and ${\leq}35d$ cohorts (p=0.044), and between the ${\leq}35d$ and >35d cohorts (p=0.007). Conclusion: Esophagectomy with cervical anastomosis within 35 days of nCRT resulted in a lower percentage of anastomotic leaks.
Hwang, Young-Jae;Kim, Nayoung;Yun, Chang Yong;Yoon, Hyuk;Shin, Cheol Min;Park, Young Soo;Son, Il Tae;Oh, Heung-Kwon;Kim, Duck-Woo;Kang, Sung-Bum;Lee, Hye Seung;Park, Seon Mee;Lee, Dong Ho
Journal of Cancer Prevention
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제23권4호
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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.
Lee, Joonki;Choe, Sunho;Park, Ji Won;Jeong, Seung-Yong;Shin, Aesun
Journal of Preventive Medicine and Public Health
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제51권6호
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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.
Kim, Su-Hwan;Lee, Jihye;Kim, Won-Kyung;Lee, Young-Kyoo;Kim, Young-Sung
Journal of Periodontal and Implant Science
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제51권2호
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pp.114-123
/
2021
Purpose: This retrospective cohort study aimed to assess the effect of nonsurgical periodontal therapy on glycated hemoglobin (HbA1c) levels in patients with both type 2 diabetes and chronic periodontitis. Methods: The intervention cohort (IC) comprised 133 patients with type 2 diabetes who received nonsurgical periodontal treatment, while the matching cohort (MC) included 4787 patients with type 2 diabetes who visited the Department of Endocrinology and Metabolism of Asan Medical Center. The patients in each cohort were divided into 3 groups according to their baseline HbA1c level: subgroup 1, HbA1c <7%; subgroup 2, 7%≤ HbA1c <9%; and subgroup 3, HbA1c ≥9%. Changes in HbA1c levels from baseline to 6 and 12 months were analyzed. In addition, the association between changes in HbA1c levels and the number of periodontal maintenance visits was investigated. Results: There were no statistically significant changes in HbA1c levels in the IC and MC or their subgroups when evaluated with repeated-measures analysis of variance. However, the IC showed maintenance of baseline HbA1c levels, while the MC had a trend for HbA1c levels to steadily increase as shown by pairwise comparisons (baseline to 6 months and baseline to 12 months). IC subgroup 1 also maintained steady HbA1c levels from 6 months to 12 months, whereas MC subgroup 1 presented a steady increase during the same period. The number of periodontal maintenance visits had no association with changes in HbA1c levels during the 1-year study duration. Conclusions: For patients with both type 2 diabetes and periodontitis, nonsurgical periodontal treatment and periodontal maintenance may help to control HbA1c levels.
Background/Aims: The Gachon Regional Occupational Cohort Study (GROCS) is a large-scale longitudinal study of occupational safety and health data (covering Work Environment Monitoring, Workers' Health Surveillance, and Occupational Health Service) conducted by the Gachon University Gil Medical Center (GUGMC) in Incheon, Republic of Korea. We conducted GROCS to identify the health effects of workers' occupational risks, behavior, socioeconomic status, and life style. Methods: The GROCS includes data from Work Environment Monitoring, Workers' Health Surveillance, and Occupational Health Service. The baseline year for all data collection was 2018. Work Environment Monitoring was conducted in 240 companies located in Incheon. General Health Examination and Special Health Examination were performed on 32,725 and 9,504 workers, respectively. Occupational Health Services were provided to 16,883 workers in 171 companies. These data have been collected and operated at an external data management institution and were provided as a retrospective cohort after removing personal identification information. Results: In 2018, the total number of companies was 2,854, among which which 488 special Health Examination, 171 Work Environment Monitoring, and 240 Occupational Health Service. The proportion of companies undergoing Special Health Examination was 17.1%, the proportion of companies undergoing Work Environment Monitoring was 8.4%, and the proportion of Companies undergoing Occupational Health Service was 6.0%. Conclusion: GROCS expects researchers to utilize its useful and reliable resource for occupational health and surveillance with for academic or political purposes to lead to improved workers' health and working environment.
Su-Youn Ko;Tae-Yoon Hwang;Kiwook Baek;Chulyong Park
Journal of Yeungnam Medical Science
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제41권1호
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pp.39-44
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2024
Background: Medication-related osteonecrosis of the jaw (MRONJ) is a significant concern, particularly among patients taking bisphosphonates (BPs), denosumab, and selective estrogen receptor modulators (SERMs) for osteoporosis. Despite the known risks, large-scale cohort studies examining the incidence and severity of MRONJ are lacking. We aimed to ascertain the incidence and risk of MRONJ among these patients, whom we stratified by age groups, medication types, and duration of use. Methods: We utilized data from the National Health Insurance Service's sample cohort database, focusing on patients aged 40 years and above diagnosed with osteoporosis. The patients were divided into three groups: those prescribed BPs only, those prescribed SERMs only, and those prescribed both. Results: The overall incidence rate of MRONJ was 0.17%. A significantly higher incidence rate was observed among those taking osteoporosis medications, particularly among females with a relative risk of 4.99 (95% confidence interval, 3.21-7.74). The SERM group also had an incidence rate comparable to that of the BP group. Severity was assessed based on the invasiveness of the treatment methods, with 71.3% undergoing invasive treatment in the medication group. Conclusion: This study provides valuable insights into the incidence and severity of MRONJ among a large cohort of patients with osteoporosis. It underscores the need for comprehensive guidance on MRONJ risks across different medication groups and sets the stage for future research focusing on specific populations and treatment outcomes.
Park, Chan Woo;Hwang, Yu Im;Koo, Hwa Seon;Kang, Inn Soo;Yang, Kwang Moon;Song, In Ok
Clinical and Experimental Reproductive Medicine
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제41권4호
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pp.158-164
/
2014
Objective: To assess whether an early GnRH antagonist start leads to better follicular synchronization and an improved clinical pregnancy rate (CPR). Methods: A retrospective cohort study. A total of 218 infertile women who underwent IVF between January 2011 and February 2013. The initial cohort (Cohort I) that underwent IVF between January 2011 and March 2012 included a total of 68 attempted IVF cycles. Thirty-four cycles were treated with the conventional GnRH antagonist protocol, and 34 cycles with an early GnRH antagonist start protocol. The second cohort (Cohort II) that underwent IVF between June 2012 and February 2013 included a total of 150 embryo-transfer (ET) cycles. Forty-three cycles were treated with the conventional GnRH antagonist protocol, 34 cycles with the modified early GnRH antagonist start protocol using highly purified human menopause gonadotropin and an addition of GnRH agonist to the luteal phase support, and 73 cycles with the GnRH agonist long protocol. Results: The analysis of Cohort I showed that the number of mature oocytes retrieved was significantly higher in the early GnRH antagonist start cycles than in the conventional antagonist cycles (11.9 vs. 8.2, p=0.04). The analysis of Cohort II revealed higher but non-significant CPR/ET in the modified early GnRH antagonist start cycles (41.2%) than in the conventional antagonist cycles (30.2%), which was comparable to that of the GnRH agonist long protocol cycles (39.7%). Conclusion: The modified early antagonist start protocol may improve the mature oocyte yield, possibly via enhanced follicular synchronization, while resulting in superior CPR as compared to the conventional antagonist protocol, which needs to be studied further in prospective randomized controlled trials.
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