1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.Surrogate decision making of chemotherapy consent: do we really provide informed consent of chemotherapy for patients?
Jung Hye KWON ; Sun Kyung BAEK ; Bong Seog KIM ; Su Jin KOH ; Hee Kyung AHN ; Joo Han LIM ; Chiyeon LIM ; Do Yeun KIM
The Korean Journal of Internal Medicine 2019;34(3):626-633
BACKGROUND/AIMS:
Despite increased demand for cancer patient's to make their own decisions based on an adequate understanding of what is involved in chemotherapy, the primary signing agent and the reasons for surrogate signing have not been appropriately evaluated.
METHODS:
The ethics committee of the palliative medicine subgroup of the Korean Cancer Study Group designed this study and solid cancer patients to whom chemotherapy was offered, from seven institutions, were evaluated. The details relating to surrogate's signing of chemotherapy consent were evaluated. Then, we analyzed the factors associated with surrogate's signing according to patient's demographics and characteristics related to chemotherapy consent.
RESULTS:
Surrogate's signing was noted for 20.7% (84/405) of patient and over half of surrogate signings were performed by the patients' son or daughter (60.7%). Two main reasons for surrogate signing were patient's incapacity (34.5%) and taking over authorization from patients (33.3%). The factors associated with more frequent surrogate's signing were absence of spouse, lower education level, outpatient, and when residents played a role as a principle provider of chemotherapy consent.
CONCLUSIONS
This study suggests the lack of patients' own decision making for chemotherapy in some situations. This ethical dilemma must be considered for adequately informed decision making for chemotherapy while ensuring the patients' autonomy is maintained.
3.Experiences and Opinions Related to End-of-Life Discussion: From Oncologists' and Resident Physicians' Perspectives.
Su Jin KOH ; Shinmi KIM ; JinShil KIM ; Bhumsuk KEAM ; Dae Seog HEO ; Kyung Hee LEE ; Bong Seog KIM ; Jee Hyun KIM ; Hye Jung CHANG ; Sun Kyung BAEK
Cancer Research and Treatment 2018;50(2):614-623
PURPOSE: The aims of this study were to explore how oncologists and resident physicians practice end-of-life (EOL) discussions and to solicit their opinions on EOL discussions as a means to improve the quality of EOL care. MATERIALS AND METHODS: A survey questionnaire was developed to explore the experiences and opinions about EOL discussions among oncologists and residents. Descriptive statistics, the t test, and the chisquare test were performed for the analyses. RESULTS: A total of 147 oncologists and 229 residents participated in this study. The study respondents reported diverse definitions of “terminal state,” and mostrespondents tried to disclose the patient's condition to the patient and/or family members. Both groups were involved in EOL care discussions, with a rather low satisfaction level (57.82/100). The best timing to initiate discussionwas consideredwhen metastasis or disease recurrence occurred orwhen withdrawal of chemotherapy was anticipated. Furthermore, the study respondents suggested that patients and their family members should be included in the EOL discussion. Medical, legal, and ethical knowledge and communication difficulties along with practical issues were revealed as barriers and facilitators for EOL discussion. CONCLUSION: This study explored various perspectives of oncologists and resident physicians for EOL discussion. Since the Life-Sustaining-Treatment Decision-Making Act will be implemented shortly in Korea, now is the time for oncologists and residents to prepare themselves by acquiring legal knowledge and communication skills. To achieve this, education, training, and clinical tools for healthcare professionals are required.
Advance Care Planning
;
Delivery of Health Care
;
Drug Therapy
;
Education
;
Humans
;
Korea
;
Neoplasm Metastasis
;
Recurrence
;
Surveys and Questionnaires
4.Translation and linguistic validation of Korean version of the Test for Respiratory and Asthma Control in Kids instrument.
Hea Lin OH ; Young Yull KOH ; Dong In SUH ; Byoung Chul KANG ; Bong Seong KIM ; Woo Kyung KIM ; Jakyoung KIM ; Jin Tack KIM ; Hyo Bin KIM ; Geunhwa PARK ; Heysung BAEK ; Dae Jin SONG ; Mee Yong SHIN ; Hyeon Jong YANG ; Sung Il WOO ; Young YOO ; Jinho YU ; So Yeon LEE ; Dae Hyun LIM
Allergy, Asthma & Respiratory Disease 2016;4(1):22-30
PURPOSE: We aimed to translate the Test for Respiratory and Asthma Control in Kids (TRACK) instrument into Korean, with subsequent linguistic validation. METHODS: The multistep process of forward translation, reconciliation, back-translation, cognitive debriefing, and proofreading of the Korean version of the TRACK was completed. RESULTS: Two bilingual medical personnel independently translated the original English version of the TRACK into Korean one. After moderating the translation into a single reconciled one, 4 other bilingual persons were invited to translate the Korean draft back into an English one. Discrepancies between the original English version and the back-translated one were reviewed, and the need to modify the reconciled Korean draft was discussed. Twenty caregivers of asthmatic children took part in interviews that examine the appropriateness of the Korean version of the TRACK. The feedback from caregivers were then reviewed by a panel of pediatric allergists and reflected in the final Korean version. The document was finally proofread to check the spelling, grammar, layout and formatting. CONCLUSION: Translation and linguistic validation of the Korean version of the TRACK instrument were completed.
Asthma*
;
Caregivers
;
Child
;
Humans
;
Linguistics*
;
Translations
5.Giant Intrathoracic Meningocele and Breast Cancer in a Neurofibromatosis Type I Patient.
Hridayesh Pratap MALLA ; Bong Jin PARK ; Jun Seok KOH ; Dae Jean JO
Journal of Korean Neurosurgical Society 2016;59(6):650-654
Intrathoracic meningoceles are relatively rare entities found in patients with neurofibromatosis type I (NF1). Given that both the BRCA1 and NF-1 genes are located on the same long arm of chromosome 17, one would expect concurrence of neurofibromatosis and breast cancer. However, incidence of such co-disorders is very rare in the literature. Here, the authors report a case of a 50-year-old female patient with NF-1 and concurrent cancer of the left breast, who had a huge bilobulated intrathoracic meningocele with thoracic dystrophic scoliosis, treated surgically via a posterior-only approach for the meningocele and spinal deformity in the same setting.
Arm
;
Breast Neoplasms*
;
Breast*
;
Chromosomes, Human, Pair 17
;
Congenital Abnormalities
;
Female
;
Humans
;
Incidence
;
Meningocele*
;
Middle Aged
;
Neurofibromatoses*
;
Neurofibromatosis 1*
;
Scoliosis
6.Clinical Applicability of Newly Developed Image-based Cell Counter for Counting CD34+ Cells: Comparison with Flow Cytometric Analysis
Wee Jin RAH ; Eun Kyung SHIN ; Hani KOH ; Jin Young SUH ; Misoo CHANG ; Eunwoo NAM ; Jong Hyun OH ; Yumi JUNG ; Ji Yeon LEE ; Sung Rok BONG ; Sung Hun HONG ; Jee Young KIM ; Sunmi HAN ; Jeoung Ku HWANG ; Chanil CHUNG ; Young Ho LEE
Clinical Pediatric Hematology-Oncology 2016;23(2):125-132
BACKGROUND: Flow cytometric analysis is the standard method for enumerating CD34+ stem cells in hematopoietic stem cell transplantation. However, it has some limitations such as expensive instrumentation, high reagent costs, and discrepancies between technicians and laboratories. We compared counts of total nucleated cells (TNCs) and CD34+ cells counts obtained from a flow cytometer with a newly-developed image-based microscopic cell counter (ADAM II) to evaluate the possibility of clinical application of the ADAM II.METHODS: We used 18 samples of circulating peripheral blood (PB) and waste tube fractions of peripheral blood stem cells (PBSCs) harvested by apheresis after G-CSF mobilization from adult volunteer donors. We assessed the reproducibility and linearity of the new procedure and compared the numbers of TNCs and viable CD34+ cells determined with the ADAM II and two different flow cytometers (FACSCalibur, FACSCanto II).RESULTS: Numbers of viable CD34+ cells determined with the ADAM II were accurate over the expected range; the intra-assay coefficient of variation was ≤19.8%. Linearity was also satisfactory (R²=0.99). TNC counts obtained with the ADAM II were highly correlated with those obtained with the FACSCalibur (R²>0.9841, P<0.0001) and FACSCanto II (R²>0.9620, P<0.0001), as were the numbers of viable CD34+ cells obtained with the ADAM II and the FACSCalibur and FACSCanto II (R²>0.9911, P<0.0001 and R²>0.9791, P<0.0001), respectively.CONCLUSION: The newly developed image-based microscopic cell counter (ADAM II) appears to be suitable for enumerating TNCs and viable CD34+ cells.
Adult
;
Blood Component Removal
;
Cell Count
;
Granulocyte Colony-Stimulating Factor
;
Hematopoietic Stem Cell Transplantation
;
Humans
;
Methods
;
Stem Cells
;
Tissue Donors
;
Volunteers
7.Phenotype and endotype in pediatric asthma.
Hyeon Jong YANG ; Bong Seong KIM ; Woo Kyung KIM ; Jakyoung KIM ; Jin Tack KIM ; Dong In SUH ; Young Yull KOH ; Youn Ho SHIN ; So Yeon LEE ; Dae Hyun LIM ; Ji Tae CHOUNG ; Hyo Bin KIM
Allergy, Asthma & Respiratory Disease 2014;2(2):85-90
Asthma is not a homogeneous disease presenting variable clinical features, but a complex disorder consisting of many different disease entities characterized by variable air-flow limitation. To date, there are little effective preventive-strategies for the development of asthma, and it has been emphasized that early identification and intervention are the best ways to reduce the associated morbidities, quality of life, and socioeconomic burden. Predicting the natural course of asthma is still difficult, although various phenotypic approaches and predictive scores are developed and widely used. The present phenotypes and predictive scores may be reliable in the population, but those appear to be unreliable in each individual in real practice. Either undertreatment or overtreatment in childhood asthma is an important issue, because they are associated with poor compliance, increments of socioeconomic burdens, and poor quality of life. There is no doubt about the clinical efficacy of inhaled corticosteroid (ICS) in childhood asthma, but the negative effect of long-term use of ICS on the height is emerging. Therefore general physicians should consider an individualized management using specific phenotypes and endotypes, and regularly re-evaluate the drug-response, level of control, and adherence/compliance to avoid inadequate treatment.
Asthma*
;
Child
;
Compliance
;
Humans
;
Phenotype*
;
Quality of Life
8.The Incidence and Clinical Characteristics of Proximal Colonic Polyps When the Polyps Are Noted on Rectosigmoid Colon by Colonoscopy.
Sae Kyung JOO ; Ji Won KIM ; Kook Lae LEE ; Byeong Gwan KIM ; Ji Bong JEONG ; Jae Kyung LEE ; Seong Joon KOH ; Young Hoon KIM
The Korean Journal of Gastroenterology 2013;62(1):42-48
BACKGROUND/AIMS: Colorectal cancer is the third most common type of cancer and second leading cause of cancer death overall. Recently, there has been an emphasis on primary screening for colorectal cancer with colonoscopy. In this study, we aimed to address clinical characteristics and incidence of colonic polyps according to location. METHODS: From January 2009 to December 2010, 6,417 total colonoscopic examinations were performed at Boramae Hospital in Seoul, Korea. We reviewed these patients retrospectively. The distal colon was defined as the rectosigmoid junction. RESULTS: Overall, 1,972 patients (31.3%) had one of more colorectal polyps. Total of 4,445 patients were excluded from this study because of combined advanced colorectal cancer, inflammatory bowel disease, or familial adenomatous polyposis. Patients who had only proximal polyps were 633 (32.1%), 530 patients (26.9%) had both proximal and distal polyps, and 809 patients (41.0%) had polyps only in the rectosigmoid region. The prevalence of the proximal polyps in patients with rectosigmoid polyps was found to be significantly related to the male gender and elderly patients. However, the prevalence of the proximal colonic polyps was not related to the size and number of rectosigmoid polyps. In 530 patients with both rectosigmoid and proximal colonic polyps, the characteristics of proximal colonic polyps as size and number were similar to those of rectosigmoid polyps. Advanced proximal adenomas without distal polyps were found in 25 (29.4%) patients whom were associated with size and pathology. CONCLUSIONS: We recommend total colonoscopic examination in all patients regardless of the size and number, especially in elderly males.
Adenoma/epidemiology/pathology
;
Adenoma, Villous/epidemiology/pathology
;
Adult
;
Age Factors
;
Aged
;
Aged, 80 and over
;
Colonic Polyps/*pathology
;
Colonoscopy
;
Colorectal Neoplasms/*epidemiology/pathology
;
Female
;
Humans
;
Incidence
;
Male
;
Middle Aged
;
Retrospective Studies
;
Sex Factors
9.Comparison of Clinical Outcomes between Endoscopic and Radiologic Placement of Self-expandable Metal Stent in Patients with Malignant Colorectal Obstruction.
Ji Won KIM ; Ji Bong JEONG ; Kook Lae LEE ; Byeong Gwan KIM ; Yong Jin JUNG ; Won KIM ; Hwi Young KIM ; Dong Won AHN ; Seong Joon KOH ; Jae Kyung LEE
The Korean Journal of Gastroenterology 2013;61(1):22-29
BACKGROUND/AIMS: This study compared the clinical outcomes between endoscopic and radiologic placement of self-expandable metal stent (SEMS) in patients with malignant colorectal obstruction. METHODS: In total, 111 patients were retrospectively enrolled in this study between January 2003 and June 2011 at Seoul National University Boramae Hospital. Technical and clinical success rates, complication rates, and stent patency were compared between using an endoscopic (n=73) or radiologic (n=38) method during the SEMS placement procedure. RESULTS: The technical success rate was higher in the endoscopic method than in the radiologic method (100% [73/73] vs. 92.1% [35/38], respectively; p=0.038). In addition, in 3 of the remaining 35 patients in the radiologic-method group, adjuvant endoscopic assistance was required. In the six patients (including the three aforementioned patients), the causes of technical failure were the inability to pass the guidewire into an obstructive lesion due to a tortuous, curved angulation of the sigmoid or descending colon (n=4), and a difficult approach to a lesion located at the descending or transverse colon (n=2). The clinical success rate, complication rate, and stent patency did not differ significantly between the two methods (p=0.424, 0.303, and 0.423, respectively). CONCLUSIONS: When the colorectal obstruction had a tortuous, curved angulation of the colon or was located at or proximal to the descending colon, the endoscopic method of SEMS placement appears to be more useful than the radiologic method. However, once SEMS placement was technically successful, the clinical success rate, complication rate, and stent patency did not differ with the method of insertion.
Adult
;
Aged
;
Aged, 80 and over
;
Colonoscopy
;
Colorectal Neoplasms/complications/*diagnosis
;
Female
;
Follow-Up Studies
;
Humans
;
Intestinal Obstruction/*diagnosis/etiology/therapy
;
Male
;
Metals/chemistry
;
Middle Aged
;
Palliative Care/*methods
;
Retrospective Studies
;
*Stents
;
Treatment Outcome
10.The Relationship of Physical and Psychosocial Risk Factors to Work-related Musculoskeletal Upper Extremity Symptoms amongst Male Automobile Manufacturing Workers.
Ki Hyun LEE ; Jin Ha YOON ; Sung Kyung KIM ; In Jung CHO ; Sung Soo OH ; Sung Hoon KIM ; Sei Jin CHANG ; Bong Suk CHA ; Sang Baek KOH
Korean Journal of Occupational and Environmental Medicine 2012;24(1):72-85
OBJECTIVES: The objective of this study was to determine the relationship of physical and psychosocial risk factors to work-related musculoskeletal upper extremity symptoms amongst automobile manufacturing workers. METHODS: The cross-sectional study was conducted using male automobile manufacturing workers in order to examine the relationship of physical and psychosocial risk factors to work-related musculoskeletal upper extremity symptoms. A total of 1,793 male workers were asked to complete a self-administered questionnaire. The questionnaire consisted of questions regarding general characteristics, health related behaviors, work-related characteristics, job stress, ergonomic risk factors, and the presence of musculoskeletal symptoms (neck, shoulder, arm, and hand). Work-related musculoskeletal symptoms were evaluated using the National Institute of Occupational Safety and Health (NIOSH) surveillance criteria. In order to measure the physical risk factors, the American National Standard Institute (ANSI) Z-365 Quick checklist was incorporated into the questionnaire. Job stressors were measured using the Korean Occupational Stress Scale (KOSS). A binary logistic regression analysis was performed that examined the relationship of physical and psychosocial risk factors to musculoskeletal symptoms. RESULTS: The result showed that the physical and psychosocial risk factors were associated with musculoskeletal upper extremity symptoms. The workers with high physical risk factors reported more musculoskeletal symptoms than those having low physical risk factors (OR: 2.37, 95% CI: 1.56~3.62). The workers with high job stress were more likely to have an increased risk of musculoskeletal upper extremity symptom compared to those with normal job stress (OR: 2.65, 95% CI: 2.03~3.47). A significant relationship between the combined effects of physical and psychosocial risk factors on musculoskeletal upper extremity symptoms was also found. The workers exposed to high physical risk factors, high job stress, and long working hours were more likely to report musculoskeletal symptoms than those having low physical risk factors, normal job stress and moderate working hours(OR: 2.37, 95% CI: 1.56~3.62). CONCLUSIONS: The results suggest that some physical and psychosocial risk factors increase the risk of work-related musculoskeletal upper extremity symptoms amongst automobile manufacturing workers. In order to prevent or reduce musculoskeletal disorders amongst automobile manufacturing workers, it is strongly recommended to manage the physical psychosocial risks occurring in the workplace.
Arm
;
Automobiles
;
Checklist
;
Cross-Sectional Studies
;
Human Engineering
;
Humans
;
Logistic Models
;
Male
;
Occupational Health
;
Questionnaires
;
Risk Factors
;
Shoulder
;
Upper Extremity

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