1.Cohort profile: Multicenter Networks for Ideal Outcomes of Rare Pediatric Endocrine and Metabolic Diseases in Korea (OUTSPREAD study)
Yun Jeong LEE ; Chong Kun CHEON ; Junghwan SUH ; Jung-Eun MOON ; Moon Bae AHN ; Seong Hwan CHANG ; Jieun LEE ; Jin Ho CHOI ; Minsun KIM ; Han Hyuk LIM ; Jaehyun KIM ; Shin-Hye KIM ; Hae Sang LEE ; Yena LEE ; Eungu KANG ; Se Young KIM ; Yong Hee HONG ; Seung YANG ; Heon-Seok HAN ; Sochung CHUNG ; Won Kyoung CHO ; Eun Young KIM ; Jin Kyung KIM ; Kye Shik SHIM ; Eun-Gyong YOO ; Hae Soon KIM ; Aram YANG ; Sejin KIM ; Hyo-Kyoung NAM ; Sung Yoon CHO ; Young Ah LEE
Annals of Pediatric Endocrinology & Metabolism 2024;29(6):349-355
Rare endocrine diseases are complex conditions that require lifelong specialized care due to their chronic nature and associated long-term complications. In Korea, a lack of nationwide data on clinical practice and outcomes has limited progress in patient care. Therefore, the Multicenter Networks for Ideal Outcomes of Pediatric Rare Endocrine and Metabolic Disease (OUTSPREAD) study was initiated. This study involves 30 centers across Korea. The study aims to improve the long-term prognosis of Korean patients with rare endocrine diseases by collecting comprehensive clinical data, biospecimens, and patient-reported outcomes to identify complications and unmet needs in patient care. Patients with childhood-onset pituitary, adrenal, or gonadal disorders, such as craniopharyngioma, congenital adrenal hyperplasia (CAH), and Turner syndrome were prioritized. The planned enrollment is 1,300 patients during the first study phase (2022–2024). Clinical, biochemical, and imaging data from diagnosis, treatment, and follow-up during 1980–2023 were retrospectively reviewed. For patients who agreed to participate in the prospective cohort, clinical data and biospecimens will be prospectively collected to discover ideal biomarkers that predict the effectiveness of disease control measures and prognosis. Patient-reported outcomes, including quality of life and depression scales, will be evaluated to assess psychosocial outcomes. Additionally, a substudy on CAH patients will develop a steroid hormone profiling method using liquid chromatography-tandem mass spectrometry to improve diagnosis and monitoring of treatment outcomes. This study will address unmet clinical needs by discovering ideal biomarkers, introducing evidence-based treatment guidelines, and ultimately improving long-term outcomes in the areas of rare endocrine and metabolic diseases.
2.Cohort profile: Multicenter Networks for Ideal Outcomes of Rare Pediatric Endocrine and Metabolic Diseases in Korea (OUTSPREAD study)
Yun Jeong LEE ; Chong Kun CHEON ; Junghwan SUH ; Jung-Eun MOON ; Moon Bae AHN ; Seong Hwan CHANG ; Jieun LEE ; Jin Ho CHOI ; Minsun KIM ; Han Hyuk LIM ; Jaehyun KIM ; Shin-Hye KIM ; Hae Sang LEE ; Yena LEE ; Eungu KANG ; Se Young KIM ; Yong Hee HONG ; Seung YANG ; Heon-Seok HAN ; Sochung CHUNG ; Won Kyoung CHO ; Eun Young KIM ; Jin Kyung KIM ; Kye Shik SHIM ; Eun-Gyong YOO ; Hae Soon KIM ; Aram YANG ; Sejin KIM ; Hyo-Kyoung NAM ; Sung Yoon CHO ; Young Ah LEE
Annals of Pediatric Endocrinology & Metabolism 2024;29(6):349-355
Rare endocrine diseases are complex conditions that require lifelong specialized care due to their chronic nature and associated long-term complications. In Korea, a lack of nationwide data on clinical practice and outcomes has limited progress in patient care. Therefore, the Multicenter Networks for Ideal Outcomes of Pediatric Rare Endocrine and Metabolic Disease (OUTSPREAD) study was initiated. This study involves 30 centers across Korea. The study aims to improve the long-term prognosis of Korean patients with rare endocrine diseases by collecting comprehensive clinical data, biospecimens, and patient-reported outcomes to identify complications and unmet needs in patient care. Patients with childhood-onset pituitary, adrenal, or gonadal disorders, such as craniopharyngioma, congenital adrenal hyperplasia (CAH), and Turner syndrome were prioritized. The planned enrollment is 1,300 patients during the first study phase (2022–2024). Clinical, biochemical, and imaging data from diagnosis, treatment, and follow-up during 1980–2023 were retrospectively reviewed. For patients who agreed to participate in the prospective cohort, clinical data and biospecimens will be prospectively collected to discover ideal biomarkers that predict the effectiveness of disease control measures and prognosis. Patient-reported outcomes, including quality of life and depression scales, will be evaluated to assess psychosocial outcomes. Additionally, a substudy on CAH patients will develop a steroid hormone profiling method using liquid chromatography-tandem mass spectrometry to improve diagnosis and monitoring of treatment outcomes. This study will address unmet clinical needs by discovering ideal biomarkers, introducing evidence-based treatment guidelines, and ultimately improving long-term outcomes in the areas of rare endocrine and metabolic diseases.
3.Cohort profile: Multicenter Networks for Ideal Outcomes of Rare Pediatric Endocrine and Metabolic Diseases in Korea (OUTSPREAD study)
Yun Jeong LEE ; Chong Kun CHEON ; Junghwan SUH ; Jung-Eun MOON ; Moon Bae AHN ; Seong Hwan CHANG ; Jieun LEE ; Jin Ho CHOI ; Minsun KIM ; Han Hyuk LIM ; Jaehyun KIM ; Shin-Hye KIM ; Hae Sang LEE ; Yena LEE ; Eungu KANG ; Se Young KIM ; Yong Hee HONG ; Seung YANG ; Heon-Seok HAN ; Sochung CHUNG ; Won Kyoung CHO ; Eun Young KIM ; Jin Kyung KIM ; Kye Shik SHIM ; Eun-Gyong YOO ; Hae Soon KIM ; Aram YANG ; Sejin KIM ; Hyo-Kyoung NAM ; Sung Yoon CHO ; Young Ah LEE
Annals of Pediatric Endocrinology & Metabolism 2024;29(6):349-355
Rare endocrine diseases are complex conditions that require lifelong specialized care due to their chronic nature and associated long-term complications. In Korea, a lack of nationwide data on clinical practice and outcomes has limited progress in patient care. Therefore, the Multicenter Networks for Ideal Outcomes of Pediatric Rare Endocrine and Metabolic Disease (OUTSPREAD) study was initiated. This study involves 30 centers across Korea. The study aims to improve the long-term prognosis of Korean patients with rare endocrine diseases by collecting comprehensive clinical data, biospecimens, and patient-reported outcomes to identify complications and unmet needs in patient care. Patients with childhood-onset pituitary, adrenal, or gonadal disorders, such as craniopharyngioma, congenital adrenal hyperplasia (CAH), and Turner syndrome were prioritized. The planned enrollment is 1,300 patients during the first study phase (2022–2024). Clinical, biochemical, and imaging data from diagnosis, treatment, and follow-up during 1980–2023 were retrospectively reviewed. For patients who agreed to participate in the prospective cohort, clinical data and biospecimens will be prospectively collected to discover ideal biomarkers that predict the effectiveness of disease control measures and prognosis. Patient-reported outcomes, including quality of life and depression scales, will be evaluated to assess psychosocial outcomes. Additionally, a substudy on CAH patients will develop a steroid hormone profiling method using liquid chromatography-tandem mass spectrometry to improve diagnosis and monitoring of treatment outcomes. This study will address unmet clinical needs by discovering ideal biomarkers, introducing evidence-based treatment guidelines, and ultimately improving long-term outcomes in the areas of rare endocrine and metabolic diseases.
4.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.
5.Effect and Safety of Travoprost 0.003% in Open Angle Glaucoma
Su Min SUNG ; Jong Heon KIM ; Chong Eun LEE ; Kyoo Won LEE ; Sam SEO
Journal of the Korean Ophthalmological Society 2021;62(4):531-537
Purpose:
To determine whether travoprost 0.003% has a similar intraocular pressure (IOP) reduction effect to that of travoprost 0.004% while reducing side effects.
Methods:
This was a prospective study from January 2018 to December 2018 that included 102 patients diagnosed with open angle glaucoma who switched from travoprost 0.004% to travoprost 0.003%. We investigated the changes in IOP, conjunctival hyperemia, corneal erosion, and eyelid pigmentation before and at 3 months after switching to travoprost 0.003%. Additionally, a questionnaire survey of these patients was conducted to determine possible side effects, including hyperemia, stinging, pruritus, irritation, blurred vision, dryness, and foreign body sensation.
Results:
IOP readings before and after switching to travoprost 0.003% were 12.95 ± 4.25 and 12.94 ± 3.89 mmHg, respectively, showing no significant change (p = 0.974). No changes were observed in corneal erosion or eyelid pigmentation; however, conjunctival hyperemia was reduced significantly from 1.60 ± 0.88 to 1.36 ± 0.84 (p = 0.001). No significant changes in hyperemia, stinging, pruritus, irritation, or foreign body sensation were reported; however, a significant improvement was noted for blurred vision and dryness (p = 0.008, p = 0.007, respectively).
Conclusions
We were able to show the effectiveness and safety of travoprost 0.003% as being as effective as travoprost 0.004% in reducing IOP and injections while improving blurred vision and dryness.
6.Discrepancy between Cytology and Histology in Cervical Cancer Screening:a Multicenter Retrospective Study (KGOG 1040)
Yung-Taek OUH ; Ji Jeong PARK ; Minjoo KANG ; Miseon KIM ; Jae Yun SONG ; So Jin SHIN ; Seung-Hyuk SHIM ; Heon Jong YOO ; Maria LEE ; Sung-Jong LEE ; Whan SHIN ; Gun Oh CHONG ; Min Chul CHOI ; Chel Hun CHOI ; Kyung-Jin MIN
Journal of Korean Medical Science 2021;36(24):e164-
Background:
Cervical cancer is the fourth common cancer in women worldwide. The Papanicolau test is the primary screening procedure to detect abnormal cervical cells.Colposcopy is the main procedure for discriminating high-grade cervical lesions. The study aimed at clarifying the discrepancy between cervical cytology and colposcopic biopsy histology as well as confounding factors.
Methods:
Eligible patients visited thirteen tertiary hospitals for colposcopic biopsy following cervical cytology and human papillomavirus (HPV) genotypes between January and December 2018. Baseline characteristics including age, body mass index (BMI), and parity were collected.
Results:
In our study, 3,798 eligible patients were included. Mean age of patients was 42.7(19–88) years and mean BMI was 22.5 (16.9–34.1) kg/m2 . The referred cervical cytologic findings consisted of 495 normal, 1,390 atypical squamous cells of undetermined significance, 380 atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion, 792 low-grade squamous intraepithelial lesion, 593 high-grade squamous intraepithelial lesion, 79 atypical glandular cells, 46 squamous cell carcinoma, and 23 adenocarcinoma. HPV-positive findings were found in 3,008 (79.2%) patients and were not detected in 914 (24.1%) cases. The risk of unexpected low-grade lesions from histology was higher in patients > 45 years (odds ratio [OR], 2.137; 95% confidence intervals [CIs], 1.475–3.096). In contrast, the risk of unexpected high-grade lesions from colposcopic biopsy was lower in patients ≥ 45 years (OR, 0.530; 95% CI, 0.367–0.747) and HPV 16/18 infection was higher than other HPV (OR, 1.848; 95% CI, 1.385–2.469).
Conclusion
Age and HPV genotypes were responsible for the discrepancies between cytology and histology. Precautions should be taken for women over the age of 45 in triage for colposcopy in order to avoid unnecessary testing.
7.Effect and Safety of Travoprost 0.003% in Open Angle Glaucoma
Su Min SUNG ; Jong Heon KIM ; Chong Eun LEE ; Kyoo Won LEE ; Sam SEO
Journal of the Korean Ophthalmological Society 2021;62(4):531-537
Purpose:
To determine whether travoprost 0.003% has a similar intraocular pressure (IOP) reduction effect to that of travoprost 0.004% while reducing side effects.
Methods:
This was a prospective study from January 2018 to December 2018 that included 102 patients diagnosed with open angle glaucoma who switched from travoprost 0.004% to travoprost 0.003%. We investigated the changes in IOP, conjunctival hyperemia, corneal erosion, and eyelid pigmentation before and at 3 months after switching to travoprost 0.003%. Additionally, a questionnaire survey of these patients was conducted to determine possible side effects, including hyperemia, stinging, pruritus, irritation, blurred vision, dryness, and foreign body sensation.
Results:
IOP readings before and after switching to travoprost 0.003% were 12.95 ± 4.25 and 12.94 ± 3.89 mmHg, respectively, showing no significant change (p = 0.974). No changes were observed in corneal erosion or eyelid pigmentation; however, conjunctival hyperemia was reduced significantly from 1.60 ± 0.88 to 1.36 ± 0.84 (p = 0.001). No significant changes in hyperemia, stinging, pruritus, irritation, or foreign body sensation were reported; however, a significant improvement was noted for blurred vision and dryness (p = 0.008, p = 0.007, respectively).
Conclusions
We were able to show the effectiveness and safety of travoprost 0.003% as being as effective as travoprost 0.004% in reducing IOP and injections while improving blurred vision and dryness.
8.Discrepancy between Cytology and Histology in Cervical Cancer Screening:a Multicenter Retrospective Study (KGOG 1040)
Yung-Taek OUH ; Ji Jeong PARK ; Minjoo KANG ; Miseon KIM ; Jae Yun SONG ; So Jin SHIN ; Seung-Hyuk SHIM ; Heon Jong YOO ; Maria LEE ; Sung-Jong LEE ; Whan SHIN ; Gun Oh CHONG ; Min Chul CHOI ; Chel Hun CHOI ; Kyung-Jin MIN
Journal of Korean Medical Science 2021;36(24):e164-
Background:
Cervical cancer is the fourth common cancer in women worldwide. The Papanicolau test is the primary screening procedure to detect abnormal cervical cells.Colposcopy is the main procedure for discriminating high-grade cervical lesions. The study aimed at clarifying the discrepancy between cervical cytology and colposcopic biopsy histology as well as confounding factors.
Methods:
Eligible patients visited thirteen tertiary hospitals for colposcopic biopsy following cervical cytology and human papillomavirus (HPV) genotypes between January and December 2018. Baseline characteristics including age, body mass index (BMI), and parity were collected.
Results:
In our study, 3,798 eligible patients were included. Mean age of patients was 42.7(19–88) years and mean BMI was 22.5 (16.9–34.1) kg/m2 . The referred cervical cytologic findings consisted of 495 normal, 1,390 atypical squamous cells of undetermined significance, 380 atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion, 792 low-grade squamous intraepithelial lesion, 593 high-grade squamous intraepithelial lesion, 79 atypical glandular cells, 46 squamous cell carcinoma, and 23 adenocarcinoma. HPV-positive findings were found in 3,008 (79.2%) patients and were not detected in 914 (24.1%) cases. The risk of unexpected low-grade lesions from histology was higher in patients > 45 years (odds ratio [OR], 2.137; 95% confidence intervals [CIs], 1.475–3.096). In contrast, the risk of unexpected high-grade lesions from colposcopic biopsy was lower in patients ≥ 45 years (OR, 0.530; 95% CI, 0.367–0.747) and HPV 16/18 infection was higher than other HPV (OR, 1.848; 95% CI, 1.385–2.469).
Conclusion
Age and HPV genotypes were responsible for the discrepancies between cytology and histology. Precautions should be taken for women over the age of 45 in triage for colposcopy in order to avoid unnecessary testing.
9.Adherence Improvement in Glaucoma Patients: Effects of Educational Intervention Using an Eye Drop Chart
Woo Seok CHOI ; Jong Heon KIM ; Chang Hoon LEE ; Chong Eun LEE ; Sam SEO
Journal of the Korean Ophthalmological Society 2021;62(12):1617-1625
Purpose:
To evaluate the effects of an educational intervention using an eye drop chart and supplementary education on glaucoma patients’ adherence.
Methods:
In this multicenter prospective study, medically treated glaucoma patients were educated on the administration of eye drops using an eye drop chart. At the time of recruitment, all of the patients completed a questionnaire on demographic characteristics and adherence. Three months after the initial educational intervention, the patients were randomly divided into two groups: an education group and a control group. The education group received supplementary education. Immediately thereafter and at 6 months, all of the patients completed the questionnaire on adherence again. Changes in instillation behavior, the relationship between the adherence score and demographic characteristics, and factors contributing to an improvement in adherence and intraocular pressure were then analyzed.
Results:
The adherence scores were significantly higher in patients with fewer medications, a higher annual income and higher educational level, and an urban residence (p = 0.038, p = 0.033, p = 0.041 and p = 0.047, respectively). Education on the administration of eye drops and use of the eye drop chart improved adherence scores from 23.05 ± 3.52 to 21.30 ± 3.95 (p = 0.021) and significantly reduced the average intraocular pressure from 14.3 ± 2.9 to 12.4 ± 3.1 mmHg (p < 0.001). Working indoors (odds ratio [OR] = 5.47, p = 0.032) and supplementary education at 3 months (OR = 4.53, p = 0.030) were also correlated with improved adherence.
Conclusions
An eye drop chart is an effective tool for improving adherence and intraocular pressure control in glaucoma patients. Improvement in adherence was especially notable in patients whose work predominantly involved indoor activity. The effectiveness of the eye drop chart was improved by supplementary education.
10.Angiotensin II type 1 receptor blockers as a first choice in patients with acute myocardial infarction.
Jang Hoon LEE ; Myung Hwan BAE ; Dong Heon YANG ; Hun Sik PARK ; Yongkeun CHO ; Won Kee LEE ; Myung Ho JEONG ; Young Jo KIM ; Myeong Chan CHO ; Chong Jin KIM ; Shung Chull CHAE
The Korean Journal of Internal Medicine 2016;31(2):267-276
BACKGROUND/AIMS: Angiotensin II type 1 receptor blockers (ARBs) have not been adequately evaluated in patients without left ventricular (LV) dysfunction or heart failure after acute myocardial infarction (AMI). METHODS: Between November 2005 and January 2008, 6,781 patients who were not receiving angiotensin-converting enzyme inhibitors (ACEIs) or ARBs were selected from the Korean AMI Registry. The primary endpoints were 12-month major adverse cardiac events (MACEs) including death and recurrent AMI. RESULTS: Seventy percent of the patients were Killip class 1 and had a LV ejection fraction > or = 40%. The prescription rate of ARBs was 12.2%. For each patient, a propensity score, indicating the likelihood of using ARBs during hospitalization or at discharge, was calculated using a non-parsimonious multivariable logistic regression model, and was used to match the patients 1:4, yielding 715 ARB users versus 2,860 ACEI users. The effect of ARBs on in-hospital mortality and 12-month MACE occurrence was assessed using matched logistic and Cox regression models. Compared with ACEIs, ARBs significantly reduced in-hospital mortality(1.3% vs. 3.3%; hazard ratio [HR], 0.379; 95% confidence interval [CI], 0.190 to0.756; p = 0.006) and 12-month MACE occurrence (4.6% vs. 6.9%; HR, 0.661; 95% CI, 0.457 to 0.956; p = 0.028). However, the benefit of ARBs on 12-month mortality compared with ACEIs was marginal (4.3% vs. 6.2%; HR, 0.684; 95% CI, 0.467 to 1.002; p = 0.051). CONCLUSIONS: Our results suggest that ARBs are not inferior to, and may actually be better than ACEIs in Korean patients with AMI.
Angiotensin II Type 1 Receptor Blockers/adverse effects/*therapeutic use
;
Angiotensin-Converting Enzyme Inhibitors/adverse effects/*therapeutic use
;
Chi-Square Distribution
;
Hospital Mortality
;
Humans
;
Kaplan-Meier Estimate
;
Logistic Models
;
Multivariate Analysis
;
Myocardial Infarction/diagnosis/*drug therapy/mortality/physiopathology
;
Proportional Hazards Models
;
Prospective Studies
;
Recurrence
;
Registries
;
Republic of Korea
;
Risk Factors
;
Secondary Prevention/*methods
;
Stroke Volume
;
Time Factors
;
Treatment Outcome
;
Ventricular Function, Left

Result Analysis
Print
Save
E-mail