Establishment of Prospective Registry of Active Surveillance for Prostate Cancer: The Korean Urological Oncology Society Database

Jung Gyoohwan,Kim Jung Kwon,Jeon Seong Soo,Chung Jae Hoon,Kwak Cheol,Jeong Chang Wook,Ahn Hanjong,Joung Jae Young,Kwon Tae Gyun,Park Sung Woo,Byun Seok-Soo 대한남성과학회 2023 The World Journal of Men's Health Vol.41 No.1

Purpose: To establish a prospective registry for the active surveillance (AS) of prostate cancer (PC) using the Korean Urologi-cal Oncology Society (KUOS) database and to present interim analysis. Materials and Methods: The KUOS registry of AS for PC (KUOS-AS-PC) was organized in May 2019 and comprises multiple institutions nationwide. The eligibility criteria were as follows: patients with (1) pathologically proven PC; (2) pre-biopsy prostate-specific antigen (PSA) ≤20 ng/mL; (3) International Society of Urological Pathology (ISUP) grade 1 or 2 (no cribriform pattern 4); (4) clinical T stage ≤T2c; (5) positive core ratio ≤50%; and (6) maximal cancer involvement in the core ≤50%. Detailed longitudinal clinical information, including multi-parametric magnetic resonance imaging and disease-specific out-comes, was recorded. Results: From May 2019 to June 2021, 296 patients were enrolled, and 284 were analyzed. The mean±standard deviation (SD) age at enrollment was 68.7±8.2 years. The median follow-up period was 11.2 months (5.9–16.8 mo). Majority of pa-tients had pre-biopsy PSA ≤10 ng/mL (91.2%), PSA density <0.2 ng/mL2 (79.7%), ISUP grade group 1 (94.4%), single positive core (65.7%), maximal cancer involvement in the core ≤20% (78.1%), and clinical T stage of T1c or lower (72.9%). Fifty-two (18.3%) discontinued AS for various reasons. Interventions included radical prostatectomy (80.8%), transurethral prostatec-tomy (5.8%), primary androgen deprivation therapy (5.8%), radiation (5.8%), and focal therapy (1.9%). The mean±SD time to intervention was 8.9±5.2 months. The reasons for discontinuation included pathologic reclassification (59.6%), patient pref-erence (25.0%), and radiologic reclassification (9.6%). Two (4.8%) patients with pathologic Gleason score upgraded to ISUP grade group 4, no biochemical recurrence. Conclusions: The KUOS established a successful prospective database of PC patients undergoing AS in Korea, named the KUOS-AS-PC registry.

Data Management and Site-Visit Monitoring of the Multi-Center Registry in the Korean Neonatal Network

Choi, Chang Won,Park, Moon Sung The Korean Academy of Medical Sciences 2015 JOURNAL OF KOREAN MEDICAL SCIENCE Vol.30 No.suppl1

<P>The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated proof checks, electronic data validation, query creation, query resolution, and revalidation of the corrected data. SVM included SVM team organization, identification of unregistered cases, source document verification, and post-visit report production. By March 31, 2015, 4,063 VLBW infants were registered and 1,693 queries were produced. Of these, 1,629 queries were resolved and 64 queries remain unresolved. By November 28, 2014, 52 participating hospitals were visited, with 136 site-visits completed since April 2013. Each participating hospital was visited biannually. DM and SVM were performed to ensure the quality of the data collected for the KNN registry. Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers.</P>

요통에 대한 협진 레지스트리 임상연구: 예비 임상연구 프로토콜

김병준 ( Byung-jun Kim ),신병철 ( Byung-cheul Shin ),허인 ( In Heo ),임경태 ( Kyeong-tae Lim ),박인화 ( In Hwa Park ),황의형 ( Eui-hyoung Hwang ) 대한한의학회 한방재활의학과학회 2017 한방재활의학과학회지 Vol.27 No.3

Objectives Collaboration medicine means cooperate with western medicine and traditional korean medicine to treat the one disease. In Korea, Interest in collaboration medicine is increasing, But the number of studies is scare. Therefore we will conduct collaboration medicine study for the low back pain. Methods This study composes prospective cohort registry study. If the patients who need collaboration medicine by doctor come, we will ask regist this study. And patient select collaboration treatment group and single treatment group. Total 120 patients will recruit from collaboration pilot project hospitals. Each group patient will observed 4 weeks. Telephone research will conducted after 1 month from the last follow up. During the treatment, patients are treated usual treatment type of each medicine. Primary outcome is NRS and secondary outcomes are EQ-5D and ODI. We will analyze difference of 1 week and 4 week outcome result. Conclusions This study is the first large sample size study effect of collaboration medicine in Korea for low back pain. We check present collaboration system and improve collaboration system. Aim of this study is to find the effectiveness collaboration medicine for low back pain in the real condition. And we expect this pilot study will provide the clinical collaboration information and basis. (J Korean Med Rehabil 2017;27(3):117-124)

한국 소아 아나필락시스의 연구 현황과 과제

이수영 ( Sooyoung Lee ) 대한천식알레르기학회 2018 Allergy Asthma & Respiratory Disease Vol.6 No.S

Anaphylaxis is a serious, life-threatening hypersensitivity reaction that is rapid in onset and might cause death when not treated promptly. Recently, the prevalence of anaphylaxis has been increasing worldwide, especially in children, and food-induced anaphylaxis is rapidly increasing. With the establishment of the Korean Academy of Pediatric Allergy and Respiratory Disease in 1987, awareness of anaphylaxis has been heightened in Korea as well. Initially, it was considered a clinical form of food or drug hypersensitivity, but not a single disease entity. After the second symposium on anaphylaxis in 2006 and the World Allergy Organization guideline on anaphylaxis in 2011, research more focused on anaphylaxis is ongoing. The study of anaphylaxis in Korean children was initially restricted to case reports due to novel triggers. Thereafter, research on the age-specific prevalence of anaphylaxis was conducted using the national big data and more recently, a large-scale hospital-based multicenter study was conducted. Also, reliable data on food-induced anaphylaxis have been attained through a large-scale multicenter case study and a population-based epidemiological study on food allergy and currently, a prospective multicenter anaphylaxis registry has been launched funded by Korea Centers for Disease Control and Prevention. These series of studies have contributed to the international competitiveness in pediatric anaphylaxis research. However, there are still unmet needs such as diagnosis, severity, treatment or intervention of anaphylaxis, education for the prevention of recurrence, and establishment of policies for social safety. Further studies addressing these issues will contribute to improvement of quality of life and overcoming of the disease. (Allergy Asthma Respir Dis 2018;6 Suppl 1:S21-30)

Clinical safety and effectiveness of the Genoss drug-eluting stent in real-world clinical practice

( Young Jin Youn ),( Jun-won Lee ),( Sung Gyun Ahn ),( Seung-hwan Lee ),( Junghan Yoon ),( Jae Hyoung Park ),( Sang-yong Yoo ),( Woong Chol Kang ),( Nam Ho Lee ),( Ki Hwan Kwon ),( Joon Hyung Doh ),( 대한내과학회 2023 The Korean Journal of Internal Medicine Vol.38 No.5

Background/Aims: The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt-chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention. Methods: The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months. Results: A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%. Conclusions: In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.

Safety and Efficacy of a New Ultrathin Sirolimus-Eluting Stent with Abluminal Biodegradable Polymer in Real-World Practice

Young Jin Youn,Sang-Yong Yoo,Jun-Won Lee,Sung-Gyun Ahn,Seung-Hwan Lee,Junghan Yoon,Jae Hyoung Park,Woong Gil Choi,Sungsoo Cho,Sang-Wook Lim,Yang Soo Jang,Ki Hwan Kwon,이남호,Joon Hyung Doh,Woong Chol Kan 대한심장학회 2020 Korean Circulation Journal Vol.50 No.4

Background and Objectives: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent. Methods: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up. Results: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects. Conclusions: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.