• Title/Summary/Keyword: Multicenter clinical study

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Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial

  • Dong-Ju Choi;Jin Joo Park;Minjae Yoon;Sung-Ji Park;Sang-Ho Jo;Eung Ju Kim;Soo-Joong Kim;Sungyoung Lee
    • Korean Circulation Journal
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    • v.52 no.10
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    • pp.785-794
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    • 2022
  • Background and Objectives: Self-monitoring of blood pressure (SMBP) is a reliable method used to assess BP accurately. However, patients do not often know how to respond to the measured BP value. We developed a mobile application-based feed-back algorithm (SMBP-App) for tailored recommendations. In this study, we aim to evaluate whether SMBP-App is superior to SMBP alone in terms of BP reduction and drug adherence improvement in patients with hypertension. Methods: Self-Monitoring of blood pressure and Feed-back using APP in Treatment of UnconTrolled Hypertension (SMART-BP) is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App compared with SMBP alone. Patients with uncomplicated essential hypertension will be randomly assigned to the SMBP-App (90 patients) and SMBP alone (90 patients) groups. In the SMBP group, the patients will perform home BP measurement and receive the standard care, whereas in the SMBP-App group, the patients will receive additional recommendations from the application in response to the obtained BP value. Follow-up visits will be scheduled at 12 and 24 weeks after randomization. The primary endpoint of the study is the mean home systolic BP. The secondary endpoints include the drug adherence, the home diastolic BP, home and office BP. Conclusions: SMART-BP is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP-App. If we can confirm its efficacy, SMBP-App may be scaled-up to improve the treatment of hypertension.

Analysis of the Numeric Rating Scale (NRS) Used in Clinical Studies Based on Randomized Controlled Studies (임상연구에서 사용되고 있는 NRS에 대한 분석 : 무작위대조군연구를 중심으로)

  • Lee, Chan;Cho, Im-hak;Heo, Gi-yoon;Kang, Hee-kyung;Kim, Min-hwa;Han, Chang-woo;Kim, So-yeon;Choi, Jun-yong;Park, Seong-ha;Yun, Young-ju;Hong, Jin-woo;Kwon, Jung-nam;Lee, In
    • The Journal of Internal Korean Medicine
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    • v.42 no.4
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    • pp.510-531
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    • 2021
  • Objectives: The purpose of this study was to review the status of numeric rating scale (NRS) usage and suggest the potential for use in multicenter retrospective studies of various diseases. Methods: Articles published from 2011 to 2021 that used the keywords "NRS", "Multi-center", and "RCT" were identified in foreign databases, including EMBASE, PubMed, CENTRAL. The articles were analyzed according to their use of "NRS" by symptoms and by disease group using the major classifications of the Korean Standard Classification of Diseases (KCD-7). Results: Classification by symptom in a total of 288 articles illustrates that the NRS was not only commonly used in pain evaluation but also for non-pain symptoms. In usage with non-pain symptoms, chief complaint of patients was the most common at 79%, and other factors included treatment satisfaction, evaluation of daily life, and sleep quality. In disease classification according to the KCD-7, the NRS was commonly used in connection with musculoskeletal and connective tissue diseases but was also utilized in various other disease groups. Conclusions: This study confirms usage of the NRS in multi-center RCTs, as the NRS was widely used in all types of diseases and symptoms. Considering the result and the advantages of the NRS, it is recommended for use as a daily evaluation tool for the collection of common data in multicenter retrospective studies.

Optimal Duration of Dual Antiplatelet Therapy after Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial

  • Ban, Seung Pil;Kwon, O-Ki;Kim, Young Deok;Kim, Bum-Tae;Oh, Jae Sang;Kim, Kang Min;Kim, Chang Hyeun;Kim, Chang-Hyun;Choi, Jai Ho;Kim, Young Woo;Lim, Yong Cheol;Byoun, Hyoung Soo;Park, Sukh Que;Chung, Joonho;Park, Keun Young;Park, Jung Cheol;Kwon, Hyon-Jo;Korean NeuroEndovascular Society,
    • Journal of Korean Neurosurgical Society
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    • v.65 no.6
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    • pp.765-771
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    • 2022
  • Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

Clinical Experience with using a Rapid Infuse at an Urban Emergency Department (일개 응급센터에서 급속가압수액주입기의 사용경험)

  • Hong, Chong Kun;Song, Hyoung Gon
    • Journal of Trauma and Injury
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    • v.19 no.1
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    • pp.41-46
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    • 2006
  • Purpose: Hypovolemia is not uncommon among trauma patients in the emergency department (ED). Successful resuscitation of a hypovolemic patient often requires rapid intravenous administration of massive amounts of fluid. A rapid fluid infuser is used in the ED for this purpose, there have been no studies of their clinical uses and effectiveness. We studied clinical experience with a rapid fluid infuser at an urban university hospital in Seoul, Korea. Methods: We reviewed the medical records of 38 patients admitted to the ED with a history of application of a rapid fluid infuser from January 2004 to July 2005. Adult trauma patients older than 15 years of age were included in this study. Clinical data on the patients and the volume of fluid used to achieve a stable blood pressure were extracted from their medical records. Results: The total number of adult trauma patients with a history of application of a rapid fluid infuser from January 2004 to July 2005 in the ED was 16. The mean systolic blood pressure for deciding to apply the rapid fluid infuser was $74.9{\pm}12.7mmHg$. The mean time and volume used to achieve a stable blood pressure were 40.4 min and$2947.3{\pm}1339.2ml$, respectively. In all patients, the amount of fluid infused before using the rapid fluid infuser was between 500 ml and 10,000 ml, compared to 1,000 ml and 6,200 ml with the rapid fluid infuser. The mean amount of fluid per min. via the rapid fluid infuser was 85.5 ml. Vital signs were stabilized in 11 patients, 6 of the 11 were discharged alive. Conclusion: The mean amount of fluid delivered per min. via the rapid fluid infuser was much less than expected; thus, there should be clinical guidelines on volume resuscitation with a rapid fluid infuser in the ED. In the future, prospective, multicenter, clinical-data collection is needed for a more sophisticated study.

Characteristics, Management, and Clinical Outcomes of Patients with Hospital-Acquired and Ventilator-Associated Pneumonia: A Multicenter Cohort Study in Korea

  • Ko, Ryoung-Eun;Min, Kyung Hoon;Hong, Sang-Bum;Baek, Ae-Rin;Lee, Hyun-Kyung;Cho, Woo Hyun;Kim, Changhwan;Chang, Youjin;Lee, Sung-Soon;Oh, Jee Youn;Lee, Heung Bum;Bae, Soohyun;Moon, Jae Young;Yoo, Kwang Ha;Jeon, Kyeongman
    • Tuberculosis and Respiratory Diseases
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    • v.84 no.4
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    • pp.317-325
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    • 2021
  • Background: Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) are significant public health issues in the world, but the epidemiological data pertaining to HAP/VAP is limited in Korea. The objective of this study was to investigate the characteristics, management, and clinical outcomes of HAP/VAP in Korea. Methods: This study is a multicenter retrospective cohort study. In total, 206,372 adult patients, who were hospitalized at one of the 13 participating tertiary hospitals in Korea, were screened for eligibility during the six-month study period. Among them, we included patients who were diagnosed with HAP/VAP based on the Infectious Diseases Society of America (IDSA)/American Thoracic Society (ATS) definition for HAP/VAP. Results: Using the IDSA/ATS diagnostic criteria, 526 patients were identified as HAP/VAP patients. Among them, 27.9% were diagnosed at the intensive care unit (ICU). The cohort of patients had a median age of 71.0 (range from 62.0 to 79.0) years. Most of the patients had a high risk of aspiration (63.3%). The pathogen involved was identified in 211 patients (40.1%). Furthermore, multidrug resistant (MDR) pathogens were isolated in 138 patients; the most common MDR pathogen was Acinetobacter baumannii. During hospitalization, 107 patients with HAP (28.2%) had to be admitted to the ICU for additional care. The hospital mortality rate was 28.1% in the cohort of this study. Among the 378 patients who survived, 54.2% were discharged and sent back home, while 45.8% were transferred to other hospitals or facilities. Conclusion: This study found that the prevalence of HAP/VAP in adult hospitalized patients in Korea was 2.54/1,000 patients. In tertiary hospitals in Korea, patients with HAP/VAP were elderly and had a risk of aspiration, so they were often referred to step-down centers.

The Toxic Exposure Patients of Daejon Province by Modified TESS Style (TESS 보고 양식을 활용한 대전 지역의 중독 양상)

  • Park Jung Kyoo;Jeong Sung Phil;Kim Seung Hwan;Yoo In Sui;Park Joon Seok;Yoo Jin Hyun;Yang Yeong Mo;Jeong Si Kyung
    • Journal of The Korean Society of Clinical Toxicology
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    • v.2 no.1
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    • pp.1-6
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    • 2004
  • Purpose: A number of reports about the intoxicated patients have been introduced, but there were few multicenter studies. The purpose of this study was to analyse the patients with toxic exposure in the Daejon province. Methods: The patients who were presented to the four academic emergency departments in Daejon with toxic exposure were enrolled from January to June 2003. The collected variables were according to the form which modified from the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers. Results: The toxic exposure patients were 362 cases which is $0.78\%$ of total patients presented to the emergency department. The most common exposure site was home ($84\%$). Eighteen percent of cases were exposed by two or more substances. The most common substance was the pesticides ($34.8\%$), and the non-prescription drugs ($32.6\%$) was followed. The suicidal attempt was the top reason for exposure ($67.1\%$). The route of exposure other than ingestion was $3.6\%$. Although the most patients left the hospital within a day, the average treatment period was 4.4 days. Thirty-one patients ($8.6\%$) were expired, and 22 among them were exposed to the paraquat. Conclusion: We reported the current status of toxic exposure in Daejon province by modified TESS style.

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Endoscopic mucosal resection using anchored snare Tip-in versus precut technique for small rectal neuroendocrine tumors

  • Seung Wook Hong;Dong-Hoon Yang;Yoo Jin Lee;Dong Hoon Baek;Jaeyoung Chun;Hyun Gun Kim;Sung Joo Kim;Seung-Mo Hong;Dae-Seong Myung
    • The Korean journal of internal medicine
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    • v.39 no.2
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    • pp.238-247
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    • 2024
  • Background/Aims: Small rectal neuroendocrine tumors (NETs) can be treated with modified endoscopic mucosal resection (EMR). However, an optimal EMR method remains to be established. We aimed to assess the non-inferiority of Tip-in EMR versus precut EMR (EMR-P) for treating rectal NETs. Methods: This prospective, multicenter, randomized controlled trial enrolled patients with rectal NETs of < 10 mm in diameter. The patients were randomly assigned to EMR-P and Tip-in EMR groups in a 1:1 ratio. Primary outcome was margin-negative (R0) resection rate between the two methods, with a noninferiority margin of 10%. Results: Seventy-five NETs in 73 patients, including 64 eligible lesions (32 lesions in each, EMR-P and Tip-in EMR groups), were evaluated. In a modified intention-to-treat analysis, R0 resection rates of the EMR-P and Tip-in EMR groups were 96.9% and 90.6%, respectively, which did not demonstrate non-inferiority (risk difference, -6.3 [95% confidence interval: -18.0 to 5.5]). Resection time in the EMR-P group was longer than that in the Tip-in EMR group (p < 0.001). One case of intraprocedural bleeding was reported in each group. Conclusions: We did not demonstrate the non-inferiority of Tip-in EMR compared to EMR-P for treating small rectal NETs. However, the R0 resection rates for both techniques were high enough for clinical application.

Factors Associated with Gastric and Duodenal Neuroendocrine Tumor Development

  • Kwangwoo Nam;Su Youn Nam
    • Journal of Digestive Cancer Research
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    • v.12 no.1
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    • pp.1-5
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    • 2024
  • The incidence and prevalence of upper gastrointestinal neuroendocrine tumors (NETs), including gastric NETs (GNETs) and duodenal NETs (DNETs), have been gradually increasing. These trends may be associated with the increased use of health checkups, which includes upper endoscopy, in conjunction with better disease recognition. However, the clinical factors associated with GNETs and DNETs remain unknown; previous studies revealed discrepancies. Recently, metabolic disorders have been indicated as potential factors that are associated with GNETs and DNETs. This review summarizes the results of previous studies and briefly introduces the results of a recent Korean multicenter study on the factors associated with GNETs and DNETs.

Characteristics of Upper Gastrointestinal Tract Involvement in Korean Pediatric Crohn's Disease: A Multicenter Study

  • Park, Ji Hyoung;Nam, Hye Na;Lee, Ji-Hyuk;Hong, Jeana;Yi, Dae Yong;Ryoo, Eell;Jeon, In Sang;Tchah, Hann
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.20 no.4
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    • pp.227-235
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    • 2017
  • Purpose: Crohn's disease (CD) can involve any site of the gastrointestinal tract (GIT). However, the characteristics of upper GIT involvement in CD are unclear, especially in the Eastern pediatric population. This study aimed to estimate the prevalence of upper GIT involvement and identify the clinical features of Korean children with CD. Methods: This was a retrospective multicenter cohort study that included 52 pediatric patients with CD who underwent esophagogastroduodenoscopy and biopsy. The clinical symptoms and endoscopic and histologic features of the upper GIT were identified according to the presence or absence of upper gastrointestinal symptoms. Results: Among the 52 patients, upper GIT involvement was noted in 50.0% (26/52). The mean age at CD diagnosis was $14.1{\pm}2.1$ years. Gastric ulcer was the most common lesion (19.2%) found on upper GIT endoscopy, followed by duodenal ulcers (15.4%). Chronic inflammation was the most common histopathologic feature (75.0%), followed by gastric erosion (17.3%). Granuloma was found in 9.6% of patients. Helicobacter pylori infection was identified in 5.8% of patients. Endoscopic and histologic findings were not significantly different, but the mean values of erythrocyte sedimentation rate ($60.7{\pm}27.1$ vs. $43.0{\pm}27.6mm/h$, p=0.037) and C-reactive protein ($16.5{\pm}28.2$ vs. $6.62{\pm}13.4mg/dL$, p=0.014) were significantly different between patients with and without upper gastrointestinal CD symptoms. Conclusion: Upper GIT involvement was relatively common in pediatric patients with CD irrespective of upper gastrointestinal symptoms, and H. pylori infection was relatively uncommon. The results of this study should aid the establishment of regional guidelines for upper GIT examination.

Clinical Characteristics of Ureteral Duplication in Children

  • Park, Min Ji;Baek, Hee Sun;Jang, Hae Min;Lee, Jun Nyung;Chung, Sung Kwang;Jeong, Shin Young;Lee, So Mi;Cho, Min Hyun
    • Childhood Kidney Diseases
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    • v.23 no.2
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    • pp.100-104
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    • 2019
  • Purpose: Ureteral duplication is a relatively common congenital urinary tract abnormality that can be associated with various clinical problems such as vesicoureteral reflux (VUR), hydronephrosis, and ectopic ureters. The purpose of this study was to analyze the clinical characteristics of pediatric patients with recently diagnosed ureteral duplication and to identify any differences from those described in previous reports. Methods: We retrospectively reviewed the clinical characteristics and course of pediatric patients who were diagnosed with ureteral duplication between January 2008 and June 2017. Results: A total of 32 pediatric patients were diagnosed with ureteral duplication during the study period. The male to female ratio was 1:2.2. Twenty-seven patients (84.4%) were first diagnosed with ureteral duplication at less than 3 months of age, and 26 (81.3%) were first diagnosed by prenatal ultrasonography. Four of the 32 patients were diagnosed with bilateral ureteral duplication, for a total of 36 occurrences of ureteral duplication. In 17 occurrences of complete ureteral duplication (47.2%), other urinary tract anomalies were also found; namely, ureterocele (7), VUR (11), and ectopic ureter (5). However, none of the patients with incomplete ureteral duplication had ureterocele or VUR. Conclusions: With the advent of routine prenatal ultrasound, ureteral duplication is being diagnosed earlier than was previously possible, enabling timely treatment of the various accompanying urinary tract anomalies. Multicenter studies are needed to establish guidelines for standardized evaluation and treatment of ureteral duplication.