• Title/Summary/Keyword: Multicenter study

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Epidemiology and Outcomes of Traumatic Brain Injury in Elderly Population : A Multicenter Analysis Using Korean Neuro-Trauma Data Bank System 2010-2014

  • Eom, Ki Seong
    • Journal of Korean Neurosurgical Society
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    • v.62 no.2
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    • pp.243-255
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    • 2019
  • Objective : Although traumatic brain injury (TBI) occurs in people of all age groups, the elderly population is at a particular risk. The proportion of elderly population in the society is markedly increasing and Korea is one of the most rapidly aging societies. Here, we analyzed the data from 904 patients older over 65 years who were registered in the Korean Neuro-Trauma Data Bank System (KNTDBS). Methods : The Korean Society of Neurotraumatology recorded data from 20 institutions between September 2010 and March 2014. This retrospective study examined the clinical epidemiology, sex difference, outcome epidemiology, sociodemographic variables, and outcomes in the geriatric population related to TBI based on data from the KNTDBS. Results : The study included 540 men and 364 women. The age distributions in the male and female groups were statistically significantly different. The most common cause of trauma was a fall and diagnosis was acute subdural hematoma. The incidence was the highest in men aged 80-84 years and in women aged 75-79 years. The most common time of arrival to hospital after TBI was within 1 hour and 119 rescue team provided first aid earliest to patients with TBI. The mortality rate stratified according to the cause of trauma was significantly different, with mortality rates of 3.77% in fall and 11.65% in traffic accident. The mortality rates according the severity of brain injury, Glasgow Coma Scale score, and treatment were statistically significant. Conclusion : To our knowledge, this study is the first to focus on elderly patients with TBI in Korea and particularly investigate mortality and characteristics related to TBI-related death based on data from the KNTDBS. Although the study has some limitations, our results may be used to obtain useful information to study targeted prevention and more effective treatment options for older TBI patients and establish novel treatment guidelines and health polish for the geriatric population.

Safety and efficacy of early corticosteroid withdrawal in liver transplant recipients: A randomized controlled trial

  • Jongman Kim;Jae-Won Joh;Kwang-Woong Lee;Dong Lak Choi;Hee-Jung Wang
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.28 no.2
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    • pp.238-247
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    • 2024
  • Backgrounds/Aims: Prolonged use of steroids after liver transplantation (LT) significantly increases the risk of diabetes or cardiovascular disease, which can adversely affect patient outcomes. Our study evaluated the effectiveness and safety of early steroid withdrawal within the first year following LT. Methods: This study was conducted as an open-label, multicenter, randomized controlled trial. Liver transplant recipients were randomly assigned to one of the following two groups: Group 1, in which steroids were withdrawn two weeks posttransplantation, and Group 2, in which steroids were withdrawn three months posttransplantation. This study included participants aged 20 to 70 years who were scheduled to undergo a single-organ liver transplant from a living or deceased donor at one of the four participating centers. Results: Between November 2012 and August 2020, 115 patients were selected and randomized into two groups, with 60 in Group 1 and 55 in Group 2. The incidence of new-onset diabetes after transplantation (NODAT) was notably higher in Group 1 (32.4%) than in Group 2 (10.0%) in the per-protocol set. Although biopsy-proven acute rejection, graft failure, and mortality did not occur, the median tacrolimus trough level/dose/weight in Group 1 exceeded that in Group 2. No significant differences in safety parameters, such as infection and recurrence of hepatocellular carcinoma, were observed between the two groups. Conclusions: The present study did not find a significant reduction in the incidence of NODAT in the early steroid withdrawal group. Our study suggests that steroid withdrawal three months posttransplantation is a standard and safe immunosuppressive strategy for LT patients.

Study on the Current Utilization and the Reason of Ceasing Korean Medicine Treatment among Children with Cerebral Palsy (뇌성마비 아동의 한방치료 이용실태와 중단원인 연구)

  • Park, Byungwook;Park, Yohan;Yu, Sunae;Hur, Youngjin;Kim, Sungchul;Yun, Youngju
    • Journal of Society of Preventive Korean Medicine
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    • v.20 no.1
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    • pp.89-97
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    • 2016
  • Objectives : The purpose of this study was to investigate the real status of the utilization of Korean medicine (KM) treatment among children with cerebral palsy (CP). Methods : In a prospective observational multicenter study for children with CP aged from 6 months to 78 months, we analyzed 69 questionnaires of children currently receiving or have received KM treatment such as acupuncture and Korean herbal medicine for CP. Results : Of all the 170 participants, 32 children was currently getting KM treatment and they were getting acupuncture therapy 2.5 times per week on average. The mean expenditure per month for acupuncture and herbal medicine was respectively 32,000won and 501,000won. 37 children have discontinued KM treatment. The most frequent reason for quitting acupuncture therapy was 'inconvenience' (40.7%), followed by 'suffering of children' (33.3%). The average duration of taking Korean herbal medicine was 3.78 months and the highest reason of stopping medicine was 'rejection of children' (32.3%), followed by the 'cost burden' (22.6%). 75% of currently KM using group answered they have experienced positive effect of KM and the rate was 48.6% among the group who have ceased KM. There was a significant difference between the two groups(p=0.025). Conclusions : Further study will be required to increase the therapeutic effect and utilization of KM among the children with CP. More efforts should be made to develop less invasive acupuncture method and various shape of KM herbal medicine and to expand the insurance coverage of KM for children with CP.

Flumazenil administration in suspected patients with acute hypnotics and sedatives poisoning: risk-benefit re-evaluation (급성 진정제 중독 추정 환자에서 플루마제닐의 투여: 위험도/이익 재평가)

  • Huh, Jae Hong;Choi, Sang Chun;Lim, Yong Gyun;Lampotang, Samsun;Park, Eung Jung
    • Journal of The Korean Society of Clinical Toxicology
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    • v.14 no.2
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    • pp.92-99
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    • 2016
  • Purpose: The use of flumazenil administration in the emergency department is still controversial because of concerns about adverse effects. The present study was conducted to re-evaluate the risk-benefit ratio associated with flumazenil administration to patients suspected of having acute hypnotics and sedatives poisoning in the emergency department. Methods: A retrospective chart review study was conducted for patients whose final diagnoses were "poisoning" and "benzodiazepine" or "sedatives-hypnotics" from Mar. 2006 to Feb. 2015. The basal characteristics of the patients, including past medical history, ingredients and dose of ingested drug and co-ingested drugs were investigated. For patients administered flumazenil, responsiveness and time from admission to flumazenil administration were investigated with supplement. All collected data were analyzed in aspect terms of risk/benefit. Results: A total of 678 patients were included in our study. Benzodiazepine was the most common sedative/hypnotic drug prescribed, and the frequency of prescription continuously increased. The proportion of TCA as co-ingestion decreased from 13.1% to 3.9% in patients with acute sedative/hypnotic poisoning. Flumazenil was administered to 55 patients (8.1%), of which 29 patients (52.7%) were applied to contraindications. Fifty-three patients (96.4%) showed positive responsiveness, including partial responsiveness after flumazenil administration. No severe adverse events were identified. Conclusion: Based on the current trends in prescription patterns for sedative/hypnotic drugs, increased use of non-TCA antidepressants, and responsiveness to administration of flumazenil, benefit seemed weighted more in this study, although the observed benefits were based on limited results. Further prospective multicenter studies will be needed to optimize benefit-risk ratio.

Analysis of maxillofacial prosthetics at university dental hospitals in the capital region of Korea

  • Kim, Jee-Hwan;Shin, Soo-Yeon;Paek, Janghyun;Lee, Jong-Ho;Kwon, Ho-Beom
    • The Journal of Advanced Prosthodontics
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    • v.8 no.3
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    • pp.229-234
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    • 2016
  • PURPOSE. The purpose of this study was to investigate the demographic patterns of maxillofacial prosthetic treatment to identify the characteristics and geographic distribution of patients with maxillofacial prosthetics in the capital region of Korea. MATERIALS AND METHODS. This retrospective analytical multicenter study was performed by chart reviews. This study included patients who visited the department of prosthodontics at four university dental hospitals for maxillofacial prosthetic rehabilitation. Patients with facial and congenital defects or with insufficient medical data were excluded. The patients were classified into three categories based on the location of the defect. Patients' sex, age, and residential area were analyzed. Pearson's chi-square test with a significance level of 0.05 was used to analyze the variables. RESULTS. Among 540 patients with maxillofacial prosthetics, there were 284 (52.59%) male patients and 256 (47.41%) female patients. The number of the patients varied greatly by hospital. Most patients were older than 70, and the most common defect was a hard palate defect. Chi-square analysis did not identify any significant differences in sex, age, and distance to hospital for any defect group (P>.05). CONCLUSION. The results of this study indicated that there was imbalance in the distribution of patients with maxillofacial prosthetic among the hospitals in the capital region of Korea. Considerations on specialists and insurance policies for the improvement of maxillofacial prosthetics in Korea are required.

Temozolomide during and after Radiotherapy for Newly Diagnosed Glioblastomas : A Prospective Multicenter Study of Korean Patients

  • Joo, Jin-Deok;Chang, Jong-Hee;Kim, Jeong-Hoon;Hong, Yong-Kil;Kim, Young-Hoon;Kim, Chae-Yong
    • Journal of Korean Neurosurgical Society
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    • v.52 no.2
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    • pp.92-97
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    • 2012
  • Objective : This study was performed to determine the safety and outcome of concurrent chemoradiotherapy (CCRT) and adjuvant chemotherapy with temozolomide for Korean patients with a newly diagnosed glioblastoma. Methods : Patients were recruited from four institutions between 2004 and 2007. The patients received fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week for 6 weeks and daily temozolomide, followed by 6 cycles of adjuvant temozolomide. The primary endpoint was overall survival (OS) and the secondary endpoints were progression-free survival (PFS), response, and safety. Results : A total of 103 patients were enrolled in this study. Ninety-six patients (93%) completed the CCRT and 54 patients (52%) received 6 cycles of adjuvant temozolomide. The response rate was 73% (53/73) and the tumor control rate was 92% (67/73). Of the 96 patients who completed the CCRT, the median OS was 18.0 months and the 1- and 2-year OS rates were 74 and 38%, respectively. The median PFS was 10.0 months and the 1- and 2-year PFS rates were 33 and 16%, respectively. The only significant prognostic factor of survival was the extent of surgical resection (p<0.05). CCRT resulted in grade 3 or 4 hematologic toxic effects in 8% of patients. No opportunistic infections were noted. Conclusion : This study is the first prospective multi-institutional report of CCRT and adjuvant chemotherapy with temozolomide for patients with a newly diagnosed glioblastoma in Korea. The current protocol may prolong the survival of Korean patients with a glioblastoma and may be tolerable in terms of toxicity.

Nutritional education for management of osteodystrophy (NEMO) trial: Design and patient characteristics, Lebanon

  • Karavetian, Mirey;Abboud, Saade;Elzein, Hafez;Haydar, Sarah;de Vries, Nanne
    • Nutrition Research and Practice
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    • v.8 no.1
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    • pp.103-111
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    • 2014
  • This study aims to determine the effect of a trained dedicated dietitian on clinical outcomes among Lebanese hemodialysis (HD) patients: and thus demonstrate a viable developing country model. This paper describes the study protocol and baseline data. The study was a multicenter randomized controlled trial with parallel-group design involving 12 HD units: assigned to cluster A (n = 6) or B (n = 6). A total of 570 patients met the inclusion criteria. Patients in cluster A were randomly assigned as per dialysis shift to the following: Dedicated Dietitian (DD) (n = 133) and Existing Practice (EP) (n = 138) protocols. Cluster B patients (n = 299) received Trained Hospital Dietitian (THD) protocol. Dietitians of the DD and THD groups were trained by the research team on Kidney Disease Outcomes Quality Initiative nutrition guidelines. DD protocol included: individualized nutrition education for 2 hours/month/HD patient for 6 months focusing on renal osteodystrophy and using the Trans-theoretical theory for behavioral change. EP protocol included nutrition education given to patients by hospital dietitians who were blinded to the study. The THD protocol included nutrition education to patients given by hospital dietitian as per the training received but within hospital responsibilities, with no set educational protocol or tools. Baseline data revealed that 40% of patients were hyperphosphatemics (> 5.5 mg/dl) with low dietary adherence and knowledge of dietary P restriction in addition to inadequate daily protein intake ($58.86%{\pm}33.87%$ of needs) yet adequate dietary P intake ($795.52{\pm}366.94$ mg/day). Quality of life (QOL) ranged from 48-75% of full health. Baseline differences between the 3 groups revealed significant differences in serum P, malnutrition status, adherence to diet and P chelators and in 2 factors of the QOL: physical and social functioning. The data show room for improvement in the nutritional status of the patients. The NEMO trial may be able to demonstrate a better nutritional management of HD patients.

Analysis of Korean Medicine Treatment in Children with Cerebral Palsy (뇌성마비 아동의 한의치료 양상 분석)

  • Jeong, Hyunwoo;Hur, Youngjin;Yun, Youngju
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.12-23
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    • 2019
  • Objectives: The purpose of this study was to analyze the aspects of the Korean medicine (KM) treatment among children with cerebral palsy (CP) according to the disease characteristics. Methods: In a prospective observational multicenter study for children with CP, we analyzed 78 baseline questionnaires of children having experience of KM treatments such as acupuncture and Korean herbal medicine and 43 follow-up data of children who have received KM during the one observation year. Results: Of all the 182 participants, 38 children were currently getting KM treatment and 40 children have discontinued KM treatment. Children with non-spastic CP and more health problems tended to use KM. The most frequent reason for quitting acupuncture therapy was 'suffering of children' and the highest reason of stopping herbal medicine was 'rejection of children'. Among the 133 participants finished one year follow-up, 43 children have received at least one KM treatment. The average number of acupuncture therapy was twice a week and the average monthly cost of acupuncture therapy and herbal medicine were 65,922 won and 476,003 won, respectively. Children under 32 month old have received significantly more acupuncture and children with non-spastic CP have taken significantly more herbal medicine. Conclusions: Further study will be required to confirm the effectiveness of KM and increase the utilization of KM among the children with CP. More efforts should be made to increase the convenience of acupuncture therapy and herbal medicine and to expand the insurance coverage of KM for children with CP.

An analysis of patients referred to the advanced general hospital pain clinic center: multicenter study in province of Jeollabuk-do, Korea (3차 병원 통증 클리닉에 의뢰되어 오는 환자들의 특성 분석: 전라북도 지역의 다기관 연구)

  • Kim, Yeon-dong;Lee, Cheolhyeong
    • Journal of the Korea Convergence Society
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    • v.12 no.2
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    • pp.311-316
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    • 2021
  • The number of patients referred to pain clinic is increasing. The purpose of this study was to describe and understand characteristic of patients referred to the tertiary pain clinic. This study was conducted on 587 patients who had been referred to pain clinics at three university hospitals in the Jeollabuk-do region from January 2011 to December 2015. The data was retrospectively collected on a record sheet prepared in the clinic. we analyzed these patients according to their age, sex, chief complaint, pain location, coexisting disease, referring department, referral causes. There were various medical problems addressed by a pain clinic consultation. It is reasonable to develop standardized guidelines for pain management. To do so, it is necessary to identify the characteristics of the patients. A study with more patients in another area will be helpful in characterizing the patients referred to the pain clinic in Korea.

The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.