• Title/Summary/Keyword: 진단 수요 분석

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A Study on the Establishment and Operation of a Regulatory Response Framework in connection with the Regulatory Strength of the Licensing Policy for New Medical Devices -Focusing on the Application of FMEA- (의료기기 신제품의 인허가정책 규제강도에 연계한 규제대응 프레임워크 수립 및 운영에 관한 연구 - FMEA 적용을 중심으로 -)

  • Kim, Gyosu;Ru, Gyuha;Kim, Yeonhee
    • Journal of Technology Innovation
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    • v.28 no.4
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    • pp.1-26
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    • 2020
  • Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

Evaluation of the usefulness of prone position for reducing the image distortion due to respiration in PET/CT (PET/CT 검사 시 호흡에 따른 영상 왜곡 감소를 위한 엎드린 자세의 유용성 평가)

  • Lee, Han Wool;Kim, Jung Yul;Choi, Yong Hoon;Lim, Han Sang;Kim, Jae Sam
    • The Korean Journal of Nuclear Medicine Technology
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    • v.23 no.1
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    • pp.59-63
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    • 2019
  • Purpose The motion due to respiration of patients undergoing PET/CT is a cause of artifacts in image and registration error between PET and CT images. The degree of displacement and distortion for tumor, which affects the measurement of Standard Uptake Value (SUV) and lesion volume, is especially higher for tumors that is small or located at the base of lungs. The purpose of this study was to evaluate the usefulness of prone position in the correction of image distortion due to respiration of patients in PET/CT. Materials and Methods The imaging equipment used in this study was PET/CT Discovery 600 (GE Healthcare, MI, USA). 20 patients whose lesions were identified in the middle and lower lungs from May to August 2018 were enrolled in this study. After acquiring whole body image in the supine position, additional images of the lesion area were obtained in the prone position with the same conditions. SUVmax, SUVmean, and volume of the lesion were measured for each image, and the displacement of the lesion on PET and CT images were measured, compared, and analyzed. Results The SUVmax, SUVmean, and volume, and displacement of the lesion were $4.72{\pm}2.04$, $3.10{\pm}1.38$, $4.68{\pm}3.20$, and $4.64{\pm}1.88$, respectively for image acquired in the supine position and $5.89{\pm}2.42$, $3.97{\pm}1.65$, $2.13{\pm}1.09$, and $2.24{\pm}0.84$, respectively for image acquired in the prone position, indicating that, for all the lesions imaged, SUVmax and SUVmean were higher and volume and displacement were smaller in the images acquired in prone position compared to those acquired in supine one(p<0.05). Conclusion These results showed that the prone position PET/CT imaging improves the quality of the image by increasing the SUV of the lesion and reducing the respiratory artifacts caused by registration error between PET and CT images. It is considered that the PET/CT imaging in the prone position is helpful in the diagnosis of the disease as an economical and efficient methods that correct registration error for the lesions in basal lung and reduce artifacts.

A Plan to Strengthen the Role of Citizens as Co-Creators of Smart City Services - Focused on the Development of Function Issue Card Technology - (스마트도시서비스 공동창의자로서의 시민 역할 강화 방안 - 기능카드 기법 개발을 중심으로 -)

  • JI, Sang-Tae;PARK, Jun-Ho;PARK, Joung-Woo;NAM, Kwang-Woo
    • Journal of the Korean Association of Geographic Information Studies
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    • v.24 no.2
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    • pp.1-11
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    • 2021
  • Lately, the Korean Government has gradually expanded participation by local residents who are users of the area in the smart city project for the construction of region specialization smart city service (hereinafter called "Smart Service") and the enhancement in the citizen's awareness. However, due to the lack of information on smart service-related technology, there has been a limitation in getting the specific opinion of citizens in the process of designing the Smart Service. In this study, reports made by 4 four local governments which were selected for implementation of 2019 "Smart Town Challenge Projects" were reviewed to diagnose the actualization level of the smart service suggested by citizens through the living lab. The analysis results show that though the smart service plan was established by using diverse design thinking methodology through the living lab, there was a limitation in having citizens design the specific functions of the smart service. So, this study suggests the function issue card technique which can be used by modulating and freely combining four elements such as information collection, processing, supplying method and technique of the smart service and the service contents. This function issue card technique was directly applied to the living lab of the smart city project to verify its effectiveness. It was found that through this technique, citizens can combine the functions and contents of the smart service to materialize smart services at the level of detailed functions. The function issue card technique suggested in this study is expected to contribute to the actualization of opinions for the role of citizens as co-creators in solving local problems in the citizen participation type smart city plan in the future, thus helping the design of the regional specialization smart service.

Differences in Cognitive and Psychological Characteristics of Psychiatric Patients with Military Service Issues versus General Psychiatric Outpatients (군 복무 적합성 평가를 위해 정신건강의학과에 내원한 환자군과 일반 외래 환자군의 인지적 및 심리적 특성의 차이)

  • Shim, Seungyun;Choi, Junho;Kim, Eunkyeong
    • Korean Journal of Psychosomatic Medicine
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    • v.28 no.2
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    • pp.143-154
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    • 2020
  • Objectives : The purpose of this study was to examine cognitive and psychological characteristics of patients with military service suitability issues compared to the general psychiatric outpatients. Methods : 108 patients who visited psychiatric clinic center due to military service suitability issues and 80 general psychiatric patients were recruited from the Department of Psychiatry of university hospital. ANCOVA and chi-equare test were used to examine differences between two groups. Furthermore, we utilized paired t-test to compare the scrore within military group depending on when they performed the psychological assessment. Results : There were no significant differences between military group and general outpatient group in WAIS-IV scores. However, military group scored remarkably higher than control group on validity scales, F-r and Fp-r whereas they scored lower on validity scale, K-r. Furthermore, military group showed significantly higher on BDI and MMPI-2-RF, EID, RCd, RC2, RC3, COG, HLP, SFD, NFC, STW, SAVE, SHY, DSF, NEGE-r, INTR-r. As a result of comparison within the military group following the periods of assessment, military group did not show the significant differences on the overall scales of MMPI-2-RF. Conclusions : The present study showed that military group tends to report their psychological distress more exaggeratedly. In addition, they had significantly elevated not only emotional distress such as depression and anxiety but interpersonal problem. The implications and limitations were discussed along with some suggestions for the future studies.

Effects for Growth and Chlorophyll in Old-barley and New-barley Seed exposed by X-ray (X-선이 묵은보리 씨앗과 햇보리 씨앗의 생장과 클로로필 농도에 미치는 영향)

  • Sang-Bok, Jeong;Sun-Cheol, Jeong;Mo-Kwon, Lee;Yun-Ho, Choi;Kang-Un, Byun;Su-Ah, Yu;Sang-Eun, Han;Jun-Beom, Heo;Wan-Sik, Shin;Won-Jeong, Lee
    • Journal of the Korean Society of Radiology
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    • v.17 no.1
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    • pp.149-156
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    • 2023
  • The purpose of this study is to compare of growth and chlorophyl between old-barley seed (OBS, 2019) and New-barley seed (NBS, 2020) exposed by X-ray. After germination the OBS and NBS, experimental group was exposed by 30 Gy X-ray using linear accelerator (Clinac IS, VERIAN, USA), by 6 MV X-ray, SSD 100 cm, 18 × 10 cm2, 600 MU/min. Length was measured every day until 9th day, and chlorophyl was analyzed using spectrophotometer(uv-1800, shimadzu, japan) after measuring weight in 9th day. Data analysis was performed the Independent T-test using SPSS ver 26.0(Chicago, IL, USA). NBS grow more faster than OBS in control group, but OBS grow more faster than NBS in experimental group. Length of control group was longer significantly every day than that of experimental group in OBS. NBS weighted more than OBS in control group, but OBS weighted more than NBS in experimental group. In comparing chlorophyl density, NBS high more than OBS in control group as well as experimental group. Growth and weight of OBS was effected more those than NBS by X-ray, but NBS in chlorophyl by X-ray. It is expected to be used as basic data for future X-ray research in barley seed.

A Review on Ocean Acidification and Factors Affecting It in Korean Waters (우리나라 주변 바다의 산성화 현황과 영향 요인 분석)

  • Kim, Tae-Wook;Kim, Dongseon;Park, Geun-Ha;Ko, Young Ho;Mo, Ahra
    • Journal of the Korean earth science society
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    • v.43 no.1
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    • pp.91-109
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    • 2022
  • The ocean is a significant sink for atmospheric anthropogenic CO2, absorbing one-third of the total CO2 emitted by human activities. In return, oceans have experienced significant declines in seawater pH and the aragonite saturation state also called ocean acidification. This study evaluates the distribution of aragonite saturation state, an indicator to assess the potential threat from ocean acidification, by combining newly obtained data from the west coast of South Korea with previous datasets covering the Yellow Sea, East Sea, northern South China Sea, and southeast coast of South Korea. In general, offshore waters absorb atmospheric CO2; however, most of the collected water samples show aragonite oversaturation. On the southeast coast, the aragonite saturation state was significantly affected by river discharge and associated variables, such as freshwater input with nutrients, seasonal stratification, biological carbon fixation, and bacterial remineralization. In summer, hypoxia and mixing with relatively acidic freshwater made the Jinhae and Gwangyang Bays undersaturated with respect to aragonite, possibly threatening marine organisms with CaCO3 shells. However, widespread aragonite undersaturation was not observed on the west coast, which receives considerable river water discharge. In addition, occasional upwelling events may have worsened the ocean acidification in the southwestern part of the East Sea. These results highlight the importance of investigating site-specific ocean acidification processes in coastal waters. Along with the above-mentioned seasonal factors, the dissolution of atmospheric CO2 and the deposition of atmospheric acidic substances will continue to reduce the aragonite saturation state in Korean waters. To protect marine ecosystems and resources, an ocean acidification monitoring program should be established for Korean waters.

Characteristics of the Factor Structure of the Child Behavior Checklist Dysregulation Profile for School-aged Children (학령기 아동의 CBCL 조절곤란프로파일(Child Behavior Checklist Dysregulation Profile)의 요인구조와 특성)

  • Kim, Eun-young;Ha, Eun-hye
    • Korean Journal of School Psychology
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    • v.17 no.1
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    • pp.17-38
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    • 2020
  • This study examined the factor structure of the Child Behavior Checklist Dysregulation Profile(CBCL-DP) for school-aged children in Korea identified differences in the level of maladjustment and problematic behaviors between the clinical group which had characteristics of CBCL-DP and the control group which did not. Confirmative factor analysis was performed on three alternative models from the literature to determine which was the most appropriate factor structure for the CBCL-DP. The result showed that the bi-factor model fit the sample data better than both the one and second-factor models. To confirm that the bi-factor model was the most appropriate factor structure, regression paths with relevant variables examined. The showed that CBCL-DP with the bi-factor model was associated with executive function difficulty as reported by parents and with school adjustment and all sub-factors of strength and difficulty as reported by teachers. The results also showed that this model had a different relationship with anxiety/depression, aggressive behavior, and attention problems than the other models. The clinical group was shown to have more executive function difficulty, worse adjustment of school life and to be less likely to engage in desired behaviors than the control group. These results indicate the CBCL-DP is more related to negative outcomes than any other factor, and that the bi-factor model was found to best fit the sample data, consistent with other studies. The early discovery of CBCL-DP can be used to provide interventions for high-risk children who exhibit emotional and behavioral problems, making its detection a significant diagnostic tool. The implications of these result, the limitations of this study, and areas for future research are discussed in this paper.

Origin and Source Appointment of Sedimentary Organic Matter in Marine Fish Cage Farms Using Carbon and Nitrogen Stable Isotopes (탄소 및 질소 안정동위원소를 활용한 어류 가두리 양식장 내 퇴적 유기물의 기원 및 기여도 평가)

  • Young-Shin Go;Dae-In Lee;Chung Sook Kim;Bo-Ram Sim;Hyung Chul Kim;Won-Chan Lee;Dong-Hun Lee
    • Korean Journal of Ecology and Environment
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    • v.55 no.2
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    • pp.99-110
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    • 2022
  • We investigated physicochemical properties and isotopic compositions of organic matter (δ13CTOC and δ 15NTN) in the old fish farming (OFF) site after the cessation of aquaculture farming. Based on this approach, our objective is to determine the organic matter origin and their relative contributions preserved at sediments of fish farming. Temporal and spatial distribution of particulate and sinking organic matter(OFF sites: 2.0 to 3.3 mg L-1 for particulate matter concentration, 18.8 to 246.6 g m-2 day-1 for sinking organic matter rate, control sites: 2.0 to 3.5 mg L-1 for particulate matter concentration, 25.5 to 129.4 g m-2 day-1 for sinking organic matter rate) between both sites showed significant difference along seasonal precipitations. In contrast to variations of δ13CTOC and δ15NTN values at water columns, these isotopic compositions (OFF sites: -21.5‰ to -20.4‰ for δ13 CTOC, 6.0‰ to 7.6‰ for δ15NTN, control sites: -21.6‰ to -21.0‰ for δ13CTOC, 6.6‰ to 8.0‰ for δ15NTN) investigated at sediments have distinctive isotopic patterns(p<0.05) for seawater-derived nitrogen sources, indicating the increased input of aquaculture-derived sources (e.g., fish fecal). With respect to past fish farming activities, representative sources(e.g., fish fecal and algae) between both sites showed significant difference (p<0.05), confirming predominant contribution (55.9±4.6%) of fish fecal within OFF sites. Thus, our results may determine specific controlling factor for sustainable use of fish farming sites by estimating the discriminative contributions of organic matter between both sites.

Treatment of Pyogenic Arthritis of the Knee Using Drainage Tube Insertion in the Posterior Compartment through the Posterior Transeptal Portal after an Arthroscopic Synovectomy (관절경적 활액막 절제술 후 후격막 삽입구를 통한 배액관의 후방 거치를 이용한 무릎의 화농성 관절염 치료)

  • Kim, Tae Ho;Yu, Chang Eon;Shin, Chung Shik
    • Journal of the Korean Orthopaedic Association
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    • v.54 no.3
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    • pp.269-275
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    • 2019
  • Purpose: This study analyzed the treatment effects of drain insertion in the posteromedial portal after an arthroscopic synovectomy and posterior septum resection for pyogenic arthritis. Materials and Methods: From June 2005 to December 2016, 56 cases (55 patients, 1 case of bilateral knee) were diagnosed with pyogenic arthritis and arthroscopic treatment was performed. Fourteen patients (25.0%) were identified with causative organisms. The average follow-up period was 12.3 months, and the mean age was 67.8 years old. Twenty-four cases were males and 31 cases were females. Kellgrene-Lawrence grade (K-L grade) I was 6 patients, II was 20 patients, III was 11 patients, and IV was 18 patients. Surgery was performed through six portal. The posterior septum was removed and a drainage tube was inserted from the posterior medial side to the posterior side of the joint. The Lysholm score was used after surgery for a functional evaluation. The K-L grade at the time of admission and at the last follow-up were compared for a radiological evaluation. Results: The mean normalization period of the C-reactive protein was 59.8 days (6-164 days). Intravenous antibiotics were used for an average of 37.1 days. The results of the functional evaluation revealed a mean Lysholm score of 64.5 (30-98) in a total of 56 cases. Two reoperations was performed, but the treatment was completed with same method in all patients. The K-L grade was similar at the time of surgery and at the last follow-up (p>0.05). Conclusion: The method of drain insertion in the posteromedial portal after arthroscopic synovectomy and posterior septum resection for pyogenic arthritis is an effective technique that can obtain satisfactory results by inducing proper exudate discharge.

The causative organisms of pediatric empyema in Korea (소아 농흉 원인균에 대한 다기관 연구(1999. 9-2004. 8))

  • Yum, Hye-yung;Kim, Woo Kyung;Kim, Jin Tak;Kim, Hyun Hee;Rha, Yeong Ho;Park, Yong Min;Sohn, Myung Hyun;Ahn, Kang Mo;Lee, Soo Young;Hong, Su Jong;Lee, Hae Ran
    • Clinical and Experimental Pediatrics
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    • v.50 no.1
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    • pp.33-39
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    • 2007
  • Purpose : In spite of medical advances, empyema is a serious complication of pneumonia in children. Vaccination practices and antibiotic prescribing practices promote the change of clinical manifestations of empyema and causative organisms. So we made a nationwide clinical observation of 122 cases of empyema in children from 32 hospitals during the 5 year period from September 1999 to August 2004. Methods : Demographic data, and clinical information on the course and management of empyema patients were collected retrospectively from medical records in secondary and tertiary hospitals in Korea. Results : One hundred twenty two patients were enrolled from 35 hospitals. The most frequent age group was 1-3 years, accounting for 48 percent of all cases. The male to female sex ratio was 1.2:1. The main symptoms were cough, fever, respiratory difficulty, lethargy and chest pain in order of frequency. Hematologic findings on admission revealed decreased hemoglobin levels ($10.4{\pm}1.6g/dL$) and increased leukocyte counts ($16,234.3{\pm}10,601.8/{\mu}L$). Pleural fluid obtained from patients showed high leukocyte counts ($30,365.8{\pm}64,073.0/{\mu}L$), high protein levels ($522.3{\pm}1582.3g/dL$), and low glucose levels ($88.1{\pm}523.5mg/dL$). Findings from pleural fluid cultures were positive in 80 cases(65.6 percent). The most common causative agent was Streptococcus pneumoniae. The majority of patients were treated with antibiotics and closed drainage. Some patients needed open drainage (16.4 percent) or decortication (3.3 percent). The mean duration of hospitalization was $28.6{\pm}15.3days$. Conclusion : We analyzed childhood empyema patients during a period of 5 years in Korean children. The most frequent age group was 1-3 years and the most common causative agent was Streptococcus pneumoniaeiae. The majority of patients were treated with antibiotics and close drainage.