• 제목/요약/키워드: grading assessment

검색결과 181건 처리시간 0.028초

국내 동물용 의료기기 관리실태 평가 및 개선방안 연구 (Performance assessment and improvement plan of the regulatory management system of veterinary medical devices in Korea)

  • 안효진;윤향진;김충현;위성환;문진산
    • 대한수의학회지
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    • 제55권2호
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    • pp.97-103
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    • 2015
  • In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

Short-course Versus Long-course Preoperative Radiotherapy plus Delayed Surgery in the Treatment of Rectal Cancer: a Meta-analysis

  • Liu, Shi-Xin;Zhou, Zhi-Rui;Chen, Ling-Xiao;Yang, Yong-Jing;Hu, Zhi-De;Zhang, Tian-Song
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권14호
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    • pp.5755-5762
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    • 2015
  • Background: Short-course preoperative radiation (SCRT) with delayed surgery was found to increase pathologic complete response (pCR) rates in several trials. However, there was no clear answer on whether SCRT or long-course chemo-radiotherapy (LCRT) is more effective. Therefore we conducted this meta-analysis to evaluate the safety and efficacy of SCRT versus LCRT, both with delayed surgery, for treatment of rectal cancer. Materials and Methods: The literature was searched from PubMed, EMBASE, Web of Science, Cochrane Library and clinicaltrials.gov up to November, 2014. Quality of the randomized controlled trials (RCTs) was evaluated according to the Cochrane's risk of bias tool of RCT. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to rate the level of evidence. Review Manager 5.3 was employed for statistical analysis. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. Results: Three RCTs, with a total of 357 rectal cancer patients, were included in this systematic review. Metaanalysis results demonstrated there were no significantly differences in sphincter preservation rate, local recurrence rate, grade 3~4 acute toxicity, R0 resection rate and downstaging rate. Compared with SCRT, LCRT was associated with significant increase in the pCR rate [RR=0.49, 95%CI (0.31, 0.78), P=0.003]. Conclusions: In terms of sphincter preservation rate, local recurrence rate, grade 3~4 acute toxicity, R0 resection rate and downstaging rate, SCRT with delayed surgery is as effective as LCRT with delayed surgery for management of rectal cancer. LCRT significantly increased pCR rate compared with SCRT. Due to risk of bias and imprecision, further multi-center large sample RCTs were needed to confirm this conclusion.

Gemcitabine Alone or in Combination with Cisplatin for Advanced Biliary Tract Carcinomas: an Overview of Clinical Evidence

  • Sun, Tian-Tian;Wang, Ji-Lin;Fang, Jing-Yuan
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권2호
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    • pp.877-883
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    • 2013
  • Background and Objective: There has been no universally agreed standard chemotherapy regimen for patients with advanced biliary tract carcinomas (BTC). We aimed to fully display and evaluate the clinical evidence for gemcitabine or gemcitabine-cisplatin combination for advanced BTC. Methods: Systematic searches were performed to identify relevant randomized controlled trials (RCTs) and uncontrolled trials. Overall survival (OS), progression-free survival (PFS), overall response rates (ORR), tumor control rates (TCR), and toxicity were evaluated. Evidence levels of the results were evaluated with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Results of the eleven gemcitabine-cisplatin trials and ten gemcitabine trials showed both chemotherapy regimens had benefits with reference to mean OS (8.63 vs. 8.79 months), mean PFS (4.86 vs. 4.72 months), pooled ORR (25.3% vs. 19.6%) and TCR (55.2% vs. 53.1%). Two RCTs showed the gemcitabine-cisplatin combination to prolong the mean PFS (mean difference [MD] 2.57, 95%CI 1.69 3.45), substantially increasing the mean OS (MD 3.59, 95% CI 3.48 3.71), and producing a similar effect in ORR (risk ratio [RR] 1.59, 95%CI 1.04 2.43), increasing TCR (RR 1.15, 95%CI 1.02 1.31) compared with gemcitabine alone, with generally manageable grade 3 or 4 adverse events. The evidence level of OS was moderate, and other outcomes (ORR, PFS, TCR, anaemia, neutropenia) were at low evidence levels. Conclusion: Available evidence was limited with low quality, which showed that both gemcitabine-cisplatin and gemcitabine alone had clinical activity with acceptable safety profiles, and gemcitabine-cisplatin appeared to be more useful for advanced BTC patients than gemcitabine alone.

SNS의 교육적 활용 방법에 대한 대학생들의 인식 분석 (An Analysis of the Awareness of Undergraduate Students Toward Educational Methods Utilizing SNS)

  • 정미현;김영록;김재현
    • 인터넷정보학회논문지
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    • 제15권5호
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    • pp.33-41
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    • 2014
  • 본 연구는 효과적인 SNS의 교육적 활용 방안을 제안하고자 SNS의 사용률이 높은 대학생들을 대상으로 구체적인 SNS의 교육적 활용 방법에 대한 의견과 그 이유에 대해 조사하였다. NVivo S/W를 이용하여 개방형 응답을 분석하였으며, 교육 주체별 SNS의 교육적 활용 방법을 가시화 하고자 교수자 영역과 학습자 영역, 공통 영역으로 범주화 하였다. 그 결과 공통 영역에는 의견 교류 및 토론, 정보 공유, 학습내용에 대한 질의응답, 설문조사, 친밀감 형성, 상담 등이 포함되었으며, 교수자 영역에는 공지사항 전달, 수업자료 제공, 실시간 평가(퀴즈), 출석 체크, 과제평가 및 피드백 등이 포함되었고, 학습자 영역에는 과제활동(그룹별/개인별), 공유자료를 이용한 예습 및 복습, 동영상을 이용한 자율학습, 과제에 대한 동료평가 및 피드백, 강의 평가 등이 포함되었다.

현 기후예측시스템에서의 기온과 강수 계절 확률 예측 신뢰도 평가 (Reliability Assessment of Temperature and Precipitation Seasonal Probability in Current Climate Prediction Systems)

  • 현유경;박진경;이조한;임소민;허솔잎;함현준;이상민;지희숙;김윤재
    • 대기
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    • 제30권2호
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    • pp.141-154
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    • 2020
  • Seasonal forecast is growing in demand, as it provides valuable information for decision making and potential to reduce impact on weather events. This study examines how operational climate prediction systems can be reliable, producing the probability forecast in seasonal scale. A reliability diagram was used, which is a tool for the reliability by comparing probabilities with the corresponding observed frequency. It is proposed for a method grading scales of 1-5 based on the reliability diagram to quantify the reliability. Probabilities are derived from ensemble members using hindcast data. The analysis is focused on skill for 2 m temperature and precipitation from climate prediction systems in KMA, UKMO, and ECMWF, NCEP and JMA. Five categorizations are found depending on variables, seasons and regions. The probability forecast for 2 m temperature can be relied on while that for precipitation is reliable only in few regions. The probabilistic skill in KMA and UKMO is comparable with ECMWF, and the reliabilities tend to increase as the ensemble size and hindcast period increasing.

국내 한약 치험례 분석을 통한 한의학적 여드름 치료법에 대한 고찰 (A Review on Acne Treatment in Korean Medicine by Analyzing Case Studies with Herbal Medicine Treatment)

  • 조은채;김규석
    • 한방안이비인후피부과학회지
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    • 제31권4호
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    • pp.65-82
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    • 2018
  • Objectives : The purpose of this study is 1) to explore the general tendency of the herbs or herbal formula for acne treatment in clinical practice 2) and to provide a basis for explaining the principles of acne treatment in Korean Medicine in order to make patients understand more easily based on pharmacological mechanism by analyzing the herbs or herbal formula using for acne treatment in clinical practice. Methods : In the domestic databases (Oriental medicine Advanced Searching Integrated System-OASIS, Korean Traditional Knowledge Portal-KTKP, National Discovery for Science Leader-NDSL, Research Information Sharing Service-RISS), we selected among the papers published using search terms related to "acne". Reports related to sasang constitutional medicine were excluded and a total of 23 papers were finally selected. Results : 29 prescriptions were retrieved from 23 papers. Chungan-tang (淸顔湯) notified formulas ranked first by Cheongsangbangpung- tang (淸上防風湯), Hwangnyeonhaedok-tang (黃連解毒湯), Dangguijakyaksan (當歸芍藥散) and Bipachungpe-eum (枇杷淸肺飮). Commonly used herbs are Forsythiae Fructus (連翹), Scutellariae Radix (黃芩), Gardeniae Fructus (梔子), Ligustici Rhizoma (川芎), and Angelicae Gigantis Radix (當歸). In most patients with inflammatory lesions or excessive flushing, exterior-releasing medicinal (解表藥) and heat-clearing medicinal (淸熱藥) were mainly prescribed for acne treatment, while in patients with acne accompanied hyperkeratinization, Excess sebum secretion, Dysmenorrhea or indigestion, qi-tonifying medicinal (補氣藥) or blood-tonifying medicinal (補血藥) were mainly used. KAGS (Korean Acne Grading System) was the most commonly used method for acne severity assessment. Conclusions : These findings suggest that the herbs or herbal formula for acne treatment in Korean Medicine is prescribed differently according to the cause and symptoms of acne in a unique way for control the whole body balance. Also, our findings could provide a basis for explaining the principles of acne treatment in Korean Medicine in order to make patients understand more easily based on pharmacological mechanism in clinical practice.

Time to Recover Consciousness in Patients with Diffuse Axonal Injury : Assessment with Reference to Magnetic Resonance Grading

  • Park, Sung-Jun;Hur, Jin-Woo;Kwon, Ki-Young;Rhee, Jong-Joo;Lee, Jong-Won;Lee, Hyun-Koo
    • Journal of Korean Neurosurgical Society
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    • 제46권3호
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    • pp.205-209
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    • 2009
  • Objective : This study was conducted to investigate the correlation between the degrees of injury on brain magnetic resonance imaging (MRI) and the time interval to recovery of consciousness in patients with diffuse axonal injury. Methods : From January 2004 to December 2008, 25 patients with diffuse axonal injury were treated at our hospital. We retrospectively investigated the patients' medical records and radiological findings. We divided the patients into three groups according to the grade of MRI finding : grade I, small scattered lesions on the white matter of the cerebral hemisphere; grade II, focal lesions on the corpus callosum; and grade III, additional focal lesions on the brain stem. Result : Seven patients belonged to the grade I group; 10 to the grade II group; and 8 to the grade III group. The mean Glasgow Coma Scale (GCS) score of all patients at the time of admission was 7.28. Recovery of consciousness was observed in 23 of the 25 patients; the remaining two patients never regained consciousness. The time interval to recovery of consciousness (awake status) ranged from 1 day to 125 days (mean 22.1 days) : grade I group patients, within approximately 1 week (mean 3.7 days); grade II group patients, within approximately 2 weeks (mean 12.5 days); and grade III group patients, within approximately 2 months (mean 59.5 days). Conclusion : Our study results suggest a correlation between the mean time interval to recovery of consciousness in patients with diffuse axonal injuries and the degrees of brain injuries seen on MRI. Patients with grade I and II diffuse axonal injuries recovered consciousness within 2 weeks, while patients with grade III injuries required approximately 2 months.

Study on the Assessment of Closed Trails at National Parks in the Baekdudaegan Mountains, South Korea

  • Kim, In-Kyu;Lee, Joon-Woo;Cho, Woo
    • 한국환경생태학회지
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    • 제29권1호
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    • pp.21-28
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    • 2015
  • This study examined the habitat status of wild birds at closed-trails and the control group of opened-trails in the national park of the Baekdudaegan mountains. After evaluating each area based on this, it's aimed at being utilized as basic data for future national park management and opening of trails. Upon field investigations and analyzing existing literary materials, it was found that there were a total of 76 bird species living around the trails. Among them, it was confirmed that 60 species can breeding and 10 species are protected by law. Upon assessing the scores of each area according to the evaluation standards of this study, Area I had 7 scores, area II had 13 scores, area III had 5 scores, and area IV had 16 scores, showing that the control group open-trail area IV between Jeongryeongchi and Seongsamjae had the highest score, and that area III of Wolyeongdae~Chotdaebong~Daeyasan~Miljae~Wolyeongdae had the lowest score. Evaluation of closed-trail according to wild bird species (Avifauna) was attempted in this study, but there were more bird species living in open-trails, while also having higher evaluation scores. Therefore, if opening trail is needed in the future due to excessive desires of visitors or inevitable social demands, it is judged that various environmental factors including mammals highly affected by people should be evaluated to open up the sector with the lowest score. Also, it is judged that through methods such as reservation systems, the number of visitors should be controlled or night-time hikes should be prohibited so that nocturnal wildlife can freely use the trails.

Calcium hydroxide intracanal medication effects on pain and flare-up: a systematic review and meta-analysis

  • Ibrahim, Ahmed Mohamed;Zakhary, Siza Yacoub;Amin, Suzan Abdul Wanees
    • Restorative Dentistry and Endodontics
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    • 제45권3호
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    • pp.26.1-26.18
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    • 2020
  • Objectives: This study aimed to systematically review the pain and flare-up effects of calcium hydroxide (CH) as intracanal medication (ICM) in non-vital mature teeth. Materials and Methods: Electronic-databases searching for published and grey literature and manual searching were conducted. Only randomized clinical trials (RCTs) were included comparing CH to other ICMs in non-vital mature teeth. The risk of bias was assessed using the RoB 2.0 Cochrane tool. The main outcomes were pain and flare-up. Qualitative and quantitative analysis, wherever applicable, was performed. The certainty of evidence (CoE) was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: Sixteen articles were included in 6 comparisons at different time points for different outcomes. CH reduced pain risk than no ICM within the 1-14-days interval (p < 0.05) and than triple-antibiotic paste within the first day (p < 0.05) and was similar to corticosteroid/antibiotics combination (p > 0.05). Chlorhexidine (CHX) or CH/CHX, however, reduced pain levels than CH alone (p < 0.05). CH showed higher flare-up risk than CHX (p < 0.05). CoE, however, ranged from very low to moderate. Conclusion: Most comparisons for different outcomes are based on very few studies, mostly low-powered, with an overall low CoE. Thus, the available evidence is considered insufficient to either support or refute CH effectiveness or to recommend one ICM over another. Therefore, further well-designed, larger RCTs are required.

환경친화적인 도로노선 계획을 위한 GIS 기반 환경성 평가기법 연구 - 도로노선대 선정방법 개발 - (Study on the GIS Based Environmental Assesment Techniques for Environmental Friendly Road Route Plan)

  • 강호근;박태권;김흥래;김상태;이상은
    • 대한환경공학회지
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    • 제31권3호
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    • pp.223-231
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    • 2009
  • 환경친화적인 도로노선대 선정을 위하여 공간분석기능을 활용한 GIS 기반 환경성평가 기법을 개발하고 실제 사례노선을 통하여 검증해 보고자 하였다. 도로건설 사업으로 인해 환경훼손을 가져오는 요인에 관한 분석을 바탕으로 영향범주를 구체화 시킨 후, 이에 관한 다양한 등급화 사례 및 법적 규제에 관한 문헌조사를 수행하였다. 공간 분석을 위한 정량화 모델로는 AHP를 선택하였다. 환경성 평가항목으로는 지형지질, 동식물, 토양생태, 수질, 대기질, 소음진동, 토지이용, 위락경관의 8개 항목을 선정하고 그에 따른 세부지표를 구성하여 이를 3등급 체계로 구분하였다. 가중치 산정을 위해 쌍대비교에 의한 설문수행 결과 동식물 1등급의 가중치가 0.191로 가장 높게 산출되었다. 위 방법을 사례지역에 대하여 검증한 결과 가장 환경친화적인 도로노선대를 생성할 수 있었다.