• 제목/요약/키워드: validation studies

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담배 흡입독성 평가를 위한 설치류 담배연기노출시스템의 유효화 (Validation of a Rodent Nose-only Exposure System for Inhalation Toxicity Evaluation of Cigarette Smoke)

  • 손형옥;이형석;신한재;박철훈;유지혜;장미;현학철
    • 한국연초학회지
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    • 제36권1호
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    • pp.20-25
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    • 2014
  • As part of a balanced testing battery, subchronic inhalation studies on rats are performed to ensure that proposed cigarette modifications do not increase the toxicity of smoke and to demonstrate any instances where a modification may actually contribute to harm reduction. For subchronic inhalation studies with aerosols, the OECD suggests an exposure regimen of 6 hours/day (OECD Guideline 413, 1981), but alternative regimens have also been published: 1 hour/day and $2{\times}1$ hour/day. The aim of this study was to validate a rodent nose-only exposure system for the assessment of inhalation toxicity of cigarette smoke. In this study, cigarette smoke exposure system is consisted of cigarette smoke generator, smoke concentration adjusting system, and 20-port nose-only exposure system. Male SD rats were exposed for 35 days ($2{\times}1$ hour/day) to 3R4F Reference cigarette smoke and analysed major monitoring items of OECD Gudeline 413. WTPM, was measured in the test atmosphere, respiratory function (Buxco Biosystems) during exposure, postexposure urinary exposure biomarkers and alveolar neutrophiles in BAL fluid (Day 35) were evaluated. Validation demonstrated steady WTPM ($257{\pm}20ug/L$, $502{\pm}27ug/L$) and spatial uniformity (<10%). Nose port temperature ($22{\sim}26^{\circ}C$ and RH (45~75%) were acceptable over 35 days. Reductions in respiratory rate and minute volume and increase in the neutrophiles in BALF and the urinary exposure biomarkers were observed cigarette smoke dose dependently. This validation and 35-day inhalation study has shown that the rodent nose-only exposure system may be useful in the inhalation toxicity assessment of cigarette smoke.

한중일 3국의 중재제도의 조화를 위한 소고 - 특허권 중재를 중심으로 - (A Study on the Harmonization of a Mediation System through a FTA among China, Japan, and Korea - Focused on the Patent Mediation -)

  • 이헌희
    • 한국중재학회지:중재연구
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    • 제23권1호
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    • pp.153-175
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    • 2013
  • The issue of patent validity becomes a subject of dispute under the FTA and there is a definite difference of opinion between China, Japan, and Korea. In other words, the validity of a judgment on the patent was exclusively under the jurisdiction of the administrative agency at a particular patent office. Thus, the issue arises where there is a potential judgment on patent validity. In this case, the Supreme Court rather than the patent office can offer a judgment from a judicial institution and can make a judgment in the case of a medication. In China, however, the lowest possibility of judgment on patent validity is predicted to occur in judicial institutions. Such a judgment is recognized as the Grand Bench Decision in Korea, and the court can judge the patent validation rather than the patent office. That is just the case in the Kilby case-it is invalid for reasons obvious in Japan. Therefore, there is a substantial difference between the three countries. Especially in Japan, where after the Kilby case, they revised the patent law in 2004 to introduce Article 104-3, placing the judgment of patent validity in the court, even if the "Apparentness"is not requisite. Per this law, infringers can argue for patent invalidity not only the judgment of the patent invalidation but also the infringement lawsuit. From the point of view of Japan, Korea became the judgment of trademark validation by extension and obvious cases can become directly to judge through the Supreme Court about the right that needs to examinations and registrations. In terms of the mediation, it also provides a clue about the judgment of intellectual property validation and expands the scope of the mediation in the future. From now on, in order to have active mediation procedures in the three countries, China, Japan, and Korea would need to unify regulations and application scopes for mediation in the FTA negotiation and to look forward to achieve a vigorous mediation approach.

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Development and validation of prediction equations for the assessment of muscle or fat mass using anthropometric measurements, serum creatinine level, and lifestyle factors among Korean adults

  • Lee, Gyeongsil;Chang, Jooyoung;Hwang, Seung-sik;Son, Joung Sik;Park, Sang Min
    • Nutrition Research and Practice
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    • 제15권1호
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    • pp.95-105
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    • 2021
  • BACKGROUND/OBJECTIVES: The measurement of body composition, including muscle and fat mass, remains challenging in large epidemiological studies due to time constraint and cost when using accurate modalities. Therefore, this study aimed to develop and validate prediction equations according to sex to measure lean body mass (LBM), appendicular skeletal muscle mass (ASM), and body fat mass (BFM) using anthropometric measurement, serum creatinine level, and lifestyle factors as independent variables and dual-energy X-ray absorptiometry as the reference method. SUBJECTS/METHODS: A sample of the Korean general adult population (men: 7,599; women: 10,009) from the Korean National Health and Nutrition Examination Survey 2008-2011 was included in this study. The participants were divided into the derivation and validation groups via a random number generator (with a ratio of 70:30). The prediction equations were developed using a series of multivariable linear regressions and validated using the Bland-Altman plot and intraclass correlation coefficient (ICC). RESULTS: The initial and practical equations that included age, height, weight, and waist circumference had a different predictive ability for LBM (men: R2 = 0.85, standard error of estimate [SEE] = 2.7 kg; women: R2 = 0.78, SEE = 2.2 kg), ASM (men: R2 = 0.81, SEE = 1.6 kg; women: R2 = 0.71, SEE = 1.2 kg), and BFM (men: R2 = 0.74, SEE = 2.7 kg; women: R2 = 0.83, SEE = 2.2 kg) according to sex. Compared with the first prediction equation, the addition of other factors, including serum creatinine level, physical activity, smoking status, and alcohol use, resulted in an R2 that is higher by 0.01 and SEE that is lower by 0.1. CONCLUSIONS: All equations had low bias, moderate agreement based on the Bland-Altman plot, and high ICC, and this result showed that these equations can be further applied to other epidemiologic studies.

한국판 헬리콥터 부모역할 지각 척도(Helicopter Parenting Scale) 타당화: 30대 초반까지의 청년을 대상으로 (Validation of the Korean version of the Helicopter Parenting Scale for an expanded age range of young adults)

  • 강시은;이재림
    • 한국가족관계학회지
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    • 제22권2호
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    • pp.3-25
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    • 2017
  • Objective: The purpose of this study was to examine the reliability and validity of the Korean version of the Helicopter Parenting Scale (HPS) using a sample of Korean young adults aged 19-34. This study is to expand the previous validation studies that exclusively focused on college students. Method: The survey data came from 1,140 young adults (398 19-24 year olds, 376 25-29 year olds, and 366 30-34 year olds) who had never been married and had at least one living parent. The young adults' perceived helicopter parenting was assessed by 10 items of the HPS for the mother and the father separately. All of the analyses including exploratory and confirmatory factor analyses were conducted for three age groups (19-24, 25-29, and 30-34 years) and for the mother and the father separately. Results: We found that three items were problematic for all age groups and for both the fathers' and mothers' helicopter parenting. After removing these three items, confirmatory factor analyses showed that the one-factor model fit our data well and the estimated factor loadings were suitable. The results were consistent throughout the age groups and the parent's gender. We also confirmed criterion-related validity using correlations between paternal and maternal helicopter parenting and three dimensions of parental career expectations indicated a reliable. Conclusion: The Korean version of HPS with seven items was found to be a reliable and valid measure for Korean young adults aged 19-34 years old.

Quality Reporting of Radiomics Analysis in Mild Cognitive Impairment and Alzheimer's Disease: A Roadmap for Moving Forward

  • So Yeon Won;Yae Won Park;Mina Park;Sung Soo Ahn;Jinna Kim;Seung-Koo Lee
    • Korean Journal of Radiology
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    • 제21권12호
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    • pp.1345-1354
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    • 2020
  • Objective: To evaluate radiomics analysis in studies on mild cognitive impairment (MCI) and Alzheimer's disease (AD) using a radiomics quality score (RQS) system to establish a roadmap for further improvement in clinical use. Materials and Methods: PubMed MEDLINE and EMBASE were searched using the terms 'cognitive impairment' or 'Alzheimer' or 'dementia' and 'radiomic' or 'texture' or 'radiogenomic' for articles published until March 2020. From 258 articles, 26 relevant original research articles were selected. Two neuroradiologists assessed the quality of the methodology according to the RQS. Adherence rates for the following six key domains were evaluated: image protocol and reproducibility, feature reduction and validation, biologic/clinical utility, performance index, high level of evidence, and open science. Results: The hippocampus was the most frequently analyzed (46.2%) anatomical structure. Of the 26 studies, 16 (61.5%) used an open source database (14 from Alzheimer's Disease Neuroimaging Initiative and 2 from Open Access Series of Imaging Studies). The mean RQS was 3.6 out of 36 (9.9%), and the basic adherence rate was 27.6%. Only one study (3.8%) performed external validation. The adherence rate was relatively high for reporting the imaging protocol (96.2%), multiple segmentation (76.9%), discrimination statistics (69.2%), and open science and data (65.4%) but low for conducting test-retest analysis (7.7%) and biologic correlation (3.8%). None of the studies stated potential clinical utility, conducted a phantom study, performed cut-off analysis or calibration statistics, was a prospective study, or conducted cost-effectiveness analysis, resulting in a low level of evidence. Conclusion: The quality of radiomics reporting in MCI and AD studies is suboptimal. Validation is necessary using external dataset, and improvements need to be made to feature reproducibility, feature selection, clinical utility, model performance index, and pursuits of a higher level of evidence.

간호사가 인지하는 간호관리자의 윤리적 리더십 측정 도구 K-ELW의 타당화 연구 (A Validation Study of the Modified Korean Version of Ethical Leadership at Work Questionnaire (K-ELW))

  • 김정언;박은준
    • 대한간호학회지
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    • 제45권2호
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    • pp.240-250
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    • 2015
  • Purpose: The purpose of this study was to validate the Korean version of the Ethical Leadership at Work questionnaire (K-ELW) that measures RNs' perceived ethical leadership of their nurse managers. Methods: The strong validation process suggested by Benson (1998), including translation and cultural adaptation stage, structural stage, and external stage, was used. Participants were 241 RNs who reported their perceived ethical leadership using both the pre-version of K-ELW and a previously known Ethical Leadership Scale, and interactional justice of their managers, as well as their own demographics, organizational commitment and organizational citizenship behavior. Data analyses included descriptive statistics, Pearson correlation coefficients, reliability coefficients, exploratory factor analysis, and confirmatory factor analysis. SPSS 19.0 and Amos 18.0 versions were used. Results: A modified K-ELW was developed from construct validity evidence and included 31 items in 7 domains: People orientation, task responsibility fairness, relationship fairness, power sharing, concern for sustainability, ethical guidance, and integrity. Convergent validity, discriminant validity, and concurrent validity were supported according to the correlation coefficients of the 7 domains with other measures. Conclusion: The results of this study provide preliminary evidence that the modified K-ELW can be adopted in Korean nursing organizations, and reliable and valid ethical leadership scores can be expected.

공간프로그램에 따른 공간배치의 유효성 평가 위한 BIM기반 병원건축 전문가시스템 개발에 관한 연구 - 서울특별시 노인전문병원 설계경기 사례를 중심으로 - (A Study on the Development of the Expert System for Validation of Spatial Layout in Terms of Space Program in Healthcare Architecture based on BIM Technologies - Focused on the Design Competition for Seoul Geriatric Hospital -)

  • 박영섭
    • 의료ㆍ복지 건축 : 한국의료복지건축학회 논문집
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    • 제16권4호
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    • pp.7-14
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    • 2010
  • The planning and design of healthcare architecture generally requires the participation and consultation of skilled experts since it has more complex space program than any other buildings. Therefore, the computer-based expert systems for the planning of healthcare architecture have been tried continuously. The recent development of BIM technologies and object-oriented CAAD systems is leading these attempts to realize gradually. Thus, this study attempts to verify whether the new evaluation model and system of the spatial layout, which are based on the validation of space program that developed in earlier studies, are applicable to real examples of design competition. Through this simulation, this study tries to find the possibility of expert systems for the planning of healthcare architecture and act as basic data for the development of new system for the integrated design environment based on BIM technologies in the near future.

Studies on 5 Protein Fractions Prediction of Forage Legume Mixture by NIRS

  • Lee, Hyo-Won;Jang, Sungkwon;Lee, Hyo-Jin;Park, Hyung-Soo
    • 한국초지조사료학회지
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    • 제34권3호
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    • pp.214-218
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    • 2014
  • This study was conducted to assess the feasibility of near-infrared reflectance spectroscopy (NIRS) as a rapid and reliable method for the estimation of crude protein (CP) fractions in forage legume mixtures (sudangrass and pea mixture, and kidney bean and potato mixture). A total of 178 samples were collected and their spectral reflectance obtained in the range of 400~2,500 nm. Of these, 50 samples were selected for calibration and validation, and 35 samples were used for calibration of the data set, and the modified partial least square regression (MPLSR) analysis was performed. The correlation coefficient ($r^2$) and the standard error of cross-validation (SECV) of the calibration models in the CP fractions, A, B1, B2, B3, and C, were 0.94 (1.05), 0.92 (0.74), 0.96 (0.95), 0.91 (0.42), and 0.83 (0.38), respectively. Fifteen samples were used for equation validation, and the $r^2$ and the standard error of prediction (SEP) were 0.87 (1.45), 0.91 (0.49), 0.94 (1.13), 0.36 (0.96), and 0.74 (0.67), respectively. This study showed that NIRS could be an effective tool for the rapid and precise estimation of CP fractions in forage legume mixtures.

Validation of a low-cost portable 3-dimensional face scanner

  • Liu, Catherine;Artopoulos, Andreas
    • Imaging Science in Dentistry
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    • 제49권1호
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    • pp.35-43
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    • 2019
  • Purpose: The goal of this study was to assess the accuracy and reliability of a low-cost portable scanner (Scanify) for imaging facial casts compared to a previously validated portable digital stereophotogrammetry device (Vectra H1). This in vitro study was performed using 2 facial casts obtained by recording impressions of the authors, at King's College London Academic Centre of Reconstructive Science. Materials and Methods: The casts were marked with anthropometric landmarks, then digitised using Scanify and Vectra H1. Computed tomography (CT) scans of the same casts were performed to verify the validation of Vectra H1. The 3-dimensional (3D) images acquired with each device were compared using linear measurements and 3D surface analysis software. Results: Overall, 91% of the linear Scanify measurements were within 1 mm of the corresponding reference values. The mean overall surface difference between the Scanify and Vectra images was <0.3mm. Significant differences were detected in depth measurements. Merging multiple Scanify images produced significantly greater registration error. Conclusion: Scanify is a very low-cost device that could have clinical applications for facial imaging if imaging errors could be corrected by a future software update or hardware revision.

Development of nodal diffusion code RAST-V for Vodo-Vodyanoi Energetichesky reactor analysis

  • Jang, Jaerim;Dzianisau, Siarhei;Lee, Deokjung
    • Nuclear Engineering and Technology
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    • 제54권9호
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    • pp.3494-3515
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    • 2022
  • This paper presents the development of a nodal diffusion code, RAST-V, and its verification and validation for VVER (vodo-vodyanoi energetichesky reactor) analysis. A VVER analytic solver has been implemented in an in-house nodal diffusion code, RAST-K. The new RAST-K version, RAST-V, uses the triangle-based polynomial expansion nodal method. The RAST-K code provides stand-alone and two-step computation modes for steady-state and transient calculations. An in-house lattice code (STREAM) with updated features for VVER analysis is also utilized in the two-step method for cross-section generation. To assess the calculation capability of the formulated analysis module, various verification and validation studies have been performed with Rostov-II, and X2 multicycles, Novovoronezh-4, and the Atomic Energy Research benchmarks. In comparing the multicycle operation, rod worth, and integrated temperature coefficients, RAST-V is found to agree with measurements with high accuracy which RMS differences of each cycle are within ±47 ppm in multicycle operations, and ±81 pcm of the rod worth of the X2 reactor. Transient calculations were also performed considering two different rod ejection scenarios. The accuracy of RAST-V was observed to be comparable to that of conventional nodal diffusion codes (DYN3D, BIPR8, and PARCS).