• Title/Summary/Keyword: e-clinical data

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Current status and future direction of digital health in Korea

  • Shin, Soo-Yong
    • The Korean Journal of Physiology and Pharmacology
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    • v.23 no.5
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    • pp.311-315
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    • 2019
  • Recently, digital health has gained the attention of physicians, patients, and healthcare industries. Digital health, a broad umbrella term, can be defined as an emerging health area that uses brand new digital or medical technologies involving genomics, big data, wearables, mobile applications, and artificial intelligence. Digital health has been highlighted as a way of realizing precision medicine, and in addition is expected to become synonymous with health itself with the rapid digitization of all health-related data. In this article, we first define digital health by reviewing the diverse range of definitions among academia and government agencies. Based on these definitions, we then review the current status of digital health, mainly in Korea, suggest points that are missing from the discussion or ought to be added, and provide future directions of digital health in clinical practice by pointing out certain key points.

Clinical Significance of Food-specific IgE Antibody Tests in Food Protein-induced Proctocolitis (식품 단백질 유발성 직결장염에서 식품 특이 IgE 항체 검사의 임상적 의의)

  • Song, Jeong-Yoon;Kang, Yu-Na;Kim, Jae-Ryong;Hwang, Jin-Bok
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.11 no.1
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    • pp.36-41
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    • 2008
  • Purpose: The aim of this study was to determine the clinical significance of food-specific IgE antibody tests in detecting triggering antigens in food protein-induced proctocolitis (FPIPC). Methods: Between February 2006 and May 2007, data from 16 consecutive FPIPC patients that underwent MAST and Uni-CAP tests on initial visits, were reviewed. The endoscopic criterion used for establishing a diagnosis of FPIPC was an increase in the number of eosinophils in the lamina propria (${\geq}60$ per 10 high power fields). Offending foods were suspected clinically based on elimination and challenge testing to mother or patient diets with the following five highly allergenic foods: dairy products, eggs, nuts and soybean, fish and shellfish, and wheat and buckwheat. We compared the results of initial MAST or Uni-CAP tests with clinically suspected offending foods. Results: For the 16 FPIPC patients, MAST tests showed positive results in 2 patients (12.5%), and Uni-CAP tests showed positive results in 3 patients (18.8%). Through clinical elimination and challenge, the 33 offending foods were identified: 7 fish and shellfish (21.2%), 6 eggs (18.2%), 6 wheat and buckwheat (18.2%), 4 dairy products (12.1%), 3 soybean (9.1%), 3 pork (9.1%), 2 nuts (6.1%), 1 beef (3.0%), and 1 mushroom (3.0%). Clinically suspected offending foods and MAST and Uni-CAP test results were found to be correlated in 1 patient (6.7%) each. Conclusion: Food specific IgE antibody tests are inappropriate for predicting offending foods in FPIPC. Clinical food elimination and challenge testing provide useful means of detecting offending foods.

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A Study on the Satisfaction of Clinical Training According to Dental Hygienist Duties (치과위생사 업무에 따른 임상실습 만족도 연구)

  • Park, Il-Soon;Lee, Sun-Hee
    • Journal of dental hygiene science
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    • v.7 no.4
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    • pp.295-302
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    • 2007
  • The purpose of this study is to make formulated examination and analysis about major two factors of dental hygienic students' satisfaction at clinical training, i.e. the contents of clinical training and their duties satisfaction, so that it can provide a basic reference material for more efficient clinical training and education. This study conducted a questionnaire survey for 427 students who were taken via simple random sampling from sophomore and junior dental hygienic students, who already experienced in clinical training courses, at some universities(and colleges) in Metropolitan and province areas. The data collected from this survey were analyzed using SPSS WIN 11.5, in parallel with t-test, one-way ANOVA and ${\chi}^2$(Chi-square) test. It was found that our students didn't feel so much satisfied at clinical training(satisfaction level = 3.34). Overall, they didn't show any significant satisfaction with the contents of training and the experiences in clinical training duties. Our dental hygiene students showed relatively low satisfaction with the contents of clinical training as well as satisfaction at clinical training duties, which ie that current clinical training in dental hygienics still remain at the level of simple assistance for dental treatment.

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Characterisation of Phenotypic and Genotypic Antibiotic Resistance Profile of Enterococci from Cheeses in Turkey

  • Kurekci, Cemil;Onen, Sevda Pehlivanlar;Yipel, Mustafa;Aslantas, Ozkan;Gundogdu, Aycan
    • Food Science of Animal Resources
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    • v.36 no.3
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    • pp.352-358
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    • 2016
  • The aim of this study was to determine the prevalence of enterococci in cheese samples and to characterize their antimicrobial resistance profiles as well as the associated resistance genes. A total of 139 enterococci were isolated from 99 cheese samples, the isolates were identified as E. faecalis (61.2%), E. faecium (15.1%), E. gallinarum (12.9%), E. durans (5.0%), E. casseliflavis (2.9%) and E. avium (2.9%). The most frequent antimicrobial resistance observed in enterococci isolates was to lincomycin (88.5%), followed by kanamycin (84.2%), gentamycin (low level, 51.1%), rifampin (46.8%) and tetracycline (33.8%). Among the isolates, the frequencies of high level gentamycin and streptomycin resistant enterococci strains were 2.2% and 5.8%, respectively. Apart from the mentioned antibiotics, low levels of resistance to ciprofloxacin, erythromycin and chloramphenicol were found. Moreover no resistance was observed against penicillin and ampicillin. The antimicrobial resistance genes including tetM, tetL, ermB, cat, aph(3’)-IIIa, ant(6)-Ia and aac(6’)-Ieaph(2”)-Ia were found in enterococci from Turkish cheese samples. In the current study, we provided data for antibiotic resistance and the occurrence of resistance genes among enterococci. Regulatory and quality control programs for milk and other dairy products from farms to retail outlets has to be established and strengthened to monitor trends in antimicrobial resistance among emerging food borne pathogens in Turkey.

A CLINICAL AND BACTERIOLOGICAL EXAMINATION AND TREATMENT OF $PAPILLON-LEF\`{E}VRE$ SYNDROME ($Papillon-Lef\`{e}vre$ Syndrome의 임상 및 미생물학적 검사와 치료)

  • Baik, Byeong-Ju;Kim, Jae-Gon;Kim, Mun-Hyeon;Kim, Hyung-Seop;Song, Yo-Han
    • Journal of the korean academy of Pediatric Dentistry
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    • v.25 no.2
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    • pp.450-457
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    • 1998
  • The $Papillon-Lef\`{e}vre$ Syndrome(PLS), a disease with autosomal recessive inheritance, is characterized by diffuse hyperkeratosis of the palms and soles, mostly prepubertal periodontitis and premature loss of primary and permanent dentition. The etiology of the destruction of periodontal tissues has not been completely clarified. In recent years, two main factors are suggested to be responsible for tooth loss ; firstly, the presence of gram negative microorganisms in the periodontal pockets of the patients. The other factor suggested is cellular deficiency in chemotaxic and phagocytic function of neutrophylic granulocytes. Resent data suggestes that mechanical debridement in conjunction with antibiotic therapy may be successful in periodontal management of $Papillon-Lef\`{e}vre$ Syndrome, particularly if administered early. In this study, a $Papillon-Lef\`{e}vre$ Syndrome patient was studied clinically, radiologically, histopathologically and microbiologically. 5 years female patient with gingival swelling and destruction of periodontal structure on the whole dentition were examined and palmar and plantar hyperkeratosis were can be seen. On microbiological analysis, Actinobacillus actino-mycetemcomitans was performed. Concurrently, the children recieved extraction of maxillary anterior teeth and construction of removable prosthetis. The combination of professional oral hygiene care and antibiotic therapy improved the dermatologic and periodontal condition.

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Comparison of the accuracy of domestic dental intra-oral scanner(e-scanner) and model scanner (국산 치과용 구강스캐너(e-scanner)와 모델스캐너의 정확도 비교)

  • Kim, Busob;Kim, Jungho
    • Journal of Technologic Dentistry
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    • v.41 no.2
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    • pp.53-61
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    • 2019
  • Purpose: The purpose of this study is to evaluate the discrepancy of scan process in dental intra oral scanner by comparing model scanner and anticipate possibility to introduce intra oral scan technique. Methods: 3D superimposition test was conducted to compare the scan discrepancy. The scanners used in this study are the e-oral scanner, the D750 model scanner, and the high precision CMM(3D Coordinate Measuring Machine). The standard of accuracy verification is ISO 5725-1; trueness and precision. Master model was manufactured by dental stone and scanned 5 times by intra oral, model scanner. Reference data was scanned 5 times by high accuracy CMM to evaluate the trueness. Results: Trueness of D750 scanner were $7.4{\mu}m$ $5.1{\mu}m$ $6.8{\mu}m$ at an abutment, an occluasal, a specific area. and trueness of e-scanner were $20.2{\mu}m$ $27.4{\mu}m$ $37.8{\mu}m$ at an abutment, an occluasal, a specific area. Precision of D750 scanner was $7.04{\mu}m$, e-scanner was $15.95{\mu}m$. Conclusion: When conducting in vitro test, The mean difference of trueness between e-scanner and D750 were $12.8{\mu}m$ at an abutment area, $22.3{\mu}m$ at an occlusal area, $31.0{\mu}m$ at a specific area and $8.91{\mu}m$ in precision. The scan discrepancies are within the range of clinical acceptance.

Prognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data

  • Fuchs, Charles S.;Muro, Kei;Tomasek, Jiri;Van Cutsem, Eric;Cho, Jae Yong;Oh, Sang-Cheul;Safran, Howard;Bodoky, Gyorgy;Chau, Ian;Shimada, Yasuhiro;Al-Batran, Salah-Eddin;Passalacqua, Rodolfo;Ohtsu, Atsushi;Emig, Michael;Ferry, David;Chandrawansa, Kumari;Hsu, Yanzhi;Sashegyi, Andreas;Liepa, Astra M.;Wilke, Hansjochen
    • Journal of Gastric Cancer
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    • v.17 no.2
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    • pp.132-144
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    • 2017
  • Purpose: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. Materials and Methods: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters. Results: Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64-0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor. Conclusions: The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.

Development of Curriculum for the Emergency Clinical Nurse Specialist (응급전문간호사의 교육과정안 개발)

  • 김광주;이향련;김귀분
    • Journal of Korean Academy of Nursing
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    • v.26 no.1
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    • pp.194-222
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    • 1996
  • Various accidents and injuries are currently occurring in Korea at increasingly high rates. Good quality emergency care service is urgently needed to cope with these various forms of accidents and injuries. In order to develop a sound emergency care system, there need to be a plan to educate and train professionals specifically in emergency care. One solution for the on going problem would be to educate and train emergency clinical nurse specialists. This study on a strategy for curriculum development for emergency clinical nurse specialist was based on the following five content areas, developed from literature related to the curriculum of emergency nursing and emergency care situation : 1. Nurses working in the emergency rooms of three university hospitals were analyzed for six days to identify categories of nursing activities. 2. Two hundreds and eleven nurses working in the emergency rooms of 12 university hospitals were surveyed to identify needs for educational content that should be included in a curriculum for the clinical nurse specialist. 3. Examination of the environment in which emergency management was provided. 4. Identification of characteristics of patients in the emergency room. 5. The role of emergency clinical nurse specialist was identified through literature, recent data, and research materials. The following curriculum was formulated using the above mentioned process. 1. The philosophy of education for emergency clinical nurse specialist was established through a realistic philosophical framework. In this frame, client, environment, health, nursing, and learning have been defined. 2. The purpose of education is framed on individual development, social structure, nursing process and responsibility along with the role and function of the emergency clinical nurse specialist. 3. The central theme was based on human, environment, health and nursing. 4. The elements of structure in the curriculum content were divided to include two major threads, I, e., vertical and horizontal : The vertical thread to consist of the client, life cycle, education, research, leadership and consultation, and the horizontal thread to consist of level of nursing (prevention to rehabilitation), and health to illness based on the health care system developed by Betty Neuman system model. 5. Behavioral objectives for education were structured according to the emergency clinical nurse specialist role and function as a master degree prepared in various emergency settings. 6. The content of the curriculum consisted of three core courses(9 credits), five major courses(15 credits), six elective courses(12 credits) and six prerequisite courses (12 credits). Thus 48 credits are required. Recommendations : 1. To promote tile quality of the emergency care system, the number of emergency professionals, has to be expanded. Further the role and function of the emergency clinical nurse specialist needs to be specified in both the medical law and the Nursing Practice Act. 2. In order to upgrade the qualification of emergency clinical nurse specialists, the course should be given as part of the graduate Program. 3. Certification should be issued through the Korean Nurses Association.

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Recovery Room Nurses' Knowledge and Stress of Emergence Delirium (회복실 간호사의 각성 섬망에 대한 지식과 각성 섬망 관련 업무 스트레스에 관한 연구)

  • Jung, In Ae;Jung, Dukyoo
    • Journal of Korean Clinical Nursing Research
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    • v.20 no.2
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    • pp.256-266
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    • 2014
  • Purpose: This study was done to identify the level of knowledge on and stress from delirium among recovery room nurses, and correlations between these factors. Methods: In this study, 125 nurses agreed to participate in the study were surveyed from October 8 to October 28, 2013. Data were analyzed using t-test, ANOVA, $Scheff{\grave{e}}$ test and Pearson correlation. Results: Average percentage of correct answers to questions about delirium was 81.9% and the mean score was 26.22 (${\pm}5.01$). The mean score for recovery room nurses' work stress from emergency delirium was 3.86 (${\pm}0.99$). Extent of knowledge on delirium significantly differed by age (F=15.017, p<.001), length of clinical experience (F=22.132, p<.001), length of recovery room experience (F=10.538, p<.001), education (F=3.312, p =.040), and marital status (t=4.107, p<.001). Stress from ED was significantly related to age (F=9.185, p<.001), clinical experience (F=7.077, p=.001), and marital status (t=-2.027, p =.045). Knowledge on delirium had a negative relationship with stress from delirium (r=-.514, p<.001). Conclusion: Results show that nurses gained knowledge of delirium from their own clinical experience indicating a need to develop educational programs to improve knowledge on delirium and plans to reduce stress from delirium for recovery room nurses.

Statistical implications of extrapolating the overall result to the target region in multi-regional clinical trials

  • Kang, Seung-Ho;Kim, Saemina
    • Communications for Statistical Applications and Methods
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    • v.25 no.4
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    • pp.341-354
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    • 2018
  • The one of the principles described in ICH E9 is that only results obtained from pre-specified statistical methods in a protocol are regarded as confirmatory evidence. However, in multi-regional clinical trials, even when results obtained from pre-specified statistical methods in protocol are significant, it does not guarantee that the test treatment is approved by regional regulatory agencies. In other words, there is no so-called global approval, and each regional regulatory agency makes its own decision in the face of the same set of data from a multi-regional clinical trial. Under this situation, there are two natural methods a regional regulatory agency can use to estimate the treatment effect in a particular region. The first method is to use the overall treatment estimate, which is to extrapolate the overall result to the region of interest. The second method is to use regional treatment estimate. If the treatment effect is completely identical across all regions, it is obvious that the overall treatment estimator is more efficient than the regional treatment estimator. However, it is not possible to confirm statistically that the treatment effect is completely identical in all regions. Furthermore, some magnitude of regional differences within the range of clinical relevance may naturally exist for various reasons due to, for instance, intrinsic and extrinsic factors. Nevertheless, if the magnitude of regional differences is relatively small, a conventional method to estimate the treatment effect in the region of interest is to extrapolate the overall result to that region. The purpose of this paper is to investigate the effects produced by this type of extrapolation via estimations, followed by hypothesis testing of the treatment effect in the region of interest. This paper is written from the viewpoint of regional regulatory agencies.