• Title/Summary/Keyword: Medical evaluation

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A study on Evaluation Methods for Safety and Performance of Electrical Stimulations for Home Use (개인용전기자극기 성능 및 안전성 평가 방법 연구)

  • Kim, San;Jang, Moo-Young;Hwang, Yoon Su;Lee, Ki-Hun;Hur, Chan-Hoi;Hong, Choongman
    • Journal of the Institute of Electronics and Information Engineers
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    • v.50 no.3
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    • pp.187-202
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    • 2013
  • The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.

Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices (의료기기 일괄허가 및 기술문서 심사를 위한 품목별 길라잡이 개발)

  • Kim, Yong-Woo;Shin, Chae-Min;Bang, Ji-Young;Yi, Jung-Yeon;Oh, Hyeon-Joo;Bae, Woo-Jin;Choi, Jin-Man;Lim, Kyung-Mi;Oh, Heon-Jin;Kim, Mi-Young;Hur, Chan-Hoi;Kim, Hyung-Bum;Choi, Min-Yong;Kwak, Ji-Young;Kim, Su-Yeon;Hwang, Sang-Yeon;Youn, Hae-Suk;Hong, Hye-Kyeong;Ahn, So-Young;Lee, Chang-Hyung;Jeong, Jin-Baek;Koo, Ja-Jung;Kang, Se-Gu;Jung, Jae-Hoon;Lim, Kyoung-Taek;Lim, Chang-Keun;Kim, Min-Su;Lee, Seong-Hyi;Lee, Jae-Keun;Park, Ki-Jung
    • Journal of Biomedical Engineering Research
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    • v.31 no.4
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    • pp.280-284
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    • 2010
  • Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

Therapeutic Approaches to the Patients Who Were Referred for Psychiatric Consultation from Medical Departments - Focused on Evaluation and Understanding - (정신과에 의뢰된 내과계 환자들에 대한 치료적 접근 -환자에 대한 평가와 이해 -)

  • Lee, Jung-Ho;Lee, Gi-Chul
    • Korean Journal of Psychosomatic Medicine
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    • v.1 no.1
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    • pp.75-80
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    • 1993
  • To understand and evaluate the patients who were referred for psychiatric consultation from medical departments, the authors reviewed the concept of disease, psychological reaction to disease, problems on psychiatric diagnosis and evaluation which were encountered at the medical ward. In addition, we reviewed what psychiatrists should do during consultation.

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Structured Assessment to Evaluate a Family Medicine Clerkship Program (가정의학 임상실습과정에 대한 구조화된 평가)

  • Park, Eun Ju;Lee, Sang Yeoup;Im, Sun Ju;Yune, So Jung;Kam, Beesung;Baek, Sun Yong;Kim, Yun-Jin;Woo, Jae Seok;Lee, Jeong-Gyu;Jeong, Dong-Wook;Cho, Young-Hye;Yi, Yu-Hyeon;Tak, Young Jin
    • Korean Medical Education Review
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    • v.19 no.1
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    • pp.47-55
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    • 2017
  • This study was conducted to analyze the strengths and weaknesses of a 3-week family medicine clerkship program based on the results of an online survey taken by the students (N=127) and a structured interview with a focus group (n=10), aimed to improve the quality of the clerkship program. The online survey contained questions pertaining to goals, schedule, contents, arrangement, atmosphere, environment, evaluation, and satisfaction regarding the clerkship. The focus group interview addressed the schedule and achievements of the program. Scores were reported on a 5-point Likert scale. Most students were highly satisfied with the overall quality of the clerkship. The structured interview results showed that 97.6% of the clerkship program was executed according to the schedule. The focus group reported a perfect score of 5 points on several measures including: accomplishment of the educational goals of the family medicine clerkship, providing many chances to obtain medical histories and perform physical examinations on real patients, experience with various symptoms and diseases, positive attitudes of faculty members when teaching, notification of the guidelines for evaluation beforehand, well-constructed and effective clerkship schedule, and reflection of student feedback. However, the focus group gave low scores on: support for health accidents of students, access to patient information, enough opportunities to practice clinical skills, appropriate rest facilities for students, and fairness of clerkship evaluation process. In conclusion, the structured evaluation performed after the 3-week clerkship program motivated students and helped them ensure an efficient clerkship. This structured evaluation also suggested basic data to make the professor who is subject of the assessment. This study shows that structured assessment is an effective method which can be used to improve the quality of clerkships.

A study on evaluator factors affecting physician-patient interaction scores in clinical performance examinations: a single medical school experience

  • Park, Young Soon;Chun, Kyung Hee;Lee, Kyeong Soo;Lee, Young Hwan
    • Journal of Yeungnam Medical Science
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    • v.38 no.2
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    • pp.118-126
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    • 2021
  • Background: This study is an analysis of evaluator factors affecting physician-patient interaction (PPI) scores in clinical performance examination (CPX). The purpose of this study was to investigate possible ways to increase the reliability of the CPX evaluation. Methods: The six-item Yeungnam University Scale (YUS), four-item analytic global rating scale (AGRS), and one-item holistic rating scale (HRS) were used to evaluate student performance in PPI. A total of 72 fourth-year students from Yeungnam University College of Medicine in Korea participated in the evaluation with 32 faculty and 16 standardized patient (SP) raters. The study then examined the differences in scores between types of scale, raters (SP vs. faculty), faculty specialty, evaluation experience, and level of fatigue as time passes. Results: There were significant differences between faculty and SP scores in all three scales and a significant correlation among raters' scores. Scores given by raters on items related to their specialty were lower than those given by raters on items out of their specialty. On the YUS and AGRS, there were significant differences based on the faculty's evaluation experience; scores by raters who had three to ten previous evaluation experiences were lower than others' scores. There were also significant differences among SP raters on all scales. The correlation between the YUS and AGRS/HRS declined significantly according to the length of evaluation time. Conclusion: In CPX, PPI score reliability was found to be significantly affected by the evaluator factors as well as the type of scale.

Reliability and Validity Analysis of the Instrument of Oriental Medical Evaluation for Hwa-Byung (화병 한의 평가도구의 신뢰도, 타당도 평가)

  • Lee, Hun-Soo;Choi, Woo-Chang;Yu, Yun-Seon;Kang, Wee-Chang;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.25 no.4
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    • pp.351-358
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    • 2014
  • Objectives: This study was performed to evaluate the reliability and validity of the instrument of oriental medical evaluation for Hwa-byung. Methods: 97 participants diagnosed with Hwa-byung divided into 5 pattern identifications by the instrument on pattern identifications for Hwa-byung were tested by the instrument of oriental medical evaluation for Hwa-byung twice a week. Results: The intraclass correlation coefficient of the test-retest analysis of oriental medical evaluation for Hwa-byung had over moderate agreement. The intraclass correlation coefficient of test-retest analysis of evaluation index of symptoms had moderate agreement for the total symptoms, and fair agreement for the physical and mental symptoms. The validity analysis of the instrument represented a positive correlation in the pattern identification of stagnation of liver Gi, malfunction of gallbladder due to phlegm stagnation, and disharmony between heart and kidneys. Conclusions: The results showed that the reliability analysis of the instrument of oriental medical evaluation for Hwa-byung showed over moderate agreement, and validity analysis represented a positive correlation except for the pattern identification of flare-up of liver fire and deficiency of both Gi and blood.

Study on the Present Gown of Oriental Medical Doctors in Korea (우리나라 현행 한의사 진료가운에 대한 조사연구)

  • 서옥경
    • Journal of the Korean Society of Costume
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    • v.52 no.3
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    • pp.139-147
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    • 2002
  • This study was carried out to survey the contentment of the oriental medical doctors to the present gown which they wear. The objects were the oriental medical doctors who work for the university hospitals and the private clinics. The subjects were mainly the evaluation of the relation to the image of oriental hospital and the gown, the evaluation of the present their gowns and the evaluation on the improvement of their gowns. The collected data were analysed by the frequency, cross-table and $\chi^2$ using SPSS program. The results showed that the oriental medical doctors who work for the university hospital evaluated the difference of the image more important than those who work for the private clinics. Also the former was more than the latter on the necessity of the difference in the gowns between the western and oriental medical doctors. The oriental doctors regarded the tradition as of great importance in the improvement of their gown. More than 70% of them wanted to separate their gown for the spring-summer from that for the autumn-winter.

Importance of Volumetric Measurement Processes in Oncology Imaging Trials for Screening and Evaluation of Tumors as Per Response Evaluation Criteria in Solid Tumors

  • Vemuri, Ravi Chandra;Jarecha, Rudresh;Hwi, Kim Kah;Gundamaraju, Rohit;MaruthiKanth, Aripaka;Kulkarni, AravindRao;Reddy, Sundeep
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.5
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    • pp.2375-2378
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    • 2014
  • Cancer, like any disease, is a pathologic biological process. Drugs are designed to interfere with the pathologic process and should therefore also be validated using a functional screening method directed at these processes. Screening for cancers at an appropriate time and also evaluating results is also very important. Volumetric measurement helps in better screening and evaluation of tumors. Volumetry is a process of quantification of the tumors by identification (pre-cancerous or target lesion) and measurement. Volumetric image analysis allows an accurate, precise, sensitive, and medically valuable assessment of tumor response. It also helps in identifying possible outcomes such disease progression (PD) or complete response as per Response Evaluation Criteria in Solid Tumors (RECIST).

Evaluation of Process and Satisfaction for Selective Courses in a Medical School (의과대학 선택교육과정의 운영절차와 만족도 평가)

  • Kim, Do-Hwan;Choi, Young-Hyu;Han, Sang Yun;Shin, Jwa-Seop;Lee, Seunghee
    • Korean Medical Education Review
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    • v.19 no.2
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    • pp.90-100
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    • 2017
  • The necessity of embracing selective courses in medical curriculum is increasing due to the expansion of medical knowledge and changes in the health care environment. In contrast to the abundant evidence regarding elective or selective courses during the clinical phase, articles focusing on the preclinical period are relatively scarce. This study aims to explore the development, implementation, and evaluation of newly-adopted selective courses in the first-year medical curriculum in a medical school which recently underwent a major curricular revision. First of all, the Curriculum Committee established goals and operating principles of the courses, and then the committee encouraged all participating professors to attend a related faculty development workshop after finalizing the list of courses. A survey was conducted at the end of each course for evaluation. Of the 36 courses opened in 2016, the overall satisfaction of students was $4.98{\pm}1.06$ (out of 6) and showed a strong correlation with students' previous expectations, reasoning- and participation-oriented teaching, and outcome of the courses including increased motivation. In the open-ended responses, students and professors described not only intended outcomes such as acquisition of medical knowledge and increased interest in new topics, but also unintended outcomes including positive impression for selective courses and even high satisfaction and rewarding experiences, especially from the teachers' perspective. Although long-term outcomes remain to be seen, the results of this study show the feasibility and impact of selective courses and will contribute to effective implementation in other medical schools.

Education of Medical humanities and Social Medicine in Schools of Korean Medicine in Korea (전국 한의과대학 및 한의학전문대학원의 인문사회의학교육 현황)

  • Cheon, Mog-Eun;Lim, Byung-Mook;Shin, Sang-Woo
    • Journal of Society of Preventive Korean Medicine
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    • v.16 no.1
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    • pp.31-42
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    • 2012
  • Objective : To set up the concept and the category of the medical humanities in Korean medicine education through researching and analysing the curriculum of 12 colleges and school of Korean medicine (KM) in Korea. Methods : We collected self-evaluation reports from 12 KM institutions, and analyzed subjects regarding medical humanities and social medicine. The subjects' relevance with medical humanities was verified using the learning objectives of KOMEEI(Korea Oriental Medicine Education and Evaluation Institute). The number of relevant subjects, the credits and educational hours, and the time of opening, etc. were analysed. Results : 12 KM institutions provide 44 subjects as medical humanities and social medicine related subjects. Among them, 17 subjects were corresponded to the actual learning objective of medical humanities. These subjects account for an average of 7% in total curriculum. Most of the subjects are required courses for premedical students and the fourth year students of medical school. Conclusions : This paper suggests the public discussion on the learning objective and the categories of the medical humanities education in KM institutions. Further studies on developing the educational contents and evaluation tools are also needed to produce good doctors with ability and personality.