• 한국의료질향상학회지
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• 제2권1호
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• pp.86-109
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• 1995

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

• The Journal of Advanced Prosthodontics
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• 제6권5호
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• pp.325-332
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• 2014

PURPOSE. The aim of this review was to analyze the evaluation criteria on mandibular implant overdentures through a systematic review and suggest standardized evaluation criteria. MATERIALS AND METHODS. A systematic literature search was conducted by PubMed search strategy and hand-searching of relevant journals from included studies considering inclusion and exclusion criteria. Randomized clinical trials (RCT) and clinical trial studies comparing attachment systems on mandibular implant overdentures until December, 2011 were selected. Twenty nine studies were finally selected and the data about evaluation methods were collected. RESULTS. Evaluation criteria could be classified into 4 groups (implant survival, peri-implant tissue evaluation, prosthetic evaluation, and patient satisfaction). Among 29 studies, 21 studies presented implant survival rate, while any studies reporting implant failure did not present cumulative implant survival rate. Seventeen studies evaluating peri-implant tissue status presented following items as evaluation criteria; marginal bone level (14), plaque Index (13), probing depth (8), bleeding index (8), attachment gingiva level (8), gingival index (6), amount of keratinized gingiva (1). Eighteen studies evaluating prosthetic maintenance and complication also presented following items as evaluation criteria; loose matrix (17), female detachment (15), denture fracture (15), denture relining (14), abutment fracture (14), abutment screw loosening (11), and occlusal adjustment (9). Atypical questionnaire (9), Visual analog scales (VAS) (4), and Oral Health Impact Profile (OHIP) (1) were used as the format of criteria to evaluate patients satisfaction in 14 studies. CONCLUSION. For evaluation of implant overdenture, it is necessary to include cumulative survival rate for implant evaluation. It is suggested that peri-implant tissue evaluation criteria include marginal bone level, plaque index, bleeding index, probing depth, and attached gingiva level. It is also suggested that prosthetic evaluation criteria include loose matrix, female detachment, denture fracture, denture relining, abutment fracture, abutment screw loosening, and occlusal adjustment. Finally standardized criteria like OHIP-EDENT or VAS are required for patient satisfaction.

• Journal of Nutrition and Health
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• 제37권8호
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• pp.669-674
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• 2004

The purpose of this study was to develop the antiallergic and hypoallergic fennented soybean foods without side effect. We manufactured Chungkukjang with addition of herbal (aloe, cinamon, licorice root) extract. Sensory evaluation was performed to evaluate the acceptability by the consumer. Clinical evaluation was performed with 10 atopic dermatitis (AD) patients who showed positive reaction with specific IgE and skin prick test. Cross-over study between nonnal Chungkukjang and Chungkukjang with aloe extract was performed. In sensory evaluation, Chungkukjang with aloe extract obtained best score overall. In clinical evaluation, 7 out of 10 AD patients showed positive reaction to soy-bean and 4 out of 10 AD patients showed positive reaction to normal Chungkukjang. 2 out of 10 AD patients showed positive reaction to Chungkukjang with aloe extract. In conclusion, Chungkukjang could be recommended as functional food with hypoallergic effect. As adding aloe extract to Chungkukjang, hypo allergic effect was increased.

• 인터넷정보학회논문지
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• 제13권1호
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• pp.45-55
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• 2012

임상시험 전체 소요시간 및 비용의 절감, 임상 데이터 질의 향상을 위해 임상시험 전자자료의 관리가 점차 중요해지고 있다. 또한 임상시험 전자자료 관리는 전자 임상시험의 안정성 및 질을 위해 규정 가이드라인을 준수하는 것이 결정적으로 필요하다. 본 연구는 전자적 시스템을 활용한 임상시험에 있어 데이터 관리의 성과를 평가하기 위한 프레임웍을 개발하고자 한다. 연구의 목적을 위해 임상시험 프로세스에 근거하여 기반능력, 연구설계, 연구진행 및 연구완료 등 네 개의 주요 메트릭을 구성함으로써 데이터 관리의 수준을 측정할 수 있는 성과척도를 도출한다. 이때 각 성과척도의 도출 기준은 임상시험 자체가 지향하는 데이터의 질 향상, 전자자료 관리 프로세스의 비용과 효율성 및 규정 준수 수준 등 네 가지의 관리적 관심을 기준으로 하며, 각 성과척도 별로 전자자료 관리 프로세스 상 실질적으로 측정 가능한 측정지표를 제시한다. 평가 프레임웍은 네 가지의 주요 측정 메트릭에 근거하여, 세 개의 데이터 영역(연구기관, 모니터링, 데이터관리센터) 별로 구성된다. 본 평가 프레임웍의 개발은 전문가 의견 수렴을 통한 델파이 방법론으로 접근한 탐색적 연구로서 향후 실증적 후속 연구를 과제로 남기고 있다.

• 대한한의학회지
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• 제45권1호
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• pp.1-16
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• 2024

Introduction: The importance of clinical skills training in traditional Korean medicine education is increasingly emphasized. Since the clinical skills tests are high-stakes tests that determine success in national licensing exams, it is essential to develop reliable multifaceted analysis methods for clinical skills tests in actual education settings. In this study, we applied the multifaceted validity evaluation methods to the evaluation results of the cardiopulmonary resuscitation module to confirm the applicability and effectiveness of the methods. Methods: In this study, we used internal consistency, factor analysis, generalizability theory G-study and D-study, ANOVA, Kendall's tau, descriptive statistics, and other statistical methods to analyze the multidimensional validity of a cardiopulmonary resuscitation test in clinical education settings over the past three years. Results: The factor analysis and internal consistency analysis showed that the evaluation rubric had an unstable structure and low concordance. The G-study showed that the error of the clinical skills assessment was large due to the evaluator and unexpected errors. The D-study showed that the variance error of the evaluator should be significantly reduced to validate the evaluation. The ANOVA and Kendall's tau confirmed that evaluator heterogeneity was a problem. Discussion and Conclusion: Clinical skills tests should be continuously evaluated and managed for validity in two steps of pre-production and actual implementation. This study has presented specific methods for analyzing the validity of clinical skills training and testing in actual education settings. This study would contribute to the foundation for competency-based evidence-based education in practical clinical training.

• 대한간호학회지
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• 제8권2호
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• pp.1-13
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• 1978

Evaluation for students’performance is a very important and difficult responsibility of head nurses. This study was undertaken to investigate and identify head nurses’attitudes toward evaluation for clinical performance of nursing students. Data were gathered through questionnaire from eighty eight head nurses at three hospitals in Kwang Ju City and four hospitals in Seoul, during the period of April 9th-26th, 1978. The questionnaire developed by the researcher included 19 statements which concerned the attitudes of head nurses: their perception about objectives of evaluation for the students clinical performance, their attitudes toward responsibility as evaluator, their attitudes toward method of evaluation, their understanding and interest in nursing students. Mean attitude score more than 60% were classified as positive or favorable, and less than 60% to be negative or unfavorable. The result obtained could be summerized as follows: 1. The mean score of head nurses’attitudes was positive (67.9%). Hypothesis I was rejected, 2. Head nurses’perception about objectives on performance evaluation was very favorable (85.5%). 3. Head nurses’attitudes toward evaluating method were negative (50.9%), post-evaluation interview were perceived to be a part of evaluating process (73.9%), although only few (22.7%) implemented. 4. The head nurses’attitudes in the responsibility as a evaluator were unfavorable (58.2%). 5. Relatively favorable response was revealed in understanding and interest about nursing students (79.6%). 6. Educational level, duration of clinical experience, marital status, and geographical region of head nurses were no significant influence on the attitudes toward evaluation for clinical performance (P > 0.05), while only age revealed significant difference (P < 0.05) Hypothesis 2, 3, 5 and 6 were accepted, hypothesis 4 was rejected.

• 대한간호학회지
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• 제22권3호
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• pp.407-415
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• 1992

The purpose of this study was to survey the use of a evaluation tools of clinical competency for nursing students. The sample consisted of the departments of nursing in 14 universities and 20 Junior colleges of nursing. Data analysis was done by frequency, percentages and factor analysis. The results of the study were as follows : 1. A common measurement tools for evaluation in the clinical area was used by 74.4% of universities and Junior colleges of nursing. Only 0-4.5% of Junior colleges of nursing and 1.5-7.4% of universities used a evaluation tools developed according to their major. 2. Theoretically, 3% of those sampled applied the nursing process as an instrumental means of nursing practice. Bloom's theory was applied by 35.8% of the schools. Most of them used their own measurement tools for evaluating their students. 3. One half of them used quantitative scales, the other half used others. 4. Professional attitudes wire included in their contents bvy 93.9% of universties and 94.1% of Junior colleges of nursing. The major areas of evaluation were knowledge, skills, attitudes and interpersonal relationships in that order. Results ; From this study can be concluded that regardless of the number of academic years of nursing and professional area, common standard evaluation tools for nursing competency were found to be needed. Theoretically, an evaluation scheme which applies the nursing process should be required. Knowledge, skill, attitude and interpersonal relationship would be essential elements to be evaluated. Maximizing the clinical competency and minimizing the conflict elements for nursing students is important. Nursing, education, students and environmental aspects must be consider in the goal of clinical education. A diagram, a checklist and a anecdote note in addition to the quantitative scale are necessary for efficient evaluation.

• 한국간호교육학회지
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• 제7권2호
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• pp.217-228
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• 2001

This study was designed to compare the effect of internship and preceptorship on satisfaction of clinical practice in nursing students. A total of 46 third grade students were assigned to 2 groups; 23 to inturnship group, 23 to preceptorship group. Satisfaction scores of clinical practice instruction and practice environment in internship group were higher than satisfactory scores of preceptorship group. There were no difference between satisfactory scores of clinical practice contents, clinical practice hour and clinical practice environment in internship and preceptorship. Satisfaction scores on clinical practice weren't significantly correlated with school credits. There were significant correlations among clinical practice contents, practice environment, practice instruction and clinical practice hour. There were significant correlations among clinical practice instruction, practice environment and clinical practice evaluation. Clinical practice instruction was the highest factor predicting satisfaction of clinical practice. In stepwise multiple regression analysis, 100% of the variance in satisfaction of clinical practice was accounted for by clinical practice instruction(59.1%), clinical practice contents(14.9%), clinical practice environment(12.3), clinical practice hour(8.8%), and clinical practice evaluation(5.5%).

• 의학교육논단
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• 제15권3호
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• pp.120-124
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• 2013

The clinical clerkship focuses students on developing their ability to perform comprehensive diagnosis and management of patients with common undifferentiated problems by the integration of knowledge and clinical reasoning. Therefore, the clerkship evaluation system should assess their actual problem solving and professional behavior. However, concern remains that clerkship evaluations are imprecise and highly variable. This review is designed to provide faculty members with concepts, options, and a methodology to actively teach and evaluate the clinical clerkship, as well as offer encouragement and inspiration to medical students. We reviewed past and current clinical clerkship evaluations and discuss several tips to improve clinical excellence such as continuity, transparency of the evaluation process, a faculty development program, practical examination of clinical skills, implementation of a checklist for recording exposure and skills, providing prompt and constructive feedback to students, self-evaluation of professional performance, varying multi-faceted assessment combinations, being outpatient clinic-centered, and having dedicated faculty members who give students one-on-one contact with a preceptor.

• 간호행정학회지
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• 제7권3호
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• pp.473-485
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• 2001

This study is intended to develop a reliable and appropriate instrument of the clinical nursing education. This research consisted of 4 steps. First step is construction of the content validity by 1 Korean literature professor and 1 teaching professor in Ga Chon Gil College, the pilot study for the content validity by 14 professors and survey with four points Likert Scale, which includes from the point 'strongly valid' to the point of 'strongly non-valid', by 113 head nurses who guide and evaluate the students in clinical practice. The third step is the test of validity and reliability of the preliminary evaluation tool. The fourth step is the test of validity and reliability of the developmental evaluation tool. The data were collected from Sep. 10th, 2001 to Sep. 28th, 2001. This study was analyzed by SPSS PC+ for descriptive statistics, factor analysis and Cronbach's Co-efficient Alpha of the collected data. The results of these analysis are like as follows. 1. Evaluation tool of Clinical practice consists of 16 items including four categories : factor 1 was labeled 'desirable attitude'(5 items), factor 2 was labeled 'correctly judgement and nursing problem solving'(4 items), factor 3 was labeled 'adaptive ability of nursing knowledge and skill'(4 items), factor 4 was labeled 'desirable human relationship'(3 items) and these contributed 71.992% of the variance in the total score. 2. Cronbach's Co-efficient Alpha for internal consistency was .9128 for the total 16 items. For further research, it need to develop a variable and reliable instrument of the student self-evaluation and instrument that based on community.