• Title/Summary/Keyword: Pre-clinical strategy

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Historical Controls, Data Banks, and Randomized Trials in Clinical Research: A Review

  • Fleming Thomas R.
    • 대한예방의학회:학술대회논문집
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    • 1994.02b
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    • pp.265-269
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    • 1994
  • A brief review is presented of the strengths and weaknesses of historical controls, data banks, and randomized trials in the evaluation of clinical treatment. Use of pre randomized versus postrandomized informed consent is discussed. Recommendations are made for the development of an appropriate clinical research strategy.

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Pre-clinical QT Risk Assessment in Pharmaceutical Companies - Issues of Current QT Risk Assessment -

  • Takasuna, Kiyoshi; Katsuyoshi, Chiba;Manabe, Sunao
    • Biomolecules & Therapeutics
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    • v.17 no.1
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    • pp.1-11
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    • 2009
  • Since the Committee for Proprietary Medicinal Products (CPMP) of the European Union issued in 1997 a "points to consider" document for the assessment of the potential for QT interval prolongation by non-cardiovascular agents to predict drug-induced torsades de pointes (TdP), the QT liability has become the critical safety issue in the development of pharmaceuticals. As TdP is usually linked to delayed cardiac repolarization, international guideline (ICH S7B) has advocated the standard repolarization assays such as in vitro IKr (hERG current) and in vivo QT interval, or in vitro APD (as a follow up) as the best biomarkers for predicting the TdP risk. However, the recent increasing evidence suggests that the currently used above biomarkers and/or assays are not fully predictive for TdP, but also does not address potential new druginduced TdP due to the selective disruption of hERG protein trafficking to the cell membrane or VT and/or VF with QT shortening. There is, therefore, an urgent need for other surrogate markers or assays that can predict the proarrhythmic potential of drug candidate. In this review, we provide an ideal pre-clinical strategy to predict the potentials of QT liability and lethal arrhythmia of the drug candidates with recent issues in this field in mind, not at the expense of discarding therapeutically innovative drugs.

An Evaluation of the Fundamental Nursing Practice in Clinical Settings by Triangulation Method (트라이앵귤레이션 방법에 의한 기본간호 현장실습교육 평가)

  • Kim, Chun-Mi;Kim, Eun-Man
    • The Journal of Korean Academic Society of Nursing Education
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    • v.17 no.2
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    • pp.235-245
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    • 2011
  • Purpose: The purpose of this study was to identify effectiveness of fundamental nursing practices in clinical settings. Method: This study adopted the triangulation method. Using one group pre-post test design, this study identified differences in self efficacy between pre and post clinical practice. The study was also designed to describe the nursing student's experience of clinical practice by using content analysis Results: 1) All students experienced bedmaking, BST check, V/C check, positioning, transferring, assisting with moving and positioning, and ROM. Sixty percent of students experienced giving oral care, and forty percent experienced shampooing patient's hair. 2) While the mean score of self efficacy was 3.88 in the pre-test, it decreased to 3.76 in the post-test. They were statistically different from each other. 3) Seven categories were elicited from the result of content analysis on the nursing student's experience, which were 'ignorant stranger', 'facing the gap between theory and practice', 'resolving the uncertainty of clinical setting', 'getting used to fundamental nursing practice', 'motivated by a desire to study and self-development', 'understanding the nursing profession's job', and 'being helpful for the future career'. Conclusion: Fundamental nursing practice in clinical settings is a useful strategy that improves fundamental nursing skills and motivates student's self-development.

Comparison of Effects of Nursing Process Reeducation according to Academic Credit Bank System Student Nurses' Clinical Experience - Expertise, Critical Thinking Disposition, Clinical Decision Making - (학점은행제 교육과정 간호사들의 임상경력에 따른 간호과정 재교육의 효과 비교 - 숙련성, 비판적사고 성향, 임상의사결정 능력을 중심으로 -)

  • Yi, Yeo-Jin
    • Journal of Korean Academy of Nursing Administration
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    • v.15 no.2
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    • pp.275-283
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    • 2009
  • Purpose: This study investigated the effects of reeducation of nursing process on nurses' expertise, critical thinking disposition, and clinical decision making. Methods: Data were collected from March to June, 2007. The subjects were 47 Academic Credit Bank System Student Nurses. They were taught 'nursing process' during 1 semester(15weeks). 47 nurses were divided into three groups according to clinical experience(under 3 years, 3 to under 5 years, 5 years or more). After 15 weeks, the effects of education were compared using a paired t-test between pre-test and post-test. Results: There was a significant difference in the 3 to under 5 years experienced nurses's expertise(t=-3.659, p=.004) between the pre-test and post-test. There was a significant difference in the 5 years or more experienced nurses's expertise(t=-5.781, p<.001) and critical thinking disposition(t=-3.345, p=.003) between the pre-test and post-test. There were no significant differences in clinical decision making(accuracy, proficiency, and confidence) of 3 groups. Conclusion: Reeducation of nursing process is a valuable teaching and an evaluation strategy for 5 years or more experienced nurses to improve expertise and critical thinking disposition. We need to develop continuing education program for improving nurses' clinical decision making.

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The effects of Pre-briefing Team-based Learning in Standardized Patients Simulation (표준화 환자 시뮬레이션 실습교육기반의 간호교육에서 사전브리핑을 활용한 팀 기반 학습 효과)

  • Kim, Hyun-Ju
    • Journal of Digital Convergence
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    • v.18 no.8
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    • pp.271-279
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    • 2020
  • Simulation practice training is used in nursing education as an education method to improve the adaptability to the clinical field, but responds to unpredictable situations and negatively affects practice satisfaction. This study applied a team-based learning utilizing a pre-briefing inequality controls ago to investigate the effect of self-efficacy, simulation practice satisfaction and clinical performance of the nursing college in the simulation based nursing education and after quasi-experimental study. Data collection in the fourth grade and P University Nursing 72 peoples, the study period is from November 15 from October 14, 2019. As a result, the experimental group that applied team-based learning using pre-briefing showed higher self-efficacy, simulation practice satisfaction, and clinical performance than the control group. Therefore, applying team-based learning to the pre-briefing process can be an important learning strategy for simulation practice training, and suggests a follow-up study to confirm the effectiveness by standardizing the pre-briefing step later.

Two-Stage Logistic Regression for Cancer Classi cation and Prediction from Copy-Numbe Changes in cDNA Microarray-Based Comparative Genomic Hybridization

  • Kim, Mi-Jung
    • The Korean Journal of Applied Statistics
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    • v.24 no.5
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    • pp.847-859
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    • 2011
  • cDNA microarray-based comparative genomic hybridization(CGH) data includes low-intensity spots and thus a statistical strategy is needed to detect subtle differences between different cancer classes. In this study, genes displaying a high frequency of alteration in one of the different classes were selected among the pre-selected genes that show relatively large variations between genes compared to total variations. Utilizing copy-number changes of the selected genes, this study suggests a statistical approach to predict patients' classes with increased performance by pre-classifying patients with similar genetic alteration scores. Two-stage logistic regression model(TLRM) was suggested to pre-classify homogeneous patients and predict patients' classes for cancer prediction; a decision tree(DT) was combined with logistic regression on the set of informative genes. TLRM was constructed in cDNA microarray-based CGH data from the Cancer Metastasis Research Center(CMRC) at Yonsei University; it predicted the patients' clinical diagnoses with perfect matches (except for one patient among the high-risk and low-risk classified patients where the performance of predictions is critical due to the high sensitivity and specificity requirements for clinical treatments. Accuracy validated by leave-one-out cross-validation(LOOCV) was 83.3% while other classification methods of CART and DT performed as comparisons showed worse performances than TLRM.

A Qualitative Study on Management Behaviors about Blood Pressure of Participants in Moxibustion Clinical Trial for Hypertension (고혈압-뜸 임상시험 참여자들의 혈압 관리행동에 대한 질적연구)

  • Moon, A-Ji;Kim, Tae-Jung;Lee, Seoung-Geun;Kim, Nam-Kwen;Lee, Key-Sang
    • The Journal of Internal Korean Medicine
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    • v.33 no.4
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    • pp.543-557
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    • 2012
  • Objectives : The purpose of this study which adopted a qualitative method was to evaluate blood pressure management behaviors of pre- and stage 1 hypertension patients and to provide fundamental data for developing a strategy about proper oriental medical treatment through analyzing factors related to a moxibustion clinical trial. Methods : Semi-structured interviews that focused on personal experiences with hypertension and its management were conducted with 10 hypertensive patients. The interviews lasted for approximately 50 minutes. Results : Most participants recognized that the direct cause of high blood pressure was unhealthy behavior rather than inheritance. Thus, the hypertensive patient believed they could recover their blood pressure to a normal level through removing the direct cause of hypertension instead of taking drugs. The reasons for these statements were that the drugs for controlling hypertension are not natural and they may have side effects. On future management plan of patients, most of them will continue to keep moxibustion and healthy behavior in the well-controlled blood pressure group. However in the uncontrolled blood pressure group, there was an increasing tendency to begin medication. Conclusions : For developing a strategy for an individual approach to hypertension management, we need to develop a client-centered attitude and strategy. That is, we need to tailor our approach to individual cases to avoid generalizations and stereotyping when developing an adherence increasing strategy.

Endoscopic Resection for Early Gastric Cancer beyond Absolute Indication with Emphasis on Controversial Issues

  • Min, Yang Won;Lee, Jun Haeng
    • Journal of Gastric Cancer
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    • v.14 no.1
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    • pp.7-14
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    • 2014
  • Endoscopic resection is the established treatment for early gastric cancer in selected patients with negligible risk of lymph node metastasis ('absolute indication'). Based on clinical observations and large pathological databases, expanding indications for endoscopic resection beyond absolute indication has been tried in Japan and Korea. However, controversies exist regarding the safety of treating early gastric cancer beyond absolute indication in terms of pathological evaluation of the resected specimen, definition of expanded indication, discrepancy between pre-endoscopic resection and post-endoscopic resection diagnoses of gastric neoplasm, and the best strategy for cases with non-curative resection. In this brief review, current evidence and clinical experience regarding issues of endoscopic resection beyond absolute indication will be summarized.

Effects of High-fidelity Simulator and Standardized Patient on Nursing Care for Children with Fever in Nursing Students (고충실도(High-fidelity) 시뮬레이터와 표준화 환자 (Standardized Patient)를 활용한 발열환아 간호 교육의 효과)

  • Ha, Young-Ok
    • Korean Parent-Child Health Journal
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    • v.20 no.1
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    • pp.10-17
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    • 2017
  • Purpose: This study was conducted to investigate the effects of simulation-based education using high-fidelity simulator and standardized patient in nursing care for children with fever on nursing students. Methods: A total of 166 senior nursing students who completed pediatric nursing practicum courses participated in this study. The single group study design with pretest and posttest was used. The simulation education was provided for 200mins including orientation, simulation preparation, simulation practicum, and debriefing. Pre and post surveys were performed using questionnaires on clinical performance competency, communication skills, critical thinking disposition and self-confidence. Results: The mean scores of clinical performance competency (t=-2.56, p<.05), communication skills (t=-6.39, p<.001), critical thinking disposition (t=-3.43, p<.001), and self-confidence (t=-3.72, p<.001) in posttest were significantly higher than those in pretest. Also, clinical performance competency in nursing care for children with fever has significant relationships with communication skills, critical thinking disposition and self-confidence. Conclusion: The results indicate that simulation-based education using high-fidelity simulator and standardized patient is an effective strategy for improving clinical performance competency, communication skills, critical thinking disposition and self-confidence in nursing students. Further study is needed to verify the effects.

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Effects of a Nursing Simulation Learning Module on Clinical Reasoning Competence, Clinical Competence, Performance Confidence, and Anxiety in COVID-19 Patient-Care for Nursing Students (코로나19 간호시뮬레이션 학습모듈이 간호대학생의 임상추론역량, 임상수행능력, 간호수행자신감 및 불안에 미치는 효과)

  • Kim, Ye-Eun;Kang, Hee-Young
    • Journal of Korean Academy of Nursing
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    • v.53 no.1
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    • pp.87-100
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    • 2023
  • Purpose: This study aimed to develop a nursing simulation learning module for coronavirus disease 2019 (COVID-19) patient-care and examine its effects on clinical reasoning competence, clinical competence, performance confidence, and anxiety in COVID-19 patient care for nursing students. Methods: A non-equivalent control group pre- and post-test design was employed. The study participants included 47 nursing students (23 in the experimental group and 24 in the control group) from G City. A simulation learning module for COVID-19 patient-care was developed based on the Jeffries simulation model. The module consisted of a briefing, simulation practice, and debriefing. The effects of the simulation module were measured using clinical reasoning competence, clinical competence, performance confidence, and anxiety in COVID-19 patient-care. Data were analyzed using χ2-test, Fisher's exact test, t-test, Wilcoxon signed-rank test, and Mann-Whitney U test. Results: The levels of clinical reasoning competence, clinical competence, and performance confidence of the experimental group were significantly higher than that of the control group, and the level of anxiety was significantly low after simulation learning. Conclusion: The nursing simulation learning module for COVID-19 patient-care is more effective than the traditional method in terms of improving students' clinical reasoning competence, clinical competence, and performance confidence, and reducing their anxiety. The module is expected to be useful for educational and clinical environments as an effective teaching and learning strategy to empower nursing competency and contribute to nursing education and clinical changes.