• Title/Summary/Keyword: Clinical Circumstances

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Foreign Bodies in the Chest: How Come They Are Seen in Adults?

  • Tae Jung Kim;Jin Mo Goo;Min Hoan Moon;Jung-Gi Im;Mi-Young Kim
    • Korean Journal of Radiology
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    • v.2 no.2
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    • pp.87-96
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    • 2001
  • The radiologic and clinical findings of foreign bodies in the chest of children are well recognized. Foreign bodies in adults are infrequent, however, and the radiologic findings of these unusual circumstances have rarely been described. We classified various thoracic foreign bodies into three types according to their cause: Type I, Aspiration, Type II, Trauma or Accident; Type III, Iatrogenic. This pictorial essay will illustrate the radiologic findings and consequences of thoracic foreign bodies in adults, which have rarely been described in the radiologic literature. The clinical significance of thoracic foreign bodies will be also be discussed.

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Comparison of the Expedited Programs for Innovative Drug Development and Approval among United States, European Union, and Republic of Korea (한국, 미국, 유럽의 혁신적 의약품 개발 및 허가제도 비교 연구)

  • Jiyeon Park;Hyewon Shin;Jangik. I. Lee
    • Korean Journal of Clinical Pharmacy
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    • v.34 no.1
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    • pp.39-61
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    • 2024
  • Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

Circumstances, Risk Factors, and the Predictors of Falls among Patients in the Small and Medium-sized Hospitals (중소병원 입원환자의 낙상발생 시 현황, 낙상위험요인 및 낙상발생 예측요인)

  • Lee, Young Jin;Gu, Mee Ock
    • Journal of Korean Clinical Nursing Research
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    • v.21 no.2
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    • pp.252-265
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    • 2015
  • Purpose: This study examined the circumstances, risk factors, and the predictors of fall incidents among patients in the small and medium-sized hospitals. Methods: Fifty patients with any fall experiences were matched by gender, age, and medical departments with 100 patients without fall incident at the same hospital. Data were collected from 5 small and medium-sized hospitals. Data were analyzed using descriptive statistics, a Chi-square test, a Fisher's exact test, and a logistic regression with the SPSS/WIN 21.0 program. Results: In the patients with falls, the largest number of falls occurred during the day shift, in the patients' rooms, and while they were walking. Further 74.0% of the patients had physical injuries, and 34.0% had to take further medical diagnostic tests. Significant differences were found between the patients with falls and the others on 14 variables (cardiovascular disease, anemia, sedative-hypnotics, vasodilators, narcotic analgesics, dizziness, general weakness, unstable gait, walking aids, anger, anxiety, depression, orientation, and fear of fall). Narcotic analgesic use, dizziness, walking aids, and cardiovascular disease were identified as the predictors of fall incidents. Conclusion: These findings are hoped to be used in developing a fall risk assessment tool and fall prevention nursing programs for small and medium-sized hospitals.

Changes in Clinical Practice Satisfaction of Healthcare Students Before and After COVID-19 (COVID-19 전·후의 보건계열 학생들의 임상 실습 만족도의 변화)

  • Namkoong, Seung;Ro, Hyo-Lyun
    • Journal of the Korean Society of Physical Medicine
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    • v.17 no.3
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    • pp.41-50
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    • 2022
  • PURPOSE: This study sought to investigate the change in the satisfaction levels of healthcare students regarding clinical practice before and after the coronavirus disease 19 (COVID-19) outbreak. METHODS: This was a longitudinal survey using a structured questionnaire. The first survey was conducted before the COVID-19 outbreak in April 2018, and the second survey was conducted after the outbreak from May to June 2022. The questionnaire used before and after COVID-19 had the same content and was categorized into the following six factors to determine clinical practice satisfaction: practice guidance, practice environment, practice time, practice evaluation, interpersonal relationships, and effectiveness of practice. Before the COVID-19 pandemic, a total of 153 healthcare students (average age: 22.43 ± 1.47 years old), participated from 4 departments: nursing, physical therapy, occupational therapy, and dental hygiene. After COVID-19, 84 students (average age: 22.75 ± 2.87 years old), from the physical therapy, occupational therapy, nursing, and dental hygiene departments participated in the survey. RESULTS: Clinical practice satisfaction was evaluated considering the factors of practical guidance, practice environment, practice time, interpersonal relationships, and practical effects. It was observed that the satisfaction with clinical practice increased in nursing, physical therapy, occupational therapy, and dental hygiene students after COVID-19 compared to the situation before the outbreak. There was no difference seen in the practice time and practice evaluation factors in the occupational therapy department and in the practice time factor in the dental hygiene department before and after COVID. CONCLUSION: In clinical practice under the extremely constrained circumstances imposed by the COVID-19 pandemic, it seems that the emotional internal response is greater, and the satisfaction with clinical practice appears to be relatively higher than before the outbreak.

Clinical Practice Guideline of Korean Medicine for Stroke : Preliminary Guideline and Recommendation (중풍환자에 대한 일차 한의임상진료 가이드라인)

  • Han, Chang-Ho
    • The Journal of Internal Korean Medicine
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    • v.33 no.4
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    • pp.347-366
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    • 2012
  • The aim of this new statement is to provide comprehensive and timely evidence-based recommendations on stroke management for clinical practitioners. Many countries are already well engaged in developing and releasing their own clinical practice guidelines, whereas Korean Medicine (KM) is still beginning. It will take time and effort to develop evidence-based guidelines and recommendations of KM or other traditional medicine because they are weak in the area of scientific evidence. The clinical practice guideline of Korean medicine for stroke was formulated through extensive review of published literature and consensus meeting of Korean medicine specialists. This project was supported by a grant of the Oriental Medicine R&D Project, the Ministry of Health and Welfare. Referring to guidelines developed in other countries, the experts in the subject tried to organize and develop guidelines and recommendations adequate for domestic medical circumstances. In December, 2008, a multi-disciplinary team called the Evidence Based Clinical Practice Guidelines Development Group (EBCPGsDG) for Stroke was organized. The writing committee was comprised of experts in internal medicine, acupuncture, rehabilitation, and Sasang constitution. Outside specialists and associated panels were invited for consultation. The scope of the guideline encompasses acupuncture, moxibustion and herbal medicine (including Korean medicine, traditional Chinese medicine, Kampo medicine) as interventions for stroke patients. It includes statements about ischemic stroke (I63), stroke not specified as hemorrhage or infarction (I64), and sequelae of cerebrovascular disease (I69) according to the International Classification of Disease (ICD). The committee subdivided the description of herbal medications into acute stroke management, subacute stroke management, post-stroke management, and secondary prevention of stroke. Guidelines on the practice of acupuncture and moxibustion were described in order for acute stroke management, subacute stroke management, chronic stroke management, and post-stroke rehabilitation. Clinicians who are working in the field of stroke care can adopt this guideline for their practice.

Attitudes of Nursing Students to Clinical Education : Q methodological Approach (임상실습에 대한 간호학생의 태도 : Q 방법론 적용)

  • 박송자
    • Journal of Korean Academy of Nursing
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    • v.23 no.4
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    • pp.544-554
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    • 1993
  • The study was designed to identify the attitude of nursing students to clinical education through Q-methodology. A C sample was developed through a review of the literature and interviews. Twenty - seven statements made up the finalized Q- sample. This was out of an initial 143 statements developed through consultation with eight professors. The P sample consisted of 25 nursing students in S Health Junior College.0 statements were written on seperate cards and were given to the 25 subjects to sort according to degree of agreement or disagreement. The Q-sorts by each subject were coded and analyzed with QUANL PC Program. The analysis discovered three major attitudes, namely “amicable adaptation” 〈type 1), “Nightingale social service” (type 2), and “realistic occupation pursuit” (type 3). The correlation was .465 between type 1 and type 2, .293 between type 1 and type 3, and .273 between type 2 and type 3. The characteristics of each type were as follows ; Type 1 (amicable adaptation) They satisfied in interpersonal relationships in the clinical setting. They would not dream of becoming Nightingale, but thought of nursing care affirmatively and performed their works faithfully and adapted themselves to the new circumstances easily, Fourteen subjects were classified as type 1. Type 2 (Nightingale: social service) They often dreamed as a child that they would be Nightingale with a white uniform and think that nursing is a gift from heaven. They have an aptitude for nursing care by nature and selected nursing science them-selves. They give care to the sick with pleasure. Seven subjects were classified as type 2. Type 3 (realistic occupation pursuit) They were not satisfied with their nursing practice. First of all they want a stable job, therefore they selected nursing science. They had conflicts in clinical practice, but were responsible for nursing and studied hard. Four subjects were classified as type 3. Through the results of this study, the attitude of nursing students to clinical education could be classified into three types. Therefore it is suggested that clinical education would be more valuable, if it was planned according to an understanding of the attitudes of nursing students to clinical education.

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Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey (한국의 다지역 임상시험 가이드라인 적용에 대한 인식: 다중 이해관계자 설문조사)

  • Sohn, Minji;Song, Yun-Kyoung;Jeon, Ah Young;Oh, Jung Mi;Kim, In-Wha
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.4
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    • pp.267-277
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    • 2019
  • Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals' domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.

Comparison between Moxibustion and the Intense Pulsed Light (IPL) and the Clinical Application of Photo-moxa (구법(灸法)과 intense pulsed light(IPL)의 특성 비교 및 광선구(光線灸)의 한방임상(韓方臨床) 활용(活用))

  • Jang, In-Soo;Sun, Seung-Ho;Nam, Dong-Hyun;Kum, Su-Eun;Seo, Hyung-Sik
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.23 no.3
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    • pp.78-83
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    • 2010
  • Objectives : The purpose of this study is to compare the principles between moxibustion and the 'Intense pulsed light (IPL)' and to investigate the clinical application of the photo-moxa for the Korean medicine fields. Methods : The characteristics of moxibustion, IPL, parabolic reflector moxa and the dermatology surgical use of moxibustion were reviewed in the literature. Results : IPL is one type of light treatments that is employed by radiating the short-pulse wave, which is transformed from the light of high intensity. There has been used parabolic reflector in Asia for more than 2,000 years, and this hand-held device used for moxibustion in traditional medicine. Moxibustion is one of the treatment tools in Korean medicine using the heat energy. The fluence or energy density of IPL in clinical circumstances is similar to parabolic reflector moxa of moxibustion. IPL and parabolic reflector moxa shared same treatment principle employing the heat energy. Therefore IPL could apply for many indications in Korean medicine as a moxibustion tool and acupuncture. Conclusions: IPL may be plausible to be a fascinate method in phototherapy of Korean medicine.

Sample Size Determination in survival Studies (생존함수의 비교연구를 위한 표본수의 결정)

  • 박미라;김선우;이재원
    • The Korean Journal of Applied Statistics
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    • v.11 no.2
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    • pp.269-285
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    • 1998
  • One of the most important issues in the area of clinical trial research is the determination of the sample size required to insure a specified power in detecting a real or clinically relevant difference of a stated magnitude. Increasingly, medical journals are requiring authors to provide information on the sample size needed to detect a given difference. We restrict our attention to the designs far comparirng two survival distributions. These are concerned with the survival time which is defined as the interval from a baseline(e.g. randomization) to failure (e.g. death, recurrence of disease). Survival times axe right censored when patients have not foiled by the time of analysis or have been loss to follow-up during the trial. For different types of clinical trials for comparing survival distributions, there have been marry research in sample size determination. We review the existing literature concerning commonly used sample size formulae in the design of randomized clinical trials, and compare the assumption, the power and the sample size calculation of these methods. We also compare by simulation the expected power and observed power of each method under various circumstances. As a result, guidelines in terms of practical usage are provided.

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Initial Impact of the COVID-19 Outbreak on ADHD Symptoms Among University Students in Japan

  • Toshinobu Takeda;Yui Tsuji;Reiko Akatsu;Tatsuya Nomura
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.34 no.2
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    • pp.69-75
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    • 2023
  • Objectives: The coronavirus disease 2019 pandemic and its associated societal responses are anticipated to have wide-ranging effects on youth development and mental health. Depression, anxiety, and attention deficit hyperactivity disorder (ADHD) are the three most common mental health problems among university students. Many factors that can threaten mental health during the outbreak affect these three conditions, as well as sleep conditions, in undergraduate students. Thus, determining how these abrupt changes in students' circumstances impact their mental health is very important from a public health perspective. Methods: We investigated the usual conditions and changes in ADHD symptoms during the outbreak, in relation to depressive and sleep-related symptoms among undergraduate students. A total of 252 students, primarily juniors, completed the online survey. Results: The results showed that 12% of the students exceeded the cut-off score of the ADHD questionnaire before the pandemic. Approximately 6%-21% of the university students, especially those with ADHD traits, rated their ADHD behaviors as worse during the outbreak than that before the outbreak. Conclusion: Female students and undergraduates with ADHD traits are more susceptible to experiencing further deterioration of ADHD (inattention) symptoms during the pandemic. In cases where it is difficult to intervene with ADHD symptoms, approaching circadian rhythm or depression will be of considerable clinical use.