• Title/Summary/Keyword: national guidelines

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Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting (의료기기 이상사례 보고에 대한 국내 이해관계자의 관점 차이)

  • Lee, Ye Jin;Yoon, Chiho;Choi, Soo Jeong;Kang, Youngjoon;Kim, Jin Kuk;Kwon, Bum Sun;Lee, You Kyoung;Nam, Ki Chang
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.171-178
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    • 2019
  • This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

Development and Evaluation of Evidence-Based Nursing Protocol for Extracorporeal Membrane Oxygenation to Critically Ill Patients (체외막산소화장치 적용 중환자를 위한 근거기반 간호 프로토콜 개발 및 효과 평가)

  • Kim, Soomi;Kim, Chul-Gyu
    • Journal of Korean Academy of Nursing
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    • v.53 no.3
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    • pp.275-294
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    • 2023
  • Purpose: This study aimed to develop an evidence-based extracorporeal membrane oxygenation (ECMO) nursing protocol for critically ill patients receiving ECMO treatment by using an adaptation process, and to verify the effects of the protocol. Methods: The protocol was developed according to the adaptation guidelines. A non-randomized controlled trial was conducted to test the protocol's effects. Data were collected between April 2019 and March 2021. The differences in physiological indicators and complication rates between the two groups were investigated using a chart review to evaluate patient outcomes. The nurses' outcome variables were evaluated using a questionnaire. Results: First, after reviewing 11 guidelines by appraisal of the guidelines for research and evaluation collaboration II, 5 guidelines with a standardization grade of over 50 points were selected. An ECMO nursing protocol was developed based on these guidelines. Second, there were no statistically significant differences in physiological indicators between the two groups of patients. However, the experimental group showed a statistically significant decrease in the infection rate (p = .026) and pressure injury rates (p = .041). The levels of satisfaction with ECMO nursing care, and empowerment and performance of the nurses who used the ECMO nursing protocol were higher than those of nurses who did not (p < .001). Conclusion: This protocol may help prevent infections and pressure injuries in patients, and improve nurses' satisfaction and empowerment. The nursing protocol developed for critically ill patients receiving ECMO treatment can be utilized in evidence-based nursing practice.

Comparison of the Building Envelope Design Elements between Green Building Design Guidelines and Green Building Certification Criteria - Focus on public institution relocation projects - (녹색건축물 디자인가이드라인과 녹색건축 인증 비교를 통한 외피계획요소에 관한 연구 - 공공기관 지방이전 건축물을 중심으로 -)

  • Kim, So-Young;Hwang, Sung-Pil;Oh, Joon-Gul
    • KIEAE Journal
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    • v.14 no.4
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    • pp.61-68
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    • 2014
  • Due to rapid climate changing and the need for energy conservation, environment friendly initiatives have emerged, and regulations to support establishment of green structures in construction have been legislated and enacted. In this study, the supporting of green build method act for rapid climate change and energy conservation. Using green build method, protecting surrounding ecosystem and developing green building continuously, I suggest alternative for protection of the environment. Identifies Envelope Design Elements among various construction Green Building Design Guidelines. Green buildings that we extract the Green Building envelope design from Design Guideline, select the object building through the green buildings examples of public institution relocation projects. Since then analyzes the planned schematic design and Green Envelope Design Elements and Green Building Certification(G-SEED). So, that future directions for planning correlation of Green Building and Design Guidelines about Green Design Elements Can be presented.

Stress and Self Care Guideline Adherence in Students with Influenza A (H1N1) (신종인플루엔자 감염학생의 스트레스와 자가치료지침 수행)

  • Park, Jin-Hee;Kang, Jeong-Hee;Kim, In-Ja
    • The Journal of Korean Academic Society of Nursing Education
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    • v.17 no.2
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    • pp.277-286
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    • 2011
  • Purpose: This study examined levels of stress and adherence to self care guidelines in elementary and middle school students who were infected with the influenza A (H1N1) virus in 2009. Method: A total of 649 students from J city participated in the survey. Stress was measured with the Impact of Event Scale-Revised which was developed by Weiss and Marmar (1997) and translated by Eun and colleagues (2005). Adherence to self care guidelines was measured with the scale developed by the authors based on the self care recommendations from Korea Centers for Disease Control and Prevention. Result: Levels of stress and adherence to self care guidelines were higher in elementary school students. However, the severity of participants' stress was less than moderate. The adherence level was significantly different depending on status of taking an antiviral agent, health education and self care education regarding the virus infection. Conclusion: Findings suggest that effects of health education under the national crisis situation due to influenza A (H1N1) virus pandemic were helpful. More in-depth study is needed to understand and to improve middle school students' self care behaviors.

A Character Analysis of the Woodland in Cultivated Areas in point of Landscape Ecology (경작지 내 소규모 수림의 경관생태적 특성 분석)

  • Cho, Hyun-Ju;Ra, Jung-Hwa
    • Current Research on Agriculture and Life Sciences
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    • v.26
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    • pp.17-22
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    • 2008
  • This research put most emphasis on setting the guidelines for improvement through character analysis of landscape ecology to cope with ecological malfunction of the woodland surrounded in cultivated areas. The results are as follows. 1) As a result of character analysis of the woodland in cultivated area in point of landscape ecology in five case sites, the size of case site 3 is the largest as $3,000m^2$ and it is shown that a colony of pine trees which is valuable in terms of ecological, scientific, historic and cultural senses. 2) As a result of analysis on expansibility of woodland in cultivated area, case site 1 is 0.25, the lowest, flexibility is 4, the highest. In order to improve ecological function in woodland, it is regarded that maintaining curve form rather than straight one. 3) As a result of analysis of morphological diversity, case site 5 shows 1.3, the highest. However, the condition of vegetation and emergence frequency of species indicates low value degree. 4) Based on the result of analysis of landscape ecological character like above, the number of guidelines for the woodland in cultivated area is three and vegetation is four.

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Proposal of Diagnostic Checklist for Rural Housing Improvement (주거환경 개선을 위한 농촌주택 진단 체크리스트 제안)

  • Kim, So-ra;Kim, Sang-Bum;Kim, Yong-gyun
    • Journal of Korean Society of Rural Planning
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    • v.29 no.4
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    • pp.165-173
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    • 2023
  • When addressing rural housing issues, it is crucial to consider various aspects and adopt a tailored approach that takes into account the local characteristics and specific needs. Providing guidelines for different stakeholders, whether residents themselves or experts involved in decision-making, is essential for effective management and improvements. In this study, an in-depth analysis of the housing situation in the target area where the rural housing improvement project was implemented was conducted. This involved engaging with residents from three villages through in-depth interviews to gain insights into their perspectives and needs. As a result, a set of housing improvement guidelines were developed, which are specific to each stakeholder group and are tailored to address the criteria of safety, aesthetics, and living environment. These guidelines facilitate informed decision-making by residents and experts alike, ensuring that improvements align with the unique circumstances of each situation, promoting a more holistic and effective approach to addressing rural housing challenges.

Patterns and Interrelationships for Meeting Guidelines of Physical Activity, Sedentary, and Dietary Behavior in Korean Adolescents (한국 청소년의 신체활동, 좌식행동, 식이행동에 대한 가이드라인 실천 패턴 및 상호관련성)

  • Kim, Jae-Woo;Kong, Sung-A;Lee, On;Kim, Yeon-Soo;Yun, E-Hwa;Kim, Shin-Ah;Choi, Bo-Youl
    • The Korean Journal of Community Living Science
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    • v.20 no.3
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    • pp.413-421
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    • 2009
  • The purpose of this study was to analyze the patterns and the interrelationships for meeting guidelines of three health behaviors including physical activity(PA), sedentary behavior(SB), and dietary behavior(DB) for Korean adolescents using 2007 KYRBS(Korea Youth Risk Behavior Survey) data. A cross-sectional design was used to assess 73392 middle-high school students. PA(moderate physical activity${\geqq}$5times/week, or vigorous ${\geqq}$3times/week), SB(watching TV, computer, DVD, video, etc. < 3 hr/day), and DB(servings of fruits ${\geqq}$1 times/day, or vegetables ${\geqq}$ 3 times/day) were categorized into two levels (meeting guidelines or not). Chi-squared tests were conducted to compare the prevalence of students not meeting these three health behaviors between boys and girls, and logistic linear regression was used to determine the interrelationships of three health behaviors. Students meeting guidelines for PA, SB, and DB were 31.0%(boys 42.6%, girls 18.0%), 74.7%(boys 75.4%, girls 74.0%), and 38.5%(boys 38.6%, girls 38.4%), respectively. In addition, there were significant differences between both genders for PA and SB (PA; $x^2(1)$=35175.11, p<.0001, SB; $x^2(1)$=19.44, p<.0001). Only 10.9% of students met all three guidelines and 12.4% did not meet all three. Pattern that simultaneously did not meet PA and DB were high in both boys(27.1%) and girls(37.2%). Students who did not meet DB were at greater risk of not meeting PA(Boys; OR 1.49, 95% CI 1.43 to 1.55, Girls; OR 1.42, 95% CI 1.34 to 1.50), and not meeting SB(Boys; OR 1.41, 95% CI 1.34 to 1.48, Girls; OR 1.36, 95% CI 1.29 to 1.43) compared with students who met DB. The findings of this study supported further evidence for the need of a multiple behavior approach considering gender and interrelationships among three behaviors.

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Comparison of the Two Impairment Classes Publicized by the American Medical Association in Complex Regional Pain Syndrome Patients (복합부위통증증후군 환자에서 미국의사협회 영구장애평가지침에서 제시된 장애등급 평가방법의 비교)

  • Shin, Hwa Yong;Choi, Yong Min;Nahm, Francis Sahngun;Park, Seong Joo;Koo, Mi Suk;Suh, Jeong Hun;Sim, Sung Eun;Jo, Ji Yon;Lee, Sang Chul;Kim, Yong Chul
    • The Korean Journal of Pain
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    • v.20 no.2
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    • pp.148-153
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    • 2007
  • Background: Complex regional pain syndrome (CRPS) is not regarded as an impairment in Korea. Guidelines for rating this impairment are under development by the Korean Academy of Medical Science based on that of the American Medical Association (AMA). However, no studies have been done on the validity of these guidelines in Korea. We therefore evaluated the validity of these guidelines using the criteria from the chapter on the central and peripheral nervous system (CNS-PNS class) and the worksheet for calculating total pain-related impairment score (TPRIS class). Methods: TPRIS and CNS-PNS classes were calculated through interviews of 28 CRPS patients. The correlation between the two classes was calculated. Results: TPRIS class and CNS-PNS class were well correlated (r = 0.593, P < 0.05). Conclusions: Both TPRIS or CNS-PNS classes were well correlated and could be used for evaluation of impairment. However, the CNS-PNS class is simpler and quicker to complete.

An Analysis of the Existing Guidelines and Clinical Trials for the Development of the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) (위식도역류질환 한약제제 임상시험 가이드라인 개발을 위한 관련 국내 가이드라인 분석 및 기존 한약임상시험과의 비교)

  • Han, Ga-jin;Leem, Jung-tae;Kim, Jin-sung;Lee, Jun-hee
    • The Journal of Internal Korean Medicine
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    • v.37 no.1
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    • pp.90-108
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    • 2016
  • Objectives: This study aimed to learn what should be considered in the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) by analyzing the existing guidelines and clinical trials.Methods: The development committee searched the existing guidelines for herbal medicinal products or GERD. Then, clinical trials related to GERD using herbal medicine were selected. The chosen trials were analyzed in terms of their inclusion and exclusion of participants, intervention, comparators, outcome, and trial design. Then, we compared the results of the analysis according to the regulations and guidelines of the Ministry of Food and Drug Safety to suggest the issues that we will have to consider when developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).Results: As a result, few guidelines for GERD and clinical trials with herbal medicinal products were located in the national institution homepage. In addition, 8 articles were found using the following combination of search terms: “Gastroesophageal reflux disease”, “GERD”, “herbal medicine”, “herbal therapy”, “Korean Medicine”, “Traditional Chinese Medicine”, and “TCM”. Even though all trials had their own unique research questions, all studies were performed using a randomization method. Most trials included participants with reflux esophagitis, but two trials targeted proton pump inhibitor-refractory GERD. The type of intervention varied, such as decoction, granules, and capsules. Additionally, individualized herbal medicines were used in two studies. Comparators were diverse, such as placebo, Western medicine, and electro-acupuncture. The most frequently used outcome for efficacy was the effectiveness rate. In addition, the outcome for evaluating quality of life, esophageal mucosa and pressure, esophageal acid reflux, and recurrence rates were used. Safety was investigated by recording adverse events and carrying out laboratory tests.Conclusions: We identified some issues by reviewing the existing guidelines and comparing them with clinical trials for GERD and herbal medicinal products. These results will be utilized for developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).

A Comparative Study of Landscape Design Competitions' Guidelines and Entry Plans -The Case of Winning Design Proposals for Urban Infrastructure of the Hangdong Bogeumjari Housing District- (조경현상설계지침과 출품작의 내용관계 비교 -항동 보금자리주택지구 도시기반시설공모 입상작을 중심으로-)

  • Hong, Youn-Soon
    • Journal of the Korean Institute of Landscape Architecture
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    • v.39 no.2
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    • pp.18-28
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    • 2011
  • This study is aimed at the improvement of administrative operations of landscape design competitions and qualitative enhancement of design quality by mutually comparing the guidelines and entry plans. The case targeted for the current study is landscape design proposals for the Seoul Hangdong Bogeumjari Housing District recently launched within a greenbelt zone in the outskirts of Seoul. The study examines from a critical perspective the design guidelines and the contents of the three winning design proposals with a focus on whether or not they have reflected the guidelines. It was observed that many provisions of the principles and conceptual guidelines which serve as clues to the designs for winning designs proposals show the direction in which the project is to be headed It was also observed that the provisions and the way they are expressed are intertwined, while, at the same time, the guidelines were not organized or developed in an orderly manner. Such a structural pattern of the guidelines is linked to the aspects of the contents of the winning design proposals as described in the following. It is observed that guidelines related to the direction in which the design to be headed are so regulatory and lengthy that they are overly standardized. This could make it difficult to read the possibility of the alternative shifts in the winning design proposals. At the same time, the attributes of winning design proposals themselves, which require observable discriminatory superiority, could serve as a factor causing excess of meanings by jumping on the bandwagon of naming. On the contrary, where autonomy of design is guaranteed or no guidelines are provided for the winning design proposals, discriminatory differences were observed, thereby making it easy to measure them This illustrates well that guidelines and structural format should be provided through a separate undertaking that has taken into careful consideration environmental traits of the site in question, objectives required and so forth.