• 제목/요약/키워드: guideline information center

검색결과 162건 처리시간 0.023초

임상시험 시험대상자설명서의 가독성 평가 (Readability of Patient Information Leaflets in Clinical Trials)

  • 최임순;용철순;이인향
    • 한국임상약학회지
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    • 제26권1호
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    • pp.33-39
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    • 2016
  • Background: Elements of informed consent including capacity, disclosure, understanding, voluntariness, and permission of the participant, are all crucial for clinical trials to be legally and ethically valid. During the informed consent process, the patient information leaflet is an important information source which prospective research subjects can utilize in their decision-making. In the adequate provision of information, KGCP guideline necessitate 20 specific items, as well as the use language that individuals can understand. This study measures the vocabulary level of patient information leaflets in an effort to provide an objective evaluation on the readability of such material. Methods: The word difficulty of 13 leaflets was quantitatively evaluated using Kim kwang Hae's vocabulary grading framework, which was compared to the difficulty level of words found in the $6^{th}$ grade Korean textbook. The quantitative outcomes were statistically analyzed using chi-squared tests and linear by linear association for ordinal data. Results: There was a statistically significant difference between the vocabulary level and frequency of words in leaflets and the 6th Korean textbook. The leaflets were on average 260 sentences and about roughly 15 pages long, including lay language (easier or equal to language used in primary school) of around 12% less; technical language of around 4.5% more. As the vocabulary grades increase, there was a distinct difference in vocabulary level between Korean textbook and each information leaflet (p < 0.001). Conclusion: Patient information leaflets may fail to provide appropriate information for self-determination by clinical trial subject through the difficulty level of its wording. Improvements in the degree of patients' understanding and appropriate use of information leaflets are collaboratively equipped to strengthen patient's autonomy and therefore guaranteeing participant's rights.

Subacute Inhalation Toxicity of 3-Methylpentane

  • Chung, Yong Hyun;Shin, Seo-Ho;Han, Jeong Hee;Lee, Yong-Hoon
    • Toxicological Research
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    • 제32권3호
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    • pp.245-250
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    • 2016
  • 3-Methylpentane ($C_6H_{14}$, CAS No. 96-14-0), isomer of hexane, is a colorless liquid originating naturally from petroleum or natural gas liquids. 3-Methylpentane has been used as a solvent in organic synthesis, as a lubricant, and as a raw material for producing carbon black. There is limited information available on the inhalation toxicity of 3-methylpentane, and the aim of this study was to determine its subacute inhalation toxicity. According to OECD Test Guideline 412 (subacute inhalation toxicity: 28-day study), Sprague Dawley rats were exposed to 0, 284, 1,135, and 4,540 ppm of 3-methylpentane for 6 hr/day, 5 days/week for 4 weeks via whole-body inhalation. Mortality, clinical signs, body weights, food consumption, hematology, serum chemistry, organ weights, and gross and histopathological findings were compared between control and all exposure groups. No mortality or remarkable clinical signs were observed during the study. No gross or histopathological lesions, or adverse effects on body weight, food consumption, hematology, serum chemistry, and organ weights were observed in any male or female rats in all exposure groups, although some statistically significant changes were observed in food consumption, serum chemistry, and organ weights. In conclusion, the results of this study indicate that no observable adverse effect level (NOAEL) for 3-methylpentane above 4,540 ppm/6 hr/day, 5 days/week for rats.

말기암 환자의 통증 양상과 통증관리에 영향을 미치는 요소들 (Pain and Its Major Influencing Factors in the Management of Terminal Cancer Patients)

  • 이수련;길호영;한태형
    • The Korean Journal of Pain
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    • 제12권2호
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    • pp.221-226
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    • 1999
  • Background : Validity of WHO guideline of cancer pain management has been proven and many trials have been done to derive solutions for inadequate cancer pain management. We assessed the severity of pain of terminal cancer patients in a few different ways and patients' characteristics influencing inadequate pain management. Methods : This study was based on 100 adult oncological patients who were confirmed as terminal stage in our institution from 3/1998 to 11/1998. Medical records were reviewed and individual patients were interviewed to obtain demographic information and medical characteristics such as: daily activity performance, metastasis, and drug-adjusted pain severity. Adequacy of prescribed analgesics in accordance with WHO guidelines of pain management and patients' characteristics influencing adequacy of pain management were assessed. Results : Among those cancer patients diagnosed as terminal stage, 85% complained of pain, and 68% of those patients reported pain above moderate severity. 38% of those patients received inadequate pain management resulting in greater severity of pain; the less adequate pain relief was(p<0.01). Sex, age, primary cancer site metastasis, symptoms such as depression and anxiety, and daily activity performance were not significantly related. Conclusions : Despite WHO guidelines for pain management, majority of the terminal cancer patients received inadequate pain management. There is a necessity for education on proper pain evaluation and strict implimentation for WHO guidelines of pain management.

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후두결핵의 임상양상과 진단 (Clinical Characteristics and Diagnosis of Laryngeal Tuberculosis)

  • 조현진;소윤경;손영익
    • 대한후두음성언어의학회지
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    • 제19권1호
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    • pp.43-46
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    • 2008
  • Background and Objectives : Clinical suspicion and appropriate diagnostic procedures are essential for the timely management of extrapulmonary type of mycobacterial disease. In the hope of suggesting a suitable guideline for the early diagnosis of laryngeal tuberculosis, the authors reviewed their clinical pathways and the characteristics of patients with laryngeal tuberculosis who were managed in the recent 10 years at a single tertiary referral hospital, Samsung Medical Center. Subjects and Method : Retrospective chart review was performed for the 25 adult patients with laryngeal tuberculosis. Among 25 cases, 12 were pathologically confirmed by laryngeal biopsy and the other 13 were clinically diagnosed by cumulative clinical information; definite laryngitis on laryngoscopy, positive AFB (acid fast bacillus) smear/culture or active pulmonary tuberculosis on chest X-ray, and substantial response to anti-tuberculosis medication. Results : Chest X-ray revealed active pulmonary tuberculosis in 72% of patients (N=18/25). Sputum AFB smear/culture was positive in 95% of all tested patients (N=21/22) and in 100% of the tested patients who have stable or no evidence of pulmonary tuberculosis (N=5/5). All patients except one who had coexisting laryngeal malignancy showed considerable improvement in their subjective symptoms and laryngeal findings within the first 2 months of anti-tuberculosis medications and they achieved complete response on subsequent sputum studies, chest X-ray and laryngeal findings after $7.0{\pm}2.3$ months of the medications. Conclusion : We suggest that chest X-ray and sputum AFB smear/culture to be the first step of work-up for the patients having laryngeal tuberculosis in suspicion since laryngeal tuberculosis is largely associated with active pulmonary tuberculosis and/or sputum AFB study offers high yield even in case of primary laryngeal tuberculosis. However laryngeal biopsy must be considered in case showing unsatisfactory response to the anti-tuberculosis medication for more than 2 months.

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장애인을 위한 유니버설 웹 유저 인터페이스 디자인에 관한 연구 (A Study of Universal Web USER INTERFACE Design for a Disabled)

  • 이중엽
    • 한국컴퓨터정보학회논문지
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    • 제12권4호
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    • pp.191-200
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    • 2007
  • 본 연구는 지식과 정보가 중심이 되고 있는 현대사회에서 장애인들은 인터넷을 이용한 정보획득이 매우 중요한 일이라고 할 수 있다. 장애인들이 웹을 통하여 보다 쉽게 정보를 찾을 수 있는 웹 유저인터페이스 디자인의 유형을 개발하고자 하였다. 본 연구에서는 현황조사와 문헌연구를 통하여 장애인을 대상으로 실험을 실시할 프로토 타입을 개발하여 장애인들을 대상으로 실험을 하고 심층면접을 통하여 쇼핑페이지에 있어서 장애인 계층을 위한 웹 인터페이스디자인의 가이드라인을 제시하였다. 장애인 계층의 인터넷 사용 활성화를 위해서는 보다 커다란 시각적 요소의 사용과 단순화된 정보의 구조, 쉬운 마우스의 조작을 위한 인터페이스디자인이 요구된다고 할 수 있다. 인터넷 사용인구의 증가와 함께 장애인 사용자도 증가하는 현 추세에서 장애인들을 위한 웹 인터페이스디자인의 가이드라인이 적용된다면 장애인 계층의 사용자는 보다 편리한 웹 사이트에서 쉽게 정보를 획득할 수 있을 것이다. 이러한 결과를 바탕으로 웹 인터페이스를 제공할 때 장애인뿐만 아니라 모든 계층을 위한 유니버설 디자인이 가능할 것이다.

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사이버위협정보 공유 활성화를 위한 관리적·기술적 개선모델 연구 (A Study on the Improvement Model for Invigorating Cyber Threat Information Sharing)

  • 윤오준;조창섭;박정근;서형준;신용태
    • 융합보안논문지
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    • 제16권4호
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    • pp.25-34
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    • 2016
  • 정부 주요인사의 스마트폰을 대상으로 한 해킹과 인터넷뱅킹 보안소프트웨어 제작업체의 내부 전산망 장악시도 및 방글라데시 중앙은행의 계좌 이체 등에서 보듯이 최근의 사이버공격은 국내외는 물론 공공과 민간영역을 구분하지 않고 동시다발적으로 발생하고 있다. 이에 본 논문에서는 이러한 사이버위협에 대처하기 위한 관계기관간의 사이버위협정보 공유 필요성을 제기하면서 법 제도 미흡, 통합된 정보시스템 미비, 민 관의 공동 협의기구 부재 등 현실태를 지적하였다. 이를 해결하기 위해 정보공유 가이드라인 제정 등 법 제도 개선, 국가정보공유센터 설립 및 통합정보시스템 구축 운영, 사이버위협정보 수집 분석 검증 등 전 과정 자동처리기술 개발, 민 관 합동 정보공유협의체 구성 등 사이버위협 정보공유 활성화를 위한 관리적 기술적 개선모델을 제시함으로써 사이버위협을 사전 차단하고 사이버공격 발생 시에도 피해의 확산을 방지하고자 한다.

엑스선촬영 각도를 측정할 수 있는 장치 개발과 흉부 X선 영상촬영에서의 적용 (Development of portable digital radiography system with device for sensing X-ray source-detector angle and its application in chest imaging)

  • 김태훈;허동운;류종현;정창원;전홍영;김규겸;홍지민;장미연;김대원;윤권하
    • 한국컴퓨터정보학회:학술대회논문집
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    • 한국컴퓨터정보학회 2017년도 제55차 동계학술대회논문집 25권1호
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    • pp.235-238
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    • 2017
  • This study was to develop a portable digital radiography (PDR) system with a function measuring the X-ray source-with-detector angle (SDA) and to evaluate the imaging performance for the diagnosis of chest imaging. The SDA device consisted of an Arduino, an accelerometer and gyro sensor, and a Bluetooth module. According to different angle degrees, five anatomical landmarks on chest images were assessed using a 5-point scale. Mean signal-to-noise ratio and contrast-to-noise ratio were 182.47 and 141.43. Spatial resolution (10% MTF) and entrance surface dose were 3.17 lp/mm ($157{\mu}m$) and 0.266mGy. The angle values of SDA device were not significant difference as compared to those of the digital angle meter. In chest imaging, SNR and CNR values were not significantly different according to different angle degrees (repeated-measures ANOVA, p>0.05). The visibility scores of the border of heart, 5th rib and scapula showed significant differences according to different angles (rmANOVA, p<0.05), whereas the scores of the clavicle and 1st rib were not significant. It is noticeable that the increase in SDA degree was consistent with the increase of visibility score. Our PDR with SDA device would be useful to be applicable to clinical radiography setting according to the standard radiography guideline at various fields.

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정부 및 공공기관의 보건 관련 웹 사이트의 웹 접근성 - 자동 및 전문가 평가 - (Web Accessibility of Healthcare Websites of Korean Government and Public Agencies: Automated and Expert Evaluations)

  • 이용정
    • 한국비블리아학회지
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    • 제26권4호
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    • pp.283-304
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    • 2015
  • 본 연구는 정부 및 공공기관의 보건 관련 웹 사이트들의 웹 접근성을 한국형 지침에 따라 평가하여 장애인이나 노령자들과 같은 정보이용 소외집단들이 겪을 수 있는 문제점들을 파악하고자 하였다. 본 연구에서는 총 27개의 보건 관련 웹 사이트의 접근성을 자동평가 및 전문가 평가를 수행하여 측정하였다. 두 단계의 평가를 실시한 결과를 종합해 볼 때, 국립병원이나 국립재활원 등과 같은 의료기관들은 웹 접근성 오류가 거의 없는 것으로 나타났으며, 그 외에도 건강보험심사평가원, 보건복지부, 보건사업진흥원, 식품의약품안전처, 그리고, 한국의료분쟁 조정중재원 등은 웹 접근성 준수율이 매우 높았다. 그러나 전문가 평가를 실시한 결과, 자동평가에서는 오류가 없는 것으로 나타났던 적절한 대체텍스트의 제공이 매우 미흡한 것으로 나타났으며, 텍스트 콘텐츠의 명도 대비가 표준에 미치지 않아 전맹자나 저시력자들의 웹 접근성을 지원하기 힘든 것으로 평가되었다. 그 외에도 기본언어표시와 마크업 오류 등 정확한 정보의 전달을 어렵게 하는 문제들이 나타났고, 반복영역 건너뛰기, 콘텐츠 선형화, 그리고 키보드 사용보장을 준수하지 않는 문제들이 발견되어 시각장애뿐 아니라 인지장애 내지 운동장애가 있는 이용자에게는 웹 접근성을 심각하게 방해하는 요소가 될 수 있는 것으로 파악되었다. 본 연구는 국내 연구로서는 처음으로 정부 및 공공기관의 보건관련 웹 사이트들의 접근성을 한국형 지침에 따라 평가했다. 또한, 이러한 웹 사이트들을 대상으로 자동 평가로 측정하기 어려운 웹 접근성의 정도와 상세한 내용 분석을 포괄하는 전문가 평가를 수행했다는 점에서 웹 접근성 연구 분야에 기여했다고 볼 수 있다.

국내 종합병원의 웹 접근성 실태에 관한 연구 (A Study on Current State of Web Content Accessibility on General Hospital Websites in Korea)

  • 김용섭;오군석
    • 인터넷정보학회논문지
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    • 제11권3호
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    • pp.87-103
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    • 2010
  • 본 연구에서는 국내외의 웹 접근성 동향을 살펴보고 웹 접근성을 보장하기 위한 법제도와 웹 접근성 실태를 소개하였다. 그리고 우리나라의 웹 접근성 지침을 근거로 종합전문요양기관 종합병원 등 80개 의료기관을 대상으로 웹 접근성 실태를 조사하였다. 평가항목은 접근성 베이스 평가기준으로 웹 접근성 지침1의 대체텍스트 제공, 지침2의 프레임사용제한, 키보드로만 운용 등 3개 항목, 사용성 베이스 평가기준으로 음성서비스 제공, 글자크기 조정, 다국어 웹사이트 제공, 웹 접근성 방침 공시 등 4개 항목에 대하여 평가를 실시하였다. 웹 접근성 준수율을 나타내기 위하여 KADO-WAH2.0을 사용하였다. 평가결과 웹 접근성 준수율이 전체적으로 미흡한 수준이었으나, 과거와 비교하여 상당한 수준까지 개선되었다. 그리고 준수하는 의료기관과 그렇지 못한 의료기관의 차이가 매우 크게 나타났다. 한편 많은 병원들이 웹 접근성에 대응하기 위한 노력을 하고 있다는 것을 알 수 있었다. 향후 공공성 공익성이라는 특성을 가진 의료기관에 대해서도 웹 접근성 확보를 위한 독자적인 접근성 지침의 수립, 웹 접근성에 대한 인식의 제고, 지속적인 교육 및 홍보, 법 제도적 보완 등을 적극적으로 추진하는 것이 바람직하다고 본다.

흑생강의 단회투여독성시험과 안전성등급화 (Single oral toxicity test and safety classification for Kaempferia parviflora)

  • 한영훈;박영철
    • 대한본초학회지
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    • 제33권4호
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    • pp.53-58
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    • 2018
  • Objectives : Kaempferia parviflora Rhizome is black ginger indigenous to Laos and Thailand. It has been used as a folk medicine to improve blood flow and promote vitality and longevity with good health and well being. For these reasons, Kaempferia parviflora Rhizome has been focused on developing it as a food or food supplement. In addition, Kaempferia parviflora Rhizome could be under consideration of new prescription based on its characteristic compounds, polymethoxyflavonoids. However, it needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was carried out to identity acute information of the toxicity of Kaempferia parviflora Rhizome powder and to make sure of its safety in clinical applications. Methods : Test substance was orally administered to male and female SD-rat at dose levels of 5000 mg/kg to estimate approximate lethal dose(ALD). Based on the acute information of the toxicity, the safety classification was estimated using the HED(human equivalent dose)-based MOS(margin of safety). Results : At 14 days after treatment with test substance. there were no of test substance related with mortalities and clinical signs. In addition, no changes in the body or organ weights and no gross or histopathological findings were observed. Thus, the ALD of Kaempferia parviflora Rhizome powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the single oral toxicity test using the highest and limit dose, 5,000 mg/kg and the decision guideline for safety classification based on HED-based MOS, it was estimated that Kaempferia parviflora Rhizome powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.