• 제목/요약/키워드: clinical guidance

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Bayesian methods in clinical trials with applications to medical devices

  • Campbell, Gregory
    • Communications for Statistical Applications and Methods
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    • 제24권6호
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    • pp.561-581
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    • 2017
  • Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

간호학생의 대상자 교육후 교육경험 만족도, 실습만족도 및 자기효능감 정도 (The Relationships between Patient Education Experience, Satisfaction with Clinical Nursing Practice and Self-Efficacy in Nursing Students)

  • 심미정
    • 문화기술의 융합
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    • 제4권1호
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    • pp.17-25
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    • 2018
  • 본 연구는 일개 대학의 간호학생을 대상으로 모성간호학 실습시 대상자에게 제공한 교육경험의 만족도, 실습만족도 및 자기효능감과의 관계를 분석하여, 실습의 질 향상을 위한 개선방안을 제시하고자 하였다. 연구결과, 간호학생들은 대상자 교육시 문제점으로는 대상자와의 접근, 교육시간 확보의 어려움 및 자신감 부족 등 이었다. 교육실시후 교육경험만족도는 3.84점, 임상실습만족도 4.00점, 자아효능감 2.68점으로 나왔다. 일반적 특성에 따른 대상자 교육경험의 만족도는 교육방법과 실습시기, 이론교육의 만족도에 따라, 임상실습만족도는 실습자의 태도, 실습만족도, 실습장소에 따라, 자아효능감은 성적, 이론교육의 만족도, 교육장소에 따라 차이가 있는 것으로 나왔다. 따라서 모성간호학 실습의 어려움과 한계를 극복하기 위해 병원관계자와 긴밀한 협력관계 유지하고, 간호학생의 요구를 반영한 교육방법과 실습지도 방안을 다각적으로 모색할 필요가 있다.

IPA을 기반한 간호대학생의 핵심기본간호술 중요도인식 및 수행도와 전공만족도 과의 관계연구 (A study on The Relationship between IPA-based Nursing Students' Recognition and Performance of Core Basic Nursing Skills and Major Satisfaction)

  • 장미영;김은재
    • 한국임상보건과학회지
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    • 제8권2호
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    • pp.1398-1407
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    • 2020
  • Purpose: The purpose of this study is a technical study to understand the relationship between the recognition and performance of core basic nursing skills of nursing college students who are ahead of clinical practice, and satisfaction with their major. Method: The subjects were 208 second-year students enrolled in the four-year nursing department located in J City and C City. General characteristics, characteristics of clinical practice, and recognition of the importance of core basic nursing skills, performance, and satisfaction with majors were investigated. Descriptive statistics, t-test, analysis of variance, multiple regression analysis and IPA are performed for data analysis Results: The results are follows. The results are follows. First, the performance was lower than that of the core basic nursing skills (p<.001). As a result of comparing the importance recognition and performance of the core basic nursing items, the importance recognition was significantly compared to the performance level in all 20 items. It showed high results. Second, it was found that there was a significant positive correlation (r=.40, p<.01) with major satisfaction in core basic nursing performance. Conclusion: These results highlight the need to develop education. It is necessary to establish a learning strategy through various learning guidance methods and self-directed learning that can improve the performance of items with low performance, although recognized as important through the Core Basic Nursing IPA for nursing students who are about to practice clinical practice. It is suggested to do repeated research applied.

어린이병원 신규간호사를 위한 간호역량 향상 교육프로그램 개발 및 효과검증 (The development and evaluation of a pediatric nurse education program to improve nursing competency for newly graduated nurses in a children's hospital)

  • 신혜경;김효영;김현정;김민경;신현주;이후연;한지희;이혜정
    • 한국간호교육학회지
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    • 제28권2호
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    • pp.179-192
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    • 2022
  • Purpose: The purpose of this study is to identify the effects of a standardized educational program to improve nursing competency on newly graduated nurses in a children's hospital after developing and applying a pediatric nurse education program. The effectiveness of the program was confirmed by evaluating the clinical competency and field adaptation. Methods: In the first step, an education program was developed using the analysis, design, development, implementation and evaluation (ADDIE) model. As a second step, a similar experimental study of a single group repeat measures design was conducted to evaluate the clinical competency and field adaptation over time after application of the program. Additionally, a focus group interviews were conducted to collect subjective data on the effects and improvement points of the program. Results: As a result of applying the program, there was a significant change in the clinical competence and the field adaptation of newly graduated nurses in a children's hospital. The categories derived from the focus group interviews were "getting special guidance," "better care," "becoming a nurse at a children's hospital" and "winning together." Conclusion: It was confirmed that the education program enhances the clinical competency of new nurses in children's hospitals. In addition, it provided the necessary data to understand the experiences of new nurses, help them adapt effectively, and establish appropriate interventions.

전문간호사 업무범위안 제정에 따른 전문의의 업무 위임 의향 (Intention to Delegate Clinical Practice of Medical Specialists in Accordance with the Enactment of the Scope of Practice for Advanced Practice Nurses)

  • 김민영;최수정;김정혜;임초선;강영아
    • 대한간호학회지
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    • 제53권1호
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    • pp.39-54
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    • 2023
  • Purpose: This study aimed to investigate the nationwide intention to delegate clinical practice of medical specialists in accordance with the enactment of the scope of practice for advanced practice nurses (APNs). Methods: Data were collected from October to December 2021 using Google Surveys. In total, 147 medical specialists from 12 provinces responded to the survey. The survey questionnaire was categorized into four legislative draft duties, according to the scope of practice (a total of 41 tasks): Twenty-nine tasks on treatments, injects, etc., performed under the guidance of a physician and other activities necessary for medical treatment (treatment domain); two tasks on collaboration and coordination; six tasks on education, counseling, and quality improvement; four regarding other necessary tasks. Participants were asked whether they were willing to delegate the tasks to APN. Results: The intention to delegate tasks to APN was higher for non-invasive tasks such as blood sampling (97.3%) or simple dressing (96.6%). Invasive tasks such as endotracheal tube insertion (10.2%), sampling: bone marrow biopsy & aspiration (23.8%) showed low intention to delegate in the treatment domain. Participants who were older, male, and had more work careers with APN, showed a higher intention to delegate tasks. Conclusion: To prevent confusion in the clinical setting, a clear agreement on the scope of APN practice as APN delegated by physicians should be established. Based on this study, legal practices that APN can perform legally should be established.

환축추 아탈구 견에서 투시기 유도를 통한 복측 나사 고정술 (Ventral Fixation of Atlantoaxial Joint under Fluoroscopic Guidance Using Screws in a Chihuahua Dog)

  • 이재훈;양희택;양우종;정다정;강은희;엄기동;최치봉;장화석;김휘율
    • 한국임상수의학회지
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    • 제25권2호
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    • pp.131-135
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    • 2008
  • 5연령의 치와와 견이 사지 부전마비를 평가하기 위해서 내원하였다. 내원 시에 보행이 불가능한 사지 부전마비와 목 부위 통증을 보였다. 방사선 상에서 환축추 아탈구와 C1 등쪽의 추궁과 C2의 가시돌기의 거리가 증가 된 소견을 보였다. 외과적 고정은 투시기 유도 하에서 복측 접근을 통하여 2개의 나사(screw)를 사용하여 실시하였으며, 외부 고정(neck brace)을 3주 동안 실시하였다. 수술 후 4주 후 임상증상이 개선되어 보행이 가능 하였으며, 방사선 상에서 고정을 유지하고 있었으며, 나사의 이주 소견은 없었다. 4개월 후에 임상증상이 완전히 회복되었다. 본 증례에서는 복측 나사 고정을 투시기 유도하에서 실시함으로, 나사의 적합한 각도로 위치 시킬 수 있었다.

간호학생이 임상실습시 느끼는 불안의 정도와 불안야기 상황연구 (Nursing Students Anxiety level and Perceptions of Anxiety-Producing Situations in the Clinical Setting)

  • 박춘자
    • 한국간호교육학회지
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    • 제3권
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    • pp.34-45
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    • 1997
  • Aspects of nursing student's clinical experiences are anxiety provoking. High anxiety may contribute to decreased learning. The purpose of this study was to identify the level of anxiety and potentially anxiety-producing clinical experience, the relation between the level of anxiety and their Trait-Anxiety and State-Anxiety. Finally, it is aimed at getting preparing data for guidance of students which can enhance learning effect of students for clinical experience. The samples of this study were 36 junior students(1 semester experience) and 44 senior students (3 semester experience) from Junior College of Nursing in Seoul on September 1996. The tools of this study were two kinds ; questionare of Spielberg' STAI measuring State and Trait-Anxiety, and author's for measuring the level of Anxiety producing situations and 10cm visual analogue scale was also used for measuring self stated level of anxiety on clinical setting. The collected data were analyzed by SPSS using percentage, t-test, ANOVA and Pearson correlation coefficient. The results of this study were as follows : 1. The self perception of anxiety level was 4.3/10cm and the level of anxiety in clinical setting situations was 3.5/5. 2. Among 20 questions for perception of anxiety-producing situations in the clinical setting. 'deficit of nursing knowledge' was the highest item(4.18), 'vagueness of role'(4.11), 'lack of nursing skill'(4.00), 'evaluation by faculty'(4.00) 'fear of making mistakes'(3.81) 'initial clinical experience on a unit'(3.76) 'initial application of nursing knowledge'(3.74) in turn. 3. The level of State-anxiety of senior students was higher than junior's (p=0.005)and the level of Trait-Anxiety of insufficient interpersonal relationship and unhealthy students were higher than others (p=0.015) There was no differences according to the student's grade in level of anxiety. 4. Both of self-stated anxiety and situationa anxiety of unhealthy students were high (p=0.007, p=0.000) and the level of self-stated anxiety of unsatisfied students for selection major and clinical experience were high (p=0.050, p=0.009). 5. Self-stated anxiety and situation anxiety (p=0.0000), self-stated- anxiety and Trait-anxiety(p=0.003), situation anxiety and Trait-anxiety(p=0.004), and Trait-anxiety and state-anxiety(p=0.000) of the students were interrelated. By the above conclusion, the nursing students still feel anxiety on clinical experience and on making a mistake due to the lack of their nursing knowledge and skill. And the students are afraid of the faculties' evaluation. In addition, the students who are not healthy and have not sufficiently interpersonal relationship feel more anxiety. But, since there was no difference significantly between each grade, we think it is needed that further study on the same topic in large samples. And, we have to equip the students with much nursing knowledge and philosophy apparently before the students have clinical experience. Finally, the faculty have to reduce the students' anxiety by making a climate of acceptance in clinical setting with good personality.

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광주·전남 임상병리과 재학생의 학과만족도 및 취업에 대한 의식도 조사 (Investigation of the Clinical Pathology Department Student Satisfaction and Their Recognition of Employment in Gwangju-Jeonnam Province)

  • 황구연;조영국
    • 대한임상검사과학회지
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    • 제42권1호
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    • pp.55-61
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    • 2010
  • This investigation has been carried out for the purpose of the examination of current Gwangju and Jeonnam clinical pathology students' recognition of their departments and of effective employment guidance. Furthermore, it has examined the students' recognition on two sides; namely, their satisfaction with their own departments and their recognition of the employment of medical technologists. This investigation, with 389 students as its subjects from the clinical pathology departments at 4 universities in the Gwangju-Jeonnam Region, has compared and analyzed the data from the survey with a questionnaire from November 2008 to June 2009 by using the SPSS 12.0 package. Some of the remarkable results from the yielded data are as follows. As for the motivation for their application to the clinical pathology departments, the investigation of the students' satisfaction with their departments has revealed that 47.5% of the subjects indicated recommendation from friends or acquaintances while 22.1% reported that they had been informed of the departments through Internet. 70.4% of the subjects graduated from general high schools, 22.3% from commercial high schools, and 6.2% from technical high schools. Applicants from general high schools tend to decrease in number every year. 28.5% of the students judged professor's capability of lecture as an important part of their acquisition of licenses, and more than 65.6% of the subjects acknowledged the necessity of their self-study at night for the acquisition of license. As for the future prospect of the occupation of clinical technologist, 46.8% of the students replied that it was promising, while 39.1% reported that they had no ideas. From this we can confirm that the students of clinical pathology lacked a viewpoint of occupation and goals for future jobs. The investigation of the students'recognition of the employment of clinical technologists has revealed that 47.8% of them wanted to be employed in the Seoul-Gyeonggi Region due to the properties of their local universities, 29.0% of themlogpecteties of monesly salary to be 1,200,000~1,300,000 won, while 22.4% 1,300,000~1,400,000 won. These fiemres indicated that these students' salary ogpectations were relativplo lower than those from cities ertiprovinces. As for the greatest difficulty after employment, 31.1% of the subjects indicated the confliction among employees from variouatiolleges, 27.3% uncertainty of duties related to es of major, 24.9% bmrdens of self-development.

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보건진료원 직무교육 교과과정개선을 위한 연구 (A Study on Curriculum Development for CHPs)

  • 권명순
    • 한국보건간호학회지
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    • 제13권2호
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    • pp.26-44
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    • 1999
  • The study was done to improve the job training course for Community Health Practioners (CHPs) by evaluating the level of help that the training provided to the CHPs in carrying out their work and to analyze the management activities of the CHPs in order to develop a more effective CHP training program. The methodologies used in the study were a questionnaire survey. The survey results were analyzed using SPSS Windows. The study results are as follows. 1. The total average level of help from the job training(Theory. Practice and Field Practice) for carrying out the CHP work was found to be $3.04\pm.53$ (of a possible 4), which indicates a high level of help. The average for clinical practices was $3.16\pm.60$. for theory. $3.11\pm.40$ and for field practice. $2.84\pm.60$. 2. For the theory content of the job training courses. the help level was low in the area of mother and child health management/family planning with an average of $2.65\pm.62$ and in the area of health information system development with an average of $2.62\pm.83$. The reason for these deficiencies were. in order of frequency. few opportunities to apply learning. training content that was inadequate. training methodologies which were incongruent with content. improper training items and insufficient class hours. For the practice. the clinical work in rehabilitation/orthopedics departments and in ENT/Opthalmology departments had averages of $2.96\pm.86$ and $2.97\pm.80$ respectively. This low level resulted from the lack of direct experience. lack of sincerity during the practice time. lack of practice guidance. insufficient time and lack of practice equipment. in that order. For the field practice. the delivery management averaged $2.06\pm.90$ as the lowest help level. In this case 68% of respondents replied that there were no relevant reasons for this deficiency. 21% responsed that there was a lack of direct experience, 7%, a lack of practice guidance and 4.8%, insufficient time. 3. There were significant differences for several demographic variables when comparing the help level of the clinical courses (practice and Field Practice). A higher help level was reported by older nurses as compared to younger ones, experienced nurses as compared to scholarship nurses, and married over single. Also for nurses who had finished more other programs and were qualified or licensed in several areas the level was high. Although it was not statistically significant the level was higher if the work area was in a rural county, not a city, and if one had more recently completed the job training(P<,05). 4. Of the respondents 58.6% replies stated the period of job training for the CHP was adequate, but 51.7% reported that the period for theory courses was too short while an other 48.3% responded that it was sufficient. For practice locations, 50% responsed that it was good to practice in medical institutions(primary, secondary and tertiary) at the same time. While 48.3% agreed that doing theory and practice simultaneously was good, and 56.9% agreed that field practice should be done after completing theory and practice training. Hence, the development of new field practice guidelines suitable for changing environments of health management are required in place of the existing ones which were considered low in help level to the practical work of the CHPs.

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한국 초.중.고.대학생들에서 약물정보습득의 방법 및 약물오남용의 위험성에 대한 평가 (Evaluation of Drug Information for Acquisition Methods and Risk of Drug Misuse in Korean Students)

  • 김진식;이옥상;임성실
    • 약학회지
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    • 제57권1호
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    • pp.55-62
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    • 2013
  • Objective: This study aims to assess the following issues - acquisition level in terms of the information on frequently used drugs of youth, access paths for the information, actual status of the use of drugs frequently used by youth, types of the used drugs, drug abuse among youth, and the consequent drawbacks. This study also takes aims at suggestion of correct role of pharmacists in consideration of drug abuse among youth. Methods: During the period from August 1, 2011 to October 31, 2012, a research design and a question development have been conducted. To the students of the schools that were randomly selected (elementary school's N=99, middle school's N=106, high school's N=115 and university's N=115), it was asked to complete given questionnaire from August 1, 2012 to August 31, 2012. During the period from September 1, 2012 to October 30, 2012, the questionnaires were collected back and the analysis and evaluation of them were carried out. Results: Drugs known to the respondents were a total of 115 different medicines and most of the drugs belonged to over-the-counter drugs. The most well known drug was pain reliever and the second most familiar drug was wound ointment. Most of the respondents found the drugs through direct use and advertisement. In everyday life, more than half of the respondents were using over-the-counter drugs as well as health supplements. The most commonly used drug was analgesic drug. It was showed that the respondents also frequently used the drugs for improving their grades and appearances. It was shown that among the cases of drug use, there were also the cases of misuse and abuse of drugs for the respondents or people around them. Reliability of pharmacists was shown to be high and many students were also satisfied with the pharmacists' guidance for medication. Conclusion: Currently many students are using different kinds of drug in daily life, and there is a possibility that the risk of misuse and abuse of drugs will be increased. Those age groups can easily engage in bad habit of drug use. Thus, promotion on accurate drug information has to be strengthened, and pharmacists are required to conduct correct guidance for drug user's medication in terms of use amount, usage, interactions among different drugs, and potential risks.