• 제목/요약/키워드: Clinical effectiveness

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다목적 안과용 레이저 시스템 안전성 성능평가 및 임상적 유효성평가 가이드라인 수립을 위한 연구 (A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System)

  • 김유림;유우진;박호준;장원석
    • 대한의용생체공학회:의공학회지
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    • 제40권6호
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    • pp.250-259
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    • 2019
  • Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

Have we Comprehensively Evaluated the Effectiveness of Endoscopic Screening for Gastric Cancer?

  • Hamashima, Chisato
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권8호
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    • pp.3591-3592
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    • 2015
  • Endoscopy has been increasingly used in clinical practice and as a standardized examination procedure for gastrointestinal diseases. However, only a few studies on endoscopic screening for evaluating mortality reduction from gastric cancer have been carried out. Even if a high detection rate is obtained in clinical practice, such a rate cannot be directly accepted as evidence providing the effectiveness of cancer screening. Endoscopic screening for gastric cancer is not an exception of possibility to detect overdiagnosis. If detection rate is used for the evaluation of the effectiveness of cancer screening, the possibility of overestimating the effectiveness of cancer screening cannot be ruled out. To avoid the effect of overdiagnosis and confirm the effectiveness of endoscopic screening, mortality reduction from gastric cancer must be carefully evaluated by conducting reliable studies. The burden of gastric cancer remains real and this cannot be ignored in Eastern Asian countries. To determine the best available method for gastric cancer screening, evaluation of its effectiveness is a must. Endoscopic screening for gastric cancer has shown promising results, and thus deserves further comprehensive evaluation to reliably confirm its effectiveness and how its optimal use can be strategically promoted.

한의약 의료기기 임상시험 교육 프로그램 개발을 위한 설문조사 연구 (Survey Research for Developing Educational Programs on Clinical Trials of Korean Medicine Devices)

  • 최익수;엄태웅;이동효;이고은;김신아;김남권
    • 대한한의학회지
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    • 제36권3호
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    • pp.84-97
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    • 2015
  • Objectives: The purpose of this study was to investigate and analyze the demands for educational programs on clinical trials of Korean medicine devices, and develop training programs based on the needs of Korean medicine. Methods: This research was conducted targeting 26 volunteer applicants who had participated in clinical trials of Korean medicine devices within the last five years (2010-2015). The survey was carried out between May 1, 2015 and May 26, 2015 via e-mail. After receiving questionnaire replies, the material was established. Using obtained data, frequency analyses were performed using SPSS 20.0 version. Results: 92% of the researchers who participated in the survey expected introduction of educational programs on clinical trials and anticipated that programs contain information that can meet the needs of each researcher. In addition, according to the analysis, introducing expert certification for clinical trials of Korean medicine devices is necessary, and offering related graduate courses are also needed. Conclusions: As a result of this study, researchers had difficulties during clinical trials of Korean medicine devices. If the educational programs were to be developed and institutional frameworks support them effectively, it would prove to be helpful to researchers in clinical trials.

폐경 여성의 비만에 응용되는 한방치료에 대한 문헌 고찰 (The Systematic Review on Clinical Studies of Traditional Korean Medicine Treatment for Obesity in Menopausal Women)

  • 남은영
    • 한방비만학회지
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    • 제19권1호
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    • pp.56-67
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    • 2019
  • Objectives: The purpose of this study is to review clinical studies of herb medicine and acupuncture treatment on obesity in menopausal women. Methods: Key words "Obesity", "Menopause", "Herb medicine", "Acupuncture", "Moxibustion", "Catgut embedding" were searched on 9 database systems (PubMed Central, Cochrane Controlled Register of Trials, Embase, China Academic Journals, Korean Traditional Knowledge Portal, Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, National Digital Science Library, DBpia) on April 30th 2019. Results: 1 case report and 17 clinical trials were collected in accordance with the selection and exclusion criteria. Among the 17 trials, 6 were randomized controlled trials, 1 was controlled clinical trial, and 10 were single-arm trials. The types of intervention were herb medicine, electroacupuncture, acupuncture, auricular acupuncture, warm needle acupuncture, moxibustion, laser acupuncture, and catgut embedding. The study design, study results and method of intervention were analyzed. Conclusions: 1 case report described the effectiveness of pharmacopuncture, 4 trials described the effectiveness of herbal medicine, 2 of electroacupuncture, 1 of laser acupuncture, and 2 of catgut embedding. Among the 17 trials, 2 studies showed that herbal medicine treatment was more effective than no treatment or selective serotonin reuptake inhibitors, and 1 study showed that electroacupuncture was more effective than hormone therapy. All of 18 selected studies reported the effectiveness of weight reduction and abdominal obesity reduction after the traditional Korean medicine treatment for obesity in menopausal women.

보건의료 조직의 협업적 의료 커뮤니케이션 시스템에 대한 연구 - 환자교육을 중심으로 (Study on a Clinical Collaborative Communication System in Healthcare Organizations -Focused on Patient Education)

  • 박화규
    • 컴퓨터교육학회논문지
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    • 제16권2호
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    • pp.79-90
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    • 2013
  • 의료조직 내에서의 커뮤니케이션 오류와 지연은 의료고객의 서비스 질 하락과 의료분쟁 등 심각한 문제를 야기 시키고 있다. 따라서, 최근 협업적 의료 커뮤니케이션 체계의 중요성이 크게 부각되고 있다. 의사, 환자/보호자, 간호사, 실험실들 간의 커뮤니케이션이 원활하게 이뤄질 때 고효율 저비용 서비스는 물론 궁극적으로 병원의 경영성과에도 도움이 된다. 이러한 동기에서 중소 및 대형병원에서 이 시스템 도입이 급증하는 추세이다. 본 논문에서는 유무선 기반의 협업적 의료커뮤니케이션(Clinical Collaborative Communication)시스템의 구현방법과 모델링을 통한 구현 연구 및 시스템 평가를 위해 S병원을 대상으로 계량적 평가를 수행하였다.

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북아메리카 집먼지진드기에 의한 알레르기 천식 환자에서 임상검사의 유용성 (Effectiveness of Clinical Examination for Detection of Dermatophagoides farinae Allergen Asthma Disease)

  • 최우순;김성철;추상규
    • 대한임상검사과학회지
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    • 제37권1호
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    • pp.16-21
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    • 2005
  • To find out the effectiveness of clinical examination for detection of dermatophagoides farinae allergen asthma disease, 50 patients (control group) and 50 healthy persons matched by sex and age to the control group, were tested for allergen asthma. The results of the study follow. The ESR there was significantly different from the comparisons of the patients' normal reference values, 95.3 % in ESR, patient groups allergen asthma and heamatology values with control group. The ESR level of allergen asthma patients, $62.23{\pm}35.09$ mm/hr, was higher than that of the controls, $9.47{\pm}5.36$ mm/hr (p<0.001). The eosinophil count level of the patients, $370.65{\pm}365.45mm^3$, was higher than that of the controls with $171.99{\pm}131.80mm^3$ (p<0.001). The IgE level of the patients, $1137.79{\pm}784.69IU/ml$, was higher than that of the controls with $71.29{\pm}14.28 IU/ml$ (p<0.001).

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Development and Effectiveness of a Smartphone Application for Clinical Practice Orientation

  • Park, Jung-Ha;Lee, Yun-Bok;Seo, Youn-Sook;Choi, Jung-Hoon
    • International Journal of Internet, Broadcasting and Communication
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    • 제13권1호
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    • pp.107-115
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    • 2021
  • This paper presents a smartphone application for the clinical practice education conducted in hospitals, with an aim to evaluate its effectiveness. A nonequivalent control group posttest design was used, which included a total of 100 nursing of school students who conducted their clinical practice. They were divided into one control and one experimental group (50 students each). The control group was directly trained in the clinical practice orientation, and the experimental group was a group who self-learned the clinical practice orientation using a smartphone application. Research data were collected between March 5 and April 27, 2019. They were analyzed with descriptive statistics and independent t-test, using the SPSS Statistics Version 24. The smartphone application customized for the clinical practice education was implemented through the following four phases: analysis, design, development, and evaluation. The developed application was registered in Google Play (for Android apps) and Apple Store, and related information was provided, making it available for download. The study showed that the satisfaction with and self-confidence in learning differed significantly between the groups. However, technology acceptance and knowledge acquired through practice showed no statistically significant difference. The research results serve as basic data for applying smartphone applications as an educational method that can replace traditional modes of education, serving as a significant indicator of the education delivery method diversification.

아건강(亞健康) 치료[치미병(治未病)]에 미치는 태극침법의 효능에 대한 임상적 관찰 (Clinical Observation on Effectiveness of Taegeuk Acupuncture for Patients in Sub-health Status: a Case Series)

  • 김재규;채한;김건형;노승희
    • Journal of Acupuncture Research
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    • 제28권4호
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    • pp.111-117
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    • 2011
  • Objectives : This study aimed to report observed effectiveness and safety of Taegeuk acupuncture for patients in sub-health status. Methods : We analyzed clinical medical records of 36 outpatients who have visited the Pusan national university Korean medicine hospital between March and June, 2010. Patients received 6 sessions of Taegeuk acupuncture according to their constitutional types. Hepatic dullness sound and symptom reduction were used for the evaluation of clinical effectiveness of Taegeuk acupuncture. One traditional Korean medicine doctor performed all treatment procedures and assessments. Patients were allowed to continue their previous medication during acupuncture treatment. However, no additional traditional Korean medicinal interventions except the acupuncture were conducted during the whole treatment period. Results : After 6 sessions of Taegeuk acupuncture, mean hepatic dullness sound scores (0~100) were reduced from $97.3{\pm}9.0$ to $24.3{\pm}23.7$ with statistical significance (n=36, p<0.001). Mean symptom reduction scores (0~100) were changed from 0 to $53.3{\pm}29.6$ with statistical significance (n=24, p<0.001). 24 patients reported 44 cases of additional improvements of perceived health condition during or after the treatment course. No serious adverse events related to the Taegeuk acupuncture treatment were observed. Conclusions : Taegeuk acupunture may be a feasible, effective and safe treatment intervention for patients with chronic symptoms. Further well-designed studies are needed to confirm those observed improvements and evaluate benefits of Taegeuk acupuncture.

한방소아과학에서 임상 실습 교육의 만족도와 유용성 조사 (A Survey of Satisfaction and Utility with Clinical Training in Pediatrics of Korean Medicine)

  • 김빛나래
    • 대한한방소아과학회지
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    • 제34권4호
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    • pp.1-10
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    • 2020
  • Objectives The purpose of this study is to evaluate the satisfaction and utility of a clinical training in Pediatrics of Korean Medicine after conducting participatory practices in clinical training. Methods A survey was conducted with 46 students who completed a clinical training in 2019. After completing Problem Based Learning (PBL), Objective Structured Clinical Examination (OSCE) and Clinical Performance Examination (CPX), they filled out the questionnaire composed of 15 questions. In addition, it was required to rank the preferences for clinical training items and describe what was good about, things that need to be improved or corrected, and other areas to be implemented as a part of the clinical training. Results 1. Mean of the total satisfaction score was 4.26. Mean satisfaction score of the educational method was 4.25, and mean score of the utility of educational effectiveness was 4.27. 2. Among the questions that evaluate satisfaction of the education program, 'I agree with OSCE as a part of the clinical training for juniors.' showed the highest score. Among the questions that evaluate utility of educational effectiveness, 'It will be helpful to treat patients as a Korean Medicine doctor in the future' showed the highest score. On the other hand, 'I actively participated in the clinical training' showed the lowest score. Conclusions A clinical training in Pediatrics of Korean Medicine can be highly valued from the viewpoint of the satisfaction and its utility.