사회이슈 및 시위정보 제공을 바탕으로 한 소통과 참여 도구로서의 온라인 플랫폼 방향성 제안

신채민,강수빈,윤중현,이채원,유은 인제대학교 디자인연구소 2023 Journal of Integrated Design Research (JIDR) Vol.22 No.3

Background : Demonstrations in Korean society are the most direct and immediate of all social movements. Therefore, it has a close impact on the daily lives of citizens, and the resulting conflict continues to increase around the three groups of protest groups, the government, and citizens, raising concerns about its seriousness. The government proposed various communication channels to resolve the conflict, but there were limitations. Therefore, this study attempted to propose an online platform to help the use of protests as a tool for provision of information and participation for social change. Methods : This study applied the double diamond design process based on the service design methodology. Through a review of previous studies, channels related to protests in the current society and their limitations were identified. Video analysis, surveys, and in-depth interviews were conducted to understand the perspectives of various stakeholders and identify problems. In the process of data analysis, affinity diagrams and personas were developed, and specific service directions and detailed functions were derived. Results : As a result of the study, it was found that the negative perception surrounding the demonstration involved various conflict situations such as infringement of the rights of protest groups, the government's response, citizens' indifference, and biased media information. Accordingly, the service function was implemented as a prototype by identifying the pain points such as lack of objective information, low accessibility, lack of communication, and on-site participation. Conclusion : Since the perception of protests is deteriorating due to the biased information continuously shown in the media and disconnected communication between citizens and groups, this study sought to find a solution in terms of an online platform. If continuous and sound public opinion and participation continue within the service envisioned in this study, it will be able to contribute to positive social changes in the future.

치과용 도재의 식약청 기준규격 개발

신채민(Chae-Min Shin),이정연(Jung-Yeon Yi),방지영(Ji-Young Bang),최재윤(Jae-Yoon Choi),이상배(Sang-Bae Lee),임경미(Kyung-Mi Lim),배우진(Woo-Jin Bae),노혜원(Hye-Won Roh),오현주(Hyeon-Joo Oh),오헌진(Heon-Jin Oh) 대한치과재료학회 2010 대한치과재료학회지 Vol.37 No.2

의료기기 일괄허가 및 기술문서 심사를 위한 품목별 길라잡이 개발

김용우,신채민,방지영,이정연,오현주,배우진,최진만,임경미,오헌진,김미영,허찬회,김형범,최민용,곽지영,김수연,황상연,윤해석,홍혜경,안소영,이창형,정진백,구자중,강세구,정재훈,임경택,임창근,김민수,이성희,이재근,박기정 대한의용생체공학회 2010 의공학회지 Vol.31 No.4

Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

미래 고령사회와 한국형 보건의료체계의 구상 : 신의료기술 임상도입 기간 단축을 위한 「신의료기술평가 원스탑 서비스」도입 방안 연구

김세정,신채민,이무열 한국보건행정학회 2013 한국보건행정학회 학술대회 논문집 Vol.2013 No.2

국내 신의료기술평가 현황과 평가 결과에 연관성을 보이는 요인 연구

강지현,김진호,신채민,박보영 대한의사협회 2024 대한의사협회지 Vol.67 No.1

Background: This study aims to evaluate factors influencing assessment results in the new Health Technology Assessment (nHTA) in Korea. Methods: We analyzed publicly available nHTA reports obtained from the program’s website. A total of 258 reports, encompassing 305 technologies, were included. Reported details were categorized into three main areas: technical characteristics, evaluation methods, and publication types. To investigate differences in evidence level (high, medium, or low) and assessment results (pass or fail) according to these categories, we employed a chi-squared test. Univariate and multivariate logistic regression analyses were further conducted to identify factors associated with evidence level and assessment results. Results: nHTA reports employing meta-analysis and included randomized trials for evidence synthesis exhibited a higher likelihood of achieving high evidence level (odds ratio [OR], 5.008; 95% confidence interval [CI], 1.265- 18.826 and OR, 27.052; 95% CI, 7.802-103.330, respectively). Increasing evidence level was significantly associated with a higher possibility of passing the assessment (OR 2.789; 95% CI, 1.284-6.057). However, in univariate analysis, neither performing meta-analysis nor including randomized trials, both of which were associated with evidence level, demonstrated a statistically significant association with assessment results. Conclusion: This study represents the first systematic analysis of factors influencing nHTA assessment results in Korea. While increased evidence level was associated with positive assessment outcomes, factors affecting the evidence level itself did not directly influence assessment results. This suggests the need for further efforts to effectively integrate high-level evidence into assessment decisions within the nHTA program.

아크릴릭 레진계 골시멘트의 기준규격 개발연구

양원선,조은정,신채민,오현주,노혜원,백성인,김민아,정정자,유규하,오현진,조양하 한국생체재료학회 2009 생체재료학회지 Vol.13 No.4

Acrylic resin bone cement is designed to fix artificial joints and implants onto bones. As such, bone cement functions to fill spaces between an implant and a bone, evenly disperse the pressure on the implant across the bone, and deliver antibiotics. This study surveyed the use status and development trends of acrylic resin bone cement and researched into various standards and literature in an effort to induce standard criteria for acrylic resin bone cement. Bone cement consists of powder and liquid; powder contains PMMA, polymerization initiators, and radiopaquer materials, and the liquid consist mainly of MMA monomers. Bone cement polymerization constitutes exothermic reaction, and the physical and mechanical properties of bone cement change according to polymerization conditions. Bone cement aims to couple implants with bones, but in the case of acrylic resin bone cement, tissue necrosis problems are being raised in association with not only such osteoconduction but also exothermic reaction; thus various research institutes are recently striving to develop diverse bioactive materials-based products in a bid to maintain the strength of bone cement and boost the adhesion of cement and bone. These products are producing good results with animal experiments, but, compared with existing PMMA products, they offer inconsistent manipulation and physical properties, and other problems such as unconfirmed internal side effects. A survey of bone cement standards in various nations indicated that there are such standards as ISO, ASTM, FDA Guidance and KS; ISO, ASTM, and KS offer similar test methods and test standards, while the FDA Guidance offers various methods designed to analyze physical, chemical and mechanical properties of bone cement. With an analysis of these standards, this study tested bone cement's compressive strength, bending strength, bending modulus, maximum temperature, and setting time by conducting physical and mechanical tests of bone cement. An extractable test was also conducted through chemical tests. In addition, for the verification of biological safety, pyrogen test, intracutaneous test, and acute toxicity test were conducted. Various test methods specified in each standard thus were verified, and finally the bone cement standards were determined. The suggested standards for bone cement offer results of the test of acrylic resin bone cement's physiochemical and mechanical properties, and biological safety, and the research findings are intended to lend themselves to the public notification of medical device standards in an effort to be used in reviewing technical files.

장내 다제내성균 탈집락화를 위한 대변 세균총 이식: 체계적 문헌고찰

이슬기,최지은,신채민,김미나 대한임상미생물학회 2021 Annals of clinical microbiology Vol.24 No.3

Background: Fecal microbiota transplantation against gut colonization using a multidrugresistantorganism is a technique used to treat infections through normalizing the gutmicrobiota via fecal microbiota transplantation in patients with confirmed colonization bycarbapenem-resistant Enterobacteriaceae (CRE) or vancomycin-resistant enterococci (VRE)based on a fecal culture test within the past one week. In this study, we aimed to determinethe safety and effectiveness of this technique. Methods: The safety and effectiveness were assessed via a systematic review. A literaturesearch was conducted using five Korean databases, such as KoreaMed, and internationaldatabases, including Ovid-MEDLINE, Ovid-EMBASE, and Cochrane Library. Results: Main results are described here. From the studies retrieved using the aforementionedsearch strategy, the remaining 581 studies were screened using the inclusion and exclusioncriteria, resulting in the selection of nine studies for further consideration. In terms of safety,many studies reported deaths and adverse reactions associated with different causes. Fewerstudies reported the rate of colonization; however, the effect of colony rate was inconsistentwhen compared to no treatment group. Additionally, none of the studies assessed therecurrence rate, a decrease in the prevalence of diseases related to infection by multidrugresistantbacteria, and the quality of life. Conclusion: Fecal bacterial colonization for the decolonization of intestinal multidrugresistantbacteria was evaluated using a technique that requires further research as there isinsufficient literature evidence to validate its safety and efficacy in treating infections throughnormalizing the intestinal flora of patients with confirmed colonization by CRE or VRE.

한국보건행정학회 창립 25주년 기념 학술대회 : "한시적 신의료기술 인정제도"도입 방안

고든솔,주예일,신채민,이무열 한국보건행정학회 2013 한국보건행정학회 학술대회 논문집 Vol.2013 No.2

거대세포 바이러스 특이항원 자극 인터페론-감마효소결합면역흡착점적법/ 효소결합면역흡착측정법의안전성과 유효성에 대한 체계적 문헌 고찰

최원정,한주희,이월숙,신채민 대한임상미생물학회 2021 Annals of clinical microbiology Vol.24 No.2

Background: This study evaluated the safety and effectiveness of the cytomegalovirus(CMV) Specific Antigen Induced Interferon-Gamma ELISPOT (enzyme-linked immunosorbentspot)/ELISA (enzyme-linked immunosorbent assay) procedure in predicting the risk of CMVinfection/disease in immunocompromised patients through a systematic literature review. Methods: The searched electronic databases included MEDLINE, EMBASE and the CochraneLibrary. A total of 884 non-duplicate citations were retrieved and a total of 25 studies (15cohort studies, 10 cross-sectional studies) were included in this review. Study subjects wereselected among patients with solid organ, hematopoietic stem cell transplantation, or thosewho were on hemodialysis. Data extraction and literature quality assessment were carried outindependently by two researchers. Results: Most of the studies were conducted on patients with solid organ transplants. As it isconducted outside the body, CMV Specific Antigen Induced Interferon-Gamma ELISPOT/ELISAassay was safe. Regarding its effectiveness, most studies on risk analysis based on prognosis related outcomes reported that the inactive group showed a significantly higher hazard ratioor odds ratio than the active group. Results of Kaplan-Meier survival analysis also showedthat the inactive group had a significantly higher incidence of CMV event (CMV infection,CMV disease, other events) than the active group. However, various thresholds for CMV cellimmune response were reported, as was a broad range of predictive diagnostic accuracies. Conclusion: CMV Specific Antigen Induced Interferon-Gamma ELISPOT/ELISA assay haspotential to stratify the risk of CMV infection/disease among solid organ transplant patients andto determine a policy for a prophylaxis/preemptive. However, additional literature evidence isneeded to establish thresholds for CMV cell immune response and standardized tests.

의료기기에 사용되는 콜라겐의 평가 가이드라인 개발

백성인,노혜원,김기범,신채민,이정연,방지영,김민아,양원선,조은정,오현주,오현진,유규하,조양하 한국생체재료학회 2010 생체재료학회지 Vol.14 No.1

To provide what types of tests and documents are required to commercialize the collagen engineered medical devices, Korea Food and Drug Administration(KFDA) evaluated some kinds of collagen engineered medical devices, and established the evaluation guidelines. The physicochemical characteristics were evaluated and compared, and the biological safety and other required standards and practices were reviewed and analysed. The developed guidelines will be helpful for preparing and reviewing the technical documents to verify the safety and effectiveness of collagen containing medical devices for industry and KFDA reviewer.