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      • 의약품 급여관리를 위한 실제임상근거(RWE) 플랫폼 마련 후향적 연구

        김동숙,변지혜,김지혜 ( Jihye Kim ),김수연,이은지,김소희,김설희,이혜영,조도연,정숙지,이정은,신주영,안형진,이대호 건강보험심사평가원 심사평가연구소 2020 연구보고서 Vol.2019 No.0

        Background Randomized controlled trials (RCTs) have limitations in reflecting the real-world data (RWD). RWD and real-world evidence (RWE) can evaluate the effectiveness of drugs in the real world, thereby overcoming the limitations of RCTs. Purpose To develop a data collection system for hospital medical records, one of the most important RWD that can evaluate the effectiveness of approved drugs in the real world, we selected ramucirumab plus paclitaxel and trastuzumab emtansine (T-DM1), which are currently used to treat gastric and breast cancer, respectively, under the national health insurance, and collected systematically RWD from medical records at relevant medical institutions in South Korea. Results This study was reviewed and approved by the Institutional Review Board of 68 institutions in South Korea (57 institutions for gastric cancer and 60 institutions for breast cancer). The investigators participating in this study conducted simulations of a representative case for each drug to analyse interinvestigator agreement and reliability. The interinvestigator agreement for major case report form (CRF) items was 73.5% in the ramucirumab plus paclitaxel study and was 71.9% in the T-DM1 study. To test the reli-ability of the collected data, the agreement between investigators and independent investigators for the records collected from 5% of all institutions was analyzed. The interinvestigator agreement for major CRF items was 0.90 in both studies each. To test the reproducibility of the results, all results from this study were independently analyzed by two statisticians. In the retrospective analysis of ramucirumab plus paclitaxel for locally advanced unresectable or metastatic gastric cancer (K-RWE (ST)), 1,336 out of 1,460 patients who were prescribed ramucirumab plus paclitaxel from May 1, 2018 to December 31, 2018, were included in screening, and a total of 1,063 patients who met the inclusion/exclusion criteria were finally included as enrolled population in the data analysis. The results comparing the K-RWE (ST) with the RAINBOW RCT showed that the objective tumor response (ORR) was lower (27.9% vs. 15.1%), the median overall survival was comparable (9.6 vs. 10.03 months), and the incidence of non-hematologic adverse events (AEs) was lower in the K-RWE (ST) compared to those in the RAINBOW RCT. In the retrospective analysis of T-DM1 for locally advanced unresectable or metastatic breast cancer (K-RWE (BR)), 972 out of 1,029 patients who were prescribed T-DM1 from August 3, 2017 to December 31, 2018, were included in screening, and a total of 824 patients who met inclusion/exclusion criteria were finally included as enrolled populations in data analysis. The ORR (43.6% vs. 37.3%) and the progression-free survival (PFS) (9.6 vs. 8.0 months) were lower in the K-RWE (BR) compared to those in EMILIA RCT which was a relatively earlier line of palliative systemic therapy. The ORR (31.0% vs. 35.0%) and PFS (6.2 vs. 6.7 months) in the K-RWE (BR) were comparable to that in the TH3RESA RCT, which had similar enrolled populations. The incidence of AE of grade 3 or higher was similar between RCTs and the K-RWE (BR). Conclusion In this study, RWD from medical records about ramucirumab plus paclitaxel and T-DM1 were systematically collected from medical institutions in South Korea, and RWE was presented for the respective drugs. Through this systemic process, we present a standardized medical record collection system for other drugs, and a model case in the future.

      • SCOPUSKCI등재

        혈액투석 의료서비스의 질평가 지표 개발

        김동숙 ( Dong Sook Kim ),정진희 ( Jin Hee Jung ),진동찬 ( Dong Chan Jin ),김미경 ( Mi Kyoung Kim ),이규덕 ( Kyoo Duck Lee ),김선민 ( Seon Min Kim ),이병란 ( Byoung Lan Lee ) 대한신장학회 2009 Kidney Research and Clinical Practice Vol.28 No.5

        Purpose: This study was a pilot study to develop structure, clinical performance and outcome measurement and criteria for increasing number of dialysis facilities and patients to provide quality of care. Methods: The six components of developing quality indicators for hemodialysis were as follows: 1) Organizing expert panel members. 2) Selecting the area: to reflect stakeholders` opinion, structured interviews were done. And literature reviews were performed to investigate guidelines and quality measurements of foreign countries. 3) Selecting clinical performance indicators: From experts` opinions and literature review. 4) Developing candidate indicators. 5) Performing demonstration survey: Systemic sampling was performed and 43 facilities were participated in self-answered medical record survey. 6) Based on preliminary evaluation model, final indicators were selected from expert panel reviews. Results: Eleven measures of structure, thirteen performance measures of process and nine monitoring measures of outcome were developed based on literature review and clinical practice guideline. As for criterion-related validity, those of process and outcome were most high and in case of face validity, those of structure and process were most high. The most valid quality indicators were the rate of internal medicine specialist, dialysis frequency per doctor, whether or not keeping emergency equipment, examination of water quality, hemodialysis adequacy (Kt/V), monitoring arterial venous graft for stenosis maintenance of iron storage, and administration of supplemental iron. Conclusion: By developing quality indicators of hemodialysis and performing demonstration evaluation, quality of care for hemodialysis patients is expected to be improved, so as to promote hemodialysis patients` health and improve on quality of life.

      • SSM - 32 / UNIX SVR2. 0에서의 TCP / IP 프로토콜의 구현

        김동숙(D.S.Kim),김종식(J.S.Kim),최원석(W.S.Choi),신석빈(S.B.Shin),김형식(H S.Kim),강성일(S.I.Kang) 한국정보과학회 1987 한국정보과학회 학술발표논문집 Vol.14 No.2

        이 논문에서는 당사에서 자체 개발한 SSM-32/UNIX System V Release2.0(SVR2.0)에 BSD의 TCP/IP 프로토콜을 구현한 내용을 설명한다. 즉, IPC Socket 인터페이스와 High Speed (10M bps)의 Ethernet driver 루틴을 포함한 TCP/IP 프로토콜을 UNIX SVR2.0 Kernel내에 구현하였다. 그리고 응용 프로그램으로 ftp(1), ftpd(8), telnet(1), telnetd(8), rcp(1), rsh(1), rshd(8), rlogin(1), rlogind(8), netstat(1), slattach (8), tftp(1), tftpd (8), ifconfig(8)등을 구현하였다.

      • KCI등재

        퇴계 사단칠정론(四端七情論)의 수양론적 고찰-정심공부(正心工夫)를 중심으로-

        김동숙 ( Kim Dong-sook ) 충남대학교 유학연구소 2016 儒學硏究 Vol.36 No.-

        본 논문은 『大學』의 正心工夫에 대한 퇴계와 고봉의 논의를 중심으로, 퇴계의 소종래로서 정의된 사칠 개념으로는 해명이 어려워 보였던 四端不中節 · 七情中節 현상이 수양론적 측면에서 마음의 主宰문제와 연결되어 설명될 수 있음을 확인한 후 그의 사칠론을 새롭게 모색해 보는 것에 목적이 있다. 이와 같은 목적을 달성하기 위하여 먼저 고봉과의 논쟁 내용 및 기타 언급을 통하여 퇴계의 사칠 개념을 정리해볼 것이다. 사단과 칠정이 본래 性에서 발한 하나의 情이라는 점에 초점을 둔 고봉은 퇴계의 소종래로부터의 정의 방식에 문제가 있음을 지적한다. 그의 논리로 보면 퇴계의 사칠론은 사단의 기적 측면과 칠정의 리적 측면이 제외된 것이자, 아울러 사단부중절과 칠정중절을 정합적으로 설명할 수 없다는 한계를 가진다. 그러나 퇴계에게 있어 사칠의 중절·부중절은 그의 소종래적 정의로부터 보장되는 것이 아닌, ``마음이 그들을 온전하게 주재하는가``에 따라 결정되는 문제이다. 퇴계의 사칠개념은 연원으로부터 정의됨과 동시에 마음이라는 수양론적 층위에서도 논의되고 있었다. 이러한 퇴고 양자의 입장과 그 대립양상은 『대학』·「정심장」해석에서 명확하게 드러난다. 퇴계는 소종래로부터의 정의방식에 입각하여 악으로의 轉化가능성을 가진 칠정을 정심공부의 대상으로 두어야 한다고 본다. 이에 고봉은 소종래적 사유로 정심공부의 대상을 결정할 수는 없다고 반론하고, 그 근거로 사단이 부중절할 가능성을 든다. 즉 사단 또한 하나의 의도로서 마음에 개입되어 잘못 발현할 수 있다는 것이다. 그러나 퇴계는 칠정을 정심공부의 대상으로 보는 입장을 견지함과 동시에, 사단 또한 마음에 담아두어도 전혀 해가 되지 않는 순선무악한 감정임을 명시한다. 그는 맹자가 말한 사단의 본래적 함의에서는 부중절이 성립되지 않는다는 것을 강조한다. 그들의 사칠 정의방식의 차이는 이와 같은 공부론 상의 해석에서도 보인다. 그러나 앞서 살펴본 바와 같이 퇴계가 사단부중절을 전면 부인했다고 볼 수는 없다. 퇴계에게 있어 사단의 중절한 발현에 직접적으로 영향을 미치는 것은 바로 마음이 그를 온전히 주재하고 있는가의 여부이다. 순선이라는 소종래적 정의가 그대로 실현되는 상황은 오직 성인의 경우에 한정된 것이다. 고봉과의 논의에서 사단부중절의 발생을 범인의 경우에 한했던 것 또한 이와 같은 맥락이다. 한편 칠정이 중절하여 선한 감정이 될 수 있는가 또한 ``악으로 흐를 수 있다``는 소종래적 정의가 아닌 리의 주재여부, 즉 마음의 수양문제로 귀결된다. 다시 말해 퇴계에게 있어 사단과 칠정의 중절 여부는 소종래로서의 정의가 아닌 마음의 주재라는 수양론적 차원에서 해명되는 문제였던 것이다. 이와 같은 내용을 토대로 본 논문은 그의 사단칠정 개념을 마음의 주재문제와 연결지어 재검토하는 것으로 마무리될 것이다. 퇴계의 사단과 칠정 개념은 "마음이 감정을 주재하면 모두 중절한다."는 수양론적 해석을 통하여 더욱 완결적으로 이해될 수 있으며, 그를 통해 보다 현실적이며 실천적인 개념으로 재고 가능하다. This paper, based on The Study of Rectifying the Mind from The Great Learning, pursues the confirmation of Not Perfectly-measured of Four-Beginnings and Perfectly-measured of Seven-Feelings whether could be interpreted through the Relationship with Theory of The Study on Rectifying the Mind and seeks the unique way of understanding of Toegye`s Four-Seven. For achieving these goals, this paper will analyze the gap between Toegye and Gobong about Four-Seven and will discuss Four-Seven of Toegye`s issues which could be questioned by Gobong who has the different point of view from. Toegye explains Four-Beginnings` manifestation connects with Purely-Good and Seven-Feelings` with qi. Per contra, Gobong focuses more on Feelings that Four-Beginnings and Seven-Feelings are revealed by Feelings originated from Nature. Gobong pointed out the limitation of Toegye`s opinion which deficient in explanation of qi from Four-Beginnings and li from Seven-Feelings and also lack of coherence of "Not Perfectly-measured of Four-Beginnings" and "Perfectly-measured of Seven-Feelings". However, for Toegye, the matter of whether Perfectly-measured or Not Perfectly-measured decided not by its Origin but the Supervision of the Mind itself that consists inside mind thoroughly. Then this paper will state Toegye`s reasoning why he introduced Seven-Feelings for studying in "The Chapter of Rectifying the Mind" of The book Great Learning, Gobong`s contention of Not Perfectly-measured of Four-Beginnings as a refutation from Toegye`s logic, and will figure the divergence of two opinions. Toegye emphasizes only Seven-Feelings as a study subject because Purely-Good nature of Four-Beginnings cannot harm inside mind yet there is a possibility of Seven-Feelings might turn into Evil. On the other hand, Gobong focuses both Four-Beginnings and Seven-Feelings for study subjects with his view which Four-Beginnings could involve inside mind with intention and eventually can cause the result of Not Perfectly-measured of Four-Beginnings. In Toegye`s opinion, Not Perfectly-measured of Four-Beginnings is just the result of wrong manifestation interrupted by intention. Toegye insists that Four-Beginnings itself cannot be described as Perfectly-measured or Not Perfectly-measured. For him, the matter of Perfectly-measured or Not Perfectly-measured of Four-Beginnings is not defined as Origins but is on the level of the expansion of the Supervision of Mind. Throughout this paper, it will be concluded by reviewing Toegye`s Four-Seven with the Supervision of Mind. Whether Perfectly-measured of Seven-Feelings morally revealed or not depends on the Supervision of Mind, not the Origin which ``Seven-Feelings might turn into Evil``. For Toegye, Four-Beginning matter contains not its definition from the Origin but the Supervision of Mind portrayed in the perspective of the Self-Cultivation Theory. Thus, Toegye`s Four-Beginnings and Seven-Feelings could be interpreted thoroughly through the perspective of the Self-Cultivation Theory and considered as practical concept.

      • KCI등재후보

        미취업 기혼여성의 진로장벽과 사회적 지지 인식이 진로결정수준에 미치는 영향

        김동숙(Kim, Dong-Sook),이영민(Lee, Young-Min) 중앙대학교 한국인적자원개발전략연구소 2011 역량개발학습연구 Vol.6 No.4

        본 연구의 목적은 구직욕구는 있으나 진로결정에 애로를 겪고 있는 미취업 기혼여성들이 지각하는 진로장벽과 사회적 지지가 진로결정에 미치는 영향을 분석하는 것이다. 경기도 소재 여성인력개발 관련 기관을 방문한 133명을 대상으로 진로장벽과 사회적 지지, 진로결정수준 척도를 활용하여 설문조사를 실시하였으며 다음과 같은 결과를 파악하였다. 첫째, 여성의 연령, 경력기간, 퇴직기간, 소득, 학력, 자녀수 등의 개인 특성 변인과 진로결정수준은 유의미한 상관이 없는 것으로 나타났다. 반면, 직업경험의 유무에 따른 분석결과, 직업경험이 없는 경우가 직업경험이 있는 경우에 비해서 진로결정수준이 낮음을 확인하였다. 둘째, 진로장벽이 진로결정수준에 중요한 영향을 미치고 있었다. 셋째, 사회적 지지의 하위요인인 정서적 지지, 평가적 지지, 물질적 지지, 정보적 지지 중 평가적 지지의 효과만이 진로결정수준에 영향을 미치는 것으로 나타났다. 넷째, 진로장벽 전체에 대한 사회적 지지 인식의 조절효과와 진로장벽의 각 하위요인에 대한 사회적 지지인식의 조절효과에 대해 분석한 결과, 진로장벽이 진로결정수준에 미치는 영향에 있어서 사회적 지지 인식은 조절효과가 나타나지 않았다. The current study was conducted to examine how the unemployed and married 133 women who desired to get a job but faced a difficulty in making a career decision perceived about career barriers. In addition, we analyzed how these perceptions of career barriers and social support have impacted on making their career decisions. The summary of this study results were as follow. First, individual traits such as women’s age, career duration, retirement period, income, academic degree, and the number of children had no correlation with career decision making level. On the other hand, low level of job experience had to do with career decision making level. Second, career barrier had significant impacts on career decision making level. Third, sub-components of social supports such as emotional supports, physical supports, and informative supports had no impacts on career decision making level, whereas evaluative support did. Fourth, regulative effects of social supports and the sub-components of career barrier regarding the social supports had no effects on career decision making level.

      • SCOPUSKCI등재

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