• 제목/요약/키워드: Clinical Data

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국내 임상시험 전자화 현황과 적용방안 (Current State and Applications of the Electronic Clinical Trial Process in Korea)

  • 왕보람;최인영
    • 한국콘텐츠학회논문지
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    • 제13권4호
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    • pp.281-289
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    • 2013
  • 최근 국내 임상시험의 양적 증가와 더불어, 임상시험 자료를 효율적으로 관리할 수 있는 Electronic Data Capture(EDC) 시스템의 도입 요구가 증가하고 있다. 이에 따라 식품의약품안전청에서는 '임상시험 전자 자료 처리 및 관리를 위한 가이드라인'을 발표하였다. 이는 향후 국내 임상시험 전자 자료 관리에 관한 법률 제정을 위한 기초가 될 것으로 기대한다. 이 연구에서는 국내 임상시험 관련 기관인 병원과 임상시험 수탁기관(CRO), 그리고 제약회사에서의 EDC 시스템 이용 현황과 관계자들이 인식하는 가이드라인 및 전자 자료 표준의 중요성 및 적용 용이성과 이해도를 조사하였다. 국내 임상시험 관련 기관에서의 EDC 시스템 이용률은 77.6% 이었지만 EDC 시스템을 이용한 임상시험 건수는 5건 미만이 가장 많았다. EDC 시스템은 주로 약물동력학 시험을 하는 phase I과 임상효과와 안전성을 평가하는 phase II 임상시험에서 주로 이용되었고, 기관별로는 CRO의 이용률이 가장 높았다. 모든 집단에서 가이드라인의 중요성은 높게 인식하였으나, 적용 용이성 측면에서는 CRO에서 가장 높았다. 또한, 임상시험 전자 자료 표준의 중요성을 높게 인식하였고, 전자 자료 수집에 있어 표준의 필요성을 높게 인식하였다. 그러나 임상시험 전자 자료 국제표준인 Clinical Data Interchange Standard Consortium(CDISC)에 대한 이해도는 아직 낮은 수준이었다. 이 연구 결과는 국내 임상시험 전자화를 위한 기초자료로 활용될 수 있으며 임상시험 자료 표준에 관한 정책수립에도 활용될 수 있을 것이다.

신장암 표준임상빅데이터 구축 및 머신러닝 기반 치료결정지원시스템 개발 (Constructing a Standard Clinical Big Database for Kidney Cancer and Development of Machine Learning Based Treatment Decision Support Systems)

  • 송원훈;박미영
    • 한국산업융합학회 논문집
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    • 제25권6_2호
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    • pp.1083-1090
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    • 2022
  • Since renal cell carcinoma(RCC) has various examination and treatment methods according to clinical stage and histopathological characteristics, it is required to determine accurate and efficient treatment methods in the clinical field. However, the process of collecting and processing RCC medical data is difficult and complex, so there is currently no AI-based clinical decision support system for RCC treatments worldwide. In this study, we propose a clinical decision support system that helps clinicians decide on a precision treatment to each patient. RCC standard big database is built by collecting structured and unstructured data from the standard common data model and electronic medical information system. Based on this, various machine learning classification algorithms are applied to support a better clinical decision making.

작업치료(학)과 학생들의 임상실습 만족도 (A Study on the Satisfaction with Clinical Practice of Occupational Therapy Students)

  • 용미현
    • 한국엔터테인먼트산업학회논문지
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    • 제13권1호
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    • pp.167-173
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    • 2019
  • 임상실습 만족도가 높을수록 업무수행능력은 더 증대되며 학생들의 임상실습에 대한 만족도를 평가하는 것이 중요하다. 작업치료(학)과 학생들의 임상실습 만족도를 알아보고자 한다. 분석방법은 SPSS 12.0 통계 프로그램을 이용하여 통계처리를 하였으며, 분석결과 임상실습 만족도는 임상실습 내용, 임상실습 후 만족감, 임상실습 환경, 임상실습 지도방법, 임상실습 시간, 임상실습 평가, 임상실습 중 자신의 내적 갈등 순이었다. 작업치료(학)과 학생들의 일반적인 특성에 따른 임상실습만족도의 차이는 전공 만족도와 실습기간에 따라 유의한 차이가 있었다. 따라서, 효율적인 임상실습이 이루어질 수 있도록 본 연구의 내용이 기초자료로 활용되길 기대한다.

T1 Map-Based Radiomics for Prediction of Left Ventricular Reverse Remodeling in Patients With Nonischemic Dilated Cardiomyopathy

  • Suyon Chang;Kyunghwa Han;Yonghan Kwon;Lina Kim;Seunghyun Hwang;Hwiyoung Kim;Byoung Wook Choi
    • Korean Journal of Radiology
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    • 제24권5호
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    • pp.395-405
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    • 2023
  • Objective: This study aimed to develop and validate models using radiomics features on a native T1 map from cardiac magnetic resonance (CMR) to predict left ventricular reverse remodeling (LVRR) in patients with nonischemic dilated cardiomyopathy (NIDCM). Materials and Methods: Data from 274 patients with NIDCM who underwent CMR imaging with T1 mapping at Severance Hospital between April 2012 and December 2018 were retrospectively reviewed. Radiomic features were extracted from the native T1 maps. LVRR was determined using echocardiography performed ≥ 180 days after the CMR. The radiomics score was generated using the least absolute shrinkage and selection operator logistic regression models. Clinical, clinical + late gadolinium enhancement (LGE), clinical + radiomics, and clinical + LGE + radiomics models were built using a logistic regression method to predict LVRR. For internal validation of the result, bootstrap validation with 1000 resampling iterations was performed, and the optimism-corrected area under the receiver operating characteristic curve (AUC) with 95% confidence interval (CI) was computed. Model performance was compared using AUC with the DeLong test and bootstrap. Results: Among 274 patients, 123 (44.9%) were classified as LVRR-positive and 151 (55.1%) as LVRR-negative. The optimism-corrected AUC of the radiomics model in internal validation with bootstrapping was 0.753 (95% CI, 0.698-0.813). The clinical + radiomics model revealed a higher optimism-corrected AUC than that of the clinical + LGE model (0.794 vs. 0.716; difference, 0.078 [99% CI, 0.003-0.151]). The clinical + LGE + radiomics model significantly improved the prediction of LVRR compared with the clinical + LGE model (optimism-corrected AUC of 0.811 vs. 0.716; difference, 0.095 [99% CI, 0.022-0.139]). Conclusion: The radiomic characteristics extracted from a non-enhanced T1 map may improve the prediction of LVRR and offer added value over traditional LGE in patients with NIDCM. Additional external validation research is required.

의료기관 종별 의무기록 중요서식 항목별 작성 실태 및 의무기록 완결점검표 분석 (A Study on Medical Laws and External Evaluation Criteria with Reference to the Essential Forms consisting Medical Records and to the Items for Each Medical Record)

  • 서순원;김광환;황용화;강선희;강진경;조우현;홍준현;부유경;이현실
    • 한국의료질향상학회지
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    • 제9권2호
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    • pp.176-197
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    • 2002
  • Backgound : This study is to suggest the standardized format of the clinical sheets and the standardized items of every clinical sheet. The standardization of the medical records will increase the faithfullnes of the contents in them and it will contribute to construct the good health information system. Method : From Jan. 1st. 2001 to March 31st 2001, we gathered as many paper clinical sheets as possible by every class of institutions to review the faithfulness of the clinical contents in them. Clinical sheets of 9 tertiary care hospitals, 6 general hospitals and 56 clinics were gathered. Two experienced medical record administrators reviewed them. The review focus was to check whether the items recommend by the hospital standardization review criteria and hospital service evaluation organization were appeared in the clinical sheets and whether the contents of every item were written. Results : Tertiary care hospitals; In case of administrative data, the contents were filled well if the items were fixed. The clinical data like C.C, history,physical examiniation were filled well, but if the items were not fixed, some items were omitted. The result is that more items are to be filled if they are fixed. General hospitals Administrative data were filled more than 50%. Final diagnosis was filled about 66.7%.But other clinical data were not filled well and not many clinical related items were appeared in the sheets.In the legal point of view, the reason for visiting hosptals or the right diagnosis, patient condition at discharge could not be confirmed well.In surgery cases, surgical procedures could not be confirmed well as many surgical related information(surgery time, fluids and blood, number of sponges, biopsy, etc) were omitted. Clinics More than 70% administrative data were filled and fixed as items. Among the clinical related data, laboratory result was the most credible data. But without the right diagnosis, drug orders were given and doctors' written signatures were not appeared over 96.4%. So the clinical sheets cannot be used as a legal document. Conculusion : There was a tendency that the contents were filled well if the items were fixed in the documents, We also suggest a clinical check list to review the completeness and faithfulness of the clinical sheets. If many hospitals use the suggested clincal check list and if they make the necessary items fixed in the clinical sheets, the quality of the medical record will increase dramatically.

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Effect on Preference of Clinical Practice Subjects

  • Jungae Kim
    • International Journal of Advanced Culture Technology
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    • 제11권1호
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    • pp.27-35
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    • 2023
  • This study was a cross-sectional descriptive survey study that confirms the effect on subjects that prefer clinical practice in order to prepare basic data for efficient clinical practice guidance for nursing college students. The study participants were 201 students attending C University, and the data collection period was from October 1 to October 15, 2022. The collected data were analyzed using SPSS 18.0 as descriptive statistics, Pearson correlation, Chi square test, ANOVA test, and Multiple regression test. As a result of the analysis, it was found that clinical decision-making and critical thinking were correlated under the statistical significance level (r=.730, p<0.01). The most favorite clinical practice department was community nursing, and male students preferred community nursing the most (Male=45.6%, χ2=.000), female students were found to prefer similar levels of practical subjects with child nursing , adult nursing, and maternal nursing(χ2=000).Clinical decision-making was found to be higher in students who preferred community nursing at a statistical significance level than those who preferred child nursing (F=4.91, p<0.01). Critical thinking was higher among students who preferred adult nursing than those who preferred other subjects (F=4.65, p<0.01). Through the analysis results, it was found that general characteristics vary, but clinical decision-making ability and critical thinking affect the preference of clinical practice subjects. Therefore, based on the results of this study, the professor of clinical practice suggests the development of a program to foster clinical decision-making and critical thinking to make students interested in clinical practice subjects.

임상용 워크스테이션의 개발에 관한 연구 (A Study on the Development of Clinical Workstation)

  • 박광석;이태수;민병구
    • 대한의용생체공학회:의공학회지
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    • 제11권1호
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    • pp.141-146
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    • 1990
  • A clinical workstation has been developed for the use in clinical ward. This system is connected to the Picture Archiving and Communication System previously installed. It provides the capabilities of image display, image processing, diagnostic report review, clinical lab data review and analytic diagrams presentation for the hospitalized patients in clinical ward. The performances of this system were evaluated during the 9 months. These results show typical aspects of clinical patterns in data transmissions, image studies and clinical lab data studies. These typical aspects should be counted in the further development of workstation for the clinical use.

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A Study of Choice for Analysis Method on Repeated Measures Clinical Data

  • Song, Jung
    • 대한임상검사과학회지
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    • 제45권2호
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    • pp.60-65
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    • 2013
  • Data from repeated measurements are accomplished through repeatedly processing the same subject under different conditions and different points of view. The power of testing enhances the choice of pertinent analysis methods that agrees with the characteristics of data concerned and the situation involved. Along with the clinical example, this paper compares the analysis of the variance on ex-post tests, gain score analysis, analysis by mixed design and analysis of covariance employable for repeating measure. Comparing the analysis of variance on ex post test, and gain score analysis on correlations, leads to the fact that the latter enhances the power of the test and diminishes the variance of error terms. The concluded probability, identified that the gain score analysis and the mixed design on interaction between "between subjects factor" and "within subjects factor", are identical. The analysis of covariance, demonstrated better power of the test and smaller error terms than the gain score analysis. Research on four analysis method found that the analysis of covariance is the most appropriate in clinical data than two repeated test with high correlation and ex ante affects ex post.

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간호학생의 임상적 판단 경험에 관한 내용분석 (Content Analysis of Experience of Nursing Students in Clinical Judgment during Nursing Practicum)

  • 서연옥;안양희;박경숙
    • 성인간호학회지
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    • 제21권2호
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    • pp.245-256
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    • 2009
  • Purpose: To describe the lived experience of nursing students when faced with clinical judgment in a nursing practicum at the hospital. Methods: A descriptive research design was utilized. Participants were 79 students in the clinical practicum. Participant consent was obtained for ethical protection. Data were collected from August to December 2007 using a semi-structured questionnaire. Content analysis was utilized for data analysis. Results: Two categories and 5 themes were extracted from the data for 'difficult' and 'easy' clinical judgments. For the student category, the two themes were 'knowledge' and 'skill', while the three themes for the clinical education environment category were, 'judgment of clinical symptoms and signs', 'differences between theory and practice' and 'human relationships'. For coping, 2 categories and 5 themes were extracted for the difficult clinical judgment situation, while one category and one theme were found for the easy clinical judgment situation. Conclusion: To develop students' clinical judgment, there is need to develop the method of clinical skills using simulation in clinical teaching. For future research, a study on factors affecting clinical judgment of nursing students in hospitals is needed.

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사상체질 임상정보 분석을 위한 웹 기반의 의사결정 나무 프로그램 개발 (Development of Decision Tree Program based on Web for Analyzing Clinical Information of Sasang Constitutional Medicine)

  • 진희정;김명근;김종열
    • 한국한의학연구원논문집
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    • 제14권3호
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    • pp.81-87
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    • 2008
  • Sasanag Contitution Medicine(SCM) is the traditional medicine theory based on constitutional medicine in Korea. It is most import ant that a personal SCM type is determined accurately ahead of applying any Sasang treatments. For this, many researches have been studied to diagnose the SCM type using constitutional clinical data. The decision tree is a tree-structured data-mining methodology. Recently, in the Korean traditional medicine society, there have been several efforts to find diagnosing tools using the decision tree method. So, we developed a decision tree program based on web for analyzing constitutional clinical information. It can use various clinical data as input data, offer filtering function to select clinical data to be used. We can find useful factor to be influential on SCM types using this program.

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