• Title/Summary/Keyword: Clinical Decision Making

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Determine Optimal Timing for Out-Licensing of New Drugs in the Aspect of Biotech (신약의 기술이전 최적시기 결정 문제 - 바이오텍의 측면에서)

  • Na, Byungsoo;Kim, Jaeyoung
    • Knowledge Management Research
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    • v.21 no.3
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    • pp.105-121
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    • 2020
  • With regard to the development of new drugs, what is most important for a Korean Biotech, where no global sales network has been established, is decision-making related to out-licensing of new drugs. The probability of success for each clinical phase is different, and the licensing amount and its royalty vary depending on which clinical phase the licensing contract is made. Due to the nature of such a licensing contract and Biotech's weak financial status, it is a very important decision-making issue for a Biotech to determine when to license out to a Big Pharma. This study defined a model called 'optimal timing for out-licensing of new drugs' and the results were derived from the decision tree analysis. As a case study, we applied to a Biotech in Korea, which is conducting FDA global clinical trials for a first-in-class new drug. Assuming that the market size and expected market penetration rate of the target disease are known, it has been shown that out-licensing after phase 1 or phase 2 of clinical trials is a best alternative that maximizes Biotech's profits. This study can provide a conceptual framework for the use of management science methodologies in pharmaceutical fields, thus laying the foundation for knowledge and research on out-licensing of new drugs.

Information Engineering and Workflow Design in a Clinical Decision Support System for Colorectal Cancer Screening in Iran

  • Maserat, Elham;Farajollah, Seiede Sedigheh Seied;Safdari, Reza;Ghazisaeedi, Marjan;Aghdaei, Hamid Asadzadeh;Zali, Mohammad Reza
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.15
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    • pp.6605-6608
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    • 2015
  • Background: Colorectal cancer is a major cause of morbidity and mortality throughout the world. Colorectal cancer screening is an optimal way for reducing of morbidity and mortality and a clinical decision support system (CDSS) plays an important role in predicting success of screening processes. DSS is a computer-based information system that improves the delivery of preventive care services. The aim of this article was to detail engineering of information requirements and work flow design of CDSS for a colorectal cancer screening program. Materials and Methods: In the first stage a screening minimum data set was determined. Developed and developing countries were analyzed for identifying this data set. Then information deficiencies and gaps were determined by check list. The second stage was a qualitative survey with a semi-structured interview as the study tool. A total of 15 users and stakeholders' perspectives about workflow of CDSS were studied. Finally workflow of DSS of control program was designed by standard clinical practice guidelines and perspectives. Results: Screening minimum data set of national colorectal cancer screening program was defined in five sections, including colonoscopy data set, surgery, pathology, genetics and pedigree data set. Deficiencies and information gaps were analyzed. Then we designed a work process standard of screening. Finally workflow of DSS and entry stage were determined. Conclusions: A CDSS facilitates complex decision making for screening and has key roles in designing optimal interactions between colonoscopy, pathology and laboratory departments. Also workflow analysis is useful to identify data reconciliation strategies to address documentation gaps. Following recommendations of CDSS should improve quality of colorectal cancer screening.

Path analysis of major satisfaction, clinical competence, career decision-making self-efficacy, and career decision level in undergraduate nursing students (간호 대학생의 전공만족도, 임상수행능력, 진로결정 자기효능감과 진로결정 수준 간의 경로분석)

  • Lee, Ji-Won;Lee, Nae-Young;Eo, Yong-Sook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.1
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    • pp.311-320
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    • 2018
  • This study was conducted to investigate the relationship among major satisfaction (MS), clinical competence (CC), career decision-making self-efficacy (CDMS), and career decision level (CDL) for undergraduate nursing students. A self-report instrument was used to measure MS, CC, CDMS, and CDL. Questionnaires were completed by 307 nursing students in three nursing colleges, and path analysis was employed to validate the proposed model and analyze the causal relationships among variables. Four constructs (MS, CC, CDMS, and career decision) were analyzed. To build a path model, MS and CC were linked to CDMS and career decision. The initial analysis suggested that the modification needed modification; therefore, a covariance link was added. The overall goodness of fit for indices indicated satisfactory path analysis. The indices were revealed as $x^2=2412$, GFI=0.996, AGFI=0.961, and RMSEA=0.068. As a result, the proposed model was acceptable with a good fit, and there were significant direct and indirect effects of paths in the model. Specifically, MS and CC had a direct influence on CDMS, and MS and CDMS directly affected CDL. Moreover, MS and CC had indirect effects on CDL through CDMS. These results imply that students' CDMS should be seriously considered when designing counseling programs for career guidance, and substantiality of CC education is needed to improve CDMS. These results may provide a practical guideline to provide educational intervention for nursing students.

Reversals in Decisions about Life-Sustaining Treatment and Associated Factors among Older Patients with Terminal Stage of Cardiopulmonary Disease (만성 심폐질환을 가진 말기 노인 환자의 연명의료 의사결정의 번복 및 관련 요인)

  • Choi, Jung-Ja;Kim, Su Hyun;Kim, Shin-Woo
    • Journal of Korean Academy of Nursing
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    • v.49 no.3
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    • pp.329-339
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    • 2019
  • Purpose: The purpose of this study was to investigate the frequency, patterns, and factors of reversals in decisions about life-sustaining treatment (LST) among older patients with terminal-stage chronic cardiopulmonary disease. Methods: This was a retrospective correlational descriptive study based on medical chart review. De-identified patient electronic medical record data were collected from 124 deceased older patients with terminal-stage cardiopulmonary disease who had made reversals of LST decisions in an academic tertiary hospital in 2015. Data were extracted about the reversed LST decisions, LST treatments applied before death, and patients' demographic and clinical factors. Multivariate logistic regression analysis was used to identify the factors associated with the reversal to higher intensity of LST treatment. Results: The use of inotropic agents was the most frequently reversed LST treatment, followed by cardiopulmonary resuscitation, intubation, ventilator therapy, and hemodialysis. Inconsistency between the last LST decisions and actual treatments occurred most often in hemodialysis. One-third of the reversals in LST decisions were made toward higher intensity of LST treatment. Patients who had lung diseases (vs. heart diseases); were single, divorced, or bereaved (vs. married); and had an acquaintance as a primary decision maker (vs. the patients themselves) were significantly more likely to reverse the LST decisions to higher intensity of LST treatment. Conclusion: This study demonstrated the complex and turmoil situation of the LST decision-making process among older patients with terminal-stage cardiopulmonary disease and suggests the importance of support for patients and families in their LST decision-making process.

An overview of the national immunization policy making process: the role of the Korea expert committee on immunization practices

  • Cho, Hee-Yeon
    • Clinical and Experimental Pediatrics
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    • v.55 no.1
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    • pp.1-5
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    • 2012
  • The need for evidence-based decision making in immunization programs has increased due to the presence of multiple health priorities, limited human resources, expensive vaccines, and limited funds. Countries should establish a group of national experts to advise their Ministries of Health. So far, many nations have formed their own National Immunization Technical Advisory Groups (NITAGs). In the Republic of Korea, the Korea Expert Committee on Immunization Practices (KECIP), established by law in the early 1990s, has made many important technical recommendations to contribute to the decline in vaccine preventable diseases and currently functions as a NITAG. It includes 13 core members and 2 non-core members, including a chairperson. Core members usually come from affiliated organizations in internal medicine, pediatrics, obstetrics, microbiology, preventive medicine, nursing and a representative from a consumer group, all of whom serve two year terms. Non-core members comprise two government officials belonging to the Korea Centers for Disease Control and Prevention (KCDC) and the Korea Food and Drug Administration. Meetings are held as needed, but at least twice a year, and sub-committees are formed as a resource for gathering, analyzing, and preparing information for the KECIP meetings. Once the sub-committees or the KCDC review the available data, the KECIP members discuss each issue in depth and develop recommendations, usually by a consensus in the meeting. The KECIP publishes national guidelines and immunization schedules that are updated regularly. KECIP's role is essentially consultative and the implementation of their recommendations may depend on the budget or current laws.

Diagnostic Classification Scheme in Iranian Breast Cancer Patients using a Decision Tree

  • Malehi, Amal Saki
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5593-5596
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    • 2014
  • Background: The objective of this study was to determine a diagnostic classification scheme using a decision tree based model. Materials and Methods: The study was conducted as a retrospective case-control study in Imam Khomeini hospital in Tehran during 2001 to 2009. Data, including demographic and clinical-pathological characteristics, were uniformly collected from 624 females, 312 of them were referred with positive diagnosis of breast cancer (cases) and 312 healthy women (controls). The decision tree was implemented to develop a diagnostic classification scheme using CART 6.0 Software. The AUC (area under curve), was measured as the overall performance of diagnostic classification of the decision tree. Results: Five variables as main risk factors of breast cancer and six subgroups as high risk were identified. The results indicated that increasing age, low age at menarche, single and divorced statues, irregular menarche pattern and family history of breast cancer are the important diagnostic factors in Iranian breast cancer patients. The sensitivity and specificity of the analysis were 66% and 86.9% respectively. The high AUC (0.82) also showed an excellent classification and diagnostic performance of the model. Conclusions: Decision tree based model appears to be suitable for identifying risk factors and high or low risk subgroups. It can also assists clinicians in making a decision, since it can identify underlying prognostic relationships and understanding the model is very explicit.

Data-Linking Infrastructure for the Health Technology Assessment (의료기술평가 기반으로서의 데이터 연계)

  • Park, Chong Yon
    • The Journal of Health Technology Assessment
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    • v.6 no.2
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    • pp.81-87
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    • 2018
  • With the recent change of healthcare environment including rapid technological development, evidences are more and more important and necessary to support relevant policies in health technology assessment to provide safe and effective health services, utilizing medical resources efficiently. Despite of the emphasis on the importance of real world data and real world evidence in health care research, current infrastructure supporting clinical research is considerably weak due to absence of legal and institutional basis. However, in accordance with the Article 26 of the Health and Medical Technology Promotion Act, there is a limited legal apparatus that can be used only in public data with other dataset for the purpose of healthcare technology assessment at the National Evidence-based Collaborating Agency. Although the use of linked data from various sources was often required in the field of clinical research, it was not yet working well due to insufficient environmental conditions. In order to support the decision-making of medical practice and health care policies, data-linking platform for clinical research is needed. If the legal system that can link up to the data of the private institutions without violating the significant value such as the protection of private informations is established, it will be a decisive foundation reinforcing the researches and policy making processes for the improvement of the national health care system.

A Study about the Human Communication between Clinical Nurse and Patient (임상간호사-환자 관계의 인간커뮤니케이션 이해)

  • 전명희
    • Journal of Korean Academy of Nursing
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    • v.29 no.4
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    • pp.841-854
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    • 1999
  • This study tried to the answer to the question : “How does the human communication happen between clinical nurse and patient\ulcorner” To answer that, a micro-ethnographic research method was used and I performed field work at the orthopedic ward in one Korean metropolitan city. After analysis of interview data, observational data and field notes, I could understand that clinical nurse-patient communication performed for clinical decision making, providing patient education and emotional support. Prepared nurse communicate with patient more effectively, eventually can establish more trust relationship with patient. Conclusively I discussed about the way of nurse's skill acquisition, need of collaborative conference with doctor and nurse, and curriculum development to promote nurses's understanding of human.

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A Study on Self-efficacy of Course Decision and Major Field Satisfaction in Dental Hygiene Students (치위생과 학생의 진로결정 자기 효능감과 전공만족 관계 연구)

  • Kim, Gey-Pyo
    • Journal of Korean Clinical Health Science
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    • v.1 no.2
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    • pp.49-57
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    • 2013
  • Purpose. This study was purposed to seek for a way to enhance the self-efficacy of students in dental hygiene department at deciding their careers by analyzing the relationship between the self-efficacy and the major satisfaction. Methods. The investigator conducted a survey targeting 253 students attending on dental hygiene departments in two 3-year-graduate colleges and 1 university located in Busan from May 1st to May 30th, 2013. The used research instruments were the major satisfaction questionnaire and the Career Decision-Making Self-Efficacy Scale Short Form(CDMSES-SF). The survey was conducted in self-administered questionnaire. The data was analyzed with SPSS (ver 12.0) and also conducted t-test, ANOVA and multi-regression analysis. Results. It was found that self-efficacy level of students in dental hygiene department was $3.22{\pm}0.38$ point, and their major satisfaction level was $3.27{\pm}0.47$ point. The factors enhancing the self-efficacy of students in dental hygiene department at deciding their careers were identified as the curriculum satisfaction, the relationship satisfaction, and the recognition satisfaction. It was identified that more these elements were increased, the higher the self-efficacy level was enhanced. Conclusions. In order to enhance the self-efficacy of students in dental hygiene department at deciding their careers, it is considered that the curriculum should be organized carefully under reasonable plan, and there should be more active communication between professors and students as well as students each other. Besides there needs some educational programs to inspire the pride and sense of duty for the dental hygiene department.

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Factors Influencing Confidence in Patient Safety Management in Nursing Students (간호대학생의 환자안전관리 수행자신감에 영향을 미치는 요인)

  • Jeong, Hyun-Sook;Kong, Jeong-Hyeon;Jeon, Mi-Yang
    • Journal of the Korea Convergence Society
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    • v.8 no.6
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    • pp.121-130
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    • 2017
  • The purposed of this study was to identify the factors that affect Confidence in Performance Patient Safety Management targeted nursing students. The study subjects were 228 nursing students. The nursing students experienced patientl safety accidents in the fall (50.0%), needle puncture (18.5%), Patient identification error (12.0%), injection medication error (7.5%) and oral medication errors (4.3%). In the logistic regression analysis, Attitude of Patient Safety Management(t=6.09, p<.001), Clinical Decision Making(t=3.97, p<.001) and gender(t=2.56, p=.011) were significant factors related to Confidence of Performance Patient Safety Management. Based on the results of this study, we propose to develop a convergence education program that considers patient safety management attitude, clinical decision making ability, and gender in order to improve confidence of performance patient safety management of nursing students.