• 대한안전경영과학회지
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• 제15권1호
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• pp.31-40
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• 2013

For the matter of elevator, one of the multi-use facilities for unspecified public, the JIS has re-established and reformed to apply to the environment in South Korea for the past 20 years. In the aspect of safety assurance, it was inevitable to suggest improved measures. The government, Ministry of Public Administration and Security has secured the safety by enhancing the safety management functions in the elevator inspection standards and expanding its safety device measures. Further, the international inspection standard has been introduced, which is about unifying inspection standard system into the international standard code. In March 14th 2012, the international standard (EN) has been amended and fully announced. Escalator and passenger conveyor among lift devices have several common danger factor that cause safety accident. First, the accident caused by decreased braking power of brake. Second, the accident caused by the rate difference between handrail and tread-board. Third, the accident caused by defects of contraflow preventing device or carelessness inspection. Fourth, the accident caused by wet tread-board or wet floor of platform which makes passenger slip and fall. As the improvements to prevent and reduce these negligent accidents, the inspection list to check and methods should be subdivided and applied for each accident likelihood cause for safety management enhancement and safety assurance of existing escalator and passenger conveyors. The escalators and passenger conveyors without safety devices in existence should be obliged to modify the part of the system or install additional safety device. With making these measures obligations, it requires to improve the system to be suitable for the international inspection standard and to have measures to prevent safety accidents. It also needs to arrange improvements for skid accident of tread-board by the external environment factors such as snow and rain.

• Communications for Statistical Applications and Methods
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• 제24권6호
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• pp.561-581
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• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.229-254
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• 2004

The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

• 한국안전학회지
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• 제33권4호
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• pp.111-118
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• 2018

Korea is facing a surge in the aging population, showing that population aged 65 and above will be accounted for 42.5% of the total population in 2065 with the emphasis on the over-80 population consisting of 19.2%. In response to this abrupt change in population structure, the number of traffic fatality accident referring to older driver as aged 65+ years had been increasing from 605 fatalities in 2011 to 815 fatalities in 2015 resulting in increases in 34.7% in oppose to happening to decreases in 17.2% about non-older driver. With Logit analysis based on Newton-Raphson algorithm utilizing older driver's traffic fatality data for the 2011-2015 years, it was found that the likelihood of an accident resulting in a fatality for super older driver aged 80 years and above considerably increased compared to other older driver with aging classification: 2.24 times for violation of traffic lane, 2.04 times for violation of U-turn, 1.48 times for violation of safety distance, 1.35 times for violation of obstacle of passing; also average annual increase of traffic accident cost related to super older driver was fairly increased rather than other older driver groups. Hence, this study proposes that improving and amending transport safety system and Road Traffic Act for super older driver needs to be urgently in action about license management, safe driving education, etc. when considering the increase of over-80 population in the near future. Also, implementing a social agreement with all ages and social groups to apply with advanced driver assistance system for older driver groups will be able to become a critical factor to enhance safe driving over the face of the country.

• 한국건설관리학회논문집
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• 제8권3호
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• pp.106-115
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• 2007

산업이 발전함에 따라 도로 터널의 사이즈와 길이는 계속적으로 증가해 왔으며 그에 따른 터널에서의 리스크 또한 증가되었다. 도로터널에서 환기방식을 결정할 때는 다양하고 많은 고려사항을 염두에 두어야 한다. 현재로서는 이러한 것들을 체계적으로 고려하여 의사결정을 지원할 수 있는 방법론 내지 시스템이 제대로 구축되어 있지 않은 실정이며 대부분 전문가의 경험을 바탕으로 한 주관적 판단에 의존하고 있다. 본 연구에서는 기존의 경제성 내지 주관적 판단에 국한하여 의사결정이 이루어지던 관행에서 벗어나 안전성, 환경친화성 등도 충분히 고려하여 결정을 내릴 수 있도록 터널별 최적의 환기방식을 선정하기 위한 일련의 절차와 기준을 제시하였다. 이 때 다속성 효용이론과, AHP기법을 적절히 활용하여 전문가 및 설계자의 주관적/정성적 평가를 객관적/정량적으로 측정할 수 있도록 하였으며, 환기 방식별 종합적 효용을 산출할 수 있는 함수를 도출하기까지의 방법론을 제시하였다. 본 논문에서 제시하는 방법론을 바탕으로 보다 합리적인 의사결정이 이루어질 것을 기대한다.

• Clinical and Experimental Reproductive Medicine
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• 제47권1호
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• pp.1-11
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• 2020

Endometriosis is a common inflammatory disease in women of reproductive age and is one of the major causes of infertility. Endometriosis causes a sustained reduction of ovarian reserve through both physical mechanisms and inflammatory reactions, which result in the production of reactive oxygen species and tissue fibrosis. The severity of endometriosis is related to ovarian reserve. With regard to infertility treatment, medical therapy as a neoadjuvant or adjuvant to surgical therapy has no definite beneficial effect. Surgical treatment of endometriosis can lead to ovarian injury during the resection of endometriotic tissue, which leads to the deterioration of ovarian reserve. To overcome this disadvantage, a multistep technique has been proposed to minimize the reduction of ovarian reserve. When considering surgical treatment of endometriosis in patients experiencing infertility, it should be kept in mind that ovarian reserve can be reduced both due to endometriosis itself and by the process of removing endometriosis. In cases of mild- to moderate-stage endometriosis, intrauterine insemination with ovarian stimulation after surgical treatment may increase the likelihood of pregnancy. In cases of severe endometriosis, the characteristics of the patient should be considered in a multidisciplinary manner to determine the prioritization of treatment modalities, including surgical treatment and assisted reproduction methods such as in vitro fertilization. The risk of cancer, complications after pregnancy, and infection during oocyte retrieval should also be considered when making treatment decisions.

• Journal of Genetic Medicine
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• 제4권1호
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• pp.1-5
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• 2007

Unprecedented amount of genetic information being generated from the result of Human Genome Project (HGP) and advances in genetic research is already forcing changes in the paradigm of health and disease. The ultimate goal of genetic medicine is to use genetic information and technology to develop new ways of treatment or even prevention of the disease on an individual level for 'personalized medicine'. Genetics is play ing an increasingly important role in the diagnosis, monitoring and management of common multifactorial diseases in addition to rare single-gene disorders. While wide range of genetic testing have provided benefits to patients and family, uncertainties surrounding test interpretation, the current lack of available medical options for the diseases, and risks for discrimination and social stigmatization may remain to be resolved. However an increasing number of genetic tests are becoming commercially available, including direct to consumer genetic testing, yet public is often unaw are of their clinical and social implications. The personal nature of information generated by a genetic test, its power to affect major life decisions and family members, and its potential misuse raise important ethical considerations. Therefore appropriate genetic counseling is needed for patient to be informed with the benefits, limitations and risks of genetic tests, prior to informed consent for the tests. Physician also should be familiar with the legal and ethical issues involved in genetic testing to tell patients how w ell a particular genetic risk factor relates with likelihood of disease, and be able to provide appropriate genetic counseling. Genetic counseling become a mandatory requirement as global standard for many genetic testing such as prenatal diagnosis, presymtomatic DNA diagnostic tests and cancer susceptibility gene test for familial cancer syndrome. In oder to meet the challenge of genetic medicine of 21 century in korean health care system, professional education program and certification board for medical genetics specialist including non-MD genetic counselors should be addressed by medical society and regulatory policy of national health insurance reimbursement for genetic counseling to be in place to promote the implementation of clinical genetic service including genetic counseling for proper genetic testing.

• 대한지역사회영양학회지
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• 제3권4호
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• pp.609-621
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• 1998

Although many people initially enroll in health education programs, there are many instances of erratic participation and dropouts. Inconsistent participation in intervention programs minimizes their impact on health promotion. Therefore, a theoretical understanding of factors influencing participation in these programs can potentially enhance the effectiveness of its educational strategy. This study used the Pender's Health Promotion Model to examine specific factors influencing incentives to participate in an elderly nutrition education program. The Elderly Nutrition Counseling and Education Program was conducted with 147 volunteers (76 males, 71 females), aged 60 to 87, at 5 separate community elderly centers, by public health dietitians from February to April 1997. Some participants dropped out during the program. Overall, 61 people(18 males, 43 females) finished all 7 steps over 2 months. Pre-intervention data were collected by trained dietitians. This data included individual cognitive-perceptual factors(perceived benefits of nutrition improvement, importance of health, perceived control over health by multidimensional health locus of control, self esteem, perceived health status, concern about health, depression scale and social health scale), which were known to influence the likelihood of health behavior, and modifying factors(socioeconomic variables, biological characteristics, behavioral factors, such as smoking, alcohol drinking and exercise). Male finalists had a significantly lower chance for health locus of control, and better social health status with their children and grandchildren, compared to males who dropped out. Female finalists had a significantly higher locus of control regarding food behavior, higher self-esteem, better recognized nutritional status, worse self-recognized health status and lower concern about health than those who dropped out. There was no significant difference between the attendees and dropouts in age, BMI$(kg/m^2)$, Nutritional Risk Index, depression scale and daily nutrient intake. These results suggest that elderly nutrition intervention plans should focus on the individual cognitive and perceptual factors, with interpersonal influences, to increase participation in nutrition in nutrition improvement programs.

• Safety and Health at Work
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• 제5권4호
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• pp.210-215
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• 2014

Background: The ongoing economic crisis in Greece has affected both stress and quality of life (QoL) at all socioeconomic levels, including professionals in the police force. The aim of this study was to examine perceived stress, job satisfaction, QoL, and their relationships in a sample of police officers in Greece. Methods: A cross-sectional study was conducted during the first trimester of 2011 in 23 police stations in the greater Athens area. A total of 201 police officers agreed to participate (response rate 44.6%). The General Health Questionnaire-28 (GHQ-28) was used to assess general health, and the World Health Organization Quality of Life-BREF Questionnaire and Perceived Stress Scale-14 (PSS-14) questionnaires were used to assess QoL and perceived stress, respectively. Results: The PSS and GHQ subscales and total scores exhibited strong, positive, and significant correlations coefficients (r): 0.52 for somatic disturbances, 0.56 for stress and insomnia, 0.40 for social dysfunction, and 0.37 for depression, yielding an r equal to 0.57 for the total GHQ score. A higher level of perceived stress was related to a lower likelihood of being satisfied with their job; in this regard, male participants and higher ranked officers reported lower job satisfaction. The PSS and GHQ scores were inversely, consistently, and significantly related to almost all of the QoL aspects, explaining up to 34% of their variability. Parenthood had a positive effect on QoL related to physical health, and women reported lower QoL related to psychological health. Conclusion: Higher levels of stress are related to an increased risk of reporting suboptimal job satisfaction and QoL. The magnitude of these associations varied depending on age, gender, and rank, highlighting the need for stress-management training.

• Journal of Preventive Medicine and Public Health
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• 제54권3호
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• pp.161-165
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• 2021

Objectives: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads heterogeneously, disproportionately impacting poor and minority communities. The relationship between poverty and race is complex, with a diverse set of structural and systemic factors driving higher rates of poverty among minority populations. The factors that specifically contribute to the disproportionate rates of SARS-CoV-2 infection, however, are not clearly understood. Methods: We evaluated SARS-CoV-2 test results from community-based testing sites in Los Angeles, California, between June and December, 2020. We used tester zip code data to link those results with United States Census report data on average annual household income, rates of healthcare coverage, and employment status by zip code. Results: We analyzed 2 141 127 SARS-CoV-2 test results, of which 245 154 (11.4%) were positive. Multivariable modeling showed a higher likelihood of SARS-CoV-2 test positivity among Hispanic communities than among other races. We found an increased risk for SARS-CoV-2 positivity among individuals from zip codes with an average annual household income