• Journal of Biomedical Engineering Research
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• v.40 no.6
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• pp.250-259
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• 2019

Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

• Tuberculosis and Respiratory Diseases
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• v.80 no.1
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• pp.52-59
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• 2017

Background: Inhaled indacaterol (Onbrez Breezhaler), a long-acting ${\beta}_2$-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. Methods: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or $300{\mu}g$), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available. Results: Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator. Conclusion: In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.

• Korean Journal of Biological Psychiatry
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• v.20 no.3
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• pp.111-117
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• 2013

Objectives We investigated the effectiveness and safety when treated in schizophrenics with paliperidone palmitate, a long acting injectable antipsychotic. Methods This was a 24-week open-label study, performed at one center in Korea. The eligible patients with schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria were enrolled. Patients received long-acting paliperidone palmitate injection (234 mg, baseline; 156 mg, week 1 ; then once 4 weeks flexible dosing). Effectiveness assessments were measured by the Positive and Negative Syndrome Scale (PANSS), The Clinical Global Impression Severity Scale (CGI-S), The Personal and Social Performance (PSP) at baseline, week 1, every 4 weeks untill 24 weeks or endpoint. Safety assessments were measured by The Extrapyramidal Symptom Rating Scale (ESRS), body weight (BW) and incidence of adverse events. Oral antipsychotics were stopped or tapered off within next 14 days. Results Of 20 patients recruited, 9 patients (45%) completed the study. Paliperidone palmitate produced a significant improvement in PANSS total score from baseline to endpoint. The response rate was 75% [mean change (${\pm}SD$) $-25.9{\pm}14.4$, all p < 0.001]. The CGI-S and PSP total scores significantly improved during 24 weeks (All p < 0.001). Eighty percent of patients reported adverse events and most common adverse events (${\geq}10%$) in paliperidone palmitate were anticholinergic adverse event, extrapyramidal symptoms, weight gain, akathisia, insomnia, headache, agitation, anxiety and GI trouble. ESRS score is not statistically significant, but tends to get better at the end of the study when compared to baseline. Conclusions Our study results demonstrated maintained effectiveness and safety of paliperidone palmitate treatment in schizophrenics. And provides both clinicians and patients with a new choice of treatment that can improve the outcome of long term therapy. Their potential effectiveness and safety should be better addressed by future randomized-controlled trials.

• Journal of Engineering Education Research
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• v.26 no.2
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• pp.23-31
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• 2023

The purpose of this study is to explore the effectiveness of VR-based industrial safety education compared with conventional methods. For the study, three types of safety learning contents(VR-based learning, rule-based learning, and case-based learning) were developed and implemented with three college students groups. The results show that VR-based learning was effective in sustaining learning outcomes compared to other two conventional contents groups. In addition, participants perceived VR-based safety learning is attractive that facilitates their learning motivation and usefulness.

• The Journal of the Convergence on Culture Technology
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• v.2 no.2
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• pp.37-44
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• 2016

This study was performed to evaluate the safety level of consciousness of college dorm life, and to suggest the problem derivation and to improve the prevention of accidents. The survey research was performed to investigate the contents of safety training for 150 people, and the effectiveness, the demands of safety were also examined. The risk factors were identified in order to assess the level of personal security awareness. The survey was performed for the knowledge of risky behaviors, such as disaster preparedness tips. The research showed that the satisfaction and effectiveness of safety training was high by investigation. Through the research, the recognition factor of the accident, which occurs by a lack of understanding for specific responses, must be enhanced using the safety training to respond adequately when disaster occurs.

• Korean Journal of Health Education and Promotion
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• v.27 no.1
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• pp.49-60
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• 2010

Objectives: The purpose was to evaluate the effectiveness of participatory road safety education program for the lower grade in elementary schools. This program was developed based on the Activated Health Education model. Methods: Study design was compromise experimental group pre-post design. 456 students in 8 schools were nonrandomly assigned to study group(n=224) or control(n=232). The students finished self-administered questionnaire before and after education. Collected data was analyzed by using the SPSS. Results: 1. The common relevant factors in road safety knowledge and attitude were 'residential state' and 'experience of traffic accident'. 2. The knowledge showed that the case and control scored at 6.48 and 6.41 points before. After this intervention, the case and control scored at 8.38 and 6.51. The difference of the case was significant(p<0.001). 3. The attitude showed that the case and control scored at 19.67 and 19.63 before. After this, the case and control scored at 19.86 and 19.63. The difference of the case was significant(p<0.05). Conclusion: In order to implement the road safety education, children's socio-demographic characteristics were considered. Because this education was effective in both improving knowledge and attitude and bringing interest, various participatory program will be applied in road safety education for children.

• Safety and Health at Work
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• v.8 no.1
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• pp.59-66
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• 2017

Background: Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. Methods: This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Results: Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Conclusion: Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.

• IE interfaces
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• v.22 no.2
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• pp.104-115
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• 2009

The objective of the study is to evaluate the effectiveness of Crew Resource Management (CRM) training program for operators in the Main Control Room (MCR) simulator of APR-1400 Nuclear Power Plant. The experiments were conducted for two different crews of operators performing six different emergency operating scenarios during four-week period. Each crew consisted of the five operators: senior reactor operator, safety technical advisor, reactor operator, turbine operator, and electric operator. All crews (Crew A and B) participated in the training program for the technical knowledge and skills which were required to operate the simulator of the MCR during the first week. To verify the effectiveness of the CRM training program; however, only Crew A was selected to attend the CRM training after the technical knowledge and skills training. The results of the experiments showed that the CRM training program improved the individual attitudes of Crew A significantly. Team skills of Crew A were found to be significantly better than those of Crew B. The CRM training did not have positive effects on enhancing the individual performance of Crew A; however, as compared to that of Crew B. Implication of these findings was discussed further in detail.

• Safety and Health at Work
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• v.9 no.3
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• pp.308-313
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• 2018

Background: A behavior-based safety initiative card-issuing system was introduced at a cement-manufacturing company in Zimbabwe in 2008 to try and curb accident occurrence. The purpose of this study was to evaluate the effectiveness of the Behaviour Based Safety Initiative card system as a tool used for reducing accident frequencies. Methods: A mixed-method approach that involving administering piloted questionnaires to 40 out of 244 randomly selected employees, making observations, and reviewing secondary data were done to collect data from different sources in the organization in 2013. A paired t-test was conducted to test whether there was significant difference in accident occurrence before and after the implementation of the BBSI. Scatterplots were also used to establish the correlation between the issuance of cards and the accident and injury occurrence. Results: The findings suggest that the introduction of the card system brought a significant decrease in accident and injury occurrence. A negative correlation between card issuance and accident occurrence was observed, i.e., the greater the number of cards issued, the fewer the number of accidents. It was also noted that the card system positively influenced the mindset of workers towards safe work practices. Conclusion: The card system had an influence on the reduction of accidents and injuries. The organization should leverage on issuing more cards to further reduce the number of accidents and injuries to zero.

• Journal of the Korean Society of Safety
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• v.30 no.3
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• pp.80-84
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• 2015

The industrial accidents in the construction business have decreased on the basis of the accreditation of KOSHA 18001, one of the occupational health and safety management system. However, the interest and investment into the KOSHA 18001 has grown down because of the worsened construction business so that the construction companies that maintain the system as a mere formality has begun to be displayed. In this regard, this study performed the interview with the internal and external review board as well as the question investigation from the persons concerned in order to apprehend the current problems in the KOSHA 18001. First of all, the internal reviewers in the KOSHA are lack in the comparison with the number of new and renew accreditation. Secondly, many persons concerned with the KOSHA has required the quantitative criteria for the accreditation. Consequently, the manpower supplement associated with the external reviewers, the grading evaluation would be strong solutions to improve the effectiveness of KOSHA 18001.