BACKGROUND: This study was conducted to evaluate vinly chloride exposure in vinyl chloride and poly vinyl chloride manufacturing factories. The object of this study was compare two different type of air sampling method that of, NIOSH and OSHA recommended and Investigate quantitative correlation between level of vinyl chloride exposure and urinary thiodiglycolic acid excretion. METHODS: Air sampling was conducted by two method and sampling mediums were located at workers breathing zone in the same location. Sampling mediums were changed in 60 minute interval and sampling pumps were recalibrated at the same time. Urine was collected before and end of shift were stored frozen and determined by GC/FID analysis. RESULTS: In NIOSH method, time weighted average was 3.562 +/- 2.898 ppm and OSHA method time weighted average was 4.051 +/- 3.700 ppm. Concentration of urinary TdGA in before shift was 0.527 +/- 0.828 g/g creatinine and end of shift was 4.190 +/- 7.665 mg/g creatinine. Difference of urinary TdGA between end of shift to before shift was 3.662 +/- 7.865 mg/g creatinine. In NIOSH method, correlation coefficient between 8hour-time weighted average (8hrs-TWA) and urinary concentration of TdGA was r=0.666. and last period vinyl chloride level (6th-TWA) and urinary TdGA concentration was r=0.972. In OSHA method, correlation coefficient between last period vinyl chloride level (6th-TWA) and urinary concentration of TdGA was r=0.976 and this was highest value. CONCLUSION: There was no statistically significant difference in NIOSH method and. OSHA method. A correlation were found between level of vinyl chloride exposure and urinary thiodiglycolic acid excretion. Also, vinyl chloride exposure had significantly effected on the urinary thiodiglycolic acid excretion.
Creatinine ; National Institute for Occupational Safety and Health (U.S.) ; Respiration ; United States Occupational Safety and Health Administration ; Vinyl Chloride*

OBJECTIVES: Workers from a factory was selected to compare 8 standard threshold shift criteria with the Korean diagnostic criteria of noise-induced hearing loss for this cohort study. METHODS: From 1990 to 1999, 491 workers at a manufacturing company with complete record of the hearing test covering the range of 0.5~6 kHz for 10 consecutive years were finally selected. Eight standard threshold shift criteria (15 dB once, NIOSH (1972), 10 dB average 3~4 kHz, OSHA STS, AAOHNS, 15 dB twice, 15 dB 1~4 kHz, OSHA STS twice) along with the Korean standard for diagnosing the noise-induced hearing loss (the average hearing threshold at 0.5, 1 and 2 kHz) were compared to calculate the degree of the threshold shift and the minimum time required to detect the change. RESULTS: Those workers showing at least one positive shift in the 'once'criteria of NIOSH (1972) were 92.5%; the 'average'criteria of 10 dB average 3~4 kHz were 35.8%; 'twice'criteria of 15 dB twice were 44.4%. The duration from the baseline to the year showing the first positive shift was from 3.2 +/- 3.1 years (NIOSH, 1972) to 6.0 +/- 2.1 years (OSHA STS twice). The percentage of true positive shift ranging from 20.4% (AAO-HNS) to 69.8% (NIOSH, 1972). There were 10 (2%) which met the Korean diagnostic criteria of noise-induced hearing loss. CONCLUSIONS: Currently the concept of hearing threshold shift in diagnosing the hearing loss was adopted in Korea thus in this study we determined the validity and the effect of the various hearing threshold shift criteria and showed that NIOSH (1972) criteria was the best of all. In the future, hearing data from various manufacturing workers should be compared to thoroughly evaluate the threshold shift criteria and to establish adequate standard for Korean workers.
Cohort Studies ; Hearing Loss ; Hearing Loss, Noise-Induced ; Hearing Tests ; Hearing* ; Korea ; National Institute for Occupational Safety and Health (U.S.) ; United States Occupational Safety and Health Administration

OBJECTIVES: This study was carried out to survey on the prevalence of Carpal Tunnel Syndrome(CTS) in high risk jobs(meat and fish processing plant and wood plant), by application of Nerve Conduction Study(NCS), a confirmatory diagnostic method. METHODS: Experimental group was 69 workers sampled from meat and fish processing plants and 17 workers sampled from wood plants, who were simple, repetitive workers using upper extremities and control group was 28 workers sampled from managers, secretaries and keepers. All employees were examined through work history, physical examination and NCS. RESULTS: 18 workers(26.09%) in meat and fish processing plants, and 5 workers(29.41%) in wood plants had compatible findings to NIOSH diagnostic criteria for CTS. The experimental group had more symptoms(complaint of upper extremities, Visual Analogue Scale >or= 4(VAS: total 10 point)), signs(Tinel and Phalen test) and prevalence of CTS than control group ( p<0.05). The prevalence of symptoms and signs were higher in short term worke r s (<7 years), but the prevalence of CTS was higher in long term workers(>or=7 years). CONCLUSIONS: The prevalence of CTS in meat and fish processing plant and wood plant were 26.09% and 29.41% respectively. Authors propose that meat and fish processing and wood plants should be managed as a risk job category which were designated by OSHA in 1996
Carpal Tunnel Syndrome* ; Meat ; National Institute for Occupational Safety and Health (U.S.) ; Neural Conduction ; Physical Examination ; Plants ; Prevalence* ; United States Occupational Safety and Health Administration ; Upper Extremity* ; Wood

PURPOSE: Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems. MATERIALS AND METHODS: We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers in 56 academic hospitals. RESULTS: The number of cancer clinical trials approved by the KFDA increased almost twofold from 2007 to 2013. The number of sponsor-initiated clinical trials (SITs) increased by 50% and investigator-initiated clinical trials (IITs) increased by almost 640%. Three hundred and forty-four clinical trials were approved by the KFDA between 2012 and 2013. At the time of the on-line survey (August 2013), 646 SITs and 519 IITs were ongoing in all hospitals. Six high volume hospitals were each conducting more than 50 clinical trials, including both SITs and IITs. Fifty-six investigators (31%) complained of the difficulties in raising funds to conduct clinical trials. CONCLUSION: The number of cancer clinical trials in Korea rapidly increased from 2007 to 2013, as has the number of multicenter clinical trials and IITs run by cooperative study groups. Limited funding for IIT is a serious problem, and more financial support is needed both from government agencies and public donations from non-profit organizations.
4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic Acid ; Financial Management ; Financial Support ; Government Agencies ; Hospitals, High-Volume ; Humans ; Korea* ; Organizations, Nonprofit ; Research Personnel ; United States Food and Drug Administration

Antineoplastic Agents ; standards ; therapeutic use ; Clinical Trials as Topic ; Disease-Free Survival ; Europe ; Evaluation Studies as Topic ; Government Agencies ; Humans ; Maximum Tolerated Dose ; Neoplasms ; drug therapy ; Quality of Life ; Remission Induction ; Survival Rate ; Treatment Failure ; United States ; United States Food and Drug Administration

BACKGROUND: The objective of this study is to suggest revised recognition standards for occupational disease due to chromium (VI) by reflecting recent domestic and international research works and considering domestic exposure status with respect to target organs, exposure period, and cumulative exposure dose in relation to the chromium (VI)-induced occupational disease compensation. METHODS: In this study, the reports published by major international institutions such as World Health Organization (WHO) International Agency for Research on Cancer (IARC) (2012), Occupational Safety and Health Administration (OSHA) (2006), National Institute for Occupational Safety and Health (NIOSH) (2013), American Conference of Governmental Industrial Hygienists (ACGIH) (2004), National Toxicology Program (NTP) (2014), and Agency for Toxic Substances and Disease Registry (ASTDR) (2012) were reviewed and the recent research works searched by PubMed were summarized. RESULTS: Considering the recent research works and the domestic situation, only lung cancer is conserved in the legislative bill in relation to chromium (VI), and the exposure period is not included in the bill. Nasal and paranasal sinus cancer was excluded from the list of cancers that are compensated as the chromium (VI)- induced occupational disease, while lung cancer remains in the list. In the view of legislative unity, considering the fact that only the cancers having sufficient evidence are included in the conventional list of cancers compensated as occupational disease, nasal and paranasal sinus cancer having limited evidence were excluded from the list. The exposure period was also removed from the legislative bill due to the insufficient evidence. Recent advices in connection with cumulative exposure dose were proposed, and other considerable points were provided with respect to individual occupational relevance. CONCLUSIONS: It is suggested that the current recognition standard which is “Lung cancer or nasal and paranasal sinus cancer caused by exposure to chromium (VI) or compounds thereof (exposure for two years or longer), or nickel compounds” should be changed to “Lung cancer caused by exposure to chromium (VI) or compounds thereof, and lung cancer or nasal and paranasal sinus cancer caused by exposure to nickel compounds”.
Chromium ; Compensation and Redress ; International Agencies ; Korea ; Lung Neoplasms ; National Institute for Occupational Safety and Health (U.S.) ; Nickel ; Occupational Diseases ; Occupational Exposure ; Paranasal Sinus Neoplasms ; Toxicology ; United States Occupational Safety and Health Administration ; World Health Organization

Antipsychotic drugs have focused on treatment of positive and negative symptoms of schizophrenia. While these drugs resulted in improvements of these symptoms, they did not yield the expected recovery to pre-morbid level of functioning. Recently, a growing number of publications have shown that the cognitive deficits are a core feature of schizophrenia and they are critical determinants of poor functional outcome. Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) is a NIMH initiative that is designed to stimulate development of drugs to improve cognition in schizophrenia. MATRICS has four main goals: 1) to promote development of novel compounds to enhance cognition in schizophrenia, 2) to increase acceptance of cognition in schizophrenia as a valid target for drug approval from the US Food and Drug Administration, 3) to help focus the economic research power of industry on this important, but neglected, clinical target, and 4) to identify promising compounds and support proof of concept trials for cognition-enhancers in schizophrenia. In this article, we reviewed the contents of MATRICS and its progress.
Antipsychotic Agents ; Cognition* ; Drug Approval ; National Institute of Mental Health (U.S.) ; Psychopharmacology ; Schizophrenia* ; United States Food and Drug Administration

As recently as about 50 years ago, hypertension was considered a natural protective mechanism that should not be treated. However, after the completion of the first Multicenter Veterans Administration Cooperative Study proving the benefits of blood pressure-lowering treatment for cardiovascular protection, there has been no more debate regarding the importance of controlling hypertension. Nevertheless, the most appropriate target blood pressure goal has been continuously debated. The recently published Systolic Blood Pressure Intervention Trial has again shifted the balance of consensus towards strict blood pressure control. Herein, I provide a brief summary history of the establishment of target blood pressure goals and current perspectives.
Blood Pressure* ; Consensus ; Hypertension* ; United States Department of Veterans Affairs

Health technology assessment was first introduced to the Republic of Korea in 2006 by amending the Medical Services Act. The Committee of New Health Technology Assessment (CNHTA) is the ministerial committee that has the responsibility of reviewing the safety and effectiveness of new health technology. CNHTA review plays a gatekeeping role for new health technology in Korea, which can increase the burden on patients in Korea, either by out-of pocket payments or co-pays for National Health Insurance covered service. This kind of gatekeeping is a function of the healthcare system in many countries where no financial cap such as a fixed budget or diagnosis-related group payment is applied. However, it has been argued that gatekeeping works against industrial promotion policy. The one-stop service introduced in 2014 is a system similar to US parallel review between the US Food and Drug Administration and Centers for Medicare and Medicaid Services. This service provides a simultaneous process of regulatory review by the Ministry of Food and Drug Safety, identification of existing technology by the Health Insurance Review and Assessment Services, and new health technology assessment by the National Evidence-based Healthcare Collaborating Agency and the Ministry of Health and Welfare. This service is expected to reduce the total review process by 3 to12 months. A limited health technology appointment service was introduced in April 2014. This service designates orphan health technologies and health technologies for rare and incurable diseases and supports evidence development at designated hospitals. Several countries have similar systems: US Coverage with Evidence Development, Canadian Conditionally Funded Field Evaluation, UK Only in Research, and many others. The future direction of Health technology assessment should focus on the life cycle management of health technology. A consistent, continuous, and transformative mechanism to manage from the research and development of health technology to delisting obsolete technology to make room for new innovative technology is warranted.
Biomedical Technology* ; Budgets ; Centers for Medicare and Medicaid Services (U.S.) ; Child ; Child, Orphaned ; Delivery of Health Care ; Diagnosis-Related Groups ; Financial Management ; Gatekeeping ; Humans ; Insurance, Health ; Korea ; Life Cycle Stages ; National Health Programs ; Republic of Korea ; United States Food and Drug Administration

Genomics ; Government Agencies ; Laboratories ; United States