[Incidence and Risk Factors of Dyslipidemia after Menopause].

PURPOSE: This study was aimed at investigating the incidence and risk factors of dyslipidemia in menopausal women using a Korean community-based longitudinal study. METHODS: The subjects were 245 postmenopausal women without dyslipidemia who had participated in the Ansan-Ansung cohort study from 2001~2002 (baseline) to 2015~2016 (seventh follow-up visit). The dyslipidemia incidence was measured as incidence proportion (%) and incidence rate per 100 person-years. The predictors of developing dyslipidemia were analyzed with Cox's proportional hazard model. RESULTS: The incidence of new dyslipidemia during the follow-up period was 78.4% (192 patients), and 11.9 per 100 person-years. Mean duration from menopause to developing dyslipidemia was 5.3 years in new dyslipidemia cases. The triglyceride/high density lipoprotein (TG/HDL-C) ratio at baseline (hazard ratio = 2.20; 95% confidence interval = 1.39~3.48) was independently associated with developing dyslipidemia. CONCLUSION: Dyslipidemia occurs frequently in postmenopausal women, principally within five years after menopause. Therefore, steps must be taken to prevent dyslipidemia immediately after menopause, particularly in women with a high TG/HDL-C ratio at the start of menopause.

Incidence and Predictors of Cataract among People with Type 2 Diabetes Mellitus: Using Secondary Data Analysis from the Ansan Cohort of the Korean Genome and Epidemiology Study.

PURPOSE: This study investigated the incidence and risk factors of cataract in people with diabetes mellitus (DM) using data from Ansan cohort of the Korean Genome and Epidemiology Study (KoGES). METHODS: Data from a total of 329 patients with type 2 DM without cataract who participated in Ansan cohort of the KoGES from baseline survey (2001-2002) to fifth follow-up visit (2011-2012) were examined. The characteristics of the subjects were analyzed with frequency and percentage, and mean and standard deviation. Cataract incidence was measured as incidence proportion (%). For risk factors of cataract, hazard ratio (HR) and 95% confidence interval (CI) were obtained using the Cox proportional hazard model. RESULTS: The cataract incidence over a 10-year follow-up period was 19.1% (15.1 in males and 25.8 in females), and mean age at the incidence of cataract was 63.48 years (61.58 years in males and 65.31 years in females). Age (HR=1.09, 95% CI=1.05-1.13) and HbA1c (HR=1.21, 95% CI=1.07-1.37) or the duration of DM (HR=1.05, 95% CI=1.00-1.09) were found to be independently associated with cataract development. CONCLUSION: Cataract development in people with DM is common, and its likelihood increases with age, HbA1c, and the duration of DM. Considering negative effect of cataract on their quality of life and economic burden, nurses should identify people with DM at a higher risk of cataract development, and plan individual eye examination programs to detect cataract development as early as possible.

Development of Performance Indicators for Clinical Research Coordinators Using the Balanced Scorecard in South Korea.

BACKGROUND: This is a methodological study that aims to develop performance indicators based on a balanced scorecard for the clinical research coordinator (CRC) position. METHODS: The CRC performance indicators were developed through a literature review, a data review, expert consultations, focus group interviews, and content validity verification. We also used these data to confirm whether the performance indicators were appropriately indexed. RESULTS: We developed 10 strategies and 31 performance management indicators based on the 4 perspectives of the balanced scorecard (financial, customer, internal business process, and learning and growth). CONCLUSIONS: This research developed CRC performance indicators using a balanced scorecard in order to improve the quality of CRC work performance. These indicators establish the direction that tasks should take; they motivate CRCs by being associated with the compensation system, competence development programs, and a balanced performance evaluation system.

Who are the assistant cooks at the community child centers in South Korea? Focus group interviews with workfare program participants.

PURPOSE: Community child centers (CCCs) were introduced to provide after-school activities and care, including meal services to children from low-income families. The assistant cooks, who have the main responsibility for making and serving food at CCCs, are a major factor influencing the eating habits of children using CCCs. In this study, we tried to identify and understand who the assistant cooks are, what their job responsibilities are, and what they need in order to be able to provide children with healthy meals. METHODS: Three focus group interviews were held with 17 workfare program participants who worked as assistant cooks at CCCs, and content analysis methods were applied using the NVivo 12 qualitative data analysis software. RESULTS: The assistant cooks reflected on their perceptions of the children's health at the CCCs, their own cooking style, and their role at the CCCs. Additionally, barriers to the optimal provision of their services were pointed out, and improvements were suggested. CONCLUSION: The results of this study can be used as a fundamental resource for the development of tailored interventions that consider a child's unique environment to address health disparities, specifically with respect to childhood obesity.

Development of Performance Indicators for Clinical Research Coordinators Using the Balanced Scorecard in South Korea.

BACKGROUND: This is a methodological study that aims to develop performance indicators based on a balanced scorecard for the clinical research coordinator (CRC) position. METHODS: The CRC performance indicators were developed through a literature review, a data review, expert consultations, focus group interviews, and content validity verification. We also used these data to confirm whether the performance indicators were appropriately indexed. RESULTS: We developed 10 strategies and 31 performance management indicators based on the 4 perspectives of the balanced scorecard (financial, customer, internal business process, and learning and growth). CONCLUSIONS: This research developed CRC performance indicators using a balanced scorecard in order to improve the quality of CRC work performance. These indicators establish the direction that tasks should take; they motivate CRCs by being associated with the compensation system, competence development programs, and a balanced performance evaluation system.

Clinical Research Coordinators' Attitude Toward Risk-Based Monitoring.

BACKGROUND: Clinical research coordinators (CRCs) are persons who collect, record, and maintain clinical trial data in accordance with the principles of Good Clinical Practice at investigators' sites. This study was conducted to examine attitudes of clinical research coordinators (CRCs) toward risk-based monitoring (RBM) prior to full-scale implementation of RBM in Korea. METHODS: The study subjects were 607 CRCs, and data were collected using a self-reported questionnaire. Collected data were analyzed by frequency, percentage, χ2 test and Fisher exact test. RESULTS: Among CRCs, 42.3% had heard of RBM and 44.6% were found to oppose its implementation. Those opposed believed that implementation of RBM would increase the workload of CRCs and CRAs' work support for CRCs. In addition, they showed many negative opinions such as poor accuracy of test data input and failure to increase the overall quality of clinical tests. In particular, such attitudes were more noticeable in CRCs with 5 or more years of experience. CONCLUSION: Before the implementation of RBM, it is necessary to come up with administrative measures such as education for practitioners and recruitment of human resources to help CRCs properly understand RBM.

Changes in the Number and Employment Conditions of Clinical Research Coordinators in South Korea.

BACKGROUND: This study was aimed to examine the number and employment conditions of clinical research coordinators (CRCs) in Korea, with comparison to data from 2010 to identify changes. METHODS: The descriptive study examined 65 sites that participated in a survey or phone interviews among 184 sites registered as clinical trial sites by the Ministry of Food and Drug Safety, and 2 site management organizations. The data were analyzed for mean, standard deviation or median, range, frequency, and percentage. RESULTS: There were 2855 CRCs in 65 sites and 3711 CRCs nationwide, which reflected an increase of 268 people every year on average since 2010. The most common employment system (60.6%) was where CRCs were hired by sites and allocated to clinical trial departments. As for employment type, 48.5% of posts were full-time, and monthly wage payment was the most common at 54.5%. An employment/personnel management department was reported at 87.9% of sites. The average duration from hiring to resignation was 19 months. CONCLUSIONS: The number of CRCs was increased, and such an increase of CRCs was attributed to the increase of investigator-affiliated CRCs rather than site-affiliated CRCs. Though the employment conditions of CRCs have been improved, most improvements were confined to site-affiliated CRCs. It is recommended that each site have a CRC registration and management system for both site-affiliated CRCs and investigator-affiliated CRCs, standardized CRC employment guidelines, and support for CRCs to participate in the training program for the overall improvement of employment conditions of CRCs in Korea.