Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance.

INTRODUCTION: Integration of controlled vocabulary-based electronic health record (EHR) observational data is essential for real-time large-scale pharmacovigilance studies. OBJECTIVE: To provide a semantically enriched adverse drug reaction (ADR) dictionary for post-market drug safety research and enable multicenter EHR-based extensive ADR signal detection and evaluation, we developed a comprehensive controlled vocabulary-based ADR signal dictionary (CVAD) for pharmacovigilance. METHODS: A CVAD consists of (1) administrative disease classifications of the International Classification of Diseases (ICD) codes mapped to the Medical Dictionary for Regulatory Activities Preferred Terms (MedDRA® PTs); (2) two teaching hospitals' codes for laboratory test results mapped to the Logical Observation Identifiers Names and Codes (LOINC) terms and MedDRA® PTs; and (3) clinical narratives and ADRs encoded by standard nursing statements (encoded by the International Classification for Nursing Practice [ICNP]) mapped to the World Health Organization-Adverse Reaction Terminology (WHO-ART) terms and MedDRA® PTs. RESULTS: Of the standard 4514 MedDRA® PTs from Side Effect Resources (SIDER) 4.1, 1130 (25.03%), 942 (20.86%), and 83 (1.83%) terms were systematically mapped to clinical narratives, laboratory test results, and disease classifications, respectively. For the evaluation, we loaded multi-source EHR data. We first performed a clinical expert review of the CVAD clinical relevance and a three-drug ADR case analyses consisting of linezolid-induced thrombocytopenia, warfarin-induced bleeding tendency, and vancomycin-induced acute kidney injury. CONCLUSION: CVAD had a high coverage of ADRs and integrated standard controlled vocabularies to the EHR data sources, and researchers can take advantage of these features for EHR observational data-based extensive pharmacovigilance studies to improve sensitivity and specificity.

Osteoarthritis Affects Health-Related Quality of Life in Korean Adults with Chronic Diseases: The Korea National Health and Nutritional Examination Surveys 2009-2013.

BACKGROUND: Osteoarthritis (OA) is a chronic disease that commonly afflicts the elderly. This disease reduces the health-related quality of life (HRQoL) and causes a significant social burden. Whether the effect of coexisting chronic conditions on HRQoL varies according to the presence of OA remains unclear. Therefore, this study aimed to investigate this notion. METHODS: A total of 13,395 participants were identified from the 2009-2013 Korean National Health and Nutrition Examination Survey for analysis. HRQoL was assessed using the European quality of life-5 dimensions (EQ-5D) index. Patients with OA were defined as those diagnosed by a physician or those who displayed both, symptoms and radiological findings consistent with OA at the time of the survey. Associations between OA and 8 chronic conditions were tested using regression analysis. RESULTS: The EQ-5D index was lower in patients with OA than in those without (mean difference, -0.145; 95% confidence interval [CI], -0.138 to -0.151; P<0.001). Most patients with OA and chronic conditions showed a lower score than those without. EQ-5D was particularly lower in OA patients with hypertension, dyslipidemia, stroke, and renal failure. The estimated ß coefficient for the interaction term was significant in renal failure (-0.034; 95% CI, -0.055 to -0.012), after adjusting for demographic and socio-economic variables. CONCLUSION: OA significantly affects HRQoL of Korean elderly individuals alone or when combined with other conditions. OA combined with renal failure is particularly detrimental. These results indicate the importance of managing OA, which is an underestimated disease in public health surveys.

Efficacy of Carboxymethylcellulose and Hyaluronate in Dry Eye Disease: A Systematic Review and Meta-Analysis.

BACKGROUND: The efficacy of two artificial tears, carboxymethylcellulose (CMC) and hyaluronate (HA), was compared in the treatment of patients with dry eye disease. METHODS: We conducted a systematic review and meta-analysis on randomized controlled trials in the PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases. The efficacy was compared in terms of the mean change from baseline in tear break-up time. The meta-analysis was conducted using both random and fixed effect models. The quality of the selected studies was assessed for risk of bias. RESULTS: Five studies were included involving 251 participants. Random effect model meta-analysis showed no significant difference between CMC and HA in treating dry eye disease (pooled standardized mean difference [SMD]=-0.452; 95% confidence interval [CI], -0.911 to 0.007; P=0.053). In contrast, fixed effect model meta-analysis revealed significant improvements in the CMC group when compared to the HA group (pooled SMD=-0.334; 95% CI, -0.588 to -0.081; P=0.010). CONCLUSION: The efficacy of CMC appeared to be better than that of HA in treating dry eye disease, although meta-analysis results were not statistically significant. Further research is needed to better elucidate the difference in efficacy between CMC and HA in treating dry eye disease.

Standard-based comprehensive detection of adverse drug reaction signals from nursing statements and laboratory results in electronic health records.

OBJECTIVE: We propose 2 Medical Dictionary for Regulatory Activities-enabled pharmacovigilance algorithms, MetaLAB and MetaNurse, powered by a per-year meta-analysis technique and improved subject sampling strategy. MATRIALS AND METHODS: This study developed 2 novel algorithms, MetaLAB for laboratory abnormalities and MetaNurse for standard nursing statements, as significantly improved versions of our previous electronic health record (EHR)-based pharmacovigilance method, called CLEAR. Adverse drug reaction (ADR) signals from 117 laboratory abnormalities and 1357 standard nursing statements for all precautionary drugs ( n = 101) were comprehensively detected and validated against SIDER (Side Effect Resource) by MetaLAB and MetaNurse against 11 817 and 76 457 drug-ADR pairs, respectively. RESULTS: We demonstrate that MetaLAB (area under the curve, AUC = 0.61 ± 0.18) outperformed CLEAR (AUC = 0.55 ± 0.06) when we applied the same 470 drug-event pairs as the gold standard, as in our previous research. Receiver operating characteristic curves for 101 precautionary terms in the Medical Dictionary for Regulatory Activities Preferred Terms were obtained for MetaLAB and MetaNurse (0.69 ± 0.11; 0.62 ± 0.07), which complemented each other in terms of ADR signal coverage. Novel ADR signals discovered by MetaLAB and MetaNurse were successfully validated against spontaneous reports in the US Food and Drug Administration Adverse Event Reporting System database. DISCUSSION: The present study demonstrates the symbiosis of laboratory test results and nursing statements for ADR signal detection in terms of their system organ class coverage and performance profiles. CONCLUSION: Systematic discovery and evaluation of the wide spectrum of ADR signals using standard-based observational electronic health record data across many institutions will affect drug development and use, as well as postmarketing surveillance and regulation.

Association between secondhand smoke exposure and blood lead and cadmium concentration in community dwelling women: the fifth Korea National Health and Nutrition Examination Survey (2010-2012).

OBJECTIVES: To assess the association between secondhand smoke exposure and blood lead and cadmium concentration in women in South Korea. DESIGN: Population-based cross-sectional study. SETTING: South Korea (Korea National Health and Nutrition Examination Survey V). PARTICIPANTS: 1490 non-smoking women who took part in the fifth Korea National Health and Nutrition Examination Survey (2010-2012), in which blood levels of lead and cadmium were measured. PRIMARY OUTCOME MEASURES: The primary outcome was blood levels of lead and cadmium in accordance with the duration of secondhand smoke exposure. RESULTS: The adjusted mean level of blood cadmium in women who were never exposed to secondhand smoke was 1.21 (0.02) µg/L. Among women who were exposed less than 1 h/day, the mean cadmium level was 1.13 (0.03) µg/L, and for those exposed for more than 1 h, the mean level was 1.46 (0.06) µg/L. In particular, there was a significant association between duration of secondhand smoke exposure at the workplace and blood cadmium concentration. The adjusted mean level of blood cadmium concentration in the never exposed women's group was less than that in the 1 h and more exposed group, and the 1 h and more at workplace exposed group: 1.20, 1.24 and 1.50 µg/L, respectively. We could not find any association between lead concentration in the blood and secondhand smoke exposure status. CONCLUSIONS: This study showed that exposure to secondhand smoke and blood cadmium levels are associated. Especially, there was a significant association at the workplace. Therefore, social and political efforts for reducing the exposure to secondhand smoke at the workplace are needed in order to promote a healthier working environment for women.

Establishing a Personal Health Record System in an Academic Hospital: One Year's Experience.

BACKGROUND: Personal health records (PHRs) are web based tools that help people to access and manage their personalized medical information. Although needs for PHR are increasing, current serviced PHRs are unsatisfactory and researches on them remain limited. The purpose of this study is to show the process of developing Seoul National University Bundang Hospital (SNUBH)'s own PHR system and to analyze consumer's use pattern after providing PHR service. METHODS: Task force team was organized to decide service range and set the program. They made the system available on both mobile application and internet web page. The study enrolled PHR consumers who assessed PHR system between June 2013 and June 2014. We analyzed the total number of users on a monthly basis and the using pattern according to each component. RESULTS: The PHR service named Health4U has been provided from June 2013. Every patient who visited SNUBH could register Health4U service and view their medical data. The PHR user has been increasing, especially they tend to approach via one way of either web page or mobile application. The most frequently used service is to check laboratory test result. CONCLUSION: For paradigm shift toward patient-centered care, there is a growing interest in PHR. This study about experience of establishing and servicing the Health4U would contribute to development of interconnected PHR.

Prevalence of chronic obstructive lung disease in Korea using data from the fifth Korea national health and nutrition examination survey.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is the fifth leading cause of death worldwide. The awareness and treatment rate of the disease are low despite its relatively high prevalence. With the added data, this study aimed to identify changes in prevalence and risk factors of COPD using the data from the 5th KNHNES. METHODS: The subjects of this study were 8,969 individuals aged 40 and older who satisfied suitability and reproducibility for pulmonary function tests. The prevalence, awareness and risk factors of COPD were predicted based on the questionnaires on gender, age, educational level, income level, smoking history, body mass index (BMI) and other COPD related questions. RESULTS: Diagnosis of COPD was based on the airflow limitation (forced expiratory volume in one second/forced vital capacity <0.7) of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The prevalence of COPD from 2010 to 2012 was 13.7%, of which 23.3% was men and 6.5% women. The prevalence was on the rise, with 12.2% in 2010, 13.2% in 2011, and 15.5% in 2012. In GOLD stage 1, the percentages of those who had cough or sputum and smoking history were 12.1% and 75.5%, respectively, but only 0.1% was diagnosed with COPD. Even after adjusting for asthma and tuberculosis, men, old age, larger amount of smoking were linked with a higher prevalence of COPD, and obese and higher educational level were associated with a lower prevalence of COPD. CONCLUSION: The prevalence of COPD in Korea has been increasing every year, and a higher prevalence was associated with male, older age, more amount of smoking, lower educational level and lower BMI.

Effect of the telephone-delivered nutrition education on dietary intake and biochemical parameters in subjects with metabolic syndrome.

As prevalence of metabolic syndrome has rapidly increased over the past decade, lifestyle changes including dietary habits are considered as a therapeutic cornerstone for metabolic syndrome, cardiovascular complications and type 2 diabetes. We evaluated the effectiveness of a telephone-delivered nutrition education to improve metabolic parameters compared with a single-visit with a dietitian in subjects with metabolic syndrome. A total of seventy-one adults who met diagnostic criteria for the metabolic syndrome were randomly assigned to either the single-visit group or the in-depth nutrition education group during a 3-month intervention study period. The in-depth telephone-delivered nutrition education group had an initial visit with a dietitian and additional two telephone counseling during the first 4 weeks of the study periods. Sixty-six subjects completed a 3-month intervention study. The trial examined participant's anthropometric changes and dietary intakes as well as changes in the metabolic syndrome factors. At the end of the trial, the in-depth nutrition education group showed significantly higher reduction in weight, body fat and abdominal circumference compared with the other group (p < 0.05). In the in-depth nutrition groups, the prevalence of metabolic syndrome was decreased to 45.5%, while 69.7% of the subjects were metabolic syndrome patients in the single-visit group (p < 0.05). These results demonstrate that the telephone-intervention counseling is a feasible mean to deliver dietary intervention in patients with metabolic syndrome.

The Prevalence of Chronic Diseases among Migrants in Korea According to Their Length of Stay and Residential Status.

BACKGROUND: Migrant health is becoming public health issues, as the migrant populations are increasing and their length of stay is prolonged. This study aims to analyze the differences in prevalence of chronic diseases among migrants according to length of stay and residential status. METHODS: An initial population pool were 3,024 who were assessed with health screening programs by Migrant Health Association. 2,459 migrants were selected for final analysis. Via Stata 10 we conducted univariate logistic regression analysis to examine the effects of their length of stay and residential status on the prevalence of hypertension, diabetes, dyslipidemia, and obesity. In the final analysis, the result of each sex was adjusted for age, nationality, length of stay, and residential status via multiple logistic regression analysis. RESULTS: Longer length of stay tends to increase the prevalence of hypertension in male; 4-6 year stay-duration group demonstrated statistically significant excess compared to 1 year or less stay-duration group (adjusted odds ratio [OR], 1.39; confidence interval [CI], 1.01 to 1.92). After adjustment, male migrants stayed more than 7 year showed considerably higher dyslipidemia than male migrants stayed less than 1 year (adjusted OR, 1.95; CI, 1.05 to 3.64). Compared to the group with 1 year or less stay-duration, the prevalence of obesity in male was significantly higher among 4-6 year (adjusted OR, 1.65; CI, 1.17 to 2.32) and 7 year or more stay-duration group (adjusted OR, 1.65; CI, 1.11 to 2.45). CONCLUSION: Longer length of stay correlated to higher prevalence of hypertension, dyslipidemia, and obesity among some population of migrants. So more researches and new developing policies are needed for this problem.