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The differential pattern and characteristics of completeness in adverse event (AE) reports generated by hospitals/clinics, pharmacies, consumer and pharmaceutical companies remain unknown. Thus, we identified the characteristics of complete AE reports, compared with those of incomplete AE reports, using a completeness score. We used Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) between January 1, 2016 and December 31, 2016. The completeness score was determined out of a total of 100 points, based on the presence of information on temporal relationships, age and sex of patients, AE progress, name of reported medication, reporting group by profession, causality assessment, and informational text. AE reports were organized into four groups based on affiliation: hospitals/clinics, pharmacies, consumers, and pharmaceutical companies. Affiliations that had median completeness scores greater than 80 points were classified as 'well-documented' and these reports were further analyzed by logistic regression to estimate the adjusted odds ratios and 95% confidence intervals. We examined 228,848 individual reports and 735,745 drug-AE combinations. The median values of the completeness scores were the highest for hospitals/clinics (95 points), followed by those for consumers (85), pharmacies (75), and manufacturers (72). Reports with causality assessment of 'certain', 'probable', or 'possible' were more likely to be 'well-documented' than reports that had causality assessments of 'unlikely'. Serious reports of AEs were positively associated with 'well-documented' reports and negatively associated with hospitals/clinics.

Therapeutic ineffectiveness involves drug-related therapeutic failure, inefficacy or resistance and has not been sufficiently studied. Objective of our study was to evaluate reporting trends in therapeutic ineffectiveness by year and describe factors affecting therapeutic ineffectiveness using the Korea Adverse Event Reporting System. Proportion of therapeutic ineffectiveness reports was based on total submitted reports between 2000 and 2016. Utilizing 2016 alone, we compared the characteristics of therapeutic ineffectiveness with age group and gender matching by random extraction. We conducted a logistic regression analysis to estimate reporting odds ratios (ROR) and its 95% confidence intervals (CI) for reports by type of reporters, e.g., doctors, pharmacists, or consumers. We presented most frequent reports by the anatomical main groups and therapeutic subgroups according to the Anatomical Therapeutic Chemical (ATC) classification system. For the 17-years, the proportion of therapeutic ineffectiveness adverse drug reactions reporting ranged from 0.0% to 3.7% between 2000 and 2016. Of 228,939 reports, 2,797 (1.2%) were submitted in 2016. Consumers accounted for 6.92% of reports and doctors accounted for 45.49%, in which, consumers were more likely to report therapeutic ineffectiveness than doctors (adjusted ROR 3.98; 95% CI, 2.92 to 5.41). According to the ATC classification system, \"nervous system\" was the most frequently reported anatomical group (18.7%) and \"parathyroid hormones and analogues\" was reported most frequently in the pharmacological subgroup (23.7%). Teriparatide, a drug used to treat osteoporosis, had the most reports (11.0%). Therapeutic ineffectiveness reports may be used as a scientific tool for the reevaluation of respective drugs in order to confirm of its therapeutic effects.

Background Adverse events (AEs) not listed on drug labels have recently been reported in young girls vaccinated against HPV, but signal detection related to the human papillomavirus (HPV) vaccine has never been conducted in South Korea using the Korea Adverse Event Reporting System database of Korea Institute of Drug Safety & Risk Management at Ministry of Food and Drug Safety. Objective To analyze signals associated with HPV vaccines using the Korean spontaneous AEs reporting system and data-mining methods and compare the results to current vaccine label information in South Korea and the United States of America, United Kingdom, European Union, and Japan to detect signals not currently listed on the labels. Setting We evaluated the Korea Institute of Drug Safety & Risk Management database from January 2005 to December 2016. After pre-screening the data, the adjusted total numbers of HPV-related AE reports and AEs were 2566 and 4748 and those of all other vaccine-related AE reports and AEs were 21,878 and 120,688, respectively. Methods Three data mining algorithms (proportional reporting ratio, reporting odds ratio and information component) were used to assess AEs. A signal was defined when the criteria for all three indicators were satisfied. The detected signals were compared to the label information of HPV vaccines from South Korea, the United States of America, United Kingdom, European Union, and Japan. Main outcome measure Signals of AE after HPV vaccination, which met all three data mining indices. Results In this study, we found a total 97 signals of AE after HPV vaccination. Of these, 78 AEs were already present on the HPV vaccine labels of South Korea and the following 19 AEs were not listed: neuralgia, tremor, neuritis, depersonalization, axillary pain, personality disorder, increased salivation, peptic ulcer, circulatory failure, hypotension, peripheral ischemia, cerebral hemorrhage, micturition disorder, facial edema, ovarian cyst, weight increase, pain anxiety, oral edema, and back pain. Moreover, AE information on the current HPV vaccine labels of South Korea, the United States of America, United Kingdom, European Union, and Japan was inconsistent. When comparing the 19 AE signals that were not listed on the drug label in South Korea with the labels from the other countries, neuritis, axillary pain, cerebral hemorrhage, facial edema, pain anxiety, and back pain appreared on the U.S. Food and Drug Administration HPV vaccine labels but not on the United Kingdom labels, and hypotension was listed only on labels in the European Union and Japan. Conclusions South Korea should develop a system for proactively updating HPV labels. These results also suggest potential research directions such as vaccination label expansion, pharmacovigilance studies, and identification of causality in AEs associated with HPV vaccination.

Chronic obstructive pulmonary disease (COPD) is considered a major cause of death worldwide, and various studies have been conducted for its early diagnosis. Our work developed a scoring system by predicting and validating COPD and performed predictive model implementations. Participants who underwent a health screening between 2017 and 2020 were extracted from the Korea National Health and Nutrition Examination Survey (KNHANES) database. COPD individuals were defined as aged 40 years or older with prebronchodilator forced expiratory volume in 1 s/forced vital capacity (FEV1/FVC < 0.7). The logistic regression model was performed, and the C-index was used for variable selection. Receiver operating characteristic (ROC) curves with area under the curve (AUC) values were generated for evaluation. Age, sex, waist circumference and diastolic blood pressure were used to predict COPD and to develop a COPD score based on a multivariable model. A simplified model for COPD was validated with an AUC value of 0.780 from the ROC curves. In addition, we evaluated the association of the derived score with cardiovascular disease (CVD). COPD scores showed significant performance in COPD prediction. The developed score also showed a good effect on the diagnostic ability for CVD risk. In the future, studies comparing the diagnostic accuracy of the derived scores with standard diagnostic tests are needed.

Background High-density lipoprotein cholesterol’s (HDL-C) long-held status as a cardiovascular disease (CVD) preventative has been called into question. Most of the evidence, however, focused on either the risk of death from CVD, or on single time point level of HDL-C. This study aimed to determine the association between changes in HDL-C levels and incident CVD in individuals with high baseline HDL-C levels (≥ 60 mg/dL). Methods 77,134 people from the Korea National Health Insurance Service-Health Screening Cohort were followed for 517,515 person-years. Cox proportional hazards regression was used to evaluate the association between change in HDL-C levels and the risk of incident CVD. All participants were followed up until 31 December 2019, CVD, or death. Results Participants with the greatest increase in their HDL-C levels had higher risks of CVD (adjusted hazard ratio [aHR], 1.15; 95% confidence interval [CI], 1.05–1.25) and CHD (aHR 1.27, CI 1.11–1.46) after adjusting for age, sex, household income, body mass index, hypertension, diabetes mellitus, dyslipidemia, smoking, alcohol consumption, moderate-to-vigorous physical activity, Charlson comorbidity index, and total cholesterol than those with the lowest increase in HDL-C levels. Such association remained significant even among participants with decreased low-density lipoprotein cholesterol (LDL-C) levels for CHD (aHR 1.26, CI 1.03–1.53). Conclusions In people with already high HDL-C levels, additional increases in HDL-C levels may be associated with an increased risk of CVD. This finding held true irrespective of the change in their LDL-C levels. Increasing HDL-C levels may lead to unintentionally elevated risk of CVD.

We aimed to assess the association of tramadol use with the risk of dementia. This population-based retrospective cohort study using the Korean National Health Insurance Service database included a total of 1,865,827 older adult patients aged 60 years or older with common musculoskeletal pain between January 1, 2003, and December 31, 2007. Individuals who were newly dispensed tramadol (N = 41,963) were identified and propensity score–matched with those who were not (N = 41,963). Over a maximum of 14-year follow-up, the incidence rates (events per 1000 person-years) of all-cause dementia were 6.1 for nonusers, 6.2 for those with cumulative tramadol use of 1–14 days, 7.7 for those with 15–90 days of use, and 8.0 for those with > 90 days of use. Longer cumulative duration of tramadol use was associated with an increased risk of all-cause dementia compared with nonuse (1 to 14 days: aHR 1.06, 95% CI 0.96–1.17; 15 to 90 days: aHR 1.14, 95% CI 1.10–1.35; and more than 90 days: aHR 1.18, 95% CI 1.00–1.39; test for trend: P  < 0.001). The results showed a similar pattern for Alzheimer’s disease and were robust across subgroup and sensitivity analyses, but not for vascular dementia. This study found that exposure to tramadol was associated with an increased risk of dementia. Taking this potential risk into consideration, clinicians should carefully weigh potential benefits and risks when prescribing tramadol to older adults with musculoskeletal pain.

Background A comprehensive understanding of excess mortality for patients with underlying conditions during the COVID-19 pandemic has yet to be achieved. Thus, this study aims to investigate excess mortality and healthcare costs during the COVID-19 pandemic among patients with ten major chronic diseases in South Korea. Methods A nationwide retrospective cohort study used the Korea Disease Control and Prevention Agency-COVID-19-National Health Insurance Service (K-CoV-N) database, integrating COVID-19 testing, vaccination, mortality, and insurance claims data for the entire Korean population. We assessed mortality and medical costs from 2017 to 2022 in patients with ten chronic conditions, including chronic lung disease (CLD), heart disease, stroke, diabetes, hypertension, chronic liver disease, autoimmune disorders, chronic kidney disease (CKD), dementia/Parkinson’s disease (DPD), and cancer. Multivariable logistic and negative binomial regression were used to compare mortality and costs between the pre-pandemic (2019–2019) and pandemic periods (2020–2022), stratified by COVID-19 infection status and vaccination history. Results Mortality rates increased significantly during the pandemic for CLD, stroke, chronic liver disease, autoimmune disease, CKD, and DPD (adjusted odds ratio (aOR) > 1.00 and p  < 0.05). In contrast, mortality decreased for diabetes, hypertension, and cancer (aOR < 1.00 and p  < 0.001). Healthcare costs also exhibited disease-specific trends, with increased spending for conditions such as CLD and autoimmune diseases, but reduced costs for diseases like stroke and DPD. Notably, diabetes, hypertension, and cancer showed decreased mortality despite rising healthcare expenditures, highlighting the role of medical innovation and advancements in chronic disease management. Conclusions This study underscores the heightened vulnerability of patients with chronic conditions during pandemics and reveals the possibility of disparities in healthcare access and resource allocation. These findings offer critical insights for future public health strategies and policy development to mitigate the impact of health crises on individuals with chronic diseases. Clinical trial This study does not include a clinical trial (Number: not applicable).

Background Rapid decline in balance is a hallmark of aging, elevating the risk of falls and other age-related geriatric illnesses among older adults. Objective Our aim was to assess whether impairment in balance function is associated with the risk of incident CVD in older adults. Design Retrospective cohort analysis. Participants A total of 129,024 participants who had undergone health screening between 2002 and 2009 were derived from the National Health Insurance Service-Senior cohort. Main measures Balance impairment was evaluated using the open-eyes one-leg standing (OLS) test. The association between balance impairment and incident CVD was analyzed using the Cox proportional hazards regression model. All participants were followed up with until either the date of the first incident of CVD, death, or 31 December 2019. Key results Those with abnormal balance function (< 10 s in OLS test) had a higher risk of CVD (adjusted hazard ratio [aHR] 1.23, CI 1.16–1.31). The association was significant in both the obese and the non-obese, but it seemed to be more pronounced in the latter. Results were supported by sensitivity analyses that did not include cases of CVD development in the first 1, 2, or 3 years and that used a different criterion to define balance dysfunction (< 9 s in OLS test). Conclusions Older adults with balance impairment were found to have an increased risk of incident CVD. Patients with impaired balance function may be a high-risk population who require preventive managements against CVD.

Glycemic variability (GV) is a risk factor for depression in patients with diabetes. However, whether it is also a predictor of incident depression in people without diabetes remains unclear. We aimed to investigate the association between visit-to-visit variability in fasting serum glucose (FSG) levels and the incidence of depression among Koreans without diabetes. This retrospective cohort study included data of people without diabetes who did not have depression at baseline and had at least three FSG measurements (n = 264,480) extracted from the 2002–2007 Korean National Health Insurance Service–National Health Screening Cohort. GV was calculated as the average successive variability of FSG. Among 264,480 participants, 198,267 were observed during 2008–2013 and their hazard ratios (HR) of incident depression were calculated. Participants with the highest GV showed a higher risk of depression in fully adjusted models than those with the lowest GV (HR, 1.09; 95% CI, 1.02–1.16). The risk of incident depression heightened with increasing GV ( p for trend < 0.001). Greater visit-to-visit GV may be associated with the risk of developing depression in people without diabetes. Conversely, maintaining steady FSG levels may reduce the risk of incident depression in people without diabetes.