Expert survey on real-world data utilization and real-world evidence generation for regulatory decision-making in drug lifecycle in Korea.

As the importance of utilizing real-world data (RWD)/real-world evidence (RWE) for supporting regulatory scientific decision-making continues to grow, experiences and inputs from experts become crucial for developing a systematic and practice-oriented plan for the use of fit-for-purpose RWD/RWE. This study aimed to survey relevant experts from government agencies, industries, and academia to identify prerequisites for the drug life cycle in Korea. The questionnaire comprised the following: (A) the definition and categories of RWD/RWE, (B) the suitability and feasibility of using RWD/RWE at each authorization stage by the types of RWD, and (C) the challenges and solutions for the use of RWD/RWE. A total of 46 respondents completed the online survey, with 89.1% of them having prior experience with RWD/RWE usage. A majority of respondents agreed that RWD can be obtained from various sources. Among these sources, the registry was the most suitable source. It is suitable to compensate for the limitations of randomized control trials and ensure quality in data collection. Though there was consensus among the respondents for the use of RWD/RWE in post-marketing surveillance, the use of such data in new drug application (NDA) was disagreeable. Respondents considered it necessary to write a protocol in advance for RWD collection and RWE generation, for all RWD types. In conclusion, this study examined the perceptions of experts for RWD/RWE use at each approval stage of drugs. The results suggest that guidelines for the fit-for-purpose use of RWD/RWE should be developed via careful deliberation among experts in the future.

Comparison of Clinical Effectiveness and Safety of Drug-Coated Balloons versus Percutaneous Transluminal Angioplasty in Arteriovenous Fistulae: A Review of Systematic Reviews and Updated Meta-Analysis.

PURPOSE: To evaluate the clinical effectiveness and safety of drug-coated balloons (DCBs) compared with those of percutaneous transluminal angioplasty (PTA) for arteriovenous fistula (AVF) stenosis via a review of systematic reviews (SRs) and an update of the current meta-analysis. MATERIALS AND METHODS: Literature was searched to retrieve SRs comparing DCBs and PTA for AVFs. A narrative review of SRs and pooled analysis were performed. RESULTS: Eleven SRs were included. DCBs demonstrated favorable outcomes at 6 and 12 months compared with PTA, with improved patency in 7 SRs and a trend toward favorable outcomes without statistical significance in 3 SRs. Target lesion revascularization (TLR) was reported in 3 SRs; 2 reviews reported a significantly lower incidence in the DCB group than in the PTA group, whereas 1 review reported no significant differences at 12 months. Four studies reporting all-cause mortality revealed no significant difference between the 2 treatments. In the updated meta-analysis including 23 studies, DCBs demonstrated improved primary patency at 6 months (risk ratio [RR], 1.27; 95% CI, 1.07-1.50) and 12 months (RR, 1.36; 95% CI, 1.19-1.55) and were associated with a lower incidence of TLR at 6 months (RR, 0.54; 95% CI, 0.41-0.73) and 12 months (RR, 0.78; 95% CI, 0.62-0.99). There was no difference in mortality between the 2 groups for 24 months. CONCLUSIONS: A review of SRs and meta-analysis update revealed the consistent benefits of DCBs over PTA in treating AVFs in terms of primary patency and TLR. Compared with PTA, DCBs do not increase mortality risk.

Influenza epidemiology and treatment in people with a visual disability: A retrospective cohort study.

BACKGROUND: Visual disabilities (VD) are expected to rise with an aging population. Persons with VD experience a higher prevalence of chronic and acute diseases. Despite the significance of influenza to this population, there is limited data comparing influenza care disparities between those with VD and those without. OBJECTIVE: The study aimed to determine the influenza burden and associated healthcare utilization in individuals with VD compared to those without disabilities. METHODS: A retrospective cohort study was conducted using the Korean National Health Information Database, encompassing three influenza seasons (2011-2012 to 2013-2014). The influenza incidence and incidence rate ratio (IRR) was calculated. Adjusted IRRs were calculated using a zero-inflated Poisson model. We assessed the risk of admissions and 30-day post-influenza mortality, employing logistic regression or survival analysis. RESULTS: A total of 504,374 patients (252,964 patients with VD and 251,410 controls) were followed for 1,471,480 person-years. The influenza incidence was higher in the VD cohort than in the control (8.8 vs. 7.8 cases per 1000 person-years). VD cohort had a higher influenza IRR (adjusted IRR 1·13, 95% confidence interval [CI] 1·02-1·25). Severe VD exhibited higher hospitalization risk (adjusted odds ratio [OR] 1·29, 95% CI 1·10-1·20) and increased medical costs. Severe VD was a significant risk factor for mortality (adjusted Hazard Ratio 1·89, 95% CI 1·04-3·45). CONCLUSIONS: People with VD have a higher influenza incidence, while their outcomes are comparable to those without. Nevertheless, severe VD significantly contributes more to hospitalization, mortality, and medical costs than controls.

Assessment of quality of care for hospitalized non-COVID-19 older adult patients with pneumonia before and after the COVID-19 pandemic.

BACKGROUND: There is limited research into the clinical implications of the coronavirus disease 2019 (COVID-19) pandemic for non-COVID-19 pneumonia in older adults, as well as their quality of care or outcomes. This study aims to assess the process and outcome quality of care for hospitalized older adult patients with pneumonia before and after the pandemic. METHODS: A retrospective cohort of older adult patients (age ≥ 65) hospitalized for non-COVID pneumonia were recruited from five Korean hospitals (January 20, 2019, to January 19, 2021). The quality of care before and after the COVID-19 pandemic was evaluated. RESULTS: A total of 7356 hospitalization episodes of older adult pneumonia were identified, and 978 cases (552 pre-pandemic and 426 during the pandemic) were analyzed. The pneumonia severity score was higher during the pandemic, and the waiting time from the emergency room to admission was also longer. Furthermore, the pneumonia mortality rate during the pandemic was higher than that in the pre-pandemic period (in-hospital mortality: 10.1% vs. 18.1%; 90-day mortality: 11.6% vs. 22.3%). A significantly higher mortality risk was observed during the pandemic than in the period prior (adjusted odds ratio: 1.74, 95% confidence interval: 1.14-2.63). CONCLUSIONS: While the quality of care for hospitalized pneumonia has been maintained during the pandemic, there has been an increase in mortality rates. Further investigations are needed to understand the underlying causes of this increase.

Exploring the health literacy status of people with hearing impairment: a systematic review.

BACKGROUND: People with hearing impairment have many problems with healthcare use, which is associated with health literacy. Research on health literacy is less focused on people with hearing impairments. This research aimed to explore the levels of health literacy in people with hearing impairment, find the barriers to health literacy, and summarize methods for improving health literacy. METHODS: A systematic review was conducted using three databases (PubMed, Cochrane, and Embase) to search the relevant articles and analyze them. The studies were selected using pre-defined inclusion/exclusion criteria in two steps: first, selection by examining the title and abstract; and second, after reading the study in full. The Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) was used to assess the quality of the articles. RESULTS: Twenty-nine studies were synthesized qualitatively. Individuals with hearing impairment were found to have lower health literacy, when compared to those without impairment, which can lead to a higher medical cost. Most of the people with hearing impairment faced barriers to obtaining health-related information and found it difficult to communicate with healthcare providers. To improve their health literacy, it is essential to explore new ways of accessing health information and improving the relationship between patients and healthcare providers. CONCLUSIONS: Our findings show that people with hearing impairment have lower health literacy than those without. This suggests that developing new technology and policies for people with hearing impairment is necessary not to mention promoting provision of information via sign language. TRIAL REGISTRATION: OSF: https://doi.org/10.17605/OSF.IO/V6UGW . PROSPERO ID: CRD42023395556.

Effects of depression on medication adherence in HIV/AIDS patients: Korea HIV/AIDS cohort study.

BACKGROUND: The number of people with HIV/AIDS has consistently increased in Korea since the first case of HIV/AIDS infection was reported in 1985. The depressive symptoms of patients with HIV/AIDS may lead to medication non-adherence. This study sought to investigate the cross-sectional and longitudinal association between depression and antiretroviral treatment adherence in the Korean HIV/AIDS population. METHODS: We included participants of the Korea HIV/AIDS cohort study between 2009 and 2017. All information was collected at the enrollment and every annual visit, including sociodemographic characteristics, health-related behaviors, HIV/AIDS infection-related factors, depression score, and frequency of skipped medication. We performed a cross-sectional analysis of 601 participants registered between 2009 and 2017. Longitudinal data were evaluated by panel regression analysis in 515 patients who registered from 2009 to 2013. RESULTS: In cross-sectional analysis, the HIV/AIDS patients with depressive symptoms were more likely to be non-adherent (adjusted OR = 0.52, 95 % CI 0.34, 0.79, p = 0.002). Medication adherence was significantly associated with a health-related lifestyle; the adjusted odds ratio of the non-smoking and non-drinking group was 1.75 (95 % CI 1.05, 2.90, p = 0.031). The longitudinal panel regression model revealed a significant negative impact of depression on medication adherence (adjusted OR = 0.50, 95 % CI 0.30, 0.84, p = 0.009). Non-smoking and non-drinking participants were 2.31 times more likely to adhere to antiretroviral treatment (95 % CI 1.29, 4.15, p = 0.005). CONCLUSIONS: Our finding of depression and lifestyle modifications being significant contributors underscore the importance of proactive interventions to optimize the treatment outcomes of PLWH.

The Impact of Visual Impairment on Healthcare Use among Four Medical Institution Types: A Nationwide Retrospective Cohort Study in Korea.

PURPOSE: The aim of this study was to determine the effect of visual impairment (VI) onset on the use of healthcare services across four types of institutions in South Korea. MATERIALS AND METHODS: We utilized data from the National Health Insurance Service database from 2006 to 2015 for 714 persons who experienced VI onset in 2009-2012 and for 2856 matched persons for a 1:4 ratio of matching controls. We compared trends in healthcare use and expenditures for eye diseases at clinics, hospitals, general hospitals, and tertiary teaching hospitals using 3 years of data prior to and after the onset of VI. RESULTS: The inpatient and outpatient healthcare expenditures of individuals with VI were higher than those without VI, peaking at the pre-VI onset period in tertiary teaching hospitals. During the pre-VI onset period, the proportion of healthcare expenditures attributed to eye diseases ranged 11%-40.8% among individuals with VI, but 1.9%-11% among individuals without VI at the four types of institutions. The differences in healthcare use between the pre- and post-VI periods were primarily observed in tertiary teaching hospitals for inpatient care. There was a peak in utilization of outpatient care in the year preceding VI onset at tertiary teaching hospitals, clinics, and hospitals, but there was a decrease in outpatient care over time during the post-VI period. CONCLUSION: Our findings suggest economic burden of healthcare in tertiary teaching hospitals during pre-VI onset period and a potential lack of regular management and continuity of care in post-VI periods.

Effect of Pharmacist-Led Intervention in Elderly Patients through a Comprehensive Medication Reconciliation: A Randomized Clinical Trial.

PURPOSE: Polypharmacy can cause drug-related problems, such as potentially inappropriate medication (PIM) use and medication regimen complexity in the elderly. This study aimed to investigate the feasibility and effectiveness of a collaborative medication review and comprehensive medication reconciliation intervention by a pharmacist and hospitalist for older patients. MATERIALS AND METHODS: This comprehensive medication reconciliation study was designed as a prospective, open-label, randomized clinical trial with patients aged 65 years or older from July to December 2020. Comprehensive medication reconciliation comprised medication reviews based on the PIM criteria. The discharge of medication was simplified to reduce regimen complexity. The primary outcome was the difference in adverse drug events (ADEs) throughout hospitalization and 30 days after discharge. Changes in regimen complexity were evaluated using the Korean version of the medication regimen complexity index (MRCI-K). RESULTS: Of the 32 patients, 34.4% (n=11/32) reported ADEs before discharge, and 19.2% (n=5/26) ADEs were reported at the 30-day phone call. No ADEs were reported in the intervention group, whereas five events were reported in the control group (p=0.039) on the 30-day phone call. The mean acceptance rate of medication reconciliation was 83%. The mean decreases of MRCI-K between at the admission and the discharge were 6.2 vs. 2.4, although it was not significant (p=0.159). CONCLUSION: As a result, we identified the effect of pharmacist-led interventions using comprehensive medication reconciliation, including the criteria of the PIMs and the MRCI-K, and the differences in ADEs between the intervention and control groups at the 30-day follow-up after discharge in elderly patients. TRIAL REGISTRATION: (Clinical trial number: KCT0005994).

Genetic nurture in educational attainment.

Health is strongly and positively correlated with education, which is one of many reasons to better understand the determinants of education. In this paper, we test for a specific type of family influence on education: genetic nurture. Specifically, we test whether a person's educational attainment is correlated with their sibling's polygenic score (PGS) for education, controlling for their own PGS. Models estimated using data from the National Longitudinal Survey of Adolescent to Adult Health (Add Health) yield strong evidence of genetic nurture; a two-standard deviation increase in a sibling's genetic predisposition to higher education is associated with a 13.6% point increase in the probability that the respondent has a college degree. Evidence of genetic nurture is robust to alternative measures of educational attainment and different measures of the polygenic score. An exploration of mechanisms suggests that omission of parental PGS explains no more than half of the estimated effect, and that the magnitude of the genetic nurture varies with the characteristics of the sibling.

Seasonal influenza vaccine uptake among adults with disabilities in Korea.

BACKGROUND: Previous research on vaccination among people with disabilities has focused on children or adolescents. OBJECTIVE: To examine variations in seasonal influenza vaccination (SIV) uptake according to disability type and age group and explore the vulnerable groups and risk factors of non-vaccination to identify areas of policy support in Korea. METHODS: This pooled cross-sectional study included adults who participated in the 2011, 2014, and 2017 National Survey of Persons with Disabilities. The dependent variable was SIV uptake. Age-stratified multivariate logistic regression was conducted to assess its relationship with disability characteristics. RESULTS: Among 18,069 adults with disabilities, the overall SIV uptake rate increased with age (33.8%, 50.1%, and 85.3% in 20-49, 50-65, and ≥65 years, respectively). In the multivariate analyses (reporting the adjusted odds ratio and 95% confidence interval), severe disability was associated with lower and higher SIV uptake rates in older adults and younger age-groups (0.88, 0.76-1.01; 1.62, 1.42-1.86; and 1.54, 1.24-1.92 in those aged ≥65; 50-64; and 20-49 years), respectively. Health behaviors (regular doctor visits, general health examinations, and non-smoking) were significantly associated with higher odds of SIV uptake. After adjusting for covariates (age, medical conditions, functional ability, and behavioral factors), individuals with brain, epileptic, and psychiatric disabilities showed lower odds of SIV uptake compared to those with internal organ disabilities across all age groups. CONCLUSIONS: Policy initiatives that can improve the health behaviors of people with disabilities (especially the elderly and people with intellectual, brain, epilepsy, and psychiatric disabilities) to promote SIV uptake are needed.

Association between CHADS2, CHA2DS2-VASc, ATRIA, and Essen Stroke Risk Scores and Functional Outcomes in Acute Ischemic Stroke Patients Who Received Endovascular Thrombectomy.

Background: CHADS2, CHA2DS2-VASc, ATRIA, and Essen stroke risk scores are used to estimate thromboembolism risk. We aimed to investigate the association between unfavorable outcomes and stroke risk scores in patients who received endovascular thrombectomy (EVT). Methods: This study was performed using data from a nationwide, multicenter registry to explore the selection criteria for patients who would benefit from reperfusion therapies. We calculated pre-admission CHADS2, CHA2DS2-VASc, ATRIA, and Essen scores for each patient who received EVT and compared the relationship between these scores and 3-month modified Rankin Scale (mRS) records. Results: Among the 404 patients who received EVT, 213 (52.7%) patients had unfavorable outcomes (mRS 3−6). All scores were significantly higher in patients with unfavorable outcomes than in those with favorable outcomes. Multivariable logistic regression analysis indicated that CHADS2 and the ATRIA score were positively correlated with unfavorable outcomes after adjusting for body mass index and variables with p < 0.1 in the univariable analysis (CHADS2 score: odds ratio [OR], 1.484; 95% confidence interval [CI], 1.290−1.950; p = 0.005, ATRIA score, OR, 1.128; 95% CI, 1.041−1.223; p = 0.004). Conclusions: The CHADS2 and ATRIA scores were positively correlated with unfavorable outcomes and could be used to predict unfavorable outcomes in patients who receive EVT.

Antibiotic prescription for acute upper respiratory tract infections: Understanding patient and physician contributions via patients' migration.

Inappropriate antibiotic use is a main driver in microbes' development of antibiotic resistance. This study explored the extent to which patient, provider, and other factors contribute to antibiotic prescriptions for acute upper respiratory tract infection. We exploited exogenous patients' temporary and permanent migration from their residential area to robustly separate patient-related, provider-related, and other factors in terms of their contributions to antibiotic use. We analyzed claims of 914,013 URI patients from the 2002-2019 Korean National Health Insurance Sample Cohort Database. The results showed that both patient- and provider-related factors affect antibiotic use for upper respiratory tract infection treatment, although providers' impact is stronger than that of patients. Further decomposition analysis confirmed that provider-related factors explain about 55% of the total variance in antibiotic use. The demand side contributes to approximately 33-34% of the variance. Providers' local market share and market competitiveness are associated with antibiotic prescription. The findings suggest that regulations to reduce antibiotic consumption in Korea should target both patients and providers with appropriate quantifiable penalties.

Effect of the age of visual impairment onset on employment outcomes in South Korea: analysis of the national survey on persons with disabilities data.

BACKGROUND: Opportunities for paid employment provide meaningful ways for those with disabilities to participate in society and achieve financial independence. Although the onset age of disabilities can alter individuals' attitudes toward accepting their disabilities and their desire for work, the lack of data limits relevant empirical research. The purpose of this study is to examine the effect of the onset age on employment, job security (permanent vs. temporary), and wage level among visually impaired adults in South Korea. METHODS: We used three years of the National Survey on Persons with Disabilities data, 2011, 2014, and 2017, and included 583 participants in this study. We used a logistic regression model for the employment status and a multinomial logistic regression model for job security. We analyzed log monthly wage by a multivariate linear regression model, which subdivided the age groups, with 20-49 years old denoting prime-aged (n = 245) and 50-64 years old denoting late-middle-aged (n = 338). For each age group, we conducted a sub-analysis by sex. RESULTS: For prime-aged adults, the employment probability decreased as the age of visual impartment onset increased, and women in particular experienced a lower employment rate for both permanent and temporary jobs when their disability onset age was above 25. However, among permanent employees, monthly wages were higher if the onset age was 25 + compared to when the onset age was 0-5 years old. In late middle-aged adults, adult onset disabilities were associated with higher odds of employment and higher wages for temporary jobs, implying these individuals worked unskilled or manual jobs. CONCLUSIONS: In prime-aged adults, higher monthly wages among permanent employees showed that they were more likely to continue their original work, whereas in late-middle-aged adults, adult-onset disabilities were associated with a higher employment rate and higher wages for temporary jobs, suggesting the need for further investigation into job quality. These findings indicate a need for differentiated policy approaches considering the onset age of visual impairment to improve labor market outcomes throughout individuals' lifespans.

Collateral impact of the COVID-19 pandemic on the use of healthcare resources among people with disabilities.

Objective: We assessed the collateral impact of the COVID-19 pandemic on healthcare service use among people with disabilities. Methods: We utilized the COVID-19 database from the Korean National Health Insurance Service claims from 2015 until June 2020. We included 5,850 people with disabilities and matched 5,850 without disabilities among those who were neither tested nor diagnosed with COVID-19. We used a quasi-experimental setting with a COVID-19 outbreak as an external event in a difference-difference estimation with matching controls. Results: Participants with disabilities recorded a larger decrease in the number of claims for total services (2.1 claims per 5 months) upon the COVID-19 pandemic's onset compared to those without disabilities (1.6 claims), and the difference-in-difference estimates were statistically significant (0.46 claims). The decline was driven by outpatient and emergency visits. The extent of the decline was large for the severe disability group overall. By disability type, those with a physical disability showed a statistically significant decline in the number of claims. Conclusion: The COVID-19 pandemic has had a collateral impact on people with disabilities' use of healthcare services. Continued assessment is needed regarding whether the collateral impact has been sustained or is following a different path.

Risk of Hypertension and Type 2 Diabetes in Relation to Changes in Alcohol Consumption: A Nationwide Cohort Study.

Little is known about the risk of hypertension and type 2 diabetes in relation to changes in frequency and amount of alcohol consumption. This study investigated associations between changes in alcohol consumption and the risk of both conditions. This study included 96,129 individuals without hypertension and/or diabetes mellitus aged ≥ 20 years between 2006 and 2008, with follow-up until 31 December 2015. This study identified 29,043 and 18,784 incident cases of hypertension and type 2 diabetes, respectively, during an average follow-up period of 6.2 ± 2.6 and 6.9 ± 1.9 years. This study measured changes in frequency and amount of alcohol consumption using standardized self-administered questionnaires over approximately 2 years. Hazard ratio (HR) and 95% confidence interval (CI) were calculated for the respective risks of the two conditions. Repeated occasional or frequent binge drinking was associated with an increased risk of hypertension (HR: 1.16 or 1.32; 95% CI: 1.11, 1.21 or 1.16, 1.51) and type 2 diabetes (HR: 1.14 or 1.36; 95% CI: 1.09, 1.20 or 1.17, 1.58) compared with continuous nondrinking. Reductions as well as increases in frequency of alcohol consumption among binge drinkers were associated with higher hypertension (HR: 1.29 or 1.30; 95% CI: 1.11, 1.49 or 1.13, 1.49) and type 2 diabetes (HR: 1.26 or 1.56; 95% CI: 1.06, 1.49 or 1.34, 1.81) risk. This study demonstrated that repeated binge drinking, even with a reduction of weekly alcohol consumption frequency, was associated with a higher risk of hypertension and type 2 diabetes.

Delay in Vaccine Access in ASEAN Countries.

Background: The introduction of new vaccines has been delayed in some countries in the Asia-Pacific region, which has led to delays in accessing vaccines for target patients. However, the approval lag of vaccines in the Asia-Pacific region has not been assessed. The objective of this study is to assess the availability and approval lag of vaccines in Asia-Pacific countries and compare them among Asia-Pacific countries, the United States (US), and Europe (EU). Methods: The information on vaccines prequalified by the World Health Organization (WHO) between 2010 and 2019 was obtained primarily from the WHO website. The date of approval of the WHO prequalified vaccine in Australia, India, South Korea, Thailand, Singapore, Malaysia, the US, and EU was retrieved from the official website of national regulatory agencies. The vaccines were divided into two groups based on their first approval pathway, that is, vaccines that were first approved by SRA (Stringent Regulatory Authority including the US, EU, and WHO) and those that were first approved by non-SRA. The absolute approval lag represented the availability of the vaccine. Relative approval lag represented the lag time between the approval date of the country of interest and the first global approval date and was measured as the median approval lag. A Mann−Whitney U test was used to examine statistical differences between relative approval lag between the SRA first and the non-SRA first groups. Results: A total of 92 vaccines were prequalified by the WHO between 2010 and 2019, but only 61 vaccines were included in the analysis. Over 50% of vaccines were first licensed by non-SRAs. Of all the WHO-prequalified vaccines, the median approval lag in the ASEAN countries in this study was longer than those in the US and EU, with a median of 30 months in Australia, 15 months in South Korea, 52 months in Thailand, and 23 months in Singapore, compared to 0 months in the US and EU. The differences in approval lags between SRA first vaccines and non-SRA first vaccines were statistically significant in South Korea and Thailand (p < 0.05). Conclusions: The approval lag of vaccines was observed in the Asia-Pacific region, indicating a gap between the Asia-pacific region and the US and EU in regard to access to new vaccines. Future studies need to analyze the background factors related to the gap in availability and vaccine approval lag in the Asia-Pacific region and assess the impact of vaccine approval lag in the region.

Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States.

(1) Background: Drug lag, the delay between the first global regulatory approval and approval by the national health authorities in other countries, impacts the accessibility of drugs. Although the Korean pharmaceutical market has grown significantly, most of its innovative drugs for public health depend on imports from foreign pharmaceutical markets. (2) Methods: We extracted data from the official websites of the Korean Ministry of Food and Drug Safety (MFDS) and the US Food and Drug Administration. Information on new molecule entity drugs, approved as imported drugs by MFDS from 2000 to 2019, was extracted. Multivariate Cox proportional hazard models on drug approval were estimated. (3) Results: In total, 424 drugs were analyzed. Orphan drugs designated by MFDS were less likely to receive approval (HR = 0.731, 95% CI: 0.572-0.934). The drugs with Korean MAHs were less likely to obtain drug approval than those with MAHs of subsidiaries of multinational pharmaceutical companies (HR = 0.524, 95% CI: 0.371-0.738). In the analyses for non-orphan drugs (n = 37), oncology drugs that need local clinical study (HR = 0.247, 95% CI: 0.093-0.657) and drugs that need more patients in a local clinical study (HR = 0.993, 95% CI: 0.988-0.999) were less likely to receive approval, with longer drug lag. The higher number of clinical studies in Korea was associated with a shorter drug lag (HR = 2.133, 95% CI: 1.196-3.805). (4) Conclusions: Our findings imply that Korean pharmaceutical companies should augment their research capabilities for new drug development. Furthermore, consideration of orphan drugs used in rare diseases is needed for drug approval to ensure the availability of these drugs in the market without approval delays.

Effect of single tablet regimen on prescription trends for treatment-naïve patients with HIV/AIDS in Korea.

Single-tablet regimens (STRs) should be considered for patients with HIV/AIDS to increase medication compliance and improve clinical outcomes. This study compared variations in the prescription trends between STRs and multiple-tablet regimens (MTRs) for treatment-naïve patients with HIV/AIDS after the approval of the new STRs, a proxy indicator for improvement in medication adherence. The medical and pharmacy claim data were retrospectively obtained from the Health Insurance Review and Assessment service, which contains basic information on the patients' sociodemographic characteristics and treatment information for the entire Korean population. From 2013 to 2018, a total of 6737 patients with HIV/AIDS were included. Most patients were men (92.8%, n = 6251) and insured through the National Health Insurance (95.1%, n = 6410). The mean number of pills in their antiretroviral treatment regimens decreased from 2.8 ± 1.2 in 2013 to 1.2 ± 1.0 in 2018. After the first STR (EVG/c/TDF/FTC) was approved in 2014, prescription transitions from MTR to STR were observed among more than 38% of patients. In 2018, most treatment-naïve patients were prescribed STRs (91.2%). There was a time lag for STR prescription trends in non-metropolitan hospitals compared with those in metropolitan cities. Our data provide a valuable perspective for evaluating ART regimen prescription patterns on a national scale.

Association between CHADS2, CHA2DS2-VASc, ATRIA, and Essen Stroke Risk Scores and Unsuccessful Recanalization after Endovascular Thrombectomy in Acute Ischemic Stroke Patients.

BACKGROUND: The CHADS2, CHA2DS2-VASc, ATRIA, and Essen scores have been developed for predicting vascular outcomes in stroke patients. We investigated the association between these stroke risk scores and unsuccessful recanalization after endovascular thrombectomy (EVT). METHODS: From the nationwide multicenter registry (Selection Criteria in Endovascular Thrombectomy and Thrombolytic therapy (SECRET)) (Clinicaltrials.gov NCT02964052), we consecutively included 501 patients who underwent EVT. We identified pre-admission stroke risk scores in each included patient. RESULTS: Among 501 patients who underwent EVT, 410 (81.8%) patients achieved successful recanalization (mTICI ≥ 2b). Adjusting for body mass index and p < 0.1 in univariable analysis revealed the association between all stroke risk scores and unsuccessful recanalization (CHADS2 score: odds ratio (OR) 1.551, 95% confidence interval (CI) 1.198-2.009, p = 0.001; CHA2DS2VASc score: OR 1.269, 95% CI 1.080-1.492, p = 0.004; ATRIA score: OR 1.089, 95% CI 1.011-1.174, p = 0.024; and Essen score: OR 1.469, 95% CI 1.167-1.849, p = 0.001). The CHADS2 score had the highest AUC value and differed significantly only from the Essen score (AUC of CHADS2 score; 0.618, 95% CI 0.554-0.681). CONCLUSION: All stroke risk scores were associated with unsuccessful recanalization after EVT. Our study suggests that these stroke risk scores could be used to predict recanalization in stroke patients undergoing EVT.

Cost-Effectiveness Analysis of Home-Based Hospice-Palliative Care for Terminal Cancer Patients.

Purpose: We compared cost-effectiveness parameters between inpatient and home-based hospice-palliative care services for terminal cancer patients in Korea. Methods: A decision-analytic Markov model was used to compare the cost-effectiveness of hospice-palliative care in an inpatient unit (inpatient-start group) and at home (home-start group). The model adopted a healthcare system perspective, with a 9-week horizon and a 1-week cycle length. The transition probabilities were calculated based on the reports from the Korean National Cancer Center in 2017 and Health Insurance Review & Assessment Service in 2020. Quality of life (QOL) was converted to the quality-adjusted life week (QALW). Modeling and cost-effectiveness analysis were performed with TreeAge software. The weekly medical cost was estimated to be 2,481,479 Korean won (KRW) for inpatient hospice-palliative care and 225,688 KRW for home-based hospice-palliative care. One-way sensitivity analysis was used to assess the impact of different scenarios and assumptions on the model results. Results: Compared with the inpatient-start group, the incremental cost of the home-start group was 697,657 KRW, and the incremental effectiveness based on QOL was 0.88 QALW. The incremental cost-effectiveness ratio (ICER) of the home-start group was 796,476 KRW/QALW. Based on one-way sensitivity analyses, the ICER was predicted to increase to 1,626,988 KRW/QALW if the weekly cost of home-based hospice doubled, but it was estimated to decrease to -2,898,361 KRW/QALW if death rates at home doubled. Conclusion: Home-based hospice-palliative care may be more cost-effective than inpatient hospice-palliative care. Home-based hospice appears to be affordable even if the associated medical expenditures double.