Is the Fast Track Safe? A Safety Evaluation of the COVID-19 Drugs with Real-World Data.

The US FDA has given emergency use authorization to multiple Covid-19 drugs. We conducted disproportionality analysis to detect adverse reaction rates (ADRs) in the US FDA's Adverse Event Reporting System. We discovered not only severe ADRs but also unique ADRs and effectiveness that might be explained by pharmacokinetics. This shows that real-time safety reviews could be effective methods for comparing the safety and efficacy of fast-track authorized drugs.

Evaluating the Landscape of Personal Health Records in Korea: Results of the National Health Informatization Survey.

OBJECTIVES: This study examined the adoption and utilization of personal health records (PHR) across Korean medical institutions using data from the 2020 National Health and Medical Informatization Survey. METHODS: Spearheaded by the Ministry of Health and Welfare and prominent academic societies, this study surveyed PHR utilization in 574 medical institutions. RESULTS: Among these institutions, 84.9% (487 hospitals) maintained medical portals. However, just 14.1% (81 hospitals) had web-based or mobile PHRs, with 66.7% (28 of 42) of tertiary care hospitals adopting them. Tertiary hospitals led in PHR services: 87.8% offered certification issuance, 51.2% provided educational information, 63.4% supported online payment, and 95.1% managed appointment reservations. In contrast, general and smaller hospitals had lower rates. Online medical information viewing was prominent in tertiary hospitals (64.3%). Most patients accessed test results via PHRs, but other data types were less frequent, and only a few allowed downloads. Despite the widespread access to medical data through PHRs, integration with wearables and biometric data transfers to electronic medical records remained low, with limited plans for expansion in the coming three years. CONCLUSIONS: Approximately two-thirds of the surveyed medical institutions provided PHRs, but hospitals and clinics in charge of community care had very limited PHR implementation. Government-led leadership is required to invigorate the use of PHRs in medical institutions.

Digital Health Profile of South Korea: A Cross Sectional Study.

(1) Backgroud: For future national digital healthcare policy development, it is vital to collect baseline data on the infrastructure and services of medical institutions' information and communication technology (ICT). To assess the state of medical ICT across the nation, we devised and administered a comprehensive digital healthcare survey to medical institutions across the nation. (2) Methods: From 16 November through 11 December 2020, this study targeted 42 tertiary hospitals, 311 general hospitals, and 1431 hospital locations countrywide. (3) Results: Since 2015, most hospitals have implemented electronic medical record (EMR) systems (90.5 percent of hospitals, which is the smallest unit, and 100 percent of tertiary hospitals). The rate of implementation of personal health records (PHRs) varied significantly between 61.9 percent and 2.4 percent, depending on the size of the hospital. Hospitals have implemented around three to seven government-sponsored information/data transmission and receiving systems for statistical or investigative objectives. For secondary usage of medical data, more than half of tertiary hospitals have implemented a clinical data warehouse or shared data model. However, new service establishments utilizing modern medical technologies such as artificial intelligence or lifelogging were scarce and in the planning stages. (4) Conclusion: This study shows that the level of digitalization in Korean medical institutions is significant, despite the fact that the development and spending in ICT infrastructure and services provided by individual institutions imposes a significant cost. This illustrates that, in the face of a pandemic, strong government backing and policymaking are essential to activate ICT-based medical services and efficiently use medical data.

Development and Validation of Targeted Gene Sequencing Panel Based Companion Diagnostic for Korean Patients with Solid Tumors.

Recently, several panels using two representative targeting methods have been developed but they do not reflect racial specificity, especially for Asians. We have developed and analytically validated the Korean Pan-cancer Companion Diagnostic (CDX) Panel to apply targeted anticancer drugs to Korean patients based on the molecular characteristics of tumors using tumor samples without matched patient normal samples. The panel included 31 genes with reported single nucleotide variants, 9 genes with reported copy number variations, and 15 genes with predictive responses to targeted drugs under clinical testing, enabling the panel to be analyzed for the targets of 30 targeted anticancer drugs. It is cost-effective and optimized for cancer type-specific therapy in Korean cancer patients across solid cancer types while minimizing the limitations of existing approaches. In addition, the optimized filtering protocol for somatic variants from tumor-only samples enables researchers to use this panel without matched normal samples. To verify the panel, 241 frozen tumor tissues and 71 formalin-fixed paraffin-embedded (FFPE) samples from several institutes were registered. This gene screening method is expected to reduce test turnaround time and cost, making it a balanced approach to investigate solid cancer-related gene regions.

Safety and Efficacy of Ultrasound-Guided High-Intensity Focused Ultrasound Treatment for Uterine Fibroids and Adenomyosis.

The objective of this study was to assess the tolerability and efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) ablation using a Haifu JC Focused Ultrasound Tumor Therapeutic System (operating transducer frequency: 0.8 MHz, 300-400 W/cm2) under real-time ultrasound guidance (2.5- to 5.0-MHz imaging probe) for uterine fibroids and adenomyosis in 1807 patients (928 with fibroids and 889 with adenomyosis). Volume change and clinical symptom improvement after treatment were evaluated based on symptom severity scores and health-related quality of life scores using the Uterine Fibroid Symptom and Quality of Life questionnaires. At 3, 6 and 12 mo after treatment, symptom severity scores and health-related quality of life scores and reductions in volumes of uterine adenomyosis and fibroids all revealed good effects. The complication rate was 4.6% (84/1807). With supportive care, all complications resolved without any permanent adverse effects. Thus, USgHIFU is an effective, non-invasive modality for treating uterine fibroids and adenomyosis with manageable complications.

HLA Allele Distribution Associated with Adverse Drug Reactions in Organ Transplant Patients.

The results of Human Leukocyte Antigen (HLA) antigen testing in transplant patients are not generally used to predict future adverse events. In this study, free-text HLA screening results of transplant patients were analyzed and stored in a database, and the frequencies of patients with adverse events according to HLA allele were extracted. Approximately 25% of patients had HLA alleles associated with serious drug side effects.

Using mobile phones in healthcare management for the elderly.

The increasing average life expectancy is simultaneously increasing the incidence of chronic diseases and the number of healthy elderly people, consequently leading to an increased demand for healthcare management methods that do not involve hospital visits. The development of health management services involving mobile phones will change the focus of medical services from hospital visits and treatments to managing the health decisions made by individuals in their daily lives. However, the elderly may experience specific difficulties in adapting to constantly evolving services. This study reviews various health-related devices such as mobile phones that are available for providing healthcare to the elderly, and the different ways of using them. As the use of mobile phone increases, it is expected that elderly mobile phone users will also be able to regularly check their health status at any time and place. The issues of an ageing population pertain to the entire society rather than only to the elderly, which make mobile-phone-based medical informatics as a health management service a worthy goal.