With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, ‘digital exceptionalism’ (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, ‘digital exceptionalism’ (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.
Artificial Intelligence ; Delivery of Health Care ; Device Approval ; Diagnosis ; Diagnostic Imaging ; Humans ; Insurance Coverage ; Korea ; Patient Care ; Societies ; Software Validation ; United States ; United States Food and Drug Administration

PURPOSE: To determine the window of time during which osteoporosis affects the management of spinal surgery and the mechanism of bone metabolism changes in males with osteoporosis by examining changes in bone metabolism in young castrated male rats. MATERIALS AND METHODS: A total of 30 Sprague-Dawley rats were randomly allocated into two study groups. Group 1 (control) received a sham surgery and Group 2 received bilateral orchiectomy to change bone mineral density (BMD). Serum osteocalcin, alkaline phosphatase (ALP), and collagen type 1 cross-linked C-telopeptide (CTX) were analyzed at postoperative date (POD) 8, 10, and 12 weeks. BMDs were measured using micro computed tomography scans. RESULTS: Femoral and lumbar BMDs were decreased in the orchiectomy groups. BMDs in the sham and orchiectomy groups showed statistically differences at POD 8, 10, and 12 weeks for the femur (p=0.032, 0.008, 0.008) and lumbar spine (p=0.151, 0.008, 0.008, respectively). Serum osteocalcin, ALP, and CTX decreased gradually; however, N-terminal type 1 procollagen (P1NP) showed a slight increase yet no significant change. CONCLUSION: In young castrated male rats, a significant decrease in BMD was observed after orchiectomy due to the mixture of two detrimental factors. Young castrated male rats did not reach peak BMD. Increased bone turnover causes bone resorption to exceed bone formation. This study may contribute to the creation of a valuable model for studies of male osteoporosis and the spinal surgery field.
Alkaline Phosphatase ; Animals ; Bone Density ; Bone Remodeling ; Bone Resorption ; Collagen ; Femur ; Humans ; Male* ; Metabolism* ; Orchiectomy ; Osteocalcin ; Osteogenesis ; Osteoporosis ; Procollagen ; Rats* ; Rats, Sprague-Dawley ; Spine

OBJECTIVE: To investigate a suitable animal model for studies of male osteoporosis. Osteoporosis has a particularly high incidence in postmenopausal women, resulting in a substantial amount of research with respect to this disease in women. However, research on osteoporosis in men is still lacking. METHODS: Twenty 10-week-old male Sprague Dawley rats were used in this study, including 4 rats used to establish a baseline bone mineral density (BMD). The other 16 rats were divided into two groups: a sham surgery group (n=8), which underwent a sham operation, and an orchiectomized rat group (OCX) (n=8), which underwent bilateral OCX at 10 weeks of age. Bone mineral density was measured in 4 rats from both the sham surgery group and the OCX group 8 weeks after the surgery, while BMD in the remainder of the rats was measured 10 weeks post-surgery. RESULTS: Femoral BMD at 8 weeks post-surgery was found to be significantly lower in the OCX group compared to the sham group; a finding that was also similar 10 weeks post-surgery. CONCLUSION: 8 weeks after undergoing orchiectomy performed via a scrotal, white rats are a suitable model for studies of male osteoporosis.
Animals ; Bone Density* ; Female ; Femur ; Humans ; Incidence ; Male ; Models, Animal ; Multiple Endocrine Neoplasia Type 1 ; Orchiectomy* ; Osteoporosis ; Rats* ; Rats, Sprague-Dawley

Primary epithelial-myoepithelial carcinoma (EMC) of the lung is an extremely rare neoplasm that originates from submucosal bronchial glands and has been found in the salivary glands, breast tissue, and sweat glands. However, only a few cases in the respiratory tract have been identified. In the literature, most pulmonary EMCs have been reported to have developed endobronchially although a few EMC cases have been presented as intraparenchymatous tumors. We have identified a case of primary EMC that developed in the peripheral lung parenchyma.
Breast ; Lung Neoplasms ; Lung* ; Respiratory System ; Salivary Gland Neoplasms ; Salivary Glands ; Sweat Glands

BACKGROUND: Exaggerated blood pressure (BP) response to exercise can be an independent risk factor for cardiovascular mortality and morbidity. The purpose of this study was to define the factor that effect on early systolic BP response to exercise. METHODS: We examined echocardiographic data, BP, heart rate from graded exercise test and brachial ankle pulse wave velocity (PWV) of 205 patients (137 men and 68 women; mean age 58 +/- 11 years; range, 19 to 83 years). Graded exercise test was conducted in BRUCE protocol. We define delta systolic blood pressure (SBP) as systolic BRUCE stage "n" BP minus baseline BP. RESULTS: Resting BP (127 +/- 16 mm Hg) was elevated to 171 +/- 26 mm Hg after peak graded exercise test. Resting heart rate (80 +/- 15 bpm) was increased to 146 +/- 27 bpm after peak graded exercise test. Stepwise regression test between baseline SBP, delta SBP, maximal SBP and left atrial volume index (LAVI) was done. Supine SBP, delta SBP, maximal SBP was not associated with LAVI (p > 0.5). But increased LAVI was significantly associated with delta SBP1 in woman (R2 = 0.192, p = 0.002). PWV was significantly associated with base line (R2 = 0.311, p < 0.01) and maximal SBP (R2 = 0.051, p < 0.01). However, PWV was not associated with delta SBP. CONCLUSIONS: LAVI and PWV were not associated with early SBP response to exercise. But in women, elevation of early SBP during exercise is associated with LAVI.
Blood Pressure* ; Exercise Test* ; Female ; Heart Rate* ; Heart ; Humans ; Male ; Pulse Wave Analysis* ; Risk Factors

The aim of this project was to use 3D scanning data collected at incident scenes and various evidence to 1) develop surveying methods based on 3D data consisting of overall and detailed scene evidence, captured by long-range and micros-canner, which can be shared by personnel working in different fields such as forensic medicine, video analysis, physical analysis, traffic engineering, and fire investigation; 2) create digital storage for human skeletons and set the foundation for virtual anthropology; and 3) improve the credibility of 3D evidence by virtual remodeling and simulation of incident scenes and evidence to provide a basis for advanced and high-tech scientific investigation. Two complete skeletons of male and female were scanned using 3D micro-scanner. Each bone was successfully reproduced and assembled in virtual space. In addition, recreating evidence scheduled for invasive examination by creating RP (rapid prototype) was possible. These outcomes could play an important role in setting up the new field of virtual anthropology. Case-specific surveying methods were developed through analysis of 3D scanning data collected by long-range surface scanners at the scenes of vehicular accidents, falls, shootings, and violent crimes. A technique and recording method was also developed for detecting forged seals by micro-scanning the pressure exerted on the seal. Appraisal methods developed in this project could be utilized to secure 3D data of human skeletal remains and incident scenes, create a standard for application, and increase objectivity, reproducibility, and accuracy of scanning methods. We plan to develop case-specific 3D data analysis techniques to improve the credibility of analysis at the NFS and to establish a 3D data collection and analysis team.
Crime ; Data Collection ; Female ; Fires ; Forensic Medicine ; Forensic Sciences ; Humans ; Male ; Skeleton ; Statistics as Topic

BACKGROUND AND OBJECTIVES: The comparison of long-term clinical effects between Sirolimus-eluting stent (SES) and Paclitaxel-eluting stents (PES) for treatment of acute myocardial infarction (AMI) remains unclear. Seeking to clarify this issue, we performed a retrospective analysis to evaluate four-year clinical outcomes of SES compared to PES treated AMI patients. SUBJECTS AND METHODS: From January 2004 to August 2006, all patients with acute ST-segment elevation myocardial infarction and acute non-ST segment elevation myocardial infarction who underwent percutaneous coronary intervention (PCI) by implantation of either SES or PES were enrolled. The occurrences of cardiac and non-cardiac deaths, recurrent infarction, target vessel revascularization (TVR) and stent thrombosis were analyzed. The composite end points of these major adverse cardiac events (MACE) were also analyzed. RESULTS: During the study period, a total of 668 AMI patients had visited, of which 522 patients (299 with SES and 223 with PES) were enrolled. During the four-year clinical follow-up, both groups showed similar occurrences of non-cardiac death (14.6+/-2.2% vs. 18.3+/-3.0%, p=0.26); cardiac death (6.8+/-1.52% vs. 11.2+/-2.6%, p=0.39); re-infarction (3.3+/-1.1% vs. 6.4+/-1.8%, p=0.31); and stent thrombosis (3.2+/-1.1% vs. 5.4+/-1.7%, p=0.53). However, occurrences of TVR {4.0+/-1.2% vs. 10.0+/-3.0%, hazard ratio (HR)=0.498, 95% confidence interval (CI)=0.257-0.967, p=0.039} and MACE (19.4+/-2.5% vs. 29.4+/-3.5%, HR=0.645, 95% CI=0.443-0.940, p=0.021) were significantly lower in the SES population. CONCLUSION: In AMI patients treated with either SES or PES implantation, the former had a significantly lower risk of TVR and MACE during four-year clinical follow-up. Rates of death, cardiac death or recurrent infarction, and stent thrombosis were similar.
Death ; Follow-Up Studies ; Glycosaminoglycans ; Humans ; Infarction ; Myocardial Infarction ; Percutaneous Coronary Intervention ; Retrospective Studies ; Stents ; Thrombosis

BACKGROUND: The major cause of metabolic syndrome and diabetes is reduced cellular performances in fuel metabolism, but the underlying pathways and mechanisms are not completely understood. Dysregulation of energy homeostasis can lead to metabolic disturbances and it predisposes diabetes, cardiovascular disease, aging, and cancer. CR6-interacting factor 1 (CRIF1) contacts coiled-coil domain that is required for both genomic stability and mitochondrial integrity. We performed this study to determine the role of CRIF1 on the mice hearts. METHODS: CRIF1-deficient mouse was embryonic lethal and we made heart specific CRIF1-deficient mouse using Cre-loxP system. We made thoracotomy and directly injected adeno-Cre virus into the heart of CRIF1-loxP mice. Beta-gal virus was used as a control. RESULTS: Serial echocardiography showed decreased left ventricular ejection fraction and fractional shortening in the CRIF1-deficient mice at four and seven weeks later compared to wild type mice (p < 0.05). H&E showed increased myocardial inflammation in the CRIF1-deficient mice. Terminal deoxynucleotidyl transferase biotin-dUTP nick end labeling staining and LC3 staining showed increased apoptosis and autophage in CRIF1-deficient mice compared with wild type (p < 0.01). Electron microscopy revealed that the mitochondria in CRIF1-deficient cardiomyocytes showed abnormal morphogenesis. For example, the cells showed excessively fragmented mitochondria, intracristal swelling, and thinning of myocardial fiber. The stability of mitochondrial complexes in CRIF1-deficient cells showed marked derangements. CONCLUSIONS: CRIF1 is required for maintenance of normal mitochondrial function and modulate apoptosis and autophagy in the heart.
Aging ; Animals ; Apoptosis ; Autophagy ; Cardiovascular Diseases ; Cell Cycle Proteins ; DNA Nucleotidylexotransferase ; Echocardiography ; Genomic Instability ; Heart ; Heart Failure ; Homeostasis ; Inflammation ; Mice ; Microscopy, Electron ; Mitochondria ; Mitochondria, Heart ; Morphogenesis ; Myocytes, Cardiac ; Stroke Volume ; Thoracotomy ; Viruses

BACKGROUND/AIMS: The delay between the onset of myocardial infarction symptoms and primary percutaneous coronary intervention (PCI) is an important prognostic factor in patients with ST-segment elevation acute myocardial infarction (STEMI). We reviewed this delay in patients with STEMI and analyzed clinical outcomes. METHODS: The study enrolled 3,399 patients (age, 61.4 +/- 12.8 years; 25.6% women) with STEMI who underwent primary PCI within 12 hours of symptom onset between October 2005 and February 2008 from the Korea Acute Myocardial Infarction Registry. The patients were divided into two groups according to the symptom-to-balloon time: group I (< or = 3 hours, n = 955) and group II (> 3 hours, n = 2444). The in-hospital mortality rates and 1-year mortality and major adverse cardiac event (MACE) rates were compared between the two groups. RESULTS: The mean time interval from the onset of symptoms to arrival at the emergency room (ER) was 188.0 +/- 133.6 minutes (median, 152 minutes). The mean time interval from the ER to reperfusion (door-to-balloon time) was 97.8 +/- 67.9 minutes (median, 80 minutes). The mean time interval from the onset of symptoms to reperfusion (symptom-to-balloon time) was 285.8 +/- 146.2 minutes (median 250 minutes). The in-hospital mortality rate was significantly lower in group I as compared with group II (3.6% versus 5.2%, p = 0.044). The 1-year mortality rate was also significantly lower in group I (4.7% versus 7.2%, p = 0.012), while the 1-year MACE rate was not significantly different between groups (17.9% versus 20.4%, p = 0.179). CONCLUSIONS: This study demonstrates that there is a significant pre-hospital time delay in patients with STEMI in Korea and this time delay is associated with increased 1-year mortality.
Angioplasty ; Emergencies ; Hospital Mortality ; Humans ; Korea ; Myocardial Infarction ; Percutaneous Coronary Intervention ; Reperfusion ; Time Factors