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With an aging population, the number of patients with difficulty in swallowing due to medical conditions is gradually increasing. In such cases, enteral nutrition is administered through a temporary nasogastric tube. However, the long-term use of a nasogastric tube leads to various complications and a decreased quality of life. Percutaneous endoscopic gastrostomy (PEG) is the percutaneous placement of a tube into the stomach that is aided endoscopically and may be an alternative to a nasogastric tube when enteral nutritional is required for four weeks or more. This paper is the first Korean clinical guideline for PEG developed jointly by the Korean College of Helicobacter and Upper Gastrointestinal Research and led by the Korean Society of Gastrointestinal Endoscopy. These guidelines aimed to provide physicians, including endoscopists, with the indications, use of prophylactic antibiotics, timing of enteric nutrition, tube placement methods, complications, replacement, and tube removal for PEG based on the currently available clinical evidence.
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Occasionally, ossification of the posterior longitudinal ligament (OPLL) causes cord compression, resulting in cervical myelopathy. OPLL differs from other causes of cervical spondylotic myelopathy in several ways, and the surgical strategy should be chosen with OPLL’s characteristics in mind. Although both the anterior and posterior approaches are effective surgical methods for the treatment of OPLL cervical myelopathy, they each have their own set of benefits and drawbacks. Anterior decompression and fusion (ADF) may improve neurological recovery, restore lordosis, and prevent OPLL mass progression. The benefits can be seen in patients with a high canal occupying ratio or kyphotic alignment. We discussed the benefits, limitations, indications, and surgical techniques of ADF for the treatment of OPLL-induced cervical myelopathy in this narrative.
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Methods@#Sixty-one patients who underwent 1- or 2-level PLIF, including the L5–S1 level, were divided into two groups based on the lordotic angle of cages (4° and 8° in 41 and 20 patients, respectively). Clinical and radiological parameters were compared. Correlation analyzes were performed to reveal the effect of flexibility and position of cages on the regional sagittal parameters. @*Results@#Pre- and postoperative clinical and radiological parameters were not different between the two groups. Although clinical outcomes improved postoperatively, sagittal parameters did not improve postoperatively in both groups. Patients who underwent 1-level PLIF at the L5–S1 level with the use of 8° cages showed no postoperative improvement (segmental angle: 16.1°–15.9°, p =0.140; lumbar lordosis: 44.8°–47.8°, p =0.740) of regional sagittal parameters. The degree of anterior location of cages showed a positive correlation with the postoperative restoration of the segmental angle (p =0.012 and p =0.050 at 1 and 2 years postoperatively, respectively). @*Conclusions@#Clinical and radiological outcomes based on the lordotic angle of cages were not different. Even with the use of 8° cages and regardless of the more anterior position of cages, sagittal alignment did not improve in cases involving the L5–S1 level. PLIF at the L5–S1 level should be used with caution because improvement in sagittal alignment did not occur.
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Purpose@#Since accurate lung cancer segmentation is required to determine the functional volume of a tumor in [ 18 F]FDG PET/CT, we propose a two-stage U-Net architecture to enhance the performance of lung cancer segmentation using [ 18 F]FDG PET/CT. @*Methods@#The whole-body [ 18 F]FDG PET/CT scan data of 887 patients with lung cancer were retrospectively used for network training and evaluation. The ground-truth tumor volume of interest was drawn using the LifeX software. The dataset was randomly partitioned into training, validation, and test sets. Among the 887 PET/CT and VOI datasets, 730 were used to train the proposed models, 81 were used as the validation set, and the remaining 76 were used to evaluate the model. In Stage 1, the global U-net receives 3D PET/CT volume as input and extracts the preliminary tumor area, generating a 3D binary volume as output. In Stage 2, the regional U-net receives eight consecutive PET/CT slices around the slice selected by the Global U-net in Stage 1 and generates a 2D binary image as the output. @*Results@#The proposed two-stage U-Net architecture outperformed the conventional one-stage 3D U-Net in primary lung cancer segmentation. The two-stage U-Net model successfully predicted the detailed margin of the tumors, which was determined by manually drawing spherical VOIs and applying an adaptive threshold. Quantitative analysis using the Dice similarity coefficient confirmed the advantages of the two-stage U-Net. @*Conclusion@#The proposed method will be useful for reducing the time and effort required for accurate lung cancer segmentation in [ 18 F]FDG PET/CT.
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Purpose@#In this study, we propose a deep learning (DL)–based voxel-based dosimetry method in which dose maps acquired using the multiple voxel S-value (VSV) approach were used for residual learning. @*Methods@#Twenty-two SPECT/CT datasets from seven patients who underwent 177 Lu-DOTATATE treatment were used in this study. The dose maps generated from Monte Carlo (MC) simulations were used as the reference approach and target images for network training. The multiple VSV approach was used for residual learning and compared with dose maps generated from deep learning. The conventional 3D U-Net network was modified for residual learning. The absorbed doses in the organs were calculated as the mass-weighted average of the volume of interest (VOI). @*Results@#The DL approach provided a slightly more accurate estimation than the multiple-VSV approach, but the results were not statistically significant. The single-VSV approach yielded a relatively inaccurate estimation. No significant difference was noted between the multiple VSV and DL approach on the dose maps. However, this difference was prominent in the error maps. The multiple VSV and DL approach showed a similar correlation. In contrast, the multiple VSV approach underestimated doses in the low-dose range, but it accounted for the underestimation when the DL approach was applied. @*Conclusion@#Dose estimation using the deep learning–based approach was approximately equal to that in the MC simulation. Accordingly, the proposed deep learning network is useful for accurate and fast dosimetry after radiation therapy using 177 Lu-labeled radiopharmaceuticals.
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With an aging population, the number of patients with difficulty in swallowing due to medical conditions is gradually increasing. In such cases, enteral nutrition is administered through a temporary nasogastric tube. However, the long-term use of a nasogastric tube leads to various complications and a decreased quality of life. Percutaneous endoscopic gastrostomy (PEG) is the percutaneous placement of a tube into the stomach that is aided endoscopically and may be an alternative to a nasogastric tube when enteral nutritional is required for four weeks or more. This paper is the first Korean clinical guideline for PEG developed jointly by the Korean College of Helicobacter and Upper Gastrointestinal Research and led by the Korean Society of Gastrointestinal Endoscopy. These guidelines aimed to provide physicians, including endoscopists, with the indications, use of prophylactic antibiotics, timing of enteric nutrition, tube placement methods, complications, replacement, and tubes removal for PEG based on the currently available clinical evidence.
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Objective@#This study aimed to explore the feasibility of cognitive-behavioral model hypochondriasis regarding coronavirus disease-2019 (COVID-19) among firefighters. In addition, we examined the possible role of their grief reaction and intolerance of uncertainty in the model of COVID-related hypochondriasis. @*Methods@#An anonymous online survey was done on October 27–28, 2022, among firefighters who witnessed people’s death. Demographic characteristics were collected, and their psychological states were assessed using rating scales such as the Obsession with COVID-19 Scale (OCS), Coronavirus Reassurance-Seeking Behaviors Scale (CRBS), Fear of COVID-19 Scale (FCV-19S), Pandemic Grief Scale (PGS), and Intolerance of Uncertainty Scale–12 (IUS-12). @*Results@#Their OCS score was expected by the CRBS (β=0.30, p<0.001), FCV-19S (β=0.10, p<0.001), PGS (β=0.29, p<0.001), and IUS12 (β=0.04, p=0.024) (F=134.5, p<0.001). The COVID-related cognitive-behavioral model of hypochondriasis was feasible among firefighters who witnessed people’s death. Their pandemic grief reaction and intolerance of uncertainty directly influenced their preoccupation with coronavirus, and viral anxiety and coronavirus reassurance-seeking behavior mediated the relationship. @*Conclusion@#Firefighters’ viral anxiety and coronavirus reassurance-seeking behavior mediated the influence of pandemic grief reaction or intolerance of uncertainty on the preoccupation with coronavirus.
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Objective@#This study assessed the reliability and validity of the Stress and Anxiety to Viral Epidemics–9 items (SAVE-9) and Stress and Anxiety to Viral Epidemics–6 items (SAVE-6) scales for measuring viral anxiety among firefighters during the coronavirus disease-2019 pandemic. @*Methods@#An online survey was conducted among 304 firefighters assigned in Gyeonggi-do. The SAVE-9 scale, initially developed for healthcare workers, was adapted for firefighters. We compared it with the SAVE-6 scale designed for the general population among the firefighters sample. The confirmatory factor analysis (CFA) was conducted to explore the factor structure of both scales. Internal consistency reliability was checked using Cronbach’s alpha and McDonald’s omega. Convergent validity was assessed in accordance with the Patient Health Questionnaire–9 and Generalized Anxiety Disorder–7 scales. @*Results@#The SAVE-9 scale demonstrated a Cronbach alpha of 0.880, while the SAVE-6 scale yielded an alpha of 0.874. CFA indicated good model fits for both SAVE-9 and SAVE-6 scales among firefighters sample. The SAVE-9 and SAVE-6 comparably measures viral anxiety of firefighters. @*Conclusion@#Both of the SAVE-9 and SAVE-6 scales are reliable and valid instruments for assessing viral anxiety among firefighters during the pandemic.
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This study was conducted to evaluate the cytotoxic and anti-inflammatory effects of the ethanol extract of Syzygium aromaticum L. (clove) buds. The cytotoxicity test was performed by cell counting method using hTERT-hNOF cells, a human immortalized gingival fibroblast cell line. To test the anti-inflammatory effects, the hTERT-hNOF cells were treated with lipopolysaccharide (LPS) extracted from Porphyromonas gingivalis KCOM 2804 (PgLPS) and ethanol extract of clove buds. The expression levels of PGE2, IL-6, and IL-8 were measured by enzyme-linked immunosorbent assay. The cytotoxicity test data showed a cell viability of ≧ 82% in hTERT-hNOF cells treated with 10 to 80 µg/mL of the ethanol extract of clove buds. The anti-inflammatory test data showed that the expression of PGE2 by PgLPS treatment was reduced to the level of the negative control group by treatment with 10 µg/mL or more of the ethanol extract of clove buds. In group treated with PgLPS and 40 µg/mL of clove bud ethanol extract, the expression levels of IL-6 and IL-8 in were inhibited by 75% and 77%, respectively (p<0.05), compared to the positive control (PgLPS treatment) group. These results suggest that the ethanol extract of clove buds can be used in developing oral hygine products for preventing periodontal disease.
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Background and Objectives@#Paroxysmal atrial fibrillation (AF) is a major potential cause of embolic stroke of undetermined source (ESUS). However, identifying AF remains challenging because it occurs sporadically. Deep learning could be used to identify hidden AF based on the sinus rhythm (SR) electrocardiogram (ECG). We combined known AF risk factors and developed a deep learning algorithm (DLA) for predicting AF to optimize diagnostic performance in ESUS patients. @*Methods@#A DLA was developed to identify AF using SR 12-lead ECG with the database consisting of AF patients and non-AF patients. The accuracy of the DLA was validated in 221 ESUS patients who underwent insertable cardiac monitor (ICM) insertion to identify AF. @*Results@#A total of 44,085 ECGs from 12,666 patient were used for developing the DLA. The internal validation of the DLA revealed 0.862 (95% confidence interval, 0.850–0.873) area under the curve (AUC) in the receiver operating curve analysis. In external validation data from 221 ESUS patients, the diagnostic accuracy of DLA and AUC were 0.811 and 0.827, respectively, and DLA outperformed conventional predictive models, including CHARGE-AF,C2HEST, and HATCH. The combined model, comprising atrial ectopic burden, left atrial diameter and the DLA, showed excellent performance in AF prediction with AUC of 0.906. @*Conclusions@#The DLA accurately identified paroxysmal AF using 12-lead SR ECG in patients with ESUS and outperformed the conventional models. The DLA model along with the traditional AF risk factors could be a useful tool to identify paroxysmal AF in ESUS patients.
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Fabry nephropathy is characterized by a deficiency of lysosomal alpha-galactosidase A, which results in proteinuria and kidney disease. The ineffectiveness of enzyme replacement therapy (ERT) for severe kidney failure highlights the need for early detection and meaningful markers. However, because the diagnosis and treatment of Fabry disease can vary according to the expertise of physicians, we evaluated the opinions of Korean specialists. Methods: A questionnaire regarding the management of Fabry nephropathy was emailed to healthcare providers with the experience or ability to treat individuals with Fabry nephropathy. Results: Of the 70 experts who responded to the survey, 43 were nephrologists, and 64.3% of the respondents reported having treated patients with Fabry disease. Pediatricians are treating primarily patients with classic types of the disease, while nephrologists and cardiologists are treating more patients with variant types. Only 40.7% of non-nephrologists agreed that a kidney biopsy was required at the time of diagnosis, compared with 81.4% of nephrologists. Thirty-eight of 70 respondents (54.3%) reported measuring globotriaosylsphingosine (lyso-Gb3) as a biomarker. The most common period to measure lyso-Gb3 was at the time of diagnosis, followed by after ERT, before ERT, and at screening. For the stage at which ERT should begin, microalbuminuria and proteinuria were chosen by 51.8% and 28.6% of respondents, respectively. Conclusion: Nephrologists are more likely to treat variant Fabry disease rather than classic cases, and they agree that ERT should be initiated early in Fabry nephropathy, using lyso-Gb3 as a biomarker.
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Background@#Optimal antiplatelet strategy for patients with ischemic stroke who were already on single antiplatelet therapy (SAPT) remains to be elucidated. This study aimed to evaluate the effect of different antiplatelet regimens on vascular and safety outcomes at 1 year after non-cardioembolic stroke in patients previously on SAPT. @*Methods@#We identified 9,284 patients with acute non-cardioembolic ischemic stroke that occurred on SAPT using linked data. Patients were categorized into three groups according to antiplatelet strategy at discharge: 1) SAPT; 2) dual antiplatelet therapy (DAPT); and 3) triple antiplatelet therapy (TAPT). One-year outcomes included recurrent ischemic stroke, composite outcomes (recurrent ischemic stroke, myocardial infarction, intracerebral hemorrhage, and death), and major bleeding. @*Results@#Of 9,284 patients, 5,565 (59.9%) maintained SAPT, 3,638 (39.2%) were treated with DAPT, and 81 (0.9%) were treated with TAPT. Multiple antiplatelet therapy did not reduce the risks of 1-year recurrent stroke (DAPT, hazard ratio [HR], 1.08, 95% confidence interval [CI], 0.92–1.27, P = 0.339; TAPT, HR, 0.71, 95% CI, 0.27–1.91, P = 0.500) and 1-year composite outcome (DAPT, HR, 1.09, 95% CI, 0.68–1.97, P = 0.592; TAPT, HR, 1.46, 95% CI, 0.68–1.97, P = 0.592). However, the TAPT groups showed an increased risk of major bleeding complications (DAPT, HR, 1.23, 95% CI, 0.89–1.71, P = 0.208; TAPT, HR, 4.65, 95% CI, 2.01–10.74, P < 0.001). @*Conclusion@#Additional use of antiplatelet agents in patients with non-cardioembolic ischemic stroke who were already on SAPT did not reduce the 1-year incidence of vascular outcomes, although it increased the risk of bleeding complications.
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This meta-analysis examined the surgical management of older patients (>80 years) with gastric cancer, who were often excluded from randomized controlled trials. We analyzed 23 retrospective cohort studies involving 18,372 patients and found that older patients had a higher in-hospital mortality rate (relative risk [RR], 3.23; 95% confidence interval [CI], 1.46–7.17; P<0.01) and more post-operative complications (RR, 1.36; 95% CI, 1.19–1.56;P<0.01) than did younger patients. However, the surgical complications were similar between the two groups. Older patients were more likely to undergo less extensive lymph node dissection and longer hospital stays. Although older patients had statistically significant post-operative medical complications, they were not deprived of surgery for gastric cancer.The comorbidities and potential risks of post-operative complications should be carefully evaluated in older patients, highlighting the importance of careful patient selection. Overall, this meta-analysis provides recommendations for the surgical management of older patients with gastric cancer. Careful patient selection and evaluation of comorbidities should be performed to minimize the risk of post-operative complications in older patients, while recognizing that they should not be deprived of surgery for gastric cancer.
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Purpose@#To develop and evaluate a deep learning technique to automatically segment bone structures in zero echo time (ZTE) for skull magnetic resonance imaging (MRI) in children. @*Materials and Methods@#From January to December 2021, 38 bone ZTE MRIs from infants and children (age range, 1–31 months) were collected for model development.Mask images were generated by manually segmenting the craniofacial bone using a commercial segmentation program. Among them, 35 ZTE series were used to train the three-dimensional (3D)-nnUnet deep learning model and the remaining three series were used for model validation. A temporally different dataset of 19 ZTE bone MRIs obtained in May 2022 from infants and children (age range, 3–168 months) was used to determine the model’s performance. Dice similarity coefficient was calculated for each test case.From 3D volume rendering images, segmentation accuracy, overall image quality, and visibility of cranial sutures were subjectively evaluated on a 5-point scale and compared with ground truth data from manual segmentation. Reasons for segmentation failure were analyzed using axially segmented ZTE images. @*Results@#For the test set, the mean Dice similarity coefficient was 0.985 ± 0.019. The segmentation accuracy was lower than the ground truth without showing a statistically significant difference between the two (3.39 ± 1.11 vs. 3.73 ± 0.77, p = 0.055). The overall image quality and suture visibility showed no significant difference (3.34 ± 0.75 vs.3.42 ± 0.69, p = 0.317; 3.55 ± 0.97 vs. 3.60 ± 0.95, p = 0.157). Common reasons for low segmentation accuracy were well-pneumatized sinuses, metal artifacts, skin at the vertex level, and bones too thin. @*Conclusion@#The deep learning-based automatic segmentation technique of bone ZTE MRIs showed comparable segmentation performance to manual segmentation. Using the deep learning-based segmentation results, acceptable 3D-volume rendering images of craniofacial bones were generated.
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Purpose@#Vibegron, a novel, potent β3 agonist, has been approved for clinical use in overactive bladder (OAB) treatment in Japan and the Unites States. We performed a bridging study to investigate the efficacy and safety of a daily 50-mg vibegron (code name JLP-2002) dose in Korean patients with OAB. @*Methods@#A multicenter, randomized, double-blind, placebo-controlled study was conducted from September 2020 to August 2021. Adult patients with OAB with a symptom duration of more than 6 months entered a 2-week placebo run-in phase. Eligibility was assessed at the end of this phase and selected patients entered a double-blind treatment phase after 1:1 randomization to either the placebo or vibegron (50 mg) group. The study drug was administered once daily for 12 weeks and follow-up visits were scheduled at weeks 4, 8, and 12. The primary endpoint was the change in mean daily micturition at the end of treatment. The secondary endpoints included changes in OAB symptoms (daily micturition, nocturia, urgency, urgency incontinence, and incontinence episodes, and mean voided volume per micturition) and safety. A constrained longitudinal data model was used for statistical analysis. @*Results@#Patients who took daily vibegron had significant improvements over the placebo group in both primary and secondary endpoints, except for daily nocturia episodes. The proportions of patients with normalized micturition and resolution of urgency incontinence and incontinence episodes were significantly higher in vibegron group than in the placebo. Vibegron also improved the patients’ quality of life with higher satisfaction rates. The incidence of adverse events in the vibegron and placebo groups was similar with no serious, unexpected adverse drug reactions. No abnormality in electrocardiographs was observed as well as no significant increase in postvoid residual volume. @*Conclusions@#Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.
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Stem cells are the foundational cells for every organ and tissue in our body. Cell-based therapeutics using stem cells in regenerative medicine have received attracting attention as a possible treatment for various diseases caused by congenital defects. Stem cells such as induced pluripotent stem cells (iPSCs) as well as embryonic stem cells (ESCs), mesenchymal stem cells (MSCs), and neuroprogenitors stem cells (NSCs) have recently been studied in various ways as a cell-based therapeutic agent. When various stem cells are transplanted into a living body, they can differentiate and perform complex functions. For stem cell transplantation, it is essential to determine the suitability of the stem cell-based treatment by evaluating the origin of stem, the route of administration, In vivo bio-distribution, transplanted cell survival, function, and mobility. Currently, these various stem cells are being imaged In vivo through various molecular imaging methods. Various imaging modalities such as optical imaging, magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), and single-photon emission computed tomography (SPECT) have been introduced for the application of various stem cell imaging. In this review, we discuss the principles and recent advances of In vivo molecular imaging for application of stem cell research.
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Background@#This study aimed to evaluate the clinical and radiological outcomes after posterior cruciate ligament (PCL) reconstruction in ≥ 50-year-old patients. @*Methods@#This retrospective case-control study reviewed 28 patients (age, ≥ 50 years) who underwent PCL reconstruction from 2004 to 2018. These patients were 1 : 1 matched to < 50-year-old patients by sex. Clinical, radiological, and survivorship outcomes of the patients were assessed at the final follow-up. Failure of PCL reconstruction was defined as the requirement for additional surgery (revision PCL reconstruction, high tibial osteotomy, or arthroplasty) due to unrelieved symptoms or grade III instability on stress radiographs. @*Results@#The mean follow-up periods (± standard deviation) in < 50- and ≥ 50-year-old patients were 3.9 ± 1.0 years and 3.6 ± 1.9 years, respectively (p = 0.583). In < 50- and ≥ 50-year-old patients, the mean International Knee Documentation Committee scores were 64.1 ± 10.3 and 53.5 ± 17.3; mean Lysholm scores were 81.4 ± 13.0 and 66.3 ± 21.5; and mean Tegner activity scores were 6.1 ± 1.4 and 4.8 ± 1.7, respectively (p = 0.032, p = 0.018, and p = 0.016, respectively). Side-to-side differences in posterior translation on Telos stress radiographs at the final follow-up were 4.4 ± 1.4 mm and 6.9 ± 3.0 mm in < 50- and ≥ 50-year-old patients, respectively (p < 0.001). According to Kaplan-Meier analysis, the failure-free survival rates of both groups were significantly different in the follow-up period (p = 0.014). The failure-free survival rates for < 50- and ≥ 50-year-old patients were 100% and 78.6%, respectively. @*Conclusions@#Clinical, radiological, and survivorship outcomes were inferior among ≥ 50-year-old patients after PCL reconstruction. Thus, surgeons should be careful when deciding and performing PCL reconstruction in patients 50 years old or over.
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Background/Aims@#Although a management fee for hospitalist service was established in Korea, the number of hospitalists required for the system to run remains outmatched. @*Methods@#In January 2020 and February 2022, before and after the establishment of the hospitalist fee system respectively, cross-sectional online surveys were conducted among internal medicine board-certified hospitalists. @*Results@#There were 59 and 64 respondents in the 2020 and 2022 surveys, respectively. The percentage of respondents who cited financial benefits as a motive for becoming a hospitalist was higher in the 2022 survey than in the 2020 survey (34.4% vs. 10.2%; p = 0.001). The annual salary of respondents was also higher in the 2022 survey than in the 2020 survey (mean, 182.9 vs. 163.0 million in South Korean Won; p = 0.006). A total of 81.3% of the respondents were willing to continue a hospitalist career in the 2022 survey. In multivariate regression analysis, the possibility of being appointed as a professor was found to be an independent predictive factor of continuing a hospitalist career (odds ratio, 4.00; 95% confidence interval, 1.09–14.75; p = 0.037). @*Conclusions@#Since the establishment of the hospitalist fee system, monetary compensation has improved for hospitalists. The possibility of being appointed as a professor could predict long-term work as hospitalists.
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Objective@#Acute renal infarction is a rare and easily misdiagnosed disease. Scarce research has been conducted on the predictive factors and prognosis of acute renal infarction due to its rarity. In this study, we analyzed the clinical and laboratory findings of a patient diagnosed with renal infarction to predict clinical outcomes. @*Methods@#In this retrospective clinical study, we collected and analyzed the medical records data of 61 acute renal infarction patients diagnosed in the emergency department (ED) of Konkuk University Hospital, Seoul, South Korea from January 2007 to December 2020. @*Results@#Lactate dehydrogenase (LDH; 93.3%, 28 of 30 patients) and D-dimer (77.8%, 28 of 36 patients) levels of the acute renal infarction patients were higher than the normal. Proteinuria was found in 26 of 47 patients. The only significant prognostic factor for the occurrence of acute kidney injury (AKI) in acute renal infarction is the ratio of the infarction volume to the total renal volume. Age, occurrence of AKI, and proteinuria were correlated with the progression of chronic kidney disease (CKD). @*Conclusion@#The ratio of the infarction volume to the total renal correlated with occurance of AKI. Age, AKI, and proteinuria were correlated with the progression of CKD.
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Background@#For acute ischemic stroke (AIS) patients with history of prior stroke (PS) and diabetes mellitus (DM), intravenous recombinant tissue plasminogen activator (IV-tPA) therapy in the 3- to 4.5-hour window is off-label in Korea. This study aimed to assess the safety and efficacy of IV-tPA in these patients. @*Methods@#Using data from a prospective multicenter stroke registry between January 2009 and March 2021, we identified AIS patients who received IV-tPA in the 3- to 4.5-hour window, and compared the outcomes of symptomatic intracranial hemorrhage (SICH), 3-month mortality, 3-month modified Rankin Scale (mRS) score 0-1 and 3-month mRS distribution between patients with both PS and DM (PS/DM, n=56) versus those with neither PS nor DM, or with only one (non-PS/DM, n=927). @*Results@#The PS/DM group versus the non-PS/DM group was more likely to have a prior disability, hypertension, hyperlipidemia, coronary heart disease and less likely to have atrial fibrillation. The PS/DM and the non-PS/DM groups had comparable rates of SICH (0% vs. 1.7%; p>0.999) and 3-month mortality (10.7% vs. 10.2%; p=0.9112). The rate of 3-month mRS 0-1 was non-significantly lower in the PS/DM group than in the non-PS/DM group (30.4% vs. 40.7%; adjusted odds ratio [95% confidence interval], 0.81 [0.41-1.59]). @*Conclusions@#In the 3- to 4.5-hour window, AIS patients with PS/DM, as compared to those with non-PS/DM, might benefit less from IV-tPA. However, given the similar risks of SICH and mortality, IV-tPA in the late time window could be considered in patients with both PS and DM.