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Publications (89)
Background and Objectives: Peritoneal dialysis (PD) requires well-functioning medical devices (MDs). PD complications can result in significant adverse events, including the discontinuation of PD, hospitalization, and death. This study aimed to evaluate the feasibility of detecting various PD complications and data related to MDs. Materials and Met...
Background
In the case of clinical practice guideline (CPG), the need for the prospective registration of protocols has been proposed several times. However, the registration of CPG protocols is not yet active. The objective of this study was to summarize the experience of the CPG protocol registration program in Korea.Methods
This study was perfor...
Background and Objectives: Peritoneal dialysis (PD) requires well-functioning medical de-vices (MDs). PD complications can result in significant adverse events, including discon-tinuation of PD, hospitalization, and death. This study aimed to evaluate the feasibility of detecting various PD complications and data related to MDs. Materials and Metho...
Background
The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This...
Background:
A clear and precise definition of the "intended use" in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in...
The E-Health Big Data Evidence Innovation Network (FeederNet) in Korea, based on the observational medical outcomes partnership (OMOP) common data model (CDM), had 72.3% participation from tertiary hospitals handling severe diseases as of October 2022. While this contributes to the activation of multi-institutional research, concerns about the comp...
Background:
The Korean Academy of Medical Sciences (KAMS) has been utilizing AGREE II to audit the quality of clinical practice guidelines (CPGs) developed in Korea. Monitoring the RIGHT Checklist adherence could help monitor the quality status and discover areas for improvement of CPG development.
Methods:
We included 129 CPGs from the past 5 y...
In recent years, there has been an emerging interest in the use of claims and electronic health record (EHR) data for evaluation of medical device safety and effectiveness. In Korea, national insurance electronic data interchange (EDI) code has been used as a medical device data source for common data model (CDM). This study performed a preliminary...
Objective:
Immediate medical device adverse event (MDAE) reporting indications of Korea include death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, and congenital malformation or abnormalities. With the advent of new codes from the International Medical Device Regulators Forum, a study was undertaken to...
Medical devices provide revolutionized healthcare developments but can lead to serious adverse events for affected patients and users. While reporting of adverse events associated with a medical device is essential and the starting point of post-market surveillance, underreporting of medical device adverse events occurs globally. Korea constructed...
Background and Objectives: Point of care test (POCT) is generally performed by non-laboratory staff who often lack an understanding on the quality control and quality assurance programs. The purpose of this study was to understand the current status of quality management of point of care (POC) blood glucose testing in a single institution where non...
Background:
The development process of clinical practice guidelines (CPGs) must adhere to development standards and must be supported and steered by a representative and consistent governing body. We aimed to investigate the current status of the most recent CPGs published in Korea through surveys of medical professional societies and literature s...
Background:
Poor reporting quality in diagnostic accuracy studies hampers an adequate judgment of the validity of the study. The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was published to improve the reporting quality of diagnostic accuracy studies. This study aimed to evaluate the adherence of diagnostic accuracy st...
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This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic C...
Background
Medical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However, for an individual to determine the reporting, he or she should recognize the current situation as an adverse event. The objective of...
Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers,...
Background:
False-positive fecal immunochemical test (FIT) results in the National Cancer Screening Program (NCSP) for colorectal cancer may lead to unnecessary procedures, such as colonoscopies, increasing the medical costs. We estimated reductions in the cost of National Health Insurance according to the accreditation status of screening facilit...
Background:
Identifying preferences for stool collection devices may help increase uptake rates for colorectal cancer screening via fecal immunochemical test (FIT). This study surveyed satisfaction with different devices utilized to collect stool samples for FIT: a conventional container and a sampling bottle (Eiken OC-Sensor).
Methods:
This cro...
Objectives:
This study aimed to evaluate the impact of seasonal variations in climate on the performance of the fecal immunochemical test (FIT) in screening for colorectal cancer in the National Cancer Screening Program in Korea.
Methods:
Data were extracted from the National Cancer Screening Program databases for participants who underwent FIT be...
Background:
Without standardization of medical laboratory's testing practices, there is an increase in false diagnoses when relying on test results. However, the effect of test standardization is difficult to assess numerically. This study's purpose is to quantify the effect of the standardization level of a laboratory on the prevalence of diabete...
Cytogenetic dosimetry is useful for evaluating the absorbed dose of ionizing radiation based on analysis of radiation-induced chromosomal aberrations. We created two types of in vitro dose-response calibration curves for dicentric chromosomes (DC) and translocations (TR) induced by X-ray irradiation, using an electron linear accelerator, which is t...
Human epididymis protein 4 (HE4) has been suggested as a useful new biomarker of lung cancer; however, few relevant large-scale studies have been published. In this study, we evaluated the utility of serum HE4 for lung cancer detection. HE4 levels were measured in serum samples from 100 lung cancer patients, 57 patients with benign lung diseases, a...
Background
Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilita...
To visualize the ETV6/ABL1 fusion signal, we prepared a mixture of two commercially available, locus-specific identifiers: a BCR/ABL1 dual color, dual fusion translocation probe, and an ETV6/RUNX1 extra signal dual color translocation probe (Abbott Vysis) (Fig. 1E, F). Metaphase and interphase FISH with the mixed BCR/ABL1 and ETV6/RUNX1 probes show...
Background/aims:
We are in the process of conducting a randomized trial to determine whether compliance with the fecal immunochemical test (FIT) for colorectal cancer screening differs according to the stool-collection method. This study was an interim analysis of the performance of two stool-collection devices (sampling bottle vs conventional con...
A pre-transplant screening work-up of donors for allogeneic hematopoietic stem cell transplantation (HSCT) is essential. Inadvertent transmission of malignancy from donors with subclinical diseases to recipients has been reported recently in several cases. A 49-year-old male was diagnosed with acute myeloid leukemia. He underwent a course of induct...
Colorectal cancer (CRC) screening by fecal occult blood test (FOBT) significantly reduces CRC mortality, and compliance rates directly influence the efficacy of this screening method. The aim of this study is to investigate whether stool collection strategies affect compliance with the FOBT.
In total, 3,596 study participants aged between 50 and 74...
Clinically, exflagellated microgametes can suggest coinfection with other parasites, as their shape is similar to those of Borrelia, spirochetes, microfilaria, and Trypanosoma. Borrelia is a helical organism containing 7-22 periplasmic flagella but no chromatin. Trypanosoma is curved with a single nucleus and small kinetoplast; the microfilaria is...
The Korean translated Appraisal of Guidelines for Research and Evaluation II (Korean AGREE II) instrument was distributed into Korean medical societies in 2011. However, inter-rater disagreement issues still exist. The Korean AGREE II scoring guide was therefore developed to reduce inter-rater differences. This study examines the effects of the Kor...
Mycobacterium neoaurum is rapidly growing mycobacteria that can cause human infections. It commonly causes bloodstream infections in immunocompromised hosts, and unlike other mycobacteria species, it rarely causes pulmonary infections. We confirmed the first pulmonary infection case in Korea caused by M. neoaurum using full-length 16S rRNA gene seq...
Background:
Glycogen storage disease II (GSD II) is caused by a deficiency of acid alpha-1,4-glucosidase and mutations in the GAA gene encoding this enzyme which are responsible for the pathogenesis of GSD II. Our goal was to determine the mutational spectrum in the GAA gene in Korean patients with GSD II.
Methods:
Three patients with GSD II wer...
The effectiveness of prostate-specific antigen (PSA) for population screening has presented controversial results in large trials and prior reviews. We investigated the effectiveness of PSA population screening in a systematic review.
The study was conducted using existing systematic reviews. We searched Ovid MEDLINE, Embase, Cochrane library, and...
Korea has a relatively short history in the development and use of clinical practice guidelines (CPGs). Additionally, it has been difficult to employ the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument due to the lack of consensus and the presence of differences in Korean medical settings and in the Korean socio-cultural e...
The most common recurrent cytogenetic abnormalities in T-lymphoblastic leukemia (T-acute lymphoblastic leukemia [T-ALL]) involve T-cell receptor (TCR) loci and a variety of partner genes, including HOX11, HOX11L2, MYC, and TAL1. In this report, we present a rare case involving simultaneous translocation of the TCR α/δ loci with different partner lo...
The National Cancer Screening Program (NCSP) has since 2004 provided annual colorectal cancer screening using the fecal immunochemical test (FIT) for individuals aged 50 years or older. The aim of this study was to examine the positivity and detection rates of the FIT and to compare the detection rates of the qualitative and quantitative FITs in pa...
Brevundimonas diminuta is a lactose non-fermenting Gram-negative rod associated with infection in immunocompromised patients. In three patients from two general wards, B. diminuta was isolated in blood culture sample. The clinical features of the patients did not coincide with the blood culture result, and pseudo-outbreak was suspected. These isola...
Most clinicians understand clinical trials as the evaluation process for new medicine before their use. However, clinical trials can also be applied to laboratory diagnostic tests (LDTs) to verify diagnostic accuracy and efficacy before their clinical laboratory implementation for patients. The clinical trial of LDT has two distinctive characterist...
Maple syrup urine disease (MSUD) is a rare, autosomal recessive disorder of branched-chain amino acid (BCAA) metabolism caused by dysfunction of the multienzyme branched-chain alpha-ketoacid dehydrogenase (BCKDH) complex. Although a few cases of MSUD have been reported in the Korean population, the genetic background of MSUD is not well understood....
Purpose: The purpose of this study was to evaluate silver in situ hybridization (SISH) as an effective test to identify HER2 gene amplification in patients with breast cancer. Methods: A systematic literature review was used to evaluate the effectiveness of SISH. The literature review covered from October 27, 2009 to December 1, 2009, and eight dom...
Because the number of patients requiring phlebotomy varies significantly at different times throughout the day, it is difficult to control wait times during peak times. We tried to solve this problem by changing from the conventional fixed-phlebotomist phlebotomy system (CFPPS), in which the phlebotomist waits for patients at a fixed location to th...
We characterized the cytogenetic changes and prognostic characteristics of 133 Korean patients with myelodysplastic syndrome (MDS), focusing on 5q- syndrome and MDS with chromosome abnormalities involving 5q deletion according to World Health Organization 2008 classification. In all patients, G banding and fluorescence in situ hybridization for 5q...
Nationwide external quality assessment (EQA) of the fecal occult blood test (FOBT) in Korea was first introduced in 2007-2009. The EQA results were analyzed to assess the current status of FOBT and to plan the continuation of the EQA program.
The surveys included 40 hospitals in the preliminary survey conducted in 2007, 249 general hospitals in 200...
Metachromatic leukodystrophy (MLD; MIM 250100), a severe neurodegenerative disorder inherited as an autosomal recessive trait, is caused by mutations in the arylsulfatase A (ARSA) gene. Although several germ line ARSA mutations have been identified in patients with MLD of various ethnic backgrounds elsewhere in the world, no genetically confirmed c...
Bisalbuminemia is a hereditary or an acquired condition characterized by the presence of 2 albumin variants with different mobilities on serum protein electrophoresis (SPE). The clinical significance of bisalbuminemia has not been clearly established. However, some regions of the albumin variant may affect the biochemical analysis of biomolecules s...
Cavernous malformations (CMs) occur most often in the brain, but they have also been observed in extracranial regions. The synchronous finding of CMs in both the brain and spinal cord is rare. Furthermore, multiple spinal cord CMs are exceedingly rare, with only one reported case in Korea. Here, we present a 65-yr-old Korean male with cerebral CMs...
No effective treatment for acute lung injury and fibrosis currently exists. Aim of this study was to investigate the time-dependent effect of bone marrow-derived mesenchymal stem cells (BMDMSCs) on bleomycin (BLM)-induced acute lung injury and fibrosis and nitric oxide metabolites and inflammatory cytokine production.
BMDMSCs were transferred 4 day...
Hereditary tyrosinemia type 1 (HT1; MIM 276700) is caused by mutations in the fumarylaceto-acetate hydrolase (FAH) gene, and is the most severe disorder associated with the tyrosine catabolic pathway. HT1 is a very rare disorder and no genetically confirmed case of HT1 in Korea has yet been reported. In this study, we present a Korean neonate with...
The Korean Laboratory Accreditation Program (KLAP) by the Korean Society of Laboratory Medicine (KSLM) was started in 1999. We summarized history and achievement of KLAP for the last 8 yr.
We analyzed 8 yr data (1999-2006) of historical events, trends of participating laboratories, and scores according to the impact of the question to the outcome o...
Thromboxane A2 (TBXA2) is a potent vasoconstrictor in cerebral circulation and is a known contributor to the pathogenesis of cerebral infarction. Thromboxane A2 synthase 1 (TBXAS1) and thromboxane A2 receptors (TBXA2R) are key components in TBXA2 function. We examined whether genetic variants in TBXA2R and TBXAS1 are risk factors for cerebral infar...
Phenylketonuria (PKU; MIM 261600) is an autosomal recessive metabolic disorder caused by a deficiency of phenylalanine hydroxylase (PAH; EC 1.14.16.1). Point mutations in the PAH gene are known to cause PKU in various ethnic groups, and large deletions or duplications account for up to 3% of the PAH mutations in some ethnic groups. However, a previ...
Several techniques are available for measuring platelet function during aspirin therapy, but none is well standardized, and the reported incidence of aspirin non-responders varies widely, from 5 to 50%. We evaluated the optical platelet aggregation test and the Platelet Function Analyzer-100 test (PFA-100) for assessing aspirin responsiveness in pa...
Adrenal hypoplasia congenita (AHC) is caused by mutations in the NR0B1 gene on chromosome Xp21.3-p21.2. It manifests as X-linked primary adrenal failure in early infancy or childhood and as hypogonadotropic hypogonadism (HHG) at puberty. Although studies of AHC patients and mutations in the NR0B1 gene have been reported throughout the world, there...
Elevated intraocular pressure (IOP) is one of the major risk factors for glaucomatous visual field defects. Each individual systemic risk factor of coronary heart disease (CHD) is associated with elevated IOP, although no reports have argued for a correlation between the risk factors for CHD and IOP after a comprehensive or collective analysis. The...
Familial neurohypophyseal diabetes insipidus (FNDI; OMIM 192340) is a rare inherited disorder with an autosomal dominant inheritance pattern. It is characterized by persistent polydipsia and polyuria induced by deficient or absent secretion of arginine vasopressin (AVP). We report a Korean kindred in whom FNDI is associated with a novel deletion mu...
Existing cardiac markers are not sensitive for reversible myocardial ischemia. Ischemia modified albumin (IMA) has recently been shown to be an early and sensitive marker of myocardial ischemia. We established a newly standardized, albumin-adjusted IMA index that was more sensitive and accurate than the conventional IMA value.
We enrolled 413 conse...
Isovaleric acidemia (IVA) is an autosomal recessive inborn error of the leucine metabolism that is caused by a deficiency of isovaleryl-CoA dehydrogenase (IVD). Recent application of tandem mass spectrometry to newborn screening has allowed a significant expansion of the recognition of individuals with IVD deficiency. Although many patients have be...
Mesenchymal stem cells (MSCs) have recently been identified and characterized in humans. Moreover, MSC secrete cytokines that can support hematopoietic progenitor growth. In the present study, we evaluated whether the efficacy of hematopoietic stem cell transplantation is improved by their co-transplantation with MSC, and whether this is positively...
The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III), updated in 2001, quantified the risk factors and made it possible to assess risks for metabolic syndrome (MS) and coronary heart diseases (CHD). Many reported the prevalence of MS by NCEP ATP III in Orientals but few did risk analysis of CHD. We investigated the ri...
Autoimmune paraneoplastic syndromes are encountered in patients with myelodysplastic syndromes. A review of case reports suggested 10% of myelodysplastic syndrome patients may experience various autoimmune syndromes, associated with immunological-mediated hematologic abnormalities, such as Coombs' negative hemolytic anemia. In patients with myelody...
With the progress of the Human Genome Project, genetic testing has become widely available and useful for the confirmation and treatment planning of various conditions. Additionally, the need for genetic counseling and consultation service has been increasing. We tried to establish and manage a medical genetic clinic within the department of labora...
B efore the completion of the Human Genome Project (HGP), the genetics tended to be reserved only to the experts in research fields. Now genetic information has become a matter of grave concern to consumers. Among other changes, gene-tic testing has increased our ability to understand and treat disease; it is increasing our understanding of the cau...
The clinical efficacy of evaluating genetic anomalies in metaphase cells versus interphase nuclei for multiple myeloma (MM) is poorly understood. Therefore, survival for 154 patients with newly diagnosed untreated MM was compared with results from analysis of metaphase and interphase cells. Metaphases were studied by conventional cytogenetics and f...
Fluorescent-labeled DNA probes were used to study 52 chronic lymphocytic leukemia (B-CLL) patients for (1) disease progression, (2) angiogenesis genes, (3) T-cell leukemia 1 gene (TCL1), (4) immunoglobulin heavy chain variable region (IGHv) and (5) chromosome 6q. Compared to stable disease, more patients with progressive disease had > or =2 anomali...
Smoking is a risk factor for coronary artery disease and triggers vascular injury by platelet aggregation and induces atherosclerosis through induction of oxidative stress. Green tea is known to have antioxidant capacity and anti-platelet activity.
Twenty adult male smokers ingested 600 mL of green tea for 4 weeks. Their lipid profile, C-reactive p...
The haptoglobin (Hp) 2-2 phenotype has been known to have less antioxidative activity than Hp 1-1 and Hp 2-1. However, few have reported the relationship between oxidative stress and Hp phenotypes by using oxidized LDL. The relationship between Hp phenotypes and oxidative stress was therefore investigated in healthy adults.
The serum Hp concentrati...
Background: Multiple myeloma (MM) has been studied by conventional cytogenetics and fluorescence in situ hybridization using DNA probes (FISH) on interphase nuclei and metaphase cells, but the relative clinical significance of proliferating (metaphase) versus non-proliferating (interphase) cells at diagnosis is poorly understood. We investigated a...
We report an unbalanced translocation involving chromosome 2 and 7 due to a balanced reciprocal translocation 2;7 in the father. The female fetus had a partial trisomy of the long arm of chromosome 2 with a partial monosomy of distal 7q. Ultrasound at the first trimester had indicated normal fetal anatomy, including normal intracranial structures....
The detection of the Philadelphia (Ph) translocation has been accomplished primarily by cytogenetic analysis and reverse transcriptase polymerase chain reaction (RT-PCR). RT-PCR is highly sensitive (1/10(4)-10(6)) but not quantitatively reliable and is thus unsuitable for the monitoring of Ph-positive cells during therapy. Interphase fluorescence i...
The reverse transcriptase-polymerase chain reaction (RT-PCR) was compared with fluorescence in situ hybridization (FISH) and real-time quantitative RT-PCR (RQ-PCR) for minimal residual disease (MRD) monitoring in 266 post-transplant bone marrow samples from 78 patients with chronic myelogenous leukemia (CML). The sensitivities of FISH to BCR-ABL po...
