The Korean Endocrine Society (KES) published clinical practice guidelines for the treatment of acromegaly in 2011. Since then, the number of acromegaly cases, publications on studies addressing medical treatment of acromegaly, and demands for improvements in insurance coverage have been dramatically increasing. In 2017, the KES Committee of Health Insurance decided to publish a position statement regarding the use of somatostatin analogues in acromegaly. Accordingly, consensus opinions for the position statement were collected after intensive review of the relevant literature and discussions among experts affiliated with the KES, and the Korean Neuroendocrine Study Group. This position statement includes the characteristics, indications, dose, interval (including extended dose interval in case of lanreotide autogel), switching and preoperative use of somatostatin analogues in medical treatment of acromegaly. The recommended approach is based on the expert opinions in case of insufficient clinical evidence, and where discrepancies among the expert opinions were found, the experts voted to determine the recommended approach.
Acromegaly ; Consensus ; Expert Testimony ; Insurance Coverage ; Insurance, Health ; Octreotide ; Somatostatin

Acromegaly is a chronic disorder caused by excessive growth hormone (GH) secretion. In most cases, the excess GH originates from GH-producing pituitary adenomas. Surgery is the preferred first-line treatment for patients with acromegaly, but medical management is considered when the disease persists after surgery or in cases where patients refuse surgery or are poor candidates for surgery. Somatostatin analogues are commonly used to treat acromegaly. The Korean Endocrine Society and the Korean Neuroendocrine Study Group have developed a position statement for the use of somatostatin analogues in the medical treatment of acromegaly. This position statement is based on evidence from the current literature and expert opinions. In the case of discrepancies among expert opinions, the experts voted to determine the recommended approach.

Acromegaly is a chronic disorder caused by excessive growth hormone (GH) secretion. In most cases, the excess GH originates from GH-producing pituitary adenomas. Surgery is the preferred first-line treatment for patients with acromegaly, but medical management is considered when the disease persists after surgery or in cases where patients refuse surgery or are poor candidates for surgery. Somatostatin analogues are commonly used to treat acromegaly. The Korean Endocrine Society and the Korean Neuroendocrine Study Group have developed a position statement for the use of somatostatin analogues in the medical treatment of acromegaly. This position statement is based on evidence from the current literature and expert opinions. In the case of discrepancies among expert opinions, the experts voted to determine the recommended approach.
Acromegaly ; Expert Testimony ; Growth Hormone ; Humans ; Octreotide ; Pituitary Neoplasms ; Somatostatin

BACKGROUND: The performance of the self-monitoring of blood glucose in patients with diabetes should be properly evaluated to ensure strict glycemic control. This study evaluated the self-testing Blood Glucose Monitoring System GlucoDr.S™ (All Medicus Co., Ltd., Korea). METHODS: This study recruited 120 patients. Use of the glucometer was evaluated according to ISO 15197:2013 guidelines. The YSI 2300 STAT PLUS Glucose Analyzer (YSI Life Sciences, USA) was used as the reference device. RESULTS: The standard deviation and coefficients of variation ranges for measurement repeatability and intermediate measurement precision conducted with 10 meters and 3 reagent lots on the same day were 2.7–3.2 mg/dL (<100 mg/dL) and 3.4–3.7% (≥100 mg/dL), respectively, and 3.7 mg/dL (<100 mg/dL) and 2.1–2.6% (≥100 mg/dL), respectively. Each coefficient of determination (R2) for linearity of the 3 reagent lots was >0.99. The influence effect of hematocrit and the 24 interference agents was not significant, except for xylose. A system accuracy test was conducted with 100 subjects taking duplicate measurements from each of the 3 reagent lots. When glucose levels were <100 mg/dL and ≥100 mg/dL, >95% of the samples were within ±15 mg/dL and within ±15% of the average measured values of the reference measurement, respectively. In Consensus Error grid analysis, all results were distributed in zone A and B. The results of the user performance evaluation using 115 lay persons were also included in the acceptance range. CONCLUSION: The GlucoDr.S™ showed acceptable performance according to the ISO 15197:2013 guidelines and could be a clinically useful self-testing glucometer.
Biological Science Disciplines ; Blood Glucose* ; Consensus ; Glucose ; Hematocrit ; Humans ; Xylose

BACKGROUND/AIMS: The resistance rate of Helicobacter pylori is gradually increasing. We aimed to evaluate the efficacy of levofloxacin-based third-line H. pylori eradication in peptic ulcer disease. METHODS: Between 2002 and 2014, 110 patients in 14 medical centers received levofloxacin-based third-line H. pylori eradication therapy for peptic ulcer disease. Of these, 88 were included in the study; 21 were excluded because of lack of follow-up and one was excluded for poor compliance. Their eradication rates, treatment regimens and durations, and types of peptic ulcers were analyzed. RESULTS: The overall eradiation rate was 71.6%. The adherence rate was 80.0%. All except one received a proton-pump inhibitor, amoxicillin, and levofloxacin. One received a proton-pump inhibitor, amoxicillin, levofloxacin, and clarithromycin, and the eradication was successful. Thirty-one were administered the therapy for 7 days, 25 for 10 days, and 32 for 14 days. No significant differences were observed in the eradication rates between the three groups (7-days, 80.6% vs 10-days, 64.0% vs 14-days, 68.8%, p=0.353). Additionally, no differences were found in the eradiation rates according to the type of peptic ulcer (gastric ulcer, 73.2% vs duodenal/gastroduodenal ulcer, 68.8%, p=0.655). CONCLUSIONS: Levofloxacin-based third-line H. pylori eradication showed efficacy similar to that of previously reported first/second-line therapies.
Amoxicillin ; Clarithromycin ; Compliance ; Follow-Up Studies ; Helicobacter pylori* ; Helicobacter* ; Humans ; Levofloxacin ; Peptic Ulcer* ; Ulcer

BACKGROUND: The amino-terminal pro-brain natriuretic peptide (NT-proBNP) is a useful biomarker for the diagnosis of acute congestive heart failure. A point-of-care test (POCT) could rapidly detect the presence of NT-proBNP during emergencies. We evaluated the analytical performance of the new Samsung LABGEO PA CHF Test (Samsung Electronics, Korea). METHODS: Based on the guidelines of the Clinical and Laboratory Standards Institute (CLSI), we compared the precision, linearity, and method with those of the E170 (Roche Diagnostics, Switzerland). Matrix comparison between the NT-proBNP values in whole blood and plasma was also performed, and the reference interval was determined using residual samples from healthy adults selected based on the evaluation criteria. RESULTS: The Samsung LABGEO PA CHF Test provided results in approximately 18 min. The coefficient of variation (CV) of within-laboratory precision was below 6.8%. A desirable linearity was observed in the range of 0–10,000 pg/mL, with R²=0.99. The correlation with E170 was also excellent (N=108, r=0.96). NT-proBNP values in the whole blood were correlated with those in the plasma (N=36, r=0.99). The reference interval for the circulating NT-proBNP concentration was determined in 118 plasma samples from healthy subjects (26-75 yr of age). The 97.5th percentile was found to be 58.3 pg/mL. CONCLUSIONS: The Samsung LABGEO PA CHF Test demonstrated a good analytical performance. It could be a powerful tool as a POCT for clinical practice, particularly during emergencies.
Adult ; Diagnosis ; Emergencies ; Healthy Volunteers ; Heart Failure ; Humans ; Methods ; Plasma ; Point-of-Care Systems* ; Point-of-Care Testing

BACKGROUND: Pyridoxal-5'-phosphate (P5P), a coenzyme of the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) reactions, is required to measure aminotransferase levels (IFCC method). However, a modified IFCC method that uses a reagent devoid of P5P is commonly used in laboratories in Korea. To determine the differences between the two methods, we compared aminotransferase levels measured by using the IFCC method and modified IFCC method. METHODS: Serum levels of AST and ALT, with and without P5P, were measured in 2,318 patients. Based on the allowable limits of performance set by the Royal College of Pathologists of Australasia (RCPA), differences between the two methods were analyzed under various conditions. RESULTS: Higher AST and ALT values were obtained by the IFCC method compared to modified IFCC method, showing significant differences between the two methods (AST, 5.8±14.2 IU/L; ALT, 2.8±6.9 IU/L) (P<0.001). Values exceeding RCPA criteria were more frequently observed in emergency orders (AST, 65.8%; ALT, 14.4%) than in routine orders (AST, 3.2%; ALT, 9.6%), as well as in inpatient wards (AST, 70.4%; ALT, 18.5%) compared to outpatient clinics (AST, 56.6%; ALT, 10.0%). However, the differences between the two methods were not significant among the disease groups, except for the acute myocardial infarction group. CONCLUSIONS: The method using reagents without P5P underestimated aminotransferase activity. The effect of P5P was more significant in patients with acute myocardial infarction, considered as P5P-deficient. In conclusion, the IFCC method with P5P should be applied for measuring AST and ALT serum levels.
Alanine Transaminase ; Ambulatory Care Facilities ; Aspartate Aminotransferases ; Australasia ; Emergencies ; Humans ; Indicators and Reagents ; Inpatients ; Korea ; Liver Function Tests ; Methods ; Myocardial Infarction ; Pyridoxal Phosphate

We report here the results of the external quality assessment scheme (EQA) of blood bank tests in Korea carried out in 2015. The proficiency testing specimens used in the survey were prepared at Ajou University Hospital. The response rates from participating laboratories for the first and second trials were 98.7% (542/549) and 98.2% (544/554), respectively. No answers to tests were considered incorrect, and the average accuracy rates for six different test items on the standard survey were as follows: ABO grouping, 99.4% to 100.0%; RhD typing, 99.4% to 100.0%; crossmatching, 93.6% to 99.0%; direct antiglobulin test (DAT) using a polyspecific reagent, 92.9% to 98.3%; DAT using an IgG monospecific reagent, 94.6% to 100.0%; DAT using a C3d monospecific reagent, 84.2% to 98.6%; unexpected antibody screening test, 94.5% to 100.0%; and antibody identification test, 93.8% to 100.0%. We performed a pilot survey on reactivities to A1 (54 responses) and H (50 responses); Rh C, c, E, and e antigen testing (47 responses); and ABO antibody titration (10-34 responses). We obtained excellent results for this EQA, and these results will be helpful for improving or maintaining the quality of the participating laboratories.
Blood Banks* ; Coombs Test ; Immunoglobulin G ; Korea* ; Laboratory Proficiency Testing ; Mass Screening

The Clinical Chemistry Subcommittee of the Korean Association for External Quality Assessment Service conducted external quality assessments in 2015. This included general chemistry and blood gas measurements as part of a scheme of six trials, comprising three samples each. All control materials were included at the same time. The overall response rates were 94.4% for general chemistry and 92.2% for blood gas. The parameters tested included sodium, potassium, chloride, blood urea nitrogen, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase, lactate dehydrogenase, gamma glutamyl transferase, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol for general chemistry, and pH, partial pressure of carbon dioxide (pCO₂), and partial pressure of oxygen (pO₂) for blood gas assessments. Two types of reports were generated: a method summary, including mean, standard deviation, and coefficient of variation for each test method; and a result summary of each participating laboratory, including mean, standard deviation, number of peer groups, and standard deviation index and variance index scores of each laboratory. The overall quality performance in 2015 was similar to that of previous years, and showed lower interlaboratory variation than that in 2014. The requisite continual improvement in clinical chemistry testing quality can be achieved through participation in similar proficiency testing programs.
Alanine Transaminase ; Alkaline Phosphatase ; Aspartate Aminotransferases ; Bilirubin ; Blood Urea Nitrogen ; Calcium ; Carbon Dioxide ; Chemistry ; Chemistry, Clinical* ; Cholesterol ; Clinical Chemistry Tests ; Creatinine ; Glucose ; Hydrogen-Ion Concentration ; Korea* ; L-Lactate Dehydrogenase ; Lipoproteins ; Methods ; Oxygen ; Partial Pressure ; Peer Group ; Phosphorus ; Potassium ; Sodium ; Transferases ; Triglycerides ; Uric Acid

BACKGROUND: The proficiency testing (PT) program for HbA1c, performed by the Korean Association of External Quality Assessment Service (KAEQAS), first started in 2007. From 2007 to 2008, the results were assessed using means as the standard within a peer group (identical method group). However, the assessment method changed to accuracy-based PT in 2009. This study aimed to analyse the results of an external quality assessment of HbA1c from 2009 to 2014. METHODS: Based on the data obtained from the external quality assessment of HbA1c from 2009 to 2014, we analysed the number of participating institutions, response rate, 'unacceptable' result rate, bias from the target value, and CVs according to each instrument code. RESULTS: The number of participating institutions was only 180 in 2009. However, it increased over the next 5 years, and as of 2014, 345 institutions were enrolled. The response rates were 93.8% to 99.1%. Since 2009, the measurement method changed and most of the participating institutions now use the high-performance liquid chromatography (HPLC) method. As of 2014, the HPLC method showed small bias from the target value and inter-laboratory CVs (<3.5%), demonstrating satisfactory performance. Immunoassays and point-of-care testing (POCT) demonstrated relatively unsatisfactory performance, showing larger inter-laboratory CVs compared to those obtained with the HPLC method, with some of them exceeding the acceptance limit of +/-8% of the target value. CONCLUSIONS: As of 2014, relatively large-scale laboratories are participating in the accuracy-based PT for HbA1c. According to the accuracy-based PT for HbA1c, POCT showed the highest 'unacceptable' rate and imprecision. Therefore, small-scale laboratories mostly using POCT for HbA1c measurement should be encouraged to participate in the accuracy-based PT program for HbA1c, and the external quality assessment program undertaken by KAEQAS should be expanded.
Bias (Epidemiology) ; Chromatography, High Pressure Liquid ; Chromatography, Liquid ; Hemoglobin A, Glycosylated ; Immunoassay ; Korea ; Laboratory Proficiency Testing ; Peer Group