Influence of government-driven quality assessment program on patients with chronic obstructive pulmonary disease.

BACKGROUND: The Korean Health Insurance Review and Assessment Service (HIRA) has launched the Chronic Obstructive Pulmonary Disease (COPD) Quality Assessment Program (CQAP) since 2014. We aimed to reveal the influence of this national program on clinical outcomes and the burden of COPD in Korea. METHODS: The CQAP is conducted annually. We used healthcare claims data linked with the results of the program provided by HIRA between May 2014 and April 2017. Patients were considered to have COPD if they visited a hospital for COPD management during the assessment term. Those who visited a medical institution for COPD and were prescribed COPD medications at least twice were assessed by the CQAP (assessed subjects, AS; not-assessed subjects, NAS). CQAP evaluated the pulmonary function test conduction rate, regular visitation rate, and prescription rates of COPD medications. RESULTS: Among the 560,000 patients with COPD, about 140,000 were assessed by the CQAP annually. In both groups, the pulmonary function test conduction rate and inhaled bronchodilator prescription rate improved since 2014. Compared to the NAS group, the risk of admission and all-cause mortality rate in the AS group were significantly reduced by 21.2% and 40.7%, respectively. In patients who were assessed for 3 consecutive years, all of the above variables were high at baseline and were not improved much from implementation of CQAP. In matching analysis, we observed this improvement to be limited in the COPD quality assessment year. CONCLUSIONS: The CQAP by the health insurance bureau has improved the management protocol and prognosis of COPD.

Impact of the Asthma Quality Assessment Program on Burden of Asthma.

BACKGROUND: In 2013, the Korean Health Insurance Review and Assessment Service launched the Asthma Quality Assessment Program (AQAP) to assess whether patients with asthma were well managed. OBJECTIVE: To show the impact of the AQAP on the medical utilization behavior for asthma. METHODS: We used claims data linked with the results of the AQAP performed between July 2013 and June 2017. Asthma was determined when subjects visited hospital for asthma. Subjects who used asthma medications on at least 2 different occasions were assessed by the AQAP (assessed subjects [Ass]; not-assessed subjects [NASs]). The AQAP evaluated conduction rate of the pulmonary function test, routine visit rate, and prescription rate of asthma medications. Primary clinics were classified as "good" and "not-good" clinics according to the results of the AQAP. RESULTS: Of the 4.3 million subjects with asthma screened, about 0.8 million were assessed by the AQAP annually. Both the conduction rate of pulmonary function test and the prescription rate of inhaled corticosteroids in the ASs and NASs were improved. In addition, the risk of admission and yearly all-cause mortality were significantly reduced (risk reduction rate, 17.1 and 24.4%, respectively, both P < .001) in the AS group compared with the NAS group. However, effects of the AQAP varied according to the subgroup, and they were restricted to the assessment term. In addition, the admission rate and all-cause mortality were decreased by 94.7% and 45.3%, respectively, in "good" clinics as opposed to the "not-good" clinics. CONCLUSIONS: Performing the AQAP improved both the management protocol and prognosis of asthma in Korea.

Clinical Efficacy of Allergen-Specific Immunotherapy from Patient and Physician Perspectives.

PURPOSE: Allergen-specific immunotherapy (AIT) is the only curative treatment for allergic diseases, but a few allergic patients receive AIT. In this multicenter cross-sectional study, we aimed to explore patient and physician perspectives on AIT through a questionnaire survey. MATERIALS AND METHODS: Allergic patients who received subcutaneous immunotherapy for at least 1 year were asked to answer a questionnaire developed by an expert panel of allergen and immunotherapy workgroup in Korea. RESULTS: A total of 267 patients (adults, 60.3%) with allergic rhinitis (91.4%), asthma (42.7%), or atopic dermatitis (20.2%) from referred hospitals completed the survey. Among patients and physicians, respectively, the overall rates of satisfaction with AIT for allergic rhinitis were 86.4% and 83.3% (kappa agreement=0.234, p<0.001), and those for asthma were 85.3% and 72.9% (kappa agreement=0.373, p<0.001). Moreover, pediatric asthmatic patients reported a significantly higher satisfaction rate than adult asthmatic patients after AIT (p=0.040). Symptom severity (p<0.001, respectively) and drug use for allergic rhinitis and asthma decreased after AIT. However, there was no significant difference in satisfaction rates between children and adults in allergic rhinitis (p=0.736). Interestingly, 35.7% and 35% of allergic rhinitis and asthma patients, respectively, reported experiencing improvement in their symptoms within 6 months of starting AIT. CONCLUSION: In this study evaluating the perspectives of patients and physicians on AIT, the majority of patients were satisfied with the efficacy and safety of AIT, but not its cost. AIT should be recommended for AR and allergic patients.

Accurate assessment of alpha-gal syndrome using cetuximab and bovine thyroglobulin-specific IgE.

SCOPE: IgE against galactose-α-1,3-galactose (α-Gal) causes alpha-gal syndrome. Bovine thyroglobulin (BTG) and cetuximab share this epitope. We aimed to determine the utility of specific IgE (sIgE) against cetuximab as compared to BTG for diagnosing alpha-gal syndrome. METHODS AND RESULTS: Twelve patients with alpha-gal syndrome, 11 patients with immediate beef or pork allergy, 18 asymptomatic individuals with meat sensitization, and 10 non-atopic subjects were enrolled. We checked the levels of sIgE against BTG and cetuximab using the streptavidin CAP assay. Additionally, IgE reactivity to BTG and cetuximab was assessed by immunoblotting. All alpha-gal syndrome patients had a high concentration of sIgE against BTG, and cetuximab. In contrast to alpha-gal syndrome, patients with immediate allergic reactions to meat consumption and those with asymptomatic sensitization had significantly lower concentration of BTG and cetuximab sIgE, and a high prevalence of sIgE against bovine or porcine serum albumin. Although the concentration of sIgE against alpha-gal was lower in individuals with asymptomatic sensitization, IgE immunoblotting showed the presence of sIgE against α-Gal in this group. CONCLUSION: Differentiation of alpha-gal syndrome from patients with immediate allergy to meat consumption or asymptomatic sensitization requires quantification of cetuximab- or BTG-induced sIgE via detection of IgE for α-gal.

Risk factors for asthma-related healthcare use: longitudinal analysis using the NHI claims database in a Korean asthma cohort.

BACKGROUND: Though insurance claims data are useful for researching asthma, they have important limitations, such as a diagnostic inaccuracy and a lack of clinical information. To overcome these drawbacks, we used the novel method by merging the clinical data from our asthma cohort with the National Health Insurance (NHI) claims data. METHODS AND RESULTS: Longitudinal analysis of asthma-related healthcare use from the NHI claims database, merged with data of 736 patients registered in a Korean asthma cohort, was conducted for three consecutive years from registration of the cohort. Asthma-related asthma healthcare referred to outpatient and emergency department visits, hospitalizations, and the use of systemic corticosteroids. Univariate and multivariate logistic regression analysis was used to evaluate risk factors for asthma-related healthcare. Over three years after enrollment, many patients changed from tertiary to primary/secondary hospitals with a lack of maintenance of inhaled corticosteroid-based controllers. An independent risk factor for emergency visits was a previous history of asthma exacerbation. In hospitalizations, old age and Asthma Control Test (ACT) score variability were independent risk factors. An independent risk factor for per person cumulative duration of systemic corticosteroids was the FEV1 (Forced expiratory volume in one second)%. The use of systemic corticosteroids was independently associated with being female, the FEV1%, and ACT score variability. CONCLUSION: We found that old age, being female, long-standing asthma, a low FEV1%, asthma brittleness, asthma drug compliance, and a history of asthma exacerbation were independent risk factors for increased asthma-related healthcare use in Korea.

Assessment of Total/Specific IgE Levels Against 7 Inhalant Allergens in Children Aged 3 to 6 Years in Seoul, Korea.

PURPOSE: Childhood allergies are a serious problem, as they may lead to lifetime chronic disease. Determination of total and specific IgE levels is known to be a diagnostic tool for allergic sensitization; however, IgE levels are affected by various factors, such as age, sex, ethnicity, and geographic area. Thus, we evaluated the distribution of total and specific serum IgE levels against seven inhalant allergens in preschool children and examined their association with allergic diseases in Seoul, Korea. METHODS: Total/specific serum IgE determination and skin prick tests for seven common allergens were performed on 509 children aged 3 to 6 years from 16 child care centers in Seoul, Korea. Demographic characteristics were surveyed from parents using a modified International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire. A diagnosis of atopic dermatitis was made by physicians. RESULTS: The geometric mean of total IgE was 80.48±3.80 kU/L in preschool children. IgE levels were higher in boys (boys, 102.34±3.52 kU/L; girls, 62.37±3.93 kU/L; P<0.001) and atopic subjects (atopic, 158.00±3.35 kU/L; non-atopic, 52.75±3.44 kU/L; P<0.001). An increased prevalence of atopy was associated with a high monthly household income (P=0.004) and higher maternal education level (above university-level education; P=0.009), as well as increased total IgE levels (P=0.036). Physician-diagnosed atopic dermatitis was associated with sensitization to inhalant allergens. CONCLUSIONS: Total IgE levels were very high as compared with those in previous reports from other countries. The most common sensitized allergen was Dermatophagoides farinae, and the positive response rate peaked at age 3 years and was maintained thereafter, particularly in boys. Specific IgE levels for seven inhalant allergens varied with age in preschool children. Although further investigations are needed with a broad range of ages and various allergens, the distribution of the total and specific serum IgE levels in preschool children might help to serve as a reference value to diagnose atopy.

Alveolar macrophages play a key role in cockroach-induced allergic inflammation via TNF-α pathway.

The activity of the serine protease in the German cockroach allergen is important to the development of allergic disease. The protease-activated receptor (PAR)-2, which is expressed in numerous cell types in lung tissue, is known to mediate the cellular events caused by inhaled serine protease. Alveolar macrophages express PAR-2 and produce considerable amounts of tumor necrosis factor (TNF)-α. We determined whether the serine protease in German cockroach extract (GCE) enhances TNF-α production by alveolar macrophages through the PAR-2 pathway and whether the TNF-α production affects GCE-induced pulmonary inflammation. Effects of GCE on alveolar macrophages and TNF-α production were evaluated using in vitro MH-S and RAW264.6 cells and in vivo GCE-induced asthma models of BALB/c mice. GCE contained a large amount of serine protease. In the MH-S and RAW264.7 cells, GCE activated PAR-2 and thereby produced TNF-α. In the GCE-induced asthma model, intranasal administration of GCE increased airway hyperresponsiveness (AHR), inflammatory cell infiltration, productions of serum immunoglobulin E, interleukin (IL)-5, IL-13 and TNF-α production in alveolar macrophages. Blockade of serine proteases prevented the development of GCE induced allergic pathologies. TNF-α blockade also prevented the development of such asthma-like lesions. Depletion of alveolar macrophages reduced AHR and intracellular TNF-α level in pulmonary cell populations in the GCE-induced asthma model. These results suggest that serine protease from GCE affects asthma through an alveolar macrophage and TNF-α dependent manner, reflecting the close relation of innate and adaptive immune response in allergic asthma model.

Economic costs for adult asthmatics according to severity and control status in Korean tertiary hospitals.

OBJECTIVE: The prevalence of asthma is increasing, and asthma causes considerable socioeconomic burden worldwide. Few studies have been conducted to evaluate the risk factors associated with economic cost of asthma in Korea. This study evaluated asthma cost according to severity, control, and patient factors in Korean tertiary hospitals. METHODS: Direct and indirect costs were assessed in physician-diagnosed adult asthmatics recruited from eight tertiary hospitals in Korea. Official direct medical costs were derived from the analysis of 1-year expenditures related to hospital care utilization and asthma medication. Nonofficial medical costs, nonmedical direct costs, and indirect costs were investigated using a questionnaire designed specifically for the study. RESULTS: A total of 314 patients with persistent asthma were recruited. Both direct and indirect costs were significantly higher for patients with severe persistent asthma than for those with mild and moderate persistent asthma ($2214 vs. $871 and $978, p < .001; $2927 vs. $490 and $443, p < .001, respectively). Costs of asthma increased significantly in poorly controlled compared with somewhat controlled and well-controlled asthma ($7009.8 vs. $2725.3 vs. $1517.3, respectively; p < .001). After stratification for severity, a significant cost increase in the poorly controlled asthma group was observed only for indirect costs and not for direct costs. A multivariate analysis showed that female gender was a risk factor for increased indirect costs. CONCLUSION: The burden of asthma was higher both for patients with severe persistent asthma and for patients with poorly controlled asthma. More effective strategies are needed to improve control status, particularly targeting patients with severe asthma.

Current status of Oriental medicine in treating Korean allergy patients.

PURPOSE: To evaluate the prevalence, compliance, pattern of use, and economic cost of OM in Korean allergy patients. METHODS: A total of 647 allergy patients were enrolled from 10 general hospitals, and were surveyed by the questionnaire. It consisted of 12 items and regarded the prescription rates, reasons for referring, their opinions for the efficacy of OM, and economic costs. RESULTS: A total of 259 (40.5%) patients had used OM, and 35.5% of these patients experienced two or more kinds of these practices. A patients' income or education level did not affect the prescription rates of OM. Of the patients that used OM, 34.6% of them were satisfied with the effect of OM treatment, and 40.9% of them were inclined to continue with their OM treatments. The most frequent reasons for choosing OM were the patient's belief that OM can predispose 'allergic constitution to normal' (30.2%), worries about the possible adverse reactions of the long-term administration of the proven drugs (20.2%), and the safety of OM (15.6%). However, 18.9% of these patients experienced perceived adverse events to their OM treatment such as skin rashes, gastrointestinal discomfort, and hepatitis. The patients that have used OM spent on average $915 US dollars annually for OM treatment. CONCLUSIONS: Many Korean allergy patients are cliental to OM. Some patients experienced a satisfactory treatment effect from OM, however, others had no treatment effect, even adverse event. Therefore, it is important to educate people to use OM appropriately to make harmony with modern medicine.

Spontaneous reporting of adverse drug events by Korean regional pharmacovigilance centers.

PURPOSE: Patterns of prescriptions are markedly influenced by regional disease entities, medical education, culture, economic status, and available pharmaceutical companies. Features of adverse drug reactions (ADRs) may vary in different countries. In this study, we analyzed the causative drugs and clinical manifestations of spontaneously reported ADRs in Korea. METHODS: Six Korean Regional Pharmacovigilance Centers collected 1418 cases of spontaneously reported adverse drug events (ADEs) by doctors, pharmacists, and nurses, and the clinical features and causative drugs were evaluated. The data were collected from general hospitals (76.5%), primary clinics, and pharmacies (23.5%). RESULTS: Based upon the World Health Organization (WHO)-Uppsala Monitoring Center criteria (certain-13.7%, probable-46.1%, possible-32.1%), 91.9% of the collected events were suspected to be ADRs and 15.8% of patients experienced serious ADRs. The most prevalent causative drugs were antibiotics (31.6%), followed by contrast dyes (14.0%), non-steroidal anti-inflammatory drugs (NSAIDs) (11.1%), anti-psychotics (5.4%), anti-convulsants (5.2%), cardiovascular agents (4.8%), anti-neoplastics (4.6%), and opiates and non-opiate pain killers (3.5%). Among the antibiotics, cephalosporins (8.1%) were the most common, followed by anti-tuberculosis agents (5.7%), quinolones (4.0%), vancomycin (3.1%), and penicillin (2.8%). The most common side effect was skin manifestations, which were seen in 42% of the patients, followed by neurologic manifestations (14%), gastrointestinal involvements (12.9%), generalized reactions (9.4%), and respiratory involvements (4.5%). CONCLUSION: Antibiotics, contrast dyes, and NSAIDs were the most common causative drugs for ADRs, which reflects the prescription pattern and the prevalence of diseases in Korea. These data may be useful in establishing a Korean pharmacovigilance system.