RESUMEN
Purpose: This study aimed to develop the Health Belief Model scale for premature birth prevention (HBM-PBP) and evaluated its psychometric properties in women of childbearing age. Methods: This study employed a cross-sectional design and included 724 women of childbearing age with intentions of future childbirth or in their first trimester of pregnancy. An item pool was formulated from the literature and in-depth interviews based on the health belief model. Content validation was conducted by experts and through cognitive interviews with women of childbearing age. Construct and concurrent validity and reliability were evaluated using factor analysis, Pearson's correlation analysis, and Cronbach's alpha. Results: The HBM-PBP consisted of 96 items, including perceived susceptibility (21 items, 5 subscales), severity (26 items, 5 subscales), benefits (27 items, 5 subscales), and barriers (22 items, 5 subscales). Convergent and discriminant validity were supported. The Cronbach's alpha coefficient of the domains ranged from 0.87 to 0.94. Conclusion: The HBM-PBP is a valid and reliable measurement scale with good psychometric properties. It can be used to measure health beliefs in women, either as a whole or in individual domains. Health professionals can leverage the HBM-PBP to discern women's health beliefs on premature birth, facilitating tailored interventions and educational efforts.
RESUMEN
BACKGROUND AND AIM: Corticosteroid use is a risk factor for avascular necrosis (AVN) and inflammatory bowel disease (IBD) patients are often exposed to higher corticosteroid usage. We investigated the epidemiology and risk factors of AVN in a nationwide population-based cohort of IBD patients. METHODS: Patients newly diagnosed with IBD were identified, and sex- and age-matched participants from the general population were selected in a 1:3 IBD:non-IBD ratio. We investigated newly diagnosed AVN and assessed the incidence rates and risk of AVN with multivariate Cox regression models. RESULTS: During the median follow-up period of 7.22±3.85 years, 357 (0.62â¯%) were newly diagnosed with AVN. The risk of AVN was higher in IBD (aHR = 1.42, 95â¯% CI: 1.25-1.62). Ulcerative colitis (UC) patients showed a particularly elevated risk of developing AVN. IBD patients with higher cumulative corticosteroid intake and exposed to a mean prednisolone-equivalent daily dose>20 mg for >1 month were at higher risk of AVN. In Crohn's disease (CD), longer exposure time to >20 mg prednisolone-equivalent presented a trend in increased risk. CONCLUSION: AVN risk was higher in IBD than in those without, particularly in UC and corticosteroid use in IBD could pose a crucial role. These underscore the importance of considering the AVN etiological factors, particularly corticosteroid use.
RESUMEN
This study determined whether compared to conventional mechanical ventilation (MV), extracorporeal membrane oxygenation (ECMO) is associated with decreased hospital mortality or fibrotic changes in patients with COVID-19 acute respiratory distress syndrome. A cohort of 72 patients treated with ECMO and 390 with conventional MV were analyzed (February 2020-December 2021). A target trial was emulated comparing the treatment strategies of initiating ECMO vs no ECMO within 7 days of MV in patients with a PaO2/FiO2 < 80 or a PaCO2 ≥ 60 mmHg. A total of 222 patients met the eligibility criteria for the emulated trial, among whom 42 initiated ECMO. ECMO was associated with a lower risk of hospital mortality (hazard ratio [HR], 0.56; 95% confidence interval [CI] 0.36-0.96). The risk was lower in patients who were younger (age < 70 years), had less comorbidities (Charlson comorbidity index < 2), underwent prone positioning before ECMO, and had driving pressures ≥ 15 cmH2O at inclusion. Furthermore, ECMO was associated with a lower risk of fibrotic changes (HR, 0.30; 95% CI 0.11-0.70). However, the finding was limited due to relatively small number of patients and differences in observability between the ECMO and conventional MV groups.
Asunto(s)
COVID-19 , Oxigenación por Membrana Extracorpórea , Mortalidad Hospitalaria , Respiración Artificial , Síndrome de Dificultad Respiratoria , Humanos , Oxigenación por Membrana Extracorpórea/métodos , COVID-19/mortalidad , COVID-19/terapia , COVID-19/complicaciones , Masculino , Femenino , Persona de Mediana Edad , Anciano , Síndrome de Dificultad Respiratoria/terapia , Síndrome de Dificultad Respiratoria/mortalidad , Síndrome de Dificultad Respiratoria/virología , SARS-CoV-2/aislamiento & purificación , AdultoRESUMEN
BACKGROUND: Premature birth rates have slightly increased globally, making its prevention critical for both short-term and long-term health outcomes. Various interventions have been developed in response to the multifaceted risk factors for premature birth, including internet-based programs. These programs offer accessibility and enhanced engagement; however, their overall efficacy in preventing premature births requires thorough evaluation. OBJECTIVE: This systematic review aims to identify the study designs and assess the effectiveness of internet-based interventions in preventing premature birth among pregnant women. METHODS: A comprehensive search of the MEDLINE, Embase, CINAHL, and Cochrane Library databases was conducted to identify randomized trials and quasi-experimental studies evaluating internet-based interventions for premature birth prevention in pregnant women. The search was inclusive, with no restrictions based on language or geographical location, allowing for a comprehensive global perspective. The time frame for the inclusion of studies extended until February 2023. The risk of bias (RoB) in each study was independently assessed by 3 authors forming pairs, using the revised Cochrane RoB tool (RoB 2) for randomized trials, as per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Owing to heterogeneity in populations, measurements, and interventions, a meta-analysis was not conducted. RESULTS: This review included 26 articles, comprising 12 intention-to-treat and 14 per-protocol studies. The overall RoB was high in most intention-to-treat studies and of some concern in most per-protocol studies. The target populations varied, including nonspecific pregnant women, those with gestational diabetes mellitus (GDM) or those at risk of GDM, individuals with anxiety or depression, and those experiencing preterm labor. Psychosocial, physiological, and wellness health outcomes were evaluated. Internet-based interventions effectively reduced stress/distress in nonspecific pregnant women but not in those experiencing preterm labor. Their effectiveness in reducing anxiety and depression varied, with inconsistent results among different groups. In women with GDM or those at risk of GDM, interventions successfully controlled fasting plasma glucose and 2-hour postprandial plasma glucose levels but did not consistently manage glycated hemoglobin levels. These interventions did not reduce the incidence of premature births across the various populations studied. The effectiveness of these internet-based interventions in addressing substance or alcohol abuse and insomnia also varied. CONCLUSIONS: Internet-based interventions show promise in improving psychosocial health and managing blood sugar to prevent premature birth, highlighting variability in effectiveness across different risk factors. Further research, including clinical trials, is vital for developing, evaluating, and disseminating effective, safe internet-based interventions. Establishing standardized measurement tools and rigorous evaluation processes is crucial for enhancing these interventions' effectiveness and reliability in clinical practice, significantly contributing to preventing premature births and improving maternal health outcomes. TRIAL REGISTRATION: PROSPERO CRD42021278847; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021278847.
RESUMEN
The COVID-19 Vaccine Safety Research Committee (CoVaSC) was established in November 2021 to address the growing need for independent, in-depth scientific evidence on adverse events (AEs) following coronavirus disease 2019 (COVID-19) vaccination. This initiative was requested by the Korea Disease Control and Prevention Agency and led by the National Academy of Medicine of Korea. In September 2022, the COVID-19 Vaccine Safety Research Center was established, strengthening CoVaSC's initiatives. The center has conducted various studies on the safety of COVID-19 vaccines. During CoVaSC's second research year, from September 29, 2022 to July 19, 2023, the center was restructured into 4 departments: Epidemiological Research, Clinical Research, Communication & Education, and International Cooperation & Policy Research. Its main activities include (1) managing CoVaSC and the COVID-19 Vaccine Safety Research Center, (2) surveying domestic and international trends in AE causality investigation, (3) assessing AEs following COVID-19 vaccination, (4) fostering international collaboration and policy research, and (5) organizing regular fora and training sessions for the public and clinicians. Causality assessments have been conducted for 27 diseases, and independent research has been conducted after organizing ad hoc committees comprising both epidemiologists and clinical experts on each AE of interest. The research process included protocol development, data analysis, interpretation of results, and causality assessment. These research outcomes have been shared transparently with the public and healthcare experts through various fora. The COVID-19 Vaccine Safety Research Center plans to continue strengthening and expanding its research activities to provide reliable, high-quality safety information to the public.
RESUMEN
OBJECTIVES: We aimed to investigate medication utilisation trends during pregnancy and identify factors associated with adverse pregnancy outcomes (APOs) in patients with rheumatoid arthritis (RA). METHODS: Female patients with RA aged 20-50 years were identified from the Korean national health insurance database between 2010 and 2020. Pregnancy episodes were divided into two groups according to pregnancy outcome: the delivery group and the APO group (abortion and stillbirth). The characteristics and medication utilisation patterns were compared between the two groups, and multivariable logistic regression analysis was conducted to identify the factors associated with APOs. RESULTS: A total of 5728 pregnancy episodes were included, comprising 4576 delivery episodes and 1152 APO episodes. The mean maternal age for all pregnancy episodes was 33.7 years; 33.3 years in the delivery group and 33.7 years in the APO group. Hydroxychloroquine was the most commonly used conventional synthetic disease-modifying antirheumatic drug (DMARD) during the preconception period and pregnancy in both groups. The prescription rate of all DMARDs decreased rapidly during pregnancy. In the multivariable analysis, use of methotrexate (adjusted OR (aOR): 2.14, 95% CI 1.57 to 2.92) and leflunomide (aOR: 2.68, 95% CI 1.39 to 5.15) within 3 months before conception was associated with APOs. CONCLUSION: Methotrexate and leflunomide are associated with an increased possibility of APOs, emphasising the importance of appropriate medication adjustment when planning for pregnancy.
Asunto(s)
Antirreumáticos , Artritis Reumatoide , Embarazo , Humanos , Femenino , Metotrexato/uso terapéutico , Leflunamida/uso terapéutico , Resultado del Embarazo/epidemiología , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Antirreumáticos/efectos adversosRESUMEN
BACKGROUND: There are limited population-based data on the role of mental disorders in adolescent pregnancy, despite the presence of mental disorders that may affect adolescents' desires and decisions to become pregnant. OBJECTIVE: This study aimed to examine the relationship between specific types of mental disorders and pregnancy rates and outcome types among adolescents aged 13-19 years, using single-year age groups. METHODS: We conducted a retrospective cohort study using data from the Merative™ MarketScan Research Databases. The study population consisted of females aged 13-19 years with continuous insurance enrollment for three consecutive calendar years between 2005 and 2015. Pregnancy incidence rates were calculated both overall and within the different categories of mental disorders. The presence of mental disorders, identified through diagnosis codes, was classified into 15 categories. Pregnancy and pregnancy outcome types were determined using diagnosis and procedure codes indicating the pregnancy status or outcome. To address potential over- or underestimations of mental disorder-specific pregnancy rates resulting from variations in age distribution across different mental disorder types, we applied age standardization using 2010 U.S. Census data. Finally, multivariable logistic regression models were used to examine the relationships between 15 specific types of mental disorders and pregnancy incidence rates, stratified by age. RESULTS: The age-standardized pregnancy rate among adolescents diagnosed with at least one mental disorder was 15.4 per 1,000 person-years, compared to 8.5 per 1,000 person-years among adolescents without a mental disorder diagnosis. Compared to pregnant adolescents without a mental disorder diagnosis, those with a mental disorder diagnosis had a slightly but significantly higher abortion rate (26.7% vs 23.8%, P-value < 0.001). Multivariable logistic regression models showed that substance use-related disorders had the highest odds ratios (ORs) for pregnancy incidence, ranging from 2.4 [95% confidence interval (CI): 2.1-2.7] to 4.5 [95% CI:2.1-9.5] across different age groups. Overall, bipolar disorders (OR range: 1.6 [95% CI:1.4-1.9]- 1.8 [95% CI: 1.7-2.0]), depressive disorders (OR range: 1.4 [95% CI: 1.3-1.5]- 2.7 [95% CI: 2.3-3.1]), alcohol-related disorders (OR range: 1.2 [95% CI: 1.1-1.4]- 14.5 [95% CI: 1.2-178.6]), and attention-deficit/conduct/disruptive behavior disorders (OR range: 1.1 [95% CI: 1.0-1.1]- 1.8 [95% CI: 1.1-3.0]) were also significantly associated with adolescent pregnancy, compared to adolescents without diagnosed mental disorders of the same age. CONCLUSION: This study emphasizes the elevated rates of pregnancy and pregnancy ending in abortion among adolescents diagnosed with mental disorders, and identifies the particular mental disorders associated with higher pregnancy rates.
Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad , Trastornos Mentales , Trastornos Relacionados con Sustancias , Femenino , Humanos , Adolescente , Embarazo , Índice de Embarazo , Estudios Retrospectivos , Resultado del Embarazo/epidemiología , Trastornos Mentales/epidemiologíaRESUMEN
BACKGROUND: Hypersensitivity pneumonitis (HP) is a condition with an uncertain global incidence, and information on its diagnosis and management is limited. This study aimed to address these knowledge gaps. METHODS: This study utilized customized claims data from the Health Insurance Review and Assessment Service (HIRA) in South Korea from January 2010, to December 2021. Patients with HP were identified based on the diagnosis code (International Classification of Diseases, 10th Revision, J67) between 2011 and 2020. Incident HP cases were defined as new HP claims, excluding those with claims in the previous year. The study examined various factors such as age, sex, comorbidities, diagnostic methods, and treatment patterns. Additionally, multivariate logistic regression analysis was performed to identify risk factors associated with treatment initiation. RESULTS: A total of 8,678 HP incident cases were confirmed, with age- and sex-adjusted annual incidence rates ranging from 1.14/100,000 in 2020 to 2.16/100,000 in 2012. The mean age of patients with incident HP was 52 years, with a higher incidence observed among males. Additionally, the most common comorbidity was asthma. Bronchoscopy was performed on 16.9% of patients, and 25.4% of patients did not receive treatment within 1 year of diagnosis. Among those who received treatment, prednisone was the most used systemic steroid, and azathioprine was the most commonly used second-line immunosuppressant. Factors associated with treatment initiation included the female sex, having asthma or gastroesophageal reflux disease (GERD), and undergoing bronchoscopy. CONCLUSION: This study provides valuable insights into the incidence, diagnosis, and treatment patterns of HP in South Korea using nationwide medical claims data.
Asunto(s)
Alveolitis Alérgica Extrínseca , Asma , Masculino , Humanos , Femenino , Persona de Mediana Edad , Alveolitis Alérgica Extrínseca/diagnóstico , Alveolitis Alérgica Extrínseca/tratamiento farmacológico , Alveolitis Alérgica Extrínseca/epidemiología , República de Corea/epidemiología , Incidencia , Comorbilidad , Asma/diagnóstico , Asma/tratamiento farmacológico , Asma/epidemiologíaRESUMEN
OBJECTIVES: This study developed an algorithm for identifying pregnancy episodes and estimating the last menstrual period (LMP) in an administrative claims database and applied it to investigate the use of pregnancy-incompatible immunosuppressants among pregnant women with systemic lupus erythematosus (SLE). METHODS: An algorithm was developed and applied to a nationwide claims database in Korea. Pregnancy episodes were identified using a hierarchy of pregnancy outcomes and clinically plausible periods for subsequent episodes. The LMP was estimated using preterm delivery, sonography, and abortion procedure codes. Otherwise, outcome-specific estimates were applied, assigning a fixed gestational age to the corresponding pregnancy outcome. The algorithm was used to examine the prevalence of pregnancies and utilization of pregnancy-incompatible immunosuppressants (cyclophosphamide [CYC]/mycophenolate mofetil [MMF]/methotrexate [MTX]) and non-steroidal anti-inflammatory drugs (NSAIDs) during pregnancy in SLE patients. RESULTS: The pregnancy outcomes identified in SLE patients included live births (67%), stillbirths (2%), and abortions (31%). The LMP was mostly estimated with outcome-specific estimates for full-term births (92.3%) and using sonography procedure codes (54.7%) and preterm delivery diagnosis codes (37.9%) for preterm births. The use of CYC/MMF/MTX decreased from 7.6% during preconception to 0.2% at the end of pregnancy. CYC/MMF/MTX use was observed in 3.6% of women within 3 months preconception and 2.5% during 0-7 weeks of pregnancy. CONCLUSIONS: This study presents the first pregnancy algorithm using a Korean administrative claims database. Although further validation is necessary, this study provides a foundation for evaluating the safety of medications during pregnancy using secondary databases in Korea, especially for rare diseases.
Asunto(s)
Lupus Eritematoso Sistémico , Nacimiento Prematuro , Recién Nacido , Embarazo , Humanos , Femenino , Nacimiento Prematuro/inducido químicamente , Nacimiento Prematuro/tratamiento farmacológico , Resultado del Embarazo , Inmunosupresores/uso terapéutico , Ciclofosfamida/efectos adversos , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/tratamiento farmacológico , Lupus Eritematoso Sistémico/epidemiología , Ácido Micofenólico/uso terapéutico , República de CoreaRESUMEN
To determine the increased risk of major adverse cardiovascular events (MACE) in patients with systemic lupus erythematosus (SLE) compared to the general population in Korea. Using data from the National Health Insurance Service database spanning 2008 to 2018, incident SLE patients aged 18 years and above were selected along with a 1:4 age- and sex-matched control group. The crude incidence rate (IR) of MACE was calculated as the number of events per 1000 person-years and the IR ratio (IRR) for MACE was adjusted using generalized estimating equations. Subgroup analysis was conducted to evaluate the risk differences of overall MACE and its composites based on age and sex stratification. The study included 8568 SLE patients and 34,272 controls. The cumulative IR of MACE per 1000 person-years in SLE patients and controls were 4.08 and 1.30, respectively. After adjusting for confounders, SLE patients had a higher risk of MACE compared to the general population (adjusted IRR of 2.40 [95% confidence interval [CI] 1.88-3.05]), with no gender differences observed. The increased risk of MACE in SLE patients was highest in the 18-39 age group (IRR 11.70, 95% CI 5.95-23.01) and gradually decreased with age. The increased risk of ischemic stroke (IRR 2.41, 95% CI 1.84-3.15) and myocardial infarction (IRR 2.19, 95% CI 1.30-3.68) in SLE patients was comparable. The risk of MACE in SLE patients is 2.40 times higher than that of the general population, with a higher relative risk observed in younger individuals.
Asunto(s)
Enfermedades Cardiovasculares , Lupus Eritematoso Sistémico , Humanos , Adolescente , Adulto Joven , Adulto , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Estudios de Cohortes , Factores de Riesgo , Incidencia , Factores de Riesgo de Enfermedad Cardiaca , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/epidemiología , República de Corea/epidemiologíaRESUMEN
There are studies on the effect of low-dose amitriptyline on pain control, but there is a lack of studies on the use of amitriptyline for chronic pain and the factors associated with the prescription of traditional doses. We used a national sample cohort of patients agedâ ≥â 18 years who were prescribed amitriptyline along with chronic pain, without psychiatric disorders, between 2002 to 2015. We categorized the prescriptions into 2 groups according to the daily dose: low doses (≤25 mg) and traditional doses (>25 mg). Multivariable logistic regression models were used to identify factors associated with traditional dose prescriptions. Among 177,769 prescriptions for amitriptyline, 15,119 (8.5%) were prescribed for chronic pain. The prevalence of prescriptions and proportion of traditional doses of amitriptyline tended to decrease during the study period. Male sex (odds ratio [OR] 1.09, 95% confidence interval [CI] 1.05-1.13); age 65-80 years (OR 1.12, 95% CI 1.08-1.16), especiallyâ ≥â 80 years (OR 1.55, 95% CI 1.45-1.65); headaches (OR 1.18, 95% CI 1.10-1.27), receiving medical aids (OR 2.58, 95% CI 2.46-2.71); and being prescribed benzodiazepines or zolpidem concomitantly (OR 1.10, 95% CI 1.06-1.15) were significantly associated with traditional dose prescriptions of amitriptyline. Although traditional dose prescriptions of amitriptyline have been declining, close monitoring is still required in the presence of the above-mentioned factors.
Asunto(s)
Amitriptilina , Dolor Crónico , Humanos , Masculino , Estudios Transversales , Amitriptilina/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Benzodiazepinas , CefaleaRESUMEN
BACKGROUND: Using statins in combination with other drugs was reported to increase the risk of myopathy. However, there was a sparse number of studies on the incidence of adverse events (AEs) associated with the concomitant use of statin and contraindicated drugs in the real world. OBJECTIVES: This study aimed to identify the risk of concomitant use of statins with contraindicated drugs by exploring signals related to statin-drug interactions. METHODS: We performed a disproportionality analysis for drugs and AEs by applying the case/non-case study using the KIDS-KAERS database (KIDS-KD), 2016-2020. A case was defined as an individual case safety reports (ICSRs) including "rhabdomyolysis/myopathy." A non-case was defined as an ICSR, including all other AEs. We applied Ω shrinkage measure model, chi-square statics model, additive model, multiplicative model, and combination risk ratio model to detect signals of myopathy due to statin with concomitant drugs including antiviral agents, immunosuppressants, and antifungals. RESULTS: Among 1 011 234 ICSRs, 2708 were cases, with 861 cases of statin monotherapy and 1248 of concomitant uses of statin. The adjusted reporting odds ratios were 3.27 (95% confidence interval [CI]: 3.11-3.43), 8.70 (95% CI: 8.04-9.40), and 1.83 (95% CI: 1.73-1.94), respectively. Several combinations of signals were detected through an additive model or multiplicative model. CONCLUSION: Signals of an increased risk of myopathy associated with the use of statins with concomitant drugs, including contraindicated drugs, were confirmed in a real-world setting.
Asunto(s)
Inhibidores de Hidroximetilglutaril-CoA Reductasas , Enfermedades Musculares , Rabdomiólisis , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Enfermedades Musculares/inducido químicamente , Enfermedades Musculares/diagnóstico , Enfermedades Musculares/epidemiología , Rabdomiólisis/inducido químicamente , Rabdomiólisis/diagnóstico , Rabdomiólisis/epidemiología , Interacciones FarmacológicasRESUMEN
BACKGROUND/AIMS: Chronic obstructive pulmonary disease (COPD) is less prevalent in females than males, but it affects mortality in females. There may be sex differences in the clinical characteristics of COPD. METHODS: We analyzed the Korea National Health and Nutrition Examination Survey dataset from 2007 to 2018. We compared the clinical characteristics and comorbidities in subjects with COPD according to sex. We adjusted the multivariate logistic regression of lung cancer prevalence according to COPD and sex by age and smoking amount. RESULTS: Females with COPD tended to be older than males with COPD (64.1 ± 0.4 yr vs. 62.3 ± 0.2 yr, respectively, p < 0.001). Approximately 89% of males with COPD had a smoking history, while 86% of females with COPD were non-smokers (p < 0.001). Household income was lower (p < 0.001) and asthma and overall malignancy were more prevalent in females with COPD than males with COPD (25.5 vs. 11.6%, respectively, p < 0.001; (6.3 vs. 5.4%, respectively, p < 0.001). However, lung cancer was more common in males with COPD than females with COPD (0.9 vs. 0.1%, respectively, p < 0.001). Lung cancer prevalence increased in males with moderate COPD compared to subjects without COPD (OR, 4.409; 95% CI, 1.741-9.419). CONCLUSION: Females with COPD had a lower smoking rate, household income, and lung cancer prevalence than males with COPD. More active COPD screening is needed for women of low socioeconomic status, even if they do not smoke.
Asunto(s)
Neoplasias Pulmonares , Enfermedad Pulmonar Obstructiva Crónica , Femenino , Humanos , Masculino , Encuestas Nutricionales , Caracteres Sexuales , Factores de Riesgo , Factores Sexuales , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Neoplasias Pulmonares/epidemiología , República de Corea/epidemiología , PrevalenciaRESUMEN
BACKGROUND AND OBJECTIVE: Despite several case reports, population-based studies on interstitial lung disease (ILD) following COVID-19 vaccination are lacking. Given the unprecedented safety issue of COVID-19 vaccination, it is important to assess the worldwide patterns of ILD following COVID-19 vaccination. This study aimed to investigate the signals of COVID-19 vaccine-associated ILD compared with other vaccinations using disproportionality analysis. METHODS: We analysed the VigiBase database during the period between 13 December 2020 and 26 January 2023. We adopted the case/non-case approach to assess the disproportionality signal of ILD for COVID-19 vaccines via 1:10 matching by age and sex. We compared COVID-19 vaccines with all other vaccines as the reference group. RESULTS: Among 1 233 969 vaccine-related reports, 679 were reported for ILD. The majority of ILD cases were related to tozinameran (376 reports, 55.4%), Vaxzevria (129 reports, 19.0%) and elasomeran (78 reports, 11.5%). The reporting OR of ILD following COVID-19 vaccination was 0.86 (95% CI 0.64 to 1.15) compared with all other vaccines. CONCLUSION: No significant signal of disproportionate reporting of ILD was observed for COVID-19 vaccines compared with all other vaccines. Moreover, when compared with the influenza vaccines that are known to cause ILD, no signal was observed. This study results might help decision-making on the subsequent COVID-19 vaccination strategy of ILD. Further large and prospective studies are required for more conclusive evidence.
Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Vacunas contra la Influenza , Enfermedades Pulmonares Intersticiales , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la Influenza/efectos adversos , Enfermedades Pulmonares Intersticiales/inducido químicamente , Enfermedades Pulmonares Intersticiales/epidemiología , Farmacovigilancia , Vacunación/efectos adversosRESUMEN
OBJECTIVES: To estimate the direct healthcare cost progression from before to after systemic lupus erythematosus (SLE) diagnosis and to compare healthcare costs by disease severity. METHODS: Patients with incident SLE diagnosed between 2008 and 2018 were identified from the Korean National Health Insurance database. Annual direct healthcare costs for 5 years before and after SLE were estimated and compared with those of age-, sex-, and calendar month-matched (1:4) controls, without SLE. Direct healthcare costs were compared by disease severity of SLE using regression analysis. RESULTS: Among 11 173 patients with SLE and 45 500 subjects without SLE, annual direct healthcare costs per person increased in the year before SLE diagnosis and peaked in the first year after diagnosis. They were 7.7-fold greater in the SLE patients than in the subjects without SLE ($5,871 vs $759). Severe SLE was associated with 3.284-fold (95% CI 3.075-3.507) higher annual costs than mild SLE during the year after diagnosis. Older age (age 60-79 years), lupus nephritis, interstitial lung diseases, and comorbidities such as avascular necrosis and chronic kidney disease were associated with higher annual direct healthcare costs (times [95% CI]) in the first year after diagnosis; aged 60-69, 1.119 [1.034-1.211], aged 70-79, 1.470 [1.342-1.611], 1.794 [1.711-1.881], 1.435 [1.258-1.638], 6.208 [4.541-8.487], and 1.858 [1.673-2.064], respectively. CONCLUSION: Patients with SLE incurred significantly high direct healthcare costs than subjects without SLE during the first year after diagnosis. Disease severity, older age, major organ involvements and comorbidities were associated with increased healthcare costs.
RESUMEN
OBJECTIVE: To compare the risk of end-stage renal disease (ESRD) between patients with early-onset lupus nephritis (EOLN) and those with delayed-onset LN (DOLN). METHODS: This retrospective study of incident cases of systemic lupus erythematosus (SLE) used nationwide Korean claims databases and data from 2008 through 2018. We divided LN patients into two groups: the EOLN group (with LN onset within 12 months of SLE diagnoses) and the DOLN group (with LN onset later than 12 months after SLE diagnoses). Patients were observed from the date of LN diagnosis to the development of ESRD, death, or the last follow-up. Cox proportional hazards modeling was used to predict hazard ratios (HRs) for progression to ESRD with death as a competing risk. RESULTS: We identified 3779 incident SLE patients who developed LN during follow-up: 60 % (n = 2281) had EOLN, and 40 % (n = 1489) had DOLN. Sixty-nine patients with EOLN (3.0 %) and 29 patients with DOLN (1.9 %) progressed to ESRD. After adjusting for confounders, the ESRD risk associated with EOLN was comparable to the risk associated with DOLN (HR 1.10, 95 % confidence interval [CI] 0.57 to 2.11). In the subgroup of patients on aggressive immunosuppressive therapy (670 with EOLN and 179 with DOLN), the ESRD risk was higher in the DOLN group (HR 2.6, 95 % CI 1.11 to 6.10). CONCLUSION: The risk of ESRD was comparable between patients with EOLN and DOLN. However, among patients on aggressive immunosuppressive therapy, compared with EOLN, DOLN was associated with a higher risk of progression to ESRD.
Asunto(s)
Fallo Renal Crónico , Lupus Eritematoso Sistémico , Nefritis Lúpica , Humanos , Nefritis Lúpica/complicaciones , Nefritis Lúpica/epidemiología , Nefritis Lúpica/diagnóstico , Estudios Retrospectivos , Estudios de Cohortes , Fallo Renal Crónico/epidemiología , Fallo Renal Crónico/etiología , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/epidemiología , Lupus Eritematoso Sistémico/diagnósticoRESUMEN
BACKGROUND: Previous studies that assessed the risk of cardiovascular outcomes in survivors of coronavirus disease 2019 (COVID-19) were likely limited by lack of generalizability and selection of controls nonrepresentative of a counterfactual situation regarding COVID-19-related hospitalization. This study determined whether COVID-19 hospitalization was associated with incident cardiovascular outcomes compared to non-COVID-19 pneumonia hospitalization. METHODS: Nationwide population-based study conducted using the Korean National Health Insurance Service database. A cohort of 132,784 inpatients with COVID-19 (October 8, 2020-September 30, 2021) and a cohort of 31,173 inpatients with non-COVID-19 pneumonia (January 1-December 31, 2019) were included. The primary outcome was the major adverse cardiovascular event (MACE; a composite of myocardial infarction and stroke). Hazard ratios (HRs) with 95% confidence intervals (CIs) of all outcomes of interest were estimated between inverse probability of treatment-weighted patients with COVID-19 and non-COVID-19 pneumonia. RESULTS: After weighting, the COVID-19 and non-COVID-19 pneumonia groups included 125,810 (mean [SD] age, 47.2 [17.6] years; men, 49.3%) and 28,492 patients (mean [SD] age, 48.6 [18.4] years; men, 47.2%), respectively. COVID-19 hospitalization was not associated with an increased risk of the MACE (HR, 0.84; 95% CI 0.69-1.03). However, the MACE (HR, 7.30; 95% CI 3.29-16.21), dysrhythmia (HR, 1.88; 95% CI 1.04-3.42), acute myocarditis (HR, 11.33; 95% CI 2.97-43.20), myocardial infarction (HR, 6.78; 95% CI 3.03-15.15), congestive heart failure (HR, 1.95; 95% CI 1.37-2.77), and thrombotic disease (HR, 8.26; 95% CI 4.06-16.83) risks were significantly higher in patients with COVID-19 aged 18-39 years. The findings were consistent after adjustment for preexisting cardiovascular disease. COVID-19 hospitalization conferred a higher risk of acute myocarditis (HR, 6.47; 95% CI 2.53-16.52) or deep vein thrombosis (HR, 1.97; 95% CI 1.38-2.80), regardless of vaccination status. CONCLUSIONS: Hospitalized patients with COVID-19 were not at an increased risk of cardiovascular outcomes compared to patients with non-COVID-19 pneumonia. Further studies are needed to evaluate whether the increased risk of cardiovascular outcomes is confined to younger patients.
Asunto(s)
COVID-19 , Enfermedades Cardiovasculares , Infarto del Miocardio , Miocarditis , Neumonía , Masculino , Humanos , Persona de Mediana Edad , Estudios de Cohortes , Miocarditis/complicaciones , Factores de Riesgo , COVID-19/complicaciones , COVID-19/epidemiología , Enfermedades Cardiovasculares/etiología , Infarto del Miocardio/epidemiología , Infarto del Miocardio/complicacionesRESUMEN
BACKGROUND: The lack of well-established operational definitions is a major limitation of Helicobacter pylori eradication studies that use secondary databases. We aimed to develop and validate operational definitions related to H. pylori eradication therapy. METHODS: Operational definitions were developed by analyzing a nationwide H. pylori eradication registry and validated using real-world data from hospital medical records. The primary endpoint was the sensitivity of the operational definitions in identifying individuals who received H. pylori eradication therapy. The secondary endpoint was the sensitivity and specificity of the operational definition in identifying successful H. pylori eradication therapy. RESULTS: H. pylori eradication therapy was defined as a prescription for one of the following combinations: 1) proton pump inhibitor (PPI) + amoxicillin + clarithromycin, 2) PPI + amoxicillin + metronidazole, 3) PPI + metronidazole + tetracycline, 4) PPI + amoxicillin + levofloxacin, 5) PPI + amoxicillin + moxifloxacin, or 6) PPI + amoxicillin + rifabutin. In the validation set, the sensitivity of the operational definition for identifying individuals who received H. pylori eradication therapy was 99.7% and 99.8% for the first- and second-line therapies, respectively. Operational definition to determine success or failure of the H. pylori eradication therapy was developed based on a confirmatory test and the prescription of rescue therapy. The sensitivity and specificity of the operational definition for predicting successful eradication were 97.6% and 91.4%, respectively, in first-line therapy and 98.6% and 54.8%, respectively, in second-line therapy. CONCLUSION: We developed and validated operational definitions related to H. pylori eradication therapy. These definitions will help researchers perform various H. pylori eradication-related studies using secondary databases.
Asunto(s)
Helicobacter pylori , Humanos , Metronidazol/uso terapéutico , Proyectos de Investigación , Antibacterianos/uso terapéutico , Amoxicilina/uso terapéutico , Inhibidores de la Bomba de Protones/uso terapéuticoRESUMEN
Development of highly efficient and robust electrocatalysts for oxygen evolution reaction (OER) under specific electrolyte is a key to actualize commercial low-temperature water electrolyzers. Herein, a rational catalyst design strategy is first reported based on amorphous-crystalline (a-c) interfacial engineering to achieve high catalytic activity and durability under diverse electrolytes that can be used for all types of low-temperature water electrolysis. Abundant a-c interface (ACI) is implemented into a hollow nanocubic (pre)-electrocatalyst which is derived from Ir-doped Ni-Fe-Zn Prussian blue analogues (PBA). The implemented c-a interface is well maintained during prolonged OER in alkaline, alkalized saline, and acidic electrolytes demonstrating its diverse functionality for water electrolysis. Notably, the final catalyst exhibits superior catalytic activity with excellent durability for OER compared to that of benchmark IrO2 catalyst, regardless of chemical environment of electrolytes. Hence, this work can be an instructive guidance for developing the ACI engineered electroctalyst which can be diversely used for different types of low-temperature electrolyzers.