Real-World Treatment Intensity and Patterns in Patients With Myopic Choroidal Neovascularization: Common Data Model in Ophthalmology.

BACKGROUND: A paucity of data addressing real-world treatment of myopic choroidal neovascularization (mCNV) in the era of anti-vascular endothelial growth factor (VEGF) drugs led us to investigate real-world treatment intensity and treatment patterns in patients with mCNV. METHODS: This is a retrospective, observational study using the Observational Medical Outcomes Partnership-Common Data Model database of treatment-naïve patients with mCNV over the 18-year study period (2003-2020). Outcomes were treatment intensity (time trends of total/average number of prescriptions, mean number of prescriptions in the first year and the second year after initiating treatment, proportion of patients with no treatment in the second year) and treatment patterns (subsequent patterns of treatment according to the initial treatment). RESULTS: Our final cohort included 94 patients with at-least 1-year observation period. Overall, 96.8% of patients received anti-VEGF drugs as first-line treatment, with most of injections from bevacizumab. The number of anti-VEGF injections in each calendar year showed an increasing trend over time; however, there was a drop in the mean number of injections in the second year compared to the first year from 2.09 to 0.47. About 77% of patients did not receive any treatment in their second year of treatment regardless of drugs. Most of patients (86.2%) followed non-switching monotherapy only and bevacizumab was the most popular choice either in the first-line (68.1%) or in the second-line (53.8%) of treatment. Aflibercept was increasingly used as the first-line treatment for patients with mCNV. CONCLUSION: Anti-VEGF drugs have become the treatment of choice and second-line treatment for mCNV over the past decade. Anti-VEGF drugs are effective for the treatment of mCNV as the non-switching monotherapy is the main treatment regimen in most cases and the number of treatments decreases significantly in the second year of treatment.

Post-operative alarm signs in the rapid response system and hospital mortality after non-cardiac surgery.

BACKGROUND: A variety of rapid response systems (RRSs) based on the systematic assessment of vital signs and laboratory tests have been developed to reduce hospital mortality through the early detection of alarm signs, while deterioration may still be reversible. This study aimed to determine the association between alarm signs and post-operative hospital mortality during post-operative days (POD) 0-3 in patients undergoing non-cardiac surgery. METHODS: This retrospective observational study used data from the registry of a single tertiary academic hospital. The study population included patients who were ≥18 years old, admitted between 1 January 2013 and 30 June 2018 for non-cardiac surgery, and subsequently transferred to the general ward. RESULTS: A total of 116 329 patients were included in the analysis. Among them, 10 099 patients (8.7%) showed positive alarm criteria and triggered the RRS in the post-operative ward during POD 0-3. In the multivariate logistic regression model, PaO2 <55 mm Hg, SpO2 <90%, and total CO2 <15 mmol/L were associated with a 3.57-, 3.46-, and 12.53-fold increase in post-operative hospital mortality, respectively. Moreover, when compared to the no alarm signs group, patients with 1, 2, 3, and ≥4 alarm signs showed a 2.79-, 2.76-, 6.54-, and 20.02-fold increase in hospital mortality, respectively. CONCLUSION: Increased post-operative hospital mortality was found to be associated with alarm signs detected by the RRS during POD 0-3. The post-operative alarm signs detected by the RRS may therefore be useful in determining high-risk patients who require medical interventions in the surgical ward.

Nationwide incidence of congenital and infantile cataract requiring surgery in Korea.

Congenital and infantile (CI) cataract is one of the most important and preventable cause of blindness in children, but the incidence has not been studied in Korea. We collected data from the national claims database of the National Health Insurance Service of Korea from 2002 through 2019. We identified children who underwent cataract surgery within the age of 5 years, and cumulative incidence rates were calculated for each of the three age criteria. 989 patients out of 4,221,459 births underwent surgery with CI cataract during the period. The cumulative incidence rates per 10,000 births were 1.60 (0-1 years), 2.38 (0-3 years), and 2.95 (0-5 years), respectively. The incidence peaked in the 2007 birth cohort, which coincides with the start of the national screening program for infants/children. Primary intraocular lens implantation was performed in 439 patients (44%). Strabismus and glaucoma requiring surgery occurred in 291 patients (29.4%) and 32 patients (3.2%), respectively, within 8 years after cataract surgery. The incidence rates of CI cataract in Korea appear to be comparable to previous studies in other regions. The early screening program for infants may reduce delayed diagnosis and increase the proportion of patients undergoing surgery at a critical time for visual development.

Multi-Institutional Collaborative Research Using Ophthalmic Medical Image Data Standardized by Radiology Common Data Model (R-CDM).

Observational Medical Outcome Partners - Common Data Model (OMOP-CDM) is an international standard model for standardizing electronic medical record data. However, unstructured data such as medical image data which is beyond the scope of standardization by the current OMOP-CDM is difficult to be used in multi-institutional collaborative research. Therefore, we developed the Radiology-CDM (R-CDM) which standardizes medical imaging data. As a proof of concept, 737,500 Optical Coherence Tomography (OCT) data from two tertiary hospitals in South Korea is standardized in the form of R-CDM. The relationship between chronic disease and retinal thickness was analyzed by using the R-CDM. Central macular thickness and retinal nerve fiber layer (RNFL) thickness were significantly thinner in the patients with hypertension compared to the control cohort. It is meaningful in that multi-institutional collaborative research using medical image data and clinical data simultaneously can be conducted very efficiently.

Patient-Centered Economic Burden of Exudative Age-Related Macular Degeneration: Retrospective Cohort Study.

BACKGROUND: Exudative age-related macular degeneration (AMD), one of the leading causes of blindness, requires expensive drugs such as anti-vascular endothelial growth factor (VEGF) agents. The long-term regular use of effective but expensive drugs causes an economic burden for patients with exudative AMD. However, there are no studies on the long-term patient-centered economic burden of exudative AMD after reimbursement of anti-VEGFs. OBJECTIVE: This study aimed to evaluate the patient-centered economic burden of exudative AMD for 2 years, including nonreimbursement and out-of-pocket costs, compared with nonexudative AMD using the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). METHODS: This retrospective cohort study was conducted using the OMOP CDM, which included 2,006,478 patients who visited Seoul National University Bundang Hospital from June 2003 to July 2019. We defined the exudative AMD group as patients aged >50 years with a diagnosis of exudative AMD and a prescription for anti-VEGFs or verteporfin. The control group was defined as patients aged >50 years without a diagnosis of exudative AMD or a prescription for anti-VEGFs or verteporfin. To adjust for selection bias, controls were matched by propensity scores using regularized logistic regression with a Laplace prior. We measured any medical cost occurring in the hospital as the economic burden of exudative AMD during a 2-year follow-up period using 4 categories: total medical cost, reimbursement cost, nonreimbursement cost, and out-of-pocket cost. To estimate the average cost by adjusting the confounding variable and overcoming the positive skewness of costs, we used an exponential conditional model with a generalized linear model. RESULTS: We identified 931 patients with exudative AMD and matched 783 (84.1%) with 2918 patients with nonexudative AMD. In the exponential conditional model, the total medical, reimbursement, nonreimbursement, and out-of-pocket incremental costs were estimated at US $3426, US $3130, US $366, and US $561, respectively, in the first year and US $1829, US $1461, US $373, and US $507, respectively, in the second year. All incremental costs in the exudative AMD group were 1.89 to 4.25 and 3.50 to 5.09 times higher in the first and second year, respectively, than those in the control group (P<.001 in all cases). CONCLUSIONS: Exudative AMD had a significantly greater economic impact (P<.001) for 2 years on reimbursement, nonreimbursement, and out-of-pocket costs than nonexudative AMD after adjusting for baseline demographic and clinical characteristics using the OMOP CDM. Although economic policies could relieve the economic burden of patients with exudative AMD over time, the out-of-pocket cost of exudative AMD was still higher than that of nonexudative AMD for 2 years. Our findings support the need for expanding reimbursement strategies for patients with exudative AMD given the significant economic burden faced by patients with incurable and fatal diseases both in South Korea and worldwide.

Incidence of preventable cardiopulmonary arrest in a mature part-time rapid response system: A prospective cohort study.

BACKGROUND: The purpose of a rapid response system (RRS) is to reduce the incidence of preventable cardiopulmonary arrests (CPAs) and patient deterioration in general wards. The objective of this study is to investigate the incidence and temporal trends of preventable CPAs and determine factors associated with preventable CPAs in a hospital with a mature RRS. METHODS: This was a single-center prospective cohort study of all CPAs occurring in the general ward between March 2017 and June 2020. The RRS operates from 07:00 to 23:00 on weekdays and from 07:00 to 12:00 on Saturdays. All CPAs were reviewed upon biweekly conference, and a panel of intensivists judged their preventability. Trends of preventable CPAs were analyzed using Poisson regression models and factors associated with preventable CPAs were analyzed using multivariable logistic regression. RESULTS: There were 253 CPAs over 40 months, and 64 (25.3%) of these were preventable. The incidence rate of CPAs was 1.07 per 1000 admissions and that of preventable CPAs was 0.27 per 1000 admissions. The number of preventable CPAs decreased by 24% each year (incidence rate ratio = 0.76; p = 0.039) without a change in the total CPA incidence. The most common contributor to the preventability was delayed response from physicians (n = 41, 64.1%). A predictable CPA with a pre-alarm sign had increased odds in the occurrence of preventable CPAs, while a cardiac cause of CPAs and RRS operating hours had decreased odds in terms of occurrence of preventable CPA. CONCLUSION: Our study showed that one-fourth of all CPAs occurring in the general wards were preventable, and these arrests decreased each year. A mature RRS can evolve to reduce preventable CPAs with regular self-evaluation. Efforts should be directed at improving physicians' response time since a delay in their response was the most common cause of preventable CPAs.

Real-world treatment intensities and pathways of macular edema following retinal vein occlusion in Korea from Common Data Model in ophthalmology.

Despite many studies, optimal treatment sequences or intervals are still questionable in retinal vein occlusion (RVO) macular edema. The aim of this study was to examine the real-world treatment patterns of RVO macular edema. A retrospective analysis of the Observational Medical Outcomes Partnership Common Data Model, a distributed research network, of four large tertiary referral centers (n = 9,202,032) identified 3286 eligible. We visualized treatment pathways (prescription volume and treatment sequence) with sunburst and Sankey diagrams. We calculated the average number of intravitreal injections per patient in the first and second years to evaluate the treatment intensities. Bevacizumab was the most popular first-line drug (80.9%), followed by triamcinolone (15.1%) and dexamethasone (2.28%). Triamcinolone was the most popular drug (8.88%), followed by dexamethasone (6.08%) in patients who began treatment with anti-vascular endothelial growth factor (VEGF) agents. The average number of all intravitreal injections per person decreased in the second year compared with the first year. The average number of injections per person in the first year increased throughout the study. Bevacizumab was the most popular first-line drug and steroids were considered the most common as second-line drugs in patients first treated with anti-VEGF agents. Intensive treatment patterns may cause an increase in intravitreal injections.

Statin use and pneumonia risk in Parkinson's disease.

INTRODUCTION: Previous studies reported that statin use was related to a lower risk of pneumonia in the general population. This study investigated the association between statin use and pneumonia risk in patients with Parkinson's disease (PD). METHODS: Patients that had been newly diagnosed with PD between 2004 and 2006 in the 2002-2017 National Health Insurance Service database in South Korea were identified. PD patients who had received one or more statin prescriptions, and experienced pneumonia during the observation period were included in the self-controlled case series (SCCS) analysis. Patients who had no previous statin prescription record were included in the Cox proportional hazard model with a time-varying covariate (statin use). The risk of pneumonia in PD patients with statin use was estimated after adjusting potential confounders. RESULTS: Of the 10,159 patients with PD, 337 individuals were eligible for the SCCS analysis. The median duration of statin exposure was 2.63 years (IQR, 0.83-5.83). The incidence of pneumonia was reduced in the statin-exposed period compared to the unexposed period (incidence rate ratio, 0.88; 95% CI, 0.86-0.91). A total of 8,022 patients were included in the Cox proportional hazard model. Statin use was related to a significantly reduced pneumonia risk (adjusted hazard ratio, 0.69; 95% CI, 0.62-0.78). CONCLUSIONS: Statin use was associated with a lower risk of pneumonia in PD patients. Statins might affect pneumonia occurrence by lowering cholesterol levels or slowing the progression of PD as neuroprotective agents. Further clinical studies are needed to delineate our findings with the underlying biological mechanisms.

Real-world incidence of endopthalmitis after intravitreal anti-VEGF injections in Korea: findings from the Common Data Model in ophthalmology.

OBJECTIVES: The aim of this study was to evaluate the real-world incidence of endophthalmitis after intravitreal anti-vascular endothelial growth factor (VEGF) injections using data from the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). METHODS: Patients with endophthalmitis that developed within 6 weeks after intravitreal anti-VEGF injections were identified in 3 large OMOP CDM databases. RESULTS: We identified 23,490 patients who received 128,123 intravitreal anti-VEGF injections. The incidence rates of endophthalmitis were 15.75 per 10,000 patients and 2.97 per 10,000 injections. The incidence rates of endophthalmitis for bevacizumab, ranibizumab, and aflibercept (per 10,000 injections) were 3.64, 1.39, and 0.76, respectively. The annual incidence has remained below 5.00 per 10,000 injections since 2011 despite the increasing number of intravitreal anti-VEGF injections. Bevacizumab presented a higher incidence rate for endophthalmitis than ranibizumab and aflibercept (incidence rate ratio, 3.17; p=0.021). CONCLUSIONS: The incidence of endophthalmitis after intravitreal anti-VEGF injections has stabilized since 2011 despite the explosive increase in anti-VEGF injections. The off-label use of bevacizumab accounted for its disproportionately high incidence of endophthalmitis. The OMOP CDM, which includes off-label uses, laboratory data, and a scalable standardized database, could provide a novel strategy to reveal real-world evidence, especially in ophthalmology.

Performance of patient acuity rating by rapid response team nurses for predicting short-term prognosis.

BACKGROUND: Although scoring and machine learning methods have been developed to predict patient deterioration, bedside assessment by nurses should not be overlooked. This study aimed to evaluate the performance of subjective bedside assessment of the patient by the rapid response team (RRT) nurses in predicting short-term patient deterioration. METHODS: Patients noticed by RRT nurses based on the vital sign instability, abnormal laboratory results, and direct contact via phone between November 1, 2016, and December 12, 2017, were included. Five RRT nurses visited the patients according to their shifts and assessed the possibility of patient deterioration. Patient acuity rating (PAR), a scale of 1-7, was used as the tool of bedside assessment. Other scores, including the modified early warning score, VitalPAC early warning score, standardised early warning score, and cardiac arrest risk triage, were calculated afterwards. The performance of these scores in predicting mortality and/or intensive care unit admission within 1 day was compared by calculating the area under the receiver operating curve. RESULTS: A total of 1,426 patients were included in the study, of which 258 (18.1%) died or were admitted to the intensive care unit within 1 day. The area under the receiver operating curve of PAR was 0.87 (95% confidence interval [CI] 0.84-0.89), which was higher than those of modified early warning score (0.66, 95% CI 0.62-0.70), VitalPAC early warning score (0.69, 95% CI 0.66-0.73), standardised early warning score (0.67, 95% CI 0.63-0.70) and cardiac arrest risk triage (0.63, 95% CI 0.59-0.66) (P<0.001). CONCLUSIONS: PAR assessed by RRT nurses can be a useful tool for assessing short-term patient prognosis in the RRT setting.