32 results on '"Chen, Evan M"'
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2. Geographic atrophy severity and mortality in age-related macular degeneration
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Ahluwalia, Aneesha, Shen, Liangbo L., Chen, Evan M., Sun, Mengyuan, Park, Michael M., Young, Benjamin K., and Del Priore, Lucian V.
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- 2021
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3. Epidemiologic trends of domestic violence–related ocular injuries among pediatric patients: data from the Nationwide Emergency Department Sample 2008-2017
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Andoh, Joana E., Miguez, Sofia, Andoh, Sarah E., Mehta, Sumarth, Mir, Tahreem A., Chen, Evan M., Jain, Srimathy, Teng, Christopher C., and Nwanyanwu, Kristen
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- 2023
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4. Ophthalmic Medication Expenditures and Out-of-Pocket Spending: An Analysis of United States Prescriptions from 2007 through 2016
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Chen, Evan M., Kombo, Ninani, Teng, Christopher C., Mruthyunjaya, Prithvi, Nwanyanwu, Kristen, and Parikh, Ravi
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- 2020
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5. Price transparency implementation: Accessibility of hospital chargemasters and variation in hospital pricing after CMS mandate
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Lu, Amanda J., Chen, Evan M., Vutam, Emily, Brandt, Jordan, and Sadda, Praneeth
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- 2020
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6. Private Equity in Ophthalmology and Optometry: Analysis of Acquisitions from 2012 through 2019 in the United States
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Chen, Evan M., Cox, Jacob T., Begaj, Tedi, Armstrong, Grayson W., Khurana, Rahul N., and Parikh, Ravi
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- 2020
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7. Domestic Violence-Related Ocular Injuries Among Adult Patients: Data from the Nationwide Emergency Department Sample, 2008–2017.
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Andoh, Joana E., Mehta, Sumarth K., Chen, Evan M., Mir, Tahreem A., Nwanyanwu, Kristen, and Teng, Christopher C.
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OCULAR injuries ,OLDER patients ,EMERGENCY room visits ,HOSPITAL emergency services ,MEDICAL care costs ,HOSPITAL admission & discharge ,CONSUMER price indexes ,PATIENT readmissions - Abstract
To investigate domestic violence (DV)-related ocular injuries among adult emergency department (ED) patients in the US. This was a retrospective, cross-sectional study of patients with a diagnosis of DV and diagnosis of ocular injury in the Nationwide Emergency Department Sample (NEDS) from 2008–2017. We identified patient- and hospital-level variables associated with DV-related ocular injuries. We calculated annual incidence rates using US Census data. Adjusting for inflation using the Consumer Price Index, we calculated mean and total charges. From 2008–2017, there were 26,215 ED visits for ocular injuries related to DV with an average incidence of 1.09 per 100,000 adult population (female patients, 84.5%; mean age [SE], 34.3 [0.2]). DV-related ocular injuries were most prevalent among patients in the lowest income quartile (39.1%) and on Medicaid (37.4%). Most ED visits presented to metropolitan teaching (55.4%), non-trauma (46.7%), and south regional (30.5%) hospitals. The most common ocular injury was contusion of eye/adnexa (61.1%). The hospital admission rate was 5.2% with a mean hospital stay of 2.9 [0.2]. The inflation-adjusted mean cost for medical services was $38,540 [2,310.8] per encounter with an average increase of $2,116 per encounter, annually. The likelihood of hospital admission increased for patients aged ≥60 years old, on Medicare, and with open globes or facial/orbital fractures (all p <.05). Contusion of the eye/adnexa was the most common ocular injury among patients with DV-related ED visits. To better facilitate referrals to social services, ophthalmologists should utilize DV screenings, especially towards women and patients of less privileged socioeconomic status. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Biodegradable PEG-poly(ω-pentadecalactone-co-p-dioxanone) nanoparticles for enhanced and sustained drug delivery to treat brain tumors
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Chen, Evan M., Quijano, Amanda R., Seo, Young-Eun, Jackson, Christopher, Josowitz, Alexander D., Noorbakhsh, Seth, Merlettini, Andrea, Sundaram, Ranjini K., Focarete, Maria Letizia, Jiang, Zhaozhong, Bindra, Ranjit S., and Saltzman, W. Mark
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- 2018
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9. COVID-19 and Utilization of Teleophthalmology: Trends and Diagnoses (CUT Group)
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Portney, David S., Zhu, Ziwei, Chen, Evan M., Steppe, Emma, Chilakamarri, Priyanka, Woodward, Maria A., Ellimoottil, Chad, and Parikh, Ravi
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Databases, Factual ,Eye Diseases ,SARS-CoV-2 ,COVID-19 ,Disease Management ,Article ,Telemedicine ,United States ,Ophthalmology ,Telehealth ,Video Visits ,Humans ,Teleophthalmology ,Delivery of Health Care - Abstract
Telehealth usage peaked at 17% of encounters (4/5-4/11/20) and then declined, accounting for 1.6% (2,031) of the 127,028 ophthalmic visits from 3/15/2020-9/1/2020. Telehealth was disproportionately used for visits related to cornea and external disease diagnoses.
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- 2021
10. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study.
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Dhodapkar, Meera M., Shi, Xiaoting, Ramachandran, Reshma, Chen, Evan M., Wallach, Joshua D., and Ross, Joseph S.
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CROSS-sectional method ,DRUG labeling ,DRUG side effects ,ELECTRONIC publications ,PATIENT safety - Published
- 2022
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11. The Effect of Sample Medication Use on Subsequent Anti-VEGF Agent Selection for Neovascular Age-Related Macular Degeneration.
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Wai, Karen M., Begaj, Tedi, Patil, Sachi, Chen, Evan M., Miller, John B., Kylstra, Jan, Aronow, Mary E., Young, Lucy H., Huckfeldt, Rachel, Husain, Deeba, Kim, Leo A., Vavvas, Demetrios G., Eliott, Dean, Mukai, Shizuo, Gragoudas, Evangelos S., Patel, Nimesh A., Sobrin, Lucia, Miller, Joan W., Parikh, Ravi, and Wu, David M.
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- 2022
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12. Economic Evaluation of the Merit-Based Incentive Payment System for Ophthalmologists: Analysis of 2019 Quality Payment Program Data.
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Berkowitz, Sean T., Siktberg, Jonathan, Gupta, Arulita, Portney, David, Chen, Evan M., Parikh, Ravi, Finn, Avni P., and Patel, Shriji
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- 2022
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13. Ophthalmic Medication Expenditures and Out-of-pocket Spending: An analysis of US prescriptions from 2007–2016
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Chen, Evan M., Kombo, Ninani, Teng, Christopher C., Mruthyunjaya, Prithvi, Nwanyanwu, Kristen, and Parikh, Ravi
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Adult ,Male ,Prescription Drugs ,Time Factors ,Adolescent ,Eye Diseases ,Middle Aged ,Drug Prescriptions ,Article ,United States ,Young Adult ,Cross-Sectional Studies ,Humans ,Female ,Health Expenditures ,Follow-Up Studies ,Retrospective Studies - Abstract
OBJECTIVE: To estimate temporal trends in total and out-of-pocket (OOP) expenditures for ophthalmic prescription medications among adults in the United States. DESIGN: A retrospective longitudinal cohort study. PARTICIPANTS: Participants in the 2007–2016 Medical Expenditure Panel Survey (MEPS), age 18 years or older. The MEPS is a nationally representative survey of the noninstitutionalized, civilian US population. METHODS: We estimated trends in national and per capita annual ophthalmic prescription expenditures by pooling data into 2-year cycles and using weighted linear regressions. We also identified characteristics associated with greater total or OOP expenditure with multivariable weighted linear regression. Costs were adjusted to 2016 US dollars using the Gross Domestic Product Price Index. MAIN OUTCOME MEASURES: Trends in total and OOP annual expenditures for ophthalmic medications from 2007–2016 as well as factors associated with greater expenditure. RESULTS: From 2007–2016, 9,989 (4.2%) MEPS participants reported ophthalmic medication prescription use. Annual ophthalmic medication utilization increased from 10.0 to 12.2 million individuals from 2007–2008 to 2015–2016. In this same time period, national expenditures for ophthalmic medications increased from $3.39 billion to $6.08 billion and OOP expenditures decreased from $1.34 to $1.18 billion. While the average number of ophthalmic prescriptions filled did not change over the study period (4.2, p=0.10), the average expenditure per prescription increased significantly from $72.30 to $116.42 (p
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- 2020
14. Socioeconomic and Demographic Disparities in the Use of Telemedicine for Ophthalmic Care during the COVID-19 Pandemic.
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Chen, Evan M., Andoh, Joana E., and Nwanyanwu, Kristen
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COVID-19 pandemic , *COVID-19 , *AMERICAN Community Survey , *OLDER patients , *BLACK people , *MEDICARE - Abstract
To identify disparities in the use of telemedicine during the coronavirus disease 2019 (COVID-19) pandemic. A cross-sectional study of completed clinical encounters in an academic ophthalmology center from March 2020 through August 2020. A total of 5023 patients comprising 8116 ophthalmic clinical encounters. Medical charts were abstracted for demographic information. We identified zip code-level socioeconomic characteristics, which were drawn from the 2019 American Community Survey 5-year estimates. The completion of a synchronous video encounter, the completion of a telephone (audio-only) encounter in the absence of any video encounters, or the completion of in-person encounters only. During the study period, 8116 total clinical encounters were completed for 5023 unique patients. Of these patients, 446 (8.9%) participated in a video encounter, 642 (12.8%) completed a telephone encounter, and 3935 (78.3%) attended clinical appointments in person only. In adjusted analysis, patients who were Black (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.52–0.80; P < 0.001) or Hispanic/Latino (OR, 0.65; 95% CI, 0.49–0.85; P = 0.002) were significantly less likely to complete a video or telephone appointment. Older patients (OR, 0.99; 95% CI, 0.98–0.99; P < 0.001), patients whose primary language was not English (OR, 0.49; 95% CI, 0.28–0.82; P = 0.01), Black patients (OR, 0.45; 95% CI, 0.32–0.62; P < 0.001), and Hispanic/Latino patients (OR, 0.56; 95% CI, 0.37–0.83; P = 0.005) were significantly less likely to complete a video encounter. Finally, among patients completing any type of telemedicine encounter, older age, (OR, 1.02; 95% CI, 1.01–1.03; P < 0.001), Medicare insurance (OR, 1.55; 95% CI, 1.11–2.17; P = 0.01), and Black race (OR, 1.97; 95% CI, 1.33–2.94; P < 0.001) were associated with using only phone visits. Ethnic/racial minorities, older patients, and non–English-speaking individuals were significantly less likely to complete a video telehealth encounter. With the expansion of telemedicine and the need to reduce the disparate impact of COVID-19 on minorities, it will be increasingly important to identify barriers to telehealth use and opportunities to improve access. [ABSTRACT FROM AUTHOR]
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- 2022
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15. The Impact of International Pricing Index Models on Anti-Vascular Endothelial Growth Factor (VEGF) Drug Costs in the United States.
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Choi, Stephanie, Chen, Evan M., Chen, Dinah, Sridhar, Jayanth, and Parikh, Ravi
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- 2022
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16. Urology Practice Acquisitions by Private Equity Firms from 2011–2021.
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Nie, James, Demkowicz, Patrick C., Hsiang, Walter, Umer, Waez, Chen, Evan M., McMahon, Gregory, Kenney, Patrick A., Breyer, Benjamin N., Parikh, Ravi, and Leapman, Michael S.
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- 2022
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17. Epidemiology of United States Inpatient Open Globe Injuries from 2009-2015.
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Siddiqui, Neha, Chen, Evan M, Parikh, Ravi, Douglas, Vivian Paraskevi, Douglas, Konstantinos AA, Feng, Paula W, and Armstrong, Grayson W
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OLDER patients , *EPIDEMIOLOGY , *GENDER , *DIAGNOSIS , *NATIVE Americans , *WHITE people - Abstract
To study the epidemiology of inpatient open globe injuries (OGI) in the United States (US). This was a retrospective cohort study of patients with a primary diagnosis of OGI in the National Inpatient Sample (NIS) from 2009 to 2015. Sociodemographic characteristics, including age, gender, race, ethnicity, insurance, and income were stratified for comparison. Annual prevalence rates were calculated using 2010 US Census data. Statistical analysis included Chi-square tests, ANCOVA, and Tukey tests. A total of 6,821 US inpatient hospital discharge records met inclusion/exclusion criteria. The estimated national prevalence of OGI during the 5-year period from 2009 to 2015 was 34,061 (95% confidence interval [CI] 31,445–36,677). The overall annual prevalence rate was 1.58 per 100,000 per year (CI 1.56–1.59). Overall, average annual prevalence rates were highest among patients 85 years or older (7.72, CI 6.95–8.49), on Medicare (3.92, CI 3.84–4.00), males (2.28, CI 2.25–2.30), African Americans (2.38, CI 2.32–2.44), and Native Americans (1.80, CI 1.62–2.00). OGI rates were lowest among Whites (1.21, CI 1.19–1.22), females (0.89, CI 0.87–0.91), those with private insurance (0.84, CI 0.82–0.86), and Asians (0.69, CI 0.64–0.74). Being in the lowest income quartile was a risk factor for OGI (p <.05). Inpatient OGIs disproportionately affected those over 85, young males, elderly females, patients of African-American descent, on Medicare, and in the lowest income quartile. Additionally, children and young children had lower rates of OGI compared to adolescents. Further studies should delineate causes for socioeconomic differences in OGI rates to guide future public health measures. [ABSTRACT FROM AUTHOR]
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- 2021
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18. Association of the Affordable Care Act Medicaid Expansion with Dilated Eye Examinations among the United States Population with Diabetes.
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Chen, Evan M., Armstrong, Grayson W., Cox, Jacob T., Wu, David M., Hoover, Donald R., Del Priore, Lucian V., and Parikh, Ravi
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EYE examination , *MEDICAID , *INSURANCE , *INCOME ,PATIENT Protection & Affordable Care Act - Abstract
To evaluate the association between Medicaid expansion and diabetic dilated eye examinations. A retrospective difference in differences (DiD) analysis using individual-level survey response data from January 1, 2009, to December 31, 2017. A total of 52 392 survey responses from 50 states and the District of Columbia between 2009 and 2017. Responders were adults aged 18 to 64 years reporting a previous diagnosis of diabetes and a household income below 138% of the US federal poverty line (FPL). The Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System data were used to identify survey responders who were asked about the presence of dilated eye examinations from years before and after Medicaid expansion implementation. The DiD in proportion of dilated eye examinations among diabetic persons aged 18 to 64 years with household incomes below 138% of the FPL between states that did and did not implement Medicaid expansion. Implementation of Medicaid expansion policies was associated with a 1.3% (95% confidence interval [CI], −3.8 to 6.4; P = 0.61), 6.3% (95% CI, 1.3–11.3; P = 0.016), 4.1% (95% CI, −0.8 to 9.0; P = 0.11), and 2.3% (95% CI, −1.6 to 6.2; P = 0.23) increase in the proportion of diabetic persons aged 18 to 64 years with incomes below 138% of the FPL receiving a dilated eye examination within the past year due to Medicaid expansion 1, 2, 3, and 4 cumulative years after expansion, respectively. Medicaid expansion policies were significantly associated with an increase in dilated eye examination rates within the first 2 years after implementation. However, this increase did not persist beyond this period, with nonsignificant increases 3 and 4 cumulative years after implementation. Healthcare policymakers should be aware that additional measures beyond expanding insurance coverage may be necessary to increase and sustain the rate of dilated eye examinations among diabetic populations. [ABSTRACT FROM AUTHOR]
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- 2020
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19. Economic Challenges of Artificial Intelligence Adoption for Diabetic Retinopathy.
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Chen, Evan M., Chen, Dinah, Chilakamarri, Priyanka, Lopez, Rieza, and Parikh, Ravi
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DIABETIC retinopathy , *MEDICARE , *ARTIFICIAL intelligence , *OPHTHALMOSCOPY , *FOOT care , *MEDICAL quality control , *SCANNING laser ophthalmoscopy - Published
- 2021
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20. Reply by Authors.
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Nie, James, Demkowicz, Patrick C., Hsiang, Walter, Umer, Waez, Chen, Evan M., McMahon, Gregory, Kenney, Patrick A., Breyer, Benjamin N., Parikh, Ravi, and Leapman, Michael S.
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- 2022
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21. The Association between Noninfectious Uveitis and Coronavirus Disease 2019 Outcomes: An Analysis of United States Claims-Based Data.
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Miller, D. Claire, Sun, Yuwei, Chen, Evan M., Arnold, Benjamin F., and Acharya, Nisha R.
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CORONAVIRUS diseases , *COVID-19 , *UVEITIS , *PROPORTIONAL hazards models , *NOSOLOGY - Abstract
To identify if noninfectious uveitis (NIU) is associated with a greater risk of Coronavirus Disease 2019 (COVID-19) infection, hospitalization, and death. A retrospective cohort study from January 20, 2020 to December 31, 2020, using a national claims-based database. Enrollees who had continuous enrollment with both medical and pharmacy coverage for 3 years before January 20, 2020. Patients with an NIU diagnosis within 3 years of the start of the study were included in the NIU cohort. Those with infectious uveitis codes or new NIU diagnoses during the risk period were excluded. Cox proportional hazard models were used to identify unadjusted hazard ratios (HRs) and adjusted HRs for all covariates for each outcome measure. Adjusted models accounted for patient demographics, health status, and immunosuppressive medication use during the risk period. Rates of COVID-19 infection, COVID-19-related hospitalization, and COVID-19-related in-hospital death identified with International Classification of Disease 10th revision codes. This study included 5 806 227 patients, of whom 29 869 (0.5%) had a diagnosis of NIU. On unadjusted analysis, patients with NIU had a higher rate of COVID-19 infection (5.7% vs. 4.5%, P < 0.001), COVID-19-related hospitalization (1.2% vs. 0.6%, P < 0.001), and COVID-19-related death (0.3% vs. 0.1%, P < 0.001). However, in adjusted models, NIU was not associated with a greater risk of COVID-19 infection (HR, 1.05; 95% confidence interval [CI], 1.00–1.10; P = 0.04), hospitalization (HR, 0.98; 95% CI, 0.88–1.09; P = 0.67), or death (HR, 0.90, 95% CI, 0.72–1.13, P = 0.37). Use of systemic corticosteroids was significantly associated with a higher risk of COVID-19 infection, hospitalization, and death. Patients with NIU were significantly more likely to be infected with COVID-19 and experience severe disease outcomes. However, this association was due to the demographics, comorbidities, and medications of patients with NIU, rather than NIU alone. Patients using systemic corticosteroids were significantly more likely to be infected with COVID-19 and were at greater risk of hospitalization and in-hospital death. Additional investigation is necessary to identify the impact of corticosteroid exposure on COVID-19-related outcomes. [ABSTRACT FROM AUTHOR]
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- 2022
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22. Medical Malpractice Lawsuits Involving Ophthalmology Trainees.
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Watane, Arjun, Kalavar, Meghana, Chen, Evan M., Mruthyunjaya, Prithvi, Cavuoto, Kara M., Sridhar, Jayanth, and Parikh, Ravi
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MEDICAL malpractice , *ACTIONS & defenses (Law) , *OPHTHALMOLOGY , *MEDICAL education - Published
- 2021
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23. COVID-19 and Use of Teleophthalmology (CUT Group): Trends and Diagnoses.
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Portney, David S., Zhu, Ziwei, Chen, Evan M., Steppe, Emma, Chilakamarri, Priyanka, Woodward, Maria A., Ellimoottil, Chad, and Parikh, Ravi
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COVID-19 , *DIAGNOSIS , *TELEMEDICINE - Published
- 2021
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24. Ophthalmologists in the First Year of the Merit-based Incentive Payment System.
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Feng, Paula W., Gronbeck, Christian, Chen, Evan M., and Teng, Christopher C.
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MEDICARE , *PAYMENT systems , *OPHTHALMOLOGISTS , *CHILD health insurance - Published
- 2021
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25. Association between Immunosuppressive Drugs and Coronavirus Disease 2019 Outcomes in Patients with Noninfectious Uveitis in a Large US Claims Database.
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Sun, Yuwei, Miller, D. Claire, Akpandak, Idara, Chen, Evan M., Arnold, Benjamin F., and Acharya, Nisha R.
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COVID-19 , *IMMUNOSUPPRESSIVE agents , *COVID-19 pandemic , *CORONAVIRUS diseases , *PROPORTIONAL hazards models , *UVEITIS , *IRIDOCYCLITIS - Abstract
To determine the dose-dependent risk of systemic corticosteroids (SCs) and the risk of other immunosuppressive therapies on coronavirus disease 2019 (COVID-19) infection, hospitalization, and death in patients with noninfectious uveitis (NIU). A retrospective cohort study from January 20, 2020, to December 31, 2020 (an era before widespread COVID-19 vaccination), using the Optum Labs Data Warehouse, a US national de-identified claims database. Patients who had at least 1 NIU diagnosis from January 1, 2017. Unadjusted and adjusted hazard ratios (HRs) were estimated for each variable and COVID-19 outcome using Cox proportional hazards models, with time-updated dichotomous indicators for outpatient immunosuppressive medication exposure. To assess the dose-dependent effect of SC exposure, the average daily dose of prednisone over the exposed interval was included in the adjusted models as a continuous variable, in addition to the dichotomous variable. Incidence rates of COVID-19 infection, COVID-19–related hospitalization, and COVID-19–related in-hospital death. This study included 52 286 NIU patients of whom 12 000 (23.0%) were exposed to immunosuppressive medications during the risk period. In adjusted models, exposure to SCs was associated with increased risk of COVID-19 infection (HR, 2.66; 95% confidence interval [CI], 2.19–3.24; P < 0.001), hospitalization (HR, 3.26; 95% CI, 2.46–4.33; P < 0.001), and in-hospital death (HR, 1.99; 95% CI, 0.93–4.27; P = 0.08). Furthermore, incremental increases in the dosage of SCs were associated with a greater risk for these outcomes. Although tumor necrosis factor-α (TNF-α) inhibitors were associated with an increased risk of infection (HR, 1.48; 95% CI, 1.08–2.04; P = 0.02), other immunosuppressive treatments did not increase the risk of COVID-19 infection, hospitalization, or death. This study from an era before widespread COVID-19 vaccination demonstrates that outpatient SC exposure is associated with greater risk of COVID-19 infection and severe outcomes in patients with NIU. Future studies should evaluate the impact of immunosuppression in vaccinated NIU patients. Limiting exposure to SCs and use of alternative therapies may be warranted. [ABSTRACT FROM AUTHOR]
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- 2022
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26. Cost Analysis of Dropless Cataract Surgery Prophylaxis with Intracameral Antibiotics and Subconjunctival Steroids.
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Massa S, Smits DJ, Nguyen AT, Patil SA, Chen EM, Shorstein NH, Friedman S, and Parikh R
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Purpose: To determine whether dropless, injection-based cataract surgery prophylaxis with intracameral antibiotic and subconjunctival steroid may reduce healthcare system costs and patient out-of-pocket costs compared to topical medication regimens., Setting: United States national medical expenditures database., Design: Retrospective cost analysis., Methods: Costs were analyzed for topical ophthalmics from the 2020 Medical Expenditure Panel Survey (MEPS) and for dropless medications from pharmaceutical invoices/catalogs. Main outcomes included system costs, from insurance and patient payments, and out-of-pocket costs for cataract surgery topical and dropless, injection-based prophylactic medication regimens, per eye and nationally. System costs for individual topical medications and same-class dropless, injection-based medications were compared using two-sided, one-sample t-tests., Results: There were 583 prophylactic topical ophthalmic purchases in MEPS. Mean system costs per eye were $76.20 ± SD 39.07 for the lowest cost topical steroid (prednisolone) compared to $4.01 for the lowest cost subconjunctival steroid (triamcinolone acetonide) (p < 0.001). Per eye, the lowest cost dropless, injection-based regimen, at $15.91, results in an $87.99 (84.7%) reduction in overall healthcare costs and a $43.64 (100%) reduction in patient out-of-pocket costs relative to the lowest cost topical regimen ($103.90 ± 43.14 mean system cost and $43.64 ± 37.32 mean out-of-pocket cost per eye). Use of intracameral moxifloxacin and subconjunctival triamcinolone acetonide can reduce annual national healthcare system and out-of-pocket costs up to $450,000,000 and $225,000,000, respectively., Conclusions: An evidence-based cataract surgery prophylactic medication regimen of intracameral moxifloxacin and subconjunctival triamcinolone acetonide can reduce healthcare system and patient out-of-pocket costs in comparison to various topical regimens., (Copyright © 2024 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.)
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- 2024
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27. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study.
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Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, and Ross JS
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- Child, Preschool, Cross-Sectional Studies, Drug Labeling, Humans, United States, United States Food and Drug Administration, Adverse Drug Reaction Reporting Systems, Drug-Related Side Effects and Adverse Reactions epidemiology
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Objective: To characterize potential drug safety signals identified from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), from 2008 to 2019, to determine how often these signals resulted in regulatory action by the FDA and whether these actions were corroborated by published research findings or public assessments by the Sentinel Initiative., Design: Cross sectional study., Setting: USA., Population: Safety signals identified from the FAERS and publicly reported by the FDA between 2008 and 2019; and review of the relevant literature published before and after safety signals were reported in 2014-15. Literature searches were performed in November 2019, Sentinel Initiative assessments were searched in December 2021, and data analysis was finalized in December 2021., Main Outcome Measures: Safety signals and resulting regulatory actions; number and characteristics of published studies, including corroboration of regulatory action as evidenced by significant associations (or no associations) between the drug related to the signal and the adverse event., Results: From 2008 to 2019, 603 potential safety signals identified from the FAERS were reported by the FDA (median 48 annually, interquartile range 41-61), of which 413 (68.5%) were resolved as of December 2021 (372 of 399 (93.2%) signals ≥3 years old were resolved). Among the resolved safety signals, 91 (22.0%) led to no regulatory action and 322 (78.0%) resulted in regulatory action, including 319 (77.2%) changes to drug labeling and 59 (14.3%) drug safety communications or other public communications from the FDA. For a subset of 82 potential safety signals reported in 2014-15, a literature search identified 1712 relevant publications; 1201 (70.2%) were case reports or case series. Among these 82 safety signals, 76 (92.7%) were resolved, of which relevant published research was identified for 57 (75.0%) signals and relevant Sentinel Initiative assessments for four (5.3%) signals. Regulatory actions by the FDA were corroborated by at least one relevant published research study for 17 of the 57 (29.8%) resolved safety signals; none of the relevant Sentinel Initiative assessments corroborated FDA regulatory action., Conclusions: Most potential safety signals identified from the FAERS led to regulatory action by the FDA. Only a third of regulatory actions were corroborated by published research, however, and none by public assessments from the Sentinel Initiative. These findings suggest that either the FDA is taking regulatory actions based on evidence not made publicly available or more comprehensive safety evaluations might be needed when potential safety signals are identified., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: no support from any organization for the submitted work; MMD reports receiving grants from the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) Scholars outside the submitted work; RR reports research support through Yale University from Arnold Ventures and the Stavros Niarchos Foundation and was an employee of the Veterans Health Administration, but the views expressed in this article are those of the authors and do not necessarily reflect those of the US Department of Veteran Affairs or the US government; XS is supported by the China Scholarship Council; JDW is supported by the FDA, Johnson and Johnson through Yale University, Arnold Ventures, and the National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health under award 1K01AA028258; JDW serves as a consultant for Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC.111; JSR is the US outreach and associate research editor at The BMJ and currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from Arnold Ventures; JSR is an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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28. Trends in Anti-Vascular Endothelial Growth Factor Agents and Panretinal Photocoagulation Use in Diabetic Retinopathy.
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Azad AD, Chen EM, Hinkle J, Rayess N, Wu D, Eliott D, Mruthyunjaya P, and Parikh R
- Subjects
- Angiogenesis Inhibitors administration & dosage, Diabetic Retinopathy diagnosis, Female, Follow-Up Studies, Humans, Intravitreal Injections trends, Laser Coagulation methods, Male, Middle Aged, Optical Imaging methods, Receptors, Vascular Endothelial Growth Factor antagonists & inhibitors, Retina diagnostic imaging, Retrospective Studies, Bevacizumab administration & dosage, Diabetic Retinopathy therapy, Laser Coagulation trends, Receptors, Vascular Endothelial Growth Factor administration & dosage, Recombinant Fusion Proteins administration & dosage, Retina surgery
- Published
- 2021
- Full Text
- View/download PDF
29. Ophthalmic Emergency Department Visits: Factors Associated With Loss to Follow-up.
- Author
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Chen EM, Ahluwalia A, Parikh R, and Nwanyanwu K
- Subjects
- Adult, Emergency Service, Hospital, Female, Follow-Up Studies, Humans, Male, Retrospective Studies, Risk Factors, Time Factors, Ambulatory Care statistics & numerical data, Appointments and Schedules, Eye Diseases therapy, Office Visits statistics & numerical data, Outcome Assessment, Health Care methods
- Abstract
Purpose: To describe follow-up rates for patients referred for outpatient ophthalmic care after emergency department (ED) discharge and identify patient and visit characteristics associated with loss to follow-up (LTFU)., Design: Single-institution retrospective cohort study., Methods: We analyzed the medical records of 2,206 patients seen in the ED for an eye-related issue who were subsequently scheduled for ophthalmology follow-up between 2013 and 2019 at a single tertiary health system. The main outcome measures were the frequency of and risk factors for LTFU and ED revisits., Results: In total, 1,649 (74.8%) patients completed follow-up within 2 months of an index ED visit. In multivariable analysis, younger age (P < .001), a nonurgent ophthalmic condition or nonophthalmic primary diagnosis (P < .001), scheduled follow-up >5 days after the ED visit (P < .001), additional follow-up appointments (<.001), no prior history of ophthalmology appointments (P = .045), a visual acuity of 20/40 or better (P = .027), and having Medicaid or being uninsured (P < .001) were significantly associated with LTFU. The presence of an interpreter significantly increased the likelihood of follow-up among non-English speaking patients (P < .001). LTFU was significantly associated with an ED revisit within 4 months of an index visit, and the ED revisit rate was significantly higher for patients LTFU vs those who completed follow-up (5.7% vs 1.1%; P < .001)., Conclusions: A quarter of patients referred for ophthalmic care after an ED presentation were LTFU. We identified numerous factors associated with LTFU that could be used to develop interventions to enhance follow-up. In addition, patients who were LTFU were more likely to revisit the ED for the same ophthalmic condition., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
30. Anti-Vascular Endothelial Growth Factor and Panretinal Photocoagulation Use after Protocol S for Proliferative Diabetic Retinopathy.
- Author
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Azad AD, Chen EM, Hinkle J, Rayess N, Wu D, Eliott D, Mruthyunjaya P, and Parikh R
- Subjects
- Aged, Angiogenesis Inhibitors administration & dosage, Cross-Sectional Studies, Diabetic Retinopathy diagnosis, Female, Follow-Up Studies, Humans, Intravitreal Injections, Male, Middle Aged, Retina, Retrospective Studies, Time Factors, Tomography, Optical Coherence, Treatment Outcome, Vascular Endothelial Growth Factor A antagonists & inhibitors, Visual Acuity, Diabetic Retinopathy therapy, Laser Coagulation methods, Ranibizumab administration & dosage
- Abstract
Purpose: To characterize the rates of panretinal photocoagulation (PRP) and anti-vascular endothelial growth factor (VEGF) medications before and after publication of the Diabetic Retinopathy Clinical Research Network protocol S., Design: A retrospective, cross-sectional study from January 2012, through September 2019, using a nationally representative claims-based database, Clinformatics Data Mart Database (OptumInsight, Eden Prairie, MN)., Participants: Eyes newly diagnosed with proliferative diabetic retinopathy (PDR), continuous enrollment, and no prior treatment with PRP or anti-VEGF agents., Methods: Interrupted time series regression analysis was performed to identify the annual change in treatment rates before and after the publication of Protocol S (November 2015)., Main Outcome Measures: Annual rates of anti-VEGF or PRP treatments per 1000 treated eyes with PDR., Results: From 2012 through 2019, 10 035 PRP or anti-VEGF treatments were administered to 3685 PDR eyes. Of these, 63.6% (n = 6379) were anti-VEGF agents, and 36.4% (n = 3656) were PRP treatments. Throughout treatment, 88.7% of eyes treated with anti-VEGF received the same agent and 7.7% were treated with both PRP and anti-VEGF agents. Panretinal photocoagulation rates declined from 784/1000 treated eyes in 2012 to 566/1000 in 2019 (pre-Protocol S: β = -32 vs. post-Protocol S: -77; P = 0.005), whereas anti-VEGF rates increased from 876/1000 in 2012 to 1583/1000 in 2019 (β = -48 vs. 161, respectively; P = 0.001). Panretinal photocoagulation rates in diabetic macular edema (DME) eyes did not significantly differ from 474/1000 in 2012 to 363/1000 in 2019 (β = -9 vs. -58 respectively; P = 0.091), and anti-VEGF rates increased from 1533/1000 in 2012 to 2096/1000 in 2019 (β = -57 vs. 187; P = 0.043). In eyes without DME, PRP use declined from 1017/1000 in 2012 to 707/1000 in 2019 (β = -31 vs. -111, respectively; P < 0.001), and anti-VEGF use increased from 383/1000 in 2012 to 1226/1000 in 2019 (β = -48 vs. 140, respectively; P < 0.001)., Conclusions: Following the publication of Protocol S, PRP rates decreased, while anti-VEGF rates increased. Panretinal photocoagulation rates did not significantly change among eyes with DME. Our findings indicate the impact that randomized controlled trials can have on real-world practice patterns., (Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
31. Neighborhood Deprivation and Adherence to Initial Diabetic Retinopathy Screening.
- Author
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Yusuf R, Chen EM, Nwanyanwu K, and Richards B
- Subjects
- Diabetic Retinopathy epidemiology, Female, Humans, Male, Morbidity trends, Residence Characteristics, United States epidemiology, Diabetic Retinopathy diagnosis, Mass Screening methods, Patient Compliance
- Published
- 2020
- Full Text
- View/download PDF
32. Local DNA Repair Inhibition for Sustained Radiosensitization of High-Grade Gliomas.
- Author
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King AR, Corso CD, Chen EM, Song E, Bongiorni P, Chen Z, Sundaram RK, Bindra RS, and Saltzman WM
- Subjects
- Animals, Brain Stem Neoplasms pathology, Cell Line, Tumor, Convection, DNA metabolism, Drug Delivery Systems, Endocytosis drug effects, Glioma pathology, Humans, Male, Nanoparticles chemistry, Nanoparticles ultrastructure, Polyesters chemistry, Polyethylene Glycols chemistry, Radiation-Sensitizing Agents pharmacology, Rats, Inbred F344, Tissue Distribution drug effects, Brain Stem Neoplasms drug therapy, DNA Repair drug effects, Glioma drug therapy, Radiation-Sensitizing Agents therapeutic use
- Abstract
High-grade gliomas, such as glioblastoma (GBM) and diffuse intrinsic pontine glioma (DIPG), are characterized by an aggressive phenotype with nearly universal local disease progression despite multimodal treatment, which typically includes chemotherapy, radiotherapy, and possibly surgery. Radiosensitizers that have improved the effects of radiotherapy for extracranial tumors have been ineffective for the treatment of GBM and DIPG, in part due to poor blood-brain barrier penetration and rapid intracranial clearance of small molecules. Here, we demonstrate that nanoparticles can provide sustained drug release and minimal toxicity. When administered locally, these nanoparticles conferred radiosensitization in vitro and improved survival in rats with intracranial gliomas when delivered concurrently with a 5-day course of fractionated radiotherapy. Compared with previous work using locally delivered radiosensitizers and cranial radiation, our approach, based on the rational selection of agents and a clinically relevant radiation dosing schedule, produces the strongest synergistic effects between chemo- and radiotherapy approaches to the treatment of high-grade gliomas. Mol Cancer Ther; 16(8); 1456-69. ©2017 AACR ., (©2017 American Association for Cancer Research.)
- Published
- 2017
- Full Text
- View/download PDF
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