Outcomes of Over 40,000 Eyes Treated for Diabetic Macula Edema in Routine Clinical Practice: A Systematic Review and Meta-analysis

Introduction: We investigated effectiveness and safety outcomes of diabetic macula edema (DME) treatment in routine clinical practice. Methods: A literature search was conducted of peer-reviewed articles published from January 2011 to September 2021. Studies of DME treatment in real-world practice of at least 6 months with at least 50 eyes at baseline were included. Randomized controlled trials (RCTs) were excluded. The primary outcome for this meta-analysis was change in visual acuity (VA) 12 months after starting treatment. Results: Of 3034 initially identified studies, 138 met selection criteria, representing more than 40,000 eyes. The mean 12-month VA gain was 4.6 letters (95% CI 3.7, 5.4; baseline 58.6) for vascular endothelial growth factor inhibitors (anti-VEGF), 4.4 (2.5, 6.3; baseline 54.2) for steroids, and 2.1 (- 1.2, 5.3; baseline 63.6) for macular laser. Australian and New Zealand studies had better baseline VA when initiating treatment compared with Asia, Europe, and North America, translating to better VA at 12 months. Fewer anti-VEGF injections were delivered in real-world practice than registrational RCTs. Neither systemic nor ocular safety was consistently reported. Conclusions: Intravitreal anti-VEGF or steroids for DME generally led to visual gains in real-world practice but these were less impressive than RCTs, with undertreatment and differences in baseline characteristics likely contributing factors. Keywords: Diabetic macula edema; Meta-analysis; Observational; Outcomes; Real-world data; Systematic review; Treatment

Evaluating Visual Acuity in the American Academy of Ophthalmology IRIS® Registry

OBJECTIVE: To describe visual acuity data representation in the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) Registry and present a data-cleaning strategy. DESIGN: Reliability and validity study. PARTICIPANTS: Patients with visual acuity records from 2018 in the IRIS Registry. METHODS: Visual acuity measurements and metadata were identified and characterized from 2018 IRIS Registry records. Metadata, including laterality, assessment method (distance, near, and unspecified), correction (corrected, uncorrected, and unspecified), and flags for refraction or pinhole assessment were compared between Rome (frozen April 20, 2020) and Chicago (frozen December 24, 2021) versions. We developed a data-cleaning strategy to infer patients\u27 corrected distance visual acuity in their better-seeing eye. MAIN OUTCOME MEASURES: Visual acuity data characteristics in the IRIS Registry. RESULTS: The IRIS Registry Chicago data set contains 168 920 049 visual acuity records among 23 001 531 unique patients and 49 968 974 unique patient visit dates in 2018. Visual acuity records were associated with refraction in 5.3% of cases, and with pinhole in 11.0%. Mean (standard deviation) of all measurements was 0.26 (0.41) logarithm of the minimum angle of resolution (logMAR), with a range of - 0.3 to 4.0 A plurality of visual acuity records were labeled corrected (corrected visual acuity [CVA], 39.1%), followed by unspecified (37.6%) and uncorrected (uncorrected visual acuity [UCVA], 23.4%). Corrected visual acuity measurements were paradoxically worse than same day UCVA 15% of the time. In aggregate, mean and median values were similar for CVA and unspecified visual acuity. Most visual acuity measurements were at distance (59.8%, vs. 32.1% unspecified and 8.2% near). Rome contained more duplicate visual acuity records than Chicago (10.8% vs. 1.4%). Near visual acuity was classified with Jaeger notation and (in Chicago only) also assigned logMAR values by Verana Health. LogMAR values for hand motion and light perception visual acuity were lower in Chicago than in Rome. The impact of data entry errors or outliers on analyses may be reduced by filtering and averaging visual acuity per eye over time. CONCLUSIONS: The IRIS Registry includes similar visual acuity metadata in Rome and Chicago. Although fewer duplicate records were found in Chicago, both versions include duplicate and atypical measurements (i.e., CVA worse than UCVA on the same day). Analyses may benefit from using algorithms to filter outliers and average visual acuity measurements over time. FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found found in the Footnotes and Disclosures at the end of this article

Development and validation of a predictive model for American Society of Anesthesiologists Physical Status

Abstract Background The American Society of Anesthesiologists Physical Status (ASA-PS) classification system was developed to categorize the fitness of patients before surgery. Increasingly, the ASA-PS has been applied to other uses including justification of inpatient admission. Our objectives were to develop and cross-validate a statistical model for predicting ASA-PS; and 2) assess the concurrent and predictive validity of the model by assessing associations between model-derived ASA-PS, observed ASA-PS, and a diverse set of 30-day outcomes. Methods Using the 2014 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Participant Use Data File, we developed and internally cross-validated multinomial regression models to predict ASA-PS using preoperative NSQIP data. Accuracy was assessed with C-Statistics and calibration plots. We assessed both concurrent and predictive validity of model-derived ASA-PS relative to observed ASA-PS and 30-day outcomes. To aid further research and use of the ASA-PS model, we implemented it into an online calculator. Results Of the 566,797 elective procedures in the final analytic dataset, 8.9% were ASA-PS 1, 48.9% were ASA-PS 2, 39.1% were ASA-PS 3, and 3.2% were ASA-PS 4. The accuracy of the 21-variable model to predict ASA-PS was C = 0.77 +/− 0.0025. The model-derived ASA-PS had stronger association with key indicators of preoperative status including comorbidities and higher BMI (concurrent validity) compared to observed ASA-PS, but less strong associations with postoperative complications (predictive validity). The online ASA-PS calculator may be accessed at https://s-spire-clintools.shinyapps.io/ASA_PS_Estimator/ Conclusions Model-derived ASA-PS better tracked key indicators of preoperative status compared to observed ASA-PS. The ability to have an electronically derived measure of ASA-PS can potentially be useful in research, quality measurement, and clinical applications.https://deepblue.lib.umich.edu/bitstream/2027.42/152155/1/12913_2019_Article_4640.pd

Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration

Purpose To define a minimum set of outcome measures for tracking, comparing, and improving macular degeneration care. Design Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM). Methods Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice. Results Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities. Conclusions The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses

Risk factors predictive of endogenous endophthalmitis among hospitalized patients with hematogenous infections in the United States

To identify potential risk factors associated with endogenous endophthalmitis among hospitalized patients with hematogenous infections. Retrospective cross-sectional study. MarketScan Commercial Claims and Encounters, and Medicare Supplemental and Coordination of Benefit inpatient databases from the years 2007-2011 were obtained. Utilizing ICD-9 codes, logistic regression was used to identify potential predictors/comorbidities for developing endophthalmitis in patients with hematogenous infections. Among inpatients with hematogenous infections, the overall incidence rate of presumed endogenous endophthalmitis was 0.05%-0.4% among patients with fungemia and 0.04% among patients with bacteremia. Comorbid human immunodeficiency virus infection/acquired immunodeficiency syndrome (HIV/AIDS) (OR = 4.27; CI, 1.55-11.8; P = .005), tuberculosis (OR = 8.5; CI, 1.2-61.5; P = .03), endocarditis (OR = 8.3; CI, 4.9-13.9; P < .0001), bacterial meningitis (OR = 3.8; CI, 1.2-12.0; P = .023), fungal meningitis (OR = 59.1; CI, 14.1-247.8; P < .0001), internal organ abscess (OR = 2.9; CI, 1.2-6.4; P = .02), lymphoma/leukemia (OR = 2.9; CI, 1.6-5.3; P < .0001), skin abscess/cellulitis (OR = 1.75; CI, 1.1-2.8; P = .02), pyogenic arthritis (OR = 4.2; CI, 1.8-9.6; P = .001), diabetes with ophthalmic manifestations (OR = 7.0; CI, 1.7-28.3; P = .006), and urinary tract infection (OR = 0.04; CI, 0.3-0.9; P = .023) were each significantly associated with a diagnosis of endogenous endophthalmitis. Patients aged 0-17 years (OR = 2.61; CI, 1.2-5.7; P = .02), 45-54 years (OR = 3.4; CI, 2.0-5.4; P < .0001), and 55-64 years (OR = 2.9; CI, 1.8-4.8; P < .0001); those having length of stay of 3-10 days (OR = 1.9; CI, 1.1-3.3; P = .01), 11-30 days (OR = 3.1; CI, 1.8-5.5; P < .0001), and 31+ days (OR = 5.3; CI, 2.7-10.4; P < .0001); and those with intensive care unit/neonatal intensive care unit (ICU/NICU) admissions (OR = 1.5; CI, 1.4-1.6; P < .0001) were all more likely to be diagnosed with endogenous endophthalmitis. Endogenous endophthalmitis is rare among hospitalized patients in the United States. Among patients with hematogenous infections, odds of endogenous endophthalmitis were higher for children and middle-aged patients, and for patients with endocarditis, bacterial meningitis, lymphoma/leukemia, HIV/AIDS, internal organ abscess, diabetes with ophthalmic manifestations, skin cellulitis/abscess, pyogenic arthritis, tuberculosis, longer hospital stays, and/or ICU/NICU admission

Reply

[...]as Dr Chen and colleagues note, patients with more severe disease frequently require longer hospitalizations and longer treatment with intravenous antimicrobials. Since treatment with intravenous antimicrobials may sometimes be continued in an outpatient setting (home health care or visits to an infusion center), we considered longer hospitalizations to be an indicator of more severe infection or worse systemic health

Trends in Hospitalization and Incidence Rate for Syphilitic Uveitis in the United States From 1998 to 2009

This study evaluates the annual incidence of syphilitic uveitis in the US and trends in hospital admissions over time. Retrospective, longitudinal incidence rate analysis of the National Inpatient Sample (NIS) data from 1998 to 2009. The NIS is a de-identified, random sample dataset of inpatient hospitalizations from 46 states. The number of cases of syphilitic uveitis was defined by (1) International Classification of Diseases, 9th Revision (ICD-9) code for syphilis and uveitis or (2) ICD-9 code for syphilitic uveitis. Annual case count, incidence rate, and trend over time were calculated. Multivariate logistic regression was used to evaluate associated factors for a syphilitic uveitis diagnosis. The study included 455 310 286 hospitalizations during a 12-year study period with a mean of 37 942 524 patients annually. Syphilis and uveitis was recorded for 1861 patients (155 annually) and syphilitic uveitis was diagnosed in 204 subjects (average of 17 cases annually). There was no change in the incidence of syphilitic uveitis, using either definition, over the study period (P for trend = .46). The mean annual incidence of syphilis and uveitis was 0.0004%, or 4 per million. Syphilitic uveitis had an annual incidence of 0.000045%, or 0.45 per million. The odds of syphilitic uveitis were lower among women (odds ratio [OR] 0.40, CI 0.28-0.57) and increased with comorbid acquired immunodeficiency syndrome (OR 4.52, CI 3.01-6.79). We report the first incidence of syphilitic uveitis in the United States. Fortunately, this remains a rare condition. The results demonstrate no change in the number of inpatient admissions for syphilitic uveitis during the study period