R01EY033233

Autonomous AI to Mitigate Disparities for Diabetic Retinopathy Screening in Youth During and After COVID-19 - Project Summary

COVID-19 has led to disruptions and delays in routine pediatric care. For children with diabetes who see their diabetes team every 3 months, this has been reduced or transitioned to telemedicine due to COVID-19. However, those without technology and internet capabilities, namely low-income and minority youth, are less likely to participate in telemedicine and may see their diabetes team less frequently during the pandemic.

Screening for diabetes complications, such as diabetic retinopathy (DR), is generally fulfilled by a separate visit to an eye-care professional (ECP) and is also less likely to occur during COVID-19. Diabetic retinopathy affects 4-15% of youth with type 1 and type 2 diabetes and is a leading cause of blindness in adults as early as age 20. Yearly screening for DR is recommended, but only 35-72% of youth undergo screening, with minority youth and children from lower socioeconomic backgrounds less likely to undergo screening. Early detection of DR through screening prevents progression to vision loss.

The current standard of care for pediatric DR screening is referral to an ECP for a dilated eye exam. Recently, the FDA approved the first autonomous artificial intelligence (AI) software that interprets retinal images taken with a non-mydriatic fundus camera, providing an immediate result for DR screening at the point of care (POC) for adults with diabetes. In a pilot study at our institution, we were the first to implement this technology in pediatrics, demonstrating safety, effectiveness, equity, and cost-savings to the patient. We also found that minority youth, those with lower household income, and Medicaid insurance were less likely to undergo recommended screening, yet were more likely to have DR. This is likely to worsen due to the disparate effects of COVID-19.

We hypothesize that implementing POC autonomous AI in the diabetes care setting will increase DR screening rates in youth with diabetes, mitigate disparities in access to screening, and be cost-effective to the healthcare system now and beyond the COVID-19 pandemic.

In this proposal, we will first determine (Aim 1) in a randomized control trial at two clinic sites if autonomous AI increases screening compared to ECP, and if those who screen positive by AI are more likely to go for follow-up at the ECP. In the second phase of this proposal (Aim 2), we will perform a prospective observational trial of AI screening to determine if AI mitigates disparities in screening and improves the proportion of at-risk, minority, and low-income youth who go for follow-up if their AI screen is positive. In Aim 3, we will use a decision model to determine if AI is cost-effective and cost-saving to the healthcare system.

If AI is shown to increase screening rates while mitigating disparities in access to care, it has the potential to reshape screening methods now and in the future.

The Johns Hopkins University

1) TO SUPPORT EYE AND VISION RESEARCH PROJECTS THAT ADDRESS THE LEADING CAUSES OF BLINDNESS AND IMPAIRED VISION IN THE U.S. THESE INCLUDE RETINAL DISEASES, CORNEAL DISEASES, CATARACT, GLAUCOMA AND OPTIC NEUROPATHIES, STRABISMUS, AMBLYOPIA, AND LOW VISION AND BLINDNESS REHABILITATION. 2) TO INCREASE UNDERSTANDING OF THE NORMAL DEVELOPMENT AND FUNCTION OF THE VISUAL SYSTEM IN ORDER TO BETTER PREVENT, DIAGNOSE, AND TREAT SIGHT-THREATENING CONDITIONS, AND, TO ENHANCE THE REHABILITATION, TRAINING, AND QUALITY OF LIFE OF INDIVIDUALS WHO ARE PARTIALLY-SIGHTED OR BLIND. 3) TO SUPPORT A BROAD PROGRAM OF BASIC VISION RESEARCH THROUGH GRANTS AND COOPERATIVE AGREEMENTS, TO ENCOURAGE HIGH QUALITY CLINICAL RESEARCH, INCLUDING CLINICAL TRIALS, OTHER EPIDEMIOLOGICAL STUDIES, AND HEALTH SERVICES RESEARCH, TO ENCOURAGE RESEARCH TRAINING AND CAREER DEVELOPMENT IN THE SCIENCES RELATED TO VISION, AND TO SPONSOR SCIENTIFIC WORKSHOPS IN HIGH PRIORITY RESEARCH AREAS TO ENCOURAGE EXCHANGE OF INFORMATION AMONG SCIENTISTS. 4) SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO ENCOURAGE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.867 - Vision Research

National Eye Institute (NEI) [HHS - NIH]

Maryland United States

State-Wide

Digital Healthcare Interventions to Address the Secondary Health Effects Related to Social, Behavioral, and Economic Impact of COVID-19 (R01 - Clinical Trial Optional) (PAR-20-243)

Amendment Since initial award the total obligations have increased 285% from $494,765 to $1,905,455.