What Is Needed For Diabetic Retinopathy Telemedicine

Ingrid Zimmer-Galler, MD

Ingrid Zimmer-Galler, MD, considers health care to be in the early-to-mid stages of telemedicine adoption.

But Zimmer-Galler, from the Johns Hopkins Office of Telemedicine, said telemedicine is facing a huge demand in diabetic retinopathy (DR). In a lecture at the 121^st Annual Meeting of the American Academy of Ophthalmology (AAO 2017) in New Orleans, LA, she explained DR telemedicine programs are highly effective, but that may not be enough.

The first issue in DR is the growing patient. Though Zimmer-Galler projects a continued exponential rise in both US funding and patient reach in telemedicine, almost 440 million people worldwide will have diabetes by 2030.

“We aren’t going to have the appropriate or adequate resources to properly evaluate and treat the rate of diabetic patients,” Zimmer-Galler said.

Another issue is in validation of emerging telemedicine practices. As per the American Telemedicine Association’s (ATA) standard for validation, DR telemedicine practices can be gauged on 4 different levels, Zimmer-Galler said: presence of minimal or no DR; presence or absence of vision-threatening DR; an ability to provide clinical recommendations; and an equivalence to Early Treatment DR Study (ETDRS) photograph standard.

“Validation is what allows us to know a telemedicine matches a current standard of care, as DR is currently an in-person evaluation,” Zimmer-Galler said. “DR telemedicine programs are highly effective and work, but we still have to validate every program and ensure it works.”

ETDRS photographs remain “by and large” the gold standard for DR patient evaluation, Zimmer-Galler said.

The future of DR telemedicine, which Zimmer-Galler expects to reach clinical practice, would include primary-care settings of automated image analysis. Nonmydriatic fundus cameras could come to the forefront, as well as the ability to transfer images to readings centers for review, before being returned to primary care physicians.

But the network of involved clinicians and specialists adds to the varying levels of validation DR telemedicine must reach. Programs must be approved by those responsible for imaging review, Zimmer-Galler said — not just ophthalmologists.

Even with validation, programs must establish quality assurance, which includes metrics such as patient satisfaction, follow-up with recommendations for referral, and the rate of DR evaluations themselves.

Zimmer-Galler called DR evaluation rates the “number 1 target,” noting that practices much address the issue that 40% to 50% of US diabetic patients do not get evaluated for DR.

Another serviceable metric for quality assurance is the rate of ungradeable images, which Zimmer-Galler noted there is no good definition for in the field. The UK Diabetic Retinopathy Screening Program suggests a minimum acceptable value for 5% ungradeable images.

There’s also consideration to be made for diabetic macular edema (DME), the leading cause of vision loss in DR patients. DME is diagnosed with the identification of retinal thickening, which requires optical coherence tomography (OCT) or stereo imaging.

Without retinal thickening, it is assessed by surrogate markers, but Zimmer-Galler noted that markers and DME are not always correlated. Surrogate markers can be absent or present in DME, and DME may be present or absent in the event of surrogate markers.

“We do to some extent sweep this under the rug,” Zimmer-Galler said. “We cannot diagnose DME without OCT or stereo imaging.”

While automated retinal image anaylsis has become practiced in Europe, no systems are currently approved by the US Food and Drug Administration.

Additionally from a need to consider regulatory, licensure, and financial restrctions for US ophthalmic telemedicine, there must also be an embrace to culture change, Zimmer-Galler said.

“Not only will patients have to accept what a little black box tells them — a physician will have to accept it as well,” Zimmer-Galler said.

That said, telemedicine’s rapid growth and overall acceptance has indicated its role in present and future health care. DR officials must consider what’s to be done for it to reach their field.

“We do need to have further work on adopting a standard guideline for adopting standard operations for telemedicine,” Zimmer-Galler said.