Registries in glaucoma: Better science, better surveillance

By Liz Meszaros

Ultimately, clinical registries can lead to better outcomes, better science, and better drug and device surveillance, according to William L. Rich, III, MD, FACS.

“What a registry does is measure your performance, both process measures in the office, and surgical interventions, and gives you a forum to compare them and improve,” explained Dr. Rich, the medical director of health policy at the American Academy of Ophthalmology. “If you don’t measure it, basically, you can’t improve.”

Dr. Rich believes clinical registries improve outcomes. He pointed to the “ACC Pinnacle experience,” which is a longitudinal registry in cardiology. The use of this registry resulted in a decrease to less than 90 minutes in door-to-balloon time in 4 years. In addition, the use of this longitudinal registry actually decreased the infarct size and creatinine kinase levels with a 30% savings for a myocardial infarction, as well as decreased hospital stays by 2 to 3 days.

Another example of the benefits of registries involves the American Society for Thoracic Surgeons, which has been sharing their outcomes data for all of their major interventions for 15 years.

“They’ve so dramatically changed the morbidity and mortality of interventional cardiac surgery that they now post them in Consumer Union,” he said. “Once you start participating in a registry, improvements can be seen in as little as a couple of months.”

Better science in glaucoma

Are the better results and prognosis for glaucoma over the past 15 years due to better diagnostics, better surgical devices, or better drugs?

“We don’t really know. Do generics have a better effect than name-brand products?” asked Dr. Rich. “We also still have huge disparities in outcomes for African-Americans and Hispanics that are not solely explained on the basis of socio-economic status and education.”

Which glaucoma devices work best?

“There has been a lot of research in the past couple of years but some issues have not been addressed: safety profile, impact on quality of life. Something called, 'patient-reported outcomes' will permeate all of our interventions in the future,” continued Dr. Rich.

When measuring comparative effectiveness, however, FDA approval is no longer enough.

“The Affordable Care Act has funded the Patient-Centered Outcomes Research Institute that will fund $1.1 billion to look at comparative effectiveness,” Dr. Rich said. “They are reaching out to ophthalmology . . . to come forward with studies on age-related macular degeneration, glaucoma, and diabetic retinopathy.”

Clinical registry also enhances science. According to Dr. Rich, this will not just be a tool to measure quality improvement. A study published recently in the New England Journal of Medicine, estimated the incremental cost per patient of doing a clinical registry-based randomized clinical trial at $50.

“This is going to revolutionize and shorten the time line for developing good trials and study the stratified patient populations we want to look at,” he explained. “The power of aggregated data cannot be underestimated. There will be a rapid evolution of new scientific inquiry to include elements of correlation, not just questions of causation, which is usually the way we design a randomized trial. This is the power of big data.”

Device identifier planned

Will it improve device surveillance? A full 60% of class III devices already have post-market surveillance and very few of those are specialty registries.

FDA is expected to announce the availability of a unique device identifier. Once we get that in DHRs, it will give physicians a much better way of looking longitudinally at the impact of devices on disease.

The PEW report, available soon, will recommend that rather than traditional device registries, physicians follow patients longitudinally to focus on outcomes and quality of life. Patient-reported outcomes will enhance the device registry as well.

All other registries look at the very short on the patient’s quality of life or on the impact on the course of disease. This is the first registry in all of medicine that will be able to do that, said Dr. Rich.

“Thanks to the support of the Hoskins Center, we’ve put together something called IRIS, Intelligent Research in Sight, an outpatient clinical registry," Dr. Rich said. “Instead of being focused in a hospital, it will be focused in the office, in academic groups, private practices, and be able to follow patients longitudinally, using probabilistic matching with a 94% ability to do that.”

The IRIS registry (launched in late March) has a goal of enrolling 2,000 physicians by 2016, with 18 million patient charts. Dr. Rich anticipates an enrollment 4,000 by 2017.

Dr. Rich closed with a comment from Harvey V. Fineberg, MD, PhD, president of the Institute of Medicine: “We are facing very challenging times in healthcare in the United States today. I believe that ophthalmology has an opportunity, not only to play a part in the solution to these challenges, but also to be an example for the health profession in going forward.”