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Using Real-World Data to Inform Patient Care

Using Real-World Data to Inform Patient Care

As vice chair of education at the Wilmer Eye Institute at Johns Hopkins, Divya Srikumaran oversees the medical student education and residency programs. As a cornea and cataract specialist, she uses innovative procedures to address complex conditions.

One of Srikumaran’s surgical specialties is a corneal transplant technique called Descemet membrane endothelial keratoplasty (DMEK). To inform her work and ensure that all patients receive the best possible treatment, she researches surgical outcomes for endothelial keratoplasty across the country, using data from claims databases and the Intelligent Research in Sight (IRIS) registry. The latter, an American Academy of Ophthalmology (AAO) registry, collects clinical outcomes data from approximately 16,000 ophthalmologists and 3,000 optometrists nationwide. Through an AAO grant, Srikumaran is using that data to study keratoplasty outcomes such as rates of complications and graft survival.

Pooling large numbers of patients from claims databases and other data registries provides epidemiologic and outcomes data on a vastly larger number of patients than could ever be seen at one institution, says Srikumaran. “We’re realizing that you can’t do all research as a randomized controlled trial, because it would take years and years and a significant amount of resources,” she says. “Instead, we’re using these alternative data sources and the real-world evidence they provide to inform patient care.” 

Srikumaran has performed similar research with Johns Hopkins surgeon Martin Makary, who is known for his work aimed at increasing efficiency in health care. Makary’s access to Medicare claims data provides another resource for Srikumaran’s study of complication rates following DMEK. “These are Medicare claims, so it only looks at patients over the age of 65, but we’ve been able to quantify serious but rare complications such as endophthalmitis, choroidal hemorrhage and retinal detachment,” she says. Because the data pool is so large — over 90,000 procedures are included in the study — Srikumaran expects to be able to draw meaningful conclusions.

Srikumaran admits that relying on claims data has its limitations. Chief among them is the lack of clinical insights and detailed information about patients’ vision. “We want to know more about the patients who are going to have a failed graft and then require another transplant in this eight-year time period,” she says. That’s where the IRIS registry can be helpful. “With IRIS, what we want to additionally know about is retention of visual acuity,” says Srikumaran. “Once you have a surgery and your vision improves, what’s the chance that you’re going to have that same vision in one year, two years, three years — five years? Patients want to know that information. In addition, what are some of the risk factors that help determine whether someone is or isn’t going to do well?  It can be useful information for our colleagues, so they can better inform their patients. And maybe there’s something we can do to address those risk factors.” 

Eye banks have proved to be yet another source of data for Srikumaran. “In the U.S., whenever there’s an adverse reaction following a transplant, surgeons are expected to document it. That data is captured by eye banks, which use it for internal monitoring,” she says. Srikumaran asked several eye banks to share that data with her so she could look at transplant outcomes in a different way: “What kinds of adverse events are patients experiencing two months after they’ve had this surgery? If there are serious issues, such as serious infections or the graft has failed, that means the patient had the surgery and within two months, it didn’t even work, so they got no improvement out of it.”

Srikumaran presented her findings on the use of data from eye banks at the World Cornea Congress in May. Ultimately, she hopes to use what she’s learned to establish quality metrics and benchmarks to share with surgeons and physicians and help inform their practices. “Some people are skeptical of the value of this kind of data because you don’t have the luxury of looking at each patient’s chart in as much detail as you would with a randomized controlled trial or similar clinical studies,” she says. “But I think the strength of this data is in the numbers. It gives you information you may not be able to obtain in any other way. Where are you ever going to have a database of 90,000 grafts where you have all of this information?” 

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