Biography:

Theodore Leng, MD, MS, is a practicing retina specialist, associate professor of ophthalmology and director of clinical and translational research at the Byers Eye Institute at Stanford, Stanford University Medical School. He has a research background in image analysis, machine learning algorithms, and clinical trial design and execution.

Disclosures: Nguyen reports serving as a consultant for Verana Health. Leng reports serving as a medical advisor for Verana Health.
September 01, 2021
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BLOG: Leveraging big data of patient-recorded outcomes for PRO-MIGS study

Biography:

Theodore Leng, MD, MS, is a practicing retina specialist, associate professor of ophthalmology and director of clinical and translational research at the Byers Eye Institute at Stanford, Stanford University Medical School. He has a research background in image analysis, machine learning algorithms, and clinical trial design and execution.

Disclosures: Nguyen reports serving as a consultant for Verana Health. Leng reports serving as a medical advisor for Verana Health.
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Research on minimally invasive glaucoma surgery continues to guide treatments and understandings of outcomes and has been instrumental in revolutionizing the field of glaucoma.

However, for all the weight ophthalmologists have placed on quantifiable metrics such as IOP and visual field stability in MIGS research, little is known about how MIGS affects patient experiences and perceptions of their disease.

The Patient-Recorded Outcomes for Minimally Invasive Glaucoma Surgery (PRO-MIGS) study aims to change that. The PRO-MIGS study partners include the FDA’s Centers of Excellence in Regulatory Science and Innovation from UCSF and Stanford, the American Academy of Ophthalmology, the American Glaucoma Society and Verana Health, the data and analytics partner of the AAO.

Theodore Leng

Researchers will use the Glaucoma Outcomes Survey (GOS), which was specially designed to focus on patient experiences, in the PRO-MIGS study. By assessing patient concerns about glaucoma before and after undergoing MIGS, researchers will have a better understanding of the effect that MIGS has on patients’ attitudes toward their disease. Health-related quality of life measurements generated by the GOS may be used to emphasize the value of MIGS to regulatory bodies, which could in turn affect reimbursement for surgery and demonstrate a new means of efficacy in future MIGS trials.

Verana Health is analyzing data from the IRIS (Intelligent Research in Sight) Registry to identify study sites that may be well suited to participate in the PRO-MIGS study. Further, researchers are leveraging the power of Verana Trial Connect, a platform that links researchers with patients who may qualify for the study based on their electronic health record data in the IRIS Registry, allowing effective patient outreach to occur. Given the IRIS Registry contains data from approximately 3.7 million patients with primary open-angle glaucoma, researchers anticipate quickly filling the 500 PRO-MIGS study participant slots.

Future clinical trials may benefit from efficient enrollment if they partner with the AAO to identify patients via the IRIS Registry and Verana Trial Connect. Use of these tools for enrollment in a trial such as the PRO-MIGS study is modestly increasing the pace of enrollment. Some patients may enroll simply because their surgeon recognizes that they fit the eligibility requirements, which is to be expected in a disease such as glaucoma given the large patient population (ie, patients who will receive MIGS) under examination.

However, studies examining treatments in low-frequency disease states (eg, orphan diseases) could greatly benefit from collaboration with the AAO and Verana Health. Similarly, if a study requires hyper-specific treatment histories or strict anatomic parameters as inclusion criteria, researchers enrolling that study could benefit from quicker identification of qualified patients if Verana Trial Connect is used during the enrollment period.

By identifying patients via big data — and by reaching out to them instead of waiting for clinicians to identify them — researchers leading clinical trials may accelerate the rate at which they can fully enroll patient cohorts, thus pushing trials over the finish line faster.

  • Reference:
  • Verana Health, FDA, CERSI, the American Academy of Ophthalmology and the American Glaucoma Society announce the start of a new patient-reported outcomes validation study. https://www.veranahealth.com/verana-health-fda-cersi-the-american-academy-of-ophthalmology-and-the-american-glaucoma-society-announce-the-start-of-a-new-patient-reported-outcomes-validation-study/. Accessed Dec. 16, 2020.