Background: Dry eye is a complex, multifactorial disease that often involves multiple sites and numerous comorbidities and can cause severe pain and mental distress that can lead to suicidal ideation and suicide. There are two dry eye variants: aqueous deficient (with prevalence 20 percent) and evaporative (with a prevalence of 85 percent). Both often coexist. Although affecting some 35 percent of the population, the American Academy of Ophthalmology does not recognize dry eye as a subspecialty and training in medical schools for dry eye and comorbidities is limited. As a result, both in research and clinical settings, diagnostic and treatment protocols tend to be non-specific, ad-hoc and inadequate, with a narrow industry-driven focus that may not include patients' actual symptoms and their etiology.
Motivation: To improve the care that dry eye and meibomian gland dysfunction (MGD) patients receive, it is necessary to re-orient toward an approach that embraces patient interests and patient-centered outcomes in research.
Goal: The overall goal of the project is to re-orient dry eye and MGD comparative clinical effectiveness research (CER) toward a patient perspective.
- Establish relationships with ophthalmic research organizations that have a focus in dry eye or MGD and are interested in adopting a patient-centered outcomes approach to research.
- Establish a Patient Council trained in research fundamentals, patient-centered outcomes research (PCOR)/CER and dry eye/MGD, who are also trained to partner with researchers and research organizations in the development of research studies.
- Provide an immersive learning experience—a practicum— for all participants, researchers and members of the patient council that simulates the collaborative development of PCOR/CER studies.
Activities: This project will establish a Patient Council of individuals trained in research fundamentals, PCOR/CER, dry eye and MGD and team collaboration. Patients, researchers and other partners interested in collaborating in dry eye and MGD PCOR/CER will participate. To ensure the sustainability of the Patient Council and its future membership, an online, secure, scalable dry eye and MGD training system will be developed.
- Dry eye/MGD in-depth online training system.
- Patient Council trained in dry eye and MGD, research fundamentals, PCOR/CER and team collaboration that will be available to advise researchers on dry eye/MGD patient-centered research.
- Research roadmaps prepared by the project team, with detailed plans for their implementation that include collaboration with the Patient Council and researchers.
Projected Outcomes and Outputs:
Short-term outcomes during the project period include the establishment of a Patient Council and PCOR/CER roadmaps prepared by the project team that include plans for future research.
Medium-term outcomes (0-2 years post-project period) include research partners engaging the Patient Council to develop research studies for submission to CER funders.
Long-term outcomes (3+ years post-project period) include the publication of patient-centered research studies.
Patient and Stakeholder Engagement Plan: The project is supported by the Not A Dry Eye Foundation, the first dry eye 501(c)3 organization founded by patients. Both the project lead and administrative official are patients and patient advocates.
Key personnel and partners include dry eye/MGD researchers, a health IT specialist and an instructional systems designer. Patients, researchers and other partners will contribute to the design, development and delivery of an online, secure, scalable and sustainable dry eye/MGD training system. All participants will take part in a practicum to have an opportunity to apply their knowledge and training in dry eye, MGD, research fundamentals and collaboration. The project team will develop roadmaps to position the organization for future research and research support funding.
Project Collaborators: Not A Dry Eye Foundation, Ocular Surface Research and Education Foundation, University of Central Florida, Adams Learning