Beyond intraocular pressure: Optimizing patient-reported outcomes in glaucoma |
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| Institution: | 1. From the Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania, USA;2. Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA;3. Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Maryland, USA;4. Wills Eye Hospital, Sidney Kimmel School of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, USA;5. Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA;6. RAND Corporation, Santa Monica, California, USA;7. Glaucoma Associates of Texas, Dallas, Texas, USA;8. Vold Vision, Fayetteville, Arkansas, USA;9. Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Center for Devices and Radiological Health United States Food and Drug Administration, White Oak, Maryland, USA |
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| Abstract: | Glaucoma, an irreversible blinding condition affecting 3–4% adults aged above 40 years worldwide, is set to increase with a rapidly aging global population. Raised intraocular pressure (IOP) is a major risk factor for glaucoma where the treatment paradigm is focused on managing IOP using medications, laser, or surgery regimens. However, notwithstanding IOP and other clinical parameters, patient-reported outcomes, including daily functioning, emotional well-being, symptoms, mobility, and social life, remain the foremost concerns for people being treated for glaucoma. These outcomes are measured using objective patient-centered outcome measures (PCOMs) and subjective patient-reported outcome measures (PROMs). Studies using PCOMs have shown that people with glaucoma have several mobility, navigational and coordination challenges; reading and face recognition deficits; and are slower in adapting to multiple real-world situations when compared to healthy controls. Similarly, studies have consistently demonstrated, using PROMs, that glaucoma substantially and negatively impacts on peoples’ self-reported visual functioning, mobility, independence, emotional well-being, self-image, and confidence in healthcare, compared to healthy individuals, particularly in those with late-stage disease undergoing a heavy treatment regimen. The patient-centred effectiveness of current glaucoma treatment paradigms is equivocal due to a lack of well-designed randomized controlled trials; short post-treatment follow-up periods; an inappropriate selection or availability of PROMs; and/or an insensitivity of currently available PROMs to monitor changes especially in patients with newly diagnosed early-stage glaucoma. We provide a comprehensive, albeit non-systematic, critique of the psychometric properties, limitations, and recent advances of currently available glaucoma-specific PCOMs and PROMs. Finally, we propose that item banking and computerized adaptive testing methods can address the multiple limitations of paper-pencil PROMs; customize their administration; and have the potential to improve healthcare outcomes for people with glaucoma. |
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| Keywords: | Glaucoma treatments Patient-reported outcomes Patient-centred outcomes Quality of life Glaucoma Computerized adaptive testing |
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