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Project involves development of patient-reported outcome measure
A collaborative effort among the FDA, bicoastal Centers of Excellence and Regulatory Science and Innovation (CERSI), and the American Glaucoma Society (AGS) has completed a project to determine patient preferences in glaucoma treatment with a focus on minimally invasive glaucoma surgery devices.
Reviewed by Malvina Eydelman, MD, and George L. Spaeth, MD
IN 2013, the FDA launched a collaborative project that recognized the value of including information from glaucoma patients in the agency’s evaluation of minimally invasive glaucoma surgical (MIGS) devices. The project involves participation of the FDA, the bicoastal Centers of Excellence and Regulatory Science and Innovation (CERSI) at University of California San Francisco-Stanford University and Johns Hopkins University, and the American Glaucoma Society (AGS).
Speaking at the AGS meeting in March, Malvina Eydelman, MD, announced that one goal of the dual-armed program has been completed and the second has entered its final phase.
“We, at the FDA, believe that patients’ input can and should inform medical device development and evaluation throughout the product life cycle,” said Dr. Eydelman, director, Division of Ophthalmic, and Ear, Nose and Throat Devices, Center for Devices and Radiologic Health, U.S. FDA, Silver Spring, MD.
“Along with that concept, we published two guidance documents defining how patient preference information and patientreported outcomes can be utilized to assess the safety and effectiveness of new medical devices.
“We have been fortunate to obtain funding from the FDA to allow collaboration between the bicoastal CERSI in this program and to work with the AGS that has been a significant contributor since the project’s inception,” she added.
What patients want
Citing a passage from the Hippocratic Oath and from an article titled “The Value of Autonomy in Medical Ethics” published in 2006, George L. Spaeth, MD, observed that the medical profession has never been very interested in sharing knowledge with patients so that the patients can make decisions likely to lead to what they want.
As a matter of fact, the idea that physicians may be required to base actions on patient-reported outcomes is one of the most frightening things that comes to mind for physicians,” said Dr. Spaeth, who has participated in the collaborative project as a representative of the AGS and is the Louis J. Esposito Research Professor, Wills Eye Institute, Jefferson Medical College, Philadelphia.
“However, it is time to start thinking about what patients want and what is important to patients,” he said. “If we say that we ought to do MIGS because it results in better patient outcomes, this project will for the first time give us information able to support that statement. It is both enormously exciting and terribly important.”
The completed project, which was being conducted with the collaboration of the Johns Hopkins CERSI, was designed to determine patient preferences in glaucoma treatment with a focus on MIGS devices. It aimed specifically to answer the question of what outcomes matter most to patients. Initially, a qualitative study comprising 25 semi-structured interviews with patients with open-angle glaucoma was conducted. A second larger preference study included 274 patients with open-angle glaucoma recruited at four centers nationwide.
“The manuscript has been submitted for publication, but to highlight some of the interesting outcomes, we found that control of IOP mattered most to patients whereas the reduction in number of drops used was very low on the list,” Dr. Eydelman said.
The second project, which involves the University of California-Stanford University CERSI, has as its goal the development of a patient-reported outcome measure (PROM) that will assess health-related quality of life in patients with mild to moderate glaucoma.
The process for developing the survey tool involves seven phases, of which six have been completed. First, a physician focus group was convened followed by several patient focus groups with the goal of gathering additional information that was used to develop the questionnaire.
Next, cognitive interviews of item content were conducted, and a web-based PROM was developed. Then, there was a second round of cognitive interviews, and the information gathered was used to refine the PROM. Now, the modified PROM, is ready for testing at sites throughout the United States.
“The last step in developing this health-related, quality-of-life measure is a field test where patients with mild-to-moderate glaucoma will complete the survey online to assess the questionnaire’s reliability, validity, and responsiveness to treatment,” Dr. Eydelman said.
At the AGS meeting, Dr. Eydelman put out a call for meeting attendees to become involved as investigators. Glaucoma practitioners who may be interested in being considered as investigators for field testing of the PROM should express their interest via e-mail (email@example.com).
“We need your help to incorporate patient perspectives into the development and evaluation process that informs innovation for MIGS devices,” she said.
Malvina Eydelman, MD
Dr. Eydelman has no financial interests to disclose.
George L. Spaeth, MD
Dr. Spaith has no financial interests to disclose.