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Compartmentalization of Discrete Repeated Measures in Patient-Reported Outcome (PRO) Questionnaires
Saryet Kucukemiroglu
Food and Drug Administration
Manasi Sheth
Food and Drug Administration
In a public health regulatory setting, it is important for patients to have access to high-quality, safe, and effective medical devices. It is important to ensure that patients and their care-partners stay at the center of the regulatory decision-making process. It is necessary to partner with patients by incorporating the patient perspective as evidence in the decision-making process, including both patient preference information (PPI) and patient-reported outcomes (PROs). PROs are often relevant in assessing diagnostic evaluations and can be used to capture a patient's everyday experience with a medical device, including experience outside of the clinician's office and the effects of treatment on a patient's activities of daily living. Furthermore, in some cases, PRO measures enable us to measure important health status information that cannot yet be detected by other measures, such as pain. To be useful to patients, researchers, and decision makers, PROs must undergo a validation process to support the accuracy and reliability of measurements from a device. Here, we present a novel approach for analyzing PROs obtained from two examples of diagnostic medical devices.