Regulatory Outlook on Patient Reported Outcome Measures: Appraising Patients’ Voices to Approach People-Centered Model of Health Care

Health systems attempt to measure an ever-increasing number of clinical measures when it’s about providing the best treatment to patients. Historically, agencies relied on lab tests such as blood panels and urine analysis instead of what the patients really felt; hence, they often missed the mark of what matters to patients. But with the growing importance of patients’ voices in health care system, the FDA (Food and Drug Administration) and other regulatory agencies are now practicing Patient-Reported Outcomes (PROs) more frequently in the drug approval process. This study presents a descriptive outline of PROs, followed by the instruments used to measure these outcomes called Patient-Reported Outcome Measures (PROMs) in clinical trial protocols. A few examples of PROM applications are provided, along with some methodological ways to evaluate PROM data. The process of instrument creation and implementation are discussed, along with the illustration of measurement tools intended to be used in the area of disorders related to neurological communication. This article examines the requirements for the PRO instruments used for evaluation of medical devices and the methods recommended by the FDA’s PRO guidance. The discipline of current psychometric measurement has the capacity to assist for the development of tools that agrees to look around the suitable places that is basically from the point of view of patient. Practicing of PROs in clinical trial protocols will expand the area of concepts that has ample of limelight already for the healthcare providers to strive for solutions regarding the clinical outcomes.