ASH Clinical News February 2015 | Page 34

Who Cares About What Patients Think? The FDA, Insurance Payers, Researchers... Maybe You Should Too W hile patient-reported outcomes (PROs) are nothing new in the field of medicine, they may now be newly appreciated. The U.S. Food and Drug Administration (FDA) defines a PRO as “a measurement based on a report that comes from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s report by a clinician or anyone else.” In other words, a PRO is how the patient feels, and how well or poorly a patient is responding to treatment, according to the patient. However, according to Amy P. Abernethy, MD, PhD, a medical oncologist and palliative medicine specialist at Duke University Health System, that type of information, which she more broadly referred to as “patient-generated health data,” has been reported by patients at the beginning of every doctor’s visit for centuries. “For doctors, patient-reported data are the beginning of every story; it is the history of the patient’s present illness,” Dr. Abernethy told ASH