PRO-Wh的at,Why,How.pptVIP

 Patient Reported Outcome  ---- What, Why and How? Jiqian Fang School of Public Health Sun Yat-Sen University 2006. 2 /cder/guidance/5460dft.pdf This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in approved medical product labeling. Claim: A statement of treatment benefit. A claim can appear in any section of a medical product’s FDA-approved labeling or in advertising and promotional labeling of prescription drugs and devices. Why? A PRO is any report of the status of a patients health condition that comes directly from the patient, without interpretation of the patient response by a clinician or anyone else. The outcome can be measured in absolute terms (e.g., severity of a symptom, sign, or state of a disease) or as a change from a previous measure. A PRO instrument (i.e., a questionnaire plus the information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in medical product clinical trials. In clinical trials, a PRO instrument can be used to measure the effect of a medical intervention on one or more concepts (i.e., symptom or group of symptoms, effects on function or group of functions, or severity of a health condition). A PRO instrument, like physician-based instruments, should be shown to measure the concept it is intended to measure, and the FDA will review the evidence that a particular PRO instrument measures the concept claimed. PRO measures often represent the effect of disease (e.g., heart failure or asthma) on health and functioning from the patient perspective. PRO ≠ QOL Quality of life: A general concept that implies an evaluation of the effect of all aspects of life on general well-being. Because this term implies the evaluation of non- health-rela