Patient Outcome

A measurable change in health, function, symptoms, quality of life or survival experienced by a patient.

Source: U.S. Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA; 2009.

A patient outcome is a measurable change in health experienced by a patient. It can cover several dimensions, from health and function to symptoms, quality of life, or survival. It is experienced by the patient themselves, the person whose health it tracks. What makes it measurable is that it can be captured and quantified, whether by a clinician's assessment or the patient's own report. It is closely related to a clinical benefit, the good a treatment does that a patient outcome can measure. A measurable change in a patient's health is what it names. The FDA's guidance on patient-reported outcome measures sets this out.

Source: FDA, Patient-Reported Outcome Measures

A patient outcome can cover health, function, symptoms, quality of life or survival, the several dimensions across which a patient's change is measured. A shift in any of these counts as a patient outcome. Covering health, function, symptoms, quality of life and survival is central to what a patient outcome captures By measuring change across health, function, symptoms, quality of life and survival, the concept keeps assessment anchored in what the patient experiences rather than in process measures alone.

Source: U.S. Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA; 2009.

A patient outcome is experienced by a patient, since it is a measurable change in health, function, symptoms, quality of life or survival that the patient undergoes. The change is defined from the patient's own circumstances rather than a process measure. This grounding in what the patient experiences is intrinsic to a patient outcome By measuring change across health, function, symptoms, quality of life and survival, the concept keeps assessment anchored in what the patient experiences rather than in process measures alone.

Source: U.S. Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA; 2009.

A patient outcome is measurable because it is a change in health, function, symptoms, quality of life or survival that can be observed or recorded, allowing the patient's condition to be compared before and after. Being able to quantify the change is what lets it serve as an outcome. This measurability across patient-relevant dimensions is part of what defines a patient outcome By measuring change across health, function, symptoms, quality of life and survival, the concept keeps assessment anchored in what the patient experiences rather than in process measures alone.

Source: U.S. Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA; 2009.

A patient outcome is a measurable change in health, function, symptoms, quality of life or survival experienced by a patient, while a clinical benefit is a favourable effect of an intervention on how a patient feels, functions or survives relative to a comparator. A clinical benefit is a favourable patient outcome attributable to an intervention. The two are connected, since clinical benefit is demonstrated through improved patient outcomes By measuring change across health, function, symptoms, quality of life and survival, the concept keeps assessment anchored in what the patient experiences rather than in process measures alone.

Source: U.S. Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA; 2009.