Patient-Reported Outcomes (PRO)

In clinical and translational outcomes research, the success of a patient's medical intervention or treatment has traditionally been assessed and documented by a physician or other clinician. Direct observation of response to an intervention is limited to objective measures. An outside observer cannot always measure outcomes of illness, treatment, or health promotion that minimize physical and emotional decline or loss of independence. Interventions affecting an individual's wellness, particularly in chronic disease progression, may have benefits beyond what can be objectively studied, including the preservation of functioning, pain relief, mood enhancement, and overall improvements in quality of life and well-being. With respect to more subjective outcomes, including quality of life, functioning, and symptom reduction, tools that have been validated and deemed sensitive are required to measure the impact of disease and illness from the afflicted individual's perspective. These measures are termed patient-reported outcomes (PRO).

Measurement of patient-reported outcomes provides valuable insight into health and illness beyond traditional efficacy or effectiveness research. In contrast to self-evident outcomes of illness such as survival, patient-reported outcomes represent the patient's perspective on the impact of disease and its treatment on his or her everyday functioning and well-being. Instruments, typically questionnaires, can be an important measure of generic quality of life or functional status. Alternatively, they may be specific to disease, treatment, or symptom. Regardless, an instrument must be grounded in clinical and psychometric theory, be representative of domains relevant to what it attempts to measure, and have been demonstrated as valid, reliable, sensitive, and specific.