Table 1. Key definitions.

Health related quality of life (HRQOL): “HRQOL is defined as the subjective assessment of the impact of disease and treatment across the physical, psychological, social and somatic domains of functioning and well-being” Revicki et al., 2000, p888 [1]

Patient-reported outcome (PRO): “A PRO is any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's 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. In clinical trials, a PRO instrument can be used to measure the effect of a medical intervention on one or more concepts (i.e., the thing being measured, such as a symptom or group of symptoms, effects on a particular function or group of functions, or a group of symptoms or functions shown to measure the severity of a health condition).” Food and Drug Administration, 2009, p6 [2]