Health-Related Quality of Life and patient-reported outcomes

Health-Related Quality of Life (HRQOL) has been 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)


A person’s HRQOL is influenced by their lived experience of illness across a broad range of dimensions. These dimensions may include: symptoms of disease and side-effects from its treatment; a person’s physical role, psychological, social, sexual and cognitive functioning; satisfaction with care and unmet needs for information or support services; financial demands; and spiritual wellbeing.

More recently the term ‘patient-reported outcome’ (PRO) has been used in the literature. ‘PROs’ refer to a range of constructs that can be reported by the patient, including symptoms and side-effects (e.g. pain, anxiety, nausea, fatigue); aspects of functioning (e.g. role, physical); and multi-dimensional constructs (e.g.  HRQOL). The Food and Drug Administration (FDA) defines a PRO as:

“…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”  (FDA, 2009, p2)


Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, et al. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res. 2000;9(8):887-900.

FDA. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims2009.