Health-related Quality of Life

CDISC-Gloss – A multi-domain concept that represents the patient’s general perception of the effect of illness and treatment on physical, psychological, and social aspects of life. NOTE: Claiming a statistical and meaningful improvement in HRQoL implies: (1) that all HRQoL domains that are important to interpreting change in how the clinical trial’s population feels or functions as a result of the targeted disease and its treatment were measured; (2) that a general improvement was demonstrated; and (3) that no decrement was demonstrated in any domain. [FDA Clinical Outcome Assessment (COA) Glossary] Compare to quality of life (QoL).