This paper presents an informal look at some of the peaks and valleys of the past, present, and future of outcomes research. It is not intended to be a comprehensive history or summary of the subject, but it describes some highlights of this important area. Additional details can be found in the book Quality of Life and Pharmacoeconomics in Clinical Trials.
One of the overall themes over the last 25 years is the progress from considering patient satisfaction to a more careful evaluation of functional states, which in turn led to the use of scales and instruments for evaluating quality of life. Because of the various types of quality of life, this term evolved, in turn, to become health-related quality of life. In recent years, the umbrella term “patient-reported outcomes” (PROs) has become accepted and is becoming widely used to describe this field. PROs cover a continuum from patient satisfaction through measures of functional states through health-related quality-of-life assessments. The terminology has been standardized by a PRO harmonization group, composed of academic, government, and industry members of various trade associations, professional societies, and government agencies (European Regulatory Issues on Quality of Life Assessment [ERIQA], International Society for Pharmacoeconomics and Outcomes Research [ISPOR], International Society for Quality of Life Research [ISOQOL], and the Pharmaceutical Research and Manufacturers of America [PhRMA] Health Outcomes Committee, plus Food and Drug Administration [FDA] observers). Their report is available on-line at www.mapi-research-inst.com.