Future role of quality-of-life assessment in outcomes research 'l hope to sensitize various investigators to the importance ot the precise use ot language and, in particular, to examine the intellectual history that is connected to such important con

摘要

Historians will confirm that the upsurge of interest in quality-of-life research during the last 30-40 years has been a major impetus to current pharmacoeconomic outcomes research, especially when applied to the medi- cally ill. More recently, the concept and assessment of quality of life has been subsumed under the label of patient-reported outcomes (PROs), with PROs including symptoms and other health status indicators. As an early witness to the establishment of the PRO concept, I can say that its development represented an effort to overcome the resistance of the US FDA to accept the patient's voice as a determinant in the selection of a drug or device. The compromise was to shift away from measuring quality indicators to measuring whatever indicators reflected the status of the person. This broadening permitted die inclusion of a variety of more biologically oriented indicators, along with various subjective qualitative indicators.