Since the 1970’s epidemiological measures focusing on “health-related quality of life” have figured increasingly as endpoints in clinical trials. Before the 1970’s these measures were known, generically, as functional measures or health status measures. Relabeled as “quality of life measures” they were first used in cancer trials. They were relabeled again in the early 2000’s as “patient-reported outcome measures” or PROMs, in their service to the FDA to support drug labeling claims. Despite their importance in medicine over the past seventy years, remarkably little historical research has been done on them. This is problematic. First, lacking a historical account, the quality of life literature itself fails to recognize how certain themes have developed, themes that should inform current practice. Second, adjunct literatures, such as philosophy, misappropriate these instruments in terms of quality of life measures originating in economics and development—measures that are more familiar to philosophical analysis.
I begin by discussing their history by linking their contemporary significance to two post-WWII trends: standardization of medical decisions and the autonomy model in medical ethics. I will show how these instruments set themselves apart from other categories of quality of life measurement by their commitment to “capturing patients’ perspectives”. This commitment, evident in high impact journals, policy bodies and funding agencies, creates an interesting tension regarding what it means to be a “measure”. I conclude that this emphasis on patient perspectives affects the ability of researchers to settle epistemic and methodological questions.
