There has been much philosophical interest regarding the ‘hierarchy of evidence’ used to determine which study designs are of most value for reporting on questions of effectiveness, prognosis, and so on. There has been much less philosophical interest in the choice of outcome measures with which the results of, say, an RCT or a cohort study are presented. In this paper, we examine the FDA’s recently published guidelines for assessing the psychometric adequacy of patient-reported outcome measures. We focus on their (...) recommendations for demonstrating content validity and also for how researchers should weigh up the sum of psychometric evidence when choosing these measures. We argue that questions regarding judgment and understanding meaning of these measures should play a more central role in determining their adequacy. (shrink)

Since the 1970’s epidemiological measures focusing on “health-related quality of life” or simply “quality of life” have figured increasingly as endpoints in clinical trials. Before the 1970’s these measures were known, generically, as performance measures or health status measures. Relabeled as “quality of life measures” they were first used in cancer trials. In the early 2000’s they were relabeled again as “patient-reported outcome measures” or PROMs, in their service to the FDA to support drug labeling claims. To the limited degree (...) that the philosophical literature addresses these measures, it tends to associate them with two major theories of well-being: subjective well-being and the capabilities approach. In this paper, I argue that philosophers ought to treat quality of life measures/proms as a distinct from these theories. I argue that quality of life/proms serve healthcare as vehicles for patient-centered care and this has important consequences for how we theorize these measures. To this end, two requirements set them apart from measures of subjective well-being and the capabilities approach: quality of life/proms need to be patient-directed and inclusive. (shrink)

In this paper I discuss how we should distinguish legitimate from illegitimate questions. I will argue that we should not make such distinctions prior to asking our questions; that questioning is more of an art than a science and that this art is part of the art of conversation in general. Nonetheless, the desire to limit in advance the questions that we can legitimately ask is not infrequent. In the philosophy of science this ambition manifests in response to concerns regarding (...) the corruption of scientific knowledge and inquiry. Similarly in the quantitative social sciences researchers develop measures by isolating in advance just those questions that they believe will best illuminate the construct under investigation. In order to preserve the integrity of their data much is done to avoid and adjust for errant respondent understandings of these questions. I argue, however, that limiting our questions in these ways does not secure knowledge and inquiry from bias, but rather unduly limits what we might come to know. Drawing on Gadamer’s work in Truth and Method I argue that we can distinguish legitimate from illegitimate questions, but that we can only do so by first asking them. (shrink)