RESEARCH LIBRARY

Patient Education and Counseling: Volume 109, Supplement, April 2023, Page 2

Physicians' responses to patient communication were assessed by both clinically matched and unmatched analogue patients (APs). Significant correlations between their ratings indicated consistency in evaluating physician communication skills. Thematic analysis identified twenty-one common themes in both clinically matched and unmatched AP responses, suggesting similar assessments of important behaviors. These findings imply that clinically unmatched APs can effectively substitute for clinically matched ones in evaluating physician communication and offering feedback when the latter are unavailable.

Qual Life Res 27, 1711–1720 (2018)

The US Food and Drug Administration (FDA), as part of its regulatory mission, is charged with determining whether a clinical outcome assessment (COA) is “fit for purpose” when used in clinical trials to support drug approval and product labeling. This paper provides a review (and some commentary) on the current state of affairs in COA development/evaluation/use with a focus on one aspect: How do you know you are measuring the right thing? In the psychometric literature, this concept is referred to broadly as validity and has itself evolved over many years of research and application.