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.
Medical Care: April 2017 - Volume 55 - Issue 4 - p 436-441
The objective of this study is to identify modifiable factors that improve the reliability of ratings of severity of health care–associated harm in clinical practice improvement and research.
Academic Medicine: Volume 88 - Issue 11 - p 1670-1675
From 2007 through 2012, the NBME team reviewed literature in physician–patient communication, examined performance characteristics of the Step 2 CS exam, observed case development and quality assurance processes, interviewed SPs and their trainers, and reviewed video recordings of examinee–SP interactions. The authors describe perspectives gained by their team from the review process and outline the resulting enhancements to the Step 2 CS exam, some of which were rolled out in June 2012.