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.