RESEARCH LIBRARY

Educational Measurement: Issues and Practice, 39: 30-36

This article proposes the conscious weight method and subconscious weight method to bring more objectivity to the standard setting process. To do this, these methods quantify the relative harm of the negative consequences of false positive and false negative misclassification.

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.