The Argument-Based Approach to Validity Applied to Clinical Outcome Assessments: Some History and Notable Features
Abstract
Developing and evaluating clinical outcome assessments (COAs) requires a framework for understanding validity. The validity framework reflected in the most recent draft guidance from the US Food and Drug Administration is the argument-based approach. In this approach, a researcher should state how they would like to interpret or use scores from some measure, identify key assumptions that need to be true for the proposed interpretation/use to be justified, and evaluate evidence for or against those key assumptions. If the collection of assumptions, known as the rationale, has convincing evidence, then a decision is made that the proposed interpretation or use of scores is valid. In this article, I briefly review how this approach to validity that has been developed within educational and psychological testing has recently made its way into COAs. I then discuss several notable features of the argument-based approach that have implications for how COAs are developed and evaluated.
Identifier Metadata
| Identifier | 110.0602/CON.2026.00576 |
| Canonical | mdoi:110.0602/CON.2026.00576 |
| Resolver URL | https://mdoi.org/110.0602/CON.2026.00576 |
| Resource URL | Open resource |
| Document URL | Open document |
| Content Type | Article |
| Authors | Kevin P. Weinfurt, PhD |
| Year | 2025 |
| Depositor | Convergence Chronicles Organisation |
| Prefix | 110.0602 |
| Registered | July 13, 2026 |
| Updated | July 13, 2026 |
| Status | Active |
| Visibility | Public |
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