ORIGINAL RESEARCH ARTICLES The Brief Pain Inventory and Its "Pain At Its Worst in the Last 24 Hours" Item: Clinical Trial

Context. In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance out- lines psychometric aspects that should be consid- ered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect...