- •Substantial variability exists in how patients are asked to rate pain intensity.
- •Measures based on patient input may be more valid and meaningful.
- •This study describes the initial development of pain intensity measures.
- •Procedures aligned with US FDA's Clinical Outcome Assessment Qualification Program.
- •Measures will be further evaluated in cognitive interviews and quantitative studies.
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Financial support for this article was provided by the ACTTION public-private partnership with the FDA, which has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, philanthropy, and other sources. No official endorsement by the FDA or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of ACTTION should be inferred. The views expressed in this article are those of the authors, none of whom have conflicts of interest related to the specific issues discussed in this article.