Brief Pain Inventory User's Guide
The Brief Pain Inventory (BPI) has become one of the most widely used measurement tools for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. Initially developed to assess pain related to cancer, the BPI has been shown to be an appropriate measure for pain caused by a wide range of clinical conditions. The BPI has been used in hundreds of studies. In some ways, the BPI is a “legacy” instrument—a self-report measure that has, over time, become a standard for the assessment of pain and its impact.
The FDA Guidance on Instrument Development
In 2006, the U. S. Food and Drug Administration (FDA) released a draft guidance for the pharmaceutical industry on the use of patient-reported outcomes (PRO) measures in medical product development to support labeling claims. The FDA draft guidance describes how the FDA evaluates PRO instruments used as effectiveness endpoints in clinical trials and details a number of considerations for PRO developers, including documentation of how the instrument was developed and evidence of its psychometric validity and reliability. Careful attention to these considerations should produce a PRO instrument that will expedite product-development discussions with the FDA, streamline FDA review of PRO endpoint adequacy and provide optimal information from the patients viewpoint about treatment benefit at the time of product approval.
In response to the FDA draft guidance, we have prepared a BPI User Guide to provide documentation of the BPI's development and psychometric properties. The information offered therein addresses the recommendations in the FDA draft guidance and establishes the BPI's adequacy as a measure to support medical product claims.
Download BPI User Guide (PDF)
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