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The Brief Pain Inventory and Its “Pain At Its Worst in the Last 24 Hours” Item: Clinical Trial Endpoint Considerations
Open accessAbstract
CONTEXT: In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it may provide a blueprint for evaluations of PRO measures that can be considered by sponsors and investigators involved in PRO research and drug registration trials. OBJECTIVE: In this review we examine the short form of the Brief Pain Inventory (BPI) and particularly the "pain at its worst in the last 24 hours" item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint. RESULTS AND CONCLUSIONS: After a systematic evaluation of the psychometric aspects of the BPI, we conclude that the BPI and its "pain at its worst in the last 24 hours" item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect. Nonetheless, when the BPI is being considered for assessment of pain endpoints in a registration trial, sponsors and investigators should consult with the appropriate FDA division early during research design to discuss whether there is sufficient precedent to use the instrument in the population of interest or whether additional evaluations of measurement properties are advisable.
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“This measure is widely used with cancer patients, has evidence of reliability and validity, and is considered the preferred method of assessing pain endpoints.”
From Greater mindfulness associated with lower pain, fatigue, and psychological distress in women with metastatic breast cancer. (2020) · cites this paper as [18]
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Metadata
- Authors
- Atkinson, T. M., Mendoza, T. R., Sit, L., Passik, S., Scher, H. I., Cleeland, C., & Basch, E.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- Corresponding author
- Atkinson, Thomas M.
- Venue
- Pain Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-03
- Volume
- 11
- Issue
- 3
- Pages
- 337-346
- ISSN
- 1526-2375 (ISSN-L)
- 1526-4637
- PMC
- PMC3806650
- OpenAlex
- W1981286526
- Cited by
- 224
- References
- 59
- Citations by year
- 2026: 9 · 2025: 17 · 2024: 21 · 2023: 12 · 2022: 18 · 2021: 16 · 2020: 22 · 2019: 16 · 2018: 15 · 2017: 17 · 2016: 7 · 2015: 11 · 2014: 11 · 2013: 18 · 2012: 5
- FWCI
- 5.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Pain Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- UNC Libraries
- Funders
- National Cancer Institute (P30CA008748, T32CA009461)
- Topics
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Keywords
- Brief Pain Inventory, patient-reported outcomes, psychometric properties, FDA draft guidance, clinical trial endpoints, content validity, construct validity, registration trials, measurement properties
- MeSH terms
- Clinical Trials as Topic, Humans, Pain Measurement, United States, United States Food and Drug Administration, Reproducibility of Results, Treatment Outcome, Endpoint Determination, Pain Management
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