Cited by 224Pain Management and Opioid UseStatistical Methods in Clinical TrialsMusculoskeletal pain and rehabilitation

The Brief Pain Inventory and Its “Pain At Its Worst in the Last 24 Hours” Item: Clinical Trial Endpoint Considerations

Open access
Atkinson, Thomas M., Mendoza, Tito R., Sit, Laura, Passik, Steven, Scher, Howard I., Cleeland, Charles, Basch, Ethan·2010·Pain Medicine

Abstract

CONTEXT: In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity,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Brief Pain Inventory (BPI) and particularly the "pain at its worst in the last 24 hours" item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint.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BPI and its "pain at its worst in the last 24 hours" item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect.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.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1111/j.1526-4637.2009.00774.x

Cites

58 of 58 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The BPI is widely used with cancer patients, has evidence of reliability and validity, and is considered the preferred method for assessing pain endpoints.

    “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]

    The Introduction describes the BPI as frequently used in clinical trials, and the BPI Conceptual Framework section says it was designed to assess pain in cancer. The Discussion finds that its measurement properties can meet FDA draft-guidance expectations for reliability and validity and support its use as a pain endpoint. It does not call the BPI the preferred method for assessing pain endpoints. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

1 of the 59 references couldn’t be matched to a known paper.

Cited by

Sorted by citations

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
Published
2010-03
Volume
11
Issue
3
Pages
337-346
ISSN
  • 1526-2375 (ISSN-L)
  • 1526-4637
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
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 › Medicine › Pharmacology › 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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review