COA At-a-Glance
Evidence of cognitive interviewing of draft instrument in target patient population
Evidence of internal consistency
Evidence of test-retest or inter-rater reliability
Evidence of concurrent validity
Evidence of known-groups validity
Evidence of ability to detect change over time
Evidence of responder thresholds
Inclusion of the COA in product labelling
- Overview
- Content Validity
- Reliability
- Validity
- Ability to Detect Change
- Responder Thresholds
- Reference(s) of development / validation
- Other references
- Inclusion of the COA in product labelling
- Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
- Existence of Scoring / Interpretation / User Manual
- Original language and translations
- References of translations
- Authors and contact information
- Condition of use: copyright
- Website
- Review copy
Overview
Instrument Name: Brief Pain Inventory- Short Form
Abbreviation: BPI-SF
Points for Consideration:
The BPI-SF was initially developed to assess pain related to cancer.
Description of Tool:
The BPI-SF is a 15-item PRO developed to assess the severity of pain and its impact on daily functions. Patients are asked whether they have had pain (other than minor headaches, sprains and toothaches) today, to shade on a diagram the areas where they feel pain and put an X on the area that hurts the most and to rate each item on a 11-level scale ranging from 0="No pain" to 10="Pain as bad as you can imagine". Higher scores represent greater pain severity.
Other Related Tools (if applicable):
Originally called the Wisconsin Brief Pain Questionnaire.
Brief Pain Inventory-long form (BPI), which contains additional descriptive items that may be clinically useful.
Brief Pain Inventory for diabetic peripheral neuropathy (BPI-DPN).
The authors recommend the use of the short form BPI for its brevity and for the patient’s ease of use.
Minimum Qualification Required by COA Administrator: No degree requirement
Comment:
The BPI-SF has been validated and used in adult populations including rare and non-rare disease
Year: 1983
Objective of Development:
To assess the severity of pain and the impact of pain on daily functions
Population of Development: Age range (therapeutic indication):
None identified
Pediatric Population(s) in which COA has been used:
None identified
COA type: PRO
Number of Items 15
Mode of Administration: Self-administered
Data Collection Mode: Pencil and paper and electronic self-administered or interview format.
Time for Completion: 5-minutes
Response Scales: The BPI-SF has varying response categories across items. Q1 - dichotomous Yes/No response scale Q2 - pictorial scale (front/back of a human figure) Qs 3-6 - 11-point NRS (0-10), anchors range from 0="no pain" to 10="pain as bad as you can imagine" Q7 - open-ended response box to provide details of treatments/medications Q8 - 11-point NRS (0-100%), anchors range from 0%="no relief" to 100%= "complete relief" Q9 (A-G) - 11-point numerical rating scale (0-10), anchors range from 0="does not interfere" to 10= "completely interferes"
Summary of Scoring:
Available scores: Composite pain severity score is the mean of 4 items. Composite pain interference score is the mean of 7 items, if >50% (i.e. 4 or more of 7 items) have been completed.
Weighting: No
Score Interpretation: Higher scores= Greater pain severity
Content Validity
Evidence of Literature Review: None identified
Evidence of Instrument Review: None identified
Evidence of Clinical or Expert Input: Yes
Evidence of concept elicitation in target patient population: Yes
Evidence of a Saturation Grid: None identified
Evidence for Selection of Data Collection Method: None identified
Recall/Observation Period: The BPI-SF has varying recall periods across items. Q1: Today Q2: The recall period is not specified, however infer today as follow on from Q1. Q3,4,8,9a-g: past 24 hours Q5: pain severity on average Q6: pain severity right now Q7: The recall period is not specified
Evidence for Selection of Reponse Options: Yes
Evidence of cognitive interviewing of draft instrument in target patient population: None identified
Evidence of Preliminary Scoring of Items and Domains: None identified
Evidence related to respondent and administrator burden: None identified
Evidence of a Conceptual Framework: None identified
Evidence of an item-tracking matrix: None identified
Evidence related to item selection: Yes
Evidence of re-testing the final version: Yes
Reliability
Internal consistency (Cronbach's alpha): Yes
Evidence of internal consistency: Cleeland CS (1994) Method: Cronbach's alpha Results: 0.80-0.92 Population/Disease: Outpatients with recurrent or metastatic cancer; n=1261
Test-retest Reliability (ICC):
Daut R L (1983)
Test-retest reliability
- Reliability for ratings of pain "worst" was 0.93 and ratings of pain "usual" or "average" was 0.83. Reliability for pain "now" severity was 0.59
- Was a definition of stability applied to identify stable patients: No
- Time frame between the two administrations: 1 day to 1 week
- Population/Disease: Cancer inpatients; n=20
Daut R L (1983)
Test-retest reliability
- Percentage agreements between testings for initial pain was 76%, for pain ever was 81% and pain in the past month was 67%.
- Was a definition of stability applied to identify stable patients: No
- Time frame between the two administrations: The mean time between visits was 91.4 days (range 14-224 days)
- Population/Disease: Cancer patients; n=56
Inter-rater/ inter-interviewer reliability (kappa):
None identified
Evidence of test-retest or inter-rater reliability: Yes
Validity
Concurrent validity (convergent, divergent):
None identified
Known-group validity:
None identified
Evidence of Translatability Assessment: None identified
Evidence related to missing data: None identified
Evidence for Selection of Recall Period: None identified
Evidence of Administration Instructions and Training Provided: None identified
Evidence of concurrent validity: None identified
Evidence of known-groups validity: None identified
Evidence of ability to detect change over time: None identified
Ability to Detect Change
Ability to detect change (Responsiveness):
None identified
Responder Thresholds
Responder Thresholds:
None identified
Evidence of responder thresholds: None identified
Reference(s) of development / validation
Cleeland, C. S., & Ryan, K. M. (1994). Pain assessment: global use of the Brief Pain Inventory. Annals of the Academy of Medicine, Singapore, 23(2), 129–138. Full Text Article: https://www.scopus.com/record/display.uri?eid=2-s2.0-0028395482&origin=inward&txGid=f3db9a5a73a9f0aa2a2d115b15716cc0
Daut, R. L., Cleeland, C. S., & Flanery, R. C. (1983). Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain, 17(2), 197–210. Full Text Article: https://pubmed.ncbi.nlm.nih.gov/6646795/
Development history described: https://www.mdanderson.org/content/dam/mdanderson/documents/Departments-and-Divisions/Symptom-Research/BPI_UserGuide.pdf
Other references
Regulatory endorsement: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-medicinal-products-intended-treatment-pain-second-draft_en.pdf
Translations: https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html
Inclusion of the COA in product labelling
Yes
Inclusion of the COA in product labelling (agency, drug, drug approval date, COA results) from PROLABELS search
Agency: EMA
Drug: Xgeva (BIOSIMILAR), denosumab
Drug approval date: 12-Jul-2011
Revision date: 24-Jan-2024
Therapeutic indication: Giant Cell Tumor of Bone
COA results: Tertiary/Exploratory endpoints
Age: skeletally mature adolescents (aged 13-17 years)
Agency: FDA
Drug: Cymbalta
Drug approval date: 19-Apr-2020
Revision date:17-Aug-2023
Therapeutic indication: Fibromyalgia
COA results: Primary endpoint
Age: 13 years and older
Existence of Scoring / Interpretation / User Manual
Yes
Original language and translations
Original language: English for the US
Translations:
Amharic
Afrikaans
Arabic
Bahasa Indonesia (in process)
Bengali
Bulgarian
Cebuano
Chinese (Simplified)
Chinese (Traditional)
Croatian
Danish
Dutch
Czech
English
Estonian
Farsi
Filipino
Finnish
French
German
Georgian
Greek
Gujarati
Hebrew
Hiligaynon
Hindi
Hungarian
Icelandic
Ilocano
Italian
Indonesian
Japanese
Kannada
Korean
Malay
Latvian
Lithuanian
Luganda
Norwegian
Malayalam
Marathi
Oriya
Polish
Portuguese (Brazil)
Portuguese (Portugal)
Punjabi
Romanian
Runyankole
Russian
Nepali (in process)
Serbian
Sesotho
Sinhala
Slovak
Slovenian
Spanish
Sotho
Swahili
Swedish
Tamil
Telugu
Thai
Turkish
Ukrainian
Urdu
Vietnamese
Welsh
Xhosa
Zulu
Contact for other translations: symptomresearch@mdanderson.org.
References of translations
None identified
Condition of use: copyright
BPI-SF © Copyright 1991 Charles S. Cleeland, PhD. Pain Research Group – Used by permission. All rights reserved.
The BPI may not be used or reproduced without permission from Charles S. Cleeland, PhD or his designee. Fees for use may apply.
Permission to alter or translate the instrument may be obtained by contacting Dr Charles S. Cleeland either by e-mail at symptomresearch@mdanderson.org or by main at:
Charles S. Cleeland, PhD
Professor and Chair, Department of Symptom Research
The University of Texas M. D. Anderson Cancer Center
1515 Holcombe Boulevard, Unit 1450
Houston, Texas 77030
Website
https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html
Review copy
Review copy available here: https://www.mdanderson.org/documents/Departments-and-Divisions/Symptom-Research/BPI-SF_English-24h_Original_SAMPLE.pdf