An Assessment of Clinically Important Differences on the Worst Pain Severity Item of the Modified Brief Pain Inventory in Patients with Diabetic Peripheral Neuropathic Pain

Overview

Journal Pain Res Manag

Date 2018 Aug 25

PMID 30140328

Citations 7

Authors

James Marcus

Kathryn Lasch

Yin Wan

Mei Yang

Ching Hsu

Domenico Merante

Affiliations

Soon will be listed here.

Abstract

Objectives: Using patient global impression of change (PGIC) as an anchor, an approximately 30% reduction on an 11-point numeric pain intensity rating scale (PI-NRS) is considered a clinically important difference (CID) in pain. Our objective was to define the CID for another pain measure, the worst pain severity (WPS) item of the modified Brief Pain Inventory (m-BPI).

Methods: In this post hoc analysis of a double-blind, placebo-controlled, phase 2 study, 452 randomized patients with diabetic peripheral neuropathic pain (DPNP) were followed over 5 weeks, with m-BPI data collected weekly and PGIC at treatment conclusion. Receiver operating characteristic (ROC) curves (via logistic regression) were used to determine the changes in the m-BPI-WPS score that best predicted ordinal clinical improvement thresholds (i.e., "minimally improved" or better) on the PGIC.

Results: Similar to the PI-NRS, a change of -3 (raw) or -33.3% from the baseline on the m-BPI-WPS optimized prediction for the "much improved" or better PGIC threshold and represents a CID. There was a high correspondence between observed and predicted PGIC categories at each PGIC threshold (ROC AUCs were 0.78-0.82).

Conclusions: Worst pain on the m-BPI may be used to assess clinically important improvements in DPNP studies. Findings require validation in larger studies.

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References

Vinik A, Rosenstock J, Sharma U, Feins K, Hsu C, Merante D . Efficacy and safety of mirogabalin (DS-5565) for the treatment of diabetic peripheral neuropathic pain: a randomized, double-blind, placebo- and active comparator-controlled, adaptive proof-of-concept phase 2 study. Diabetes Care. 2014; 37(12):3253-61. DOI: 10.2337/dc14-1044. View

Dworkin R, OConnor A, Audette J, Baron R, Gourlay G, Haanpaa M . Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc. 2010; 85(3 Suppl):S3-14. PMC: 2844007. DOI: 10.4065/mcp.2009.0649. View

Zelman D, Gore M, Dukes E, Tai K, Brandenburg N . Validation of a modified version of the brief pain inventory for painful diabetic peripheral neuropathy. J Pain Symptom Manage. 2005; 29(4):401-10. DOI: 10.1016/j.jpainsymman.2004.06.018. View

Schneider E, Ziegler D, Wilhelm S, Schacht A, Birklein F . Patient expectations in the treatment of painful diabetic polyneuropathy: results from a non-interventional study. Pain Med. 2014; 15(4):671-81. DOI: 10.1111/pme.12363. View

King M . A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res. 2011; 11(2):171-84. DOI: 10.1586/erp.11.9. View

Alleman C, Westerhout K, Hensen M, Chambers C, Stoker M, Long S . Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes Res Clin Pract. 2015; 109(2):215-25. DOI: 10.1016/j.diabres.2015.04.031. View

Sadosky A, Mardekian J, Parsons B, Hopps M, Bienen E, Markman J . Healthcare utilization and costs in diabetes relative to the clinical spectrum of painful diabetic peripheral neuropathy. J Diabetes Complications. 2014; 29(2):212-7. DOI: 10.1016/j.jdiacomp.2014.10.013. View

Atkinson T, Mendoza T, Sit L, Passik S, Scher H, Cleeland C . The Brief Pain Inventory and its "pain at its worst in the last 24 hours" item: clinical trial endpoint considerations. Pain Med. 2009; 11(3):337-46. PMC: 3806650. DOI: 10.1111/j.1526-4637.2009.00774.x. View

Ehde D, Nitsch K, Smiley J . Measurement characteristics and clinical utility of the Brief Pain Inventory-Short Form for individuals with multiple sclerosis. Rehabil Psychol. 2015; 60(4):365-6. DOI: 10.1037/rep0000065. View

10.

Cleeland C, Ryan K . Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994; 23(2):129-38. View

11.

Mendoza T, Mayne T, Rublee D, Cleeland C . Reliability and validity of a modified Brief Pain Inventory short form in patients with osteoarthritis. Eur J Pain. 2005; 10(4):353-61. DOI: 10.1016/j.ejpain.2005.06.002. View

12.

Veves A, Backonja M, Malik R . Painful diabetic neuropathy: epidemiology, natural history, early diagnosis, and treatment options. Pain Med. 2008; 9(6):660-74. DOI: 10.1111/j.1526-4637.2007.00347.x. View

13.

Jelsness-Jorgensen L, Moum B, Grimstad T, Jahnsen J, Opheim R, Berset I . Validity, Reliability, and Responsiveness of the Brief Pain Inventory in Inflammatory Bowel Disease. Can J Gastroenterol Hepatol. 2016; 2016:5624261. PMC: 4930809. DOI: 10.1155/2016/5624261. View

14.

Cleeland C . Research in cancer pain. What we know and what we need to know. Cancer. 1991; 67(3 Suppl):823-7. DOI: 10.1002/1097-0142(19910201)67:3+<823::aid-cncr2820671412>3.0.co;2-s. View

15.

Hurst H, Bolton J . Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004; 27(1):26-35. DOI: 10.1016/j.jmpt.2003.11.003. View

16.

Yang M, Qian C, Liu Y . Suboptimal Treatment of Diabetic Peripheral Neuropathic Pain in the United States. Pain Med. 2015; 16(11):2075-83. DOI: 10.1111/pme.12845. View

17.

Williams V, Smith M, Fehnel S . The validity and utility of the BPI interference measures for evaluating the impact of osteoarthritic pain. J Pain Symptom Manage. 2006; 31(1):48-57. DOI: 10.1016/j.jpainsymman.2005.06.008. View

18.

DAmato C, Morganti R, Greco C, Di Gennaro F, Cacciotti L, Longo S . Diabetic peripheral neuropathic pain is a stronger predictor of depression than other diabetic complications and comorbidities. Diab Vasc Dis Res. 2016; 13(6):418-428. DOI: 10.1177/1479164116653240. View

19.

Farrar J, Pritchett Y, Robinson M, Prakash A, Chappell A . The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders. J Pain. 2009; 11(2):109-18. DOI: 10.1016/j.jpain.2009.06.007. View

20.

Tesfaye S, Boulton A, Dickenson A . Mechanisms and management of diabetic painful distal symmetrical polyneuropathy. Diabetes Care. 2013; 36(9):2456-65. PMC: 3747929. DOI: 10.2337/dc12-1964. View