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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
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.
Authors
J Marcus, K Lasch, Y Wan, M Yang, C Hsu, D Merante
Journal
Pain Research and Management
Therapeutic Area
Endocrinology and metabolism
Center of Excellence
Patient-Centered outcomes
Year
2018
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