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

James Marcus, Kathryn Lasch, Yin Wan, Mei Yang, Ching Hsu, Domenico Merante, James Marcus, Kathryn Lasch, Yin Wan, Mei Yang, Ching Hsu, Domenico Merante

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.

Figures

Figure 1
Figure 1
Box plot of raw change in the m-BPI score from the baseline to week 5/end of study by PGIC categories. The center line inside the box represents the median, the box's hinges are the 25th and 75th percentile, the whiskers bound the central 95 percent of the distribution, the circles beyond the whiskers are outliers, and the diamond represents the mean. BPI, Brief Pain Inventory; m-BPI, modified Brief Pain Inventory; PGIC, patient global impression of change.
Figure 2
Figure 2
ROC curve of raw change in the m-BPI-WPS score from the baseline to week 5/end of the study and PGIC. AUC, area under the curve; m-BPI-WPS, modified Brief Pain Inventory-worst pain severity; ROC, receiver operating characteristic.
Figure 3
Figure 3
ROC curve of percentage change in the m-BPI-WPS score from the baseline to week 5/end of the study and PGIC. AUC, area under the curve; m-BPI-WPS, modified Brief Pain Inventory-worst pain severity; PGIC, patient global impression of change; ROC, receiver operating characteristic.

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