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
Autor: | Domenico Merante, Ching Hsu, Kathryn Lasch, Mei Yang, James C Marcus, Yin Wan |
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Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
Male
medicine.medical_specialty Article Subject Statistics as Topic Pain Logistic regression law.invention 03 medical and health sciences Bridged Bicyclo Compounds 0302 clinical medicine Randomized controlled trial Diabetic Neuropathies Double-Blind Method law Post-hoc analysis Outcome Assessment Health Care Medicine Humans Hypoglycemic Agents 030212 general & internal medicine Brief Pain Inventory Pain Measurement lcsh:R5-920 Receiver operating characteristic business.industry Peripheral neuropathic pain humanities Clinical trial Anesthesiology and Pain Medicine Neurology ROC Curve Pain severity Physical therapy Female business lcsh:Medicine (General) 030217 neurology & neurosurgery Research Article |
Zdroj: | Pain Research & Management Pain Research and Management, Vol 2018 (2018) |
ISSN: | 1918-1523 1203-6765 |
Popis: | 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. |
Databáze: | OpenAIRE |
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