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...
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| Format: | Article |
| Language: | English |
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Wiley
2018-01-01
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| Series: | Pain Research and Management |
| Online Access: | http://dx.doi.org/10.1155/2018/2140420 |
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| _version_ | 1832560949514469376 |
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| author | James Marcus Kathryn Lasch Yin Wan Mei Yang Ching Hsu Domenico Merante |
| author_facet | James Marcus Kathryn Lasch Yin Wan Mei Yang Ching Hsu Domenico Merante |
| author_sort | James Marcus |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-6b71a547bdfa4b93b0029707689c24ea |
| institution | Kabale University |
| issn | 1203-6765 1918-1523 |
| language | English |
| publishDate | 2018-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Pain Research and Management |
| spelling | doaj-art-6b71a547bdfa4b93b0029707689c24ea2025-02-03T01:26:19ZengWileyPain Research and Management1203-67651918-15232018-01-01201810.1155/2018/21404202140420An Assessment of Clinically Important Differences on the Worst Pain Severity Item of the Modified Brief Pain Inventory in Patients with Diabetic Peripheral Neuropathic PainJames Marcus0Kathryn Lasch1Yin Wan2Mei Yang3Ching Hsu4Domenico Merante5Pharmerit International, Bethesda, MD, USAPharmerit International, Boston, MA, USAPharmerit International, Bethesda, MD, USADaiichi Sankyo, Inc., Basking Ridge, NJ, USADaiichi Sankyo, Inc., Basking Ridge, NJ, USADaiichi Sankyo Development Ltd., Gerrards Cross, Buckinghamshire, UKObjectives. 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.http://dx.doi.org/10.1155/2018/2140420 |
| spellingShingle | James Marcus Kathryn Lasch Yin Wan Mei Yang Ching Hsu Domenico Merante 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 Pain Research and Management |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | assessment of clinically important differences on the worst pain severity item of the modified brief pain inventory in patients with diabetic peripheral neuropathic pain |
| url | http://dx.doi.org/10.1155/2018/2140420 |
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