PMID- 30140328
OWN - NLM
STAT- MEDLINE
DCOM- 20181121
LR  - 20191210
IS  - 1918-1523 (Electronic)
IS  - 1203-6765 (Print)
IS  - 1203-6765 (Linking)
VI  - 2018
DP  - 2018
TI  - 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.
PG  - 2140420
LID - 10.1155/2018/2140420 [doi]
LID - 2140420
AB  - 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.
FAU - Marcus, James
AU  - Marcus J
AUID- ORCID: 0000-0001-5223-4173
AD  - Pharmerit International, Bethesda, MD, USA.
FAU - Lasch, Kathryn
AU  - Lasch K
AUID- ORCID: 0000-0002-5332-2906
AD  - Pharmerit International, Boston, MA, USA.
FAU - Wan, Yin
AU  - Wan Y
AD  - Pharmerit International, Bethesda, MD, USA.
FAU - Yang, Mei
AU  - Yang M
AD  - Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
FAU - Hsu, Ching
AU  - Hsu C
AD  - Daiichi Sankyo, Inc., Basking Ridge, NJ, USA.
FAU - Merante, Domenico
AU  - Merante D
AD  - Daiichi Sankyo Development Ltd., Gerrards Cross, Buckinghamshire, UK.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20180722
PL  - United States
TA  - Pain Res Manag
JT  - Pain research & management
JID - 9612504
RN  - 0 (Bridged Bicyclo Compounds)
RN  - 0 (Hypoglycemic Agents)
RN  - S7LK2KDM5U (mirogabalin)
SB  - IM
MH  - Bridged Bicyclo Compounds/*therapeutic use
MH  - Diabetic Neuropathies/*complications/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Male
MH  - *Outcome Assessment, Health Care/classification/methods
MH  - *Pain/diagnosis/drug therapy/etiology
MH  - Pain Measurement/classification/*methods
MH  - ROC Curve
MH  - Statistics as Topic
PMC - PMC6081576
EDAT- 2018/08/25 06:00
MHDA- 2018/11/22 06:00
PMCR- 2018/07/22
CRDT- 2018/08/25 06:00
PHST- 2018/02/05 00:00 [received]
PHST- 2018/05/22 00:00 [accepted]
PHST- 2018/08/25 06:00 [entrez]
PHST- 2018/08/25 06:00 [pubmed]
PHST- 2018/11/22 06:00 [medline]
PHST- 2018/07/22 00:00 [pmc-release]
AID - 10.1155/2018/2140420 [doi]
PST - epublish
SO  - Pain Res Manag. 2018 Jul 22;2018:2140420. doi: 10.1155/2018/2140420. eCollection 
      2018.