PMID- 24800101
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140506
LR  - 20220316
IS  - 2090-8083 (Print)
IS  - 2042-0080 (Electronic)
IS  - 2042-0080 (Linking)
VI  - 2014
DP  - 2014
TI  - Minimal clinically important difference in Parkinson's disease as assessed in 
      pivotal trials of pramipexole extended release.
PG  - 467131
LID - 10.1155/2014/467131 [doi]
LID - 467131
AB  - Background. The minimal clinically important difference (MCID) is the smallest 
      change in an outcome measure that is meaningful for patients. Objectives. To 
      calculate the MCID for Unified Parkinson's Disease Rating Scale (UPDRS) scores in 
      early Parkinson's disease (EPD) and for UPDRS scores and "OFF" time in advanced 
      Parkinson's disease (APD). Methods. We analyzed data from two pivotal, 
      double-blind, parallel-group trials of pramipexole ER that included pramipexole 
      immediate release (IR) as an active comparator. We calculated MCID as the mean 
      change in subjects who received active treatment and rated themselves "a little 
      better" on patient global impression of improvement (PGI-I) minus the mean change 
      in subjects who received placebo and rated themselves unchanged. Results. MCIDs 
      in EPD (pramipexole ER, pramipexole IR) for UPDRS II were -1.8 and -2.0, for 
      UPDRS III -6.2 and -6.1, and for UPDRS II + III -8.0 and -8.1. MCIDs in APD for 
      UPDRS II were -1.8 and -2.3, for UPDRS III -5.2 and -6.5, and for UPDRS II + III 
      -7.1 and -8.8. MCID for "OFF" time (pramipexole ER, pramipexole IR) was -1.0 and 
      -1.3 hours. Conclusions. A range of MCIDs is emerging in the PD literature that 
      provides the basis for power calculations and interpretation of clinical trials.
FAU - Hauser, Robert A
AU  - Hauser RA
AD  - University of South Florida, Parkinson's Disease and Movement Disorders Center, 
      Byrd Institute, National Parkinson Foundation Center of Excellence, Tampa, FL 
      33613, USA.
FAU - Gordon, Mark Forrest
AU  - Gordon MF
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877, USA.
FAU - Mizuno, Yoshikuni
AU  - Mizuno Y
AD  - Department of Neurology, Juntendo University School of Medicine, Tokyo 113-8421, 
      Japan.
FAU - Poewe, Werner
AU  - Poewe W
AUID- ORCID: 0000-0003-4367-0971
AD  - Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.
FAU - Barone, Paolo
AU  - Barone P
AD  - Center for Neurodegenerative Diseases, Department of Medicine and Surgery, 
      University of Salerno, Salerno, Italy.
FAU - Schapira, Anthony H
AU  - Schapira AH
AD  - Department of Clinical Neurosciences, University College London Institute of 
      Neurology, London, UK.
FAU - Rascol, Olivier
AU  - Rascol O
AD  - Clinical Investigation Center, INSERM CIC-9302 and UMR-825 and Departments of 
      Clinical Pharmacology and Neurosciences, Toulouse University Hospital, Toulouse, 
      France.
FAU - Debieuvre, Catherine
AU  - Debieuvre C
AD  - Boehringer Ingelheim France S.A.S., Reims, France.
FAU - Frassdorf, Mandy
AU  - Frassdorf M
AD  - Boehringer Ingelheim Pharmaceuticals, GmbH & Co. KG, Ingelheim, Germany.
LA  - eng
PT  - Journal Article
DEP - 20140401
PL  - United States
TA  - Parkinsons Dis
JT  - Parkinson's disease
JID - 101539877
PMC - PMC3995302
EDAT- 2014/05/07 06:00
MHDA- 2014/05/07 06:01
PMCR- 2014/04/01
CRDT- 2014/05/07 06:00
PHST- 2013/10/31 00:00 [received]
PHST- 2014/01/28 00:00 [accepted]
PHST- 2014/05/07 06:00 [entrez]
PHST- 2014/05/07 06:00 [pubmed]
PHST- 2014/05/07 06:01 [medline]
PHST- 2014/04/01 00:00 [pmc-release]
AID - 10.1155/2014/467131 [doi]
PST - ppublish
SO  - Parkinsons Dis. 2014;2014:467131. doi: 10.1155/2014/467131. Epub 2014 Apr 1.