Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release
Joint Authors
Schapira, Anthony H. V.
Hauser, Robert A.
Gordon, Mark Forrest
Mizuno, Yoshikuni
Poewe, Werner
Barone, Paolo
Debieuvre, Catherine
Fräßdorf, Mandy
Rascol, Olivier
Source
Issue
Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2014-04-01
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Hauser, Robert A.& Gordon, Mark Forrest& Mizuno, Yoshikuni& Poewe, Werner& Barone, Paolo& Schapira, Anthony H. V.…[et al.]. 2014. Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release. Parkinson’s Disease،Vol. 2014, no. 2014, pp.1-8.
https://search.emarefa.net/detail/BIM-1047208
Modern Language Association (MLA)
Hauser, Robert A.…[et al.]. Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release. Parkinson’s Disease No. 2014 (2014), pp.1-8.
https://search.emarefa.net/detail/BIM-1047208
American Medical Association (AMA)
Hauser, Robert A.& Gordon, Mark Forrest& Mizuno, Yoshikuni& Poewe, Werner& Barone, Paolo& Schapira, Anthony H. V.…[et al.]. Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release. Parkinson’s Disease. 2014. Vol. 2014, no. 2014, pp.1-8.
https://search.emarefa.net/detail/BIM-1047208
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1047208