Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release
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”...
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| Format: | Article |
| Language: | English |
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Wiley
2014-01-01
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| Series: | Parkinson's Disease |
| Online Access: | http://dx.doi.org/10.1155/2014/467131 |
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| author | Robert A. Hauser Mark Forrest Gordon Yoshikuni Mizuno Werner Poewe Paolo Barone Anthony H. Schapira Olivier Rascol Catherine Debieuvre Mandy Fräßdorf |
| author_facet | Robert A. Hauser Mark Forrest Gordon Yoshikuni Mizuno Werner Poewe Paolo Barone Anthony H. Schapira Olivier Rascol Catherine Debieuvre Mandy Fräßdorf |
| author_sort | Robert A. Hauser |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-54d7f5bec96e4559aeda590d57da22b7 |
| institution | Kabale University |
| issn | 2090-8083 2042-0080 |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Parkinson's Disease |
| spelling | doaj-art-54d7f5bec96e4559aeda590d57da22b72025-08-20T03:34:20ZengWileyParkinson's Disease2090-80832042-00802014-01-01201410.1155/2014/467131467131Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended ReleaseRobert A. Hauser0Mark Forrest Gordon1Yoshikuni Mizuno2Werner Poewe3Paolo Barone4Anthony H. Schapira5Olivier Rascol6Catherine Debieuvre7Mandy Fräßdorf8University of South Florida, Parkinson’s Disease and Movement Disorders Center, Byrd Institute, National Parkinson Foundation Center of Excellence, Tampa, FL 33613, USABoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877, USADepartment of Neurology, Juntendo University School of Medicine, Tokyo 113-8421, JapanDepartment of Neurology, Innsbruck Medical University, Innsbruck, AustriaCenter for Neurodegenerative Diseases, Department of Medicine and Surgery, University of Salerno, Salerno, ItalyDepartment of Clinical Neurosciences, University College London Institute of Neurology, London, UKClinical Investigation Center, INSERM CIC-9302 and UMR-825 and Departments of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, Toulouse, FranceBoehringer Ingelheim France S.A.S., Reims, FranceBoehringer Ingelheim Pharmaceuticals, GmbH & Co. KG, Ingelheim, GermanyBackground. 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.http://dx.doi.org/10.1155/2014/467131 |
| spellingShingle | Robert A. Hauser Mark Forrest Gordon Yoshikuni Mizuno Werner Poewe Paolo Barone Anthony H. Schapira Olivier Rascol Catherine Debieuvre Mandy Fräßdorf Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release Parkinson's Disease |
| title | Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release |
| title_full | Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release |
| title_fullStr | Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release |
| title_full_unstemmed | Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release |
| title_short | Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release |
| title_sort | minimal clinically important difference in parkinson s disease as assessed in pivotal trials of pramipexole extended release |
| url | http://dx.doi.org/10.1155/2014/467131 |
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