Minimal clinically important change on the Unified Parkinson;S Disease Rating Scale
Royal Free and University College Medical School, University College London, London, United Kingdom. Movement Disorders
(Impact Factor: 5.68).
08/2006; 21(8):1200-7. DOI: 10.1002/mds.20914
The Unified Parkinson's Disease Rating Scale (UPDRS) is the main outcome measure in clinical trials of Parkinson's disease (PD). The minimal change that represents a clinically meaningful improvement is unknown. The objective of this study was to determine the minimal change on the UPDRS that represents a clinically meaningful improvement in early PD after 6 months of treatment. Data from two independent randomized treatment trials over 6 months involving 603 patients with de novo PD were analyzed to determine the minimal clinically important change (MCIC), referred to the status before treatment, for the UPDRS motor, activities of daily living (ADL), and total scores. An anchor-based method using ratings on a seven-point global clinical improvement was used. A change of five points on the UPDRS motor part was found to be the most appropriate cutoff score for all Hoehn and Yahr stages I to III, and a change of eight points for the UDPRS total score. For the UDPRS ADL score, an MCIC of two points for Hoehn and Yahr stages I/I.5 and II and of three points for Hoehn and Yahr stage II.5/III was the most appropriate cutoff score. These data give the first estimate for cutoffs defining clinically important changes in UPDRS ADL and motor scores. Further studies using larger databases from more diverse study populations are encouraged to better define and solidify the MCIC for the UPDRS.
Available from: Walter Maetzler
- "From the 44 patients included in this study, 5 showed changes in the UPDRS III scores between 0 and 2 points, which was considered clinically not meaningful (Schrag et al., 2006;Shulman et al., 2010) and led to the exclusion of these patients from further analysis. The remaining 39 PD patients showed an improvement in the score of ≥5 points during On-compared to Off-medication, which was considered clinically significant (Schrag et al., 2006;Shulman et al., 2010). Detailed demographic and clinical data are presented in Table 1.-medication were only observed under single tasking conditions, and affected (1) gait velocity, (2) turning peak velocity, and (3) turning step duration. "
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ABSTRACT: Background: In Parkinson’s disease (PD), the effects of dopaminergic medication on straight walking and turning were mainly investigated under single tasking (ST) conditions. However, multitasking situations are considered more daily relevant. Methods: Thirty-nine early to moderate PD patients performed the following standarized ST and dual tasks (DT) as fast as possible for one minute during On- and Off-medication while wearing inertial sensors: straight walking and turning, checking boxes, and subtracting serial 7s. Quantitative gait parameters, as well as velocity of the secondary tasks were analyzed. Results: The following parameters improved significantly in On-medication during ST: gait velocity during straight walking (p=0.03); step duration (p=0.048) and peak velocity (p=0.04) during turning; velocity of checking boxes during ST (p=0.04) and DT (p=0.04). Velocity of checking boxes was the only parameter that also improved during DT. Conclusion: These results suggest that dopaminergic medication does not relevantly influence straight walking and turning in early to moderate PD during DT.
Available from: Joseph F Signorile
- "This current randomized controlled trial examining the effect of power training on bradykinesia and multiple upper and lower body strength and power contains analyses of significant new data from a previously reported study. Power calculations indicated that a sample size of 14 participants per group was required to detect an effect size of Cohen's d ¼ .56, a decrease of 5 points in the UPDRS motor score, a minimal clinically meaningful change for mild to moderate PD (Hoehn and Yahr stage I to III) , in the two exercise groups compared with the control group (power ¼ .8, alpha ¼ .05, "
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To evaluate the effects of PWT on bradykinesia and muscular performance in older patients with PD.
Twenty-six patients with mild to moderate PD were randomly assigned to a PWT or control group (CON). The PWT program was three months, incorporating two sessions/wk of high-speed resistance training combined balance and agility drills. Outcome measures included: upper and lower limb bradykinesia scores, one repetition maximums (1RM) and peak powers on biceps curl, chest press, leg press, hip abduction and seated calf, and quality of life (PDQ-39).
The PWT group produced significant improvement in both upper and lower limbs bradykinesia scores, 1RM and muscle peak power (p < .05), which surpassed the CON group except for power during the seated calf exercise. No significant correlations between changes in clinical measure of bradykinesia and muscle peak power were observed after training. Significant improvements were seen in the PDQ-39 overall score, subsections for mobility, activities of daily living and social support for the PWT group.
The 3-month PWT program significantly reduced bradykinesia and increased muscle strength and power in older patients with PD. Power training is an effective training modality to improve physical function and quality of life for PD.
Available from: Olivier Rascol
- "There is a paucity of MCID data based on a patient-rated tool, such as the Patient-rated Global Impression of Improvement (PGI-I). Most of the published MCID data focus on patients with early PD and come from clinical trials of ropinirole or rasagiline  , but not pramipexole. Using both PGI-I and CGI-I as anchors, we describe MCID data from two placebo-controlled studies of pramipexole extended release (ER) in patients with early PD (EPD) and advanced PD (APD). "
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ABSTRACT: 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.
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