Research Article

Determination of minimal clinically important change in early and advanced Parkinson's disease†

  1. Robert A. Hauser MD1,*,
  2. Peggy Auinger MS2,
  3. on behalf of the Parkinson Study Group2

Article first published online: 24 MAR 2011

DOI: 10.1002/mds.23638

Issue

Movement Disorders

Movement Disorders

Volume 26, Issue 5, pages 813–818, April 2011

Additional Information

How to Cite

Hauser, R. A., Auinger, P. and on behalf of the Parkinson Study Group (2011), Determination of minimal clinically important change in early and advanced Parkinson's disease. Mov. Disord., 26: 813–818. doi: 10.1002/mds.23638

Author Information

  1. 1

    Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida, USA

  2. 2

    Department of Neurology, Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA

*Parkinson's Disease and Movement Disorders Center, NPF Center of Excellence, University of South Florida, 5 Tampa General Circle, Suite 410, Tampa, FL 33606, USA

  1. †

    Relevant conflict of interest/financial disclosures: Dr. Hauser has received fees from Teva Pharmaceuticals for consulting, advisory board participation, and speaker programs. Although clinical trials of rasagiline were analyzed in this study, Teva Pharmaceuticals was not involved and did not sponsor this study.This data-mining project was supported by the Parkinson's Disease Foundation's Advancing Parkinson's Treatments Innovations Grant to the Parkinson Study Group.Full financial disclosures and author roles may be found in the online version of this article.

Publication History

  1. Issue published online: 21 APR 2011
  2. Article first published online: 24 MAR 2011
  3. Manuscript Accepted: 22 NOV 2010
  4. Manuscript Revised: 14 NOV 2010
  5. Manuscript Received: 23 JUL 2010

Funded by

  • Parkinson's Disease Foundation's
  • Parkinson Study Group

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Keywords:

  • minimal clinically important change;
  • Parkinson's disease;
  • clinical global impression;
  • treatment;
  • clinical trial

Abstract

Two common primary efficacy outcome measures in Parkinson's disease (PD) are change in Unified Parkinson's Disease Rating Scale (UPDRS) scores in early PD and change in “off” time in patients with motor fluctuations. Defining the minimal clinically important change (MCIC) in these outcome measures is important to interpret the clinical relevance of changes observed in clinical trials and other situations. We analyzed data from 2 multicenter, placebo-controlled, randomized clinical trials of rasagiline; TEMPO studied 404 early PD subjects, and PRESTO studied 472 levodopa-treated subjects with motor fluctuations. An anchor-based approach using clinical global impression of improvement (CGI-I) was used to determine MCIC for UPDRS scores and daily “off” time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI-I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I–III) in early PD was determined to be −3.5 points based on mean scores and −3.0 points based on ROC curves. In addition, we found an MCIC for reduction in “off” time of 1.0 hours as defined by mean reduction in “off” time in active treated subjects self-rated as minimally improved on CGI-I minus mean reduction in “off” time in placebo-treated subjects self-rated as unchanged (1.9–0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies. © 2011 Movement Disorder Society

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