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Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study.

  • Martinez-Martin P Center for Networked Biomedical Research in Neurodegenerative Diseases (CIBERNED), Carlos III Institute of Health, Madrid, Spain.
  • Deuschl G Department of Neurology, UKSH, Kiel Campus Christian-Albrechts-University, Kiel, Germany.
  • Tonder L Medtronic, Minneapolis, Minnesota, United States of America.
  • Schnitzler A Department of Neurology, Institute of Clinical Neuroscience and Medical Psychology, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany.
  • Houeto JL Department of Neurology, CIC-INSERM 1402, CHU of Poitiers, University of Poitiers, Poitiers, France.
  • Timmermann L Universitätsklinikum Giessen und Marburg, Marburg Campus, Marburg, Germany.
  • Rau J The Coordinating Center for Clinical Trials, Philipps University, Marburg, Germany.
  • Schade-Brittinger C The Coordinating Center for Clinical Trials, Philipps University, Marburg, Germany.
  • Stoker V Medtronic, Minneapolis, Minnesota, United States of America.
  • Vidailhet M Department of Neurology, Sorbonne Université, ICM UMR1127, INSERM &1127, CNRS 7225, Salpêtriere University Hospital, AP-HP, Paris, France.
  • Krack P Department of Neurology, University Hospital Bern, University of Bern, Bern, Switzerland.
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  • 2020-08-22
Published in:
  • PloS one. - 2020
Activities of Daily Living
Cohort Studies
Deep Brain Stimulation
Humans
Levodopa
Middle Aged
Parkinson Disease
Quality of Life
Severity of Illness Index
Treatment Outcome
English The EARLYSTIM Study compared deep brain stimulation (DBS) with best medical treatment (BMT) over 2-years, showing a between-group difference of 8.0 from baseline in favor of DBS in health-related quality of life (HRQoL), measured with the PDQ-39 SI (summary index). This study obtained complementary information about the importance of the change in HRQoL as measured by the PDQ-39, using anchor-based (Patient Global Impression of Change, PGIC) and distribution-based techniques (magnitude of change, effect size, thresholds, distribution of benefit) applied to the EARLYSTIM study data. Anchor-based techniques showed a difference follow-up-baseline for patients who reported "minimal improvement" of -5.8 [-9.9, -1.6] (mean [95%CI]) in the DBS group vs -2.9 [-9.0, 3.1] in the BMT group. As the vast majority (80.8%) of DBS patients reported "much or very much improvement", this difference was explored for the latter group and amounted to -8.7 for the DBS group and -6.5 in the BMT group. Distribution-based techniques that analyzed the relative change and treatment effect size showed a moderate benefit of the DBS on the HRQoL, whereas a slight worsening was observed in the BMT group. The change in the DBS group (-7.8) was higher than the MIC (Minimally Important Change) estimated value (-5.8 by the anchor; -6.3 by triangulation of thresholds), but not in the BMT (0.2 vs. -3.0 to -5.4, respectively). Almost 90% of the patients in the DBS group declared some improvement (58.3% and 56.7% beyond the estimated MIC), which was significantly different from the BMT group whose proportions were 32.0% and 30.3%, respectively. The number needed to treat to improve ≥1 MIC by DBS vs BMT was 3.8. Change in depression, disability and pain influenced the improvement of the DBS group. DBS improved HRQoL in a high proportion of patients to a significant and moderate degree, at 2 years follow-up.
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  • English
Open access status
gold
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https://roar.hep-bejune.ch/global/documents/123311
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