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Optimizing Treatment in Undertreated Late-Stage Parkinsonism : A Pragmatic Randomized Trial

Hommel, Adrianus L.A.J. ; Meinders, Marjan J. ; Weerkamp, Nico J. ; Richinger, Carmen ; Schmotz, Christian ; Lorenzl, Stefan ; Dodel, Richard ; Coelho, Miguel ; Ferreira, Joaquim J. and Tison, Francois , et al. (2020) In Journal of Parkinson's Disease 10(3). p.1171-1184
Abstract

Background: Treatment of patients with late-stage parkinsonism is often sub-optimal. Objective: To test the effectiveness of recommendations by a movement disorder specialist with expertise in late-stage parkinsonism. Methods: Ninety-one patients with late-stage parkinsonism considered undertreated were included in apragmatic a pragmatic multi-center randomized-controlled trial with six-month follow-up. The intervention group received a letter with treatment recommendations to their primary clinician based on an extensive clinical assessment. Controls received care as usual. The primary outcome was the Unified Parkinson Disease Rating Scale (UPDRS)part-II (Activities of Daily Living). Other outcomes included quality-of-life (PDQ-8),... (More)

Background: Treatment of patients with late-stage parkinsonism is often sub-optimal. Objective: To test the effectiveness of recommendations by a movement disorder specialist with expertise in late-stage parkinsonism. Methods: Ninety-one patients with late-stage parkinsonism considered undertreated were included in apragmatic a pragmatic multi-center randomized-controlled trial with six-month follow-up. The intervention group received a letter with treatment recommendations to their primary clinician based on an extensive clinical assessment. Controls received care as usual. The primary outcome was the Unified Parkinson Disease Rating Scale (UPDRS)part-II (Activities of Daily Living). Other outcomes included quality-of-life (PDQ-8), mental health (UPDRS-I), motor function (UPDRS-III), treatment complications (UPDRS-IV), cognition (Mini-mental-state-examination), non-motor symptoms (Non-Motor-Symptoms-scale), health status (EQ-5D-5L) and levodopa-equivalent-daily-dose (LEDD). We also assessed adherence to recommendations. In addition to intention-to-treat analyses, a per-protocol analysis was conducted. Results: Sample size calculation required 288 patients, but only 91 patients could be included. Treating physicians followed recommendations fully in 16 (28%) and partially in 21 (36%) patients. The intention-to-treat analysis showed no difference in primary outcome (between-group difference=-1.2, p=0.45), but there was greater improvement for PDQ-8 in the intervention group (between-group difference=-3.7, p=0.02). The per-protocol analysis confirmed these findings, and showed less deterioration in UPDRS-part I, greater improvement on UPDRS-total score and greater increase in LEDD in the intervention group. Conclusions: The findings suggest that therapeutic gains may be reached even in this vulnerable group of patients with late-stage parkinsonism, but also emphasize that specialist recommendations need to be accompanied by better strategies to implement these to further improve outcomes.

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type
Contribution to journal
publication status
published
subject
keywords
activities of daily living, Parkinsonian disorders, quality of life, randomized controlled trial, treatment
in
Journal of Parkinson's Disease
volume
10
issue
3
pages
14 pages
publisher
IOS Press
external identifiers
  • scopus:85089127904
  • pmid:32568111
ISSN
1877-7171
DOI
10.3233/JPD-202033
language
English
LU publication?
yes
id
ba781a6f-928e-4e8b-b893-f39a6439ea71
date added to LUP
2020-08-20 09:25:03
date last changed
2024-05-29 19:13:18
@article{ba781a6f-928e-4e8b-b893-f39a6439ea71,
  abstract     = {{<p>Background: Treatment of patients with late-stage parkinsonism is often sub-optimal. Objective: To test the effectiveness of recommendations by a movement disorder specialist with expertise in late-stage parkinsonism. Methods: Ninety-one patients with late-stage parkinsonism considered undertreated were included in apragmatic a pragmatic multi-center randomized-controlled trial with six-month follow-up. The intervention group received a letter with treatment recommendations to their primary clinician based on an extensive clinical assessment. Controls received care as usual. The primary outcome was the Unified Parkinson Disease Rating Scale (UPDRS)part-II (Activities of Daily Living). Other outcomes included quality-of-life (PDQ-8), mental health (UPDRS-I), motor function (UPDRS-III), treatment complications (UPDRS-IV), cognition (Mini-mental-state-examination), non-motor symptoms (Non-Motor-Symptoms-scale), health status (EQ-5D-5L) and levodopa-equivalent-daily-dose (LEDD). We also assessed adherence to recommendations. In addition to intention-to-treat analyses, a per-protocol analysis was conducted. Results: Sample size calculation required 288 patients, but only 91 patients could be included. Treating physicians followed recommendations fully in 16 (28%) and partially in 21 (36%) patients. The intention-to-treat analysis showed no difference in primary outcome (between-group difference=-1.2, p=0.45), but there was greater improvement for PDQ-8 in the intervention group (between-group difference=-3.7, p=0.02). The per-protocol analysis confirmed these findings, and showed less deterioration in UPDRS-part I, greater improvement on UPDRS-total score and greater increase in LEDD in the intervention group. Conclusions: The findings suggest that therapeutic gains may be reached even in this vulnerable group of patients with late-stage parkinsonism, but also emphasize that specialist recommendations need to be accompanied by better strategies to implement these to further improve outcomes.</p>}},
  author       = {{Hommel, Adrianus L.A.J. and Meinders, Marjan J. and Weerkamp, Nico J. and Richinger, Carmen and Schmotz, Christian and Lorenzl, Stefan and Dodel, Richard and Coelho, Miguel and Ferreira, Joaquim J. and Tison, Francois and Boraud, Thomas and Meissner, Wassilios G. and Rosqvist, Kristina and Timpka, Jonathan and Odin, Per and Wittenberg, Michael and Bloem, Bas R. and Koopmans, Raymond T. and Schragand, Anette}},
  issn         = {{1877-7171}},
  keywords     = {{activities of daily living; Parkinsonian disorders; quality of life; randomized controlled trial; treatment}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{1171--1184}},
  publisher    = {{IOS Press}},
  series       = {{Journal of Parkinson's Disease}},
  title        = {{Optimizing Treatment in Undertreated Late-Stage Parkinsonism : A Pragmatic Randomized Trial}},
  url          = {{http://dx.doi.org/10.3233/JPD-202033}},
  doi          = {{10.3233/JPD-202033}},
  volume       = {{10}},
  year         = {{2020}},
}