TY - JOUR
T1 - Optimizing Treatment in Undertreated Late-Stage Parkinsonism
T2 - A Pragmatic Randomized Trial
AU - Hommel, Adrianus L.A.J.
AU - Meinders, Marjan J.
AU - Weerkamp, Nico J.
AU - Richinger, Carmen
AU - Schmotz, Christian
AU - Lorenzl, Stefan
AU - Dodel, Richard
AU - Coelho, Miguel
AU - Ferreira, Joaquim J.
AU - Tison, Francois
AU - Boraud, Thomas
AU - Meissner, Wassilios G.
AU - Rosqvist, Kristina
AU - Timpka, Jonathan
AU - Odin, Per
AU - Wittenberg, Michael
AU - Bloem, Bas R.
AU - Koopmans, Raymond T.
AU - Schragand, Anette
AU - Care of Late Stage Parkinsonism (CLaSP) Consortium
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - activities of daily living
KW - Parkinsonian disorders
KW - quality of life
KW - randomized controlled trial
KW - treatment
U2 - 10.3233/JPD-202033
DO - 10.3233/JPD-202033
M3 - Article
C2 - 32568111
AN - SCOPUS:85089127904
SN - 1877-7171
VL - 10
SP - 1171
EP - 1184
JO - Journal of Parkinson's Disease
JF - Journal of Parkinson's Disease
IS - 3
ER -