PMID- 30952118
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210126
IS  - 1933-0693 (Electronic)
IS  - 0022-3085 (Linking)
VI  - 132
IP  - 5
DP  - 2019 Apr 5
TI  - Comparing two randomized deep brain stimulation trials for Parkinson's disease.
PG  - 1376-1384
LID - 2018.12.JNS182042 [pii]
LID - 10.3171/2018.12.JNS182042 [doi]
AB  - OBJECTIVE: Several randomized studies have compared the effect of deep brain 
      stimulation (DBS) of the subthalamic nucleus with the best medical treatment in 
      large groups of patients. Important outcome measures differ between studies. Two 
      such major studies, the life-quality study of the German Competence Network for 
      Parkinson's disease (LQ study) and the US Veterans Affairs/National Institute of 
      Neurological Disorders and Stroke trial (VA/NINDS trial), were compared here in 
      order to understand their differences in outcomes. METHODS: Unless otherwise 
      noted, analyses were based on those subjects in each study who received a DBS 
      implant (LQ study 76 patients, VA/NINDS trial 140 patients) and who had data for 
      the measurement under consideration (i.e., no imputations for missing data), 
      referred to hereafter as the "as-treated completers" (LQ 69 patients, VA/NINDS 
      125 patients). Data were prepared and analyzed by biostatisticians at the US 
      Department of Veterans Affairs Cooperative Studies Program Coordinating Center, 
      the Coordinating Center for Clinical Trials Marburg, and Medtronic, under the 
      direction of two authors (G.D. and K.A.F.). Data were extracted from the 
      respective databases into SAS data sets and analyzed using SAS software. Analyses 
      were based on the 6-month follow-up data from both studies because this was the 
      endpoint for the LQ study. RESULTS: Pre-DBS baseline demographics differed 
      significantly between the studies, including greater levodopa responsiveness 
      (LDR) in the LQ study population than in the VA/NINDS group. After DBS, LQ 
      subjects demonstrated greater improvement in motor function (Unified Parkinson's 
      Disease Rating Scale, Motor Examination [UPDRS-III]), activities of daily living 
      (ADLs), and complications of therapy. Medication reduction and improvements in 
      life quality other than ADLs were not significantly different between LQ and 
      VA/NINDS subjects. When the two populations were compared according to pre-DBS 
      LDR, the "full responders" to levodopa (>/= 50% improvement on UPDRS-III with 
      medication) in the two studies showed no significant difference in motor 
      improvement with DBS (LQ 18.5 +/- 12.0-point improvement on UPDRS-III vs VA/NINDS 
      17.7 +/- 15.6-point improvement, p = 0.755). Among levodopa full responders, ADLs 
      improved slightly more in the LQ group, but scores on other UPDRS subscales and 
      the Parkinson's Disease Questionnaire-39 were not significantly different between 
      the two studies. CONCLUSIONS: This comparison suggests that patient selection 
      criteria, especially preoperative LDR, are the most important source of 
      differences in motor outcomes and quality of life between the two studies.
FAU - Deuschl, Gunther
AU  - Deuschl G
AD  - 1Department of Neurology, Universitatsklinikum Schleswig-Holstein, Kiel Campus, 
      Christian-Albrechts-University Kiel, Germany.
FAU - Follett, Kenneth A
AU  - Follett KA
AD  - 2Division of Neurosurgery, University of Nebraska Medical Center.
AD  - 3VA Medical Center, Omaha, Nebraska.
FAU - Luo, Ping
AU  - Luo P
AD  - 4Department of Veterans Affairs Cooperative Studies Program Coordinating Center, 
      Edward Hines Jr. VA Hospital, Hines, Illinois.
FAU - Rau, Joern
AU  - Rau J
AD  - 5The Coordinating Center for Clinical Trials, Philipps University, Marburg, 
      Germany.
FAU - Weaver, Frances M
AU  - Weaver FM
AD  - 6Center of Innovation for Complex Chronic Health Care, Edward Hines Jr. VA 
      Hospital, Hines, Illinois.
FAU - Paschen, Steffen
AU  - Paschen S
AD  - 1Department of Neurology, Universitatsklinikum Schleswig-Holstein, Kiel Campus, 
      Christian-Albrechts-University Kiel, Germany.
FAU - Steigerwald, Frank
AU  - Steigerwald F
AD  - 7Department of Neurology, University Hospital and Julius-Maximilian-University, 
      Wuerzburg, Germany; and.
FAU - Tonder, Lisa
AU  - Tonder L
AD  - 8Medtronic, Inc., Minneapolis, Minnesota.
FAU - Stoker, Valerie
AU  - Stoker V
AD  - 7Department of Neurology, University Hospital and Julius-Maximilian-University, 
      Wuerzburg, Germany; and.
FAU - Reda, Domenic J
AU  - Reda DJ
AD  - 4Department of Veterans Affairs Cooperative Studies Program Coordinating Center, 
      Edward Hines Jr. VA Hospital, Hines, Illinois.
LA  - eng
PT  - Journal Article
DEP - 20190405
PL  - United States
TA  - J Neurosurg
JT  - Journal of neurosurgery
JID - 0253357
SB  - IM
OTO - NOTNLM
OT  - Parkinson's disease
OT  - deep brain stimulation
OT  - functional neurosurgery
OT  - outcomes
EDAT- 2019/04/06 06:00
MHDA- 2019/04/06 06:01
CRDT- 2019/04/06 06:00
PHST- 2018/07/26 00:00 [received]
PHST- 2018/12/18 00:00 [accepted]
PHST- 2019/04/06 06:00 [pubmed]
PHST- 2019/04/06 06:01 [medline]
PHST- 2019/04/06 06:00 [entrez]
AID - 2018.12.JNS182042 [pii]
AID - 10.3171/2018.12.JNS182042 [doi]
PST - epublish
SO  - J Neurosurg. 2019 Apr 5;132(5):1376-1384. doi: 10.3171/2018.12.JNS182042.