Early versus delayed bilateral subthalamic deep brain stimulation for parkinson's disease: A decision analysis†
Corresponding Author
Alberto J. Espay MD, MSc
Department of Neurology, Movement Disorders Center, The Neuroscience Institute, University of Cincinnati, Cincinnati, Ohio, USA
Department of Neurology, University of Cincinnati, 260 Stetson St., Suite 2300, P.O. Box 670525, Cincinnati, OH 45267-0525Search for more papers by this authorJennifer E. Vaughan BPhil
Department of Neurology, Movement Disorders Center, The Neuroscience Institute, University of Cincinnati, Cincinnati, Ohio, USA
Search for more papers by this authorConnie Marras MD, PhD, FRCPC
Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada
Department of Medicine, University of Toronto, Toronto, Ontario, Canada
Search for more papers by this authorRob Fowler MD, FRCPC, MS
Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
Search for more papers by this authorMark H. Eckman MD, MS
Department of Internal Medicine, Division of General Internal Medicine, Center for Clinical Effectiveness, University of Cincinnati Medical Center, Cincinnati, Ohio, USA
Search for more papers by this authorCorresponding Author
Alberto J. Espay MD, MSc
Department of Neurology, Movement Disorders Center, The Neuroscience Institute, University of Cincinnati, Cincinnati, Ohio, USA
Department of Neurology, University of Cincinnati, 260 Stetson St., Suite 2300, P.O. Box 670525, Cincinnati, OH 45267-0525Search for more papers by this authorJennifer E. Vaughan BPhil
Department of Neurology, Movement Disorders Center, The Neuroscience Institute, University of Cincinnati, Cincinnati, Ohio, USA
Search for more papers by this authorConnie Marras MD, PhD, FRCPC
Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada
Department of Medicine, University of Toronto, Toronto, Ontario, Canada
Search for more papers by this authorRob Fowler MD, FRCPC, MS
Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada
Search for more papers by this authorMark H. Eckman MD, MS
Department of Internal Medicine, Division of General Internal Medicine, Center for Clinical Effectiveness, University of Cincinnati Medical Center, Cincinnati, Ohio, USA
Search for more papers by this authorPotential conflict of interest: Nothing to report.
Abstract
The long-term benefits of subthalamic nucleus deep brain stimulation (STN DBS) applied earlier in the disease course, before significant disability accumulates, remain to be determined. We developed a Markov state transition decision analytic model to compare effectiveness in quality-adjusted life years (QALYs) of STN DBS applied to patients with PD at an “early” (“off time” 10–20%) versus “delayed” stage (“off time” >40%). A lifelong time horizon and societal perspective were assumed. Probabilities and rates were obtained from literature review; utilities were derived using the time trade-off technique and a computer-assisted utility assessment software tool applied to a cohort of 22 STN-DBS and 21 non-STN-DBS PD patients. Uncertainty was assessed through one- and two-way sensitivity analyses and probabilistic sensitivity analysis using second-order Monte Carlo simulations. Early STN DBS was preferred with a quality-adjusted life expectancy of 22.3 QALYs, a gain of 2.5 QALYs over those with delayed surgery (19.8 QALYs). Early STN DBS was preferred in 69% of 5,000 Monte Carlo simulations. Early surgery was robustly favored through most sensitivity analyses. Delayed STN DBS afforded greater QALYs when using utility estimates exclusively from non-STN-DBS patients and, for the entire group, if the rate of motor progression were to exceed 25% per year. Although decision modeling requires assumptions and simplifications, our exploratory analysis suggests that STN DBS performed in early PD may convey greater quality-adjusted life expectancy when compared to a delayed procedure. These findings support further evaluation of early STN DBS in a controlled clinical trial. © 2010 Movement Disorder Society
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REFERENCES
- 1 Limousin P,Pollak P,Benazzouz A, et al. Bilateral subthalamic nucleus stimulation for severe Parkinson's disease. Mov Disord 1995; 10: 672–674.
- 2 Herzog J,Volkmann J,Krack P, et al. Two-year follow-up of subthalamic deep brain stimulation in Parkinson's disease. Mov Disord 2003; 18: 1332–1337.
- 3 Kleiner-Fisman G,Fisman DN,Sime E,Saint-Cyr JA,Lozano AM,Lang AE. Long-term follow up of bilateral deep brain stimulation of the subthalamic nucleus in patients with advanced Parkinson disease. J Neurosurg 2003; 99: 489–495.
- 4 Rodriguez-Oroz MC,Zamarbide I,Guridi J,Palmero MR,Obeso JA. Efficacy of deep brain stimulation of the subthalamic nucleus in Parkinson's disease 4 years after surgery: double blind and open label evaluation. J Neurol Neurosurg Psychiatry 2004; 75: 1382–1385.
- 5 Pinter MM,Alesch F,Murg M,Seiwald M,Helscher RJ,Binder H. Deep brain stimulation of the subthalamic nucleus for control of extrapyramidal features in advanced idiopathic parkinson's disease: one year follow-up. J Neural Transm 1999; 106: 693–709.
- 6 Defer GL,Widner H,Marie RM,Remy P,Levivier M. Core assessment program for surgical interventional therapies in Parkinson's disease (CAPSIT-PD). Mov Disord 1999; 14: 572–584.
- 7 Morgante L,Morgante F,Moro E, et al. How many parkinsonian patients are suitable candidates for deep brain stimulation of subthalamic nucleus? Results of a questionnaire. Parkinsonism Relat Disord 2007; 13: 528–531.
- 8 Schupbach M,Gargiulo M,Welter ML, et al. Neurosurgery in Parkinson disease: a distressed mind in a repaired body? Neurology 2006; 66: 1811–1816.
- 9 Lang AE,Widner H. Deep brain stimulation for Parkinson's disease: patient selection and evaluation. Mov Disord 2002; 17 ( Suppl 3): S94–S101.
- 10 Volkmann J. Deep brain stimulation for the treatment of Parkinson's disease. J Clin Neurophysiol 2004; 21: 6–17.
- 11 Kleiner-Fisman G,Herzog J,Fisman DN, et al. Subthalamic nucleus deep brain stimulation: summary and meta-analysis of outcomes. Mov Disord 2006; 21 ( Suppl 14): S290–S304.
- 12 Schupbach WM,Maltete D,Houeto JL, et al. Neurosurgery at an earlier stage of Parkinson disease: a randomized, controlled trial. Neurology 2007; 68: 267–271.
- 13 Charles PD. Deep brain stimulation for early stage parkinson's disease. ClinicalTrials gov 2008ClinicalTrials.gov Identifier: NCT00282152. Available at http://clinicaltrials.gov/ct2/show/NCT00282152.
- 14 Deuschl G; German Parkinson Study Group (GPS). Controlled trial of deep brain stimulation in early patients with Parkinson's disease. ClinicalTrials gov 2008ClinicalTrials.gov Identifier: NCT00354133. Available at http://clinicaltrials.gov/ct2/show/NCT00354133.
- 15 Brauer CA,Bozic KJ. Using observational data for decision analysis and economic analysis. J Bone Joint Surg Am 2009; 91 ( Suppl 3): 73–79.
- 16 Inadomi JM. Decision analysis and economic modelling: a primer. Eur J Gastroenterol Hepatol 2004; 16: 535–542.
- 17 Umemura A,Jaggi JL,Hurtig HI, et al. Deep brain stimulation for movement disorders: morbidity and mortality in 109 patients. J Neurosurg 2003; 98: 779–784.
- 18 Lyons KE,Wilkinson SB,Overman J,Pahwa R. Surgical and hardware complications of subthalamic stimulation: a series of 160 procedures. Neurology 2004; 63: 612–616.
- 19 Beric A,Kelly PJ,Rezai A, et al. Complications of deep brain stimulation surgery. Stereotact Funct Neurosurg 2001; 77: 73–78.
- 20 Jaggi JL,Umemura A,Hurtig HI, et al. Bilateral stimulation of the subthalamic nucleus in Parkinson's disease: surgical efficacy and prediction of outcome. Stereotact Funct Neurosurg 2004; 82: 104–114.
- 21 Jankovic J,Kapadia AS. Functional decline in Parkinson disease. Arch Neurol 2001; 58: 1611–1615.
- 22 Alves G,Wentzel-Larsen T,Aarsland D,Larsen JP. Progression of motor impairment and disability in Parkinson disease: a population-based study. Neurology 2005; 65: 1436–1441.
- 23 Hilker R,Schweitzer K,Coburger S, et al. Nonlinear progression of Parkinson disease as determined by serial positron emission tomographic imaging of striatal fluorodopa F 18 activity. Arch Neurol 2005; 62: 378–382.
- 24 Galvin JE. Cognitive change in Parkinson disease. Alzheimer Dis Assoc Disord 2006; 20: 302–310.
- 25 Anderson KE. Dementia in Parkinson's disease. Curr Treat Options Neurol 2004; 6: 201–207.
- 26 Office of Vital Records and Statistics (VRS). Utah's Vital Statistics—Births and Deaths 2002. Salt Lake City, Utah; 2004. Report No.: 225.
- 27 Factor SA,Feustel PJ,Friedman JH, et al. Longitudinal outcome of Parkinson's disease patients with psychosis. Neurology 2003; 60: 1756–1761.
- 28 Schrag A,Ben Shlomo Y,Brown R,Marsden CD,Quinn N. Young-onset Parkinson's disease revisited—clinical features, natural history, and mortality. Mov Disord 1998; 13: 885–894.
- 29 Vingerhoets FJ,Villemure JG,Temperli P,Pollo C,Pralong E,Ghika J. Subthalamic DBS replaces levodopa in Parkinson's disease: two-year follow-up. Neurology 2002; 58: 396–401.
- 30 Doubilet P,Begg CB,Weinstein MC,Braun P,McNeil BJ. Probabilistic sensitivity analysis using Monte Carlo simulation. A practical approach. Med Decis Making 1985; 5: 157–177.
- 31
Critchfield GC,Willard KE,Connelly DP.
Probabilistic sensitivity analysis methods for general decision models.
Comput Biomed Res
1986;
19:
254–265.
10.1016/0010-4809(86)90020-0 Google Scholar
- 32 Martin AJ,Glasziou PP,Simes RJ,Lumley T. A comparison of standard gamble, time trade-off, and adjusted time trade-off scores. Int J Technol Assess Health Care 2000; 16: 137–147.
- 33 Stiggelbout AM,Kiebert GM,Kievit J,Leer JW,Habbema JD,De Haes JC. The “utility” of the time trade-off method in cancer patients: feasibility and proportional trade-off. J Clin Epidemiol 1995; 48: 1207–1214.
- 34 Gonzalez EF,Eckman MH,Pauker SG. “Gambler”: a computer workstation for patient utility assessment. Med Decis Making 1992; 12: 350.
- 35 Fryback DG,Lawrence WF,Martin PA,Klein R,Klein BE. Predicting quality of well-being scores from the SF-36: results from the Beaver Dam Health Outcomes Study. Med Decis Making 1997; 17: 1–9.
- 36 Marsden CD,Parkes JD. “On-off” effects in patients with Parkinson's disease on chronic levodopa therapy. Lancet 1976; 1: 292–296.
- 37 Palmer CS,Schmier JK,Snyder E,Scott B. Patient preferences and utilities for “off-time” outcomes in the treatment of Parkinson's disease. Qual Life Res 2000; 9: 819–827.
- 38 Verbaan D,Marinus J,Visser M, et al. Cognitive impairment in Parkinson's disease. J Neurol Neurosurg Psychiatry 2007; 78: 1182–1187.
- 39 Krause M,Fogel W,Mayer P,Kloss M,Tronnier V. Chronic inhibition of the subthalamic nucleus in Parkinson's disease. J Neurol Sci 2004; 219: 119–124.
- 40 Hilker R,Portman AT,Voges J, et al. Disease progression continues in patients with advanced Parkinson's disease and effective subthalamic nucleus stimulation. J Neurol Neurosurg Psychiatry 2005; 76: 1217–1221.
- 41 Aybek S,Gronchi-Perrin A,Berney A, et al. Long-term cognitive profile and incidence of dementia after STN-DBS in Parkinson's disease. Mov Disord 2007; 22: 974–981.
- 42 Oh MY,Abosch A,Kim SH,Lang AE,Lozano AM. Long-term hardware-related complications of deep brain stimulation. Neurosurgery 2002; 50: 1268–1274.
- 43 Kassirer JP,Pauker SG. The toss-up. N Engl J Med 1981; 305: 1467–1469.
- 44 Derost PP,Ouchchane L,Morand D, et al. Is DBS-STN appropriate to treat severe Parkinson disease in an elderly population? Neurology 2007; 68: 1345–1355.
- 45 Spottke EA,Volkmann J,Lorenz D, et al. Evaluation of healthcare utilization and health status of patients with Parkinson's disease treated with deep brain stimulation of the subthalamic nucleus. J Neurol 2002; 249: 759–766.
- 46 Meissner W,Schreiter D,Volkmann J, et al. Deep brain stimulation in late stage Parkinson's disease: a retrospective cost analysis in Germany. J Neurol 2005; 252: 218–223.
- 47 Tomaszewski KJ,Holloway RG. Deep brain stimulation in the treatment of Parkinson's disease: a cost-effectiveness analysis. Neurology 2001; 57: 663–671.
- 48 Valldeoriola F,Morsi O,Tolosa E,Rumia J,Marti MJ,Martinez-Martin P. Prospective comparative study on cost-effectiveness of subthalamic stimulation and best medical treatment in advanced Parkinson's disease. Mov Disord 2007; 22: 2183–2191.
- 49 Fraix V,Houeto JL,Lagrange C, et al. Clinical and economic results of bilateral subthalamic nucleus stimulation in Parkinson's disease. J Neurol Neurosurg Psychiatry 2006; 77: 443–449.
- 50 Mulley AG. The Role of Decision Analysis in the Translation of Research Findings into Clinical Practice. In: AC Gelijns, editor. Modern Methods of Clinical Investigation. Washington, DC: National Academy Press; 1990. p. 78–87
- 51 Movement Disorders Society Task Force for Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord 2003; 18: 738–750.