title: Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial).
abstract: BACKGROUND
  Chronic back and leg pain conditions result in patients' loss of function, reduced quality of life and increased costs to the society.
  
  
  OBJECTIVE
  To assess health-related quality of life (HRQoL) and cost implications of spinal cord stimulation plus non-surgical conventional medical management (SCS group) versus non-surgical conventional medical management alone (CMM group) in the management of neuropathic pain in patients with failed back surgery syndrome.
  
  
  METHODS
  A total of 100 patients were randomised to either the SCS or CMM group. Healthcare resource consumption data relating to screening, the use of the implantable generator in SCS patients, hospital stay, and drug and non-drug pain-related treatment were collected prospectively. Resource consumption was costed using UK and Canadian 2005-2006 national figures. HRQoL was assessed using the EuroQol-5D (EQ-5D) questionnaire. Costs and outcomes were assessed for each patient over their first 6-months of the trial.
  
  
  RESULTS
  The 6-month mean total healthcare cost in the SCS group (CAN$19,486; 12,653 euros) was significantly higher than in the CMM group (CAN$3994; 2594 euros), with a mean adjusted difference of CAN$15,395 (9997 euros) (p<0.001). However, the gain in HRQoL with SCS over the same period of time was markedly greater in the SCS group, with a mean EQ-5D score difference of 0.25 [p<0.001] and 0.21 [p<0.001], respectively at 3- and 6-months after adjusting for baseline variables.
  
  
  CONCLUSIONS
  The addition of SCS to CMM in patients with neuropathic leg and back pain results in higher costs to health systems but also generates important improvements in patients' EQ-5D over the same period.
authors: Centre for Health Economics, Alcuin A Block, University of York, York YO10 5DD, United Kingdom. am126@york.ac.uk
authors: Andrea
authors: A
authors: Manca
authors: Krishna
authors: K
authors: Kumar
authors: Rod S
authors: RS
authors: Taylor
authors: Line
authors: L
authors: Jacques
authors: Sam
authors: S
authors: Eldabe
authors: Mario
authors: M
authors: Meglio
authors: Joan
authors: J
authors: Molet
authors: Simon
authors: S
authors: Thomson
authors: Jim
authors: J
authors: O'Callaghan
authors: Elon
authors: E
authors: Eisenberg
authors: Germain
authors: G
authors: Milbouw
authors: Eric
authors: E
authors: Buchser
authors: Gianpaolo
authors: G
authors: Fortini
authors: Jonathan
authors: J
authors: Richardson
authors: Rebecca J
authors: RJ
authors: Taylor
authors: Ron
authors: R
authors: Goeree
authors: Mark J
authors: MJ
authors: Sculpher
mesh_terms: D000700:Analgesics / Q000191:economics / Q000627:therapeutic use*; D001315:Australia; D002170:Canada; D003362:Cost-Benefit Analysis; D004599:Electric Stimulation Therapy / Q000191:economics / Q000706:statistics & numerical data*; D005060:Europe; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data* / Q000639:trends; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data; D006304:Health Status; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007557:Israel; D008136:Longevity; D017116:Low Back Pain / Q000191:economics* / Q000523:psychology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000009:adverse effects; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010523:Peripheral Nervous System Diseases / Q000191:economics* / Q000523:psychology / Q000628:therapy; D011183:Postoperative Complications / Q000191:economics* / Q000523:psychology / Q000628:therapy; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D013116:Spinal Cord / Q000502:physiology / Q000601:surgery; D013122:Spinal Diseases / Q000601:surgery; D013131:Spine / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D013577:Syndrome; D017211:Treatment Failure
chemical_list: D000700:Analgesics