title: Quality of life increases in patients with painful diabetic neuropathy following treatment with spinal cord stimulation.
abstract: This study aims to explore the changes in pain intensity and quality of life (QoL) experienced by patients with painful diabetic neuropathy (PDN) treated with spinal cord stimulation (SCS) and conventional medical practice (CMP).
  
  
  
  Patient-reported pain intensity and QoL data were obtained from participants in an international multicentre randomised controlled trial comparing SCS versus CMP. Data were collected at randomisation and 6 month follow up by means of a visual analogue scale for pain intensity, the EuroQoL Visual Analogue Scale (EQ VAS) and the EuroQol EQ-5D index. Quality-adjusted life years (QALYs) were calculated for each treatment using the 'area under the curve' method. Differences in QALYs were calculated after adjusting for between-treatment imbalances in baseline QoL.
  
  
  
  At 6 months, patients allocated to SCS reported larger reductions in pain intensity and improvements in QoL measured by the EQ-5D utility score and EQ VAS as compared to those allocated to CMP. Initial calculations of QALYs for the SCS and CMP groups suggested no statistical differences between the groups. Adjusting for imbalances in baseline EQ-5D scores showed SCS to be associated with significantly higher QALYs compared to CMP.
  
  
  
  SCS resulted in significant improvement in pain intensity and QoL in patients with PDN, offering further support for SCS as an effective treatment for patients suffering from PDN. From a methodological point of view, different results would have been obtained if QALY calculations were not adjusted for baseline EQ-5D scores, highlighting the need to account for imbalances in baseline QoL.
authors.affiliation: Department of Public Health, Epidemiology and Biostatistics, Room 124, Murray Learning Centre, University of Birmingham, Birmingham, B15 2TT, UK. r.duarte@bham.ac.uk.
authors.forename: Rui V
authors.initials: RV
authors.lastname: Duarte
authors.affiliation: Department of Health Economics, University of Birmingham, Birmingham, UK.
authors.forename: Lazaros
authors.initials: L
authors.lastname: Andronis
authors.affiliation: Department of Neurosurgery, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Mathieu W P M
authors.initials: MW
authors.lastname: Lenders
authors.affiliation: Department of Neurosurgery, Medisch Spectrum Twente, Enschede, The Netherlands.|Department of Clinical Neurophysiology, University of Twente, Enschede, The Netherlands.
authors.forename: Cecile C
authors.initials: CC
authors.lastname: de Vos
mesh_terms: D000328:Adult; D000368:Aged; D003920:Diabetes Mellitus / Q000473:pathology; D003929:Diabetic Neuropathies / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D062187:Spinal Cord Stimulation / Q000379:methods*; D016896:Treatment Outcome
keywords: EuroQoL-5D; Neuropathic pain; Painful diabetic neuropathy; Quality of life; Spinal cord stimulation