title: Cost-utility of laparoscopic Nissen fundoplication versus proton pump inhibitors for chronic and controlled gastroesophageal reflux disease: a 3-year prospective randomized controlled trial and economic evaluation.
abstract: BACKGROUND
  Very few randomized controlled trials (RCTs) have compared laparoscopic Nissen fundoplication (LNF) to proton pump inhibitors (PPI) medical management for patients with chronic gastroesophageal reflux disease (GERD). Larger RCTs have been relatively short in duration, and have reported mixed results regarding symptom control and effect on quality of life (QOL). Economic evaluations have reported conflicting results.
  
  
  OBJECTIVE
  To determine the incremental cost-utility of LNF versus PPI for treating patients with chronic and controlled GERD over 3 years from the societal perspective.
  
  
  METHODS
  Economic evaluation was conducted alongside a RCT that enrolled 104 patients from October 2000 to September 2004. Primary study outcome was GERD symptoms (secondary outcomes included QOL and cost-utility). Resource utilization and QOL data collected at regular follow-up intervals determined incremental cost/QALY gained. Stochastic uncertainty was assessed using bootstrapping and methodologic assumptions were assessed using sensitivity analysis.
  
  
  RESULTS
  No statistically significant differences in GERD symptom scores, but LNF did result in fewer heartburn days and improved QOL. Costs were higher for LNF patients by $3205/patient over 3 years but QOL was also higher as measured by either QOL instrument. Based on total costs, incremental cost-utility of LNF was $29,404/QALY gained using the Health Utility Index 3. Cost-utility results were sensitive to the utility instrument used ($29,404/QALY for Health Utility Index 3, $31,117/QALY for the Short Form 6D, and $76,310/QALY for EuroQol 5D) and if current lower prices for PPIs were used in the analysis.
  
  
  CONCLUSIONS
  Results varied depending on resource use/costs included in the analysis, the QOL instrument used, and the cost of PPIs; however, LNF was generally found to be a cost-effective treatment for patients with symptomatic controlled GERD requiring long-term management.
authors.affiliation: Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph's Healthcare, Hamilton, ON, Canada. goereer@mcmaster.ca
authors.forename: Ron
authors.initials: R
authors.lastname: Goeree
authors.forename: Rob
authors.initials: R
authors.lastname: Hopkins
authors.forename: John K
authors.initials: JK
authors.lastname: Marshall
authors.forename: David
authors.initials: D
authors.lastname: Armstrong
authors.forename: Wendy J
authors.initials: WJ
authors.lastname: Ungar
authors.forename: Charles
authors.initials: C
authors.lastname: Goldsmith
authors.forename: Christopher
authors.initials: C
authors.lastname: Allen
authors.forename: Mehran
authors.initials: M
authors.lastname: Anvari
mesh_terms: D003362:Cost-Benefit Analysis; D018662:Fundoplication / Q000009:adverse effects / Q000191:economics* / Q000379:methods; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000191:economics* / Q000601:surgery / Q000628:therapy*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000191:economics / Q000379:methods; D009864:Ontario; D011183:Postoperative Complications / Q000191:economics / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D017494:Proton Pumps / Q000191:economics* / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D013269:Stochastic Processes
chemical_list: D017494:Proton Pumps