PMID- 21402295
OWN - NLM
STAT- MEDLINE
DCOM- 20110620
LR  - 20110315
IS  - 1524-4733 (Electronic)
IS  - 1098-3015 (Linking)
VI  - 14
IP  - 2
DP  - 2011 Mar-Apr
TI  - 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.
PG  - 263-73
LID - 10.1016/j.jval.2010.09.004 [doi]
AB  - 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. OBJECTIVES: 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.
CI  - Copyright (c) 2011 International Society for Pharmacoeconomics and Outcomes 
      Research (ISPOR). Published by Elsevier Inc. All rights reserved.
FAU - Goeree, Ron
AU  - Goeree R
AD  - Programs for Assessment of Technology in Health (PATH) Research Institute, St. 
      Joseph's Healthcare, Hamilton, ON, Canada. goereer@mcmaster.ca
FAU - Hopkins, Rob
AU  - Hopkins R
FAU - Marshall, John K
AU  - Marshall JK
FAU - Armstrong, David
AU  - Armstrong D
FAU - Ungar, Wendy J
AU  - Ungar WJ
FAU - Goldsmith, Charles
AU  - Goldsmith C
FAU - Allen, Christopher
AU  - Allen C
FAU - Anvari, Mehran
AU  - Anvari M
LA  - eng
GR  - Canadian Institutes of Health Research/Canada
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Value Health
JT  - Value in health : the journal of the International Society for Pharmacoeconomics 
      and Outcomes Research
JID - 100883818
RN  - 0 (Proton Pumps)
SB  - IM
MH  - Cost-Benefit Analysis
MH  - Fundoplication/adverse effects/*economics/methods
MH  - Gastroesophageal Reflux/drug therapy/*economics/surgery/*therapy
MH  - Humans
MH  - Laparoscopy/adverse effects/economics/methods
MH  - Ontario
MH  - Postoperative Complications/economics/epidemiology/etiology
MH  - Prospective Studies
MH  - Proton Pumps/*economics/therapeutic use
MH  - Quality-Adjusted Life Years
MH  - Stochastic Processes
EDAT- 2011/03/16 06:00
MHDA- 2011/06/21 06:00
CRDT- 2011/03/16 06:00
PHST- 2010/05/25 00:00 [received]
PHST- 2010/09/21 00:00 [revised]
PHST- 2010/09/23 00:00 [accepted]
PHST- 2011/03/16 06:00 [entrez]
PHST- 2011/03/16 06:00 [pubmed]
PHST- 2011/06/21 06:00 [medline]
AID - S1098-3015(10)00043-4 [pii]
AID - 10.1016/j.jval.2010.09.004 [doi]
PST - ppublish
SO  - Value Health. 2011 Mar-Apr;14(2):263-73. doi: 10.1016/j.jval.2010.09.004.