Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

<p>Abstract</p> <p>Background</p> <p>To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients u...

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Main Authors: Lazo-Langner Alejandro, Rodger Marc A, Barrowman Nicholas J, Ramsay Tim, Wells Philip S, Coyle Douglas A
Format: Article
Language:English
Published: BMC 2012-01-01
Series:BMC Medical Research Methodology
Subjects:
Risk-Benefit Analysis
Decision Making
Meta-Analysis
Methods
Monte Carlo Method
Risk
indirect comparison
Online Access:http://www.biomedcentral.com/1471-2288/12/3
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spelling doaj-ed4b8c46c537483399bca0be9530a97b2020-11-24T21:11:28ZengBMCBMC Medical Research Methodology1471-22882012-01-01121310.1186/1471-2288-12-3Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysisLazo-Langner AlejandroRodger Marc ABarrowman Nicholas JRamsay TimWells Philip SCoyle Douglas A<p>Abstract</p> <p>Background</p> <p>To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery.</p> <p>Methods</p> <p>Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis) we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding) and benefit (thrombosis averted) were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding.</p> <p>Results</p> <p>The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement.</p> <p>Conclusions</p> <p>Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance.</p> http://www.biomedcentral.com/1471-2288/12/3Risk-Benefit AnalysisDecision MakingMeta-AnalysisMethodsMonte Carlo MethodRiskindirect comparison
collection DOAJ
language English
format Article
sources DOAJ
author Lazo-Langner Alejandro
Rodger Marc A
Barrowman Nicholas J
Ramsay Tim
Wells Philip S
Coyle Douglas A
spellingShingle Lazo-Langner Alejandro
Rodger Marc A
Barrowman Nicholas J
Ramsay Tim
Wells Philip S
Coyle Douglas A
Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis
BMC Medical Research Methodology
Risk-Benefit Analysis
Decision Making
Meta-Analysis
Methods
Monte Carlo Method
Risk
indirect comparison
author_facet Lazo-Langner Alejandro
Rodger Marc A
Barrowman Nicholas J
Ramsay Tim
Wells Philip S
Coyle Douglas A
author_sort Lazo-Langner Alejandro
title Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis
title_short Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis
title_full Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis
title_fullStr Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis
title_full_unstemmed Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis
title_sort comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis
publisher BMC
series BMC Medical Research Methodology
issn 1471-2288
publishDate 2012-01-01
description <p>Abstract</p> <p>Background</p> <p>To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery.</p> <p>Methods</p> <p>Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis) we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding) and benefit (thrombosis averted) were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding.</p> <p>Results</p> <p>The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement.</p> <p>Conclusions</p> <p>Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance.</p>
topic Risk-Benefit Analysis
Decision Making
Meta-Analysis
Methods
Monte Carlo Method
Risk
indirect comparison
url http://www.biomedcentral.com/1471-2288/12/3
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AT ramsaytim comparingmultiplecompetinginterventionsintheabsenceofrandomizedtrialsusingclinicalriskbenefitanalysis
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AT coyledouglasa comparingmultiplecompetinginterventionsintheabsenceofrandomizedtrialsusingclinicalriskbenefitanalysis
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