A unified framework for classification of methods for benefit-risk assessment

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Mehdi NajafzadehJoshua J Gagne

Abstract

Patients, physicians, and other decision makers make implicit but inevitable trade-offs among risks and benefits of treatments. Many methods have been proposed to promote transparent and rigorous benefit-risk analysis (BRA). To propose a framework for classifying BRA methods on the basis of key factors that matter most for patients by using a common mathematical notation and compare their results using a hypothetical example. We classified the available BRA methods into three categories: 1) unweighted metrics, which use only probabilities of benefits and risks; 2) metrics that incorporate preference weights and that account for the impact and duration of benefits and risks; and 3) metrics that incorporate weights based on decision makers' opinions. We used two hypothetical antiplatelet drugs (a and b) to compare the BRA methods within our proposed framework. Unweighted metrics include the number needed to treat and the number needed to harm. Metrics that incorporate preference weights include those that use maximum acceptable risk, those that use relative-value-adjusted life-years, and those that use quality-adjusted life-years. Metrics that use decision makers' weights include the multicriteria decision analysis, the benefit-l...Continue Reading

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Citations

Nov 13, 2015·Expert Review of Pharmacoeconomics & Outcomes Research·David John Mott, Mehdi Najafzadeh
Dec 22, 2015·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Joshua J GagneSebastian Schneeweiss
Dec 22, 2015·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Joshua J GagneSebastian Schneeweiss
Oct 21, 2016·Clinical Pharmacology and Therapeutics·S SchneeweissR J Willke
Oct 22, 2016·Clinical Pharmacology and Therapeutics·G K RajuJ Woodcock
Mar 28, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Kaatje BollaertsVincent Bauchau
Aug 15, 2018·American Journal of Law & Medicine·Sebastian Schneeweiss, Robert J Glynn
Dec 29, 2020·Hand : Official Journal of the American Association for Hand Surgery·Amirreza FatehiGregg A Vagner

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