Method for Calculating the Simultaneous Maximum Acceptable Risk Threshold (SMART) from Discrete-Choice Experiment Benefit-Risk Studies.

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ID: 279206
2023
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Abstract
Medical decisions require weighing expected benefits of treatment against multiple adverse outcomes under uncertainty (i.e., risks) that must be accepted as a bundle. However, conventional maximum acceptable risk (MAR) estimates derived from discrete-choice experiment benefit-risk studies evaluate the acceptance of individual risks, assuming other risks are fixed, potentially leading decision makers to misinterpret levels of risk acceptance.Using simulations and a published discrete-choice experiment, we demonstrate a method for identifying multidimensional risk-tolerance measures given a treatment level of benefit.Simultaneous Maximum Acceptable Risk Thresholds (SMART) represents combinations of risks that would be jointly accepted in exchange for specific treatment benefits. The framework shows how the expectation of utility associated with treatments that involve multiple risks are related even when preferences for potential adverse events are independent. We find that the form of the marginal effects of adverse-event probabilities on the expected utility of treatment determines the magnitude of differences between SMART and conventional single-outcome MAR estimates.Preferences for potential adverse events not considered in a study or preferences for adverse-event attributes held constant in risk-tolerance calculations may affect estimated risk tolerance. Further research is needed to understand the right balance between realistically reflecting clinical treatments with many potential adverse events and the cognitive burden of evaluating risk-risk tradeoffs in research and in practice.SMART analysis should be considered in preference studies evaluating the joint acceptance of multiple potential adverse events.Conventional approaches to calculate maximum-acceptable risk (MAR) using discrete-choice experiment data account for 1 adverse-event risk at a time, requiring that decision makers infer the acceptability of treatments when patients are exposed to multiple risks simultaneously.The Simultaneous Maximum Acceptable Risk Threshold (SMART) maps combinations of adverse-event risks that would be jointly acceptable given a specific treatment benefit and provides a transparent and precise portrayal of acceptance of multiple risks.Risk levels that would be accepted using individual MAR estimates might not be acceptable when simultaneous risks are considered, especially when marginal expected disutility of risk is decreasing nonlinearly with risk probabilities.Preference researchers should calculate SMARTs in any discrete-choice study in which 2 or more adverse-event risks are presented, particularly if risk preferences are nonlinear.
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fairchild2023methodmedical Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Fairchild, Angelyn Otteson;Reed, Shelby D;Gonzalez, Juan Marcos;
Journal Medical decision making : an international journal of the Society for Medical Decision Making
Year 2023
DOI
10.1177/0272989X221132266
URL
Keywords
discrete choice experiment patient preferences maximum acceptable risk (mar) simultaneous maximum acceptable risk threshold (smart)

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