Methods for reducing uncertainty in personalized medicine

Abstract

<bold>Background.</bold> Evidence uncertainty and paternalistic practices in genomic medicine lead to suboptimal decision-making circumstances, and may result in unfavorable patient outcomes. Reducing decision uncertainty, combined with a shared (patient and clinician) decision-making approach, is believed to result in better overall treatment decisions that better meet patients' needs and fewer negative consequences. <bold>Objective.</bold> (1) To demonstrate the use of value of information analysis to estimate the societal value and research priority of a trial studying pharmacogenomic-guided antiplatelet selection, and (2) to obtain key stakeholder opinions on the necessity and feasibility of a shared decision tool for whole genome sequencing. <bold>Methods.</bold> Objective (1) was accomplished using an expected value of sample information (EVSI) approach. Objective (2) was accomplished using qualitative analysis of key informant interview transcripts. See additional abstracts for more information. <bold>Results.</bold> (1) Substantial value could be realized by performing a pharmacogenomic clinical trial, although reducing uncertainty in the pharmacogenomic association was less valuable than reducing uncertainty in adverse event outcomes. (2) Genetic services providers were open to shared decision-making tools and would use the tool if validated. <bold>Conclusions.</bold> Decision tools are potentially useful for helping genetics stakeholders assess uncertain evidence thresholds, make policy choices, or facilitate treatment decisions.