Genomic Tests for Substance Use Disorders in Clinical Care: Examining Challenges and Opportunities - In 2023, more than 100,000 people died of an opioid overdose in the United States, and 2.5 million adults in the U.S. have an opioid use disorder (OUD). Paradoxically, people’s access to opioids often happens in the context of medical procedures and are prescribed by clinicians. Opioids are effective in treating moderate to severe pain and are often prescribed following surgical procedures such as back surgery. Iatrogenic harms associated with opioid use for medical purposes (e.g., OUD) pose an ethical and medical conundrum: How to properly balance the risks associated with opioid use with the potential medical benefits in terms of pain management and improved clinical outcomes? To help inform this decision, companies have developed genetic tests that use polygenic risk scores (PRS) to estimate a person’s genetic risk for developing an OUD. The FDA recently approved one such test, and tests for other substance use disorders (SUD) are in development. A tool that can accurately estimate a person’s genetic risk for OUD, could help prevent opioid prescription, use, and save lives. However, the use of genetic tests to identify people at increased risk of OUD or any SUD is itself, ethically challenging. How reliable are these tests perceived to be, in which circumstances should they be ordered, how much genetic risk for OUD is too much to deny opioids to a patient in pain, how should OUD risk information be managed in the medical record, who could have access to OUD risk results, and how could this information be misused? Furthermore, OUD, other SUDs, and pain are stigmatized which may influence clinician and patient decision-making regarding ordering genetic tests for OUD and integrating results. Little empirical research has examined the ethical and clinical implications of these novel tests in medicine. The proposed study examines key stakeholders’ (e.g., patients scheduled for surgery, patients with history of OUD, surgeons, pain management specialists, medical geneticists, legal experts) views, concerns, expectations, decision-making factors, and proposals for the responsible use of OUD genetic tests. The long-term goal of this research is to promote patient well-being and advance genomic science by generating data and analysis to inform the responsible use of genetic tests for SUDs in medicine. The objective of this study is to empirically examine stakeholders’ views, concerns, expectations, and decision-making factors on whether and how to responsibly integrate genomic risk estimates for OUD in surgical care. In Aims 1 and 2, we will conduct semi-structured interviews with patients scheduled for surgery, patients with history of OUD, surgeons, pain management specialists, medical geneticists and other relevant clinicians to examine their views, concerns, expectations, decision-making factors, and proposals for the responsible use of PRS for OUD. In Aim 2, we will also experimentally examine which factors drive clinician decision-making regarding whether to order OUD genetic tests. Finally, in Aim 3, we will conduct a modified Delphi panel with stakeholders to identify the most pressing challenges and potential solutions for the responsible use of OUD genetic tests in medicine.
