Project Summary This project will develop a Clinical Outcome Assessment (COA) for the FDA’s Medical Device Development Tool (MDDT) program assessing patient-reported outpatient opioid use, then calculating the gold standard metric of milligrams of morphine equivalents (MME) using the CDC MME Conversion dataset. In the qualified context of use of a clinical trial with informed consent to report all opioid use, the tool will be a robust survey module capable of capturing and standardizing use of prescribed, purchased or borrowed opioids. Such a research tool will support investigators and medical product developers seeking regulatory approval for opioid-sparing and substance use disorder (SUD) interventions. Devices, digital health solutions and over the counter physical interventions reduce pain,[1-3] but physicians and payor programs need codes to implement proven solutions, and regulatory agencies increasingly prioritize proof of opioid reduction in addition to pain relief. To facilitate medical product development and evaluation, there is a public health need for a robust opioid use measure qualified by the FDA to encourage medical device innovation and allow for intra-trial standardization. Current methods of gathering opioid use information include paper surveys, web-based surveys, and apps. These non-validated collection methods are often pre-loaded with a specific set of opioids limited to those commonly prescribed by the practice where the clinical trial is taking place and are often unique to the trial. While these tools and methods fail to capture of opioids from other sources, nor are they robust enough to be a standard data collection tool for this context of use. Over 90% of opioid prescribed in previous years are unused;[4] only 22% say they got their opioids from a prescriber rather than friends and family.[5] Phase 1 will confirm with the FDA to confirm that the Phase 2 project meets the MDDT guidelines, establish CDC compliance, conduct expert content mapping, and obtain IRB approval for Phase 2 clinical trials. During Phase 2, after structured usability interviews of any edits of the existing survey, programmed logic will optimize interoperability with existing clinical trial data collection software. The survey will be validated in the context of use of a pain-relieving medical device trial, and will be validated for reliability, internal consistency, MME algorithm accuracy, and convergent and divergent validity in a substance use reduction clinic. The DOSE tool will then be incorporated into a secure web-based server for accessed use as an MDDT.

Project Narrative This project will develop, validate, and qualify a Clinical Outcome Assessment (COA) assessing patient-reported outpatient opioid use, then calculating the gold standard metric of milligrams of morphine equivalents (MME) for the FDA’s Medical Device Development Tool program. The Dose- Opioid-Source Evaluation (DOSE) tool will be a robust survey module capable of capturing prescribed, purchased, or borrowed opioids in all forms in response to acute and chronic pain, with efficient logic to optimize reporting adherence and interoperability with existing clinical trial data collection software. Until a qualified opioid outcome standard exists, demonstrating devices to be therapeutically viable and facilitating reimbursement for acceptance will fail, stifling non- pharmacologic innovation.