Creation and Validation of the Dose-Opioid-Source Evaluation tool (DOSE) - a Robust Opioid Use Clinical Outcome Assessment for Qualification as an FDA Medical Device Development Tool (MDDT)

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.

Grant Number: 4R44DA058952-02
NIH Institute/Center: NIH
Principal Investigator: Amy Baxter