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)

项目摘要 该项目将为FDA的医疗设备开发临床结果评估(COA) 开发工具(MDDT)计划评估患者报告的门诊阿片类药物使用，然后 使用疾病预防控制中心计算吗啡当量(MME)的黄金标准度量 MME转换数据集。在知情同意的情况下使用临床试验的限定情况下 报告所有阿片类药物的使用，该工具将是一个强大的调查模块，能够捕获和标准化 使用处方、购买或借用的阿片类药物。这样的研究工具将支持调查人员 医疗产品开发商寻求监管机构批准阿片类药物的节约和物质使用 障碍(SUD)干预。 设备、数字健康解决方案和非处方物理干预可以减少疼痛，[1-3]但是 医生和付款人计划需要代码来实施经过验证的解决方案，而监管机构 除止痛外，越来越重视阿片类药物减少的证据。为医疗提供便利 产品开发和评估，公共卫生需要一种强有力的阿片类药物使用措施 获得FDA的资格，以鼓励医疗器械创新并允许进行内部试验 标准化。 目前收集阿片类药物使用信息的方法包括纸质调查、基于网络的调查、 和应用程序。这些未经验证的收集方法通常预先加载了一组特定的阿片类药物 仅限于正在进行临床试验的诊所通常开出的处方 通常是试验所特有的。虽然这些工具和方法无法从其他来源捕获阿片类药物 它们也不够强大，不足以成为这种使用情况下的标准数据收集工具。 前几年开出的阿片类药物有90%以上是未使用的；[4]只有22%的人说他们得到了阿片类药物 而不是从朋友和家人那里。 第一阶段将与FDA确认，以确认第二阶段项目符合MDDT指南， 建立CDC合规性，执行专家内容映射，并获得IRB对第二阶段的批准 临床试验。在第二阶段，在对现有调查的任何编辑进行结构化可用性访谈后， 编程逻辑将优化与现有临床试验数据收集软件的互操作性。 这项调查将在使用止痛医疗器械试验的背景下进行验证，并将 经过可靠性、内部一致性、MME算法准确性和 减少药物使用诊所中的不同效度。然后，剂量工具将被合并到 安全的基于Web的服务器，可作为MDDT访问使用。

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.