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)

创建和验证剂量阿片类药物来源评估工具 (DOSE) - 稳健的阿片类药物使用临床结果评估，以获得 FDA 医疗器械开发工具 (MDDT) 资格

• 批准号: 10739706
• 负责人: Amy Lynn Baxter
• 金额: $ 15.91万
• 依托单位: MMJ LABS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10739706
• 关键词: Acute Pain; Adherence; Algorithms; Assessment tool; Clinic; Clinical; Clinical Trials; Code; Collection; Comprehension; Computer software; Data; Data Collection; Data Set; Devices; Dose; Equation; Evaluation; Family; Formulation; Friends; Goals; Grant; Guidelines; Home; Hour; Informed Consent; Institutional Review Boards; Intake; Intervention; Interview; Language; Logic; Maps; Measures; Medical; Medical Device; Methods; Online Systems; Opioid; Outcome; Outpatients; Pain; Pain Clinics; Paper; Patients; Phase; Phase II Clinical Trials; Physical Medicine; Physicians; Public Health; Qualifying; Readability; Records; Reporting; Research; Research Personnel; Secure; Site; Source; Standardization; Statutes and Laws; Structure; Substance Use Disorder; Surveys; Testing; Text; Therapeutic; Time; Validation; Validity and Reliability; Writing; assessment application; chronic pain; clinical outcome assessment; clinical practice; cognitive testing; data standards; diaries; digital health; improved; innovation; interoperability; milligram; morphine equivalent; opioid sparing; opioid use; pain reduction; pain relief; pill; prescription opioid; product development; programs; reduced substance use; response; tool; tool development; usability; web page

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.

项目摘要 本项目将为FDA的医疗器械开发临床结局评估（COA） 评估患者报告的门诊阿片类药物使用的MDDT计划，然后 使用CDC计算吗啡当量（MME）毫克的黄金标准度量 MME转换数据集。在知情同意的情况下使用临床试验的合格背景下， 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，能够收集和标准化 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 和医疗产品开发商寻求阿片类药物节约和物质使用的监管批准 干预措施（SUD）。 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 医生和付款人计划需要代码来实施经过验证的解决方案， 越来越多地优先考虑阿片类药物减少的证据，以及疼痛缓解。为了方便医疗 产品开发和评估，公共卫生需要一个强大的阿片类药物使用措施 经FDA认证，以鼓励医疗器械创新，并允许进行内部试验 标准化 目前收集类阿片使用信息的方法包括纸质调查、网络调查， 和应用程序。这些未经验证的收集方法通常预装了一组特定的阿片类药物 仅限于临床试验所在地的实践中通常规定的药物， 往往是审判中特有的虽然这些工具和方法未能从其他组织中捕获阿片样物质， 这些数据来源并不可靠，也不足以成为这种使用环境下的标准数据收集工具。 前几年超过90%的阿片类药物未被使用;[4]只有22%的人说他们得到了阿片类药物 而不是朋友和家人。[5]《中国日报》 第1阶段将与FDA确认，以确认第2阶段项目符合MDDT指南， 建立CDC合规性，进行专家内容映射，并获得IRB对第2阶段的批准 临床试验在第2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。 该调查将在使用止痛医疗器械试验的背景下进行验证， 验证了可靠性、内部一致性、MME算法准确性和收敛性， 在减少药物使用诊所的不同有效性。然后，将剂量工具纳入 安全的基于Web的服务器，可作为MDDT访问使用。