Migraine Clinical Outcome Assessment System (MiCOAS)

偏头痛临床结果评估系统 (MiCOAS)

• 批准号: 10415455
• 负责人: Richard B. LIPTON
• 金额: $ 31.31万
• 依托单位: VECTOR PSYCHOMETRIC GROUP LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-10 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10415455
• 关键词: Migraine; Clinical; Outcome; Assessment; System

PROJECT SUMMARY ABSTRACT The proposed Migraine Clinical Outcome Assessment System (MiCOAS) aims to improve and standardize endpoints and the assessment of those endpoints in migraine clinical trials. Such standardized clinical outcome assessments (COAs), developed to incorporate the patient voice and empirically supported by gold-standard instrument development techniques, will aid in the interpretability of results from and across migraine clinical trials and, by extension, advance the development and approval of migraine treatments. The UG3 phase of the grant will first assemble a group of stakeholders (substantive research experts, patient advocates, clinicians, psychometricians, regulators, and payers) to guide the project (AIM 1). Comprehensive systematic review of the migraine literature will be undertaken to fully understand current migraine outcomes, in both acute and preventative migraine trials (AIM 2). Results from qualitative research using patient-centered interviews (AIM 3) will ensure that endpoints identified during AIM 1 and AIM 2 as targets for development/refinement are meaningful to patients. The UH3 grant stage will use additional patient-centered qualitative research to fully understand the patient experience with respect to the target endpoints identified in UG3 and what aspects are most important to them, patient language in discussing said endpoints, and any possible areas of study that were not previously identified (AIM 4). Using the patient-interview results, outcome measures will be developed using gold- standard techniques. In the expected case of developing/refining a preventative quality-of- life/impact/disability-type measure, a new data collection of migraine patients will be designed and executed and gold-standard psychometric techniques will be employed to empirically evaluate and refine candidate items, finalize the items selected to the final assessment, and evaluate the initial validity and fit-for-purpose of the outcome assessment. A separate data collection will also be designed, executed, and analyzed for the draft outcome assessments intended for acute migraine trials (AIM 5). The overarching purpose of this grant is to develop a publicly available core set of migraine endpoints and their related COAs for migraine. Given this, proper dissemination of findings through scientific outlets in the form of presentations and manuscripts is essential (AIM 6). Successful completion of the overall goal of the proposed project will result in standardized and empirically-supported migraine COAs for clinical trials that are meaningful to patients and statistically robust.

项目概要 摘要 拟议的偏头痛临床结果评估系统（MiCOAS）旨在改进和标准化 偏头痛临床试验中的终点以及这些终点的评估。这种标准化的临床结果 评估（COA），旨在纳入患者的声音并得到黄金标准的经验支持 仪器开发技术将有助于偏头痛临床结果的可解释性 试验，进而推动偏头痛治疗方法的开发和批准。 UG3阶段 赠款将首先召集一组利益相关者（实质性研究专家、患者倡导者、临床医生、 心理测量师、监管机构和付款人）来指导该项目（AIM 1）。全面系统审查 将开展偏头痛文献研究，以充分了解当前偏头痛的结果，包括急性和 预防性偏头痛试验（AIM 2）。使用以患者为中心的访谈（AIM 3) 将确保在 AIM 1 和 AIM 2 期间确定的作为开发/改进目标的端点 对患者有意义。 UH3 资助阶段将使用额外的以患者为中心的定性研究来充分了解患者 关于 UG3 中确定的目标终点的经验以及哪些方面对他们来说最重要， 讨论所述终点以及以前没有的任何可能的研究领域时的患者语言 已确定（目标 4）。根据患者访谈结果，将使用黄金制定结果衡量标准 标准技术。在开发/完善预防性质量的预期情况下—— 生命/影响/残疾类型的测量，将设计和执行偏头痛患者的新数据收集 将采用黄金标准心理测量技术来根据经验评估和完善候选人 项目，最终确定最终评估的项目，并评估初始有效性和目的适合性 结果评估。还将针对草案设计、执行和分析单独的数据收集 用于急性偏头痛试验的结果评估（AIM 5）。这笔赠款的首要目的是 开发一套公开的偏头痛核心终点及其相关的偏头痛 COA。鉴于此， 通过科学渠道以演示文稿和手稿的形式适当传播研究结果 必不可少（目标 6）。成功完成拟议项目的总体目标将导致标准化 和经验支持的偏头痛 COA 进行对患者有意义且具有统计意义的临床试验 强壮的。