Migraine Clinical Outcome Assessment System (MiCOAS)

项目摘要 偏头痛临床结果评估系统（MiCOAS）旨在改善和标准化 终点和偏头痛临床试验中这些终点的评估。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，将有助于解释结果，并在偏头痛临床 试验，并通过扩展，推进偏头痛治疗的开发和批准。UG 3阶段 格兰特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）来指导项目（AIM 1）。全面系统综述 偏头痛的文献将进行充分了解目前的偏头痛的结果，在急性和 预防性偏头痛试验（AIM 2）。使用以患者为中心的访谈（AIM）进行定性研究的结果 3)将确保在AIM 1和AIM 2期间确定的终点作为开发/改进的目标， 对患者有意义。 UH 3赠款阶段将使用额外的以患者为中心的定性研究，以充分了解患者 关于UG 3中确定的目标终点的经验，以及哪些方面对其最重要， 在讨论所述终点时的患者语言，以及之前未涉及的任何可能的研究领域 已识别（AIM 4）。使用患者访谈结果，将使用金标准制定结局指标- 标准技术。在开发/完善预防性质量的预期情况下， 生活/影响/残疾类型的措施，一个新的偏头痛患者的数据收集将被设计和执行 和黄金标准的心理测量技术将被用来经验评估和完善候选人 项目，最终确定最终评估所选的项目，并评估初始有效性和适用性 结果评估。一个单独的数据收集也将设计，执行，并分析草案 急性偏头痛试验的结果评估（AIM 5）。该补助金的主要目的是 开发一套公开可用的偏头痛终点及其相关的偏头痛COA。鉴于此， 通过科学渠道以演讲和手稿的形式适当传播研究结果， 基本（AIM 6）。成功完成拟议项目的总体目标将导致标准化 以及经验支持的偏头痛COA，用于对患者和统计学有意义的临床试验 健壮。

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.