Outcomes Research in Rheumatic Diseases

项目总结/摘要 风湿性疾病的结局研究 博士Dinesh卡纳是密歇根大学（UM）的医学教授，也是UM的主任 硬皮病项目。他寻求延长K24中期职业研究者奖，以患者为导向 研究（POR）继续这一成功的研究计划，同时投入大量时间进行指导 下一代本科生、医学生、住院医生、临床和博士后研究员，以及 初级教员实习生。K24更新申请的目标是支持候选人继续 作为一个导师的影响，并承担领导作用，在合作POR计划，以继续增长， 研究澳大的POR培训计划，并招募对POR感兴趣的新学员。 自从成功资助K24初始赠款以来，候选人积极指导学员和初级 教师在不同的POR项目谁发表在同行评审的期刊，并收到独立 经费候选人已经成功地与其他学科和机构建立了合作联系， 追求卓越的计划，并有强大的机构支持，以创建这个计划。K24基金 将保留30%的候选人的努力，并减轻未来的临床和行政责任。一 目前资助的研究机会多样化的投资组合存在未来的学员在POR。 拟议的研究包括四个现有的项目和一个新的项目，解决病人的POR领域 报告的结局、结局指标和临床试验设计。目前资助的研究包括：1） 负责系统性硬化症：通过自我管理改善患者结局（由 PCRI）; 2）系统性硬化症相关间质性肺病联合反应指数的发展 (R01，由NIH/NIAMS资助）; 3）一项由制药商发起的多中心国际II期试点研究， 评价皮下阿巴西普与安慰剂在弥漫性皮肤系统性硬化症中的作用-一项双盲试验， 安慰剂对照、随机对照试验（由NIH/NIAID、密歇根大学自身免疫研究所资助 卓越中心和布里斯托迈尔斯施贵宝）;和4）维布妥昔单抗的剂量递增安全性研究 弥漫性皮肤系统性硬化症（由NIH/NIAID/免疫耐受网络资助）。的目的 一项新提议的研究是实施NIH患者报告结局测量信息 系统（PROMIS®）在临床实践中使用的试点集群随机对照试验。

Project Summary/Abstract Outcomes research in rheumatic diseases Dr. Dinesh Khanna is a professor of medicine at the University of Michigan (UM) and director of the UM Scleroderma Program. He seeks the extension of the K24 Mid-Career Investigator Award in Patient-Oriented Research (POR) to continue this successful research program while dedicating significant time for mentoring the next generation of undergraduates, medical students, residents, clinical and post-doctoral fellows, and junior faculty trainees. The goals of the K24 renewal application are to support the candidate's continued impact as a mentor and assume leadership roles in collaborative POR programs, to continue the growth of a research training program for POR at the UM, and to recruit new mentees who are interested in POR. Since the successful funding of the initial K24 grant, the candidate has actively mentored trainees and junior faculty on different POR projects who have published in peer-reviewed journals and received independent funding. The candidate has launched successful collaborative links with other disciplines and institutions in the pursuit of program excellence, and there is strong institutional support to create this program. The K24 grant would preserve 30% of the candidate's effort and relieve future clinical and administrative responsibilities. A diverse portfolio of currently funded research opportunities exists for future trainees in POR. The research proposed includes four current projects and one new project addressing POR areas of patient reported outcomes, outcome measures, and clinical trial design. The currently funded studies include: 1) Taking charge of systemic sclerosis: Improving patient outcomes through self-management (funded by PCORI); 2) Development of a systemic sclerosis-associated interstitial lung disease combined response index (R01, funded by NIH/NIAMS); 3) An investigator-initiated, multicenter international phase II pilot study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial (funded by NIH/NIAID, University of Michigan Autoimmunity Center of Excellence and Bristol Myers Squibb); and 4) A dose escalation safety study of brentuximab vedotin in diffuse dutaneous Systemic Sclerosis (funded by NIH/NIAID/Immune Tolerance Network). The aim of the new proposed study is to implementation the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) in clinical practice using a pilot cluster randomized controlled trial.