Outcomes Research in Rheumatic Diseases

项目摘要/摘要 风湿病的结局研究 Dinesh Khanna博士是密歇根大学(UM)医学教授兼密歇根大学主任 硬皮病计划。他寻求延长K24职业生涯中期研究员奖的期限，以病人为导向 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续订申请的目标是支持候选人继续 在协作POR计划中担任导师和领导角色，以持续发展 在密歇根大学研究POR培训计划，并招募对POR感兴趣的新学员。 自从最初的K24奖助金成功资助以来，候选人积极指导学员和初级学员 不同POR项目的教师，曾在同行评议的期刊上发表文章，并获得独立的 资金问题。候选人成功地与其他学科和机构建立了合作关系 追求计划的卓越，并有强有力的制度支持来创建这个计划。K24助学金 将保留30%的候选人的努力，并减轻未来的临床和管理责任。一个 为POR的未来受训者提供目前资助的各种研究机会组合。 建议的研究包括四个当前项目和一个针对POR患者领域的新项目 已报告的结果、结果测量和临床试验设计。目前获得资助的研究包括：1) 负责系统性硬化症：通过自我管理改善患者预后(资金来源 PCORI)；2)建立系统性硬化症相关间质性肺疾病综合反应指数 (R01，由NIH/NIAMS资助)；3)由调查员发起的多中心国际第二阶段试点研究 评价皮下注射阿巴他卡与安慰剂治疗弥漫性皮肤系统性硬化症--一项双盲试验 安慰剂对照、随机对照试验(由密歇根大学自身免疫研究所/NIAID资助 卓越中心和百时美施贵宝(Bristol Myers Squibb)；以及4)布妥昔单抗的剂量递增安全性研究 弥漫性自发性系统性硬化症(由NIH/NIAID/免疫耐受网络资助)。该计划的目的是 新提议的研究将实施NIH患者报告的结局测量信息 该系统(PROMIS®)在临床实践中使用的是试点整群随机对照试验。

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.