Outcomes Research in Rheumatic Diseases

风湿性疾病的结果研究

• 批准号: 8917860
• 负责人: DINESH KHANNA
• 金额: $ 17.96万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8917860
• 关键词: 25-hydroxyvitamin D; Acute-Phase Proteins; Address; Area; Arthritis; Autoantibodies; Biometry; Blood; Blood capillaries; Characteristics; Chest; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Design; Cognitive; Collaborations; Committee Members; Consensus; Cutaneous; Cyclophosphamide; Data; Databases; Development; Diffuse; Diffuse Scleroderma; Dyspnea; Ensure; Environment; Faculty; Fibromyalgia; Fibrosis; Focus Groups; Funding; Future; Gastrointestinal Diseases; Genetic Markers; Goals; Gout; Grant; High Resolution Computed Tomography; Inflammation; Information Systems; Interstitial Lung Diseases; Interview; Joints; Literature; Lung; Measurement; Measures; Mediator of activation protein; Medical; Mentors; Michigan; Mid-Career Clinical Scientist Award (K24); Modeling; Molecular; Mycophenolate; Nail Fold; National Heart, Lung, and Blood Institute; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Observational Study; Oral; Outcome Measure; Outcomes Research; Patient Outcomes Assessments; Patients; Physiological; Placebos; Property; Psychometrics; Randomized Controlled Trials; Registries; Reporting; Research; Research Methodology; Research Personnel; Research Project Grants; Research Support; Research Training; Resources; Rheumatism; Rheumatoid Arthritis; Rheumatology; Role; Scleroderma; Secure; Serological; Serum; Skin; Structure; Students; Swelling; Systemic Lupus Erythematosus; Systemic Scleroderma; Taxonomy; Techniques; Time; Tissues; Training; Training Programs; United States National Institutes of Health; Universities; Validation; Vascular Diseases; Vitamin D; Work; X-Ray Computed Tomography; biobank; biopsychosocial; capillary; clinical phenotype; cohort; experience; gastrointestinal symptom; indexing; interest; mycophenolate mofetil; patient oriented research; programs; prospective; repository; response; systematic review; theories; trial comparing; trial design

DESCRIPTION (provided by applicant): Outcomes research in rheumatic diseases The goals of the K24 application are to support my continued development and impact as a mentor, to establish a research training program for patient-oriented research (POR) in the Division of Rheumatology at the University of Michigan (UM), and to expand my current POR program. In the past few years, I have actively mentored trainees and junior faculty on different POR projects and the immediate objective of the proposed K24 is to secure protected time to continue my efforts and develop future clinical investigators with a focus on patient-reported outcome measures and trial design in rheumatic diseases. In addition to directing a large Scleroderma program, I continue to work extensively in other arthritides (gout and rheumatoid arthritis) and have support of established clinical researchers in systemic lupus erythematosus and fibromyalgia, providing a rich environment of POR at UM. Given my commitment to mentoring, recent collaborations with the UM Department of Biostatistics, UM's rich resources dedicated to POR, and strong institutional support to create this program, the K24 Award provides an invaluable opportunity to expand my mentoring efforts and to establish a specialized structured POR program. The program will ensure that medical and biostatistical students and fellows interested in becoming independent investigators will be supported by an interdisciplinary team of mentors and will acquire training in clinical research methods and biostatistics. K24 grant would preserve my time at 50% effort and relieve future clinical and administrative responsibilities. A diverse portfolio of currently funded research opportunities exists for future trainees in POR. Research proposed includes two current projects and two new projects addressing POR areas of patient reported outcomes, clinical trial design, and database development. The two current NIH funded studies include: 1. To develop and evaluate the psychometric properties of gastrointestinal symptoms item bank developed under the NIH Patient-Reported Outcomes Measurement Information System initiative; and 2. To develop a combined response index for scleroderma clinical trials in an ongoing NIH funded longitudinal observational study. The aims of two new proposed studies are: 1. To determine the relationship between the vitamin D status and physiological, radiological, and dyspnea measures of scleroderma-associated interstitial lung disease (SSc-ILD) in an ongoing NIH funded clinical trial comparing oral mycophenolate mofetil vs. oral cyclophosphamide in 150 patients with active SSc-ILD. 2. To develop an early diffuse scleroderma observational registry through the coordinated efforts of several young investigators at large U.S. scleroderma centers. The goals of the registry include: i) to determine whether the clinical phenotypes and autoantibodies at baseline in early, diffuse scleroderma are associated with, and predict, clinical, radiological, and patient-reported outcomes and survival; and ii) to develop a repository of scleroderma blood and tissue to explore the cellular and molecular mediators of SSc and their association with clinical phenotypes and autoantibodies.

描述（由申请人提供）：风湿性疾病的结果研究K24应用程序的目标是支持我作为导师的持续发展和影响，以在密歇根大学（UM）的风湿病学系建立研究培训计划（POR），并扩大我的POR计划。在过去的几年中，我积极指导了学员和初级教职员工对不同的POR项目，而拟议的K24的直接目标是确保受保护的时间继续我的努力，并开发未来的临床研究人员，并着重于风湿病中的患者报告结果指标和试验设计。除了指导大型硬皮病计划外，我继续在其他关节炎（痛风和类风湿关节炎）中广泛工作，并支持全身性红斑狼疮和纤维肌痛的既定临床研究人员，从而为UM提供了丰富的POR环境。鉴于我致力于指导，最近与UM生物统计学部的合作，UM的丰富资源致力于POR，以及强大的机构支持以创建该计划，K24 Award为扩大我的指导工作并建立专业的结构化POR计划提供了宝贵的机会。该计划将确保有兴趣成为独立调查员的医学和生物统计学生和研究员将得到跨学科的导师团队的支持，并将获得有关临床研究方法和生物统计学的培训。 K24 Grant将以50％的努力来保留我的时间，并减轻未来的临床和行政责任。 POR的未来学员存在着目前资助的研究机会的各种投资组合。拟议的研究包括两个当前的项目和两个新项目，涉及患者报告的结果，临床试验设计和数据库开发。当前的两项NIH资助的研究包括：1。开发和评估在NIH患者报告的结果测量信息系统计划下开发的胃肠道症状物品库的心理测量特性；和2。在正在进行的NIH资助的纵向观察性研究中，为硬皮病临床试验开发一个组合的响应指数。两项新提出的研究的目的是：1。确定维生素D状态与生理，放射学和肺炎疾病与硬皮病相关的间质肺疾病（SSC-ild）的措施在正在进行的NIH持续的NIH临床临床试验中比较口服mycophenaly mycophenaly mofetil vs.scclophophophophomided cyclophophapophamide in 1500-150000000000000色。 2。通过在美国大型硬皮病中心的几位年轻调查人员的协调努力来开发早期的弥漫性硬皮病观察注册。注册表的目标包括：i）确定早期基线时基线时的临床表型和自身抗体是否与弥漫性硬皮病有关，并预测临床，放射学和患者报告的结果和生存； ii）开发存储库 硬皮病血液和组织探索SSC的细胞和分子介质及其与临床表型和自身抗体的关联。