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.

Public Health Relevance

The goals of the K24 application are to support my continued development as a mentor and to establish a research training program for patient oriented research. The proposed program is interdisciplinary, and focuses in expanding clinical research opportunities and mentoring in rheumatic diseases. The K24 Award would ensure that I have the protected time to be able to expand my current mentoring activities while continuing to advance my patient oriented research program in patients with rheumatic disease. Research includes two current projects and two new projects addressing patient-oriented research areas of patient-reported outcomes, clinical trial design, and database development.

National Institute of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Midcareer Investigator Award in Patient-Oriented Research (K24)
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Study Section
Arthritis and Musculoskeletal and Skin Diseases Special Grants Review Committee (AMS)
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Witter, James
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University of Michigan Ann Arbor
Internal Medicine/Medicine
Schools of Medicine
Ann Arbor
United States
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Bernstein, Elana J; Khanna, Dinesh; Lederer, David J (2018) Screening High-Resolution Computed Tomography of the Chest to Detect Interstitial Lung Disease in Systemic Sclerosis: A Global Survey of Rheumatologists. Arthritis Rheumatol 70:971-972
Nagaraja, Vivek; Mara, Constance; Khanna, Puja P et al. (2018) Establishing clinical severity for PROMISĀ® measures in adult patients with rheumatic diseases. Qual Life Res 27:755-764
Kafaja, Suzanne; Valera, Isela; Divekar, Anagha A et al. (2018) pDCs in lung and skin fibrosis in a bleomycin-induced model and patients with systemic sclerosis. JCI Insight 3:
Namas, Rajaie; Tashkin, Donald P; Furst, Daniel E et al. (2018) Efficacy of Mycophenolate Mofetil and Oral Cyclophosphamide on Skin Thickness: Post Hoc Analyses From Two Randomized Placebo-Controlled Trials. Arthritis Care Res (Hoboken) 70:439-444
Khanna, Dinesh; Serrano, Jennifer; Berrocal, Veronica J et al. (2018) A Randomized Controlled Trial to Evaluate an Internet-Based Self-Management Program in Systemic Sclerosis. Arthritis Care Res (Hoboken) :
Samokhin, Andriy O; Stephens, Thomas; Wertheim, Bradley M et al. (2018) NEDD9 targets COL3A1 to promote endothelial fibrosis and pulmonary arterial hypertension. Sci Transl Med 10:
Gourh, Pravitt; Remmers, Elaine F; Boyden, Steven E et al. (2018) Brief Report: Whole-Exome Sequencing to Identify Rare Variants and Gene Networks That Increase Susceptibility to Scleroderma in African Americans. Arthritis Rheumatol 70:1654-1660
Homer, Kate LaRiviere; Warren, Jeffrey; Karayev, Dmitry et al. (2018) Performance of Anti-Topoisomerase I Antibody Testing by Multiple-Bead, Enzyme-Linked Immunosorbent Assay and Immunodiffusion in a University Setting. J Clin Rheumatol :
Murphy, Susan L; Barber, Mary Whitehouse; Homer, Kate et al. (2018) Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study. Arthritis Care Res (Hoboken) 70:1653-1660
Pauling, John D; Domsic, Robyn T; Saketkoo, Lesley A et al. (2018) Multinational Qualitative Research Study Exploring the Patient Experience of Raynaud's Phenomenon in Systemic Sclerosis. Arthritis Care Res (Hoboken) 70:1373-1384

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