Methodology core

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ABSTRACT The foci of expertise in the VERITY Methodology Core align with the overall objectives of the CCCR (“VERITY”). First, VERITY is the hub of rheumatic and MSK disease clinical research in our growing, vibrant Research Community, and the Core has the breadth of expertise to enhance the rigor of the broad range of studies undertaken in our Research Community. Second, one of the key VERITY objectives is to design interventions whose efficacy should be evaluated in studies providing the highest level of evidence, including RCTs when feasible and observational studies when randomization cannot occur. The Methodology Core will contribute to this mission by optimizing trial design to expedite the translation of efficacious new treatments into clinical practice. Similarly, the Core’s work on prioritization of RCTs is needed to focus resources on trials that have the greatest opportunity to advance clinical care. Finally, the Core advances VERITY’s focus on patient- centeredness. We have the ability to harness advancements in information technology and health-promoting wearable devices to design and implement studies that improve patients’ engagement, self-management, adherence, physical activity, and well-being. Care can be personalized and outcomes improved through novel interventions that draw from genetic and environmental risk assessment and counseling, disease risk calculators, behavioral economics, health coaching, and efforts to reduce health disparities. The key Specific Aims of the Methodology Core are: Aim 1: To ensure the highest possible methodological rigor in the design and implementation of studies aimed at improving outcomes in persons with rheumatic and musculoskeletal conditions. Aim 2: To develop and advance methods to optimize design and conduct of clinical trials. Aim 3: To incorporate intervention approaches based on behavioral theory and behavioral economic principles and to infuse cultural perspectives and perceptions of racial and ethnic minorities into interventions. The Methodology Core links innovative ideas from the Research Community with rigorous study designs, innovative trials, methods development, data management and analysis, compliance with data safety and Health Insurance Portability and Accountability Act (HIPAA) regulations, and clear reporting of findings.