Methodology core

摘要 Verity方法学核心的专业知识重点与CCCR的总体目标保持一致 (“Verity”)。首先，Verity是我们不断发展、充满活力的风湿病和MSK疾病临床研究的中心 研究社区，核心具有广泛的专业知识，以加强范围广泛的严谨 在我们的研究社区进行的研究。第二，Verity的关键目标之一是设计 应在提供最高水平证据的研究中评估其有效性的干预措施，包括 可行时进行随机对照试验，不能进行随机化时进行观察性研究。方法论的核心将 通过优化试验设计来加速将有效的新疗法转化为 临床实践。同样，需要核心关于随机对照试验优先次序的工作，以便将资源集中在下列试验上 有最大的机会推进临床护理。最后，核心推动了Verity对患者的关注- 以中心为中心。我们有能力利用信息技术的进步和促进健康 设计和实施研究的可穿戴设备，以提高患者的参与度、自我管理、 坚持、体育锻炼和幸福感。通过创新可以实现个性化护理并改善结果 从遗传和环境风险评估和咨询中提取的干预措施，疾病风险 计算器、行为经济学、健康指导，以及减少健康差距的努力。关键的特定 方法论核心的目标是：目标1：确保设计中尽可能严格的方法论 和实施旨在改善风湿性和肌肉骨骼疾病患者预后的研究 条件。目的2：开发和改进优化临床试验设计和实施的方法。目标3： 融合基于行为理论和行为经济学原理的干预方法，并 在干预措施中灌输文化视角和对种族和少数民族的看法。 方法论核心将研究界的创新想法与严格的研究设计联系起来， 创新试验、方法开发、数据管理和分析、遵守数据安全和 《健康保险可携带性和责任法案》(HIPAA)规定，并明确报告调查结果。

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.