Methodology core

方法论核心

• 批准号: 10017672
• 负责人: Elena Losina
• 金额: $ 36.51万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-20 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10017672
• 关键词: Accounting; Address; Adherence; Behavior Therapy; Behavioral; Biochemical; Bioinformatics; Caring; Clinical; Clinical Research; Clinical Trials; Communities; Complex; Conduct Clinical Trials; Consultations; Counseling; Data; Data Analyses; Data Collection; Data Management Resources; Data Set; Disease; Ensure; Environmental Risk Factor; Equilibrium; Ethics; Experimental Designs; Faculty; Feasibility Studies; Focus Groups; Genetic Risk; Goals; Grant; Health; Health Insurance Portability and Accountability Act; Health Promotion; Information Technology; Interdisciplinary Study; Intervention; Language; Level of Evidence; Link; Longevity; Methodology; Methods; Mission; Monitor; Musculoskeletal; Musculoskeletal Diseases; Observational Study; Online Systems; Outcome; Patient Preferences; Patients; Perception; Personal Satisfaction; Persons; Phenotype; Physical activity; Probability; Quality of life; Randomized; Randomized Controlled Trials; Regulation; Reporting; Research; Research Design; Research Personnel; Resources; Rheumatism; Rheumatology; Risk Assessment; Safety; Self Management; Statistical Data Interpretation; Sum; Toxic effect; Translations; Treatment Efficacy; Weight; Work; advanced analytics; base; behavioral economics; clinical care; clinical practice; comparative effectiveness study; cost; cost effectiveness; data management; design; disorder risk; epidemiology study; ethnic minority population; experience; follow-up; health disparity; high risk; imaging biomarker; improved; improved outcome; innovation; instrument; longitudinal analysis; member; method development; novel; novel strategies; outcome forecast; patient engagement; patient oriented; preference; racial minority; recruit; theories; therapy design; trial design; wearable device

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.

摘要 VERITY方法核心的专业知识焦点与CCCR的总体目标一致 （“VERITY”）。首先，VERITY是风湿和MSK疾病临床研究的中心，在我们不断增长的，充满活力的 研究共同体，并具有核心的专业知识的广度，以提高广泛的严谨性， 在我们的研究社区进行的研究。第二，VERITY的主要目标之一是设计 干预措施的有效性应在提供最高水平证据的研究中进行评估，包括 可行时为RCT，无法进行随机化时为观察性研究。核心方法将 通过优化试验设计，加速将有效的新治疗方法转化为 临床实践同样，核心委员会关于随机对照试验优先次序的工作需要将资源集中在 有最大的机会来推进临床护理。最后，核心推进了VERITY对患者的关注- 中心主义我们有能力利用信息技术和促进健康的进步， 可穿戴设备设计和实施研究，以提高患者的参与度，自我管理， 坚持，身体活动和幸福。护理可以个性化，通过新颖的方法改善结果 从遗传和环境风险评估和咨询，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。关键具体 方法论核心的目标是：目标1：确保设计中尽可能高的方法论严谨性 和实施旨在改善风湿性和肌肉骨骼疾病患者结局的研究 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： 结合基于行为理论和行为经济学原则的干预方法， 将少数种族和族裔的文化观点和看法纳入干预措施。 方法论核心将来自研究社区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、数据安全合规性， 健康保险可携带性和责任法案（HIPAA）法规，并明确报告调查结果。