Methodology core

方法论核心

基本信息

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
项目类别：
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

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

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项目摘要

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.

抽象的 Verity方法论核心方面的专业知识的焦点与CCCR的整体目标保持一致（“ Verity”）。首先，Verity是流变和MSK疾病临床研究的枢纽研究界和核心具有广泛的专业知识，可以增强广泛的严格在我们的研究社区进行的研究。第二，关键的真实目标之一是设计在提供最高证据的研究中应评估效率的干预措施，包括当无法进行随机化时可行和观察性研究时，RCT会发生。方法核心将通过优化试验设计来加快将有效的新疗法转化为临床实践。同样，核心在RCT的优先级方面的工作也需要将资源集中在试验上有最大的机会来促进临床护理。最后，核心的促进了Verity对患者的关注 - 中心。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，以改善患者的参与，自我管理，坚持，体育锻炼和福祉。可以个性化的护理，并通过小说改善结果遗传和环境风险评估和咨询，疾病风险的干预措施计算器，行为经济学，健康指导以及减少健康差异的努力。特定于关键方法论核心的目的是：目标1：确保设计中最高的方法论严格性并实施旨在改善风湿性和肌肉骨骼的人的结果的研究状况。目标2：开发和推进方法以优化临床试验的设计和进行。目标3：根据行为理论和行为经济原则结合干预方法，并注入文化观点以及对种族和少数民族的看法。方法论核心将研究界的创新思想与严格的研究设计联系起来，创新的试验，方法开发，数据管理和分析，遵守数据安全和健康保险可移植性和问责制法（HIPAA）法规，并清楚地报告调查结果。