Methodologic Core

方法论核心

• 批准号: 10705722
• 负责人: Elena Losina
• 金额: $ 32.76万
• 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: 2017-09-15 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705722
• 关键词: Accounting; Address; Affect; Area; Behavior Therapy; Behavioral; Biochemical; Bioinformatics; Caring; Clinical; Clinical Research; Communities; Complex; Computerized Medical Record; Conduct Clinical Trials; Consultations; Data; Data Analyses; Data Security; Data Sources; Ensure; Epidemiology; Equilibrium; Ethics; Faculty; Geography; Goals; Grant; Health; Health Promotion; Healthcare; Heterogeneity; Information Technology; Intervention; Intervention Trial; Language; Level of Evidence; Link; Machine Learning; Manuscripts; Mediation; Methodology; Methods; Monitor; Musculoskeletal; Musculoskeletal Diseases; Observational Study; Online Systems; Outcome; Outcome Assessment; Outcome Measure; Patients; Perception; Persons; Phenotype; Physical activity; Population; Positioning Attribute; Quality of Care; Quality of life; Randomized; Randomized, Controlled Trials; Registries; Regulation; Reporting; Research; Research Design; Research Methodology; Resources; Rheumatism; Rheumatology; Risk Factors; Role; Secure; Social Network; Source; Statistical Data Interpretation; Symptoms; Time; Toxic effect; Work; advanced analytics; behavioral economics; clinical care; clinical practice; comorbidity; comparative effectiveness study; cost; cost effectiveness; data management; data privacy; design; disparity reduction; diverse data; efficacious treatment; electronic data; ethnic minority; experience; health care disparity; illness length; imaging biomarker; implicit bias; improved; improved outcome; innovation; insight; instrument; joint destruction; marginalization; member; method development; multidisciplinary; novel; patient engagement; patient oriented; preference; racial minority; randomized, clinical trials; recruit; social health determinants; social influence; social media; theories; tool; wearable device

PROJECT SUMMARY Rheumatic diseases and musculoskeletal (MSK) disorders often persist for decades, have profound impact on quality of life, and require complex and costly management. Complexity of management is governed by the heterogeneity in risk factors for these conditions, concomitant comorbidities, and variability in responsiveness to specific treatments. This complexity requires that epidemiologic analyses use data from a range of sources, including real-world data from electronic medical records and registries. Randomized clinical trials are critical for the identification of efficacious treatments to control symptoms and/or arrest joint destruction. Observational studies and intervention trials must account for complex phenotypes and varying durations of disease; importantly, they must also address the balance between efficacy and toxicity. Outcomes of rheumatic and MSK conditions are influenced by social determinants of health, which affect access to high value care, especially for racial and ethnic minorities. Studies of the determinants of access to quality care -- including implicit bias, geographic diversity, and the role of social networks -- have the potential to improve outcomes in populations often marginalized from health care. Confronting these complex study questions and diverse data sources requires sophisticated, state-of-the-art research methods. The VERITY Methodology Core (MC) focuses on addressing these methodologic needs and analytic challenges. The VERITY MC is a centralized resource with the overarching goal of providing critical insight into the design, planning and conduct of clinical research in patients with rheumatic or MSK disorders. The focus of expertise in the VERITY MC aligns with the overall objectives of the CCCR (“VERITY”). The Specific Aims of the MC include: 1. Ensure methodological rigor in the design and implementation of studies aimed at improving outcomes in persons with rheumatic and musculoskeletal conditions; 2. Develop and advance methods to optimize design and conduct of clinical trials; and 3. 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 MC has the requisite breadth of expertise to enhance the rigor of the broad spectrum of studies undertaken by the VERITY Research Community. The MC is well positioned to support one of the key VERITY objectives -- to design studies, providing the highest level of evidence, including RCTs when feasible, or trial emulation based on real world data when randomization is not feasible or ethically justified. The MC advances VERITY’s focus on patient-centeredness, particularly as it relates to social determinants of health.

项目总结 风湿性疾病和肌肉骨骼(MSK)疾病往往会持续数十年，对 生活质量，并需要复杂和昂贵的管理。管理的复杂性由 这些情况的危险因素的异质性、伴随的并存和反应的变异性。 到特定的治疗方法。这种复杂性要求流行病学分析使用来自一系列来源的数据， 包括来自电子病历和登记处的真实数据。随机临床试验至关重要 用于确定有效的治疗方法以控制症状和/或阻止联合破坏。观察性的 研究和干预试验必须考虑到复杂的表型和不同的病程； 重要的是，它们还必须解决有效性和毒性之间的平衡问题。风湿病和风湿病的结局 MSK的状况受到健康的社会决定因素的影响，这些因素影响了获得高价值保健的机会， 尤其是对种族和少数民族而言。关于获得优质医疗服务的决定因素的研究--包括 隐含的偏见、地理多样性和社交网络的作用--有可能改善 人口往往被边缘化，得不到医疗保健。 面对这些复杂的研究问题和多样化的数据源，需要复杂的、最先进的 研究方法。Verity方法论核心(MC)专注于解决这些方法论 需求和分析挑战。Verity MC是一个集中化的资源，其主要目标是 为临床研究的设计、规划和实施提供批判性见解 风湿性或MSK疾病。Verity MC的专业知识重点与 CCCR(“Verity”)。MC的具体目标包括：1.确保设计方法的严格性和 实施旨在改善风湿性和肌肉骨骼疾病患者预后的研究 2.开发和改进优化临床试验设计和实施的方法；以及3. 纳入基于行为理论和行为经济学原则的干预方法，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。 管理委员会具备所需的专业知识，以加强广泛研究的严谨性。 由Verity研究社区进行。MC处于有利地位，可以支持其中一个关键的Verity 目标--设计研究，提供最高水平的证据，包括可行的随机对照试验或试验 当随机化不可行或在伦理上不合理时，基于真实世界数据的仿真。MC进步了 Verity的重点是以患者为中心，特别是当它与健康的社会决定因素有关时。