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.

项目摘要 风湿性疾病和肌肉骨骼（MSK）疾病通常持续数十年，对 生活质量，需要复杂且昂贵的管理。管理的复杂性受 这些条件，合并症和响应能力的可变性的风险因素的异质性 进行特定的治疗。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注册表的现实世界数据。随机临床试验至关重要 鉴定有效治疗以控制症状和/或阻止关节破坏。观察 研究和干预试验必须说明复杂的表型和疾病持续时间的不同。 重要的是，他们还必须解决有效性和毒性之间的平衡。风湿性和 MSK条件受到健康的社会决定者的影响，这会影响获得高价值护理的机会， 特别是对于种族和少数民族。研究获得优质护理的决定者的研究 - 包括 隐性偏见，地理多样性和社交网络的作用 - 有可能改善结果 人口通常是从医疗保健中被边缘化的。 面对这些复杂的研究问题和不同的数据源需要精致，最先进的 研究方法。 Verity方法论核心（MC）重点是解决这些方法论 需求和分析挑战。 Verity MC是一种集中资源，其总体目标 对患者的临床研究的设计，计划和进行批判性见解 风湿病或MSK疾病。在Verity MC中专业知识的重点与 CCCR（“ Verity”）。 MC的具体目的包括：1。确保设计中的方法论严格 实施旨在改善风湿性和肌肉骨骼的人的结果的研究 状况; 2。开发和推进方法以优化临床试验的设计和行为；和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。 MC具有必要的专业知识，以增强广泛研究的严格性 由Verity研究社区承担。 MC的位置很好，可以支持其中一个关键的现实 目标 - 设计研究，提供最高水平的证据，包括可行的RCT或试用 当随机化不可行或在道德上合理时，基于现实世界数据的仿真。 MC进步 Verity专注于以患者为中心的人，尤其是与健康的社会决定者有关。