Methodologic Core

方法论核心

基本信息

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
项目类别：
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

项目摘要

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.

项目概要风湿性疾病和肌肉骨骼 (MSK) 疾病通常会持续数十年，对人体产生深远影响生活质量，并需要复杂且成本高昂的管理。这些疾病的危险因素、伴随的合并症以及反应的变异性存在异质性这种复杂性要求流行病学分析使用来自各种来源的数据，包括来自电子病历和登记的真实数据至关重要。用于确定控制症状和/或阻止观察性关节破坏的有效治疗方法。研究和干预试验必须考虑复杂的表型和不同的疾病持续时间；重要的是，他们还必须解决风湿和毒性结果之间的平衡。 MSK 斯隆的状况受到健康社会决定因素的影响，从而影响获得高价值护理的机会，特别是针对少数种族和族裔的研究，包括获得优质护理的决定因素。隐性偏见、地理多样性和社交网络的作用——有可能改善结果经常被边缘化的人群无法获得医疗保健。面对这些复杂的研究问题和多样化的数据源需要复杂、最先进的技术 VERITY 方法论核心 (MC) 专注于解决这些方法论。 VERITY MC 是一个集中式资源，其总体目标是：为患者临床研究的设计、规划和实施提供重要见解风湿病或 MSK 疾病。 VERITY MC 的专业重点与总体目标一致。 CCCR（“VERITY”）的具体目标包括： 1. 确保设计和方法的严谨性。开展旨在改善风湿病和肌肉骨骼疾病患者预后的研究条件； 2. 开发和推进优化临床试验设计和实施的方法；结合基于行为理论和行为经济学原理的干预方法，将少数种族和族裔的文化观点和观念融入干预措施中。 MC 拥有必要的广泛专业知识，以提高广泛研究的严谨性由 VERITY 研究社区承担 MC 处于有利位置来支持 VERITY 的关键之一。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，基于现实世界数据的仿真将得到改进。 VERITY 注重以患者为中心，特别是因为它与健康的社会决定因素有关。