Methodologic Core

项目摘要 风湿性疾病和肌肉骨骼（MSK）疾病往往持续数十年，对人类健康有深远的影响。 生活质量，并需要复杂和昂贵的管理。管理的复杂性取决于 这些疾病风险因素的异质性、伴随的合并症和反应性的变异性 具体的治疗。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， 包括来自电子医疗记录和登记处的真实世界数据。随机临床试验至关重要 用于鉴定控制症状和/或阻止关节破坏的有效治疗。观察性 研究和干预试验必须考虑复杂的表型和疾病持续时间的变化; 重要的是，它们还必须解决功效和毒性之间的平衡问题。风湿性关节炎和 MSK的状况受到健康的社会决定因素的影响，这些决定因素影响到获得高价值护理的机会， 特别是对少数民族和种族。关于获得优质护理的决定因素的研究，包括 隐性偏见、地理多样性和社交网络的作用--有可能改善 经常被边缘化的人口得不到保健服务。 面对这些复杂的研究问题和多样化的数据来源， 研究方法VERITY方法论核心（MC）专注于解决这些方法论问题。 需求和分析挑战。VERITY MC是一种集中式资源，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， 风湿性或MSK病症。VERITY MC的专业知识重点与以下总体目标一致： CCCR（“真实性”）。MC的具体目标包括：1。确保设计方法的严谨性， 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; 2.开发和推进优化临床试验设计和实施的方法; 3. 采用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。 MC拥有必要的专业知识广度，以提高广泛研究的严谨性 由VERITY研究社区提供。MC处于有利地位，可以支持关键的VERITY 目的-设计研究，提供最高水平的证据，包括随机对照试验（如果可行），或试验 当随机化不可行或道德上不合理时，基于真实的世界数据的仿真。MC前进 真理的重点是以病人为中心，特别是因为它涉及到健康的社会决定因素。

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.