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Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part II-How
Osman Nuri Yogurtcu1, Laura E Gressler2, Jens Eldrup-Jorgensen3
1Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Background And Objective:
Coordinated Registry Networks (CRNs) are networks of healthcare partners that create and utilize information from clinical society registries and other sources to drive evidence-based improvements in healthcare. In Part I of this three-part series, we introduced the systemic coordinated inter-organizational networks (SCIONs) theory, which is proposed as a unique mode of societal coordination that fosters trust, cooperation, and adaptability among partner organizations to address complex societal problems, including healthcare. In this article, we analyze how CRNs function like SCIONs to better understand how CRNs can promote innovation to improve outcomes, quality, and efficiency.
Methods:
The SCIONs theory is used to describe the structure and functions of CRNs and to consider how they might be optimized in practice. We apply the SCIONs theory to an extended case study of the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) to describe the structure and functions of this CRN.
Results:
The criteria to identify SCIONs-characteristics, modes of coordination, and performance evaluation-are applied to the VQI as CRN (and to the VQI as an extended case study). CRNs may drive radical innovation in quality improvement, research, regulatory decision-making, and medical product development. The consequences of these innovations in vascular surgery have been measured by reduced patient stays, reduced barriers in care access, and improved care quality metrics. A partnership between the SVS VQI and the Medical Device Epidemiology Network further expanded VQI's capabilities and integrated Medicare data for a robust evaluation of patient outcomes. Key factors making innovation possible include regional sub-networks, collaborative stakeholder relationships, and a dedicated network-coordinating organization that provides technical expertise, leadership, and data quality assurance for effective collaboration.
Conclusion And Implications For Translation:
The description of the VQI as a SCION offers a generalizable model for the CRN as real-world data collection and analysis that has transformed healthcare delivery and improved patient outcomes at scale. The CRN model is proposed for development broadly across medical and surgical specialties in the US as well as primary care.
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