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Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part III-Questions
Osman Nuri Yogurtcu1, Laura E Gressler2, Jens Eldrup-Jorgensen3
1Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration, Silver Spring, MD, USA.
Background And Objective:
Previous work in this series has introduced real-world evidence (RWE), coordinated registry networks (CRNs), and systemic, coordinated, inter-organizational networks (SCIONs) theory. The application of SCIONs theory to CRNs illuminates how their structure and function foster trust and cooperation in a network of organizations to successfully address complex problems in healthcare. This third part in the series asks questions about how SCIONs theory can benefit CRNs and how the experience of CRNs can further develop the SCIONs theory.
Methods:
This manuscript analyzes reciprocal relationships related to SCIONs theory and CRN practice, examining how each can be used to benefit the other. While SCIONs theory has not yet formally been used to direct the development of a CRN, future application is proposed. Conversely, we explored how the practical experiences of CRNs can inform and refine our understanding of SCIONs, including identifying areas for theoretical development and through an exploration of the current limitations of CRNs.
Results:
The SCIONs theory may usefully direct CRN development in key leadership areas, including increasing human capital, encouraging organizational adaptiveness, expanding institutional capacity, mobilizing political engagement, and generating cooperative behavior. CRNs, guided by SCIONs theory, can offer a pathway towards a more efficient, equitable, and learning-oriented healthcare system. A comprehensive approach proposed for CRNs may facilitate the expansion of the evaluation component in SCIONs theory.
Conclusion And Implications For Translation:
CRN program managers should prioritize strategic approaches that foster human capital, organizational adaptability, and institutional capacity. Government agencies may consider investments in CRN as a way to build RWE infrastructure that improves quality and efficiency of healthcare broadly. Public discourse may benefit from a clearer understanding of the role of cooperation in society to address issues that government and markets are not well suited to address. The literature on SCIONs can support the non-profit literature in the way the business literature supports the for-profit sector.
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