Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part I-Coordinated Registry Networks and Systemic Coordinated Inter-Organizational Networks.

Background and Objective: Over the past decade substantial government and market-driven efforts focused on the use of real-world evidence (RWE) to improve healthcare decision-making. A successful strategy has been mounted by specialty societies and their registries that have created RWE through a model known as the Coordinated Registry Network (CRN), which has accelerated innovation, improved care quality, addressed the safety and efficacy of medical products, and supported medical research. This three-part manuscript works to understand how the CRNs have succeeded by applying organizational sociology and the theory of Systemic Coordinated Inter-Organizational Networks (SCIONs). Methods: We describe CRNs as organizations that evolved from the traditional registries of clinical specialty societies. We present the SCIONs theory, a network of organizations that deploy a coordination strategy based on trust and cooperation to solve complex problems. By applying sociological concepts, we identified key characteristics and functions that can inform the development of CRNs, providing practical guidance for their implementation. Results: Our analysis reveals that CRNs offer a unique mode of coordination that can address complex healthcare challenges, leveraging traditional market and government efforts. CRNs can support the vision of a learning health system and evidence-based medicine by harnessing the power of RWE, transforming, and improving healthcare delivery. Conclusion and Implications for Translation: CRNs have the potential to transform evidence generation in healthcare by curating and integrating multiple data sources that can address the data needs of multiple CRN partners. This American solution to the provision of evidence for supporting decision-making in healthcare builds on professional society relationships; the CRN model has demonstrated success in large national registries and warrants expansion to other specialty areas. By understanding the organizational sociology of CRNs, we can unlock their full potential to drive innovation, efficiency, and quality improvement in healthcare.