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

INTRODUCTION

Real-world data (RWD) collected as part of routine clinical care can play a critical role in generating real-world evidence (RWE) and enhancing decision-making across the healthcare ecosystem. In the United States (U.S.), successful large-scale coordinated registry networks (CRNs) have demonstrated significant value within the unique structure of the U.S. healthcare system and, if expanded, could help address longstanding challenges related to the quality and use of RWD in healthcare.^[1,2,3] This three-part manuscript applies organizational sociology and systemic coordinated inter-organizational networks (SCIONs) theory^[4] to understand how CRNs work and have succeeded.

The CRNs are data-driven strategic partnerships that differ from other RWE efforts in many ways. They build on clinical registries of professional societies by linking them to other data platforms to meet the many needs for evidence in the learning health system (LHS),^[5] such as for clinical care support, quality improvement, research, and making regulatory decisions.^[6–8] CRNs have overcome impediments to the production of RWE through the unique set of relations described for curation that is done in the context of clinical care. CRNs successfully curate data out of clinics by maintaining access to the detailed context of care that is necessary for accurate coding and interpretation of data describing patient care. CRNs also link registries to complementary data sources—including medical claims, vital records, and patient/app-generated data—they provide data on patients over time and more granular RWE. Clinicians and their professional societies provide the timely selection of appropriate data elements and direct analysis addressing the needs of clinical care in a changing environment. Studies have documented that CRNs outperform legacy sources of evidence in terms of efficiency (faster data collection at lower costs) and usefulness.^[3,9,10] The term “registry” is a legacy term that may not accurately convey the more encompassing concept of CRN.

Hage, Valadez, and Hadden (2024),^[4] who originated the SCIONs theory, describe it as a third coordination mode that successfully addresses difficult social problems where the two long-standing societal coordination modes, market competition and state coordination,^[11] have not.

CRNs have succeeded, as this third mode, whereas other models have not, after a decade of intense investment in health information technology (IT) by the private sector and in government. Billions of annual venture capital over past years^[12] have not solved the problems of RWE described here. Government investments (Sentinel,^[13] COVID-related^[14]) have had limited success, foundering on inability to produce sufficient granular data. The model used by industry and government, which involves curating data after it has been aggregated, severs the connection to the original source of the data, making it difficult to establish a clear source of truth. Furthermore, this method also disrupts the relationships between data creators, experts, and innovators, hindering the ability to tap into the collective experience and knowledge of a large network. This, in turn, slows down the dissemination of innovative solutions, ultimately hindering progress in addressing complex health issues. In addition, the repetitive curation of health data for single-purpose studies by multiple entities is not sustainable. Our manuscript describes how CRNs operate under the coordination of clinical specialty societies as a collaborative model in clinical practice.

Countries with highly developed registries have managed their health systems more efficiently and produced better health outcomes.^[15] In the United States, successful, large-scale CRNs demonstrated the value to the distinct structure of US healthcare and if scaled may help address some of the longstanding issues related to quality and use of RWD in our healthcare ecosystem.

This Part I of the three-part argument sets out the concepts of CRN and SCION. In Part II, the SCIONs theory is applied to CRN practice, and an extended case study is offered; the Vascular Quality Initiative is described using the concepts of SCIONs theory. Part III evaluated the utility of SCIONs theory for CRN development, and the contribution to the SCIONs theory by this review of CRNs is considered.

METHODS

The framework of action theory^[16] is sociology’s approach to providing practical solutions to real-world problems. By applying the insights of organizational sociology, we aim to enhance CRN development and create a foundation for the subsequent sections of this article. This approach also serves as a bridge to evaluating the effectiveness of CRNs and further refining the theory of SCIONs. Moving from this theoretical foundation, we turn our attention to the practical building blocks of RWE and the development of LHSs.

RESULTS

CRNS: A UNIQUE SET OF ORGANIZATIONAL RELATIONSHIPS

CRNs are data-driven networks that stimulate and coordinate innovations across various clinical settings, supporting clinical improvements based on evidence developed in clinical practice.^[28] CRNs evolved out of traditional registries of clinical specialty societies, which have been part of healthcare since the early 20^th century.^[29] Most CRNs began as quality improvement programs and have expanded to include a range of evidence-based initiatives [Figure 1]. CRNs have evolved into robust and sustainable infrastructure that supports and informs regulatory decision-making, addressing overtreatment, innovation in medical processes and products, and research on patient-centered outcomes.^{[3,10,30–45]} Potential future applications include pandemic preparedness, medical product price negotiations, and determination of payment for care services.^[42]

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Figure 1:

The applications of CRNs in healthcare span quality improvement, public health preparedness, clinical trials and regulatory science, and coverage and payment. While CRNs are already being utilized for various purposes, potential future applications (indicated by **) can further leverage CRN capabilities in addressing evolving healthcare challenges.

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Over the years, some of these registries have transformed into large, sophisticated CRNs, supported by numerous information technology contractors.^[46] The operations on these data sources in participating clinics involve extraction,^[47] curation,^[48] standardization,^[49] interoperability,^[50] and harmonization^[49]—prespecified processes essential to ensure integration into a multipurpose, accessible data source. Although CRNs were initially established in the surgical and procedure specialties, they are currently being developed or planned in most clinical specialty areas.

The National Medical Device Registry Taskforce^[2] first used the term CRN for clinical registries that strategically linked data from a variety of sources, traditionally limited to 30-day follow-up. A CRN links many RWD sources (e.g., medical claims data, electronic health records, and patient-generated health information). They also bring together legacy registries, combine related specialty areas, or facilitate regional efforts to improve coverage in a larger CRN.

A maturity model^[28] supports the development of CRN capacity by providing a continuum for CRN evaluation. Mature CRNs are associated with professional societies such as the American College of Cardiology, the Society of Thoracic Surgeons, the Society for Vascular Surgery, the American College of Surgeons, and the American Academy of Orthopedic Surgeons, among others.^[51]

Various medical specialties are increasingly using CRNs to drive technology-driven practices, improve patient outcomes, and advance medical research. The Intelligent Research in Sight registry^[52] supports technology-driven practices in ophthalmology. The American Heart Association/American Stroke Association has built a suite of programs collectively called “Get with the Guidelines” that use a registry of multiple diseases.^[53] The I-SPY program,^[54] which can be considered a CRN, is a network of oncology practices aggregating data from an adaptive phase 2 platform trial that integrates continuous improvement of medical science and quality of care for the treatment of breast cancer. The National Institute of Dental and Craniofacial Research developed the Temporomandibular Joint Implant Registry and Repository, a patient-led CRN, to address temporomandibular joint disorders treated by multiple clinical specialties.^[55,56] Also, the Cystic Fibrosis Foundation Patient Registry^[57] addresses a rare condition. These last two mentioned are patient-led registries offering a different model for conditions for which professional societies have difficulties.

CRN is not the branding for specific organizations but rather a concept describing advanced clinical registries that use similar strategies to solve problems. CRNs that bring together data in primary care^[58] and community health centers^[59] are also being established. The evaluation of COVID-19 vaccines^[60] using linked claims from the Centers for Medicare and Medicaid Services (CMS) for individuals across time has important similarities and could be considered a CRN.

The CRN’s unique organizational relationships explain how they have overcome the challenges posed by “missing” and “messy” data, which plague RWE. As a novel coordination mechanism, CRNs effectively prespecify data by collaborating directly with clinicians at specific care sites, who possess the comprehensive contextual knowledge necessary to overcome these challenges. Clinical societies also provide a forum in which essential data elements are identified and modes of standardizing coding are promoted. Consultation with the people who create and collect the data is also essential to ensure the continued utility of data as clinical practice evolves. Commercial aggregators that separate data from the context of the collection cannot replicate the relationships that underpin the CRN’s success in data curation. Data aggregated but cut off from the context of clinical care cannot be adequately curated.^[61–64] Another challenge pertains to the missingness of data in numerous digitalized sources. For example, in cardiology, almost 25% of the data collected in the National Cardiovascular Disease Registry is not found in the electronic health records. Currently, missing data is addressed via manual curation, leveraging a high level of knowledge of clinical context.

The linkage of data to enrich registries and provide longitudinality has been another hallmark of CRNs. Cohorts of RWE typically lack follow-up data because patients in the United States move between providers over time, making it difficult to follow these patients longitudinally. The study of the progression of disease and the safety and efficacy of treatment has successfully been addressed by data linkage.^[60–65] The linkage of registries to CMS claims data has provided this longitudinality for CRNs.^[66] Methods are well developed to maintain the confidentiality and security of the records.^[67]

The sustainability of the CRNs also stems from the unique set of relationships between participating clinics and many partners using the data. Each partner in the network can contribute to and benefit from the CRN in unique ways.^[18] Despite the intensive labor and high cost of data curation, CRNs efficiently distribute costs among partners by collecting and curating data once and utilizing it across multiple partners. Researchers have documented CRN-generated RWE as “better, faster, and cheaper” than evidence from the types of studies traditionally used to evaluate medical products, owing to the unique relationships involved.^{[7,8,32,34,68]} The achievements of CRN in enhancing the quality of care represent a radical innovation, given as a technical definition by the sociological theory below. The CRN’s quality improvement functions are well documented while contrasted to programs that seek quality improvement through traditional, top-down process management, such as audit and feedback programs for medical professionals, which have shown little impact on the quality of care.^[69–71]

SCIONS

Sociologist Jerald Hage and colleagues have proposed the theory of SCIONs, which are collaborative networks of organizations united by a shared societal goal. SCIONs manifest as alternative organizational structures that address societal problems where market forces and governmental efforts have not succeeded.^[4] According to Hage and colleagues, SCIONs offer two key advantages, that is, their source of value, that make them a viable alternative: Firstly, the varied change strategies within SCIONs enable rapid organizational adaptation and flexibility. Secondly, continuous coordination in SCIONs fosters collaboration and effectiveness, leading to impactful institutional change.^[4] The limitations of government and market-driven forces are well understood, including challenges such as vested interests, sunk costs, previous organizational success, and single-loop thinking (evaluating the implementation of a strategy without evaluating the strategies themselves as a second loop).^[16] “Bounded rationality” renders organizational change difficult, even when individuals in an organization understand the obstacles.^[78] A distinction between individual learning and organizational learning has led to the search for new organizational structures that address social problems that current institutions are unable to resolve. For a deeper understanding of CRNs as a prime example of SCIONs, we refer the reader to Hage, Valadez, and Hadden (2024).^[4] This work explores the capabilities and limitations of market forces and government in detail, characterizes SCIONs, and explains why SCIONs can succeed where business and government cannot.

The characteristics of SCIONs, their coordination mechanism, and performance evaluation criteria are listed in Table 1 and described below.

DISCUSSION

This paper presents the CRN as a successful strategy for building an RWE infrastructure that supports the evidentiary needs for health and healthcare. The emergence of CRNs can be traced back to a broader historical context of the need for EBM and the vision for an LHS that can provide evidence for a variety of needs, utilizing data collected during clinical practice. CRNs have evolved out of clinical specialty society registries, linking with other data resources to cater to a variety of needs. Research has shown that this model yields evidence that is both more valuable (allowing for the study of heterogeneity of effect with large sample sizes) and efficient (requiring less money and time) than previous studies. The specific types of cooperation-based relationships between clinics and other partners in the network described by SCIONs theory and observed for CRNs in the next part of this three-part series enable CRNs to create value.

This work also presents the SCIONs, theory to illuminate an emerging organizational type that has successfully resolved problems where business and government approaches have not. In Part II of this series, we apply the theory of SCIONs to CRNs, including a review of a specific CRN experience and an extended case study on, the Vascular Quality Initiative (VQI)/ Vascular Implant Surveillance and Interventional Outcomes Network (VISION). Part III looks at how organizational sociology can be used to figure out how the CRN model can grow in more clinical areas. It also talks about the other things that an emerging RWE national infrastructure will need and what the problems with CRNs are.

CONCLUSION AND IMPLICATIONS FOR TRANSLATION

The application of SCIONs theory advances the CRN literature by highlighting the distinct nature of relationships that enable them to succeed in areas where other organizational relationships have failed. Professional societies, with their registries driving change, have succeeded in improving the quality of healthcare, accelerating innovation, and controlling costs in the US in a few areas. More generally, market forces have not succeeded in addressing these ongoing challenges in US healthcare after decades of attempts.^[85] European and other countries have developed national, government-sponsored registries that have played a critical role in producing better outcomes at a lower cost.^[86] One may compare the utility of the CRN to the European national health registries; however, the distinctive characteristics of US healthcare have led to the development of CRNs that effectively tackle these issues, albeit in limited specialty areas currently. The implication of this work for translation is to understand how organizations based on cooperation have succeeded and how the model can be spread to other specialty areas in the United States as a unique American solution.

Leveraging action theory that is fundamental to the SCION literature, this paper bridges Parts II and III of this paper series, making arguments for the application of institutional sociology to the development of quality improvement and health information systems, i.e., RWE and CRNs. Hage, Valadez, and Hadden^[4] have observed that SCIONs theory is useful for describing concrete interventions that have been successful. They provide an extended study of NicaSalud, a SCION that has decreased infant and maternal mortality in Nicaragua. “Evaluations of SCIONs in different settings will consolidate [the SCIONs] theory that has been advanced here as well as solving some of the most vexing problems facing the world today.” That is, the development of SCIONs theory should aid in the development of solutions for complex societal problems that the government and industry have yet to address. The SCIONs theory provides a service, similar to the business literature that supports the development of for-profit operations.

Action theory is also well-suited as a bridge for the translation of medical, public, and population health research into policy and practical actions that improve the health and well-being of populations.^[87] Action theory in sociological analysis, when applied to the problems addressed in this paper, provides implications for program managers, government agencies, and the public^[16] as a translation of medical science and public health into practice. Action theory works in the same way, pushing sociology to ensure theoretical formulations are useful for social change and, reflexively, to improve them, translating findings into better theories.

In the associated papers, the translation of the findings of this three-part series is discussed using action theory. In Part II, the theory of SCIONs is applied to CRN activities, demonstrating how a highly functional CRN can create value by improving evidence generation. This enhanced evidence generation, in turn, supports quality improvement and efficiency in healthcare. In Part III, the application of SCIONs theory for program managers, government agencies, and the public is specifically evaluated. Finally, we also address the reflexive aspect of action theory by answering questions about how the study of CRNs may contribute to the further development of SCIONs theory.