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Gliklich RE, Dreyer NA, Leavy MB, et al., editors. 21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User’s Guide: 3rd Edition, Addendum [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Mar.

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21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User’s Guide: 3rd Edition, Addendum [Internet].

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5Registry Networks

, M.B.A. (Lead); , M.D., M.P.H.; , Ph.D., M.S.P.H.; , M.D., Ph.D.; , M.S.

Author Information

Introduction

Patient registries are “organized systems that use observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.”1 Health reform and value-based payment are driving increased need for standardized performance measurement on a national level.2 Registries collect standardized, structured data on patient populations that span institutions, geographic areas and track patients over varying periods of time. These characteristics make them well-suited platforms for performance measurement, including patient health outcomes, as well as clinical research.36

As interest increases in using registry-generated information to improve health care performance and create new knowledge, registry networks have developed to support, engage and connect registry stewards, organizations that rely on registry information and others with an interest in the medical condition, treatments, outcomes, etc. A registry network is a formal community of organizations operating or using information from patient registries to measure and improve patient health outcomes. Registry networks may be general in nature or focused on specific domains. These networks provide a supportive infrastructure that organizes participants to undertake activities related to the specific goals of the network. Although registry networks may be established for different purposes, at a fundamental level they are strategically collaborative groups where organizations and individuals come together to advance their work, generate and share knowledge, and solve shared challenges. Although some patient registries have existed for decades, the demand for registry information is increasing as the number of registries created for quality improvement, research, medical product evaluation, payment and other purposes continues to grow. This trend has underscored the need for information about registry capabilities, as well as the need to support communities that help organizations new to the field benefit from the experience of more established registries. In addition to their knowledge sharing activities, registry networks build a common infrastructure, create new knowledge, and provide a place to learn about the registries and other registry participants and contributors. Additionally, some registry networks provide access to technical infrastructure such as access to combined datasets or metadata, often facilitated by member registry adoption and use of data standards that the network has developed. Overall, registry networks create communities of registry practice that foster learning and professional development.

Given their role in a growing registry enterprise, greater awareness of registry networks and how they operate is needed. This chapter begins by describing different kinds of registry networks and providing an overview of major activities. Additional sections then outline how registry networks are formed, including a discussion about funding, sustainability challenges and solutions, and considerations related to international networks.

Types of Registry Networks

Registry networks are formed for different purposes and have varying structures to meet the strategic objectives of their members.7 Some networks focus on a particular clinical area or patient population, while others are more broad-based and open to a range of clinical domains and purposes. Registry networks may target registries within a particular country, while others are explicitly multinational. Some networks provide technical infrastructure that facilitates linking of registries with each other, while others also include additional data sources (e.g., administrative claims data) that are linked to registry patients to augment the scope of data collected and/or duration of patient followup. In such instances this registry network infrastructure becomes the “core” of knowledge networks powered by registries and other health information systems. The different registry network types are described below.

General

General networks of registries admit organizations operating or planning to operate registries and others allied to the registry field, regardless of their specific focus area. As such, these serve as broad-based, multi-stakeholder professional communities of registry practice. They provide a forum for sharing and creating leading practices, facilitate the development of resources for the registry community, and create formal structures for frequent and meaningful interaction between network participants. They offer access to information about participating registries, such as in a catalog or inventory. General networks may also serve as conveners for consensus-building activities, such as the creation of common data standards that facilitate interoperability between registries and other information systems. While they exist for a variety of purposes, general networks share a common mission to accelerate the development and use of registries to improve health and health care. Examples of general registry networks include the National Quality Registry Network (NQRN), a program of the Physician Consortium for Performance Improvement (PCPI®), and the Registry Workgroup hosted by the Council of Medical Specialty Societies (CMSS).

Clinically Focused

Clinically-focused networks, such as the North American Association of Central Cancer Registries (NAACCR), are formed when the potential benefit as well as the need to coordinate the activities of registries that share a common clinical focus area is recognized. By concentrating resources on specific clinical areas, clinically-focused networks can convene expert working groups and other formal mechanisms that create infrastructure such as data standards, particularly in cooperation with general networks of registries. These networks can also develop performance measures specific to physicians and health care professionals practicing in a particular clinical area.

Clinically-focused networks often create consensus around best clinical practice standards using research and learnings within the clinical objectives of the registry. From there, participating registries are well-positioned to facilitate the sharing of technical, specialty and/or condition-specific professional resources and tools. These registry networks often seek to build a national or international network that can, at least in some aspects, provide specific functionality or capability uniformly across the network. Once combined, the datasets of clinically-focused networks are an important source of information for benchmarking and other observational research in those areas.

Research

While networks of registries of any type can facilitate research, some networks focus primarily on developing research methods and/or conducting research studies in one or more clinical areas. An example is the TREAT-NMD Neuromuscular Network that provides community and infrastructure to accelerate research and therapy development into neuromuscular diseases, increase collaboration, and improve patient care. Research networks offer centralized support for research, as well as infrastructure that facilitates the exchange and aggregation of data sets. Such networks also provide forums through which researchers can set common agendas and seek funding to address shared priorities. These networks may make their data sets available to researchers both inside and outside of the network, thereby acting as a source of data for the broader research community. These capabilities are additive in that participation by a registry in a research network does not preclude individual registries from conducting their own research. Activities that add to the value of research networks include the ability to create large combined data sets, establish shared governance and other formal structures to ensure that data collected are usable for research, and engage a broader range of stakeholders in and outside of the health care delivery system who may not otherwise contribute to or benefit from the network.

The Medical Device Epidemiology Network (MDEpiNet) is another important example of an entity that, in part, serves a research-oriented registry network. Initiated by the US Food & Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) in 2010, MDEpiNet is a collaborative program through which CDRH and external partners share information and resources to enhance our understanding of the safety and effectiveness of medical devices after they are marketed. Already, more than 40 stakeholder groups including government agencies, manufacturers, patient advocacy groups, universities, health care provider organizations, and other research organizations have become involved in various meetings, exchanges, and workgroups in an effort to develop this new network. One of its main objectives is to foster the development of national and international registries that can be used for medical device postmarketing surveillance activities.810 In particular MDEpiNet has provided a forum for bringing together registry leaders from around the world to form international consortia focused on advancing registry methods and analyzing data generated by existing orthopedic and cardiovascular registry programs. Together, these networks are developing a national/international infrastructure and methodological approaches for conducting robust studies and surveillance to improve the understanding of medical device safety and effectiveness throughout the medical device life cycle.

Major Activities of Registry Networks

Knowledge Sharing

Networks of registries facilitate the creation of communities of registry practice. Before most registry networks were formed, registry leaders learned their trade and solved problems alone or with ad hoc assistance from within their own informal networks. Information is shared and knowledge transferred, but on a limited and ad hoc basis. By forming registry networks, participants at all experience levels benefit by sharing ideas and collaborating on shared work products. Registry networks frequently convene committees, task forces and working groups. Participants share knowledge using multiple channels with varying levels of formality, including in-person programs, Webinars, blogs, and online chat rooms. These collaborations often result in development of resources such as guides and tools as well as consensus standards for the community supported by the network.

For example, the NQRN is a voluntary network of organizations interested in registries. The NQRN uses a multi-stakeholder model in which organizations operating or planning registries collaborate with users of information from registries, including health plans, health systems, researchers, organizations representing patients and consumers, federal and state government representatives and others. The NQRN’s governance helps to ensure that the network facilitates knowledge sharing that is of value to all participants. The NQRN’s committees and task forces produce resources and education designed to accelerate the dissemination of leading practices and lessons learned by the network to the broader health care community.

Creating Common Infrastructure

An important purpose for collaboration across registries is to define common data standards. Data standards are essential building blocks for the sharing of data across registries for research, quality improvement and other purposes. While the creation of common data standards is important for all registries, registry networks are well-suited to carry out this work. By convening working groups of registries and other organizations, registry networks can build trust, leading to a desire on the part of registry stakeholders to collaborate by achieving consensus on how to prioritize the data elements and their definitions.11

Harmonizing data standards occurs at two levels: the concept to be measured and the selected definition, including the source and timing of measurement. Typically, a harmonization process begins with a discussion of what concepts are most essential for harmonization. For example, a registry collaboration focused on enabling comparisons of risk-adjusted outcome performance might decide only to harmonize select outcome and case-mix concepts, whereas a different collaboration focused on expanding the dataset for medical device tracking might focus instead on harmonizing device technical and identification parameters that improve the comparability of device information across the registries in the network.

Building consensus is an essential element required to achieve data standard harmonization. Individuals representing the various registry stakeholders must be confident that the methodology for evaluating differences in measure concept prioritization and data definition is transparent and impartial. This typically begins with a review of the evidence followed by a presentation of proposals to be voted on by committee members. Often, a Delphi technique with anonymous iterative voting is used to reach consensus above a certain threshold.12 Some registries have been able to broker this consensus-building directly, while others have worked with third-party facilitators.

Defining data standards must be followed by dissemination and implementation if widespread adoption is to be achieved. Any switch to a new standard invariably means a loss of compatibility with existing data. Stakeholders will only make this investment when the use case of the standards outweighs the loss of continuity in existing data. Even with a strong use case, strong stakeholder engagement in managing the transition from the old to the new standard is required. Due to their multi-stakeholder membership models and governance structures, generalized registry networks are well-positioned to act as conveners for creating consensus standards that lower barriers to interoperability and information exchange, increasing the usefulness of registry information.

Creating New Knowledge From Registry Networks

Existing registries, along with other health information systems, provide information that is fundamental to the generation of new knowledge. Registry networks bring relevant registry experts and other stakeholders together to discuss evidence gaps, methodologies, data considerations and other challenges. These groups are then well equipped to identify areas where research work is most needed.

As an example, in the medical device setting, a single existing entity rarely has all the elements necessary to provide robust, long-term device evaluation including unique device identifiers (UDIs), operator proficiency, technical procedural information, long-term followup and large enough patient cohorts. Deficiencies of any single registry or data source could be overcome if the registry can be linked to one or more additional registries or other data sources that hold data necessary for robust device evaluation.

Creating a Professional Home for Registry Practice

The idea of a “network of registries” described here reflects the broader concept of a community of practice (CoP). Etienne Wenger offers the following definition, “Communities of practice are groups of people who share a concern, a set of problems, or a passion about a topic, and who deepen their knowledge and expertise in this area by interacting on an ongoing basis.”13 In the area of health care practice and research, professional associations often serve as de-facto CoPs for practitioners in a specific clinical field. Practice-based research networks (PBRNs) can also serve this role for primary care providers. The Agency of Health Research and Quality (AHRQ) defines PBRNs as “groups of primary care clinicians and practices working together to answer community-based health care questions and translate research findings into practice.”14

Communities, or in this case, registry networks, develop their practice by responding to the practical needs of members. These activities commonly take the form of problem solving, articulating and responding to requests for information, seeking out the experiences of one another, reusing assets (e.g., proposals, letters, formulas), discussing developments (e.g., new technologies, regulations, research findings); documenting developments (e.g., case studies, data collection); conducting site visits; mapping knowledge and identifying gaps (e.g., research agenda setting); and coordinating and conducting special projects (e.g., harmonizing data element definitions across registry programs).

While a CoP is typically driven by a core group of people who are passionate and devote time to helping to lead the community, not all the members necessarily participate equally. Multiple levels of participation usually exist, reflecting differences in members’ perspectives, needs, and ambitions (Figure 5-1). Wenger has identified the three key factors for successful CoPs: identification, leadership, and time. Accurately negotiating the domain (i.e., scope) of a CoP allows members to identify with its purpose and also to derive a new identity as a participant in the CoP. Ensuring that a core group of leaders step up to nurture the community and “take care of logistics” guards against the loss of momentum and member interest. Finally, members are keenly aware of the other priorities that compete for their time, so it is important to ensure a “high value for time” ratio for members.

This figure depicts the community of practice as a series of concentric circles, to represent the varying levels of participation that individuals can have with the CoP. At the very center is a core group, which typically consists of coordinators and leaders. Slightly less removed than that group is an active group of members, which often includes experts in the field. Next comes occasional participants, including members who may check in with the CoP every once in a while. Next are peripheral participants, which often includes beginners (either in the field as a whole or those who are new to the CoP) and “lurkers” - those who tend to observe the CoP without participating actively. Finally, there are transactional individuals who may not “participate” in the CoP per se, but play a particular role in its operation. These include support staff, sponsors, and clients.

Figure 5-1

Levels of participation in a community of practice. Source: Slide: Levels of participation. http://wenger-trayner.com/resources/slide-forms-of-participation/. Accessed January 10, 2017. Used with permission.

In addition to formal knowledge-sharing practices, registry networks provide an organized professional community with benefits that include targeted discussions on leading practices and standards. Social and professional networking, both formal and spontaneous, pave the way for connections that foster mentorship between new and experienced registry stewards and users as well as informed discussions based upon on-the-ground experience at the detailed level that is required to implement successful registry programs. Registries require detailed planning and execution across a number of different areas: technology including data privacy and security; international regulations and ethics, often tailored to multiple countries; deep therapeutic knowledge of study design, feasibility, and operational considerations; and a number of often complex observational study methods specific to collecting and analyzing registry data. Registry networks foster building relationships with registry experts across all of these topics. For those in leadership positions with responsibility for successful implementation, a professional home is a critical component that allows those in a network to have a formal knowledge tree and access to experts who can help shape future of their enterprise, as well as increase awareness among potential community members.

Creating a Registry of Registries

Registry networks often maintain listings of registry programs relevant to their area of focus. The level of detail provided in these listings reflects the network’s purpose for the list and resources available for creating and maintaining it. When establishing a database of registries, there is always a need to balance the comprehensive with the feasible. For example, organizers of the NQRN created its initial list as an Excel spreadsheet to identify possible registries to invite into the network. The NQRN now asks participating programs to send updates to their entry, provide information about the registry’s purpose and appropriate contact information. The AHRQ is sponsoring the development of a collaborative Web-based registries forum that is paired with another registry list, the Registry of Patient Registries (RoPR; https://patientregistry.ahrq.gov/). The RoPR focuses on registry programs in the United States and promotes collaboration, reduces redundancy and improves transparency in registry research. The RoPR is integrated with ClinicalTrials.gov – the central listing of clinical studies maintained by the National Library of Medicine (NLM).

Condition-specific registry networks can have varying objectives for their registry listings. For example, the goal of NAACCR is to help public health departments meet the needs of federal and state authorities, and its listing is inclusive of all state-based registries in the United States and province-based registries in Canada, as well as those of large counties or cities. The TREAT-NMD has positioned itself to conduct distributed research across its multiple major country-based registry programs, chiefly for pharmaceutical companies and academics who want access to data in multiple registries. The International Consortium of Cardiovascular Registries (ICCR) is principally focused on helping its core group of about a dozen national or larger subnational registry programs share promising practices and work collaboratively on common projects.

These registry listings serve the broader community in multiple ways. They raise awareness of similar research initiatives, enabling direct outreach for knowledge sharing and networking. This can facilitate the use of existing registries as sources of secondary data for additional research questions. While supporting the creation of registries is a key goal of many in this community, researchers are also invested in efficient research spending. When possible, leveraging existing systems is preferred over spending valuable research dollars to create duplicate data systems designed to achieve the same goals.

Setting Up a Registry Network

The decision to establish a registry network may occur when existing or developing registries or users of registry data (e.g., federal regulators) recognize the need to achieve organizational efficiencies and/or to obtain and analyze data across larger populations than a single registry is able to access. Registry networks may therefore reach across organizational, state, regional, national and international boundaries. Some of the time, it is a regulator, such as the U.S. Food and Drug Administration (FDA), that identifies the need for a network of registries and provides startup funds to encourage development, as is the case for the International Consortium of Orthopedic Registries (ICOR) and the ICCR. In other instances, a research organization such as the Patient Centered Outcomes Research Institute (PCORI) will launch a network of registries or electronic health records systems (PCORnet) to support its research agenda while also expecting that the network will become self-sustaining over time. In the case of the NQRN, the impetus came from the CMS Administrator, who urged disparate groups (specialty societies, health plans, and payers) to combine their efforts into a single entity.

For each circumstance, it is critically important that the founders of a new registry network agree early on the mission and scope of the new entity. It is also important that a new network not duplicate what is already being done by another network. If a closely related network already exists, potential members are likely to weigh the benefits of joining a new network versus partnering with and expanding the scope of an existing one. This is especially true if the new network will be relying on contributions of volunteer time and other resources during its startup phase. For participants in other networks to be willing to join, they must be confident that the new network will provide value to their organization in a reasonable amount of time in return for participation, in particular a return or outcome that they are unlikely to realize otherwise or elsewhere.

Just as it is important to agree early on what work will be done together through the network, there must also be a shared understanding about what activities will remain outside of the network’s scope. For example, network participants may agree to share lessons learned and best practices. Conversely, members may reserve the right to individually advocate on behalf of their registry, organization or providers and patients, even if their position differs from that of other network members. Participants may want the freedom to apply together (all members or a subset thereof) for public or private funding support. Others, especially federal officials and regulators, may limit themselves to an ex-officio or observer role while still participating in and learning from the network.

Governance

Although a voluntary self-governing network of registries, such as the NQRN, has considerable latitude in how it operates, network founders would be wise to solicit input from other stakeholders as they establish initial governance, formulate a strategic plan, and initiate operations. In the absence of existing practices, some networks write a charter, adopt bylaws, and begin to operate with the intent of reviewing initial practices, policies and procedures. Early questions for the founders to consider include whether the members are organizations or individuals, what expertise among advisory board and steering committee members is necessary and desirable to ensure network success, how long members will be asked to serve, and whether decisions will be made by voting or if full consensus will be required. The roles, responsibilities, and terms of officers and other governing body members should be established with succession and continuity in mind. Inaugural board members are often appointed, whereas elections may become the preferred approach once a network has matured.

A network established with private or public funds usually has less latitude as it begins operations than a voluntary network. It is critical that the governing body and professional staff have a clear understanding of the funder’s expectations and requirements with respect to membership, accountability, meetings (open or closed), reporting, and other policies and procedures. A network receiving federal funds may elect to operate under the auspices of an umbrella organization such as a university or professional organization that already has the necessary systems and controls in place to ensure compliance with agency requirements. Establishing such systems can be a consuming and complicated task for a fledgling organization.

Membership Rules and Expectations

Registry network founders generally know the individuals or organizations they wish to invite to become members. If a network anticipates a dependence on volunteer time and voluntary financial contributions, the invitation to join must explicitly state those expectations. The founders will be well advised to have done some early “scouting” of potential members and have confidence that those invited will want to join and will be able to fulfill the stated requirements. Organizations may establish different membership categories and accompanying expectations to ensure that there is broad representation across desired stakeholder groups. For example, registry networks may establish lower membership fees or participation expectations for nonprofit patient and consumer groups as compared to scientific partners or for-profit enterprises. Within membership categories, fees and expectations may also be based on organizational size, operating budget, and/or provision of non-monetary contributions such as time, space and contributors.

Member Recruitment

A critical role for any network is to recruit members who will contribute in ways that fulfill the mission, goals and objectives of the organization. In the case of a registry network, this may include experts in a clinical domain such as cancer or heart disease, registry operations, patient and consumer engagement, legal matters and other key areas. As a registry network is being formed, it will be important to state the value proposition for each stakeholder group that is recruited. While many individuals and organizations are altruistic, each is likely to be considering the unstated question, “What’s in it for me?” Failure to be able to articulate the value proposition for each member may result in a potential member deciding not to join, to only watch from the sidelines, or to adopt a passive approach to membership at a time when action is needed. Additional considerations include desired registry characteristics (e.g., focus, capture rates, data validation strategy).

Staff Support and Succession Planning

The scope, funding, and governance model of a registry network determine whether the organization operates informally using volunteers, hires professional management, or engages an association management company to support operations. The network’s scope, size, budget, and funding sources (Federal, private, other) determine the degree to which professional managers are needed to support its activities. Just as governing bodies need succession planning, so do managers. The best managers and boards begin succession planning as soon as they begin work. In doing so, they recognize the evolving requirements for network success, develop the habit of identifying talented people, and create opportunities for professional growth for promising professionals they want to recruit or retain.

Infrastructure, Communications, Monitoring Use and Value

As communities, registry networks thrive on communication. Registry networks exist across organizational boundaries and are typically sustained by regular reaffirmation of the goals of the network and progress towards those goals. Registry networks may choose to host conferences or side-meetings alongside existing conferences to build social connections, share updates, and enhance knowledge sharing. Newsletters, Webinars, case studies, and blogs can also be used to sustain the community. Registry networks also benefit from shared work. As exemplified with NQRN, centralized resources within the network, such as project managers, can be invaluable to support cross-network efforts as the priorities of individual members can easily be shifted towards their primary organizational responsibilities. Teleconferencing and videoconferencing technology can effectively enable cross-organizational teams, alongside file sharing and online productively platforms.

Registry network activities may also include creating technical infrastructure for interoperability among the network’s registries and with other health data systems. Whether the scope of these activities is restricted to governance, e.g., the convening of working groups to create consensus standards, or includes the formation of a technical infrastructure for information exchange, a network’s ability to create infrastructure is dependent on the relationships created and maintained through the communication channels of the network. When technical data-sharing infrastructure is to be built, considerations include network structure (i.e., centralized vs. a distributed data network), and the use of standardized data use and business associate agreements.

Large, more general networks of registries are well-positioned to build technical infrastructure due to their multi-stakeholder membership. These networks can serve as umbrella groups for organizations with specific clinical or other focus areas, enabling the creation of true consensus standards that represent health care as a whole. For example, the International Registry for Health and Lung Transplantation (IRHLT) began in 1983 and now captures longitudinal follow-up data on approximately two-thirds of thoracic transplants across the globe.16 These data provide clinicians and other stakeholders with a comprehensive view of current clinical practice and associated patient outcomes that can be used to advise best practice. Vendors and other organizations that implement technical standards are motivated to do so when those standards reflect a broad consensus. In the absence of a collaborative network to foster harmonization, organizations typically direct their individual requests of vendors to implement organization-developed standards, which often define the same clinical concepts as other standards do, with minor differences.

Funding and Sustaining a Registry Network

Planning for the funding and sustainability of a registry network depends very much on the network’s purpose and goals. It is critical to understand early on and continually assess the needs of network participants and other stakeholders so that solicitation efforts and resource utilization are optimized to meet those needs. Although there may be overlap, network funding strategies can be divided into those that respond to a need identified by an external group (market-responsive) and those based on a previously unrecognized or unmet need identified by the founders. In the latter case, the founders may gain the support of funders by educating them and convincing them of that need (market-creation). Sustainability strategies should be expected to evolve as a network matures and has more value to offer to supporters.

Market-responsive funding results when, as examples, a regulatory agency, product manufacturer, health plan or system, patient or consumer group, or a funder of research (public, private, foundation), decides that a registry network will best address a problem that concerns them. A network solution may be preferred or necessary to conduct surveillance across different jurisdictions, geographies or populations, especially if no existing single registry holds enough data or individual records to address problems such as disease outbreaks, rare diseases, or medical device defects in a timely manner. For example, depending on its goal, scope and robustness, registry networks can be very appealing to regulatory agencies, especially if the network is able to increase power to assess long-term safety and effectiveness data on a broad patient population. Psonet is an international population-based network of registries with psoriasis or psoriatic arthritis patients taking a systemic agent. Funded by the Italian Drug Agency and European Academy of Dermatovenereology, Psonet aims to improve surveillance of psoriasis and psoriatic arthritis in Europe. A common protocol was written to support the collection of a common set of variables to allow for combining data across registries resulting in a larger, more diverse patient population.17,18

Financial support for a registry network can come from a variety of sources, including from specialty societies (e.g., American College of Cardiology, National Cardiovascular Registry and Society for Thoracic Surgery collaboration), health systems (High Value Healthcare Collaborative), research organizations that sponsor comparative effectiveness research (e.g., PCORI, AHRQ), or industry. In these circumstances, the societies or health systems have patient data, but external funding support of a network of data holders is needed to achieve the semantic interoperability necessary for data to be exchanged across systems, aggregated and analyzed. Network sustainability in both instances is possible, although not guaranteed, because participants are responding to an identified market need.

Registry networks may also be created by established registry stewards who are frequently sought out by new registry developers for guidance and solutions to common startup challenges such as vendor selection, privacy and security policies, business associate agreements and the “nuts and bolts” of running a registry. In this instance, new registry developers need to learn, and established stewards seek a more efficient means of sharing leading practices. Such a network, although it may depend greatly on volunteer time and in-kind support, may begin to operate with the support of an organizational sponsor, later soliciting grants, establishing dues, and charging registration fees to support its work. One example of this approach is the NQRN.

Market creation strategies for registry networks are similar to those pursued by individual registries. Once a network is established and its mission and goals have been established, its participants may solicit funding to address research questions that they have identified. A network, if it becomes a platform for data sharing, aggregation and analysis, may receive compensation for providing de-identified aggregated data to parties seeking to meet their business needs without building their own network or data warehouse. It is at this point that a network of registries may itself become sustainable while also contributing to the sustainability of its component registries.

Considerations for International Networks

Although most registry collaboration to date has been national, a growing number of registries are working across countries to harmonize standards, share data, and contribute to research and development of leading practices. International collaboration offers several advantages: for pharmacovigilance, a pooled international sample can quicken the discovery of problematic drugs or devices; for research, data pooled across multiple countries can lead to more generalizable evidence; and for professional and institutional learning, a broader range of practice settings can capture higher variation in performance and more opportunity for discovering and analyzing outliers.

International registry networks are not without their challenges. The data harmonization required for surveillance, pooled research, or comparisons must build on consensus that bridges health systems, reimbursement structures, and cultures, often with different stakeholders holding decision-power in each system. A pragmatic approach that starts with the most interested countries and their key decision makers is essential to get started. Beyond harmonization, actual sharing of data is also made more difficult by divergent national rules. Privacy laws, for example, vary by country and sometimes by region, allowing greater or lesser ease global aggregation or de-identified patient-level data. Again, an approach selecting those countries with data privacy laws that are facilitative of international collaboration is suggested. Operationally, running an international registry network is also challenging. Communication, for example, relies more heavily on video and teleconferences that must span a broad range of global time zones and require a single common language or use of simultaneous translation. But most international registry networks have managed to organize regular, typically annual, in-person meetings to facilitate relationship building and counterbalance reliance on virtual meetings, although the cost burden for attendees or funders of these meetings can be significant. Despite these challenges, successful international registry networks have and will continue to develop. We share four examples below.

International Consortium of Orthopedic Registries (ICOR)

The ICOR is a U.S. FDA-sponsored initiative that is quickly evolving into a public-private partnership, with over 30 registries participating worldwide.19 The purpose of ICOR is to facilitate and enhance inter-registry collaboration by providing of a supportive infrastructure and developing a distributed data network that uses innovative approaches to analyze the data.

Launched in 2011, the ICOR initiative addresses gaps in evidence and data related to medical implants. The network is composed of more than 70 stakeholders and over 30 orthopedic registries, representing 14 nations. ICOR is implementing a worldwide surveillance system and a meaningful UDI system with two important goals: (1) completing demonstration projects of research and surveillance for hip and knee implants, and (2) harmonizing worldwide implant data through creation of an implant library. Numerous papers have been published based on ICOR collaboration.

International Consortium of Cardiovascular Registries (ICCR)

The successes of ICOR are being replicated in cardiac and vascular fields by the ICCR with two major initiatives of MDEpiNet: The International Consortium of Transcatheter Valve Registries (ICTVR) and The International Consortium of Vascular Registries (ICVR).20

These two initiatives provide a collaborative platform through which registries and other stakeholders around the world can begin a dialogue, discuss data challenges and develop aggregate level innovative analytic methods for conducting worldwide studies. An additional goal is to work with stakeholders, such as manufacturers and regulators, to improve their understanding of the safety and effectiveness of aortic valves and vascular devices designed to be implanted percutaneously. For example, the ICTVR and ICVR initiatives are creating one of the largest networks that includes registries and academic centers with the research and clinical capabilities needed to address the most important issues related to cardiovascular device surveillance.

International Medical Device Regulators Forum (IMDRF) Registry Working Group

To address the challenges in international regulatory approaches to registry-based evidence, the International Medical Device Regulators Forum (IMDRF) created the Registry Working Group to develop white papers detailing the essential principles related to:21

  • Linkage of electronic data from patient, device and outcome registries and related data repositories or identifiers (such as UDIs), including the principles of data access, security, informatics formats, governance and other key areas related to global regulatory applications for medical device evaluation; and
  • Optimal methodologies for analysis of heterogeneous data sources applied to medical device safety, signal detection, performance and reliability.

The IMDRF’s vision is to provide guidance to stakeholders that will enable greater international regulatory collaborations among those that strongly rely on registries and collaborative distributed data consortia.

International Consortium for Health Outcomes Measurement (ICHOM)

ICHOM is another effort that functions partially as a registry network. Its stated goals are to enable value-based health care by defining and driving adoption and reporting of outcome measures that matter to patients.22 The core of ICHOM’s work has been to align registry and institutional outcome measurement efforts internationally around a common set of clinical outcomes and case-mix factors per condition, called “Standard Sets.” ICHOM has been successful in producing twelve of these Sets and continues to add more each year. These standards are published in peer-reviewed journals and are openly available for public use without restriction. ICHOM’s work has been recognized by the Organization for Economic Cooperation and Development as an example of defining more meaningful outcome measures than those typically collected today.

In addition to defining standards, ICHOM supports implementation of outcomes measurement and has plans to support benchmarking across member institutions internationally. Its work is supported by a variety of public and private partners.

Conclusion

Given the increasing use of patient registries as sources of health information,1,23 the expectations of registry stewards and users of registry information have risen considerably in a relatively short span of time. Registry networks have responded by forming communities of registry practice in the United States and internationally.

While registry networks differ in their focus and operational model, all strive to increase the reach and utility of registries through the sharing of knowledge, and in some networks, infrastructure including data standards. Registry networks facilitate knowledge sharing and creation, oversee the development of standards for improved interoperability, and create professional communities of registry practice. Their success hinges upon there being awareness of network activities and resources, and on encouraging all who are interested in registries to get involved and take advantage of what networks of registries have to offer.

When compared to other organizations in health care, such as professional societies, registry networks are still in an early stage of development. Anecdotal evidence, such as steadily rising attendance at registry network conferences suggests that registry networks are providing a valuable service to the patient registry enterprise. Given the increasing number of registries and patient records contained therein, registry networks are in a strong position to promote data exchange and aggregation, develop data standards, lower barriers to registry use, and increase adoption. As registries diversify and increase in numbers, the authors recommend further research to measure the impact registry network activities have on the broad health care improvement objectives.

Ultimately, the strongest argument for these networks comes from the engagement of the users and the resulting strong communities and work product, including research projects facilitated by the networks. Energized participation, international growth and increased reach among networks such as those described in the examples and case studies contained within this chapter illustrate the utility of registry networks to all involved.

References for Chapter 5

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