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Creating a research data network for cardiovascular disease: the CVRN Expert Rev. Cardiovasc. Ther. 6(8), 1043–1045 (2008)
David J Magid Author for correspondence
Institute for Health Research, Kaiser Permanente, PO Box 378066, Denver, CO 80237, USA; University of Colorado Health Science Center, CO, USA Tel.: +1 303 614 1321 Fax: +1 303 614 1285
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“Research data networks – defined linkages that allow aggregation of electronic and other patient-level data from geographically and administratively distinct health systems – offer tremendous potential to address … public health questions.”
Denver VA Medical Center; University of Colorado Health Sciences Center; and, Kaiser Institute for Health Research, 1055 Clermont Street, Denver, CO 80220, USA Tel.: +1 303 370 7575
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Groups such as Healthy People 2010 [1] and the American Heart Association [101] have set bold goals for reducing the risk of heart disease, stroke and other cardiovascular conditions; improving delivery of cardiovascular care; and improving patient outcomes. However, current data systems in the USA are severely limited in their ability to systematically and longitudinally track our progress toward achieving these goals [2] . Lack of accepted data standards and disconnected information systems are major barriers to risk factor and disease surveillance, as well as to the early detection of previously unrecognized adverse events related to new drugs and devices. Research data networks – defined linkages that allow aggregation of electronic and other patient-level data from geographically and administratively distinct health systems – offer tremendous potential to address these important public health questions.
Alan S Go, MD
Value of research data networks
Jerry H Gurwitz, MD Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Community Health Plan, and Fallon Clinic, 630 Plantation Street, Worcester, MA 01605, USA Tel.: +1 508 791 7392
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John S Rumsfeld, MD, PhD
Director, Comprehensive Clinical Research Unit, Division of Research, Kaiser Permanente of Northern California, 2000 Broadway Street, 3rd Floor, Oakland, CA 94612-2304, USA Tel.: +1 510 891 3553 Fax: +1 510 891 3606
[email protected]
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The emergence of research data networks is facilitated in part by recent technological advances. Information within hospitals and health plans is increasingly managed electronically in order to improve clinical productivity. Research data networks can leverage these investments to track trends in cardiovascular epidemiology and treatment. They can also systematically monitor for unexpected therapy-related adverse events rather than relying on the accumulation of anecdotal reports that often raise questions, but rarely provide definitive answers. Recent well-publicized examples of this kind of uncertainty include possible risks for myocardial infarction with some antidiabetic agents [3] and for
10.1586/14779072.6.8.1043
late thrombosis in drug-eluting coronary stents [4] . Changes in clinical outcomes related to changing patterns of care can also be studied more rapidly with research data networks. Finally, such networks can draw from large numbers of geographically dispersed subjects, making analyses more generalizable and feasible, especially in typically under-represented population subgroups.
“…current data systems in the USA are severely limited in their ability to systematically and longitudinally track our progress…” However, the adoption of health information technology will not, by itself, produce cross-organizational data systems that can be effectively used for research. Before data can be aggregated to conduct research, it must be reformatted to a standard and collaborations established across systems. Otherwise, one cannot be certain that observations from different sites represent valid, reliable and consistent measures of the same underlying concept. In addition, it is necessary to establish a governance structure that oversees the functioning of the research data network and the data security procedures that ensure patient confidentiality. Without well-functioning procedures for governance and data security, healthcare organizations are unlikely to share their data as part of a data network. Cardiovascular Research Network
The National Heart, Lung and Blood Institute, recognizing the need for a cardiovascular research data network to
© 2008 Expert Reviews Ltd
ISSN 1477-9072
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Magid, Gurwitz, Rumsfeld & Go
provide answers to questions requiring longitudinal data from large community-based samples, established the Cardiovascular Research Network (CVRN) in late 2007. The overall goal of the CVRN is to provide a systematic understanding of the epidemiology of cardiovascular disease; its diagnosis and management; and robust data on cardiovascular-related clinical outcomes, resource utilization and costs. The 15 participating CVRN organizations are all members of the geographically diverse HMO Research Network, a consortium of health plan research centers committed to public domain research that advances population health through its work with over 10 million health plan members [5] . Research centers and investigators from the following parent organizations participate in the CVRN: the Kaiser Permanente Regions of Northern California, Southern California, Colorado, Hawaii, Northwest (Oregon) and Georgia; Fallon Community Health Plan; Group Health Cooperative; Geisinger Health System; Henry Ford Health System; Harvard Pilgrim Health Care; HealthPartners; Lovelace Sandia Health System; Marshfield Clinic; and Scott and White (all USA). The CVRN data network is guided by three key principles: • The creation and maintenance of a distributed architecture for data storage based on standardized data definitions • Governance based on data holders’ ability to opt in or out of individual activities • Transfer of the minimum amount of required data in order to maximize data security Data within the CVRN reside locally behind the firewalls of the parent organizations, and each healthcare organization controls data access and use. This approach decreases the likelihood of data security breaches, and increases privacy and protection for patients and participating organizations. While each participating healthcare organization has the ability to opt in or out of specific studies, data holders are not able to restrict dissemination of findings from agreed-upon protocols where they permit their data to be used. Finally, to maximally protect individuals’ confidential information and proprietary information for private organizations, data transfer is minimized to only the data elements necessary to address the specific questions of interest in analysis-ready data files that contain as little potentially identifiable information as possible. The CVRN data network is supported by the HMO Research Network’s Virtual Data Warehouse (VDW), a distributed standardized data resource, designed to meet the needs of collaborative research projects. Each of the CVRN sites contributes to the VDW, but maintains control of its own data. The VDW is comprised of: • Computerized datasets of variables with identical names, formats and specifications stored behind separate security firewalls at each CVRN site • Informatics tools that facilitate storage, retrieval, processing and managing the datasets 1044
• Access policies and procedures governing use of VDW datasets • A data dictionary documenting the elements of the VDW The VDW currently contains standardized data elements for enrollment, demographic characteristics, inpatient and outpatient utilization, diagnoses, procedures, vital signs, laboratory results and outpatient pharmacy dispensing. The CVRN was initially funded to conduct three core research projects targeting hypertension recognition, treatment and control; the quality of care and outcomes of warfarin therapy for atrial fibrillation and venous thromboembolism; and the use and outcomes of implantable cardioverter defibrillators in patients with heart failure. The CVRN has received additional funding to study longitudinal outcomes of patients receiving drug eluting stents, to assess the risks and benefits of varying durations of clopidogrel therapy in patients receiving intracoronary stents and to assess the comparative effectiveness of second-line antihypertensive agents in patients whose blood pressure is not controlled on a thiazide diuretic alone. The efficient execution of these multiorganizational projects will be facilitated by the use of the CVRN.
“The efficient execution of multi-organizational studies is dependent on the existence of the CVRN.” As one example of a project a data network such as the CVRN can complete, the CVRN investigators compared the effectiveness of β-blocker therapy for patients with chronic heart failure [6] . The study examined the comparative effectiveness of β-blockers (atenolol, metoprolol tartrate and carvedilol) on 1-year risk of readmission for heart failure and death, for 11,326 adults hospitalized with heart failure at multiple medical centers within two CVRN organizations. Data from the participating sites were put into a single analytic database that included information on exposure to β-blockers, patient characteristics and clinical outcomes needed to address the study question. The study found that, compared with atenolol, there was no significant difference in the adjusted risk of hospitalization with carvedilol or metoprolol tartrate. However, compared with atenolol, metoprolol tartrate was associated with a 19% higher adjusted risk of death, but there was no significant difference with carvedilol. The study results argue for additional head-tohead randomized trials comparing the effectiveness and safety of currently available β-blockers for heart failure and the project demonstrates how the CVRN can aggregate electronic patientlevel data from geographically and administratively distinct health systems to answer an important clinical question. The future
The 15 CVRN sites are geographically distributed throughout the USA and collectively provide longitudinal healthcare to over 10 million persons with broad age, gender, racial and ethnic diversity. The CVRN has completed substantial work to integrate data systems across the member organizations, allowing research projects to be completed in a cost-effective and timely manner. Current CVRN projects showcase the ability of the CVRN to address research questions with high clinical and public health relevance Expert Rev. Cardiovasc. Ther. 6(8), (2008)
Creating a research data network for cardiovascular disease: the CVRN
for a broad array of clinical conditions and therapies. These projects share a common theme of leveraging automated databases in geographically diverse community-based populations to evaluate cardiovascular epidemiology, management and outcomes. The efficient execution of multi-organizational studies is dependent on the existence of the CVRN research data network. This data network will also support future directions for the CVRN, which include: • Clinical trials of cardiovascular therapies and preventative strategies • Assessments of the effectiveness and cost–effectiveness of clinical informatics systems in facilitating patient and/or physician decision-making for cardiovascular disease prevention, screening, diagnosis or treatment
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US Department of Health and Human Services. Healthy People 2010: Understanding and Improving Health and Objectives for Improving Health (Volume 1). US Government Printing Office, Washington, DC, USA (2000). Goff DC Jr, Brass L, Braun LT et al. Essential features of a surveillance system to support the prevention and management of heart disease and stroke. A scientific statement from the American Heart Association Councils on epidemiology and prevention, stroke, and cardiovascular nursing and the interdisciplinary working groups on quality of care and outcomes
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• Research on determinants of disease for uncommon disease phenotypes • Genetic and pharmacogenetic investigations • Collaboration on research projects with other cardiovascular networks Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
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Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stents – promise and uncertainty. N. Engl. J. Med. 356(10), 1059–1060 (2007).
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Go AS, Yang J, Gurwitz JH, Hsu J, Lane K, Platt R. Comparative effectiveness of beta-adrenergic antagonists (atenolol, metoprolol tartrate, carvedilol) on the risk of rehospitalization in adults with heart failure. Am. J. Cardiol. 100(4), 690–696 (2007).
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American Heart Association Strategic Goals www.americanheart.org/ presenter?identifier=4429
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