Engagement, Research, and Evidence
Leveraging the National Patient-Centered Clinical Research Network for Better Cardiovascular Health
- cardiovascular diseases
- electronic health record
- medical record linkage
- pragmatic clinical trials
A deluge of information and new approaches spanning the continuum from discovery to implementation and policy promises to fundamentally alter our understanding of cardiovascular health and healthcare. Although the existing system for cardiovascular research has yielded impressive results, it remains fractured, slow, costly, and hindered by systematic gaps. Further, even when it delivers answers, they are often accompanied by uncertainty about how to interpret or apply that knowledge across different populations. If cardiovascular medicine is to maintain its traditional excellence in innovation and evidence generation, then our current research paradigms must evolve.
At the same time, external forces are affecting healthcare, including the imperatives to improve the value of care by increasing quality and reducing costs, grapple with disparities in care and outcomes, and achieve meaningful integration with other technologies using electronic health data and sophisticated analytics. Also medical practice needs to be reoriented toward considering the needs, preferences, and values of individual patients and consumers instead of focusing narrowly on providing products and services. This approach is especially poignant for US healthcare, whose decades-old reimbursement model is transforming into a more patient-centered system.
These challenges present a daunting prospect. But what if the move toward integrated, patient-centered, accountable healthcare could be harnessed to simultaneously drive improvements in our clinical research enterprise? What if building systems for electronic health data can also provide robust scaffolding for efficient evidence generation while breaking down silos that impede the flow of information and knowledge among all stakeholders, including patients?
Throughout the current US medical care system, many decisions are made without the benefit of high-quality evidence.1 By creating a system that generates evidence as a routine component of care, we can transform the clinical enterprise to better inform decisions about health, the use of therapeutic and diagnostic technologies, and the provision of healthcare services while enabling more efficient implementation of effective, high-quality healthcare. Remaining gaps in knowledge or practice can then be swiftly addressed as we leverage a perfect storm of rapidly evolving health information technologies, electronic health records, and consumer-oriented mobile applications for research and quality-improvement purposes—all against a background of consolidation in practices, hospitals, health systems, and even payers. Ultimately, this integrated approach to healthcare can improve quality and outcomes while speeding cycles of discovery, development, and implementation.
Laying a Foundation for a National Learning Health System
To see how this system could work in practice, let us first consider some elements of a traditional clinical trial. In such trials, a program is developed to answer a narrow research question; this approach often involves establishing redundant systems for trial conduct and data collection in parallel with existing care systems. After an often lengthy interval, the research question is answered, whereupon the program is dismantled, to be built up again from scratch when the next question comes along.
Recognizing that resources are wasted in both healthcare and research spheres, the Institute of Medicine and others have promoted the concept of a learning healthcare system that embeds research within health systems and conducts it in partnership with patients and other stakeholders. Although this idea has permeated thinking about research and healthcare for some time, it was not until the Patient-Centered Outcomes Research Institute invested $300 million to develop a national patient-centered research system that we have been able to implement and evaluate these concepts at scale.
The National Patient-Centered Clinical Research Network (PCORnet) seeks to enable a mature learning health system capable of conducting research with enhanced quality, speed, and efficiency in real-world settings, thereby yielding trustworthy information that helps people make informed healthcare decisions (Figure). With an array of collaborative partner networks focused on health issues ranging from rare diseases to epidemic conditions, PCORnet comprises a community of research able to draw on data from >40 million people representing diverse populations and environments at >100 healthcare organizations.2 PCORnet is also remarkable for its commitment to engaging all stakeholders—including patients and their advocates—in establishing research priorities and providing input into research designs. PCORnet’s transformative approach to engagement empowers these patients as partners or citizen-scientists to bring different perspectives to bear and challenge practices that may be redundant or excessively costly, or which fail to provide a good return on investment in the form of actionable evidence that improves care and outcomes.
Cardiovascular Disease and PCORnet
Given that cardiovascular disease remains an urgent public-health problem, a collaborative research group led by Drs Mark Pletcher, Véronique Roger, and Rhonda Cooper-DeHoff has formed to catalyze and develop pathways for improving cardiovascular health through patient-centered research (PCORnet’s Front Door study design portal; http://pcornet.org/frontdoor/). Network partners have created a common data model3 mapping key domains of electronic health records in a uniform, structured format, developed a system of collaboration and paying forward each other’s research, and reimagined approaches to research that leverage routine health-system encounters.
PCORnet’s ADAPTABLE trial (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness)4 offers an example of what can be accomplished in cardiovascular research with such a system. This large randomized trial, which aims to enroll 20 000 participants, addresses an important question for patients and clinicians by comparing the effectiveness and safety of 2 commonly used daily doses of aspirin (81 mg versus 325 mg) for secondary cardiovascular prevention. ADAPTABLE leverages innovative features, including electronic patient identification, approach, consent, and follow-up, and study data are collected from electronic health records at participating sites spanning the country. It is important to note that it was codesigned in close collaboration with a group of study participants—the ADAPTORS. Early results show that it is possible to electronically identify, approach, and enroll participants at rates far greater than the 1 participant per site per month typical of cardiovascular trials. It is also important to note that while the seemingly simple question of optimal aspirin dosing for secondary prevention has persisted for decades, finding the answer has required not just technological or scientific progress but also the evolution of an organizational vision that allows it to be addressed efficiently and affordably.
As lessons from ADAPTABLE accumulate and are used to inform ongoing efforts, PCORnet and its network partners are eager to offer its unique capabilities for developing and testing new therapies to the cardiovascular community as we rethink cardiovascular research. Together, all of our stakeholders are working to build communities that will contribute to better medical decision making and improved health for the entire country.
Sources of Funding
This article was supported in part by funding from the National Patient-Centered Clinical Research Network.
Dr Hernandez is the coprincipal investigator of the National Patient-Centered Clinical Research Network Coordinating Center and the ADAPTABLE clinical trial sponsored by the Patient-Centered Outcomes Research Institute. The other author reports no conflict of interest.
The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.
Circulation is available at http://circ.ahajournals.org.
- © 2017 American Heart Association, Inc.
- 1.↵National Academies Press. Evidence-based medicine and the changing nature of healthcare: 2007 IOM annual meeting summary. Washington, DC: National Academies Press; 2007. https://www.ncbi.nlm.nih.gov/books/NBK52829/. Accessed January 31, 2017.
- 2.↵National Patient-Centered Clinical Research Network (PCORnet). PCORnet offers a first glimpse of the nation’s largest patient-centered clinical research network. October 31, 2016. http://www.pcornet.org/2016/10/pcornet-offers-first-glimpse-nations-largest-patient-centered-clinical-research-network/. Accessed February 2, 2017.
- 3.↵National Patient-Centered Clinical Research Network (PCORnet). Common data model. http://www.pcornet.org/pcornet-common-data-model/. Accessed January 30, 2017.
- 4.↵National Patient-Centered Clinical Research Network (PCORnet). ADAPTABLE –The aspirin study. http://theaspirinstudy.org/. Accessed January 30, 2017.