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Clinical, Translational and Implementation Science: Part 2 - PCORnet

In last week’s issue of OTSP, I reviewed the importance of clinical and translational research in the overall strategy for advancing research at UF and UF Health, and the role of the UF Clinical and Translational Research Institute, which was recently re-funded by NIH, in this effort. In the past several weeks, two exciting developments have added significantly to our research prowess in this area, both of which entail funding from the Patient-Centered Outcomes Research Institute, or PCORI, and both of which can be considered part of the burgeoning fields of “implementation science” and “comparative effectiveness research.”

Along the continuum of translational research — from fundamental science at the bench to clinical application to dissemination in the community — an emerging field called “implementation science” has been defined by NIH as “the study of methods to promote the integration of research findings and evidence into health care policy and practice…As a newly emerging field, the definition of implementation science and the type of research it encompasses may vary according to setting and sponsor. However, the intent of implementation science and related research is to investigate and address major bottlenecks (e.g., social, behavioral, economic, management) that impede effective implementation, test new approaches to improve health programming, as well as determine a causal relationship between the intervention and its impact.”

Comparative effectiveness research, which is complementary to implementation science in translating research discoveries into better health, is “designed to inform health care decisions by providing evidence on the effectiveness, benefits and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries or ways to deliver health care.” (See broader discussion here)

Why do implementation science and comparative effectiveness research? Did you ever wonder about the fact that although we spend $3 trillion on health care in the United States, which accounts for almost $1 of every $5 of gross national product, there is hardly any research on the factors related to the effectiveness of the things on which we spend our money? If you were in charge of Medicare and Medicaid, which accounted for about $1 trillion of the $3 trillion in total, wouldn’t you want to reserve some funds for the “R&D” of what you were doing?

Enter PCORI. The Patient-Centered Outcomes Research Institute was established by the 2010 Patient Protection and Affordable Care Act. PCORI is sponsored by the government, but is an independent, private, nonprofit organization. It is charged with examining the relative health outcomes, clinical effectiveness and appropriateness of different medical treatments by evaluating existing studies and conducting its own. Its 19-member board includes patients, physicians, nurses, hospitals, drug makers, device manufacturers, insurers, payers, government officials and health experts. Medicare may take the institute’s research into account when deciding what procedures it will cover, so long as the new research is not the sole justification and the agency allows for public input. Private health plans typically follow Medicare in determining coverage for medical treatments.

PCORI is focused on transforming clinical research by engaging patients, care providers and health systems in collaborative partnerships that leverage health data to advance medical knowledge and improve health care. In this spirit, PCORI developed PCORnet, the National Patient-Centered Clinical Research Network.PCORnet is a large, highly representative, national network for conducting comparative effectiveness research. It fosters a range of observational and experimental comparative effectiveness research trials by establishing a resource of clinical data gathered in a variety of health care settings, including hospitals, doctors’ offices and community clinics and by embedding research into everyday clinical practice. Data are collected and stored in standardized, interoperable formats under rigorous security protocols, and data sharing across the network uses a variety of methods that ensure confidentiality by preventing patient identification.

Elizabeth A. Shenkman, Ph.D.

William R. Hogan, M.D.


On Aug. 20, we were thrilled to announce that UF was one of 13 national PCORnet centers funded by PCORI. Specifically, a statewide partnership led by Elizabeth Shenkman, Ph.D., a professor and chair of the department of health outcomes and policy in the College of Medicine, and Bill Hogan, M.D., a professor of health outcomes and policy and director of biomedical informatics at the CTSI — and also including the University of Miami, Florida State University, health care systems, health plans, providers and patients — was approved for a three-year, $7.9 million funding award to support patient-centered health care research throughout Florida and the country. Within UF, collaboration will occur among faculty from several colleges, including dentistry, engineering, journalism, medicine, pharmacy, public health and health professions, and liberal arts and sciences. To capture and share insights across the state, the consortium is also partnering with the UF Institute of Food and Agricultural Sciences and its county extension offices’ community advisory boards, located in each of the state’s 67 counties.

The funding award will create a clinical data research network in Florida that is part of the larger national PCORnet initiative. It designates a statewide partnership, called the OneFlorida Clinical Research Consortium, as one of the 13 clinical data research networks nationwide that will work to accelerate the translation of promising research findings into improved patient care.

The OneFlorida consortium includes 22 hospitals, 1,240 clinical practices and 4,100 physicians, and collectively provides health care for close to 40 percent of Floridians. The UF Clinical and Translational Science Institute leads the development of the consortium. OneFlorida initially will focus on high blood pressure, obesity and two rare genetic diseases, Duchenne muscular dystrophy and Phelan-McDermid syndrome. In a statewide survey, almost 75 percent of Floridians identified high blood pressure as their No. 1 health care concern, and clinicians routinely identify that condition as a critical issue for their patients.

In many ways, Florida’s older, more diverse population mirrors future U.S. demographics, so research conducted in Florida can serve as a model for researchers nationwide looking to study the future health care needs of the nation and to examine health disparities across ethnicities and socioeconomic status. The consortium also will contribute to the national network by allowing researchers access to secure longitudinal health care records representing over 9 million patients through the OneFlorida Data Trust. Access to these data will allow research teams to engage in cohort discovery and conduct studies more efficiently.

OneFlorida began in 2010 as a partnership between UF and FSU and their associated health system and physician partners, with funding from an NIH supplement to the UF Clinical and Translational Science Award and a State of Florida Grant intended to promote collaboration among state universities. In 2013, the University of Miami and its Clinical and Translational Science Institute along with three additional health systems joined OneFlorida. This expanded consortium received funding in 2014 from the Florida Department of Health James and Esther King Biomedical Research Program to form the OneFlorida Cancer Control Alliance. In 2015, it became a member of the National Institute for Drug Abuse Clinical Trials Network through a partnership with the University of Miami, which is the lead institution.

In addition to its statewide university and clinical partners, OneFlorida engages community members and patients in research. Shirley Bloodworth, a member of the UF Clinical and Translational Science Institute’s Citizen Scientist Program and a OneFlorida patient co-investigator, noted, “I am intrigued by the need for people to better understand and to have better health care, and if it’s going to be supplied by big data, citizen scientists can be instrumental in that,” said Bloodworth, who participates in the workgroup on hypertension. “I hope to provide researchers with the general public’s perspective on what our most pressing needs are.”

OneFlorida, and its membership in PCORnet, places patients, clinicians, health systems and researchers at the forefront of health care transformation. The OneFlorida partners will bring together health research and health care delivery to study questions about conditions, care and outcomes that matter most to patients, families and clinicians. OneFlorida also will leverage health care data in unique ways, both in the state and nationally, to better understand which treatments, medicines, procedures and care delivery methods work best for different patient populations. OneFlorida represents teamwork and partnerships, at their very best, coming together to improve health and health care.

The Power of Together,

David S. Guzick, M.D., Ph.D. UF Senior Vice President for Health Affairs & UF Health President

About the author

David S. Guzick, M.D., Ph.D.
Senior Vice President, Health Affairs, President, UF Health

For the media

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Matt Walker
Media Relations Coordinator
mwal0013@shands.ufl.edu (352) 265-8395