Data Innovators The Patient-Centered Outcomes Research Institute

Published on September 2nd, 2014 | by Daniel Castro

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5 Q’s for Sarah Greene, Senior Program Officer at PCORI

The Center for Data Innovation spoke with Sarah Greene, a senior program officer at the Patient-Centered Outcomes Research Institute (PCORI), a non-profit organization authorized by Congress to fund and disseminate research that will help patients and caregivers make more informed decisions. Greene spoke about PCORI’s National Patient-Centered Clinical Research Network (PCORnet), a major initiative to build health data infrastructure for comparative effectiveness research.

Daniel Castro: There have been many attempts to unlock health data for medical research. How is PCORnet different?

Sarah Greene: The most distinctive aspect of PCORnet is that patients and other healthcare stakeholders are deeply involved side by side with the researchers in thinking through the best ways to reengineer the research enterprise and unlock the power of health data. We’re creating a research infrastructure in which healthcare providers, patients and researchers can collaborate and determine high-priority research questions, ways to collect data more efficiently using tools that patients are already accustomed to, and how to ensure that research results are returned to the health systems, patients, and providers who need them at the point of making care decisions. We believe that having patients as partners in this endeavor will catalyze the entire research community to harness the power and potential of health data in ways that haven’t been done on this scale before.

Also, as part of building this infrastructure, we’ve convened 11 Task Forces to help address some of the persistent impediments that create inefficiencies in the research process. For example, one of the Task Forces is identifying the most effective ways to engage with patients on the value of research. Another is developing recommendations for conducting clinical trials in real-world health systems that don’t impede or interfere with clinical operations.

The Task Forces are variously comprised of researchers, patients, clinicians, data experts, and health system leaders, ensuring that we have multiple, diverse perspectives and experiences represented. It’s invaluable to bring patients and researchers together under the Task Force auspices to facilitate collaboration and learning. All too often, these groups are “siloed.” Researchers talk to other researchers, clinicians talk to clinicians, and patients talk with fellow patients. PCORnet is bringing these diverse groups together for collaborative problem-solving and breakthrough thinking about how to improve the way research is conducted in the US.

Castro: What types of challenges do you face bringing together all the different stakeholders who collect and manage patient data?

Greene: The challenges that PCORnet faces can be divided into two broad categories: technical and philosophical. There are many technical challenges, including the level of effort required on the part of each network to harmonize their data and achieve the interoperability with other networks that is necessary to conduct research. Building the technical capability for the data to be used for research will take time, given the different types of data available across the PCORnet sites and that health data are currently stored in numerous different systems and formats.

The variety of philosophical perspectives among the networks pose an equally important challenge. Several of the PCORnet network partners have been operational for a long time, from a few years to decades, while others are coming together for the first time. Each group has its own organizational ethos and culture. We’re asking these groups to come together as members of PCORnet and develop a “network of networks.” In some cases, this means adopting new operational approaches. Moreover, collaborating very directly and intensively with patients, families, and other healthcare stakeholders is new to some of the networks. With that in mind, we’re lucky to be working with a group of networks that have coalesced around the value of PCORnet, and we’re confident that we will overcome both the technical and philosophical challenges.

Castro: With clinical and patient-generated data coming from so many different sources, how do you ensure high quality data?

Greene: Researchers are very well-acquainted with the techniques needed to verify and validate the quality of data, recognizing that high-quality data are the backbone of reliable and rigorous research. Each of the networks will run quality checks to ensure that the data conform to logical expectations—for instance, we would regard a diagnosis of Alzheimer’s in someone born in 2010 as signaling a problem with the underlying data. Similarly, we know that the expected range of values for Body Mass Index is 15 to 40. Therefore we can build in data checks that will flag a BMI of less than 15 or greater than 40 as a potential quality indicator. PCORnet’s experienced data analysts at the participating networks will help execute these quality checks based on guidance from our Coordinating Center leadership.

Castro: What types of questions do you hope to address with larger amounts of de-identified patient data that could not be answered with smaller data sets?

Greene: Larger amounts of aggregated, de-identified data confer some key advantages for research. With a larger population, we’ll have the capability of studying rare diseases in a much more impactful way. We can also drill down into subpopulations to better understand whether outcomes vary by granular patient characteristics, including age, sex, race, general health status, or other attributes.
PCORnet will be able to examine how care in real-world community-based healthcare settings may affect disease outcomes. That is, we’ll be able to assess whether differences in outcomes are attributable to patient characteristics, or whether there are differences based on where they receive care and how that care is delivered. We can also study uncommon risks associated with a particular treatment that may not be visible in a smaller data set.

Castro: What is the timeline for when PCORnet should start delivering tangible results to patients?

Greene: To some extent, the answer to this depends on the definition of “tangible results.” We believe that an important result of PCORnet is that we are promoting a cultural shift in health research by involving patients and those who care for them as partners. Having patients and other stakeholders co-create the 29 networks and help set direction for PCORnet as whole is a unique early result in and of itself. Each network is also utilizing creative methods to engage their broader populations, so that patients and other stakeholders can tell us which research questions and outcomes are most important to them. This tangible engagement is well under way.

As for results from the research studies that will eventually be conducted on the PCORnet platform, those are expected further down the road. We’re in the initial months of an 18-month development phase of PCORnet, which is predominantly dedicated to building the infrastructure that will allow us to actually conduct research in phase 2. Phase 2 will begin in the fall of 2015, and our goal for that phase is for PCORnet to be able to conduct multiple observational studies and/or interventional studies. We intend to launch a first pragmatic clinical trial using PCORnet’s data and infrastructure in the first part of 2015.

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About the Author

Daniel Castro is the director of the Center for Data Innovation and vice president of the Information Technology and Innovation Foundation. Mr. Castro writes and speaks on a variety of issues related to information technology and internet policy, including data, privacy, security, intellectual property, internet governance, e-government, and accessibility for people with disabilities. His work has been quoted and cited in numerous media outlets, including The Washington Post, The Wall Street Journal, NPR, USA Today, Bloomberg News, and Businessweek. In 2013, Mr. Castro was named to FedScoop’s list of “Top 25 most influential people under 40 in government and tech.” In 2015, U.S. Secretary of Commerce Penny Pritzker appointed Mr. Castro to the Commerce Data Advisory Council. Mr. Castro previously worked as an IT analyst at the Government Accountability Office (GAO) where he audited IT security and management controls at various government agencies. He contributed to GAO reports on the state of information security at a variety of federal agencies, including the Securities and Exchange Commission (SEC) and the Federal Deposit Insurance Corporation (FDIC). In addition, Mr. Castro was a Visiting Scientist at the Software Engineering Institute (SEI) in Pittsburgh, Pennsylvania where he developed virtual training simulations to provide clients with hands-on training of the latest information security tools. He has a B.S. in Foreign Service from Georgetown University and an M.S. in Information Security Technology and Management from Carnegie Mellon University.



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