February is American Heart Month and a fitting time to spotlight the many ways PCORnet® infrastructure is helping research teams advance cardiovascular health insights that are meaningful to patients. A new brief outlines some of the most impactful cardiovascular research powered by PCORnet®, as well as published results that have already helped shape the cardiovascular research landscape.

“Heart disease is the leading cause of death in the U.S., accounting for one in every four deaths annually,” said Adrian Hernandez, PCORnet® Coordinating Center co-principal investigator. “To change these statistics, we need to better understand which interventions work to improve outcomes, not just in a controlled research setting, but across the broad fabric of the U.S. population. The PCORnet infrastructure was developed with exactly this aim in mind.”

Research teams can use PCORnet to access insights from high-quality data alongside research expertise and connection to people with lived experience to fuel comparative clinical effectiveness research in cardiovascular health and many other therapeutic areas. Using PCORnet resources, researchers have uncovered insights related to:

• prevention of cardiovascular disease and heart events;
• optimal cardiovascular treatment approaches; and
• the utility of technology in supporting outcomes for cardiovascular disease.

Interested in harnessing insights on cardiovascular health for your next patient-centered study? Knock on the PCORnet® Front Door to start the conversation and begin collaborating with the Network.

On January 9, PCORI will release the Broad Pragmatic Studies (BPS) PCORI Funding Announcement (PFA) to support high-quality patient-centered comparative clinical effectiveness research (CER). Category 3 supports PCORnet^® Studies that advance PCORI’s National Priorities for Health with direct costs of up to $12 million.*

PCORnet^® Studies are defined as those that:

• Include two or more PCORnet-partnered Clinical Research Networks
• Share study progress and performance metrics
• Exchange best practices with the Network to promote continuous learning and improvement
• Demonstrate a commitment to stakeholder engagement and partnership
• Use PCORnet resources to improve the efficiency of patient-centered CER

Are you ready to learn more and apply? Letters of Intent (LOI) are due February 6. Take these three steps to prepare:

1. Contact the PCORnet^® Front Door as soon as possible. All applicants submitting to the BPS Category 3 PFA are required to contact the PCORnet^® Front Door prior to submitting their LOI. The PCORnet^® Front Door can advise on study feasibility and costs associated with working with PCORnet, provide data to inform study design, offer best practices for stakeholder engagement, and more.
2. Register for the January 24 PCORI Applicant Town Hall to learn more about this PFA and how to submit a responsive LOI and application.
3. Check out this webinar for an overview of PCORnet and the specific requirements for the Category 3: PCORnet^® Studies option in the BPS PFA. 

If you are interested in using PCORnet to power your next research effort, now is the time. Be on the lookout for more information from PCORI on January 9.

*Category 3 will support direct costs up to $10 million. However, projects may request to apply for up to $12 million in direct costs with certain justifications and approvals described within the PFA prior to application submission. Funding for innovations to support CER, such as novel approaches to returning results to participants and the use of Fast Healthcare Interoperability Resources (FHIR) technologies to engage, may also be requested in the LOI phase.

PCORnet® was a hot topic at the 2023 PCORI Annual Meeting, which took place October 4-5 virtually and in Washington, D.C. Every year, the event brings together researchers, clinicians, patients, and other partners across the health care ecosystem who are passionate about furthering patient-centered research. PCORI funded PCORnet in 2013 as a national resource where high quality health data, patient partnership, and research expertise unite to deliver answers that advance health outcomes.

The flagship infrastructure in patient-centered research

In her opening remarks, PCORI Executive Director Nakela Cook highlighted PCORnet as the flagship infrastructure for enhancing and accelerating patient-centered outcomes research, one of PCORI’s five national priorities for health. Via a partnership of clinical research networks representing major healthcare institutions across the U.S., the Network allows research teams to generate rich insights into 30 million patient encounters at more than 40 health systems. These data are deidentified to adhere to stringent patient privacy standards.

“With PCORnet, every patient interaction becomes an opportunity to leverage data that’s collected during healthcare delivery to conduct comparative clinical effectiveness research (CER) and build a stronger evidence base,” Cook said.

Cook’s claim of a stronger evidence base is backed up by hundreds of studies and more than 600 publications enabled by PCORnet data resources. This year’s plenary session titled “Powered by PCORnet: Infrastructure to Fuel National-Scale Research” gave attendees a snapshot of some of the most impactful research that the Network has powered over its 10-year history. Session speakers highlighted the growth and contributions of PCORnet over the last decade and discussed how PCORnet is positioned to support national-scale research to speed evidence generation.

PCORnet® Coordinating Center Co-Principal Investigator Adrian Hernandez opened the session by teeing up the big-picture health challenges we are currently facing in the U.S.: our healthcare burden is up, life expectancy is down, and bending the curve back requires deeper engagement of patients and communities. At the same time, the speed of science is evolving to open up new treatment options and opportunities.

“PCORnet has been designed to be part of the solution,” Hernandez said. “It is an impactful infrastructure for patient-centered CER that we hope that everyone can take advantage of.”

Hernandez emphasized PCORnet-enabled collaboration between researchers, clinicians and patient partners helps fuel both high-quality observational studies and pragmatic trials that are ushering in a new era for patient-centered CER. He called out landmark studies like ADAPTABLE, which utilized virtual visits and other pragmatic design elements before the pandemic popularized them, as well as PREVENTABLE, the PCORnet Bariatric Study, and HERO, which all addressed patient-centered questions that require insights from the broad fabric of the U.S. population.

Mariell Jessup, Chief Science and Medical Officer at the American Heart Association, discussed the importance of PCORnet as a resource to facilitate more representation in research as well as supporting the conduct of research results that will be implemented in clinical care settings.

“I see PCORnet as key to supporting discoveries from the bench to bedside,” Jessup said. “We’re excited about the future, and we think that PCORnet is a very important tool.”

The plenary also looked ahead to opportunities for PCORnet in its second decade. Mark Pletcher, professor of Epidemiology and Biostatistics at the University of California, San Francisco, highlighted two ideas: using the PCORnet® Common Data Model to study the quality of patient care, and expanding data collection to include insights from outside health care systems to better capture the U.S. population.

“PCORnet is uniquely situated to support the conduct of large studies that include the collection of patient-reported outcomes,” Pletcher said.

Two days, multiple shout-outs
While the plenary was the most high-profile event centering PCORnet at the annual meeting, the Network was referenced throughout the two-day event.

In the session “PCORI Rare Disease Research: Portfolio Highlights and Future Direction,” Anita John, Medical Director of the Washington Adult Congenital Heart program Children’s National Hospital, lauded PCORnet as especially powerful in the context of rare disease research. As an example, John shared how PCORnet data resources supported the formation of the Congenital Health Initiative, the first patient-powered longitudinal registry to improve the future of care for those living with congenital heart disease.

“This is something that we have wanted to do as a community for a long time, but our partnership with PCORnet has really enabled this to flourish,” John said.

If you weren’t able to make the PCORI Annual Meeting but are interested in learning about more outcomes from PCORnet-leveraged research, check out the recordings of the sessions from the two-day event.

Tools powered by PCORnet® to accelerate research. 

Take full command of your research!  PCORnet now offers four new tools that empower you to maximize every aspect of your research, including study planning, design, start-up, and execution.

• Data Sharing Agreement (DSA) speeds prep-to-research queries
• Clinical Research Collaboration Agreement speeds the contracting process for PCORI-funded studies
• SMART IRB and IREx List supports fast and easy search of crucial details about PCORnet-participating sites
• Data Study Flow Resources facilitates fast and consistent IRB applications in your PCORnet-leveraged study

The Network’s established partnerships and efficient workflows with participating sites make these new tools possible. Researchers can efficiently streamline patient-centered clinical effectiveness research by using the Network and these four new tools to address some of the most time-consuming, costly, and difficult aspects of study start-up.

Reach out today for more information about how each tool can support your study.

Why and how should you use PCORnet®? That’s the question PCORnet leaders sought to answer when they recently presented at an adjunct event for AcademyHealth’s 2023 Annual Research Meeting (ARM) and at a half-day virtual convening held by NORC in collaboration with PCORI. Both events were a chance to showcase the uniqueness of PCORnet, which was developed in 2014 with funding from PCORI as a national resource for all.

The Network represents data from everyday healthcare encounters with more than 30 million people across the U.S. each year through partnerships with eight large clinical research networks, or CRNs. These data are brought into a standard, query-ready language by the PCORnet® Common Data Model, and patient communities are continuously engaged in all PCORnet-enabled efforts to ensure that research questions and outcomes are meaningful to patients. In today’s clinical research ecosystem where data, patient insights, and clinician expertise are often siloed elements that need to be plucked from separate resources, PCORnet unites all three, offering users a synergy they can’t find elsewhere.

“Since the Network was developed, it has proven its ability to drive fast, representative research results time and again,” said Adrian Hernandez, PCORnet® Coordinating Center principal investigator and executive director for the Duke Clinical Research Institute. “With each new project, our processes are more streamlined, our data are broader and more refined, and our connections across the PCORnet® Network Partners are tighter. These are success stories we want to get out into the research community. The Network is open for business and open to all—just knock on the PCORnet® Front Door to get started.”

Roadshow recaps

The first stop on PCORnet leaders’ roadshow was at AcademyHealth’s 2023 ARM, an event that draws more than 2,500 stakeholders at the intersection of health, health care, and policy to share important findings and showcase the latest research on how to improve our nation’s health system.

After a brief introduction to PCORnet and its use for research, the event kicked into high gear with breakout sessions to shed light on how PCORnet infrastructure is addressing barriers related to using real-world data and incorporating patient and stakeholder engagement in national-level comparative clinical effectiveness research studies. Breakout sessions focused on PCORnet-accessible data, the PCORnet® Front Door, and potential funding opportunities available from PCORI.

“Having three topic-specific breakout sessions allowed us to get into the details potential users of the Network want to know,” said Hernandez. “For example, how does the data query process work in PCORnet, what data are available to address a given research question, and how can the PCORnet® Network Partners support your patient engagement strategy? ARM was a fantastic forum to answer these questions.”

The half-day virtual convening, hosted by NORC in collaboration with PCORI, “An Assessment of PCORnet: Stakeholder Convening,” offered attendees a deep dive into the PCORnet experience from the perspective of those who have used the Network first-hand. The meeting was split into two sections. The first focused on the preliminary findings from the assessment of PCORnet users’ experiences presented by NORC. The second section focused on discussing future opportunities to advance and evolve the Network.

The highlights of this event were the panel discussions, which captured thoughts from PCORnet® Steering Committee patient partners, the Coordinating Center, PCORnet® CRN principal investigators, PCORnet® Study investigators, and research funders. From sharing their personal experiences, to reflections on the preliminary assessment findings and opportunities to advance the Network, the discussion was a thoughtful reflection of how PCORnet infrastructure has grown and its potential to drive important patient-centered research.

“We’ve only scratched the surface of the Network’s full potential,” said Hernandez. “The high attendance at our two roadshows is a strong indicator that the research community sees PCORnet as a key resource on the journey to a healthcare ecosystem where the patient voice is at the fore of every effort.”

PCORnet leaders will maintain the momentum, with more events planned in the coming year. Watch this space for updates and opportunities to attend!

Flash back to 2016, when Hamilton had just premiered on Broadway, the Rio Olympics were in full swing, and Duke University cardiologist Neha Pagidipati first heard about a relatively new network of clinical research networks capable of producing granular insights from large, representative patient datasets across the U.S. At the time, Neha was trying to understand national patterns of weight management, and PCORnet® was one of the few available data sources capable of capturing a tremendous sample size without loss of important detail she needed to deliver on her study’s goals.

“PCORnet immediately caught my interest because it could capture lab results, blood pressure, and body mass index (BMI) data at scale,” said Neha. “With support from 11 sites participating in PCORnet, our study team successfully teased out associations between weight change and cardiometabolic risk factors in a massive, real-world population of U.S. adults with overweight or obesity. The results shed much-needed light on these conditions that impact millions of people living in the United States.”

The observational study, which looked at outcomes related to more than 800,000 people over a 12-month period, addressed exactly the kind of evidence gaps the Network was designed to answer when it was first funded in 2014.

While randomized controlled trials (RCTs) have long been the gold standard of clinical research, they typically include smaller, carefully selected, homogenous populations and are undertaken in specialized care settings. For these reasons, they often don’t illuminate all the information patients need to know, like how an intervention fares in real-world settings and among people with a wider range of circumstances.

PCORnet was developed with support from the Patient-Centered Outcomes Research Institute (PCORI) to address these gaps by serving as a national resource that brings together data from everyday health encounters, research expertise, and patient partnership. Observational research fueled by the Network complements RCTs with real-world insights that drive improved health outcomes across the U.S.  PCORnet also supports more efficient participant recruitment and other services to advance the conduct of RCTs.

From big idea to proven national resource

The groundbreaking nature of PCORnet meant there was no blueprint for building the Network infrastructure. In 2016, when Neha first used the Network, the PCORnet® Common Data Model (CDM) was still in development. In fact, at the time, BMI codes were not yet fully mapped, meaning Neha’s study had to work through some kinks to align the disparate ways of coding BMI in medical records across the clinical research networks (CRNs) comprised of dozens of health systems and clinics that are participating in PCORnet. PCORnet® CRNs also had not worked with one another long enough to establish seamless processes and advanced knowledge of the data available for research.

Today, all that has changed.

“PCORnet has made progress in leaps and bounds from its early days in 2016,” said Neha. “The organization of the Network is smoother, and results are much more accelerated, vetted by PCORnet® CRNs who have worked together for years. The data available is also much more advanced. Today’s PCORnet® CDM maps a wealth of rich data fields to support observational research, and it is growing all the time.”

Currently working on her fourth PCORnet-supported study, Neha knows the Network better than most. Her latest research is comparing the safety and effectiveness of two glucose-lowering drugs in patients with type 2 diabetes. Neha wanted to include a relatively high number of patients taking these drugs who also have diabetic kidney disease (DKD), which drove her to once again select PCORnet as her research network of choice.

“We needed a network that could not only capture lab data across a broad enough population to meet our DKD participant target, but also allowed us to track long-term outcomes in these patients,” said Neha. “Frankly, PCORnet resources offer the only networked datasets out there that could support this research.”

In addition to the safety and efficacy questions, Neha’s study is also trying to understand why patients with type 2 diabetes may not receive guideline-recommended screening for DKD. It is the largest study to date asking these important questions, which is significant considering the high prevalence of type 2 diabetes and broad use of glucose-lowering drugs across the nation.

Neha says demand for PCORnet will only continue to increase as communities reap the benefits this kind of patient-centered, real-world research offers.

“We won’t find the answers communities need if we only look to studies with a small number of homogenous participants,” said Neha. “Real-world, patient-centered answers start to surface only when we look across the country with a wide lens, capturing all types of people in all types of circumstances — this is the true power of PCORnet, and its infrastructure delivers.”