On March 11, 2020, the World Health Organization declared the outbreak of COVID-19 a global pandemic, marking a pivotal moment in modern history as nations around the globe grappled with the virus’s rapid spread. The declaration triggered a collective call to action, with government, communities, and researchers uniting to find answers. PCORnet®, one of the few national research infrastructures offering access to insights from everyday health-related encounters with more than 30 million people annually, was at the intersection of all three.

From supporting a key collaboration with the U.S. Centers for Disease Control and Prevention to enabling the swift establishment of a research-ready community of healthcare workers, PCORnet resources were critical to powering key COVID-19 insights in the acute phase of the pandemic. Today, PCORnet resources continue to serve at the forefront of learning on important topics like long COVID and the effectiveness of repurposed medications to treat COVID-19. Check out the latest PCORnet brief highlighting efforts to deliver answers, then and now, to our nation’s most pressing COVID-19 questions.

Are you interested in using PCORnet resources to support your patient-centered research? Reach out to the PCORnet® Front Door today to start engaging with PCORnet® Network Partners.

Have you ever wondered just how health data from people’s clinic visits are anonymized and transformed into insights that can improve health outcomes? Each step in the process, from collecting the data to removing personally identifying information and ensuring quality, is critical to the ultimate outcome: a clean, representative dataset that can be queried by researchers to better understand real-world experiences across the U.S. with no traceability back to the original records.

Through a clever analogy to the chocolate-making process, a resource on the PCORnet website helps patients better understand how data from their electronic health records, or EHRs, are made safe and secure for research use via PCORnet. This resource, which begins with cacao seeds (representing individual health records) and ends in delicious, ready-to-eat chocolate (research-ready datasets for query) was created by PaTH, a PCORnet® Clinical Research Network. Its step-by-step illustration of the journey fosters greater understanding of the often-confusing process of data transformation, a critical undertaking before researchers can leverage data from everyday healthcare encounters to answer important questions about health outcomes.

The PCORnet website has a treasure trove of resources, like this guide, to educate investigators, patients, and policymakers and improve research through evidence-based practices. Check it out today! Interested in the EHR data journey, but short on time? Watch this brief video explainer illustrating the process in under five minutes. Don’t let this sweet learning opportunity pass you by!

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 and diverse 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, representative 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.

The Patient-Centered Outcomes Research Institute (PCORI) will release several patient-centered comparative clinical effectiveness research (CER) funding opportunities on January 9, inviting research teams to utilize the PCORnet infrastructure and resources to support both interventional and observational research addressing health issues faced by large populations in the United States.

A new report from a multidisciplinary workgroup, including patients and caregiver partners, focused on intellectual and developmental disabilities (IDD), provides insight into critical research gaps and needs in IDD as well as prioritize unanswered patient-centered CER questions which may be addressed using PCORnet. The workgroup also developed recommendations for enhancements and preparatory activities for future patient-centered CER on IDD by which the PCORnet infrastructure may be leveraged.

Intellectual and Developmental Disabilities

The IDD Workgroup identified numerous CER questions spanning both general healthcare topics and specific conditions meaningful to individuals within this patient population, that can be studied using PCORnet. In addition to these potential opportunities for national-scale PCORnet® Studies, further topics and opportunities to use the network for priority questions are possible with scalable data enhancements across PCORnet.  To advance patient-centered CER for individuals with IDD, the Workgroup outlined steps in which sites and investigators within PCORnet® Clinical Research Networks can help promote health equity by potentially examining evidence-based interventions for common chronic diseases that have not previously been studied in IDD populations and help ensure individuals with IDD that have been historically invisible to the health care system are visible.

The data query of electronic health records (EHR) that informed this report is the largest known, national-scale descriptive analysis of IDD populations using EHR data. The query was conducted for a broad range of eleven IDD-related condition groups. The data reveals the IDD population served by these CRN sites includes 300,000 individuals with autism and more than one million patients with Attention Deficit Hyperactivity Disorder, known as ADHD. The query report also highlights unequitable access to healthcare. Individuals with an IDD diagnosis often receive care in an emergency location. The analysis also highlights common comorbidities that include diabetes, hypertension, and seizure disorders. The Workgroup noted a lack of high-quality CER studies on diabetes and hypertension within this population, underscoring the potential of PCORnet resources for IDD researchers. Read the full report.

Interested in harnessing insights on these topics and others for CER studies? The application period for PCORI’s Funding Announcement begins on January 9.

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 and diverse 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 diverse 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.

In the breakout session “How PCORI is Advancing Social Determinants of Health (SDOH) Data Collection and Use in Research to Promote Health Equity,” Nik Koscielniak, program officer for the PCORI Infrastructure and Innovation program, explained how PCORI expanded PCORnet to promote the collection and accessibility of SDOH data, which are related to the conditions in which people live, work, learn, and play. These factors have a significant impact on overall health outcomes and can help us understand the root causes of health disparities.

“Infrastructure and capacity-building efforts are essential to support improvements and standards in the collection, accessibility and use of SDOH data for research and learning,” he 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.

A differentiator for PCORnet® has always been its ability to capture insights on diverse populations that clinical research studies often miss—and now that diversity is about to get even more robust. PCORI approved funding for the addition of 16 sites to expand the reach of the eight PCORnet® Clinical Research Networks (CRNs), a move that underscores PCORI’s continuing investment in the Network’s growth.

“PCORnet is a go-to resource for researchers who want to study the full fabric of the U.S. population —people from all walks of life, identifying across all racial and ethnic groups, living in all places and circumstances,” said Betsy Shenkman, PCORnet Steering Committee Chair. “This expansion makes the Network’s breadth and depth even more robust, empowering PCORnet users to close more gaps in evidence than was previously possible.”

Data insights from the following 16 sites will be available in spring of 2024.

Expanding the ADVANCE CRN:

• Oregon Health and Science University in Portland, OR
• University of Washington in Seattle, WA

Expanding the GPC CRN:

• University of California, Los Angeles in Los Angeles, CA

Expanding the INSIGHT CRN:

• Houston Methodist in Houston, TX

Expanding the OneFlorida+ CRN:

• Jackson Health System in Miami, FL
• University of California, Irvine in Irvine, CA
• University of Arkansas for Medical Sciences in Little Rock, AK

Expanding the PaTH CRN:

• Boston Medical Center in Boston, MA
• RUSH University in Chicago, IL

Expanding the PEDSnet CRN:

• Texas Children’s Hospital in Houston, TX
• Children’s National Hospital in Washington, DC

Expanding the REACHnet CRN:

• Ochsner LSU Health in Shreveport, LA
• University of California, San Francisco in San Francisco, CA
• DHR Health Institute for Research and Development in Edinburg, TX

Expanding the STAR CRN:

• Essentia Health in Duluth, MN
• Stanford HealthCare in Stanford, CA