News and Events

New Study Finds Risk of Myocarditis and Pericarditis Is Substantially Higher After COVID-19 Infection Than After Vaccination

Posted on by Jodi Snare

The U.S. Centers for Disease Control and Prevention (CDC) have published results from a study that used PCORnet®, the National Patient-Centered Clinical Research Network, to better understand the comparative risks of cardiac complications among more than 800,000 patients who tested positive for COVID-19, and more than 4 million children and adults who received mRNA COVID-19 vaccines. The study found that adolescents and young adults who tested positive for COVID-19 were more likely to experience myocarditis, inflammation of the heart, or pericarditis, inflammation of the tissue surrounding the heart, than same aged individuals who received mRNA COVID-19 vaccines.

“The results of this study give important context to concerns about the link between heart conditions and mRNA COVID-19 vaccination,” said Adi Gundlapalli, MD, PhD, Chief Public Health Informatics Officer of CDC’s Center for Surveillance, Epidemiology, and Laboratory Services and senior author of the paper. “The data show that while rare adverse events can occur, COVID-19 vaccines are safe — and, importantly, the risk of experiencing a cardiac complication as a result of COVID-19 infection is much greater than the risk of these events as a result of vaccination.”

While other studies have explored the risk of cardiac complications after infection and vaccination, this study was the largest to date to explore this relationship in the United States. It investigated risk across a wider range of ages, including children as young as 5 years of age into adulthood. “This study provides critical information to parents, clinicians, and policymakers. Much of the information about cardiac complications has only mentioned vaccines. There is a real risk after COVID-19 as well, and these risks need to be discussed together,” Deepika Thacker, MD, a pediatric cardiologist with the Nemours Children’s Health System.

The study was a collaborative effort from investigators at CDC and PCORnet, a distributed research “network of networks” connecting health records across more than 60 healthcare systems in the U.S.

This study analyzed electronic health record information from 40 PCORnet-partnered health care systems to look for patterns across adolescents and young adults who either tested positive for SARS-CoV-2, the virus that causes COVID-19, or received any dose of the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines between January 1, 2021, and January 31, 2022. The study team looked for patients with near-term (within 7, 21, or 42 days) diagnoses of myocarditis, pericarditis, or multisystem inflammatory syndrome (MIS), a rare but serious condition linked to SARS-CoV-2 infection mostly in younger populations.

This study found a myocarditis or pericarditis incidence of 0 to 35.9 cases per 100,000 among males and 0 to 10.9 among females within 21 days of receiving a first dose, second dose, or unspecified dose of mRNA COVID-19 vaccine across age groups. The incidence was significantly higher among those infected with SARS-CoV-2, which was found to be 17.6 to 114.0 cases per 100,000 for males and 10.8 to 61.7 per 100,000 for females. The risk of myocarditis or pericarditis within 21 days was 2- to 20-times as high after SARS-CoV-2 infection than after mRNA COVID-19 vaccination for males and females across all age groups and vaccine doses.

“CDC and PCORnet are playing an important role in ensuring that the public has the information they need to weigh the benefits and risks of vaccination compared to becoming infected with COVID-19 and subsequent complications,” said Dr. Jason Block, a general internal medicine physician at the Harvard Pilgrim Health Care Institute and the lead author of the study.

“Anyone on the fence about vaccination should gain confidence from these findings that the risk of myocarditis or pericarditis from the mRNA COVID-19 vaccines is very small. Getting vaccinated against COVID-19 is the best way for people to reduce their risk for infection and for cardiac complications associated with COVID-19.”

ADAPTABLE Study Lauded as Top 10 Clinical Research Achievement

Posted on by Jodi Snare

ADAPTABLE, the first demonstration project of PCORnet®, the National Patient-Centered Clinical Research Network, has been named by the Clinical Research Forum as a Top 10 Clinical Research Achievement Awardee for 2022. The awards celebrate outstanding achievements and major advances in clinical research from across the U.S. Honorees were selected by a panel that considered clinical research studies published in peer-reviewed journals in 2021, with specific attention given to innovation and novelty involved in the advancement of science.

The ADAPTABLE research team, including patient partners known as Adaptors, will formally accept the achievement award on April 19 at a ceremony in Chicago, IL. The team will then present at Translational Science 2022 and meet with members of the U.S. Congress to promote the importance of funding for clinical research.

A major achievement in pragmatic study design
ADAPTABLE, which sought to determine the safest and most effective dose of aspirin for patients with existing cardiovascular disease, broke ground as the first major randomized comparative effectiveness trial conducted using the broad and rich data resources of PCORnet. The trial’s novel strategies set a blueprint for the future of pragmatic study design by integrating research within patient care and using technology to effectively alleviate site and patient burden.

The infrastructure of PCORnet was central to ADAPTABLE’s successful execution. Via the Network, the study team leveraged electronic health records (EHRs) to identify potential participants, and then followed up with traditional outreach such as phone calls, letters, emails, and conversations in clinics. Data from PCORnet-accessible EHRs, patient-reported outcomes, insurance, and Medicare claims data were used to capture primary endpoints for the study where possible. Collecting data in this way minimized the need for in-person visits and thereby reduced participant burden.

At the heart of the study’s novel design were the Adaptors, who worked alongside researchers in all aspects of the trial, including helping to design the protocol, consent form, study portal, and study materials.

Ultimately, investigators found no significant difference in either protective effects or bleeding risk between the 81 mg and 325 mg doses of aspirin. However, the patients in the group taking the lower dose were less likely to switch doses mid-study or discontinue aspirin completely.

Publication of ADAPTABLE’s results in the New England Journal of Medicine was met with praise. An accompanying editorial penned by Colin Baigent, professor of epidemiology at the Nuffield department of population health at Oxford University and director of the Medical Research Council Population Health Research Unit, called the trial “a major achievement … because it has shown a method of conducting trials efficiently and at low cost in the United States, and this method can now be adapted and used more widely. This should allow many more clinical questions to be answered, with obvious benefits to health care consumers.”

Study of 2 million Patients Finds New Symptoms and Conditions Months After COVID-19 Are Infrequent but Potentially Serious and Long-Lasting

Posted on by Jodi Snare

Patients who tested positive for COVID-19 were more likely than patients who tested negative to have new symptoms and health conditions more than a month later, according to a study of over 2 million patients in the United States.

While most COVID-19 patients recovered fully, approximately one in ten had new symptoms or health conditions, also referred to as “long COVID” or “post-COVID conditions”, suggesting that doctors should monitor the health of their COVID-19 patients for many months after they test positive for the virus.

Earlier studies have reported a variety of symptoms and conditions can follow four or more weeks after a COVID-19 illness. These symptoms or conditions can be ongoing, returning, or new. They range from shortness of breath, tiredness, muscle weakness, and “brain fog” (difficulty thinking or concentrating) to serious or long-lasting new health conditions, such as new-onset type 2 diabetes and nerve disorders. However, not many reports have assessed whether certain symptoms and conditions are more common among people who had COVID-19 compared with people who did not.

“Several studies have documented a variety of post-COVID conditions, but we had little information about the occurrence of these conditions at the population level or about the ongoing medical needs of patients with COVID-19,” said Dr. Alfonso Hernandez-Romieu, an infectious disease physician and epidemic intelligence service officer at the U.S. Centers for Disease Control and Prevention (CDC) and the lead investigator for the study.

Public health researchers from CDC, universities, health systems, and public health institutes accessed electronic health record data from healthcare facilities participating in PCORnet®, the National Patient-Centered Clinical Research Network.

The researchers identified more than 2 million patients of all ages in 42 participating healthcare systems who had a COVID-19 test between March and December 2020 and received medical care for any reason 31–150 days after they were tested. Researchers compared 170,000 patients who tested positive for COVID-19 to 1.9 million patients who tested negative for COVID-19 and separated data for hospitalized and nonhospitalized patients.

The most common new symptoms among adults who tested positive for COVID-19 were shortness of breath, tiredness, and sleep disorders. Children and young adults who tested positive for COVID-19 more commonly experienced constipation or diarrhea, tiredness, and shortness of breath.

Among the hospitalized patients, the researchers found that about 1 in 10 hospitalized patients who had a positive COVID-19 test had new symptoms like shortness of breath, fatigue, abnormal heart rate, or other problems, like endocrine or neurologic problems, a month or more after their positive test. Hospitalized patients with a positive COVID-19 test were more likely than hospitalized patients with a negative test to get these new symptoms.

Also, patients who had more severe COVID-19 illness were more likely to be newly diagnosed with symptoms or health conditions within 31–150 days. Adults who had been hospitalized and placed on a ventilator were more likely to have new symptoms and conditions than patients who had not been on a ventilator. The rate of new-onset type 2 diabetes was higher among adults who had been hospitalized, and the rate of new neurological disorders was higher among adults who had been placed on a ventilator during their COVID-19 illness.

“Although new symptoms and conditions occurred infrequently, applying the proportions of these rare events to the millions of adults and children infected with SARS-CoV-2 means that tens of thousands of people might develop post-COVID conditions after their initial bout with the disease,” said Dr. Thomas Carton of the Louisiana Public Health Institute, principal investigator for REACHnet, a PCORnet Network Partner, and a researcher in the study.

“Some patients may have sought care after their initial COVID-19 illness for symptoms that were long-lasting as well as chronically debilitating conditions such as type 2 diabetes and nerve disorders,” said Dr. Hernandez-Romieu. “Greater awareness of post-COVID conditions among health care professionals is crucial for meeting the needs of patients with prolonged or chronic consequences of COVID-19,” he said.

……….

This research was supported by Cooperative Agreement number 6- NU38OT000316, funded by the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention or the Department of Health and Human Services.

 

Read about this important research in JAMA Network and in a lay summary.

PCORI Approves Funding to Support Phase 3 of PCORnet

Posted on by Jodi Snare

The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors recently approved $61.3 million to implement phase 3 of PCORnet. This financial support will provide 8 PCORnet Clinical Research Networks (CRNs) with the ability to optimize their infrastructure resources to support PCORnet in its third phase as a national resource for conducting rapid, efficient, and patient-centered research.

The CRNs will work to ensure maximization of resources developed in prior phases of PCORnet. Key activities include increasing the diversity of patient populations and care settings within PCORnet, efficiently implementing studies addressing PCORI’s strategic research priorities, strengthening patient and stakeholder engagement, and providing high-quality data to power studies.

“As a network, we are tremendously grateful for the steadfast support of PCORI and are eager to begin our work on phase 3 of PCORnet. Our recently awarded CRNs will, undoubtedly, bring continuity to our work, building on the foundation of all CRNs that have previously worked with PCORnet,” said Russell Rothman, PCORnet Steering Committee Chair.

The CRNs awarded funding are:

The PCORI Board of Governors also approved 5 awards to fund coordinating center functions to help advance the important work of the network. Learn more about the awards.

HERO Research Program Reaches 55,000 Healthcare Workers in 2021

Posted on by Jodi Snare

The PCORI-funded Healthcare Worker Exposure Response & Outcomes (HERO) Registry grew to include over 55,000 healthcare workers in all 50 states over the past year.

Funded by the Patient-Centered Outcomes Research Institute (PCORI), coordinated by the Duke Clinical Research Institute (DCRI), and enabled by PCORnet®, the National Patient-Centered Clinical Research Network, HERO relies on partnerships with PCORnet Network Partners who ensures that any interested healthcare or emergency worker can easily join the registry.

Read about the HERO Research Program’s accomplishments in 2021 and how the program is conducting research with and for healthcare workers and highlighting healthcare workers voices and opinions through its “hot topics” research.

PCORnet®-Supported PREVENTABLE Study Achieves 2K Participant Milestone Leveraging Pragmatic Lessons from the Network

Posted on by Jodi Snare

A pragmatic study of the effectiveness of statins in adults aged 75 or older without known cardiovascular disease has successfully randomized the first 2,000 participants in partnership with PCORnet®, the National Patient-Centered Clinical Research Network. The study, known as Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE), builds on past Network success in pragmatic approaches for clinical study design, including the highly lauded ADAPTABLE study of aspirin dosing in 15,000 patients with heart disease.

“Few studies are focused exclusively on participants aged 75 or older, in part because recruitment in this population is historically challenging,” said Schuyler Jones, who is helping lead the recruitment core for the study. “But insights into this population are also critically important—these are our friends, neighbors, parents and grandparents, and answers to research questions are central to their quality of life. Tailoring a trial to meet their needs is key, and as a large, nationally representative network with proven expertise in pragmatic trials, PCORnet is a huge asset in helping us achieve that goal.”

Bringing the ADAPTABLE approach to a harder-to-recruit patient population

The PREVENTABLE study is important because nearly half of Americans aged 75 or older take statins to reduce risk of cardiovascular events, but we don’t yet know if statins are helpful for older adults without heart disease. To find out, PREVENTABLE will enroll 20,000 participants, whom the team is engaging through a similar pragmatic design as the PCORnet-enabled ADAPTABLE study. Specific approaches carried forward from ADAPTABLE to make participation easier include:

  • Embedding research in the health care system by enrolling patients in their usual care settings and in partnership with their primary care clinicians;
  • Engaging potential participants during screening and recruitment by using informational videos, panel discussions with research participants, and an e-consent platform; and
  • Pairing electronic health record data with other forms of follow-up, including calls and in-person visits for cognitive and functional assessments, to ensure complete collection of outcomes.

However, several aspects of PREVENTABLE make recruitment more challenging than ADAPTABLE. For instance, while ADAPTABLE looked at patients with known heart disease, PREVENTABLE participants do not have known heart disease and thus have fewer medical visits to facilitate recruitment. Because they are not ill, they may also be less motivated to join a study. Finally, PREVENTABLE’s recruitment effort is in the midst of the COVID-19 pandemic, which has disproportionately affected older adults and perhaps made them hesitant regarding trial participation.

“I have been proud of the study team’s efforts to pivot in response to these challenges and find novel ways to engage patients, whether that is in the clinic, in community centers, or on the pickleball court,” said Jones. “Slowly, but surely, we are bringing more participants into the fold, and we are tasked with enrolling our first 5,000 patients by August 2022. At the end of this study, we will have amassed a huge amount of knowledge around what it takes to recruit older participants for research, which will support future efforts to seek insights into this important, but vastly understudied population.”

Data Privacy statement for PCORnet® released, detailing how the Network protects patient information

Posted on by Jodi Snare

Network Partners with PCORnet®, the National Patient-Centered Clinical Research Network, have released a statement explaining how the Network handles sensitive data and protects patient privacy. The statement is yet another way that the PCORnet community continues to demonstrate its commitment to deliver on the founding values of patient centricity and trust.

“The PCORnet infrastructure was designed to facilitate research that is uncompromising in its patient centricity, and there is no question that patients have a right to know how we are safeguarding their privacy,” said Keith Marsolo, PhD, a co-investigator in the Distributed Research Network Operations Center of the Coordinating Center for PCORnet.  “We have always had stringent protections in place, and now our data privacy statement takes the additional important step of sharing with patients exactly how their personal data is handled with care.”

Shedding light on common questions

The PCORnet data privacy statement is comprehensive, detailing the Network’s protective infrastructure, how patient information is collected and securely shared, and how the data is accessed and used for research. It also clears up some common misconceptions about PCORnet-enabled data. For example, a key security feature of the PCORnet infrastructure is that the data actually stay under the care of the participating healthcare institution and are not amassed into a single data pool or data warehouse.  Data are only accessed within the context of specific research projects, and the participating institutions decide whether or not to share the minimally necessary data needed for research on a case by case basis.

Importantly, the statement was drafted and approved as a collaborative effort by PCORnet Network Partners and written to be easily understandable by audiences despite its technical nature. “The commitment PCORnet places on data privacy is one of the many ways PCORnet exemplifies its commitment to patients. I take a great deal of pride in knowing that PCORnet is steadfastly committed to keeping patients, their goals, and their privacy at the heart of the mission. By involving partners, such as myself, in processes like the development of the data privacy statement, blind spots are alleviated and true collaboration is formed,” said PCORnet Patient Partner, Susan Lowe. PCORnet patient partners who participate in the governance of the Network reviewed the statement for clarity, and they –along with the rest of the PCORnet Steering Committee – voted to adopt the statement.

“We believe that this statement will serve as a win-win for both patients and researchers,” said Marsolo. “When patients are given full transparency as to how their personal information is handled with care, trust is built. With that trust, we can continue to build on and use the PCORnet infrastructure to deliver fast, trustworthy answers that deliver better health outcomes for all.”

Solid Data, Expert Vetted, Patient-Centered: What PCORnet® Designation Tells You About a Study

Posted on by Jodi Snare

Since its launch, PCORnet®, the National Patient-Centered Clinical Research Network, has become synonymous with impactful, pragmatic research conducted at national scale. To support more quality, patient-centered research, Network leadership worked in close partnership with the Patient-Centered Outcomes Research Institute (PCORI) to launch the PCORnet Study Designation program.

A study designated as a PCORnet study is one that meets criteria demonstrating commitment to conducting important patient-centered research differently, and that, in turn, benefits from the full support of PCORnet and its continued growth as a learning health network. Achieving PCORnet Study Designation is an accomplishment that research teams can use when promoting their studies and results.

“Study designation is one way that we support research efforts that are designed specifically in service to the patient, from engagement in the design and conduct of studies to dissemination of results,” said Russell Rothman, MD, the Chair of the PCORnet Steering Committee.  “If we can help those studies succeed by offering the knowledge and lessons learned from the studies and experts in the Network, we can help ensure research that matters to patients continues to progress—and, at the end of the day, that’s what the Network is all about.”

Some of the most consequential studies conducted through PCORnet carry Study Designation, including ADAPTABLE, HERO, PREVENTABLE, MedWeight and more. To qualify for Study Designation, a research project must:

  • Include two or more PCORnet Clinical Research Networks, or “CRNs”
  • Ensure that participants and patients are engaged throughout the project lifecycle
  • Are committed to broad dissemination of findings and returning study results to participants
  • Agree to share study progress, performance metrics, and best practices with the Network regularly
  • Leverage the PCORnet Common Data Model as appropriate

The Designation Process

Requests for Study Designation are submitted to the PCORnet Front Door for administrative review and intake, and then are reviewed by impartial volunteers from across the Network. Reviewers can approve, deny, or request clarification, and typically a decision is reached within two weeks of submission. Once approved, the Network is deeply invested in the quality and success of these efforts. That’s why Designated Studies enjoy a robust level of support across the Network through regular communication with experts at PCORnet CRNs and the PCORnet Coordinating Center. Designated studies are also required to share monthly metrics for start-up, enrollment, safety and more, which embeds transparency and accountability into the process.

To learn more, check out our Study Designation Fact Sheet.

Can Existing Medications Help Treat People with COVID-19? PCORnet® Will Help Researchers Find Out.

Posted on by Jodi Snare

A new COVID-19 study supported by the National Institutes of Health (NIH) as part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program will use PCORnet®, the National Patient-Centered Clinical Research Network, to quickly access enrolling sites, streamline study start-up timelines, and engage the community perspective. The ACTIV-6 study will work collaboratively with participants to develop a platform that will generate evidence about a pressing question in the pandemic: Can medications that are approved for other indications also be helpful in treating patients with mild or moderate COVID-19?

There is currently no approved medication that can be self-administered to ease symptoms of people suffering from mild disease at home and reduce the chance of their needing hospitalization. At the end of the study, the ACTIV-6 team hopes its ongoing evidence-generating clinical trial platform will shed light on the utility of up to seven medications that are already approved for other indications in alleviating the symptoms and clinical outcomes of people with COVID-19.

Putting the needs of everyday people front and center
“There is a lot of research devoted to treatment of severe COVID-19, but it is important to remember most people with COVID-19 are recovering from home, and they are looking for answers on how to feel better,” said Kris Anderberg, the project lead for the ACTIV-6 stakeholder committee. “We formed our ACTIV-6 stakeholder committee to ensure we are appropriately listening to the voices of everyday patients and focusing our research in a way that will make results meaningful to the broader community.”

Impressive progress has been made by vaccines to help curb the pandemic, but new variants and surges of infections in different regions are reminders that COVID-19 remains an evolving threat. To speed insights, ACTIV-6 will be conducted as a platform trial, meaning that it will study multiple medications concurrently, and will be conducted remotely, both key characteristics that will enable more pragmatic and efficient research. In addition, medications will be administered orally or by inhaler and will be easy for participants to take at home. Participants will be assigned randomly to receive either a placebo or one of the treatments, which will be sent to them by mail.

“The medications under consideration already have been tested in humans, so they provide an opportunity to deliver meaningful insights sooner on COVID-19 home treatment options,” said Anderberg. “We are excited about developing this platform as a meaningful tool to inform treatment of those affected by the pandemic.”

Inaugural PCORnet-Powered Study Delivers Insights and Inspiration for Novel Trial Design

Posted on by Jodi Snare

In a milestone moment for PCORnet®, the National Patient-Centered Clinical Research Network, the ADAPTABLE study team today shared results in a late-breaking clinical trials session during the 70th annual American College of Cardiology Scientific Session. The results, which were simultaneously published in the New England Journal of Medicine, establish PCORnet as a powerful resource for successfully conducting novel pragmatic clinical trials. They also provide important insights into optimal aspirin dosing and set a blueprint for the future of pragmatic research.

“As the first randomized controlled study using PCORnet, ADAPTABLE has been closely watched by researchers who are interested in the potential of large-scale, pragmatic, patient-centered trials to deliver fast, high-quality answers,” said ADAPTABLE Principal Investigator Schuyler Jones. “Today’s results leave no doubt that the novel research framework supported by PCORnet is not only possible, but necessary for the future of clinical research.”

ADAPTABLE compared two doses of aspirin (81 mg vs. 325 mg) to determine which dose was the safest and most effective for preventing a heart attack, stroke, or death in people diagnosed with existing cardiovascular disease. Ultimately, investigators found no significant difference in either protective effects or risk for bleeding between the two doses. However, the group taking the higher dose switched doses more frequently (41.6 percent of participants taking 325 mg switched doses, as compared to 7 percent who switched from the 81 mg group). Participants in the higher dose group were also more likely to discontinue aspirin completely (11 percent discontinued in the 325 mg group, as compared to 7 percent in the 81 mg group).

Inspiring a new research paradigm

While these answers are helpful for people with heart disease and providers, perhaps even more meaningful is the pragmatic and patient-inspired framework their work established. PCORnet is at the center of that framework, enabling access to data from participants’ everyday health care encounters via a distributed research network model. In collaboration with 40 health centers, one health plan, and numerous patient partners from PCORnet, the ADAPTABLE study team enrolled over 15,000 people to participate in the study.

Via PCORnet, the team leveraged electronic health records (EHRs) to identify those potential participants, and then followed up with traditional outreach such as phone calls, letters, emails, and conversations in the clinic. Data from PCORnet-accessible EHRs, patient-reported outcomes, insurance, and Medicare claims data were used to capture primary endpoints for the study where possible in lieu of in-person visits, minimizing participant burden.

ADAPTABLE patient partners, known as Adaptors, worked alongside researchers in all aspects of the trial, from helping to design the protocol, consent form, study portal, and study materials through the current dissemination of results. “By representing and sharing the patient voice at every touchpoint of the study, the Adaptors asked researchers to think about how research could be done differently,” said Greg Merritt, an ADAPTABLE patient partner. “I think if patients have more opportunities to share their lived experiences, we can shape the future of research.”

“Traditional research methods are often slow and cumbersome, so when we launched ADAPTABLE our strategy was to use PCORnet to pave a new pathway by enthusiastically embracing novel strategies that make research participation easier,” said Jones. “Since that time, the pandemic has only intensified the urgency for better, faster methods to address common clinical decisions. With the successful completion of ADAPTABLE, we now have a blueprint to meet that need.”

For more information on ADAPTABLE’s results, visit the website to read a summary of results and watch a Town Hall where Adaptors lead a discussion about ADAPTABLE results and lessons learned.