COVID-19

Two RECOVER Studies Leverage PCORnet® for New Insights on ‘Long COVID’

Posted on by Jodi Snare

As COVID-19 viral variants continue to spread, so too grows the population of those who experience COVID-19’s effects months after the acute illness has passed. Now two new manuscripts in Nature Medicine and JAMA Pediatrics show how the RECOVER initiative is using PCORnet®, the National Patient-Centered Clinical Research Network, to shed new light on who is impacted and how.

PCORnet: A key tool for RECOVER research

RECOVER research is funded by the National Institutes of Health and aims to understand why some people do not fully recover and develop long COVID. RECOVER brings together patients, caregivers, clinicians, community leaders, and scientists from across the nation and comprises multiple studies at institutions aligned toward this common goal.

PCORnet is a critical resource for RECOVER research because of the Network’s broad and deep data reach representing the everyday encounters of tens of millions of Americans. While most research to date has studied the signs and symptoms of long COVID independently, PCORnet enables a more holistic analysis that can shed light on trends around the condition’s diverse and complex presentations.

New characterizations of long COVID

A major challenge of long COVID is that it has been difficult to pin down how and why it presents across different patients. Now, a RECOVER study has used PCORnet to determine that adults with long COVID generally fall into four adult sub-groups (technically known as subphenotypes) based on the conditions they are diagnosed with following COVID. The results were published in Nature Medicine.

The team explored the electronic health records, or EHRs, of more than 34,000 COVID-positive patients across two PCORnet Clinical Research Networks: INSIGHT and OneFlordia+. By pairing PCORnet-leveraged data with machine learning analysis, the team assessed more than 130 symptoms and conditions before arriving at the following four subgroups that are reproducible, meaning another large-scale study would produce similar results:

  • Patients with new conditions of cardiac and renal symptoms (75% of patients in INSIGHT and 25.43% of patients in OneFlorida+)
  • Patients with new respiratory system, sleep and anxiety problems (75% in INSIGHT and 38.48% of patients in OneFlorida+)
  • Patients with new musculoskeletal and nervous system problems (37% in INSIGHT and 23.35% of patients in OneFlorida+)
  • Patients with new digestive and respiratory symptoms (10.14% in INSIGHT and 12.74% of patients in OneFlorida+)

These findings mark an important disease characterization milestone that could help clinicians and health systems develop more meaningful care models to meet the needs of patients with long COVID.

Long COVID in children

Another study surfaced several key insights about long COVID in children, which were recently published in JAMA Pediatrics. The retrospective cohort study used de-identified EHRs from more than 650,000 children across PEDSNet, a PCORnet Partner Network. All the children were under 21 years old, had previously been tested for COVID-19, and had visited a care provider within PEDSNet at least once in the three years before testing. The study found:

  • The burden of pediatric long COVID that presented to health systems was low, meaning long COVID in children is fairly uncommon.
  • Myocarditis was the most commonly diagnosed long COVID-associated condition in children, which differs from adults.
  • Acute illness severity, young age, and comorbid complex chronic disease increased the risk of long COVID.

These findings suggest that while long COVID impacts both children and adults, it does not impact them in the same way. Future studies, including long-term prospective studies, are needed to more fully characterize trends around how long COVID plays out in different populations.

When Answers Can’t Wait: PCORnet® Data Resources Speed COVID-19 Research

Posted on by Jodi Snare

The urgent need for COVID-19 insights demanded that researchers everywhere join forces to bridge clinical science with data science and speed meaningful answers to patients. PCORnet®, the National Patient-Centered Clinical Research Network, was one of the earliest collaborators in the pandemic in April of 2020 when the U.S. Centers for Disease Control and Prevention (CDC) reached out to the Coordinating Center for PCORnet with a question: Could PCORnet infrastructure be used for real-time reporting and surveillance of COVID-19 patterns across the country?

Meeting the moment

The answer was yes. A core strength of PCORnet infrastructure lies in the Network’s partnership with diverse health systems that hold electronic health records for more than 66 million people across the United States. These records reside in different systems. However, using a Common Data Model, the participating Network Partners de-identify and standardize them so a researcher can ask the same question to millions of people at once. By allowing researchers to break free of the patchwork of siloes that represent most of America’s healthcare data, PCORnet can surface a much-needed birds eye view of historic health patterns across the country.

PCORnet resources were not designed for real-time reporting, and yet COVID-19 answers couldn’t wait. So PCORnet researchers worked with the CDC in partnership with the Public Health Informatics Institute (PHII), a program of the Task Force for Global Health, to build a custom Common Data Model specific to COVID-19. Then, they tapped this de-identified, firewall-protected dataset on a bi-weekly basis to surface trending patterns of infection across the U.S. With this approach, they could get the answers they needed without sacrificing important patient privacy or confidentiality protections.

Informing the pandemic

Scientists have learned more about COVID-19 at a faster pace than any disease in human history, and the CDC’s collaboration with PCORnet has been an important part of that journey. Over the past year, the partnership has resulted in key publications to support public health:

Racial and ethnic disparities during the COVID-19 pandemic

In January, CDC’s Morbidity and Mortality Weekly Report published results of a PCORnet-utilized study that found that therapeutic use of monoclonal antibodies, which are highly effective at preventing the progression of COVID-19, were prescribed unequally in Black, Asian, and Hispanic COVID-19 patients, adding important evidence about the complex topic of health equity in the time of COVID-19.

New symptoms after COVID-19 infection

In February, JAMA Network published results from another CDC-PCORnet collaborative effort, which found that 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.” The findings suggest that doctors should monitor the health of their COVID-19 patients for many months after they test positive for the virus.

Rates of myocarditis and pericarditis after COVID-19 vaccination

In April, CDC’s Morbidity and Mortality Weekly Report published results illustrating how PCORnet resources were used to discover 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.

According to Tom Carton, who is the Principle Investigator of REACHnet, these accelerated findings during the pandemic have pushed research into a new realm that will serve communities long after it subsides.

“Having now seen the phenomenal pace and quality of insights we have been able to achieve through the pandemic, the research paradigm has evolved, and there’s no going back,” he said.

Behind the scenes of a trailblazing collaboration

To continue bringing these kinds of insights to light, collaboration is key. CDC and PCORnet-affiliated researchers used regular briefings to discuss the most urgent answers needed to protect public health and how to best leverage PCORnet to find them. Their initial questions were general in nature: What is the COVID-19 positivity rate by care setting? What are the ages, sex, and other demographics of people getting infected?

As the pandemic continued, PCORnet-driven answers began to surface. The queries were able to capture information on patients with COVID-19 through diagnostic codes as well as lab test results. They also captured data from both ambulatory and in-patient care settings, which many other distributed research networks were unable to provide. As a result, the CDC could look at a large, representative sample of patients and investigate the characteristics of people who were getting infected and seeking care for the virus, predictors of who develops severe disease or complications, and whether there are long-term consequences of COVID-19 infection.

Research in a post-pandemic environment

The CDC-PCORnet collaboration is currently moving into its third year, and PCORnet-accessible data is now integrated into CDC data surveillance systems. While the stakeholders are still exploring important COVID-19-related topics, they are also discussing potential future areas where PCORnet resources can support rapid insights, including HIV and other infectious diseases.

“We’ve firmly established trust with the CDC in PCORnet, and we’ve proven the Network’s value to speed answers to emerging, fast-moving questions in times of crisis,” said Carton. “I envision this as an ongoing collaboration wherein the PCORnet infrastructure will be an important tool to help CDC better respond to and support public health, both now and in the future.”

Racial and Ethnic Minority Groups Don’t Receive COVID-19 Monoclonal Antibody Treatment Equally, Says New PCORnet®-Leveraged Study

Posted on by Jodi Snare

Throughout the pandemic, racial and ethnic minority groups in America have experienced worse outcomes from COVID-19. These groups also often have a higher burden of risk factors for severe COVID-19, such as higher prevalence of hypertension, diabetes, and obesity. Newly published results from a PCORnet®-leveraged study identify a factor that also may be at play: Inequitable receipt of COVID-19 treatments across racial and ethnic groups.

The study, which was published in the U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report, used PCORnet resources to explore patient receipt of three different medications used for treatment of COVID-19 during the pandemic. It found that therapeutic use of monoclonal antibodies (mAb), which are highly effective at preventing the progression of COVID-19, were used unequally in Black, Asian, and Hispanic COVID-19 patients, adding important evidence about the complex topic of health equity in the time of COVID-19.

“This research adds to the growing body of evidence that while we are all experiencing the pandemic, we are not experiencing it equally,” said Thomas Carton, co-author and PCORnet investigator for the study. “Using the PCORnet infrastructure, we were able to rapidly illuminate the disparities in mAb COVID-19 treatment use. This marks an important step toward addressing racial and ethnic health equity gaps that aren’t new but were highlighted by the pandemic.”

Specifically, the study found that Hispanic patients testing positive for SARS-CoV-2, the virus that causes COVID-19, received monoclonal antibodies 58% less often than non-Hispanic patients. Black, Asian and patients of other races received monoclonal antibodies 22%, 48%, and 47% less often than White patients, respectively. In inpatient settings, differences in treatment with dexamethasone and remdesivir were observed, but at a smaller scale. Black patients actually received remdesivir more often than White patients.

The disparities in monoclonal antibody use might reflect systemic factors such as limited access to testing and care, especially within the window needed to qualify for monoclonal treatment, inadequate insurance coverage, and transportation challenges; lack of a primary care provider to recommend treatment; variations in treatment supply and distribution; potential biases in prescribing practices; and limited penetration of messaging in some communities about monoclonal antibodies availability and effectiveness to prevent disease progression. Additional reasons might include hesitancy about receiving treatment.

The path forward

According to Carton, insights from this research underscore the need for better awareness and solutions to ensure equitable receipt of therapies in the treatment of COVID-19.

“Expanded research, resources, community partnerships, and efforts are needed at multiple levels to make meaningful progress to address inequities, especially those related to health, which have been made worse by the pandemic,” said lead author Jennifer Wiltz, Deputy Medical Director of the CDC National Center for Chronic Disease Prevention and Health Promotion. “I hope this latest research inspires action across communities, clinical groups, and sectors to address the gaps we’ve illuminated and bring us closer to equitable health care for all.”

The authors would like to see drivers understood and barriers addressed. As an example of program underway,  CDC’s COVID Response and Resilient Communities initiative, puts community health workers in communities of greatest burden, allowing them to reach communities, facilitate access to services, and improve service delivery for people who otherwise face barriers to care.

CDC Uses PCORnet® Resources to Shape National Understanding of COVID-19

Posted on by Jodi Snare

Network Partners of PCORnet®, the National Patient-Centered Clinical Research Network, are leveraging their rich data to help answer important questions during the COVID-19 pandemic. One of the early collaborators with this work is the U.S. Centers for Disease Control and Prevention (CDC) in partnership with the Public Health Informatics Institute (PHII), a program of the Task Force for Global Health. Through this partnership (formally established in October 2020), PHII contracted with Harvard Pilgrim Health Care, a component of the PCORnet Coordinating Center responsible for developing and executing queries. Harvard Pilgrim Health Care is working with the other component of the PCORnet Coordinating Center and REACHnet to implement descriptive and advanced analytic queries across 43 PCORnet sites.

The CDC collaboration has been made possible through the efforts of PCORnet partners to rapidly adapt the PCORnet Common Data Model that captures and standardizes biweekly updates of patients with a diagnosis of COVID-19, a SARS-CoV-2 test, or other respiratory conditions. To date, aggregate data stripped of any personal identifying information related to nearly half a million patients with a COVID-19 diagnosis or SARS-CoV-2 test result have been shared with CDC.

“As a massive research network that can capture information from many healthcare systems, PCORnet has had an important role during a pandemic response,” said Tom Carton, current chair of the PCORnet Steering Committee. “The health records that underpin the PCORnet data infrastructure offer much more depth than the simple case reports with limited information that have been largely available to date. Via PCORnet, CDC and others are learning detailed surveillance information about the patterns of infection and course of the virus that is essential to help our leaders, institutions, and patients understand and combat this pandemic.”

“With our queries, we are able to capture information on patients with COVID-19 through diagnostic codes as well as lab test results,” said Jason Block, who is supporting efforts of the PCORnet Coordinating Center to better define COVID-19 using data accessible from the Network. “As a result, we are able to look at a large, representative sample of patients and get to the bottom of the characteristics of people who are getting infected and seeking care for this virus, predictors of who develops severe disease or complications, and whether there are long-term consequences of COVID-19 infection.”

“Our most recent queries are highlighting some interesting trends across COVID-19-postive patients,” said Block. “For example, we are seeing substantial changes in the use of medications for treatment of COVID-19. In hospitals, nearly all patients received hydroxychloroquine in the early phase of the pandemic; very few are receiving that treatment now, replaced by common use of remdesevir and dexamethasone. Also, we found that some of the early racial disparities in COVID-19 infection have decreased over time, as the pandemic has expanded across the entire population; important disparities still exist among hospitalized patients, with higher hospitalization rates among Black patients. It will be equally important to understand these trends as we continue to pursue vaccine adoption across the U.S.”

Block and his colleagues have begun discussions with CDC about potential options to track uptake of vaccines across the Network.

Networks like PCORnet protect patient data by keeping it safe within healthcare organizations and only sending de-identified, aggregated information from patient records through secure means to inform public health action. CDC continues to work with PCORnet leaders to determine how to best leverage data from a large network of healthcare organizations to support CDC’s COVID-19 response.

“At a time when the entire world is seeking answers to combat this pandemic, PCORnet’s Network Partners have rallied to collaborate with CDC as part of the solution,” said Pastor Bruce Hanson, a patient advocate serving on the PCORnet CDC COVID-19 Workgroup. “We are optimistic that we will glean many meaningful insights in the coming weeks and months.”

The team is working on disseminating those insights more broadly across healthcare and public health communities. Information on the type of data the team is gathering is currently shared publicly on GitHub. Stay tuned for more on the PCORnet-enabled COVID-19 response.

PCORnet is Delivering Important COVID-19 Answers

Posted on by Jodi Snare

With access to coordinated heath data from more than 70 million people across the United States, PCORnet®, the National Patient-Centered Clinical Research Network, is a key resource in the fight against COVID-19. To maximize its utility, the Patient-Centered Outcomes Research Institute (PCORI) offered enhancement funding for nine existing PCORnet-enabled research studies. The idea behind these enhancement awards is to leverage existing infrastructure from PCORI-funded research to more efficiently expand understanding of COVID-19 and address this public health crisis.

One of many lessons learned from the COVID-19 pandemic is that good public health decisions in times of crisis require fast analysis of diverse patient data. While many healthcare organizations across the U.S. have the capacity to use their electronic health records (EHRs) and claims data as tools for horizon-scanning and disease surveillance, few offer the infrastructure to support the large-scale integration needed in the pandemic. The coordinated, interoperable infrastructure of PCORnet supports that needed speed and efficiency.

Following are a few snapshots of how PCORI-funded enhancement awards are supporting the use of PCORnet to combat the pandemic:

For more information about PCORI’s enhancement awards for COVID-19 research, check out the PCORI funding website.

PCORnet®-Enabled HERO Registry Tops 20K Participants as Pfizer Partners for Vaccine Safety Study

Posted on by Jodi Snare

The Healthcare Worker Exposure Response & Outcomes (HERO) Registry, which unites healthcare workers to better understand and stop COVID-19, has enrolled over 22,000 participants. HERO is 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. Its goal is to use the experiences of frontline health workers to develop fast knowledge to keep these workers and their communities safe and healthy in the COVID-19 pandemic.

"We are thrilled to see the HERO Registry continue to grow, a clear indication that frontline health workers across the nation are united in their commitment to fight COVID-19, both in and out of the hospital setting," said Emily O’Brien, principal investigator for the HERO Registry. "Their experiences are tremendously valuable in helping the research community better understand the physical and mental toll of this virus, which will improve COVID-19 care across the board."

The partnership with PCORnet Network Partners has been central to the registry’s success. Network Partners have ties to a well-established community of healthcare systems with experience collaborating on large clinical studies engaging patients and clinicians alike. This community’s support ensures that any interested healthcare or emergency worker can easily join the registry.

Targeting the next phase of COVID-19: long-term vaccine safety

An advantage of real-world registries is their ability to evolve naturally as the pandemic progresses. For example, now that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization of COVID-19 vaccines, the HERO Registry is serving as a key tool in understanding the real-world experiences of healthcare workers taking vaccines.

In December, Pfizer funded the HERO-Together study, which is using the HERO Registry to follow healthcare workers for two years to assess their experiences after receiving one of the COVID-19 vaccines such as the Pfizer-BioNTech COVID-19 vaccine. Like previous studies that leveraged the HERO Registry, HERO-TOGETHER is making participation easy, allowing vaccinated health workers to quickly and securely provide information about their health and any unexpected medical care they have received.

What’s next for the HERO Registry?

The HERO Registry will continue to evolve in the coming years, and its community of engaged healthcare workers are certain to help answer more important questions about the short- and long-term impacts of COVID-19 within this essential community.

Is There a Connection Between COVID-19 and Popular Hypertension Medications?

Posted on by Jodi Snare

PCORnet® Study Comparing Blood Pressure Control Strategies Seeks Answers

During the COVID-19 pandemic, researchers are using PCORnet®, the National Patient-Centered Clinical Research Network, to support several efforts to rapidly inform the nation’s response to the disease caused by the novel coronavirus. The PCORnet Study, “Using PCORnet to Compare Blood Pressure Control Strategies,” is leveraging a broad cohort of hypertensive patients to better understand what, if any, connection exists between the use of ACE inhibitors or angiotensin receptor blockers and incidence and severity of a COVID-19 infection.

This effort is an enhancement to a study that was already underway with funding from the Patient-Centered Outcomes Research Institute (PCORI). The research team recognized the opportunity to capitalize on the work and resources they had built during their study to answer an important question about the coronavirus’s effects on people with heart disease. They received supplemental funding from PCORI to pursue this additional aim.

“Millions of people around the world use ACE inhibitors and angiotensin receptor blockers for blood pressure control, and early concerns exist that the novel coronavirus may enter human cells through receptors that increase with the use of these medications, making those patients more susceptible,” said Rhonda Cooper-DeHoff, co-principal investigator of the study from the University of Florida College of Pharmacy. “Because of the research-ready infrastructure created through PCORnet, our study team was able to expand our aims to rapidly explore this concern.”

PCORnet is a network of networks with fast access to secure, curated data from millions of patients across the largest health systems in the United States, making it a powerful resource for the rapid insights needed in a pandemic environment. Cooper-DeHoff’s study team is drawing on electronic health record data from 1.5 million patients to explore whether there is a statistically significant relationship between the use of blood pressure medications and incidence or severity of coronavirus infection. The PCORnet Common Data Model, which standardizes data across each PCORnet Network Partner, is structured to enable the team to quickly classify detailed medication use, as well as other important patient insights like underlying conditions and comorbidities.

“The robust infrastructure of PCORnet, and particularly the Common Data Model that unites millions of disparate data points so they are usable and meaningful for research, is giving us a significant head start in our search for answers,” said Mark Pletcher, from UCSF, co-Principal Investigator. “In a traditional clinical study, these types of efforts can take years. That’s time we don’t have in a pandemic environment, where we need answers fast.”

Results from this study are expected in late 2020.

A comparison of blood pressure control strategies

Prior to receiving the supplemental funding, “Using PCORnet to Compare Blood Pressure Control Strategies” was focused on three other aims anticipated to give meaningful answers to questions that are important to patients. Pletcher and Cooper-DeHoff also hopes the framework for the study, the PCORnet Blood Pressure Control Laboratory, will serve as a platform used in future research to improve surveillance of patients with hypertension and enhance comparative effectiveness research on the topic.

The first study aim, BP Track, is to conduct national surveillance of blood pressure control with a goal to understand disparities. BP MAP, the second aim, is a cluster-randomized trial comparing two versions of a blood control quality improvement intervention from the American Medical Association. Finally, BP Home is a patient-level randomized trial comparing standard home blood pressure monitoring with a smartphone-linked blood pressure monitoring system. Details of each of these efforts, as well as interim results, have been published at Circulation: Cardiovascular Quality and Outcomes.

“The broad scope of PCORnet means that, unlike many studies of blood pressure control, we are working with a sample that represents the full spectrum of the country,” said Pletcher. “What’s more exciting is that it won’t end with these aims; the PCORnet Blood Pressure Control Laboratory is designed to be a reusable platform to help us pinpoint the health care processes related to blood pressure control that need improvement, learn from high-performing health systems, and better understand how to improve blood pressure control and adherence in our patient communities.”

Patients at the heart of every effort

Every PCORnet Study demonstrates patient engagement in all study aspects and commits to disseminating study progress, metrics, best practices, and results across the Network and in relevant patient communities. “Using PCORnet to Compare Blood Pressure Control Strategies” is no exception, with the University of California San Francisco’s Health Research Alliance of patients engaged in the process. These patients serve on the study’s advisory board for all aims, offering input on materials and methods, dissemination, and more.

“Blood pressure control is part of the daily health regimen for millions of Americans, which makes patient input in this study absolutely crucial,” said Pletcher. “With their guidance, we can ensure that we not only explore the right questions, but also deliver answers to the community in a way that is well received and impactful to our national health.”

Full results from BP Track, BP MAP, and BP Home are all expected late summer 2021.

PCORnet® Gives Reason to Celebrate Connection and Community this Clinical Trials Day

Posted on by Jodi Snare

As COVID-19 pandemic continues to spread, keeping many across the world at home and disconnected from their communities, PCORnet®, the National Patient-Centered Clinical Research Network, is rallying to build coalitions and deliver hope. May 20 is Clinical Trials Day, a time to remember that clinical research has always been about bringing together people to build a healthier world—and in the era of COVID-19, patient engagement in research is more important than ever.

May 20 is commemorates the day James Lind performed the first-ever clinical trial in 1747, which was focused on scurvy. While it is a day to applaud Lind’s work in paving the way for future clinical trials, it is also fitting to celebrate the communities—clinicians, health systems, patients, and caregivers—who have propelled medical innovations forward since that time. Collaborative research has disarmed numerous diseases that were once a threat to global survival, but today are largely contained. Now, research is tackling the challenge of COVID-19, and PCORnet is enabling two opportunities for communities to come together to find answers.

  • The Healthcare Worker Exposure Response & Outcomes (HERO) Registry is a large, national clinical research community. It invites healthcare workers across America to share clinical and life experiences to understand the perspectives and problems they face on the COVID-19 pandemic front lines.
  • Those registered in the HERO Registry may have the opportunity to participate in HERO-HCQ, a randomized clinical trial of approximately 15,000 HERO Registry participants. It will test whether hydroxychloroquine can prevent COVID-19 infection in healthcare workers.

While there is still much unknown about the novel coronavirus, one thing is clear: clinical research is the best hope for answers. This Clinical Trials Day, celebrate the power of community, and if you are someone working in a healthcare setting that is caring for people with COVID-19, consider participating in the HERO registry by following the registry link above.

PCORnet® COVID-19 Common Data Model Launched, Enabling Rapid Capture of Insights on Patients Infected with the Novel Coronavirus

Posted on by Jodi Snare

COVID-19 has upended life globally, and the need for patient-centered insights and answers has never been more pronounced. Leadership of PCORnet®, the National Patient-Centered Clinical Research Network, is responding with bold action by creating a COVID-19-specific Common Data Model (CDM). The new CDM will allow researchers to use information gathered from patients across PCORnet’s vast network to better define and understand who is getting infected with SARS-CoV-2 and how the virus affects them.

“PCORnet is one of very few data resources with the scope and infrastructure to support the nation’s needs for fast answers to important questions during this pandemic,” said Keith Marsolo, who is co-leading the development of the CDM. “We are unleashing the Network’s full potential to combat this crisis, and that includes the development of a COVID-19-specific CDM that transforms data across the Network into a research-ready state to power critical studies and rapidly inform the nation’s response.”

CDMs standardize millions of data points generated from patient visits at clinics and hospitals into a common language that can be used for research while securely protecting personal patient information behind firewalls. Development of a CDM specific to COVID-19 is important because a lot of the existing data on patients with COVID-19 has come from varied sources, which lack the rich clinical details that the research community needs to determine the best response to this pandemic.

“Patients are seeking meaningful answers to the COVID-19 pandemic, and that is going to require an in-depth look at who this virus infects, how it spreads, and how it responds to treatment,” said Pastor Bruce Hanson, patient advocate. “This new CDM enabled by PCORnet will set the stage for that type of research, unlocking details that will empower our nation to address the pandemic as swiftly and accurately as possible.”

To ensure they are keeping pace with the fast-moving pandemic, hospitals and clinics within PCORnet networks are updating their data weekly for patients with a respiratory illness or lab order for a COVID-19 test. They will use that data to better understand the characteristics COVID-19 patients share, allowing researchers to more quickly identify infected patients and understand their experience with the virus. With new symptoms of COVID-19 coming to light on a near-daily basis, the insights from these data will be important to help fight the pandemic.

“While the immediate goal of the PCORnet COVID-19 CDM is to quickly initiate a basic snapshot of infected patients, the CDM’s long-term potential is much more exciting,” said Jason Block, who is co-leading the effort to better define COVID-19 using data accessible from the Network. “As we evolve the CDM, we will be able to characterize COVID-19 patients over time for more in-depth analyses across the disease course.”

PCORnet®-Enabled HERO Registry Launched, Unites Frontline Healthcare Workers to Fight COVID-19

Posted on by Jodi Snare

The Healthcare Worker Exposure Response & Outcomes (HERO) Registry launched today, marking the first major milestone in a rapid-response effort to answer important questions about protecting healthcare workers from COVID-19. The HERO program is 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.

“The HERO Registry will leverage PCORnet® resources and capacity to help us develop fast knowledge to keep healthcare workers safe and healthy, which ultimately will help protect us all,” said Adrian Hernandez, MD, MHS, principal investigator for the PCORnet Coordinating Center and the HERO program.

With the launch of the registry, the HERO program is seeking participation from hundreds of thousands of healthcare workers, including nurses, therapists, physicians, emergency responders, food service workers, environmental services workers, interpreters, and transporters—anyone who works in a setting where people receive health care. Participants will receive surveys and could be selected to participate in clinical trials. Healthcare workers can sign up via the registry and participate as much or as little as they like. The registry will follow a protocol developed by the DCRI and data guidelines to keep healthcare worker information secure.

“We’re calling on all healthcare workers to share their perspectives so that we can understand and provide answers to the problems they face in real time—and over time,” said Emily O’Brien, PhD, principal investigator of the HERO Registry and assistant professor in Duke University’s Department of Population Health Sciences.

The first rapid-cycle clinical trial using the registry, HERO-HCQ, is slated to start enrolling healthcare workers at the end of April, when sites within the PCORnet network will use the registry to identify about 15,000 interested healthcare workers to participate. The trial will randomize eligible participants to either one month of hydroxychloroquine or one month of placebo and will examine whether the drug is effective in preventing COVID-19 infection. Study results will be shared widely with the healthcare community.

Using PCORnet to conduct the study offers several major advantages over traditional trials. The network has a wealth of information to draw on in setting up the registry. It also has a well-established community of healthcare systems with experience collaborating on large clinical studies engaging patients and clinicians alike. This community will facilitate the oversight essential to ensure the study is carried out ethically and allow any interested healthcare or emergency worker to easily join the registry.

“Hospitals, health systems, and health plans that participate in PCORnet have worked in partnership for years and are well poised to deliver fast, reliable research infrastructure to study COVID-19,” said Chris Forrest, MD, PhD, co-chair of the HERO Registry and principal investigator of PEDSnet, one of multiple PCORnet Partner Networks participating in HERO-HCQ. “Infrastructure issues that might cause lag time for other studies are hurdles PCORnet has already crossed. PCORnet was developed for exactly this type of research challenge, and the network is ready to meet the moment.”