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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 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.

Use of Smartphone Technology Won’t Yield Lower Blood Pressure Readings, Says New PCORnet® Research

Posted on by Jodi Snare

Mobile technology is fueling new frontiers in healthcare, promising easier management of chronic conditions through applications that send reminders, record readings, track trend lines, and allow users to share results with their clinician at the push of a button. In theory, such apps will drive better engagement and accountability, improving health outcomes. But do the apps live up to the hype? New research results from a PCORnet-powered study, published in JAMA Internal Medicine, say the answer is ‘not always’ when it comes to smart blood pressure apps.

The study team used PCORnet to conduct a large pragmatic clinical trial comparing the effectiveness of managing uncontrolled blood pressure across two randomized groups: one performing self-measurement with a standard home monitor (the usual wrap cuff with output on the device), and the other using a similar device enhanced with a connected smartphone application. The app reminded participants to check blood pressure and featured measurement tracking, interpretation, annotation and visualization tools. It also supported users in emailing a summary of their measurements to a clinician.

Newly released results from the study suggest that there is no significant advantage to using the enhanced blood pressure monitoring device with a connected smartphone app versus a standard device. The group using the connected app did not experience any additional reduction in blood pressure, and no more of the patients who used the enhanced device would recommend it to their peers than those who used a standard device.

PCORnet as a facilitator for patient-centered insights

The results of this study are important because self-management of hypertension is becoming more commonplace due to the rise of telehealth care in recent years. Given that uncontrolled blood pressure contributes to 500,000 deaths per year in the U.S., a clear understanding of the most effective tools to support patients in effectively managing the condition is critical.

PCORnet was uniquely positioned to support the study because of its broad reach into a large percentage of the U.S. population. The Network’s established connections across major health systems and shared use of a Common Data Model to standardize disparate electronic health record (EHR) data codes allowed researchers to rapidly glean insights representative of a broad swath of America while minimizing the burden to study participants.

The study team used PCORnet to extract baseline data from EHRs of the 2,100 study participants. Then they compared those numbers to in-clinic blood pressure measurements from EHRs after six months using either the standard device or the enhanced device. The study team also conducted a short patient satisfaction survey.

Both groups had an apparent reduction of approximately 11 mm Hg from their baseline reading to their most recent office BP measurement. Satisfaction rates of participants assigned to the standard monitor or the enhanced monitor with app were statistically insignificant.

While these outcomes are consistent with prior literature, the study team supports future research to evaluate novel technologies that may better support blood pressure control.

Which of the Two Newer Classes of Diabetes Drugs is Better? Patients and PCORnet® Will Guide Answers

Posted on by Jodi Snare

Two newer classes of type 2 diabetes medications have the potential to transform the way people manage the condition that currently impacts more than 32 million Americans. Recent studies have shown that sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA) not only control blood sugar, but may also reduce risk of heart attack, stroke, hospitalization for heart failure, and death due to cardiovascular causes in those with established cardiovascular disease and those at high risk. These events are the most common cause of disability and death in patients with type 2 diabetes. The development of SGLT2i  and GLP-1 RA medications represent a tremendous breakthrough. But questions remain. Which is better? And, perhaps even more intriguing, might these medicines work even better in combination?

PRECIDENTD (PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes) is a study combining the power of PCORnet, the National Patient-Centered Clinical Research Network, and patient insights to find out. The study, which is funded by the Patient-Centered Outcomes Research Institute, plans to recruit 9,000 adults with type 2 diabetes and with or at high risk for heart disease via eight PCORnet sites to be randomly assigned treatment with an SGLT2i, a GLP-1 RA, or both. These patients will be followed by the study team for an average of nearly four years to determine which medication approach is most effective at reducing major health events, such as heart attack, stroke, kidney problems, and death.

“Of the 32 million Americans living with type 2 diabetes, more than 20 million also have, or are at high risk for, heart disease,” said Brendan Everett, principal investigator for PRECIDENTD. “Two newer classes of drugs that effectively treat both conditions concurrently represent a huge advance in diabetes care that’s no less significant than the introduction of statins for heart health in 1991. But no study has compared the classes head-to-head to guide patients on which one is better, and in what circumstances. Those are the questions PRECIDENTD hopes to answer.”

Breaking the ‘curse of knowledge’ is key, says patient partner

The research team knows it can’t deliver answers on its own. Encouraging patients to participate in a randomized trial is always a challenge. To understand and overcome potential obstacles to participation, PRECIDENTD established a patient-centered advisory board comprised of people with diabetes to share their experience and serve as influencers for patients participating in the study.

One of those patient influencers, Ed Simeone, says reaching diabetes patients effectively comes down to breaking the “curse of knowledge,” or the assumption that everyone in the room shares your knowledge and perspective.

“When study materials are packed with technical jargon, they aren’t educational or motivating to the layperson,” said Ed. “We need to transcend that jargon and help patients understand that what sits before them is an opportunity to have a remarkable impact on diabetes care. No diabetes patient should suffer a stroke simply because the potential benefits of the new treatments available weren’t clear.”

Ed sits in regular Zoom calls along with five other patients, the study principal investigator, and medical professionals spanning endocrinology, cardiology and more, to explain what goals and health outcomes are important to the diabetes community. Together, the advisory board develops tactics to ensure the study team works with all stakeholders and enrolls participants from racial and ethnic groups with high diabetes prevalence, many of which have also historically been excluded from diabetes research. Patient partners were pivotal in designing PRECIDENTD’s endpoints and engagement materials; when the study concludes, they will play an important role in sharing results, too, ensuring that the findings are integrated into usual care and make sense to frontline providers and their patients.

“Other studies I’ve participated in took blood and moved on,” said Ed. “As an advisory board member, I see my advice come to life. They are thirsty for our perspective and bring a humility that, frankly, could serve all future research.”

The PRECIDENTD study is currently setting up contracts with enrolling sites through PCORnet. Results are expected in 2028, which will help patients, their families, and their healthcare providers decide which type of diabetes medication is best for their specific combination of medical conditions, preferences, and goals.

PCORnet® Is Helping Researchers Unravel the Mystery of Long-Haul COVID

Posted on by Jodi Snare

Today, almost 60 percent of the U.S. has been infected with COVID-19, a figure the CDC says is likely a conservative estimate. While most people infected recover fully in a matter of weeks, millions of people continue to suffer the effects of COVID-19 months—or even years—after initial infection. When COVID-19 effects are felt for this long after initially testing positive, it is described as post-acute sequelae of SARS-Cov-2 (PASC) infection, or “long COVID”. Many facets of long COVID remain a mystery. Who is likely to suffer long COVID? What’s the best way to treat it? What, if any, lasting health effects might long COVID produce? To answer these questions, researchers within PCORnet®, The National Patient-Centered Clinical Research Network, have been funded through the National Institutes of Health RECOVER initiative to leverage PCORnet data resources to understand long COVID in adults and children.

“Studying long COVID is exactly the type of research that the PCORnet infrastructure was designed to support,” said Charles Bailey, co-leader of EHR cohort studies for RECOVER. “We don’t have a reliable definition of the condition yet, so we don’t know what we are looking for. However, using PCORnet resources, we aim to sharpen the clouded picture of long COVID and bring much-needed insights to patients and providers.”

RECOVER’s EHR cohort will be a collaboration across all eight Clinical Research Networks participating in PCORnet, representing 41 institutions across the United States. PCORnet Network Partners provide an unprecedented breadth and depth of real-world data, nationally renowned investigators including informaticians, clinicians, and learning health system experts, and a robust track record for large-scale observational research, comparative effectiveness studies, surveys, and pragmatic clinical trials. RECOVER will use these resources to rapidly generate evidence around long COVID in both adults and children.

Delivering long-awaited answers to long-haul COVID

The EHR cohorts will contribute to the RECOVER Initiative in several meaningful ways, including the creation of new phenotypes, or sets of identifiable characteristics, for long COVID.

One of the most exciting features of RECOVER is that it will use its EHR cohorts to develop models and algorithms that can effectively predict who is at risk of long-haul COVID, answering a question that has puzzled researchers since the pandemic began. These models will also help RECOVER researchers examine disparities between different populations and will further help to illustrate the effects of vaccines on long COVID.

“National-scale research networks like PCORnet have been absolutely essential in helping us get answers through the pandemic, and I’m excited to see the insights RECOVER will contribute to that body of knowledge,” said Bailey. “To patients living with debilitating COVID-19 symptoms for months or years need hope: We see you, and RECOVER is going to relentlessly pursue the answers you’ve long been awaiting.”

PCORnet® Resources Are Being Used to Reduce Gaps in Congenital Heart Disease Care

Posted on by Jodi Snare

PCORnet®, the National Patient-Centered Clinical Research Network, is helping a research team to better understand how gaps in care impact the experience of adults with congenital heart disease, or CHD. The CHI-RON study, which stands for Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult-Centered Care, is combining clinical and claims data insights from PCORnet with patient-reported data to help guide health care providers in how best to care for this population, not only at the point of diagnosis, but also throughout their lives.

“Many patients with CHD are diagnosed and treated as children, but it is important to remember that treatment isn’t a cure,” said Anitha John, co-principal investigator of the study. “CHD patients should continue care throughout adulthood to catch any serious cardiac issues early enough to support a positive prognosis.”

But achieving ongoing CHD care can be tricky. Because these are rare diseases, many patients fall out of care simply because there are a very small subset of providers—less than 500 across the country—who are board certified to care for these patients in adulthood. There’s also little data on the outcomes of patients who lapse in care, leaving adult CHD patients unsure of how their journey might unfold.

A holistic look at the CHD journey across three data sources

The CHI-RON study is the first of its kind to fill in these knowledge gaps by exploring three distinct types of data at once: patient-reported outcomes, claims, and electronic health records, or EHRs.

For patient-reported insights, the project is leveraging the first patient-powered registry for adults with CHD—the Congenital Heart Initiative. Patients who are recruited for this research participate via enrollment in the registry, which allows researchers to ask patients directly about health, wellness and any specific barriers to care. The effort is led by Children’s National Hospital and Louisiana Public Health Institute.

But patient-reported outcomes alone aren’t enough to fully understand the big picture of the CHD journey. That’s why the researchers are using PCORnet resources to add insights from EHR data spanning 14 participating research sites and 3,000 demographically widespread individuals. With health records for 66 million patients available for observational studies, PCORnet provides vast scale to power research on rare conditions affecting even small numbers of people.

In partnership with two claims data partners, HealthCore and CVS Health, researchers are using PCORnet to add a third layer of insights from administrative claims, which provide information on doctors’ visits, bills, insurance information and more. Existing relationships were leveraged to connect with the claims partners directly.

“PCORnet is a fantastic resource to help us fully understand the impact of gaps in CHD care,” said Tom Carton, co-principal investigator of CHI-RON. “It is essentially turbo-charging our patient-reported data with two additional layers of insights from claims and EHRs, unlocking answers that would be impossible to achieve in isolation.”

Patient-centered study design

Like all research designated as PCORnet Studies, CHI-RON is designed to put patient needs front and center. Patients sit on the study’s multi-stakeholder advisory board, adding vocal input to its metrics, endpoints and design. The partnership with the Adult Congenital Heart Association (ACHA) has also allowed the team to provide participants with much-needed resources on their underlying cardiac condition. More importantly, the ACHA collaboration has provided participants with the opportunity to interact with other patients—a key request by many of the CHI participants.

Patients also provided input into the study’s recruitment materials, sharing insights on what strategies would and wouldn’t work across the CHD community. Even the study’s name was chosen by patients, who thought the reference to Homer’s The Iliad was fitting given the character Chiron’s ability to turn wounds into healing.

“While other CHD registries exist, they are provider-based and not patient-powered,” said John. “CHI-RON’s registry is driving thousands of organic patient responses to support our research, while also giving patients living with CHD a community in which they no longer feel alone.”

The study team hopes this three-year study will empower CHD patients by establishing a system to study different care protocols and interventions aimed at reducing gaps in care.

PCORnet® Shines at 2022 Health Datapalooza

Posted on by Jodi Snare

Every year, the Health Datapalooza and National Health Policy Conference brings together leaders in data and policy to directly confront the biggest challenges and opportunities facing U.S. health care. As a pivotal resource generating fast, trustworthy answers to health questions raised by the COVID-19 pandemic, PCORnet®, the National Patient-Centered Clinical Research Network, was a hot topic at this year’s event. Researchers showcased how the Network was used across three distinct COVID-related projects during a presentation that demonstrated how PCORnet® empowered rapid COVID-19 insights.

“The concrete results that PCORnet Network Partners delivered through the pandemic are impressive, and this was a wonderful opportunity to share them broadly with an audience of policy leaders, big thinkers and problem solvers,” said Russell Rothman, moderator for the presentation and chair of the PCORnet Steering Committee. “The Network’s collaborative use of data, powerful infrastructure and commitment to patient engagement has made it an important resource for bringing meaningful insights to questions around everything from healthcare worker burnout to national trends, long-COVID, and more. I’m proud of what we’ve accomplished and look forward to using the Network for more good work in the future.”

PCORnet-enabled answers to COVID-19

With access to data from everyday encounters with more than 66 million people across the U.S., PCORnet has long been successfully supporting large-scale, multi-site research. However, interest in the Network surged during the pandemic, when its broad scope and research-ready infrastructure helped deliver rapid answers to inform public health. PCORnet leaders Russell Rothman, Emily O’Brien, Tom Carton and Suchitra Rao presented at the 2022 conference about results from three different PCORnet-enabled projects:

HERO Research Program: The HERO Research Program was rapidly launched in April 2020 to understand the challenges facing healthcare workers and recruit healthcare workers for COVID-19 research studies. It now includes over 55,000 people in every U.S. state who report on their perspectives and experiences via an online portal.

Collaboration with the CDC: Researchers partnering with the U.S. Centers for Disease Control (CDC) are using PCORnet resources to shape the national understanding of COVID-19 by leveraging electronic health record (EHR) data that has been standardized to the PCORnet® Common Data Model. To date, researchers have used aggregated, de-identified data representing nearly half a million patients with a COVID-19 diagnosis and/or positive lab test to learn about patterns of infection, treatment effectiveness, vaccination, virus variants, healthcare utilization, and complications of infection and recovery.

RECOVER: PCORnet resources are furthering the goals of the NIH-funded Researching COVID to Enhance Recovery (RECOVER) initiative by developing large EHR databases to enhance our understanding of the epidemiology and risk of long-COVID. This PCORnet-enabled research program includes two teams focusing on children and adults respectively and working collaboratively to characterize risk factors for long-COVID.

“Each of these projects are distinct and really showcase the spectrum of PCORnet Network Partner strengths,” said Tom Carton of the Louisiana Public Health Institute, principal investigator for REACHnet, a PCORnet Network Partner, and an investigator with the CDC collaboration. All are enabled by PCORnet and centered around the needs of patients. This is only the beginning.”

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.