COVID

Telehealth Visits Provide Opportunity for PCORnet® Data Resources

Posted on by Jodi Snare

The COVID-19 pandemic prompted a shift to the use of telehealth visits, opening a new frontier in healthcare delivery and an opportunity for PCORnet® data resources to assist researchers in studying the effectiveness of this rapidly evolving method of healthcare delivery.

Many patients, including those managing chronic diseases and those in underserved populations, including people who live in rural areas, adopted telehealth visits during the pandemic, transforming them from once-rare occurrences to the norm. The PCORnet infrastructure now includes data from these virtual encounters, supporting patient-centered comparative clinical effectiveness research (CER) on telehealth.

A new report on the most recent network query of PCORnet data resources helps investigators identify populations well suited for such research.  Titled “Characterizing Telehealth Visits Across Clinical Research Networks Participating in PCORnet®, The National Patient-Centered Clinical Research Network,” the query explored data from January 2019 to September 2022 about patients’ ages, chronic conditions and comorbidities,  socioeconomic status, geographic location as well as the locales and monthly count of telehealth encounters.

Telehealth topics covered include trends in use, disparities in delivery before and during the pandemic,  and how patients use the delivery method to manage chronic conditions in underserved populations.

Network queries like this involve hundreds of healthcare sites and data from more than 30 million patient electronic health records (EHRs). The scope of information available can help clinicians and researchers understand how the PCORnet infrastructure can support future studies on a range of healthcare services, conditions, populations, and more.

Another recent public query of PCORnet data resources, titled “Cohort of Patients with Intellectual and Developmental Disabilities Across Clinical Research Networks Participating in PCORnet®, The National Patient-Centered Clinical Research Network,” looked at healthcare use by people with intellectual and developmental disabilities (IDD) at PCORnet® Network Partners. This query, the largest known, national-scale descriptive analysis of IDD populations using EHR data, demonstrates how the PCORnet data infrastructure can be used to support national-scale research  for IDD patients.

Check out these reports in the Resource section and learn how PCORnet data resources can power CER studies on a range of topics.

PCORnet® Resources to Power Study Exploring the Relationship Between COVID-19 and Diabetes

Posted on by Jodi Snare

A large new study will use PCORnet® to explore the relationship between COVID-19 and diabetes with the goal of guiding future treatment interventions and public health approaches. Vanderbilt University Medical Center (VUMC) received a four-year, $28 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, this week to support this research.

The COVID-19 and Diabetes Assessment (CODA) Study will use PCORnet and the TID Exchange, a research network of diabetes centers, to identify and recruit 1,600 participants who either have a known COVID-19 infection within the past 90 days and have also been diagnosed with diabetes during that period, or  have a recent diabetes diagnosis and no known COVID-19 infection in the past year. The study will compare and follow the two groups for two years.

With the ability to engage with hundreds of healthcare sites and access to electronic health record data from more than 30 million patients annually, PCORnet resources are critical to ensuring the CODA Study captures a broad and diverse representation of patients. In alignment with the patient-centered focus of PCORnet® Network Partners, the study will also answer important questions patients are asking about the link between diabetes and COVID-19. Namely, to what extent does COVID-19 cause worse glycemic control, vascular function, inflammation, and increased risk for blood clots in people with either type 1 or type 2 diabetes? The study will also explore the role of genomic, social, and environmental factors on metabolic function and the impact of COVID-19 infection and COVID-19 treatments on diabetes-related outcomes.

“This study will greatly expand our knowledge about the relationship between COVID-19 and diabetes and will also provide us novel information about what factors influence the early course of diabetes in children and adults with type 1 or type 2 diabetes,” said principal investigator and project leader Russell Rothman, MD, MPP, of VUMC and Principal Investigator of the STAR Clinical Research Network.

Rothman will co-lead the CODA Study alongside Alvin C. Powers, MD, of Vanderbilt University; Jonathan Schildcrout, PhD, of Vanderbilt University; and Jason Block, MD, MPH, of the Harvard Pilgrim Health Care Institute. Recruitment will begin soon.

The RECOVER Post-Acute Sequelae of SARS-CoV-2 (PASC) Electronic Health Record (EHR) Cohort Study

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: RECOVERCOVID
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Christopher Forrest, L. Charles Bailey, Grace Lee
Site Name: The Children’s Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: NIH
Funding Date: 2021
Study Duration: 2022 – 2025
Participating Clinical Research Networks: ADVANCE, GPC, PaTH, PEDnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19; SARS-CoV-2 Infection
Population: Pediatrics 21 years and younger
Status: Active, not recruiting

Research Question(s):

  1. What are the long term health effects of COVID-19 after a person has recovered from infection?
  2. How can we better detect, predict, treat these health effects and prevent future infection?

Primary Publication(s):
Severity of Acute COVID-19 in Children <18 Years Old March 2020 to December 2021
Forrest CB, Burrows EK, Mejias A, et al. Severity of Acute COVID-19 in Children <18 Years Old March 2020 to December 2021. Pediatrics. 2022 Apr 1;149(4):e2021055765. doi:10.1542/peds.2021-055765. PMID: 35322270.

Clinical Features and Burden of Postacute Sequelae of SARS-CoV-2 Infection in Children and Adolescents
Rao S, Lee GM, Razzaghi H, et al. Clinical Features and Burden of Postacute Sequelae of SARS-CoV-2 Infection in Children and Adolescents. JAMA Pediatr. 2022;176(10):1000–1009. doi:10.1001/jamapediatrics.2022.2800

PCORnet® Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (PCORnetPASC)

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Website: RECOVERCOVID
ClinicalTrials.gov#: NCT05292274
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Rainu Kaushal
Site Name: Weill Cornell Medicine
PCORnet® Network Partner: INSIGHT
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2025
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19; SARS CoV 2 Infection
Population: 18 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):

  1. What are the long term health effects of COVID-19 after a person has recovered from infection?
  2. How can we better detect, predict, and treat these health effects and prevent future infection?

Primary Publication(s):
Prevalence of Select New Symptoms and Conditions Among Persons Aged Younger Than 20 Years and 20 Years or Older at 31 to 150 Days After Testing Positive or Negative for SARS-CoV-2
Hernandez-Romieu AC, Carton TW, Saydah S, et al. Prevalence of select new symptoms and conditions among person aged younger than 20 years and 20 years or older at 31 to 150 days after testing positive or negative for SARS-CoV-2. JAMA Netw Open. 2022;5(2):e2147053.

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 and diverse 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. Participants have reported in real-time their intentions to vaccinate, their feelings of moral injury and burnout, thoughts about returning to schools, and more. Through HERO, researchers conducted two important studies on COVID-19 prevention and vaccination.

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.”