PCORnet Archives - Rethinking Clinical Trials

October 11, 2023: In This Friday’s PCT Grand Rounds, Incorporating Social Determinants of Health Into PCORnet

Posted on October 11, 2023October 10, 2023 by Damon Seils

Keith Marsolo, PhD

In this Friday’s PCT Grand Rounds, Keith Marsolo of Duke University will present “Incorporating Social Determinants of Health Into PCORnet.”

The Grand Rounds session will be held on Friday, October 13, 2023, at 1:00 pm eastern.

Marsolo is an associate professor of population health sciences at Duke University and a cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records Core Working Group.

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March 22, 2023: A Decade of PCORnet Research in This Week’s PCT Grand Rounds

Posted on March 22, 2023March 22, 2023 by Damon Seils

Headshots of Erin Holve, Russell Rothman, Schuyler Jones, and Neha Pagidipati In this Friday’s PCT Grand Rounds, Erin Holve, Russell Rothman, Schuyler Jones, and Neha Pagidipati will present “From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®.” The Grand Rounds session will be held on Friday, March 24, 2023, at 1:00 pm eastern.

Holve is the chief research infrastructure officer for PCORI. Rothman is the principal investigator of the PCORI-funded Mid-South Clinical Data Research Network and a member of the PCORnet Executive Committee. Jones is an associate professor of medicine and population health sciences at Duke University. Pagidipati is an associate professor of medicine at Duke University.

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November 22, 2022: ADAPTABLE Points to Need for Better Integration of Patient-Reported Health Data Into Pragmatic Trials

Posted on November 22, 2022November 22, 2022 by Damon Seils

Headshot of Dr. Emily O'Brien A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). The findings highlight the need for better integration of patient-reported health data into pragmatic research studies.

Results of the study were published in JAMA Cardiology.

Patient-reported health data can assist investigators in capturing clinical events in pragmatic clinical trials. However, little information is available about the fitness for use of patient-reported data in large-scale health research.

In this study, analysts evaluated the concordance of a set of variables that were both reported by patients through an online portal and available in the EHR as part of the trial. The validity of participant self-report varied by the method of data collection, the participant population, and the type of information collected. For example, patient report of clinical events had low sensitivity compared with EHR data for myocardial infarction, stroke, and major bleeding events. Coronary revascularization was the most concordant event by data source, but agreement was only moderate.

“As the use of direct-to-participant research designs grows, it’s important to understand how participant-reported data lines up with other data types,” said Emily O’Brien, an associate professor in population health sciences at Duke University and the lead author of the study.

“Our findings suggest that some caution is warranted in this space—especially if relying on participant report alone for capture of cardiovascular events—and we need more research on how to best design questions and set up participant portals to maximize validity of this type of data,” O’Brien said.

ADAPTABLE, the first major randomized comparative effectiveness trial conducted by the National Patient-Centered Clinical Research Network (PCORnet), seeks to determine the optimal dose of aspirin therapy for secondary prevention of atherosclerotic cardiovascular disease. The trial relies on both existing EHR data sources and patient-reported health data captured through an online portal.

This is the first study to assess validity of participant-reported health data collected through an online portal. The study’s results are consistent with prior evidence suggesting that the validity of participant-reported events varies by data collection modality, participant subgroup, and the type of information collected.

This work was supported by a supplemental grant award to the NIH Pragmatic Trials Collaboratory Coordinating Center from the National Center for Complementary and Integrative Health.

Read the full report in JAMA Cardiology.

Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Posted on November 1, 2022 by terren.green@duke.edu

Speakers

Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
Department of Population Health Sciences

Russell Rothman, MD, MPP
Senior Vice President, Population and Public Health
Director, Vanderbilt Institute for Medicine and Public Health
Vanderbilt University Medical Center

Keywords

HERO Registry; HERO TOGETHER; Hydroxychloroquine; COVID-19; PCORI; PCORnet

Key Points

On March 21, 2020, in response to the COVID-19 pandemic, PCORI contacted leadership at Duke Clinical Research Institute and PCORnet and a decision was made to focus on the space of healthcare workers. The HERO Program was fully approved and began recruiting participants on April 22, 2020.

The HERO Registry aimed to create a diverse virtual community of healthcare workers and their families and communities, ready for future COVID-19 research.

The HERO Registry explored topics that mattered most to participants and found these topics changed with time. Important issues early on included COVID-19’s effects on the workplace, vaccine access and willingness, and impact on home life. Later, burnout and lack of appreciation and support became larger issues.

The first trial undertaken by the HERO Program, HERO-HCQ, evaluated the efficacy of hydroxychloroquine (HCQ) to prevent COVID-19 in healthcare workers. Over 1300 participants were recruited from the HERO Registry. No statistically significant benefit was found.

The HERO TOGETHER study leveraged the HERO Registry to estimate real-world incidence of safety events among vaccinated individuals. The most common safety events reported included non-hospitalized arthritis/arthralgia and non-hospitalized non-anaphylactic allergic reaction.

Learn more

On the HERO Program website.

Discussion Themes

– The HERO Registry survey collected a large broad range of information. Participant feedback revealed that shorter more targeted surveys focusing on the most high-value information may have been less burdensome for participants..

– The creative multi-faceted approach to recruitment that includes diverse stakeholder engagement could be successful in creating research registries for other important health issues. .

April 29, 2022: BP Track: National Surveillance for Blood Pressure Control and Related Process Metrics Using PCORnet (Mark J. Pletcher, MD, MPH; Rhonda Cooper-DeHoff, PharmD, MS; Alanna M. Chamberlain, PhD, MPH)

Posted on May 5, 2022June 21, 2022 by terren.green@duke.edu

Speakers

Mark J. Pletcher, MD, MPH
Professor of Epidemiology and Biostatistics and Medicine
University of California, San Francisco

Rhonda Cooper-DeHoff, PharmD, MS, FAHA, FACC, FCCP
Association Professor and Research Foundation Professor
University of Florida College of Pharmacy

Alanna M. Chamberlain, PhD, MPH
Associate Professor of Epidemiology
Mayo Clinic

Keywords

Blood pressure; PCORnet; Common data model; BP MAP; BP Track; BP Home; COVID-19

Key Points

Uncontrolled blood pressure (BP) is the leading preventable cause of death in the US, but treatment methods and monitoring metrics are not consistent or clear across patients and healthcare systems.

PCORnet is made up of many health systems across the country. Varying types of electronic health record (EHR) data from these health systems are combined into a common data model.

The BP Control Laboratory, funded by PCORnet, used surveillance and efficient pragmatic randomized controlled trials to improve BP control in the US. Three projects were funded: BP Track, BP MAP, and BP Home.

BP Track leveraged the PCORnet common data model to create 10 blood pressure control metrics.

BP levels in the BP Tack study were fairly stable and controlled from 2017 to 2019, prior to the COVID-19 pandemic.

BP Track saw a substantial decrease in BP control during the COVID-19 pandemic that has not rebounded to pre-pandemic levels.

Discussion Themes

– The next iteration of the BP Track study hopes to collect data at the individual patient level in order to do individual risk modelling.

– The decrease in BP control during the pandemic may have future implications for increased cardiovascular disease.

Read more about the results from the BP Track study.

April 27, 2022: This Week’s PCT Grand Rounds Will Feature BP Track, an EHR-Based National Blood Pressure Surveillance System

Posted on April 27, 2022January 9, 2024 by Damon Seils

Head shots of Dr. Mark Pletcher, Dr. Rhonda Cooper-DeHoff, and Dr. Alanna Chamberlain In this Friday’s PCT Grand Rounds, Dr. Mark Pletcher of the University of California, San Francisco, Dr. Rhonda Cooper-DeHoff of the University of Florida, and Dr. Alanna Chamberlain of the Mayo Clinic will present “BP Track: National Surveillance for Blood Pressure Control and Related Process Metrics Using PCORnet.” The Grand Rounds session will be held on Friday, April 29, at 1:00 pm eastern.

The BP Control Laboratory Surveillance System, or BP Track, is a serial, EHR-based, cross-sectional study of blood pressure control across the United States built on PCORnet. BP Track queries submitted through PCORnet are used to produce blood pressure control metrics for a series of 1-year measurement periods using blood pressure measurements obtained as part of standard clinical care, medication prescribing, and other EHR data linked to healthcare encounters.

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April 8, 2022: COVID-19 Surveillance in PCORnet: Year 2 Update (Jason Block, MD, MPH; Thomas W. Carton, PhD, MS)

Posted on April 14, 2022June 21, 2022 by terren.green@duke.edu

Speakers

Jason Block, MD, MPH
Associate Professor
Harvard Pilgrim Health Care Institute
Harvard Medical School

Thomas W. Carton, PhD, MS
Chief Data Officer
Louisiana Public Health Institute

Keywords

PCORnet; COVID-19; Electronic health record (EHR); Surveillance data

Key Points

PCORnet is a national network of 66 million people with EHR-derived data available for research.

After significant database modifications to effectively include COVID-19 related data, the CDC PCORnet COVID-19 project began in April 2020 with the first query. 43 participating institutions update data monthly.

There have been 40 queries of the PCORnet COVID-19 data completed to date looking at descriptive trends of COVID-19 by care setting and demographics, vaccinations, chronic disease, and treatments.

PCORnet COVID-19 data tracks percent hospitalized and relative risk of testing positive for COVID-19 by race over time.

Data also shows treatment disparities with monoclonal antibodies over time by race and ethnicity. White patients or non-Hispanic patients who tested positive for COVID-19 were more likely to be treated with monoclonal antibodies than any other race or ethnicity.

PCORnet COVID-19 data have also been used to investigate myocarditis and pericarditis after both COVID-19 vaccination and COVID-19 infection. Males ages 12 to 29 have increased risk of cardiac complications after COVID-19 infection compared with COVID-19 vaccination.

PCORnet is evolving to improve the capture of information, advance analytics, and provide better collaboration between federal public health and PCORnet investigators.

Discussion Themes

- Complete surveillance data is difficult to obtain when not all testing or vaccination is being reported.

- State vaccination data does not always get added the EHR until the patient has another primary care encounter.

- The ability to continue doing this kind of work relies on a national public health infrastructure.

April 6, 2022: COVID-19 Surveillance in PCORnet to Be Featured in Grand Rounds This Week

Posted on April 6, 2022 by Damon Seils

Headshots of Dr. Jason Block and Dr. Thomas Carton In this Friday’s COVID-19 Grand Rounds session, Dr. Jason Block of Harvard Medical School and Dr. Thomas Carton of the Louisiana Public Health Institute will present “COVID-19 Surveillance in PCORnet: Year 2 Update.”

The Grand Rounds session will be held on Friday, April 8, at 1:00 pm eastern. Join the online meeting.

The NIH Pragmatic Trials Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency. This week’s session will be the second presentation by Dr. Block and Dr. Carton about PCORnet’s COVID-19 surveillance. Access the previous session from June 5, 2020.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

Grand Rounds April 8: COVID-19 Surveillance in PCORnet: Year 2 Update (Jason Block, MD, MPH; Thomas W. Carton, PhD, MS)

Speaker:

Jason Block, MD, MPH
Associate Professor
Harvard Pilgrim Health Care Institute
Harvard Medical School

Thomas W. Carton, PhD, MS
Chief Data Officer
Louisiana Public Health Institute

Topic: COVID-19 Surveillance in PCORnet: Year 2 Update
Date: Friday, April 8, 2022, 1:00-2:00 pm ET

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