Announcements and Press Releases

Rigorous patient privacy + connected insights: With PPRL, PCORnet® researchers can have the best of both

Posted on by Jodi Snare

Two recent manuscripts published in the journal BMC Research Notes and JAMIA describe the framework and implementation of a new method of connecting patient data across disparate healthcare ecosystems in PCORnet while maintaining the highest levels of privacy and security. Privacy-preserving record linkage, or PPRL, connects electronic health records (EHRs) and administrative claims databases, unlocking the ability to fill important gaps in data, while still making sure the private information of the individual stays protected.

“There’s a growing appreciation for the fact that traditional health systems are not the only places where important information about our overall health resides,” said Tom Carton, who co-led the PPRL Implementation Workgroup for PCORnet. “PPRL is a method that allows us to fill these gaps in data while maintaining the highest privacy standards so we can better understand what is driving good or bad health outcomes.”

How PPRL works

PPRL has been used as an encryption technique since the 1990s in the computer science community, but only recently has it made the jump to healthcare. The method involves a technique called hashing to create an irreversible and unique code (such as a number) given a set of inputs, like patient demographics or first and last names. These codes allow researchers to link patient records across data sources in a way that is compliant with HIPAA, the Health Insurance Portability and Accountability Act. As a result, users of PCORnet can now assign a universal patient identifier code across multiple datasets from PCORnet Partner Networks without compromising any personal information.

“PPRL is going to bring tremendous value by solving two key problems that currently plague large-scale research,” said Keith Marsolo, co-lead of the PPRL Implementation Workgroup for PCORnet. “First, it will allow users to flag and de-duplicate records across multiple datasets, meaning that people who get care from multiple health systems in the same geography will be more accurately counted. And second, it will allow us to much more easily link EHRs and claims data sets across PCORnet, providing a more complete picture of patients’ health experiences.”

The current state of PPRL in PCORnet

The PCORnet PPRL Implementation Workgroup successfully demonstrated the ability to use PPRL to identify overlap across approximately 170 million patient records accessible via PCORnet; they also created a de-duplicated summary of demographic and clinical characteristics for patients from 61 Partner Networks. This project, which was one of the largest linkage efforts of its kind in the U.S., enables current and future studies—including several PCORnet rare disease studies—to benefit from connected insights across EHR claims, and patient reported data.

“This is an exciting advance for researchers and patients alike,” said Marsolo. “With PPRL in place, meaningful research can proceed uninhibited by gaps in understanding with zero sacrifice to patient privacy and security. It’s a win-win.”

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.

Gastrectomy has more favorable safety outcomes for Black and Hispanic patients—but that may not mean it’s the better weight loss surgery

Posted on by Jodi Snare

The PCORnet® Bariatric Study has found that there are significant differences in safety and utilization outcomes for Black and Hispanic patients who had Roux-en-Y gastric bypass (bypass) compared with sleeve gastrectomy (gastrectomy). While weight loss and diabetes outcomes were similar across racial and ethnic groups for both bypass  and gastrectomy, Black and Hispanic patients had a greater risk of hospitalization and adverse events with bypass surgery, according to the findings published in JAMA Surgery.

However, patients and providers shouldn’t necessarily conclude that gastrectomy is a superior choice of surgery for Black and Hispanic patients, the researchers noted. In fact, previous research conducted by the PCORnet Bariatric Study team found that more patients of all races and ethnicities who had bypass kept weight off five years after surgery than those who underwent gastrectomy. Those who had bypass were also significantly less likely to see a return of obesity-related medical conditions like Type 2 diabetes. The PCORnet Bariatric Study team says that these latest findings point to disparities in pre- and post-operative care rather than differences in the procedures themselves.

“As with many health care options, no one weight-loss surgical procedure is the best choice for every patient because tradeoffs are associated with each,” said Kathleen McTigue, M.D., M.P.H., M.S. “Results of this latest research should serve as a wake-up call for the medical community to identify and eliminate the barriers to safe bariatric surgery so that Black and Hispanic patients have the same experience as others.”

A continuation of important work

The PCORnet Bariatric Study was originally launched in 2016 as a retrospective, observational comparative effectiveness study designed to capture accurate estimates of 1-, 3-, and 5-year benefits and risk of bariatric surgery. Using PCORnet resources, the study team collaborated with 25 health care systems across the U.S. for insights related to more than 60,000 patients.

Of the original 60,000, 36,871 patients who underwent a primary bypass or sleeve gastrectomy between 2005 and 2015 were included in the current study.

“PCORnet has established partnerships across the nation’s leading health systems that allowed us to conduct bariatric research at the largest scale to date with patient data that is secure and fully de-identified,” Kathleen McTigue, M.D., M.P.H., M.S. “Bariatric procedures are only continuing to rise, and patients deserve a complete picture of what to expect. This research is an important piece of that puzzle, and we are looking forward to unlocking more insights in the months to come.”

PCORI Annual Meeting Reinforces PCORnet® as a Powerful Resource, Effectively Surfacing Patient-Centered Insights

Posted on by Jodi Snare

The 2022 PCORI Annual Meeting took place on October 26-27, providing opportunities for leaders from PCORnet®, the National Patient-Centered Clinical Research Network, to showcase the Network’s impact. By highlighting how PCORnet has been used to answer important questions relevant to the lives of patients and those who care for them, presenters at the meeting, they demonstrated how the Network is an established, leading resource to support the next era of clinical research.

The virtual event drew researchers, clinicians, patients, and other stakeholders across the healthcare ecosystem who are interested in the progress of PCORI’s funding initiatives, including PCORnet, in determining which care approaches work best, for whom, and under what circumstances. PCORnet was featured in 10 sessions across the two-day event.

Among the highlights of the meeting was a roundtable discussion titled “PCORnet-enabled Responses to COVID-19,” which showcased how PCORnet helped surface answers across three programs during the pandemic: ACTIV-6 for vaccines development, RECOVER for understanding “long COVID,” and the U.S. Centers for Disease Control (CDC) COVID-19 surveillance project to track trends through time.

“The urgency of the COVID-19 pandemic is exactly the type of situation PCORnet was developed to support,” said Adrian Hernandez, co-principal investigator of ACTIV-6. “The common thread across all of these studies is that using PCORnet resources enabled researchers to connect with data and communities quickly to inform the right public health response to the pandemic with more speed than would have been possible without the PCORnet infrastructure.”

Another high point of the PCORI Annual Meeting was a panel discussion on building and sustaining learning health systems featuring Kathleen McTigue, principal investigator of PaTH, a PCORnet Clinical Research Network. McTigue discussed how PaTH is leveraging PCORnet infrastructure and findings to move from discovery to implementation. McTigue also spoke of the larger potential for PCORnet to help health systems improve.

“There are real opportunities to leverage the data query infrastructure system of PCORnet to try to make easier for health systems to open these conversations,” she said.

If you weren’t able to make the PCORI Annual Meeting but are interested in learning about more outcomes from PCORnet-leveraged research, check out the recordings of the sessions described above as well as the eight PCORnet-focused posters that were presented across the two-day event by visiting this site. From integrating claims data to complement electronic health records in PCORnet to creating a precision cancer survivorship cohort, the posters illustrate novel ways PCORnet is being used to drive meaningful health outcomes.

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.

PCORnet® Leaders Will Share Network Success, Future Priorities at 2022 PCORI Annual Meeting

Posted on by Jodi Snare

The 2022 PCORI Annual Meeting is fast approaching on October 26-27, and PCORnet®, the National Patient-Centered Clinical Research Network, will be featured prominently across the two-day event as PCORI’s premier health data infrastructure investment. This virtual meeting will bring together researchers, clinicians, patients, and other stakeholders across the healthcare ecosystem. It highlights the progress of PCORI’s funding initiatives, including PCORnet, which help determine what care approaches work best, for whom, and under what circumstances.

Registration is free, providing easy access to all the insights, data, and other useful information and experiences that will be shared. Here are PCORnet-featured sessions you won’t want to miss: 

Name Type Date Description
PCORnet®-Enabled Responses to COVID-19 Breakout Session featuring:

Thomas Carton
Rainu Kaushal
Adrian Hernandez
Florence Thicklin
Susanna Naggie

 October 26

1:15 PM-2:15 PM ET

 The session will focus on results related to three active PCORnet-leveraged projects funded by federal health agencies: the Accelerating COVID-19 Therapeutic Interventions and Vaccines-6 (ACTIV-6) trial, the Researching COVID to Enhance Recovery (RECOVER) trial, and a Centers for Disease Control and Prevention-funded COVID-19 surveillance project.
PCOR Infrastructure to Accelerate Progress Toward an Integrated Learning Health System (LHS) Breakout Session featuring:

Kathleen McTigue
Issa Dahabreh
Erin Holve
Meghan Lane-Fall

 October 27

10:00 AM-11:00 AM ET

 This session will explore efforts to support LHS models and contemplate innovations in data and technology approaches, workforce development, and methodologies essential to achieving an integrated LHS vision. The session will also describe how PCORI is developing internal continuous learning mechanisms to develop the role of a funder in an integrated LHS. 
HERO Registry: Strategies and Resets to Diversify Engagement and Recruitment through Representative Stakeholders’ Involvement and Focused Outreach Poster Presentation featuring:

Renee Leverty

 October 26

10:15 AM-10:45 AM ET

 

October 27

11:15 AM- 11:45 AM ET

 An exploration of the best strategies and resets to diversify engagement and recruitment through representative stakeholders’ involvement and focused outreach.
PCORnet®, The National Patient-Centered Clinical Research Network: Priorities for the PCORnet Coordinating Center: 2022 and Beyond Poster Presentation featuring:

Lauren Cohen
Jenny Cook

 

 October 26

10:15 AM-10:45 AM ET

 

October 27

11:15 AM-11:45 AM ET

 

 

 What’s coming next for PCORnet? This presentation offers a glimpse into the future of PCORnet’s Coordinating Center priorities for 2022 and beyond.
Vaccination for COVID-19: Perspectives from the Healthcare Worker Exposure Response and Outcomes (HERO) Community Over 2 years of the COVID-19 Pandemic 2020-2022 Poster Presentation featuring:

Lauren Cohen

 October 26

10:15 AM-10:45 AM ET

 

October 27

11:15 AM-11:45 AM ET

 

 The PCORnet-supported HERO community has been an essential resource for understanding COVID-19, including vaccination trends, over the past two years. This poster presentation will offer a glimpse into the perspectives gleaned from this community to inform current and future vaccine campaigns.
Developing and Implementing a Multi-Stakeholder System for Enabling Patient-Driven Research in Multiple Sclerosis via the iConquerMS Research Network Poster Presentation featuring:

Laura Kolaczowski

 October 26

10:15 AM-10:45 AM ET

 

October 27

11:15 AM-11:45 AM ET

 This poster will present the development of a robust process for participant-driven research (PDR) in multiple sclerosis (MS) via the iConquerMS People-Powered Research Network, including features of the iConquerMS.org portal, engagement of people affected by MS, and more.
Enhancing PCORnet® Clinical Research Network Data Completeness by Integrating Multistate Insurance Claims with Electronic Health Records Poster Presentation featuring:

 

Lemuel Russ Waitman

 October 26

10:15 AM-10:45 AM ET

 

October 27

11:15 AM- 11:45 AM ET

 PCORnet Clinical Data Research Networks capture healthcare use within their health systems, but may lack information on care received elsewhere in the community. This poster describes a reusable environment that integrates hospital and electronic health records data in the PCORnet Common Data Model with statewide Medicare and Medicaid claims. It also assesses how claims and clinical data complement each other to identify obesity and related diseases.
Does Interval Between Online Follow-Up Visits Affect Visit Completion, Medication Adherence, or Trial Completion Overall or in Age Subgroups? Poster Presentation featuring:

Jeff Whittle

 October 26

10:15 AM 10:45 AM ET

 

October 27

11:15 AM-11:45 AM ET

 Large pragmatic trials often use online approaches for follow-up. This poster explores the impact of the time interval between remote study visits on visit completion, medication adherence, and trial completion. The study team randomized participants in the ADAPTABLE trial to three- versus six-month intervals between follow-up visits to determine the impact of each interval.
Facilitating Peer-to-Peer Conversations Around Key Clinical Trial Recruitment Barriers in the Limit-JIA (Juvenile Idiopathic Arthritis) Trial Using Low-Fidelity Video Capture Poster Presentation featuring:

Melanie Kohlheim

 October 26

10:15 AM-10:45 AM ET

 

October 27

11:15 AM-11:45 AM ET

 In response to parents’ confusion about JIA treatment and fear around administering injections to their children, this poster shares research related to the best COVID-friendly strategies to break down or minimize these barriers.
Precision Cancer Survivorship Cohort: Developing a Cohort Using the OneFlorida+ Infrastructure Poster Presentation featuring:

Erin Mobley

 October 26

10:15 AM-10:45 AM ET

 

October 27

11:15 AM-11:45 AM ET

 This poster describes the development of the Precision Cancer Survivorship Cohort, which allows for the examination of factors associated with various constructs across the cancer survivorship continuum, with a particular focus on identifying issues of equity across age, race, ethnicity, and socioeconomic status.

 If you haven’t registered for the 2022 PCORI Annual Meeting, now is the time! Registration provides access to the sessions occurring live as well as the recorded webinars you can watch at your convenience. Don’t miss this exciting opportunity to learn what’s next for the future of patient-centered research.

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 diverse 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.

The science of patient engagement: How PCORnet® is leading the next hot topic in clinical research

Posted on by Jodi Snare

PCORnet®, the National Patient-Centered Clinical Research Network, was designed with the premise that having patients as equal partners in all aspects of the network would revolutionize the way we seek research answers. Now, a new manuscript published in Learning Health Systems shares how the PCORnet infrastructure can serve as a model for the burgeoning science of patient engagement, providing much-needed insights on how large research networks can effectively engage patients.

“If we can learn how to effectively partner with patients across the research continuum—from defining research questions through study design, conduct, and dissemination—we can generate findings that are more relevant, complete, and trusted by communities,” said Elizabeth Cope, senior director of public and population health at AcademyHealth and lead author of the manuscript. “As one of the few large-scale networks that has incorporated patient partners across its governance, infrastructure, and research projects, PCORnet offered us a unique opportunity to learn about the diverse array of engagement practices across affiliate networks.”

Key Takeaways

The manuscript’s authors worked with PCORnet® Clinical Research Networks, or CRNs, to conduct an engagement practice scan between June 2020 and February 2021. They looked at documents, worksheets, and interview transcripts, ultimately identifying 87 engagement structures, assets, and services across the CRNs. Some takeaways from the scan include:

Infrastructure matters. By investing in a standing engagement infrastructure with established patient relationships, the research community can also help address two of its most highly cited barriers to engagement in patient-centered research—time and money. All PCORnet® CRNs include patients on their steering or oversight committees as well as in the review and approval process of research projects. They also all maintain staff dedicated to overseeing their engagement strategies. The authors concluded that such infrastructure and established processes are important for engagement to be meaningful. To make the most of an engagement infrastructure, researchers should invest in mechanisms to reinforce it, including team training to navigate power dynamics and development of supportive environments that promote diversity and inclusion.

Engagement tactics in PCORnet aren’t one-size-fits-all. While engagement of patients in governance is a requirement of funding for all PCORnet® CRNs, the specific tactics were left to the individual networks to determine. Given the diverse settings and populations served by these networks, variation in specific practices is to be expected. Each CRN adopted distinct strategies. For example, the study team observed varied governance configurations, as well as distinct assets and services maintained by each CRN.

We need more engagement science research—and PCORnet could be key. While Network Partners have already published work related to their engagement in research, there is more to be done. The Network Partners’ experiences with tactics like community engagement studios, patient engagement panels, methods for prioritizing research topics, citizen scientist programs, and blended research teams could support comparative effectiveness studies that inform strategies for continuous quality improvement in engagement practices. The study’s authors see their publication as a stepping-stone toward such research, which could guide study teams in matching engagement strategies with known contextual factors.

“At the end of the day, we want patient-centered research to be the norm and not the exception,” said Cope. “To get there, we need to look at engagement through the lens of scientific rigor to understand what strategies work best in specific settings and across distinct audiences. PCORnet Network Partners have built a foundation that can deliver those answers, which will drive scaling and uptake of effective practices across future networks.”