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Mental Health in Sexual, Gender, and Racial Minorities: A Q&A with Bowen Chung

Mental health disorders can impact anyone, but unfortunately, too often minority communities struggle even more. The LGBTQ community is almost three times more likely than others to experience a mental health condition, such as major depression or generalized anxiety disorder. Racial and ethnic minorities are also at higher risk, and studies have revealed these communities receive lower quality mental health care. So, what are the drivers behind these alarming statistics, and what can be done to mitigate them?

We had a conversation with Bowen Chung to learn more. Chung is the co-principal investigator for the Community and Patient Partnered Participatory Research Network and principal investigator for Resilience Against Depression Disparities, a PCORnet demonstration study that seeks to answer these questions and improve mental health care for underserved communities. PCORnet, the National Patient-Centered Clinical Research Network, is an ambitious initiative launched by PCORI with a mission to make research faster, less expensive, and more meaningful to people than it is to date.

Headshot of Bowen Chung
Bowen Chung, MD

PCORnet: In what ways are racial/ethnic, sexual, and gender minority groups uniquely impacted by mental health disorders, like depression and anxiety?

Chung: It’s no secret that being different than other people — whether it means your race, gender, or sexual orientation — is often a source of stress in our society. We all crave acceptance. Consider that until the 1970s, homosexuality was thought of as a mental health disorder that needed to be “fixed.” Only in the mid-80s was there a change toward the idea that self-acceptance is the bedrock of good mental health, so the research community is really late to the party on understanding the LGBTQ experience. Racial/ethnic, gender, and sexual minorities also often suffer from poor mental health outcomes due to multiple factors, including inaccessibility of high-quality mental health care services, cultural stigma surrounding mental health care, and discrimination.

PCORnet: How is the Resilience Against Depression Disparities study designed to help these minority communities?

Chung:  This project is studying whether offering a seven-session resiliency class improves the mood of lesbian, gay, bisexual, transgender, and queer adults in racial and ethnic minority communities over and above primary care depression quality improvement programs, which have been shown to improve outcomes for minorities more significantly than for non-minorities but are seldom available in safety-net systems. The resiliency classes are 90 to 120-minute sessions led by community health workers that teach skills like how to stop negative thoughts, communication tactics, and prioritizing pleasant activities to improve the mood. They offer a different option for those individuals who may be impacted by the stigma of the word “depression.” When we remove that stigma by focusing instead on mood improvement via positive thought patterns and activities, will we see better outcomes? That’s what this study aims to find out.

PCORnet: How does the infrastructure of PCORnet help further mental health research? What does it make possible that would otherwise not be possible?

Chung: PCORnet is indispensible to us in this study for two reasons. First, through PCORnet’s partner networks, we had access to PRIDEnet, which gave us a wealth of insights that improved our training. They helped us answer questions, like what is the best way to ask someone about his or her gender identity? PRIDEnet also sensitized us to the fact that lesbian, gay, bisexual, transgender, and queer individuals are really not one community; these groups are distinct, and they also comprise subgroups based on race, ethnicity, geographic location, socioeconomic status, age, and more.

The second reason PCORnet is indispensable is its infrastructure, which is allowing us to complete this study at incredible speed, reduced cost, and with the broad inclusion of people and families across the research spectrum. When we first scoped this study, we estimated it would cost $5 million and take eight years. We are doing it at $2.5 million in four. The power of uniting people, clinicians, health systems, and data for a common goal is real, and our study is proof.

The Resilience Against Depression Disparities Study is actively recruiting. For more information on how you can join, contact Bowen Chung at [email protected].

 

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

PCORnet Partner Network Launches Creative Strategy to Reduce Homelessness in Chicago

In the winter months, when freezing temperatures overtake Chicago, people without homes cradle themselves in makeshift tents to shelter from Chicago’s infamous frigid wind. They are young and old, educated and uneducated, men, women, and children. And they are not alone—in fact, on an average night in 2017, nearly 7,000 people could be found on Chicago’s streets and shelters, and thousands more are just one unexpected setback away from joining them. Recently, the Chicago Department of Public Health has been encouraging health institutions to contribute to a housing pool that would provide rental assistance to these individuals, but the proposal has lacked the data to support a solid economic argument that patients with chronic illnesses would benefit from permanent supportive housing. With the help of a collaboration between the Chicago-based clinical research network CAPriCORN (a partner network of PCORnet, the National Patient-Centered Clinical Research Network), All Chicago, the Alliance to End Homelessness in Suburban Cook County, and Chicago’s public health agencies, that tide may be about to turn.

“Public health advocates have
long theorized that people
experiencing homelessness are
among health systems’ most expensive patients because their living condition puts them at
risk for so many health problems.”

Bill Trick – Principal Investigator, Cook County Health & Hospitals System

“Public health advocates have long theorized that people experiencing homelessness are among health systems’ most expensive patients because their living condition puts them at risk for so many health problems,” said Bill Trick, site principal investigator for the Cook County Health & Hospitals System, a participant in CAPriCORN. “If that is true, a housing pool funded by health systems would be a win-win in that it would not only help these individuals, but also treat the fundamental factor impeding successful management of chronic medical conditions, which is homelessness, effectively reducing overall healthcare costs.”

The challenge until now has been that there is little hard data to support advocates’ claim that homelessness is linked to higher expense for health systems. That’s because people without homes are difficult to track. Few have insurance and most have no reliable address on record. The temporary nature of homelessness also means patients tend to move between different health systems whose health records are not shared, resulting in uncoordinated delivery of healthcare.

That’s why advocates working with Chicago’s Homeless Management Information System, a federally funded and locally administered technology system that is used to collect client-level data on homeless individuals and families, collaborated with CAPriCORN, a clinical research network that boasts a high level of engagement with Chicago’s homeless population. The goal was to link homeless agency data to the CAPriCORN network’s clinical data to generate some real numbers to show how people experiencing homelessness access and use different healthcare facilities. If, as expected, the data reveals a high degree of fragmentation or excessive use of hospitalization, these numbers would be influential in motivating health systems’ leaders to contribute to the housing pool.

Maintaining individuals’ privacy is critical, which is why the project team used the Medical Research Analytics and Informatics Alliance (MRAIA) as its third-party data hub. Using the hub’s expertise, the researchers ran hashing software to de-identify sensitive information like names and date of birth. A hash is a mathematical function: you give it an input value and the function emits a complex and unique output value, with the same input always yielding the same output. In this way, the research team was able to preserve privacy, while still linking the data of individuals experiencing homelessness among five of CAPriCORN’s clinical sites. Because CAPriCORN, like all PCORnet partner networks, uses the Common Data Model to standardize its data, the team was able to pull health utilization data in an efficient way.

The project is currently in its final stages as researchers analyze the data. Results are expected in about a month, and the team has high hopes for compelling results.

“…it’s a challenge worth fighting for, and we will be thrilled if our effort can facilitate a safe and stable
living environment for even one person experiencing homelessness in the Chicago area.”

Bill Trick – Principal Investigator, Cook County Health & Hospitals System

“Unfortunately, the number of people without a home in Chicago is substantial, and even if this project achieves its aims of influencing health systems in favor of the housing pool, it will only be a small dent in a much larger challenge,” said Trick. “However, it’s a challenge worth fighting for, and we will be thrilled if our effort can facilitate a safe and stable living environment for even one person experiencing homelessness in the Chicago area.”

 

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

 About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

PCORI Board Approves Research to Promote Partnerships Between PCORnet and Other Organizations

The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors recently approved more than $20 million for studies that will use PCORnet, the National Patient-Centered Clinical Research Network, to test ways to improve care for people with arthritis, blood pressure, depression and inflammatory bowel disease.

PCORnet is PCORI’s initiative to improve the nation’s capacity to conduct patient-centered comparative clinical effectiveness research (CER) more efficiently by harnessing the power of large amounts of health data and patient partnerships.

Each of the four projects will actively foster relationships between researchers and stakeholder partners within PCORnet and in outside organizations, such as large patient groups, to support research using PCORnet’s resources. Each of the studies also focuses on linking disparate data sources for a more-complete picture of patient care.

The newly approved awards are the following:

  • $7 million for a Duke University project that will determine whether a six-month course of abatacept, a common treatment for juvenile idiopathic arthritis (JIA), given soon after diagnosis will prevent the advancement of joint and eye inflammation or the need for additional treatment.
  • $6.5 million for a study at the University of California, San Francisco, that will compare two ways of helping doctors improve their methods for controlling patients’ blood pressure. It will also compare two types of home blood pressure monitors to see which is more effective at helping patients achieve personal goals.
  • $4.8 million for a Massachusetts General Hospital project about patients with severe depression comparing the effectiveness of usual care to therapy that uses a patient’s genes to guide medication decisions.
  • $2.4 million for a study led by the Crohn’s and Colitis Foundation to compare three treatments — ustekinumab, vedolizumab and tofacitinib — for patients with inflammatory bowel disease for whom TNF inhibitors, a class of biologic drugs, are not effective.

“These studies will enhance the PCORnet research that PCORI has previously funded while taking a crucial step toward promoting PCORnet’s long-term sustainability by meeting the needs of additional research funders besides PCORI,” said PCORI Executive Director Joe Selby, MD, MPH. “We’re proud of the achievements of the participating individuals and organizations that have prepared PCORnet to develop and lead clinical research that will more efficiently answer important questions that patients and clinicians face.”

More details on the projects are available here. To date, PCORI has invested $160.7 million in 39 studies and projects that use PCORnet’s capacities to conduct a range of patient-centered research, including randomized controlled trials, observational studies and surveillance research. These PCORI-funded research projects have focused on obesity, heart disease, diabetes, arthritis, multiple sclerosis and rare diseases, among other conditions.

The four projects approved today were among 13 CER studies that PCORI’s Board approved for funding. Information about the other studies can be found here.

With these latest awards, PCORI’s Board has approved more than $2 billion since 2012 to fund more than 400 patient-centered CER studies and other projects to enhance the methods and infrastructure necessary to conduct CER rigorously and efficiently. All awards were approved by the Board pending completion of a business programmatic review by PCORI staff and issuance of a formal award contract.

 

About PCORnet 

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

 About PCORI 

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org. 

People-Centered Research Foundation Names Richard Turman Chief Operating Officer

The People-Centered Research Foundation (PCRF) announced that Richard Turman, MPP, will be joining the organization as chief operating officer. Mr. Turman currently serves as the deputy director of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products. At the PCRF, he joins a team of national leaders in clinical research who established the nonprofit organization to accelerate people-driven research. Visit the PCRF Website to learn more. 

Learn more about how PCORnet evaluates foundational data quality.

 

About PCORnet 

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

 

 About PCORI 

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org. 

Empowering the Digital Patient: How Three PCORnet Partner Networks Answered the Call from Patients and Caregivers Who Want to Share Their Own Health Data

In the past few years, Kiely Law has noticed a common frustration in the autism community. Families and adults with autism want to know why it is so hard to share their medical records with the research registry she co-founded, the Interactive Autism Network. As research director of the Interactive Autism Network, a partner network of PCORnet, the National Patient-Centered Clinical Research Network, she knows the importance of listening to and responding to participant concerns.

According to Law, one major barrier to using patient health records for research is the format. “Many participants in the Interactive Autism Network have offered to send in scanned copies of their medical records. Unfortunately, reviewing each chart manually and extracting specific data for research use is simply not practical on a large scale. We have over 57,000 participants in our network,” said Law.

When Law surveyed the families in the Interactive Autism Network to see how many wanted to share medical records for research purposes, 67 percent said yes.

“The families I work with are
not satisfied being passive
observers in autism research.”

Kiely Law – Principal Investigator, Interactive Autism Network

“The families I work with are not satisfied being passive observers in autism research,” said Law. “They want to feel empowered to use their experience to create new knowledge that will lead to better care.”

These results echo other recent survey outcomes. In fact, one 2016 study published in the Journal of Medical Internet Research found that, while there were general concerns about the detrimental consequences of data falling into the wrong hands, 39 of 40 patients surveyed thought the altruistic benefits of sharing health care data for research outweighed the risks.

Taking action

As it turns out, Law wasn’t the only PCORnet principal investigator hearing this feedback. Investigators from NephCure and Phelan-McDermid had similar experiences, prompting the three partner networks to take action. With support from PCORI funds and in collaboration with PCORnet’s Coordinating Center, the networks launched a pilot study. Their research question: Is it possible to empower patients to share their own health data in a research-ready format by using a secure personal health record app?

Finding the right technology was key, and that’s where Medfusion, a leading healthcare IT company focused on patient-centered solutions, came in. The company was excited by the idea of a patient-driven health data portal and offered to design the technology, including a mobile app, at no cost.

With Medfusion’s help, the team designed a portal that pulled in patients’ health data in the standard Consolidated Clinical Document Architecture format. Consolidated Clinical Document Architecture is a common way of coding electronic clinical documents so they can be read and understood more easily by a broad range of people. From there, the team worked with Medfusion’s software to match this data to PCORnet’s Common Data Model, which readies data for research use.

Research participants used the app to collect records from their healthcare providers and send the data to their research registry. “Our aim was to offer patients an easy-to-access portal that puts them in control of their own health data and empowers them to share it at will with the research community,” said Law. “I’m pleased to say that we were successful, and we are excited about the possibilities of this technology for the future.”

The technology offers a way to make families partners in research. Rather than passively waiting to see what research brings, these families may contribute to and influence future insights. For researchers, it offers the promise of improved registries that are complemented by these rich, patient-provided health records.

Next steps

The pilot, which ended in February, was an exciting step forward, but Law said that the process and technology have not yet been perfected.

“We realized that the vision we had was possible, but the process is still more cumbersome than we would like, so there is more to be done to make it a practical solution,” she said. “The next step would be another exploration building on the lessons we have learned.” 

“We have more work to do,
but we all feel good about
moving forward on a solution
that puts power back in the
hands of patients and caregivers.
That’s what patient-centered
research is all about.”

Kiely Law – Principal Investigator, Interactive Autism Network

In the meantime, Law and her other study collaborators at NephCure and Phelan-McDermid are continuing efforts to bring more patient-centered solutions to light.

“This pilot study was unique because it was a direct result of grassroots feedback at the community level,” said Law. “We have more work to do, but we all feel good about moving forward on a solution that puts power back in the hands of patients and caregivers. That’s what patient-centered research is all about.”

 

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

 

 About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

PCORnet in the News

PCORnet, the National Patient-Centered Clinical Research Network, a PCORI initiative, continues to advance patient-centered research. Several manuscripts written by PCORnet colleagues have recently been published in prominent journals:

  • The Mid-South Clinical Data Research Network wrote a paper published in the March 2018 edition of BMC Obesity. This paper discusses results of a survey on patient willingness to participate in weight-related research by body mass index and characteristics.
  • Academic Pediatrics published the PCORnet Antibiotics and Childhood Growth Study team’s manuscript detailing how the study successfully integrated and studied data from children across 36 participating institutions.
  • Communications colleagues at the Duke Clinical Research Institute wrote an article that examines three models of patient engagement. This paper looks at what works best for patients, their caregivers, research sponsors, and investigators. “Models of Engagement: Patients as Partners in Clinical Research” was published in the February issue of Applied Clinical Trials.
  • Patient Related Outcomes Measures recently published a paper written by members of PCORnet’s Research Committee about the Network’s Collaborative Research Groups. The paper looks at how these groups are collaborating across networks and institutions within PCORnet.
  • Findings from the Natural Experiments for Translation in Diabetes 2.0 study were published in Current Diabetes Reports. The report looks at how public and private health policies affect diabetes care and prevention.

Our PCORnet colleagues are constantly seeking out new ways to promote patient-centered research. Be on the lookout for more publications of our exciting work in the months to come!

 

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

 About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

AMIA’s 2018 Informatics Summit Is Coming; Mark Your Calendar Now For These PCORnet-Led Sessions

The American Medical Informatics Association (AMIA) is set to hold its annual Informatics Summit on March 12-15 in San Francisco, CA. The summit is known across the industry as a showcase of leading perspectives in translational, clinical research, implementation, and data science. PCORnet will have a significant presence at the event—including PCORnet Data Committee member Lesley Curtis, who will be giving the opening keynote. Numerous other PCORI and PCORnet colleagues will also be at the summit sharing their research, so mark your calendars for the dates and times below.

Not able to attend in person? You can still support your colleagues by following and continuing the conversations online @AMIAInformatics, #TBICRI18, and by following @PCORnetwork.

Here is a list of the sessions led by your PCORI and PCORnet Colleagues at 2018 AMIA Informatics Summit:

Sessions on March 12th

  • PCORnet: Infrastructure, Research Studies, Engagement: Anthony Solomonides, NorthShore University HealthSystem; Abel Kho, Northwestern University; Charles Bailey, Children’s Hospital of Philadelphia; Katherine Kim, University of California Davis; Maryan Zirkle, Patient-Centered Outcomes Research Institute; Shayna Barbash, Patient-Centered Outcomes Research Institute
    • Session Number & Type: Tutorial T05
    • Time & Location: 8:30 AM to 12:00 PM, Mission
  • Opening Plenary Session and Keynote: Lesley Curtis, Duke Clinical Research Institute
    • Session Number & Type: Opening Plenary Session and Keynote
    • Time & Location: 1:30 PM to 3:00 PM, Cyril Magnin Ballroom

Sessions on March 13th

Sessions on March 14th

Sessions on March 15th

  • Nursing Documentation and the Clinical Research Informatics Pipeline: Jeffrey Klann, Harvard University School of Medicine; Sarah Collins, Brigham and Women’s Hospital; Kenrick Cato, Columbia University; Russ Waitman, University of Kansas Medical Center; Bonnie Westra, University of Minnesota
    • Session Number & Type: Panel S36
    • Time & Location: 8:30 AM to 10:00 AM, Cyril Magnin I


About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

 About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

Researchers Created an Infrastructure that Allows for Linkage of PCORnet to Other Distributed Networks to Solve for Missing Data; Here’s What They Learned (Part 2)

Earlier this week, we published part one of this two-part series in which we highlighted how the combined use of claims data and electronic health record data can drive better research outcomes. However, we also noted that combining these two datasets comes with inherent challenges due to differences in coding and categorization of records.

In an effort to overcome these challenges, two pilot projects funded through a public-private partnership with the Patient-Centered Outcomes Research Institute (PCORI), the U.S. Food and Drug Administration (FDA), and the Regan-Udall Foundation (participating in an advisory capacity) took on an ambitious effort: creating an infrastructure capable of linking PCORnet—one of PCORI’s most innovative initiatives that offers researchers electronic health record data—and the FDA’s Sentinel program, which offers mostly claims data. Part one of this series explored the pilot project focused on the congenital Zika virus, and this article will explore the second pilot, which focused on monitoring exposure to antimicrobials.

An Initiative to Monitor Exposure to Antimicrobials

The challenge: Antibiotics and similar drugs, together called antimicrobial agents, have been used for the last 70 years to treat patients who have infectious diseases. Unfortunately, these drugs have been used so widely and for so long that the infectious organisms the antibiotics are designed to kill have adapted to them, making the drugs less effective. Exacerbating this problem is overuse and misuse of these medicines. In hospitals, approximately 30 percent of antibiotics are unnecessary or prescribed incorrectly. Sometimes patients are treated with antibiotics for diseases or conditions that are not caused by bacterial infections. With better data, we can better inform hospitals and doctors on over-prescribing of antibiotics and encourage them to only give antibiotics when necessary. This study team piloted a methodology to create antibiotic use reports from PCORnet and Sentinel data for sending such reports to the Centers for Disease Control and Prevention’s National Healthcare Safety Network. The National Healthcare Safety Network compares rates of antibiotic use across similar hospitals and reports these comparisons back to hospitals.

The process: The team’s primary focus was to develop a PCORnet technical infrastructure in partnership with Sentinel that would generate more complete information on how antibiotics are being used and prescribed. The structure provides a framework that can benefit healthcare facilities locally as well as through reporting to the National Healthcare Safety Network. Once developed, the team implemented this augmented data structure at five healthcare institutions across three PCORnet partner networks (CAPriCORN, Mid-South, and REACHnet).

“PCORnet and Sentinel both have Common Data Models to standardize data, but neither were sufficient for the goals of our project,” said Bill Trick, principal investigator for CAPriCORN. “For example, these models may tell us that antibiotics were dispensed at a hospital, but not the location in the hospital, which was important to our research. As a result, we had to work in tandem with the Sentinel team to extend both Common Data Models and build something unique to this project.”

“We are proud of our outcomes
with this work and see it as
a stepping stone for future researchers.

Bill Trick – Principal Investigator, CAPriCORN

The result: The team effectively developed a final data model, dictionary, and analytic questions that are now available for use beyond the project institutions. In fact, the infrastructure has already been leveraged to pilot a system to monitor dangerously low blood sugar events among hospitalized patients with diabetes.

“We are proud of our outcomes with this work and see it as a stepping stone for future researchers,” said Trick. “We are already working on a new system to monitor antibiotic resistant organisms within healthcare settings using the lessons learned from this study.”

The Road Ahead for Data Linkage Infrastructure

Trick and Bill Hogan, the principal investigator for the Zika pilot, both stressed that developing an infrastructure that allows data linkage of two distributed networks like Sentinel and PCORnet was no small feat. Data is complex, and many challenges can make the linkage process time consuming and tedious. However, both feel the merits far outweigh these burdens.

“Once we take the effort to build these linked infrastructures, health institutions can benefit from national assessments that will tell us much richer detail about the health of our country,” said Hogan. “PCORnet and Sentinel are both valuable tools individually, but together they augment each other, painting a more detailed picture of what we seek to understand.”

These detailed pictures of our pressing health challenges are key because with greater detail, we don’t have to theorize with gaps in information. At the same time, we can get to the bottom of questions that need answers with greater speed and confidence. With that in mind, it is a pretty sure bet that we will see more data linkage efforts in the future.

This article is second in a two-part series on PCORnet’s data linkage projects. Learn more in Part 1.

 

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.

 About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

When Patients Partner with Researchers: Bill Larsen on the ADAPTABLE Study

Partnerships between patients and researchers hold the promise to improve clinical research and health outcomes. But what does patient engagement mean and what does it involve? To gain a better understanding of the patient and researcher relationship, we talked with a patient representative, Bill Larsen, who partners with researchers in the ADAPTABLE Study.

ADAPTABLE is funded by the Patient Centered Outcomes Research Institute (PCORI) and is a demonstration study of PCORnet, the National Patient-Centered Clinical Research Network, a PCORI initiative.

The ADAPTABLE Study is researching two different doses of aspirin to determine what the best dose is for people living with heart disease to prevent a future heart attack or stroke. In ADAPTABLE, there is a team of patient representatives known as the Adaptors. Adaptors have been involved in ADAPTABLE from the beginning, working alongside the study team, participating in team meetings, and providing review and input to the protocol, consent form, study portal, and study materials.

PCORnet: How can patients inform researchers in clinical trials?

Bill_Larson_Adaptor_HeadshotLarsen: I view my role to be that of a communicator, asking questions that are of interest to those represented in the research study, and providing relevant information and feedback to the concerned parties. Active dialogue among all concerned is what enriches the conversation and leverages the contributions of each individual to best achieve the research goals of the team.

Here are a few of the questions that I have raised in ADAPTABLE, and continually review, as the project proceeds:

  • Is the proposed research really important to those most affected by the disease being studied?
  • Does the recruitment approach present any obstacles to the study participants?
  • Are the written recruitment materials clear and appealing?
  • Do follow-up calls to initial inquiries cover the points I believe are most important?
  • Are expectations for patient participation realistic?
  • Are safety and security issues satisfactorily addressed?
  • How will the participant be kept informed during the research process?
  • In reporting the final results, are there at least some that will be written in lay language?
  • Will results be distributed for maximum coverage to the affected population?

Patient representatives can help ensure that the answers to these, and other questions, fully reflect the interests, concerns, and welfare of the entire patient population.

PCORnet: Why is patient-centered research important?

Larsen: Until recent years, the focus of medical research has been heavily weighted toward basic science. This is understandable and undeniably important. It is essential for the development of new medications and procedures designed to benefit the patient.

But before the findings of basic science can be implemented, they must be tested in a real-world setting. The branch of medical research devoted to this stage is called “translational.” In order to translate the findings of basic scientific discoveries into actual solutions, they need to be tested in a controlled environment, typically in a clinical setting where the doctor and patient interact. How to achieve this is more complex than meets the eye. The concerns of both the doctor and patient must be addressed by the translational research team before success can be achieved.

From the outset of the ADAPTABLE study, we Adaptors have provided the patient perspective in all aspects. We represent all areas of the country and bring great diversity of gender, race, ethnicity, and age. We work side by side with the research team and the other parties at every stage and throughout the endeavor. We raise key questions and will continue to do so throughout the duration of the project.

PCORnet: What activity do you appreciate most from your work on the ADAPTABLE Study?

Larsen: It is the complete immersion in the whole research process, the opportunity to view it from the inside out and feel empowered to have an impact on a study with results that may potentially benefit many people. From this, I have gained a greater appreciation of the complex environment of medical research, and the underappreciated importance of the expanded role the patient must play for the benefit of all.

Want to read more? Check out the complete interview with Bill Larsen. To learn more about ADAPTABLE, join the March PCORnet Best Practice Sharing Session where study leaders will be discussing lessons learned so far.

 

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.


About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

Researchers Created an Infrastructure that Allows for Linkage of PCORnet to Other Distributed Networks to Solve for Missing Data; Here’s What They Learned (Part 1)

Imagine that you are a researcher trying to identify the number of people receiving a certain treatment for a medical condition. As you explore the available data, you quickly discover that there are many data sources to choose from. The two most commonly used types of data are electronic health record data and claims data. Electronic health record data can tell you what happened when patients visited their doctors, such as what conditions they were tested for, the results of those tests, and what medications were prescribed. Claims data, however, can tell you what an insurance provider actually paid for, which can tell you whether the patient filled their prescription after his or her diagnosis of the specific medical condition. Both data sources are critical to research, but neither, on its own, offers a complete picture of the patient history. To increase the likelihood of identifying the appropriate people and answer your question, you need both.

PCORnet + Sentinel: What’s the Value of a Linkage Infrastructure?

Unfortunately, due to differences in how claims data and electronic health record data are categorized and coded, it is difficult to combine these data for clinical research. Two pilot projects funded through a public-private partnership with the Patient-Centered Outcomes Research Institute (PCORI), the U.S. Food and Drug Administration (FDA), and the Regan-Udall Foundation (participating in an advisory capacity) tried to solve this challenge by creating an infrastructure that links PCORnet—one of PCORI’s most innovative initiatives—and the FDA’s Sentinel program. This article, the first in a two-part series, will focus on one of those pilots, which was an effort to better understand and monitor the natural progression of the Zika virus.

Although PCORnet and Sentinel are both large distributed research networks, PCORnet mostly contains the clinical data that comes from electronic health records generated when people visit their doctor, while Sentinel mostly uses the claims data produced by the billing and paying for health services to monitor the safety of regulated medical products. As we noted above, clinical and claims data offer different, but equally valuable insights that, when combined, can offer a more complete picture of patient care.

Congenital Zika Project with OneFlorida

Researchers used this partnership to better understand the natural progression of the mosquito-borne Zika virus across Florida last year.

The challenge: While most people infected with the Zika virus will only experience mild or even nonexistent symptoms, women who are infected with Zika during pregnancy are at risk of having babies that suffer from a birth defect of the brain called microcephaly and other severe brain and birth defects. While Sentinel had been tracking Zika surveillance for some time, researchers believed that linking to the PCORnet infrastructure could enhance those efforts. The project team worked to develop a strategy for tracking the number of babies born with microcephaly within the OneFlorida partner network. Its specific aim was to not only detect outbreaks, but also to understand the natural progression of congenital Zika syndrome.

The process: The study team started by identifying available electronic health record data elements in the PCORnet Common Data Model that can contribute to Zika surveillance. Then they coordinated with Sentinel to develop a shared set of diagnosis and procedure codes that would allow them to identify infants with microcephaly who have signs or symptoms consistent with congenital Zika syndrome.

“By coordinating our coding,
we were able to help Sentinel
and PCORnet speak the same language.

Bill Hogan – Co-Principal Investigator, OneFlorida

“By coordinating our coding, we were able to help Sentinel and PCORnet speak the same language,” said Bill Hogan, co-principal investigator for OneFlorida. “The idea was for the public health data from Sentinel and the electronic health record data from PCORnet to work seamlessly together.”

The result:  The team found that many, but not all, data elements needed for enhanced congenital Zika syndrome surveillance are available and easily extracted from electronic health records. The data review also found that head circumference, a standard data point found in electronic health records, can indicate microcephaly with 70 percent accuracy.

“There is every indication that this model has great potential to bridge health care and public health systems to serve as a much-needed source of more complete public health information,” said Hogan.

This article is first in a two-part series on PCORnet’s data linkage projects. Learn more in Part 2.

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org. 

About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.