All posts by meagan.daly@duke.edu

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.

PCORnet Blog

The Unsung Role Caregivers Play in People-Driven Research

Valentine’s Day is upon us, but when you are a caregiver for someone, there’s no need for a special day to show your love. For the 43.5 million unpaid caregivers in the United States, unconditional care that goes above and beyond is a constant daily practice. It’s not a stretch to say that these caregivers are society’s unsung heroes. They are the medical schedulers, the insurance organizers, the medicine administrators, and the health care advocators. They often know the answers to dosage and symptom questions better than the patients they support. This deep knowledge makes caregivers an important, albeit often overlooked, resource for researchers.

More on Phelan-McDermid

To learn more about Phelan-McDermid Syndrome and PCORnet’s commitment to effective engagement in other rare disease research areas, check out this story:

Diversity, Communication and Trust: Three PPRNs Share the Recipe for Effective Engagement in Rare Disease Research 

To shed more light on the caregiver role and how it can improve people-driven research, we talked to Megan O’Boyle. In addition to being a caregiver to Shannon, her 17-year-old daughter with Phelan-McDermid syndrome, O’Boyle is the principal investigator for the Phelan-McDermid Syndrome Data Network, a partner network of PCORnet, the National Patient-Centered Clinical Research Network. PCORI, which was authorized by Congress in 2010, launched PCORnet as its most ambitious initiative to date. As Shannon’s caregiver, O’Boyle navigates symptoms ranging from sleeplessness to seizures and serves as her daughter’s advocate in schools, hospitals, doctors’ offices, and more.

PCORnet: Can you tell us a little background on your personal experience with research as a caregiver?

O’Boyle: When I was first getting my feet wet as a caregiver for Shannon, I noticed there were two kinds of moms: those who dove headfirst into every opportunity to move research forward and those who were overwhelmed with the massive responsibilities that often come with caregiving and consistently opted out. I was solidly in the second camp! It wasn’t that I was complacent about my daughter’s condition; no mom is. We all fight fiercely to give our child the best life possible. I wasn’t interested in research because I didn’t think the outcomes from any study would be helpful to her in her lifetime, and I wanted to put my energy instead toward helping Shannon in other ways. But the Phelan-McDermid Syndrome Foundation persisted, and I reluctantly tiptoed into the research waters. Now, here I am, years later, the principal investigator for an entire research network.

PCORnet: What changed your mind on participating in research?

O’Boyle: It was a couple of things. First, I learned that, contrary to what I initially thought, there is research going on right now that can make a tangible difference in Shannon’s life. I used to think of research in terms of “a cure.” But that’s not really how progress is usually made. There are a lot of smaller steps on the road to a cure that allow us to understand the disease more so we can improve the quality of life for our loved ones. The second thing that changed my perspective was the realization that because Shannon’s condition is very rare (only about one in 10,000 people are affected), there is a much lower awareness and motivation to propel research than there is with more common conditions, such as autism or diabetes. Phelan-McDermid syndrome caregivers are a very small group of people armed with the insights needed to bring about solutions for our loved ones. If we didn’t join forces and make our voice heard in the research community, who would?

PCORnet: How can caregivers add unique value to the research community?

O’Boyle: The value and power of caregivers has been underestimated in the past, but researchers are increasingly seeking these perspectives in research studies. Caregivers bring insights that are different from the patient perspective, but equally valuable. We tend to keep excellent records of our loved ones’ health status. While a patient may be fuzzy on what day or time a symptom occurred, we remember these things in detail. We are also extremely compliant, maybe even more so than patients. For example, I may forget to take my own prescription and think it’s no big deal, but there is no way I would let my daughter miss a treatment. Caregivers also bring a strong sense of motivation to the table. We often feel helpless watching our loved ones suffer. Research empowers us.

PCORnet: What advice would you give to caregivers who are considering research participation?

O’Boyle: Caregivers often don’t realize their own power. I hear feedback all the time from caregivers who ask, “What could I possibly offer? I’m not an expert in this disease. I’m not a doctor.” Even though you may not have gone to medical school, living with a condition day in and day out 100 percent qualifies as expert status. So, I would tell caregivers to not be intimidated by research and to recognize how valuable they are to bringing results to patients. At the same time, don’t feel as though you have to dive into the deep end of research. There are many smaller ways to participate. Even just joining a registry is a great way to help that requires very little time investment.

PCORnet: Any final thoughts?

O’Boyle: The funny thing about being a caregiver is that no one ever sets out to become one. It falls in your lap, turns your life upside down, and at that point you can shape your experience in a variety of ways. I think back now to the leaders at the Phelan-McDermid Syndrome Foundation who nudged me toward research, and I am grateful because it ignited a passion I didn’t even know was there. If sharing my story helps someone else down that same path, I’ll feel like I have paid it forward.

 

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 Leaders Accept New Roles with Research and Data Committees

The new year brought additional opportunities for network members to participate in PCORnet’s governing committees. The PCORnet Council is pleased to welcome several colleagues to new roles within the Research and Data Committees.

Keith Marsolo will now serve as chair of PCORnet’s Data Committee. Marsolo is an associate professor in the division of Biomedical Informatics at Cincinnati Children’s Hospital Medical Center. His research focuses on how to obtain meaningful insights from electronic health records at scale through the use of common data models. He is a co-investigator in the ImproveCareNow partner network as well as the PEDSnet partner network. As chair of the Data Committee, Marsolo also joins the PCORnet Executive Committee as a non-voting member.

Russ Waitman, our former Data Committee chair, will remain on the Data Committee as a member. Waitman is an associate professor of Internal Medicine, director of Medical Informatics, and associate vice chancellor for Enterprise Analytics at the University of Kansas Medical Center. He is currently the co-principal investigator for the Greater Plains Collaborative partner network.

Also joining the Data Committee as a member is Mark Weiner, assistant dean for Informatics and professor of Medicine and Clinical Sciences at Temple University’s Lewis Katz School of Medicine. Weiner is the informatics lead for Temple as part of the PaTH partner network. His research interests and work help to bridge the gap between health services research, clinical and research operations, quality improvement, and medical informatics.

On the Research Committee, we are extending a welcome to James McClay, who will now serve as a member. McClay, an associate professor of Emergency Medicine and chair of the Biomedical Informatics graduate program at the University of Nebraska Medical Center, is the Greater Plains Collaborative co-principal investigator. He is internationally recognized for his work developing innovative methods for the capture, encoding, and reuse of clinical data to improve the quality and safety of health care.

Congratulations to all of these members on their new roles!


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.

Promises Kept and New Resolutions: PCORnet’s Year in Review

As we close the door on 2017 and begin a new year, it’s a good time to ask: has PCORnet, the National Patient-Centered Clinical Research Network, a PCORI initiative, remained steadfast in its mission? We pledged to enable people to make informed healthcare decisions by conducting clinical research that is better, faster, less expensive, and more relevant to their needs than what is currently possible. How did we do? What will we work toward in the year to come? ‘Tis the season for reflection and resolutions, so let’s dive in.

Better Research Through the Common Data Model

PCORnet taps data from numerous sources, which is what makes it such a valuable tool for researchers. But having numerous data sources adds complexity, too. That’s because seven different hospitals may capture the same heart attack in seven different ways. Enter the PCORnet Common Data Model, which is the tool that helps map these disparate sources to a common language, ensuring that there is consistency. PCORnet is constantly refining its Common Data Model, and in 2017, it celebrated the release of version 3.1., expanding the Network’s capacity to do more kinds of research in areas that are often overlooked.  While the 3.1 release in 2017 was an important stepping-stone, even more exciting changes are on the horizon in 2018.

“In early 2018, we are set to
release Common Data Model 4.0,
which is going to include additional
tables where our partner networks
can store more data.

Lesley Curtis, PhD – PCORnet Data Committee Member

“In early 2018, we are set to release Common Data Model 4.0, which is going to include additional tables where our partner networks can store more data,” said Lesley Curtis, PCORnet Data Committee member. “These tables represent a big step forward for us because they will allow PCORnet to answer a broader range of questions that are important to our patient communities with greater precision.”

Faster Research Through New Data Sharing Agreement and SMART IRB

Institutional reliance forms and agreements may not be the most tantalizing piece of the clinical research pie, but they are vital in ensuring all stakeholders are on the same page when it comes to important issues like data privacy and the protection of research participants. They can also create a snag for study start-up and hinder progress if not implemented correctly with study teams and PCORnet partners. That’s why in 2017, PCORnet released a new data sharing agreement for its sites that clearly defines the standard terms that the PCORnet Coordinating Center will adhere to when it receives data from PCORnet’s partner networks. Version 2.0 of the data sharing agreement was released in May 2017.

PCORnet also worked in coordination with the National Institutes of Health’s National Center for Advancing Translational Sciences to further participate in the SMART IRB Reliance Platform. Institutional review boards were put in place to protect the rights and welfare of people participating in research. Approval of these boards is an important step in the research process, but having each site’s board review the same protocol is often time consuming, slowing down study start-up. The goal of SMART IRB is to maintain the rights and welfare of people participating in research while reducing unnecessary burdens. PCORnet has a unique opportunity to use SMART IRB within the Network, while simultaneously providing feedback and harmonizing its effort with the National Institutes of Health and other research entities.

Less Expensive Research via the PCORnet Front Door

Wouldn’t it be nice if reliable clinical research was not only faster, but also less expensive? With PCORnet’s Front Door, we are getting closer to that vision. In 2017, PCORnet opened its Front Door, offering potential investigators (including patient groups, healthcare organizations, clinicians, government, industry scientists, and sponsors) a central gateway to access and leverage PCORnet’s unique infrastructure and collaborate on patient-centered clinical research. Via the Front Door, investigators can request access to the PCORnet Distributed Research Network Operations Center to obtain aggregated data results for informing research project development. They can also find potential collaboration opportunities at a fraction of the time and cost than was previously possible. But you don’t have to take our word for it. Robert McBurney, co-principal investigator for the iConquerMS partner network, raved about his Front Door experience.

“As a user of the Front Door, we
were able to quickly reach
networks and clinics we normally
would spend weeks trying to connect with.

Robert McBurney, PhD – Co-PI, MS-PPRN, iConquerMS and CEO of the Accelerated Cure Project for MS

“I cannot overstate the tremendous value PCORnet’s Front Door provided my team of investigators. Every step of the process was thorough and efficient,” said McBurney. “As a user of the Front Door, we were able to quickly reach networks and clinics we normally would spend weeks trying to connect with.”

Research That Matters Through Collaborative Research Groups

Who should decide what questions need answering? Clinicians? Patients? Caregivers? Researchers? If we want to conduct research that is meaningful, the answer is: all of the above. That’s why PCORnet announced the launch of 11 Collaborative Research Groups in 2017. These groups, which focus on a specific disease area or community, are composed of people across multiple disciplines and are focused on looking at health challenges holistically to prioritize the research questions that will best help patients and clinicians make more informed healthcare decisions.

These groups also consider PCORnet’s infrastructure and how it can best be used to find answers to these questions. Their deep knowledge of the Network means that Collaborative Research Groups can identify funding opportunities where PCORnet is uniquely positioned to make the most impact.

Looking Ahead: a Sustainable PCORnet via the People-Centered Research Foundation

It was always PCORI’s vision for the Network to become a self-sustaining resource for the nation. To that end, in 2017 PCORnet investigators formed the People-Centered Research Foundation. This nonprofit is intended to advance and support the Network’s long-term sustainability.

PCORI’s principles of patient-centeredness and engagement are deeply embedded in the People-Centered Research Foundation, and the nonprofit boasts an all-star leadership team. Former Food and Drug Administration Commissioner Robert Califf chairs the foundation’s distinguished Board of Directors, and Kathy Hudson, former deputy director for Science, Outreach, and Policy at the National Institutes of Health, is its chief executive officer.

With these big changes already in play, 2018 is gearing up to be an exciting time for PCORnet. Stay tuned for more announcements in the coming months, and in the meantime, let’s all raise a glass to PCORnet’s productive 2017 and a healthier future to come for our nation.

 

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.

Call for Abstracts: 2018 AcademyHealth Annual Research Meeting

The 2018 AcademyHealth Annual Research Meeting (ARM) is a great opportunity to showcase PCORnet research. ARM, which will take place Jun. 24-26 in Seattle, Washington, is now accepting abstracts for panels on critical and emerging issues in health services research, policy roundtables, research panels, student posters, and abstract sessions. The abstract submission deadline is January 11th.

One of the themes highlighted in ARM’s call for abstracts is “Patient-Centered Research,” including:

  • Sharing best stakeholder engagement strategies to successfully conduct patient-centered outcomes research (PCOR).
  • Generating PCOR/comparative effectiveness research (CER) evidence within PCORnet: Challenges and Opportunities.
  • Developing new PCOR/CER methodology and strategies.
  • PCOR influence on policy and national research directions.
  • Reporting on patient-centered interventions in clinical trials.
  • Designing and testing of individually tailored interventions in research.
  • Engaging patients and families as partners in research studies.
  • Determining value of engagement in dissemination and implementation.
  • Learning lessons from PCORI research.

We hope that many PCORnet networks and studies have the opportunity to highlight their work at this conference. If your abstract is accepted, please contact Jenny Cook on the PCORnet communications team so we can highlight your work. Good luck!

 

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.