All posts by meagan.daly@duke.edu

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.

PCORnet Blog

Invisible No More: COPD PPRN Moves Research Forward to See the Full Picture

AuthorsElisha Malanga is the Chief Research Officer of the COPD Foundation, a patient-led advocacy organization dedicated to improving the lives of those affected by COPD and the prime organization for the COPD Patient-Powered Research Network (COPD PPRN). She has worked with the COPD Foundation since 2008 and has led numerous efforts including the creation of the Foundation’s peer reviewed scientific journal, Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation.

Richard A. Mularski, MD, MSHS, MCR has been involved with the COPD PPRN from inception and is a founding Co-PI. He is a senior investigator at The Center for Health Research, Kaiser Permanente; an affiliate associate professor of medicine at Oregon Health & Science University; and senior physician with board certifications in pulmonary medicine, critical care medicine, internal medicine, and palliative medicine.

Cara B. Pasquale, MPH is the director of the COPD PPRN as well as a Co-PI. She has worked with the COPD Foundation since 2014 and has helped build the overall structure and governance of the COPD PPRN and works directly with patient partners. She has 11 years of work experience in coordinating and managing projects and 8 years of public health experience including working with researchers to translate their work into policy, systematic literature reviews, and engaging stakeholders for large scale collaborations.


People living with COPD, or chronic obstructive pulmonary disease, often describe COPD as an “invisible disease” that is underdiagnosed, under researched, and underfunded. COPD is an umbrella term used to describe many lung diseases that often get worse over time, including emphysema, chronic bronchitis, refractory asthma, and severe bronchiectasis. Approximately one in five Americans over the age of 45 suffer from COPD. It is the third leading cause of death in the United States.

November is COPD Awareness Month

Ways to Get Involved:

  • Web-based platform, COPD360social.org, helps patients and caregivers unite as a community.
  • Check out online campaigns that highlight COPD stories.
  • “Go Orange” with the COPD Foundation to promote COPD awareness.

Learn more at COPDfoundation.org

To address the urgent research needs of people living with COPD, the COPD Foundation and the Center for Health Research at Kaiser Permanente Northwest founded the COPD Patient-Powered Research Network (COPD PPRN) within PCORnet, the National Patient-Centered Clinical Research Network. PCORnet is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The COPD PPRN brings together thousands of COPD patient partners and those at risk, offering them the opportunity to share their information and participate in research. To date, over 6,400 people have shared their experiences through surveys and agreed to participate in research that is meaningful to them.

Now, thanks to a collaborative effort between the COPD PPRN and another PCORnet partner network, information gaps surrounding COPD may be able to be filled quicker. In 2016, the COPD PPRN began a collaboration with the Patient Outcomes Research to Advance Learning Clinical Data Research Network (PORTAL CDRN). PORTAL brings together three leading health care delivery systems (Kaiser Permanente, HealthPartners, and Denver Health) and their affiliated research centers along with patients, clinicians, and operational leaders.

This collaboration between the two PCORnet partner networks has allowed the organizations to marry COPD PPRN patient-reported information with PORTAL’s electronic health records from participants in the Kaiser Permanente Northwest healthcare system. Electronic health records usually capture clinical information such as tests, diagnoses, and events like hospitalization. Information reported by COPD PPRN participants often includes patients’ perceptions of their quality of life (for example, whether or not they are able to go to work, how much pain they experience, or how often they are in the hospital). Combining these data sources will ensure that the experiences of people living with COPD are included in research and make the data stronger.

Collaborators at Kaiser Permanente Northwest built a system to safely allow the transfer of their data to the COPD PPRN. The COPD PPRN then integrated this data by using the PCORnet Common Data Model format. Now that the data integration is complete and validation testing successful, the COPD PPRN is exploring ways to scale the process, such as using this method in the response to funding opportunities. Ultimately, it hopes to use the process and technology it developed to link with more CDRN sites across PCORnet and other health systems.

People living with COPD, just like people with other diseases represented across PCORnet, are eager for the answers that patient-centered outcomes research might be able to provide. Large datasets that bring patients’ clinical data together with patient-reported experiences and preferences could provide researchers with the ability to develop, test, and implement better, personalized treatment strategies.


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.

Unlocking Patient and Caregiver Partnerships in Obesity Research: ObesityWeek 2017

As researchers dive into the details of obesity science, they are learning that, like most mechanisms of the human body, obesity is a result of myriad factors at play. In simpler terms, if the relationship between excess weight and the human body were to have a Facebook status, it would almost certainly be: “it’s complicated.”

PCORnet, the National Patient-Centered Clinical Research Network, a PCORI initiative, has been an integral component in unlocking what we don’t know about obesity. At ObesityWeek 2017, an international event focused on the science, clinical application, surgical intervention, and prevention of obesity, PCORnet colleagues showed attendees the latest research they’ve uncovered. Many PCORnet representatives were part of ObesityWeek, which took place on Oct. 29 to Nov. 2 in Washington, D.C. However, this recap will focus on how patient, caregiver, and other stakeholder partnerships have informed two important PCORnet demonstration studies: the PCORnet Obesity Observational Study: Short-and Long-term Effects of Antibiotics on Childhood Growth (ABX) and the PCORnet Bariatric Study.

ABX: How Will Parents Respond?

Parents and pediatricians often reach for antibiotics to treat middle ear infections, strep throat, fevers and other common ailments of childhood. But some research suggests that doing so increases those children’s risk of obesity in early childhood. The ABX Study is using PCORnet’s vast network to tap routinely collected medical data from nearly 700,000 children. The study has looked at the relationship between these children’s weight trajectory and early antibiotic exposure.

At ObesityWeek, Jason Block, principal investigator of the ABX study, shared that ABX established a cohort, or group of patients, that were exposed to antibiotics under the age of two and tracked their weight at the age of five. He presented initial results, and the study team’s next steps to explore the relationship between antibiotic use and weight gain to determine how growth patterns vary by subgroups. Final study results are expected soon.

Bill Heerman, also presented on the results of a focus group that relates to the ABX study. His research asks: even if early exposure to antibiotics does raise the risk of obesity, would parents withhold the medication? His team conducted eight focus groups at four PCORnet sites to find out. The answer? In a nutshell, probably not. In a setting of acute illness for their children, the long-term impact of obesity is not a major factor in parent decision-making. Parents placed greater value on the short-term comfort of their children than the longer-term potential risk of obesity, especially if the risk was small.

The Bariatric Study: What are Patients’ Communication Preferences for Long-Term Weight Loss Surgery?

When it comes to bariatric surgery, a type of surgery intended to achieve weight loss, it turns out that one size definitely does not fit all. PCORnet’s Bariatric Study is comparing the health benefits and safety of the three main types of weight-loss surgery patients commonly undergo today: roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy. Leveraging the PCORnet Common Data Model to organize data into a standard structure, the Bariatric Study is collecting health data from thousands of adults and hundreds of adolescents who underwent bariatric surgery in 2005 through 2015. The study is following these patients for up to five years after surgery to estimate the one-, three-, and five-year benefits and risks of each procedure. Why do we need this study? Just ask the patient co-principal investigator for the Bariatric Study, Neely Williams, who explained what it was like to be part of a diverse patient community seeking bariatric surgery in her opinion editorial in The Tennessean.

At ObesityWeek, Co-Principal Investigator David Arterburn, presented some of the initial results of the Bariatric Study. Specifically, he and his study team offered preliminary insight into which surgical procedure—roux-en-y gastric bypass, adjustable gastric banding, or sleeve gastrectomy—resulted in the most long-term weight loss based on an observation of more than 46,000 adults. Final study results are forthcoming.

Another key aim of the PCORnet Bariatric Study is to uncover patients’ communication preferences around 1) the risks and benefits of bariatric surgery; 2) which bariatric procedure to use; and 3) the optimal follow-up care after bariatric surgery. The study team is interviewing surgeons about their preferences, too. At ObesityWeek, key partners in the Bariatric Study, including the Obesity Action Coalition, organized “empathy exercises” to share some of what they have learned, allowing people to better understand some of the quality-of-life issues faced by people with obesity. They also hosted and participated in a weight bias Tweet Chat, asking patients and researchers to talk about obesity stigma and how it affects care decisions and delivery.

ObesityWeek was a success, offering many PCORnet colleagues a chance to involve patients, parents, and the larger research community in their work—a core tenet of PCORnet’s mission. If you missed the event, but would like to join the conversation, follow #OW2017 online. In addition, check back here for study updates and results.

 

 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.

2017 PCORI Annual Meeting Features PCORnet Research and Opportunities

“Delivering Results, Informing Choices.” That was the theme of the 2017 Patient-Centered Outcomes Research Institute (PCORI) Annual Meeting, and PCORI naturally wanted to showcase how its most ambitious effort to date is bringing that theme to life. That’s why it’s no surprise that PCORnet, the National Patient-Centered Clinical Research Network, was front and center at the event, which was held Oct. 31–Nov. 2 in Arlington, Virginia.

In fact, a full-day workshop titled, “PCORnet in Action: Utilizing PCORnet for Research,” was a central component of the Annual Meeting. Speakers at the workshop shared how researchers are beginning to use PCORnet the way its creators always envisioned: to ask and answer the questions that matter most to patients in a way that makes research faster and better than it has been to date.

Showcasing Studies

The workshop included three panel discussions, with the first featuring actual users of PCORnet who discussed how the Network added value to their studies. These speakers also showed how the studies are engaging patients and providers, an important part of PCORI’s mission. A highlight was Rebekah Angove, engagement director of the REACHnet partner network, who talked about her work with the Louisiana Experiment Assessing Diabetes (LEAD) study. This study is looking at how policy changes are affecting patients with diabetes in Louisiana. Angove outlined some of the strategies her study team is using to ensure that the voices of patients and clinicians are included.

Building on Angove’s discussion of patient engagement, Andrew Nierenberg, principal investigator of the Mood Network, talked about PCORnet’s ability to grow existing relationships where trust is already established.

“Trust is the engine for
adding value to a study.

Andrew Nierenberg, MD – PI, Mood Network

In fact, he said he’s seen it first-hand in his work with the Healthy Hearts Healthy Minds and Healthy Mind Healthy You PCORnet demonstration studies, which are looking at the effect of practicing mindfulness with different patient groups. “Trust is the engine for adding value to a study,” he said.

Finally, Maureen Smith, principal investigator of the ADVANCE partner network, described another PCORnet demonstration study, which is looking at ways to design a better system for managing the health information of older patients. Older patients often see multiple physicians and frequently receive health care from emergency departments and hospitals. This study allowed multiple health systems to compare the effectiveness and cost of their Case Management Programs to other health systems, while remaining de-identified. That way, if one health system showed patients with better outcomes than another, it wouldn’t be public, and yet systems could still use the information to improve their programs. Smith said that many health systems could benefit from PCORnet’s networked infrastructure and Common Data Model.

Getting to Know PCORnet Resources

The second panel discussion focused on the resources available through PCORnet. Kiely Law, principal investigator of the Interactive Autism Network, specifically called out the efforts of the PCORnet Engagement Committee, which seeks to equally and effectively engage people in research. Tim Carey, principal investigator of PCORnet’s Mid-South partner network, and Keith Marsolo, a member of the PCORnet Data Committee, presented information on other important PCORnet resources: the PCORnet Front Door, Collaborative Research Groups, the data curation process, and the Common Data Model.

The third panel discussion looked at examples of recently launched projects that are using PCORnet resources. Thomas Carton, principal investigator of the REACHnet partner network; Sara Loud, an investigator with the iConquerMS partner network; and Betsy Shenkman, principal investigator of the OneFlorida partner network, each described the experience of using PCORnet to achieve three very different aims. Carton leveraged a Collaborative Research Group to form partnerships between researchers and the Center for Disease Control and Prevention (CDC) in order to quickly develop a study proposal on curbing opioid use, while Loud shared how her team used PCORnet to quickly identify 11 sites to collaborate on a proposal for a multiple sclerosis study. Finally, Shenkman discussed how her team used the Front Door to identify potential participants for a project about hypertension.

PCORnet Plenaries and Posters

It wasn’t only during the workshop but also throughout the Annual Meeting that PCORnet leaders participated in panel discussions. Sharon Terry, co-principal investigator of the PCORnet Coordinating Center and chair of the Engagement Committee, and Stephanie Buxhoeveden, an Engagement Committee member in the iConquerMS partner network, participated in a panel discussion on giving people access to research results that matter. Both panelists stressed that patients should receive data collected during clinical studies, including their own individual patient data and full research results from the study.

PCORI’s Take on the
Annual Meeting

Wondering what PCORI thought of the Annual Meeting? Check out Executive Director Joe Selby’s blog, where he shares the moments he found most inspiring!

Poster sessions throughout the Annual Meeting also featured PCORnet work. Posters highlighted study results, as well as lessons learned from PCORnet partner networks related to topics such as community building, data linkage, and stakeholder engagement.

If you were unable to attend the PCORI Annual Meeting in person, you can watch archived webcasts of plenary and breakout sessions. Interested in PCORnet activities at the Annual Meeting? You can access presenters’ slides from the PCORnet in Action Workshop and the PCORnet posters .

 

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.

Academic Medicine Features PCORnet Partner Network OneFlorida

Florida is an ideal place to conduct clinical research in real-world settings where people receive healthcare. As the state with the third highest population in the country, Florida is known for its racial, ethnic, and geographic diversity. This makes it well suited to test how healthcare practices impact a broad range of people. However, to tap into the power of Florida’s diversity, clinicians, academic healthcare centers, and community partners need to work together.

Academic Medicine, the journal of the Association of Medical Colleges, featured a report in its November 2017 issue describing how the OneFlorida Clinical Research Consortium is joining stakeholders from across the state to make research better and faster than it is today. OneFlorida is a partner network in PCORnet, the National Patient-Centered Clinical Research Network, a PCORI initiative.

The report describes how the University of Florida, Florida State University, and the University of Miami joined forces to form OneFlorida. It also explores the network’s programs, as well as the demographic and health status of its patients.

 

 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 Opportunity Knocks: PCORnet’s ‘Front Door’ Offers Researchers Fast, Easy Access to Rich Data

PCORnet, the National Patient-Centered Clinical Research Network, a PCORI initiative, is increasingly generating buzz as a game changer in clinical research. The Network has been described in many ways: a bridge that unites patients, families, providers, and researchers; a learning health system with the power to drive more meaningful, faster, and less costly patient-centered insights; and a collaborative platform that offers researchers access to large amounts of previously untapped health data collected in everyday patient care settings.

While all of these points are important and compelling, one of the most fundamental questions about PCORnet is often overlooked: how does one actually use it?

The answer starts with PCORnet’s Front Door feature, which is now open to all interested investigators. Managed by the PCORnet Coordinating Center, the Front Door gives potential investigators, including patient groups, healthcare organizations, clinicians, government, industry scientists, and sponsors, a central gateway to reach PCORnet resources. Via the Front Door, investigators can query data, find potential collaboration opportunities, and more.  Since it launched, several researchers have already leveraged PCORnet’s rich opportunities and data assets for their studies, including research veteran Robert McBurney.

Currently the co-principal investigator for the Multiple Sclerosis Patient-Powered Research Network (MS-PPRN), iConquerMS, and CEO of the Accelerated Cure Project for Multiple Sclerosis, McBurney is no stranger to clinical research. Last year, while pursuing funding for a multiple sclerosis (MS) study, McBurney sought out the Front Door to determine if PCORnet’s resources were the right fit for the study, as well as to connect with PCORnet investigators to collaborate on study planning.

“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, and, once connected, we found ourselves diving into a wide range of data, including several interesting demographic populations that are crucial to the advancement of MS treatments.”

“I cannot overstate the
tremendous value PCORnet’s
Front Door provided my team
of investigators. Every step of the
process was thorough and efficient.

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

McBurney took full advantage of a broad range of offerings through the Front Door, beginning with compiling an official Letter of Intent for the proposed study and submitting a Request for Collaborators and a PCORnet Query. He worked closely with the PCORnet Coordinating Center to ask his research question to thousands of people across the country at the same time, seek out potential collaborators, and determine his study’s feasibility. What’s more, he accomplished all of this in a few weeks as opposed to the months-long process typically experienced without PCORnet’s help.

Melanie Canterberry, senior analyst for REACHnet, a PCORnet Clinical Data Research Network, is another user of PCORnet data. In a conversation with the Centers for Disease Control and Prevention (CDC), she learned of a need for health data to monitor and evaluate an expansion of the nation’s screening program for latent tuberculosis infection (LTBI). Canterberry found herself in the perfect position to dive into PCORnet’s resources. Her goal was to obtain baseline data about LTBI within the PCORnet Common Data Model (CDM) to establish feasibility for the CDC study.

“After a group meeting to outline the needs of the CDC, working within PCORnet allowed us to compile a set of TB/LTBI-focused preliminary results for the CDC from two CDRNs in about two to three weeks,” said Canterberry. “One success factor for us was the CDC’s well-defined needs and familiarity with medical codes used in the CDM, which allowed for efficient query development and ensured we were able to provide them with useful results to inform their study.”

As a collaborative platform and a learning health system, PCORnet is taking insights learned from McBurney, Canterberry and other PCORnet users to continuously improve the resources available to the public through the Front Door. In the meantime, the Front Door remains open to all relevant stakeholders seeking a more efficient, less costly method of clinical research. Users have the option to submit a request for Study Feasibility Review, Data Network Queries, Network Collaborators, and/or PCORnet Study Designation.

Want more information? Email us your questions or submit a request for information or consultation at frontdoor@pcornet.org. We look forward to working with you!

 

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 continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

Attending AMIA 2017? Here’s What You Need to Know

The American Medical Informatics Association (AMIA) is set to hold its biggest conference to date on November 4-8, 2017, in Washington, DC. Numerous PCORI and PCORnet colleagues will be there sharing leading-edge scientific research. AMIA’s 2017 Annual Symposium will host over 100 scientific sessions, presenting work spanning translational bioinformatics, clinical research informatics, public health informatics, and more. This year, the symposium revolves around the theme “Precision Informatics for Health: The Right Informatics for the Right Person at the Right Time,” which speaks to the heart of PCORnet’s people-centered mission.

Are you attending the meeting? Please support your PCORI and PCORnet colleagues by joining the sessions listed below. You can also download the schedule, follow and continue the conversations online @AMIAInformatics #AMIA2017.

Presenter What When
Hossein Estiri Applying unsupervised learning to characterize rare observations in clinical data: the DQe-p tool Monday, November 6: 10:30-10:48am
Gunston
Jeffrey Klann Web-Service-Enabled Apps for Research: SMART-on-FHIR for OMOP and PCORNet   Monday, November 6: 11:00-11:30am
Lincoln West
Keith Marsolo Laura Qualls
Bradley Hammill Jeffrey Brown
The PCORnet Learning Cycle Tuesday, November 7: 8:30-10:00am
International Ballroom West
Jon Puro Social and Behavioral Determinants of Health: Fundamental Informatics Challenges for Enriching Health IT Systems Tuesday, November 7: 1:45-3:15pm
Georgetown
Jeffrey Klan Reuse of PCORnet Data to Support the Precision Medicine Initiative: Data Model Harmonization Tuesday, November 7: 2:21 PM–2:39 PM
International Ballroom Center
Jiang Bian Implementing a Hash-based Privacy-Preserving Entity Resolution Tool in the OneFlorida Clinical Data Research Network Tuesday, November 7: 5:00-6:30pm  Columbia Hall
Casie Horgan Standardization of Prescribing Data in PCORnet: RxNorm Concept Unique Identifiers in Multi-Site Research Tuesday, November 7: 5:00-6:30pm  Columbia Hall
Levon Utidjian Developing Computable Phenotypes of Pediatric Chronic Conditions in PEDSnet Wednesday, November 8: 11:42-12:00pm
Jefferson East


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 continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

PCORnet Blog

Matching Patients to Clinical Trials for People Affected by Hereditary Cancers

Author: Sue Friedman, DVM, is Executive Director for Facing Our Risk of Cancer Empowered (FORCE) which is a lead organization in PCORnet’s ABOUT Patient Powered Research Network (PPRN).  Friedman is a Co-Principal Investigator for ABOUT.

It’s an exciting time for hereditary cancer research as the pace of new personalized medicine treatments and targeted therapies has increased. But for these new therapies to translate into better health, they must be tested on specific populations through clinical trials. Unfortunately, less than 5% of adults with cancer enroll in clinical trials and about a fifth of adult cancer clinical trials fail to recruit enough participants to complete the research.

Matching patients to clinical trials for prevention, detection and treatment is even more challenging for groups that are a subset of a larger disease population, such as people with, or at high risk for hereditary breast, ovarian, pancreatic, melanoma and prostate cancers (HBOC) such as those enrolled in the ABOUT Network.

ABOUT is a PPRN within PCORnet, the National Patient-Centered Clinical Research Network. PCORnet is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). ABOUT grew out of the work of a national nonprofit advocacy organization for individuals and families impacted by HBOC — Facing Our Risk of Cancer Empowered, Inc. (FORCE) — and a multiyear collaboration between FORCE and hereditary cancer researchers at the University of South Florida Morsani College of Medicine.

In 2015, FORCE, received a Celgene Innovative Impact Award to develop more HBOC patient-friendly resources to help our community learn about, and enroll in specific clinical trials. The project used the resources of ABOUT to engage in a pilot program that sought to improve clinical trial participation for hereditary breast and ovarian cancer by identifying patients’ information needs around clinical trials and developing patient-friendly education and clinical trial matching materials. The project had three key components: a survey, a custom research matching database and educational tools.

Community voice on research participation
The community engagement survey we designed for this project included over 1,100 cancer survivors and “previvors” (high-risk individuals who are survivors of a predisposition to cancer but who haven’t had the disease.) Not surprisingly, the results indicated that the technical language of clinical trials and the challenge for patients to determine whether they are eligible present substantial barriers. Many participants also expressed frustration that they did not get to learn the results of the research study in which they participated. Dissemination of research results is an active area of focus for FORCE and ABOUT and when we collaborate with researchers, we help them share their results back to the community.

Research study search tool
The project’s second component is our new and improved research study search tool. It searches two databases for studies enrolling people with HBOC: clinicaltrials.gov and FORCE’s own custom study database which is enriched with studies enrolling people with or at high risk for hereditary cancer. Users can look up studies by type:

  • Treatment
  • Prevention and detection
  • Risk assessment
  • Quality of life and wellbeing
  • Registries, surveys and interviews

Searches may also be sorted by the type of cancer, specific genetic mutations, tumor markers and keywords.

Click to Enlarge Image: Screenshot of research study search portal.

The tool provides an easy-to-read, user-friendly description of the study, which defines inclusion and exclusion criteria, an overview of what is expected of participants, information about enrolling sites and the study contact information. The dynamic glossary feature provides definitions of research terms without leaving the webpage. All of these easy-to-read and user friendly features help address the challenges that survey respondents expressed regarding technical language and complicated eligibility criteria. Making the tool easily searchable by different categories helps reduce the difficulty of matching patients to clinical trials.

Click to Enlarge Image: Example of user-friendly study detail page

Educational resources
The third component, which also focuses on eliminating the barriers mentioned in the survey,  is the development of new educational resources about:

  • Why you should consider enrolling in research
  • How to find research studies for which you are eligible
  • Legal protections for participants
  • Glossary
  • Frequently asked questions about clinical trials.

We are now developing training modules so that our 200 volunteers can assist patients in using the tool and direct them to additional resources.

We are already integrating the research study search tool we developed through this project into ABOUT efforts, for example our most recent ABOUT participant newsletter included a “featured research” link to the study portal we created. ABOUT is also using what we learned through this project to inform people about the Athena WISDOM Study, a PCORI- funded study that aims to determine whether we can improve breast cancer screening by incorporating risk assessment into the process.

Athena WISDOM Study

The Athena WISDOM Study is a PCORI-funded study that aims to determine whether we can improve breast cancer screening by incorporating risk assessment into the process.

  • Read PCORI’s Blog Post on the Athena WISDOM Study. 

A patient advocate who was trained by FORCE has been actively engaged in the WISDOM study team, from writing its grant, planning recruitment efforts and participating in the future dissemination of study results. We are also excited about using our matching tool to enroll participants in the PCORI funded “Healthy Mind, Healthy You: A Study of Mindfulness” Cross-PPRN study.

We are well on our way to achieving our goal to better target study promotion to the most appropriate audiences and track use and outcomes. Ultimately, we hope that this work will further the mission of PCORI and PCORnet and bring patients and researchers together. Stay tuned for updates over the next year!


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 continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

PCORnet Executive Committee Welcomes Three New Members, Names New Chair

The PCORnet Council, the main governing body of PCORnet, has approved the slates for PCORnet’s Executive Committee, welcoming three new committee members and appointing a new committee chair.

Kiely Law, research associate in the Department of Pediatrics at the Johns Hopkins School of Medicine and co-founder of the Interactive Autism Network (IAN), has joined the Executive Committee. Advancing autism spectrum disorder (ASD) research is both a professional and personal mission for Dr. Law. In 1996, her son was diagnosed with autism at the age of three, giving her personal insight into the unique value of information collected directly from those living with the struggles and triumphs of autism every day.

The Executive Committee also welcomed Kathleen McTigue as a new member. She is an associate professor of medicine and epidemiology at the University of Pittsburgh and a general internist whose research has focused on the epidemiology of obesity and on using technology to provide evidence-based and patient-centered care. Dr. McTigue is also the lead principal investigator of the PaTH Clinical Data Research Network and a co-principal investigator of the PCORnet Bariatric Study, one of the first PCORnet observational studies.

Elizabeth Shenkman, chairperson for the Department of Health Outcomes and Policy and director of the OneFlorida Clinical Research Consortium, is another new Executive Committee member. Dr. Shenkman’s research focuses on determining which combinations of health care delivery, community, and patient factors influence quality and outcomes of care, as well as developing corresponding evidence-based strategies to improve health outcomes.

In addition to welcoming these new members, the Executive Committee also congratulates Russell Rothman on his appointment to the committee’s chair position. Dr. Rothman is a professor of Internal Medicine, Pediatrics and Health Policy, director of the Vanderbilt Center for Health Services Research and chief of the Internal Medicine/Pediatrics Section. He is also the principal investigator for the Mid-South Clinical Data Research Network and co-chair of the Steering Committee of the ADAPTABLE study. His research focuses on improving care for patients with diabetes, obesity and other chronic diseases.

Congratulations to all on these new appointments!


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 continually seeking input from a broad range of stakeholders to guide its work. More information is available atwww.pcori.org.

PCORnet Leaders Speak Out at Public Workshop to Further Use of Real-World Evidence

The Duke Margolis Center for Health Policy and U.S. Food and Drug Administration (FDA) recently hosted a public workshop to discuss how to effectively use real-world evidence (RWE) – the insights gleaned from information collected outside of a clinical trial, such as electronic medical records—in drug development and regulatory decision-making. PCORI and its innovative initiative, PCORnet, the National Patient-Centered Clinical Research Network, were front and center at the event, with several of our renowned experts sharing how PCORnet is ready to put RWE practices into action and propel healthcare forward.

The opportunity: a living textbook of medicinal products
With RWE, there is a massive opportunity to achieve a totality of information that a single study or trial will never allow, said Dr. Adrian Hernandez, director, Health Services and Outcomes Research, Duke Clinical Research Institute (DCRI) and panel participant at the workshop. He added that by partnering with the FDA and other stakeholders to develop the right framework for using real-world data (RWD) such as electronic medical records, we can more effectively use RWE to complement other kinds of research and create a living textbook about medicinal products and the experiences of patients who use them.

Dr. Hernandez was a panelist at the workshop’s session that spotlighted matching RWE to regulatory use cases. To illustrate how RWE can fill crucial knowledge gaps, he used a personal example: his own mother, a premature coronary disease patient who wants to help other patients like her but finds clinical trials inconvenient for her lifestyle. Dr. Hernandez explained how pragmatic clinical trials like PCORnet’s ADAPTABLE study are engaging participants electronically to better suit patients’ lifestyles and needs.

According to Dr. Hernandez, another key element to effectively leverage RWE lies in understanding the benefit to risk ratio. By creating a parallel system that addresses safety and benefits that matter to patients (e.g. will this improve my quality of life, not just length of life?), we can create a learning healthcare system where patients, clinicians, healthcare systems, and regulators use RWE to generate outcomes that matter most to patients.

 

 

 

 

 

 

 

 

 

 

Joe Selby, executive director, PCORI, also spoke at the workshop, discussing how to chart a collective path as we move forward with the use of RWD and RWE. He shared key elements he believes are essential to the future success of RWE.

 First, he touched on the importance of data linkage and bringing stakeholders and partners together to understand data. He also discussed the need for a societal change. Patients must become aware of barriers to improving their care and have platforms where they can use their own voices to solve these issues.

Dr. Selby also stressed that we aren’t going to learn anything unless we actually dive in and start doing research. Take, for example, PCORnet demonstration studies. Aimed to answer critical research questions, demonstration studies give researchers a chance to compile a list of learnings and trail blaze a new path for collecting data. PCORI is currently funding several of these demonstration studies.

Dr. Selby also touched on standardization and the need to bring stakeholders together to discuss measures that haven’t yet been incorporated into any common data model. He closed with a mention of the need to develop an infrastructure to conduct pragmatic trials in the real world, something that PCORnet and its teams have in their sights for the coming years.

By closing gaps in data, we will close gaps in care
Dr. Kevin Haynes, clinical epidemiologist in translational research for HealthCore, a PCORnet Health Plan Research Network, was a panelist at the workshop highlighting the development of fit-for-purpose RWD. Throughout his discussion, he stuck to a common theme: “We need to close the gaps in data necessary to close the gaps in evidence and ultimately gaps in care.”

We need to close the gaps in
data necessary to close the gaps
in evidence and ultimately gaps in care.

Dr. Kevin Haynes – Clinical Epidemiologist, HealthCore

Dr. Haynes stressed the need to integrate data, and he proposed two forms of data that must be linked: longitudinal data, such as Medicare data, and the data that is held deep inside a clinical system over defined periods of time that is unavailable to today’s administrative claims. HealthCore is one of two PCORI-funded health plan networks partnering with PCORnet’s CDRNs and PPRNs to take the lead in developing a stepwise approach toward successful linkages of claims and EHR data.

You can find additional information about the regulatory use of real-world evidence in this white paper, which both Adrian Hernandez and Richard Platt, co-Principal Investigator of PCORnet’s Coordinating Center, helped compose as contributing authors.

Were you unable to catch the event? Watch the webinar recording and see what you missed!

 

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 continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.