All posts by laura.oldham@duke.edu

PCORnet Joins Forces with Sentinel to Link Data for More Robust Public Health Research

What if the National Patient-Centered Clinical Research Network (PCORnet) teamed up with another robust distributed research network to combine powers in the pursuit of clinical research? Could researchers use the linkage to enhance complete data for surveillance and glean insights that allow people to make better informed, evidence-based decisions on important health-related matters? A new collaboration seeks to answer these questions.

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) are demonstrating the value of data linkage between PCORnet—one of PCORI’s most innovative initiatives to revolutionize clinical research—and other disparate distributed networks, such as the FDA’s Sentinel program. While PCORnet predominantly contains Electronic Health Record (EHR) clinical data, Sentinel uses claims data to monitor the safety of regulated medical products, including drugs, vaccines, biologics, and medical devices. Both EHR and claims data offer valuable insights that, when combined, allow for a more complete picture of overall health. Altogether, this collaboration seeks to advance patient-centered research in regulatory science and enhance patient-clinician decision-making.

“We are delighted to be teaming up with the FDA, the Sentinel Initiative, and Reagan-Udall Foundation for this exciting and promising initiative that speaks to the future of patient-centered research and PCORnet’s value with researchers and other stakeholders,” said Joe Selby, M.D., M.P.H., executive director of PCORI. “Collaborations like this will be essential if we’re going to transform traditional clinical research, conduct definitive studies, and put people and other healthcare stakeholders in the driver’s seat to enable better informed healthcare decisions.”

The two pilot projects began in November 2016 and involve researchers in partnership with PCORnet’s OneFlorida Clinical Data Research Network and Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN).

OneFlorida Project: Planning for Congenital Zika Syndrome Surveillance in PCORnet and Sentinel

The first project focuses on leveraging EHR and claims data to reduce transmission rates of the mosquito-borne Zika virus. 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. This project is working to develop a strategy for tracking the number of babies born with microcephaly within OneFlorida’s Clinical Data Research Network. Ultimately, the project team will categorize database information on infants born with microcephaly and work with the Sentinel team to enhance surveillance of congenital Zika syndrome.

CAPriCORN Project: Initiatives to Monitor Exposure to Antimicrobials in PCORnet and Sentinel (DataMIME)

The second pilot project seeks to harmonize data on usage of antimicrobials, which include drugs such as antibiotics, antivirals and antifungals. Because most bacteria, viruses, and other microbes multiply rapidly, they can quickly evolve and develop resistance to antimicrobial drugs, making it challenging to treat and control the spread of infections from multi-drug resistant organisms. This project will use the PCORnet Common Data Model to develop an open source methodology that can help the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network, the FDA’s Sentinel program and local hospital administrations detect and analyze pathogen trends and understand how best to minimize antimicrobial resistance.

 

The FDA and PCORI are providing separate funding for both pilot projects, which are expected to conclude in autumn of 2018.

 

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.

Creaky and Creative: AR-PoWER Captivates Audiences with Fun and Interactive Engagement Approaches

May is National Arthritis Awareness Month, a time to raise awareness about the number one cause of disability in the country: arthritis. According to the Arthritis Foundation, more than 50 million adults have doctor-diagnosed arthritis, and by the year 2040, that number is expected to grow to more than 78 million. A Patient-Powered Research Network (PPRN) for the PCORI-funded National Patient-Centered Clinical Research Network (PCORnet), AR-PoWER is using its unique and engaging voice to communicate with audiences through witty social media posts and creative events to increase awareness about arthritis and get individuals and communities involved in the movement toward improving the lives of those living with arthritis.

Created by CreakyJoints, the online, nonprofit patient support community for arthritis patients, AR-PoWER is the first ever patient-led, patient-centered research registry for arthritis, bone, and inflammatory skin conditions. AR-PoWER is designed to provide patients with a collaborative online platform to help combat joint, bone, and skin diseases; however, this registry is taking its work a step further. From clever Facebook and Twitter posts to eccentric fashion shows, AR-PoWER is redefining what it means to effectively connect and engage with audiences. Its newest addition? The launch of an optimized, interactive app designed to help patients continuously stay connected within the arthritis community and stay up to date on arthritis research through features that allow them to track their symptoms, medications and medical history and even capture biosensor data to monitor well-being.

With thousands of loyal Twitter followers, CreakyJoints is clearly doing something right within the social media landscape, so we welcomed the opportunity to sit down with social media guru for CreakyJoints and AR-PoWER, Joe Coe, to discuss tips and tricks to help other PPRNs and CDRNs boost their social media presence.

“Knowing how to effectively communicate your organization’s message on social media is one of the most important tools to have in your online arsenal. The best way to reach your audience is to meet people where they are already at, and today, that’s social media,” said Coe. “Simply posting on Facebook or Twitter whenever you get the chance isn’t enough. You have to find a unified voice for your organization and use it to build trust with your audience. Remember to be creative and take risks, and most importantly, remain adaptable. The online sphere is constantly evolving; what works for you today may not work for you tomorrow.”

In 2017, 81 percent of the population in the U.S. reported owning a social networking profile. That means that for organizations looking to engage audiences, the ability to navigate social media with savvy is crucial. Coe further elaborated on how other PPRNs like AR-PoWER can build a strong social media presence, including the following tricks of the trade:

  • Social media is a visual medium—be sure to share visually stimulating images or graphics.
  • Stay up-to-date on trending hashtags other healthcare organizations are using to capture those audiences in your posts. Not sure what those are? Check out Symplur, a free platform that connects you to the daily top trending hashtags in healthcare.
  • Stay away from jargon and use language that is accessible.
  • Keep it short and sweet—communicate your message in two or three sentences.
  • Take risks! Clever or witty posts are excellent at engaging audiences.

Are you interested in learning more about how to effectively engage audiences through social media? Be sure to attend our Social Media Best Practice Sharing Session (BPSS) June 8, 2017 at 11:00 am EDT designed to help PCORnet’s Partner Networks effectively use social media to elevate their profile and boost audience engagement.

 

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.

A Look into PCORnet’s Coordinating Center: Harmonizing Data Across a Vast Network

At the center of the National Patient-Centered Clinical Research Network (PCORnet), PCORI’s most ambitious initiative to date, lies the PCORnet Coordinating Center, a hard-working engine that combines three prominent research organizations, Duke Clinical Research Institute, Genetic Alliance, and Harvard Pilgrim Health Care Institute, to effectively manage the entire Network’s data and engagement activities. The Coordinating Center takes on everything from coordinating PCORnet’s operational activities to supporting and collaborating with PCORnet’s vast Partner Networks, comprised of Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs), to help them pursue PCORnet’s goal of moving toward a continuous learning healthcare system. But how do they do it?

In this blog, we take a closer look at one component of the Coordinating Center, the PCORnet Distributed Research Network Operations Center (DRN OC). The DRN OC performs many activities to strengthen PCORnet’s data infrastructure, but today we will focus on its efforts to harmonize data across our Network.

“The tremendous effort undertaken on a quarterly basis by PCORnet’s DRN OC and PCORnet’s data contributing sites is an excellent example of the collaborative nature of this Network.” said Darcy Louzao, operation lead of the DRN OC. “It is a process that continues to strengthen PCORnet’s data for the conduct of more efficient, high quality research studies.”

To fully understand how the process works, let’s start with some background. PCORnet is a distributed research network, which means that the data it leverages is not centralized in one location; rather, it allows each institution to remain in control of its data to safeguard patient privacy. Data—such as date of birth, blood pressure, or diagnoses—are harmonized across multiple locations so that when a researcher asks a question, such as “How many patients have high blood pressure?” CDRNs can all answer the question in the same way. Maintaining a distributed research network requires substantial and ongoing effort. One healthcare system in the Midwest might chart a patient’s high blood pressure in an entirely different way than another system in the Northeast, which would lead to inaccurate research results without harmonization. What seems like an easy question can quickly become complicated. So how can you ask a research question to hundreds of institutions and get back meaningful, trustworthy results to improve clinical decision-making?

The answer starts with PCORnet’s more than 80 data contributing sites, which act as the data sources for PCORnet’s CDRNs. These data contributing sites standardize their data to the Common Data Model (CDM) so that it all maps to the same consistent format. By undertaking this step, the DRN OC creates a platform that enables much more rapid responses to research questions. In order to maximize the value and quality of PCORnet’s data to researchers, the DRN OC then collaborates with each data contributing site to curate the data via quarterly reports that offer a comprehensive look at trends and ensure each data contributing site is correctly standardizing their data to the CDM.

The program we use to curate our data generates nearly 10,000 output tables every quarter. These tables consist of raw data that document patient encounters (such as electronic health records, claims, and administrative data) from each data contributing site. A program developed by the DRN OC then converts the information populating these tables into unique reports for each network that include summary tables and trend charts. This report is useful for both the data contributing site and the DRN OC to review to identify opportunities for continual quality improvements. For example, a trend chart from this report that illustrates data longitudinally and can easily identify outliers, which may indicate an error in how data were standardized to the CDM. Thus, in addition to ensuring PCORnet researchers have access to quality data, the DRN OC is helping our data contributing sites better understand and learn from their own data.

 

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.

Health Datapalooza Conference Session Highlights Patient Roles in PCORnet

When Heather Siefers visits her doctor to discuss her Multiple Sclerosis (MS), her doctor will tell her about the data from her lab tests and measures such as her liver function, blood pressure and weight. However, Siefers asks: shouldn’t data on quality of life indicators be captured alongside clinical data? She is also interested in capturing data on how long she has slept (or not slept) and how often she experienced numbness in her legs or memory fog.

This critical question about the types of data most important to patients as well as other important questions were explored in-depth when Siefers, a patient representative on PCORnet’s Data Committee, joined other patients and researchers last week at Health Datapalooza, an event held in Washington, D.C. that brings together a diverse audience of over 1,600 people from the public and private sectors to learn how health and health care can be improved by harnessing the power of data.

The National-Patient Centered Clinical Research Network (PCORnet), a PCORI initiative committed to furthering people-centered research and driving meaningful patient outcomes, hosted a panel discussion at the conference: “PCORnet, a PCORI Initiative: Integrating the Patient’s Voice in Data Network Development.” This session featured:

This session addressed how to incorporate the patient voice in data sharing and data governance while developing a collaborative research experience.

Jim Uhrig (top left), Lesley Curtis (top right), Heather Seifers (bottom left), and Lewis Raynor (bottom right) participate in PCORnet panel discussion at Health Datapalooza.

Uhrig discussed the patient role in creating the My Path Story Booth Project, a project modeled off of NPR’s StoryCorps, which allows patients and caregivers to record a conversation to share with researchers so they can better understand peoples’ experiences with health and illness.He also discussed patient involvement with PATH’s Network Protocol Review Committee, which facilitates a single Institutional Review Board (IRB) process for patient-centered research involving multiple health systems. An IRB is a type of committee used in research that formally approves, monitors, and reviews biomedical and behavioral research and assures that the rights and welfare of participants in studies are protected.

This committee includes a patient representative and investigator from each of the PaTH institutions. Patients and investigators discuss how research norms differ across institutions and help to promote learning by IRB staff at participating sites as well as suggest protocol improvements.

Raynor discussed the role of the CRGs in developing a patient-centered data infrastructure for PCORnet. The Health Disparities CRG focuses data infrastructure development on elements in the PCORnet Common Data Model (CDM) that pertain to social determinants of health, including ethnicity and race, and works to propose additional elements to the CDM that would facilitate research on safety net and vulnerable populations. Patients are involved at every level of decision-making for this CRG.

Siefers spoke about her role on the PCORnet Data Committee, which oversees PCORnet’s data network and advances informatics and research data innovations that support PCORnet’s goals. Although professionally she has experience collecting and analyzing data as a microbiologist, she came to her role on the PCORnet Data Committee with no experience coding data. After an initial learning curve of feeling like she did not understand her role, Siefers now recognizes that her contribution is not in the design of a data system but making sure the patient “voice” is incorporated into the data system design and that it supports the PCORI mission. Posing questions about the importance of quality of life data is one example of why the patient voice is crucial throughout PCORnet governance.

Lesley Curtis served as a moderator, posing and fielding questions for panelists. Curtis and other PCORnet leaders also spent time at Health Datapalooza meeting with government and industry representatives at a breakfast session which highlighted how PCORnet and its Front Door can help advance patient-centered research.

The panel discussion and networking opportunities at Health Datapalooza offered PCORnet the opportunity to highlight the important role of patients throughout the research process and to further its mission to enable people to make informed healthcare decisions by efficiently conducting clinical research relevant to their needs.

You can follow the discussions at Health Datapalooza on twitter using the hashtag #hdpalooza.

 

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.

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.

PCORnet Blog

Health Systems & PCORnet: Working Together to Answer Crucial Questions

Authors:

Rainu Kaushal, MD, MPH, is the chair of the Department of Healthcare Policy and Research, executive director of the Center for Healthcare Informatics and Policy (CHiP), executive director of the Health Information Technology Evaluation Collaborative (HITEC), and the Nanette Laitman Distinguished Professor of Healthcare Policy and Research at Weill Cornell Medicine. She is the principal investigator of the New York City Clinical Data Research Network (NYC-CDRN), the Health Policy, Health System, and Public Health Collaborative Research Group, and a PCORnet Demonstration Study: “Identifying and Predicting Patients with Preventable High Utilization.”

Alex Low is the Project Manager of the NYC-CDRN.

The Patient-Centered Outcomes Research Institute (PCORI) funds Demonstration Studies to prove the capacity of its most ambitious endeavor, the National Patient-Centered Research Network, PCORnet, while answering critical research questions. Demonstration Studies fall into one of four initiatives: Interventional Studies, Obesity Observational Studies, Patient-Powered Research Network (PPRN) Studies, and Health Systems Studies. Health Systems Studies test PCORnet’s ability to engage health systems leaders and clinicians across Clinical Data Research Networks (CDRNs); to do focused and agile research that leverages the Common Data Model (CDM) and new health system data; and to do analyses rapidly and iteratively with systems leaders to facilitate their development of learning healthcare systems. Learning healthcare systems, as defined by the Institute of Medicine (IOM), are designed to emphasize a collaborative approach that shares data and insights across boundaries to drive better, more efficient medical practice and patient care. This guest blog examines many of the activities and key questions that are most important to the health system leaders working on these studies.


As strong advocates for efficient and effective working relationships between PCORnet and health systems, we see a significant benefit to both parties that should motivate them. PCORnet is dedicated to advancing learning health care systems and generating patient-centered, actionable evidence—making health systems a required partner for its activity. Meanwhile, health systems need high quality evidence as well as access to analysis-ready, comprehensive, longitudinal data sets to better characterize, compare, and understand their populations. Currently, more than 100 healthcare organizations participating in PCORnet allow for exploration of these opportunities.

PCORI and the National Academy of Medicine (NAM) have recognized the value of this symbiotic relationship, co-sponsoring several national meetings with leaders from health systems and PCORnet over the last few years to discuss the potential value of big data networks like PCORnet to answer questions of importance to health systems. Together with other principal investigators from PCORnet, we have taken a leading role in helping organize these meetings. The efforts started with two workshops in 2014 that were part of the Roundtable on Value and Science-Driven Health Care, and continued with two meetings in 2016 that were part of Accelerating Clinical Knowledge Generation and Use.

Themes and opportunities that emerged from those meetings included the importance of (a) timely dissemination of data; (b) key roles for health system leadership in PCORnet; (c) an integrated, national clinical data infrastructure; (d) linking health care delivery data to health plan data; and (e) establishing partnerships between research and clinical practice. Health system leaders helped to identify the topics where they could best leverage a data resource like PCORnet, their data requirements, potential extensions to the PCORnet CDM, and opportunities for engagement. They discussed the importance of embedding research into the delivery of care and then creating a feedback loop so health systems can rapidly adopt those insights—all important aspects of a learning healthcare system.

Some of the key research themes and opportunities emerging from these meetings and subsequent discussions have included:

  • Identifying and managing high healthcare utilizers
  • Identifying and managing the needs of specific populations by diagnoses (e.g. behavioral health) or patient characteristics (e.g., socioeconomic status)
  • Comparative performance of alternative models of healthcare delivery (e.g. ACOs)
  • Novel analytical tools and methods (e.g. risk adjustment and predictive modeling)
  • Assessment of value in healthcare (including quality, safety, and utilization)
  • Collection of social determinants of health data
  • Assessment of ways to link PCORnet data to other data
  • Clearinghouse of health care delivery practices and outcomes
  • Dissemination science

PCORI has already put some of these themes into practice by funding health systems planning activities across PCORnet. During the six-month period, the CDRNs interviewed hundreds of health system leaders, clinicians, patients, and others from across the country to identify their priorities for using PCORnet and the research topics that would provide them with the most value. This process led to rich guidance that subsequently informed an initial set of four health system demonstration projects. We are leading one of those projects, which is focused on characterizing patients with preventable high utilization in New York City, Florida, and Chicago. In parallel, we are working with Elizabeth Shenkman, PhD, co-principal investigator for the PCORI-funded OneFlorida CDRN, to lead the PCORnet Health Systems, Health Policy, and Public Health Collaborative Research Group (CRG), which is bringing together researchers, health systems, patients and others to identify and develop fundable research proposals leveraging PCORnet and expanding the CDM.

These are important steps. The next challenge will be developing an ongoing framework for collaboration among health systems and CDRNs at the national level. To advance this framework, we continue to welcome input from all stakeholders on ways in which they can leverage PCORnet for health system projects, and especially welcome your participation in our CRG. Please reach out to Rainu Kaushal at rak2007@med.cornell.edu if you’re interested in joining. By leveraging PCORnet to integrate data capture for health care delivery and ongoing research, health systems can advance the concept of learning health systems, thereby driving research, operational, and policy agendas and improving healthcare delivery for patients on a wide scale.

In a recent video, Rainu Kaushal discusses the importance of how PCORnet provides robust, research-ready data for health system leaders to improve healthcare and delivery of care.

 

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.

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.