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PCORI funded the development of PCORnet^®, the National Patient-Centered Clinical Research Network, to make it easier and more efficient to conduct research. PCORnet is made up of Partner Networks that harness the power of large amounts of health data and patient partnerships.

Patient-Powered Research Networks (PPRNs) are networks operated and governed by patients, families, caregivers, and community members in close collaboration with clinical researchers, with the goal of shaping and conducting research to better serve their communities and improve their health outcomes. Several PPRNs, including IBD Partners, participated as Partner Networks in PCORnet.

PCORI funded IBD Partners’ participation in PCORnet from 2015 to 2019. This report outlines IBD Partners’ achievements in building its research infrastructure capacity to

1. Create ways to involve patients, families, and caregivers in decision making about the network
2. Create a way to collect and share data reported by patients for research
3. Involve patients, caregivers, families, and communities in the research process, including recruiting people to participate in research studies
4. Lead or join in research studies that focus on the community’s priorities

Network at a glance

IBD Partners was created to focus on patients with Crohn’s disease and ulcerative colitis. These two health problems are also called inflammatory bowel disease, or IBD. Patients with IBD have chronic inflammation of their gastrointestinal tract. The PPRN is a virtual network led by the University of North Carolina at Chapel Hill. The network consists of patient members from across the United States.

How does the network operate?

IBD Partners collected data from patient members through online surveys and a patient portal. Surveys collect data on patients’

• Personal characteristics
• Disease characteristics
• Health behaviors
• Symptoms and quality of life related to IBD

Using health apps and devices, the network also collected data on fitness, nutrition, sleep habits, and weight.

IBD Partners created ways to make it easier for the PPRN to manage small and low-risk studies.

How did the network involve patients and other partners?

IBD Partners established a Patient Governance Committee that included six patients who

• Helped develop the network’s mission
• Helped the research focus on what matters to patients with IBD
• Reviewed proposed studies
• Created policies related to informed consent and privacy protections
• Enhanced communication among patients in the network
• Reviewed input from patients in the network

The Patient Governance Committee met monthly.

IBD Partners also created a Project Selection Committee. The committee included researchers, doctors, foundation representatives such as individuals from the Crohn’s and Colitis Foundation, and patients. Twice a year, the committee reviewed research proposals that request use of network data.

IBD Partners required all projects to include a patient on the research team. Research teams could either find their own patient or include a patient from the Patient Governance Committee. Patients worked with the research team to create a plan for getting the word out about the results for each study.

Patient members of IBD Partners used the network’s patient portal to suggest, vote on, and discuss research ideas.

Who is in the network?

As of March 2019, 18,318 patients were part of IBD Partners.

While a Partner Network in PCORnet, IBD Partners participated in 52 research studies.

How does the network support future research?

Other networks can use the data collection and management tools that IBD Partners created.

IBD Partners has funding from the Crohn’s and Colitis Foundation to continue its work through the end of 2019. The foundation will also maintain survey systems through the end of all currently funded PCORnet projects.

Glossary

Patient-Powered Research Networks (PPRN): PPRNs are operated and governed by patient groups and their partners and are focused on particular conditions or populations.

PCORnet: PCORnet is a network of networks that brings together patients, clinicians, researchers, and healthcare systems to share information and participate in research.

Overview

PCORI funded the development of PCORnet^®, the National Patient-Centered Clinical Research Network, to make it easier and more efficient to conduct research. PCORnet is made up of Partner Networks that harness the power of large amounts of health data and patient partnerships.

Patient-Powered Research Networks (PPRNs) are networks operated and governed by patients, families, caregivers, and community members in close collaboration with clinical researchers, with the goal of shaping and conducting research to better serve their communities and improve their health outcomes. Several PPRNs, including IBD Partners, participated as Partner Networks in PCORnet.

PCORI funded IBD Partners’ participation in PCORnet from 2015 to 2019. This report outlines IBD Partners’ achievements toward the PPRN goals of developing and optimizing research and engagement infrastructure capacity to

• Establish a governance structure that fully engages patients and other stakeholders for the purposes of contributing to research
• Create a data infrastructure conducive to the ongoing collection of patient-reported data
• Meaningfully engage patients, caregivers, families, and community members in the research process, including identifying and recruiting participants for clinical trials and other research studies
• Lead or partner in the conduct of comparative effectiveness studies responsive to the research priorities of their communities

Network Infrastructure

IBD Partners was created to focus on patients with Crohn’s disease and ulcerative colitis, collectively called inflammatory bowel disease (IBD). Coordinated by the University of North Carolina at Chapel Hill, the PPRN was a virtual network that included patient members from geographically diverse areas across the United States.

Network Governance and Operations

IBD Partners primarily collected data from patient members through surveys administered online and through a patient portal. Surveys collected patients’ names and contact information as well as demographic information, disease characteristics, health behaviors, disease outcomes, and other patient-reported outcomes. Where possible, survey items were based on validated instruments. The network also collected data about fitness, nutrition, sleep habits, and weight; data were imported from third-party apps and devices.

The network created processes to review and manage small and low-risk studies with minimal regulatory and management burden. For example, the network sought to modify existing IRB applications rather than create new ones.

Stakeholder Engagement

IBD Partners established a Patient Governance Committee (PGC) composed of six patients who

• Contributed to the development of the PPRN’s mission
• Helped make the research agenda patient-driven
• Reviewed proposed network studies
• Created network policies related to informed consent and privacy protections
• Enhanced communication among network participants
• Reviewed input from network participants

The PGC met monthly via conference calls and communicated regularly through email.

IBD Partners established a Project Selection Committee (PSC) composed of researchers, physicians, foundation representatives, and patients. The PSC evaluated research proposals that requested network data. The PSC meets twice a year to review proposals.

IBD Partners also required all approved projects to include a patient on the research team. The project lead could either identify his or her own patient or request the participation of a patient from the PGC. Patients worked with the research team to develop and implement a research dissemination plan specific to each study.

In addition, through the Research Prioritization section of the network’s patient portal, patient members of IBD Partners proposed, voted on, and discussed research ideas.

Demographics and Research Capacity

As of March 2019, 18,318 patients were part of IBD Partners.

While a partner in PCORnet, IBD Partners participated in 31 cross-sectional or retrospective studies, 11 prospective cohort studies, 4 randomized controlled trials, 2 discrete choice experiments, and 4 other projects, including a linkage project, a data visualization project, a marketing project, and an electronic health record data transfer pilot.

Future Opportunities

IBD Partners developed data collection and management tools that may be useful to other networks. The project team also developed a system of logic checks for survey-based data to identify logical inconsistencies in the data.

The infrastructure for this PPRN is operational. The network plans to maintain current infrastructure through the end of 2019 with funding from the Crohn’s and Colitis Foundation. The foundation will also maintain the longitudinal cohort and survey infrastructure through the end of all currently funded PCORnet projects.