Results Summary
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.
Clinical Data Research Networks (CDRNs) are one type of network supported by PCORI. CDRNs consist of two or more healthcare systems, including hospitals, integrated delivery systems, and federally qualified health centers. Each CDRN transforms data gathered from routine patient care across its participating health systems to a consistent format, the Common Data Model (CDM), to enable rapid response to research-related questions.
PCORI funded the Greater Plains Collaborative’s (GPC) participation in PCORnet from 2015 to 2019. This report outlines GPC’s achievements in building its research infrastructure capacity to
- Create ways to involve patients, healthcare providers, health plans, and health systems in the research process and decision making about the network
- Continue building the PCORnet CDM to add new types of data, ensure data quality, answer questions and requests, link to data outside the network, and keep data secure and private
- Create an efficient infrastructure to carry out clinical trials
- Create rules and guidance to protect people who take part in research studies, keep participants’ information confidential, and examine the risks of proposed studies
- Work with PCORnet partners and partners outside the network to do research studies, build information systems, and share knowledge and practices
- Create a plan to fund the network after PCORI funding ends
Network at a glance
The GPC collected data for more than 20 million patients. Led by the University of Kansas Medical Center Research Institute, the network included 11 additional partners in nine states. GPC research focused on three topics: amyotrophic lateral sclerosis (ALS), breast cancer, and obesity. ALS is a progressive, fatal nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control.
| Title | Greater Plains Collaborative |
| Network design | Clinical Data Research Network (CDRN) |
| Lead partners | University of Kansas Medical Center Research Institute |
| Other partners | Children’s Mercy Hospital Indiana University – Regenstrief Institute Marshfield Clinic The Medical College of Wisconsin University of Iowa Health Care University of Minnesota Medical Center University of Missouri Health Care University of Nebraska Medical Center University of Texas Health Science Center at San Antonio University of Texas Southwestern Medical Center The University of Wisconsin–Madison |
| Population | 20,119,151 patients |
| Area(s) of focus | ALS, breast cancer, and obesity |
How does the network operate?
The GPC established guidelines across its 12 partners to represent the interests of patients, clinicians, health systems, and researchers. GPC councils used these guidelines when making decisions about taking part in research projects. These councils represented patients, health systems, and researchers.
The GPC streamlined research processes by developing agreements across organizations for sharing data and protecting the ethical rights and privacy of the people participating in research. The network also developed 14 standard processes for how research teams should conduct research using GPC data.
The GPC developed a system to share and compare data. All GPC partners linked their hospital tumor registries with the CDM to support cancer research. A CDM establishes a standard way of defining and formatting data. Network partners stored patient data securely. To answer research questions, the network provided data that could not be used to identify patients and followed strict security rules.
How did the network involve patients and other partners?
The GPC developed guidelines so that researchers would know how to involve patients and partners in GPC research projects. Members from a patient advisory council reviewed research proposals and were involved in all research projects. Each of the 12 partners had a patient advisor and patient engagement officer who were part of the patient advisory council.
The GPC developed a buddy system to match new patient advisors and patient engagement officers with established members to help them learn about their roles. In addition, the network provided each partner with position descriptions of these roles for each site to use when recruiting patients to get involved.
Who is in the network?
The GPC database had data for 20,119,151 patients as of June 27, 2019. These data came primarily from electronic health record and billing systems but also from insurance claims and a registry that stored data about patients with tumors. Most GPC sites contributed data starting in 2010; however, some sites had data available prior to that. The GPC also used Medicare and Medicaid claims data to increase data completeness.
| Population* (as of 06/27/19) |
|---|
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Race
Ethnicity
Age
Sex
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*Reflects a subset of total network data.
How is the network supporting research?
GPC participated in 20 research studies. The GPC also partnered with Patient-Powered Research Networks (PPRNs) and other research institutions on other PCORnet-related studies. PPRNs are operated and governed by patient groups and their partners and are focused on particular conditions or populations.
How does the network support future research?
CDRNs follow PCORI standards to make sure their networks continue after PCORI’s funding ends. CDRNs format their data to the CDM and involve patients and healthcare providers in planning and carrying out research studies.
Glossary
Clinical Data Research Networks (CDRN): CDRNs are networks that originate in healthcare systems, such as hospitals, health plans, or practice-based networks, and securely collect health information during the routine course of patient care.
Common Data Model (CDM): A CDM establishes a standard way of defining and formatting data.
Institutional Review Board (IRB): A group that follows federal regulations, state laws, and institutional policy to review, monitor, and approve research in order to protect the ethical rights and privacy of the subjects involved.
PCORnet: PCORnet is a network of networks that brings together patients, clinicians, researchers, and healthcare systems to share information and participate in research.
Professional Abstract
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.
Clinical Data Research Networks (CDRNs) are one type of network supported by PCORI. CDRNs consist of two or more healthcare systems, including hospitals, integrated delivery systems, and federally qualified health centers. Each CDRN transforms data gathered from routine patient care across its participating health systems to a consistent format, the Common Data Model (CDM), to enable rapid response to research-related questions.
PCORI funded the Greater Plains Collaborative’s (GPC) participation in PCORnet from 2015 to 2019. This report outlines the GPC’s achievements in developing and optimizing research infrastructure capacity to
- Engage patients, practicing clinicians, health plans, and health systems meaningfully in network governance and the research process
- Continue building the PCORnet CDM to support new data elements, maintain high-quality data sets, respond to queries, link to external data sources, and ensure patient privacy and data security
- Establish an efficient infrastructure for conducting clinical trials
- Develop research oversight infrastructure that protects research subjects, preserves participants’ confidentiality, and evaluates the risks of proposed studies
- Collaborate with PCORnet and external partners to conduct research studies, build infrastructure, and share knowledge and practices
- Develop a plan for financial sustainability beyond the PCORI infrastructure-funding period
Network Infrastructure
The GPC collected data for more than 20 million patients. Led by the University of Kansas Medical Center Research Institute, the network included 11 additional partners in nine states. GPC used its data to focus on three disease cohorts: amyotrophic lateral sclerosis (ALS), breast cancer, and obesity.
| Title | Greater Plains Collaborative |
| Network design | Clinical Data Research Network (CDRN) |
| Lead partners | University of Kansas Medical Center Research Institute |
| Other partners | Children’s Mercy Hospital Indiana University – Regenstrief Institute Marshfield Clinic The Medical College of Wisconsin University of Iowa Health Care University of Minnesota Medical Center University of Missouri Health Care University of Nebraska Medical Center University of Texas Health Science Center at San Antonio University of Texas Southwestern Medical Center The University of Wisconsin–Madison |
| Population | 20,119,151 patients |
| Area(s) of focus | ALS, breast cancer, and obesity |
Network Governance and Operations
The GPC established a governance structure across its 12 partners to represent patients, clinicians, health systems, investigators, and researchers. A governance council made decisions about the network’s participation in specific clinical trials based on requirements for levels of stakeholder engagement. Three advisory councils representing patients, health systems, and translational science programs also provided input on these decisions.
The GPC streamlined research processes by developing master data sharing agreements across partners, developing standard procedures for conducting research, and using the SMART Institutional Review Board model.
The GPC developed a database to share and compare data elements captured in the individual GPC data warehouses. All GPC partners linked their hospital tumor registries with the CDM to support cancer research. Network partners stored patient data securely behind HIPAA-compliant firewalls. To answer research questions, the network provided de-identified data following stringent security procedures.
Stakeholder Engagement
The GPC network developed principles and processes to monitor stakeholder engagement both during research projects and within the network. Members of the patient advisory council reviewed all requests for proposals, co-developed meeting agendas, reviewed the progress of GPC pilot awards, helped plan conferences and led conference sessions, and were involved throughout the life cycle of research projects. The patient advisory council also provided feedback on engagement plans by reviewing final reports. The patient advisory council included a patient advisor and patient engagement officer from each of the 12 network partners.
In order to support patient stakeholders, the GPC developed a buddy system to match new patient advisors and patient engagement officers with more established members to get new members oriented to their role and provide ongoing coaching. In addition, the network developed position descriptions to help partners consistently describe these roles when recruiting new patient stakeholders.
Network Demographics
The GPC had data on 20,119,151 patients as of June 27, 2019. The network’s de-identified database gathered data primarily from electronic health record and billing systems and merged these data with claims from the Centers for Medicare & Medicaid Services to increase data completeness. Most GPC sites contributed data starting in 2010; however, some sites had data available prior to that.
| Population Demographics (as of 06/27/19)* |
|---|
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Race
Ethnicity
Age
Sex
|
*Reflects a subset of total network data.
Demonstrating Research Capacity
GPC participated in six observational retrospective cohort studies, six pilot studies, three randomized controlled studies, one pilot study, one descriptive analysis study, one registry study, one secondary data analysis study, and one observational prospective cohort study. The GPC also partnered with Patient-Powered Research Networks (PPRNs) and academic research institutions on other PCORnet-related studies. PPRNs are operated and governed by patient groups and their partners and are focused on particular conditions or populations.
Future Opportunities
CDRNs follow PCORI standards to enhance the sustainability of the network, including adhering to the CDM, fostering patient and clinician engagement at all stages of the research process, participating in multi-network PCORnet research, and building external collaborations.