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 PEDSnet’s participation in PCORnet from 2015 to 2019. This report outlines PEDSnet’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
PEDSnet is a national pediatric learning health system. Led by Children’s Hospital of Philadelphia, PEDSnet was made up of eight children’s hospital systems in 12 states and had data on more than six million children, adolescents, and young adults. The PEDSnet’s database had information on all pediatric diseases and specialties.
| Title | PEDSnet |
| Network design | Clinical Data Research Network (CDRN) |
| Lead partners | Children’s Hospital of Philadelphia |
| Other partners | Boston Children’s Hospital Children’s Hospital Colorado Cincinnati Children’s Hospital Medical Center Nationwide Children’s Hospital Nemours Children’s Health System St. Louis Children’s Hospital Seattle Children’s Hospital |
| Participants | 8 hospital systems, including 3,500 hospital beds for children and 10,000 doctors |
| Population | 6,209,564 individuals who received care at a partner hospital |
| Area(s) of focus | Children |
How does the network operate?
PEDSnet created a steering board to oversee the network and provide guidance about the future of PEDSnet. The board was made up of two parent leaders and a clinical or scientific leader from each partner hospital system. PEDSnet also had a research committee to supervise all research activities, a data committee to oversee data quality and find ways to link different data sources, and an engagement committee to support patient involvement in the network. Other committees supported different network activities. A coordinating center handled day-to-day business, including helping with study paperwork.
The network developed agreements about using and sharing data and participated in a single Institutional Review Board, or IRB. An IRB is a group that makes sure research is ethical. Partner hospital systems stored patient data securely. To answer research questions, the network provided data to researchers and followed strict security rules. Data provided by the network could not be used to identify patients.
How did the network involve patients and other partners?
Parents made up 20 percent of the steering board. An engagement committee made up of parents and healthcare providers from partner hospital systems reviewed and gave input on all research requests. The committee also promoted ways to increase patient, parent, and healthcare provider involvement in research. Some committee members worked one-on-one with researchers to make sure studies involved patients and families.
In addition, the network developed web-based trainings and other resources to help youth, parents, and researchers create partnerships where patients are engaged at all stages of the research process. The network also shared the results of research that used PEDSnet data with patients, families, and others. Some doctors led groups that focused on one topic such as patient safety or kidney disorders. These groups focused on ways to engage patients and parents in research within their own area.
Who is in the network?
The PEDSnet Data Network had data on 6,209,564 individuals as of June 28, 2019. The main data sources are electronic health records, but some studies included other types of data. PEDSnet data are stored in a CDM specific to children and then transformed to the PCORnet CDM. Data are available from 2009.
| Population (as of 06/28/19) |
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Race/ethnicity
Sex
Age
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How is the network supporting research?
While a Partner Network in PCORnet, PEDSnet participated in 64 studies.
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. CDRNs also take part in research with other networks in PCORnet and build relationships outside of PCORnet.
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 PEDSnet’s participation in PCORnet from 2015 to 2019. This report outlines PEDSnet’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
PEDSnet is a national pediatric learning health system. Led by Children’s Hospital of Philadelphia, PEDSnet was made up of eight pediatric medical centers, whose primary markets were located in 12 states, with data on more than six million children, adolescents, and young adults. PEDSnet’s data encompasses all pediatric diseases and specialties.
| Title | PEDSnet |
| Network design | Clinical Data Research Network (CDRN) |
| Lead partners | Children’s Hospital of Philadelphia |
| Other partners | Boston Children’s Hospital Children’s Hospital Colorado Cincinnati Children’s Hospital Medical Center Nationwide Children’s Hospital Nemours Children’s Health System St. Louis Children’s Hospital Seattle Children’s Hospital |
| Participants | 8 hospital systems, including 3,500 hospital beds for children and 10,000 doctors |
| Population | 6,209,564 individuals who received care at a partner hospital |
| Area(s) of focus | Children |
Network Governance and Operations
PEDSnet established a steering board to provide oversight and strategic direction for the network. The board is made up of two parent leaders and a clinical or scientific representative from each partner institution. PEDSnet also established a research committee to supervise all research and data activities, a data committee to oversee technical processes related to data such as data integration and data quality, and an engagement committee to support patient involvement in the network. Other committees supported different network activities. A coordinating center handled daily operations and provided administrative, communication, and study logistics support.
To streamline research, the network developed data use and data sharing agreements and used a single Institutional Review Board. Network partners stored patient data securely behind HIPAA-compliant firewalls. To answer research questions, the network provided de-identified data to researchers following stringent security procedures.
Stakeholder Engagement
Parent representatives made up 20% of the steering board. An engagement committee composed of parents and clinicians from network partners reviewed all research requests and provided input on study design. The engagement committee also identified and disseminated effective strategies to increase patient, parent, and clinician involvement in specific stages of research. Some members worked one-on-one with investigators to ensure research proposals included patient-centered engagement plans.
In addition, the network developed interactive, web-based trainings and other resources to help youth, parents, and researchers create partnerships where patients are engaged at all stages of the research process. The network also shared the results of research that used PEDSnet data with patients, caregivers, clinicians, health insurers, and other health systems. Clinician-led specialty groups focused on ways to engage patients and parents in nephrology, psychiatry, rheumatology, gastroenterology, urology, and patient safety. Each of these specialty-specific networks employed the PEDSnet infrastructure and engaged parents, youth, and clinicians in all phases of their research studies.
Network Demographics
The PEDSnet Data Network had data on 6,209,564 individuals as of June 28, 2019. The main data sources are electronic health records. Additional data were collected by individual studies from health insurance and medication claims, birth records, and child and parent surveys. PEDSnet data are stored in a pediatric-specific CDM, which is transformed to the PCORnet CDM. Data are available from 2009 onward.
| Population Demographics (as of 06/28/19) |
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Race/ethnicity
Sex
Age
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Demonstrating Research Capacity
While a Partner Network in PCORnet, PEDSnet participated in 6 clinical trials and 58 observational studies. The network also completed seven pilot studies that tested the feasibility of linking disparate data sources.
Future Opportunities
CDRNs also 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.