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 health 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 into a consistent format, the Common Data Model (CDM), to enable rapid response to research-related questions.
PCORI funded the patient-centered SCAlable National Network for Effectiveness Research’s (pSCANNER) participation in PCORnet from 2015 to 2019. This report outlines pSCANNER’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
pSCANNER collected data for more than 30 million patients. Led by the University of California, San Diego, the network included health systems and Veterans Health Administration (VA) medical centers. pSCANNER focused on congestive heart failure, Kawasaki disease, and weight management and obesity. The goal of pSCANNER was to make healthcare data more accessible and usable for research so clinicians and patients can make more informed health decisions.
| Title |
patient-centered SCAlable National Network for Effectiveness Research (pSCANNER) |
| Network design |
Clinical Data Research Network (CDRN) |
| Lead partners |
University of California, San Diego |
| Other partners |
University of California, Davis
University of California, Irvine
University of California, Los Angeles
University of California San Francisco
San Mateo Medical Center
Cedars-Sinai Medical Center
University of Southern California (with Los Angeles County Department of Health Sciences, AltaMed Health Services Corporation, The Children’s Clinic of Long Beach, QueensCare Health Centers)
VA Medical Centers
University of Washington
University of Colorado
University of Texas Health Science Center |
| Population |
>30 million patients |
| Area(s) of focus |
Heart failure, Kawasaki disease, weight management and obesity |
Network Governance and Operations
pSCANNER established an executive committee to manage the network, monitor performance, and evaluate research collaboration requests. The executive committee included a patient representative, four primary investigators, and collaborators focused on network sustainability and stakeholder engagement.
The network had six working groups, each of which focused on a specific area:
- Data harmonization: collaborating with other networks to integrate the CDM
- Technical and analytics: developing tools and algorithms
- Natural language processing: developing tools for extracting information from clinical notes
- Governance streamlining and coordination: documenting policies and streamlining IRB processes
- Sustainability: developing strategies for sustainability and engagement of national leaders
- Patient engagement and patient-powered research: engaging patients, patient advocates, and clinicians in the network; convening a stakeholder advisory board
The network designed its data sets to adhere to the CDM so pSCANNER could respond to research requests from PCORnet Partner Networks as well as researchers outside the network. Working within a streamlined process for approving research collaborations, the network decided whether to approve collaboration requests within one week of their submission. pSCANNER sites then independently decided whether to participate in network-approved collaborations.
pSCANNER sites maintained their patient data within their own institutional firewalls and followed stringent procedures to de-identify data, when required to answer research questions. To facilitate Institutional Review Board (IRB) reviews, many pSCANNER sites except the Veterans Health Administration signed on to the Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board (SMART IRB) Reliance platform.
Stakeholder Engagement
The network recruited patients, patient advocates, clinicians, researchers, and health system administrators to participate in pSCANNER, including serving on the stakeholder advisory board and participating in working groups. In addition, a patient representative was a voting member of the executive committee.
Network Demographics
As of April 30, 2019, pSCANNER had collected electronic health record data for more than 30 million patients. Diverse patient populations, including veterans, underserved communities, and patients with low incomes, were represented.
| Population Demographics (as of 04/30/19) |
|
Race/ethnicity
- 38% white
- 9% non-white
- 53% missing/other
- 7% Hispanic
Sex
Age
- 5% ≤18 years
- 1% 19–21 years
- 20% 22–44 years
- 26% 45–64 years
- 19% 65–74 years
- 20% 75–89 years
- 7% 89+ years
- 3% unknown
|
Demonstrating Research Capacity
While a Partner Network in PCORnet, pSCANNER participated in three randomized controlled trials, two retrospective observational studies, and two internal retrospective observational studies.
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.
