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 Outcomes Research To Advance Learning (PORTAL) network’s participation in PCORnet from 2015 to 2019. This report outlines PORTAL’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
PORTAL collected data for more than 30 million people receiving care at three healthcare delivery systems: Kaiser Permanente, HealthPartners, and Denver Health. Ten research centers affiliated with these health systems worked with patients, clinicians, and operational leaders to develop the infrastructure needed to collaborate and conduct comparative effectiveness research. In addition to the general data set on all eligible members in these systems, PORTAL created three cohorts for more targeted study: colorectal cancer survivors, adults with severe congenital heart defects, and people with obesity or who are overweight.
Title |
Patient Outcomes Research To Advance Learning (PORTAL) |
Network design |
Clinical Data Research Network (CDRN) |
Lead partner |
Kaiser Permanente Northern California |
Other partners |
HealthPartners
Denver Health |
Participants |
30,010,606 |
Network Governance and Operations
To develop the PORTAL network, representatives from several network leadership groups established a framework for research collaboration and created governance policies. Patients, clinicians, and a steering committee that included the principal investigators of all nine participating sites and two representatives of PORTAL’s patient advisory council reviewed and provided guidance on these policies. The policies included information about the network’s purpose, guiding principles, organizational structure, decision-making procedures, data infrastructure, and governance and process for selecting PORTAL principal investigators. In addition, PORTAL established subgroups to oversee operations, data, governance, and science. PORTAL also created a set of templates and procedures to streamline its processes, including patient and clinician engagement, publications, data analyses, and IRB oversight.
PORTAL established procedures for network partners to store patient data securely behind HIPAA-compliant firewalls. To answer research questions, the network provided de-identified data following stringent security procedures.
Stakeholder Engagement
Patient engagement in the PORTAL network centered on two areas.
Ten patients served on a patient engagement council. These patients helped create the PORTAL governance charter; provided guidance about colorectal cancer research questions; reviewed study conceptualization, design, proposals, data collection plans, and manuscripts; and supported research dissemination. They took part in webinars, conferences, and in-person meetings; collaborated with researchers on studies; and helped develop materials to guide other patients through the process of becoming a council member. To help patient council members become more comfortable in their role, PORTAL provided training on reading and reviewing research articles, grant proposals, and conference posters.
Patients also participated in a previously established online community called Smart Patients. Through Smart Patients, researchers were able to pose questions to patients, receive feedback on research project ideas, and learn directly from patients about their lived experiences with conditions being studied.
Network Demographics
As of April 29, 2019, PORTAL had data for 30,010,606 patients across all participating sites. These data were available for all three health systems between 2009 through 2018. PORTAL collected data from electronic health records; systems managing insurance claims and enrollment, pharmacy, and laboratory information; as well as tumor registries, birth and death records, and the Social Security Death Index. The network combined, transformed, and standardized these data through a virtual data warehouse and the PCORI CDM.
Population Demographics (as of 04/29/19) |
Race/
- 44% white
- 19% non-white
- 37% missing
Ethnicity
- 26% non-Hispanic
- 19% Hispanic
- 54% unknown
Age
- 21% 0–21 years
- 63% 22–65 years
- 15% 66 years or older
Sex
|
Demonstrating Research Capacity
While a Partner Network in PCORnet, PORTAL participated in one randomized controlled trial, one observational study, two secondary data analysis studies, and 15 pilot projects.
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 multinetwork PCORnet research, and building external collaborations.