PaTH is a Clinical Research Network made up of nine academic health systems: Boston Medical Center, Geisinger, Johns Hopkins University, Johns Hopkins Health System, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, RUSH, Temple Health System, Lewis Katz School of Medicine at Temple University, the University of Pittsburgh, UPMC and UPMC Health Plan, The Ohio State University, The Ohio State University Wexner Medical Center, University of Michigan, and Michigan Medicine. PaTH functions as an integrated research network and learning health system, providing an infrastructure for pragmatic clinical trials and observational studies that need populations beyond a single health system to answer important clinical questions. This infrastructure includes institutional relationships, a streamlined and centralized Institutional Review Board (IRB), site champions to assist in identifying co-investigators, and data intra-operability between the partner electronic health records (EHR). PaTH is part of the National Patient-Centered Clinical Research Network (PCORnet) and is partially funded by the Patient-Centered Outcomes Research Institute (PCORI).
The Patient-Centered Outcomes Research Institute (PCORI) is a Washington, DC-based nonprofit, nongovernmental funding agency interested in comparative clinical effectiveness research and patient-centered outcomes research that Congress authorized in the Patient Protection and Affordable Care Act of 2010. PCORI aims to determine which health care options are best for patients and care providers by promoting high-integrity, evidence-based information learned through research guided by patients, caregivers, and the broader health care community. PCORI has funded 33 research networks that together form the National Patient-Centered Clinical Research Network, or PCORnet, which supports faster, more useful patient-centered research nationwide. To learn more about PCORI and PCORnet, visit www.pcori.org and www.pcornet.org.
PaTH is made up of nine academic health systems: Boston Medical Center, Geisinger, Johns Hopkins University, Johns Hopkins Health System, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, RUSH, Temple Health System, Lewis Katz School of Medicine at Temple University, the University of Pittsburgh, UPMC and UPMC Health Plan, The Ohio State University, The Ohio State University Wexner Medical Center, University of Michigan, and Michigan Medicine.
PaTH is capturing (or planning to capture) data from the following sources:
  • electronic health records (EHR)
  • patients (i.e., patient-reported outcome measures)
  • insurance claims data from institutional health plans and Medicare (pending)
Not all EHR data is available in PaTH. Data elements that are available are those specified by the PCORI Common Data Model (CDM), which includes variables defined in a standardized manner (e.g., sex, race, encounter dates, encounter types, weight, blood pressure, etc.). Additional variables—called the PaTH Common Data Elements (CDEs)—have also been defined by PaTH when needed for specific research projects. We can work with researchers to define new CDEs that are needed for their study.
Patient-reported outcome (PRO) measures are patient responses to survey questions. PROs were collected from PaTH’s priority patient cohorts (idiopathic pulmonary fibrosis, atrial fibrillation, and healthy lifestyles and weight). PRO surveys for these patient cohorts include quality of life measures, medication compliance, etc. We can work with researchers to include PRO data collection for their studies.
Insurance claims data in PaTH from UPMC Health Plan® and Geisinger Health Plan. Claims from the other institutional health plans may be added.
PaTH provides an infrastructure for pragmatic clinical trials and observational studies that need populations beyond a single health system to answer important clinical questions.
Investigators at the PaTH/PCORnet institutions are eligible to propose research studies using PaTH/PCORnet data. Community partners are also able to use resources.
If you have an idea for a research study using PaTH, the first step is to contact your institution’s PaTH site Principal Investigator or site Project Manager for an initial discussion. Then, complete the PaTH Research Clinical Question and Preliminary Data Request Form. Your request will be reviewed by PaTH’s Future Research Topics Group for approval, and you will be asked to present your proposal at a Future Research Topics conference call. You can track publications and presentations here.
Certainly! PaTH can support projects funded from a variety of sources, including the National Institutes of Health (NIH) and Agency for Healthcare Research and Quality (AHRQ) among others.
PaTH is very interested in supporting student and trainee research projects whenever possible. However, PaTH does not have funds set aside for this purpose. If you are a student or trainee, please contact your institution’s site Principal Investigator to determine if there are institutional resources to support your proposed research using PaTH.
Costs for using PaTH depend on your research needs. We created a PaTH cost model that describes the different types of data, personnel, and other resources that PaTH could offer your project and the associated costs. Data costs depend on the complexity of the data needed—for example, limiting your data requests to data in the PCORnet CDM will be less costly than requesting new data elements. If your research project requires research staff (i.e. a project manager, research assistants), you may wish to hire your own staff or hire PaTH project staff who are already familiar with the PaTH Network. The cost model also includes other services you may be interested in, such as website/marketing services.
Patient and stakeholder engagement is a priority of PCORI, PCORnet, and the PaTH Network. PaTH has Community Partners who serve on the PaTH research team, including patients from the IPF, atrial fibrillation, and healthy lifestyles and weight cohorts as well as representatives from the Institutional Review Board (IRB). If you are applying for funding through PCORI, it is imperative that you include patient and stakeholder engagement in your proposal. More information about what PCORI means by engagement and the PCORI Engagement Rubric can be found here.. You can also view the University of Pittsburgh and UPMC Stakeholder Engagement Resource Guide here. PaTH Project Manager Jody McCullough may be able to help you plan your patient engagement ideas.

Publications based on research using the PaTH Network should cite the PCORI PaTH Contract: “This work is (partially) supported through the Patient-Centered Outcomes Research Institute Program Award (PCORI CDRN #1306-04912).”

Publications based on research reviewed by the PaTH Network Protocol Review Committee (PNPRC) should state the following: “This study underwent review by the PaTH Network Protocol Review Committee (PNPRC). The PNPRC was established to ensure input from each institution prior to review by the central IRB at Johns Hopkins University. The PNPRC has representation from at least one local IRB official and one patient representative from each PaTH institution.”

The lead author who is planning to prepare an abstract or manuscript using the PaTH Clinical Research Network in any way needs to record their publications and/or presentations within 30 days of acceptance. Articles that are rejected must also be reported. This requirement includes studies that have received additional funding outside of the PaTH Clinical Research Network but still use the PaTH infrastructure.

PCORI mandates that “To the extent Recipient desires to submit, publish, or distribute any publication arising from the CDRN (?) Project, Recipient shall inform PCORI and PCORI shall be provided with the opportunity to review and comment on the draft article or manuscript prior to its submission for publication or distribution. PCORI shall provide comments to Recipient not later than fourteen (14) days after the provision of the draft to PCORI."

To cite PaTH, refer to the PCORnet branding guidelines.

The PaTH Network Protocol Review Committee (PNPRC) is charged by the PaTH Executive Committee to review all investigational protocols that will use the PaTH network prior to submission to the overseeing Institutional Review Board (IRB).

The PNPRC reviews research study applications prior to a formal IRB submission in order to provide a forum for more comprehensive input from patient partners, identify concerns an IRB committee might have, and attempt to create consistency about how IRBs would address the concerns. The PNPRC provides feedback to investigators regarding the investigational protocol and offers recommendations to the PaTH IRB of record. The overseeing IRB shall have ultimate authority to review and approve protocols.

The PNPRC is comprised of one IRB professional and one patient or community stakeholder from each PaTH Network site. The PaTH Network site Principal Investigator will nominate representatives to participate in the PNPRC. These representatives will possess appropriate experience, authority, and knowledge to assist in growing PaTH. The PNPRC is chaired by one of the network site IRB professionals. The chair is designated by the Executive Committee and can vary based on the lead IRB site for a particular protocol.





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