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Type | Nonprofit organization |
---|---|
Legal status | 501(c)(1) organization |
Joe V. Selby, MD, MPH | |
Website |
www |
The Patient-Centered Outcomes Research Institute (PCORI) is a United States-based non-profit institute created through the 2010 Patient Protection and Affordable Care Act. [1] As a nongovernmental 501(c)(1) organization, it focuses on patient-centered outcomes research (PCOR) that produces findings about the comparative trade-offs of healthcare options that help people and caregivers make more informed healthcare decisions.
Created through the Affordable Care Act, PCORI seeks to "integrate the patient’s voice into the research process" [2] and fund research that that may result in a change in medical practice in areas of importance to patients, caregivers, and clinicians. [3] PCORI was created to
"to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations, and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services, and items described." [4]
PCORI funds research studies that focus on patient-centered outcomes, rather than only on comparative effectiveness research (CER) alone. [5] [6] [7] Patient-centered outcomes research involves questions and outcomes "meaningful and important to patients and caregivers" [8]to help them make informed decisions for their own care. In this way, it is different from the United Kingdom's National Institute for Health and Care Excellence, which determines cost-effectiveness directly based on quality-adjusted life year valuations.
PCORI is funded through the Patient-Centered Outcomes Research Trust Fund (PCORTF), which was authorized by the United States Congress as part of the Patient Protection and Affordable Care Act of 2010. [9] Its annual income comes from the general fund of the Treasury and a small fee assessed on Medicare, private health insurance, and self-insured plans. The act mandates a $2 fee, adjusted for inflation, for each person covered on a group plan. [10] [11]
PCORI is fully U.S. government funded, and does not seek nor accept contributions from any other source. All its financial reports are public, along with an annual audit by the U.S. Government Accountability Office (GAO). [12] [13] In 2018, its revenue was $506,485,458, with approved research awards of $308,000,000. [14] Since its founding, PCORI has funded over $2.5 billion USD in patient-centered outcomes research and related projects. [15]
PCORI's authorizing legislation requires it "to guarantee peer review of all research results and to make those results publicly accessible within 90 days of their receipt, requirements that were the first of their kind for a US-based research funding organization." [16] To assist in this process, the PCORI board of governors requires all awardees to submit a comprehensive final report for PCORI-based external peer review, which is then posted and freely available on its website to include both "lay and technical abstracts of the report; the complete, approved final report and study protocol; and a summary of the peer review critiques and the authors’ responses to those critiques." [16]
National priorities were established to guide research. These include "assessment of options for prevention, diagnosis, and treatment; improving health care systems; dissemination and communications research; addressing disparities; and accelerating patient-centered outcomes research and methodology." [17] From these, there have been 65 research standards developed to support patient-centered outcomes research [18] used to guide over 600 funded studies awarded over the nine years PCORI has existed. [19] All studies that have been funded, their reports on results, and the articles that have come from them are searchable and available through the PCORI site.
Funding from PCORI enabled the development of PCORnet, a collaboration of several research networks that together facilitate clinical research using health data collected in the course of care through electronic health records, claims data, patient registries, and other sources. [20] Each participating site in PCORnet maintains its own data behind its own firewalls and transforms the data into a format specified by the PCORnet Common Data Model so that it can be used to conduct clinical research. [21] [22]
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