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PCORI is pleased to share an important update on how we plan to implement our expanded authority to consider the potential burdens and economic impacts of healthcare services in the research we fund.

This authority, part of our 2019 reauthorizing law, clarifies that PCORI-funded studies should capture “the full range of clinical and patient-centered outcomes,” specifically adding “the potential burdens and economic impacts” of healthcare services to the patient-centered outcomes and clinical effectiveness measures that have been the hallmarks of the research we have funded to date.

The Principles

The four Principles that will guide us in our research funding application and review process, and the work we do more broadly, are:

Identifying Outcomes Important to Patients and Caregivers
  • Considering the full range of outcomes important to patients and caregivers, including potential burdens and economic impacts, is central to PCORI-funded research.
Identifying Outcomes Important to Stakeholders
  • PCORI-funded research may consider the full range of outcomes relevant to other stakeholders, when these outcomes have a near-term or longer-term impact on patients.
Collection of Data as Appropriate and Relevant
  • The collection of data on potential burdens and economic impacts of intervention options must be appropriate and relevant to the clinical aims of the study.
Conduct of Certain Types of Economic Analysis
  • PCORI may support the conduct of certain types of economic analyses, as part of a funded research study or independently, to enhance the relevance and value to patients and other stakeholders of information PCORI-funded investigators collect on potential burdens and economic impacts.
View/Download the Principles

PCORI considers this both a challenge and an exciting opportunity to make our work even more useful to our stakeholders. To do this in a way that best serves the entire healthcare community, we sought public comment on a set of draft Principles to guide how we will implement this authority while ensuring that our funded studies remain patient centered and useful.

PCORI’s Board of Governors has now approved a set of Principles that take account of the valuable input received during the 60-day comment period. We heard from dozens of individuals and organizations representing the voices of patients, caregivers, clinicians, insurers, researchers, purchasers, representatives of the life sciences industry, and others.

View a report on the public comments and click here to read a summary of the comments we received and PCORI's responses.

Promoting Health Equity

Our stakeholders also made clear their deep concern about health disparities and the vital need to promote health equity—a concern PCORI shares. We know the burden of direct and indirect costs to patients and others, as well as additional social risk factors and social determinants of health, have an impact on health disparities and inequities in access to care and outcomes. So PCORI will continue to support patient-centered outcomes research that seeks to eliminate these problems.

This means that in considering relevant burdens and economic impacts along with clinical effectiveness, our awardees should consider including outcomes that capture social risk factors and social determinants of health. We will seek ongoing opportunities to engage with patients, caregivers, and others across the healthcare community to further define this priority, as well as develop guidance for applicants and potential methodology standards to advance that work.

Some things won’t change as we move ahead. PCORI will continue to emphasize the importance of generating authoritative, useful, relevant patient-centered outcomes and clinical effectiveness data. As in the past, PCORI will not develop or employ a dollars-per-life year or per quality adjusted life year as a threshold to establish what type of health care is cost-effective, nor recommend or mandate coverage, reimbursement, or other policies for any public or private payer. And, as before, we will not fund studies seeking to conduct a formal cost-effectiveness analysis.

All of us at PCORI appreciate the wide-ranging and informative input we received through the public comment period. We were particularly pleased to have solicited additional meaningful perspectives and gratified both by commenters’ enthusiasm, constructive suggestions for improving the draft Principles, and identification of several key areas to address on a strategic and ongoing basis as we continue to carry out our work.

Implementation of Principles

PCORI’s goal now is to implement these Principles in a way that is both transparent and timely, providing detailed guidance for applicants and the broader research and stakeholder communities we serve. We also recognize that this process will evolve over time based on experience and additional input, and we’ll continue to work with stakeholders across the healthcare community as we do this.

As part of that effort, PCORI is establishing a resource center to support our staff, PCORI’s Methodology Committee, and others as we address specific questions and priorities in implementing this new authority. We plan to host a series of convenings to connect stakeholders with researchers to identify relevant, impactful outcomes and advance discussions about a patient-centered approach to addressing rising healthcare costs and value. That will support our efforts to develop additional guidance for applicants and researchers; advance scientific methods related to collecting and considering burden and economic impact data; and conduct ongoing evaluation of our Principles, guidance, and methods.

PCORI is now poised to generate the full range of evidence, including on burdens and economic impacts, that those making important healthcare decisions tell us they need to make decisions about the value of different health services. We’re confident this will position PCORI as a trustworthy resource for the full range of critical, authoritative data needed to advance a healthcare system that delivers greater value to all, reduces costs, and provides more effective patient-centered care.


Updated: March 25, 2021

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