Skip to main content
Patient-Centered Outcomes Research Institute
Patient-Centered Outcomes Research Institute
  • Blog
  • Newsroom
  • Find It Fast
  • Help Center
  • Subscribe
  • Careers
  • Contact Us

PCORI

Patient-Centered Outcomes Research Institute

Search form

  • About Us
    Close mega-menu

    About Us

    • Our Programs
    • Governance
    • Financials and Reports
    • Procurement Opportunities
    • Our Staff
    • Our Vision & Mission
    • Contact Us

    Fact Sheets: Learn More About PCORI

    Download fact sheets about out work, the research we fund, and our programs and initiatives.

    Find It Fast

    Browse through an alphabetical list of frequently accessed and searched terms for information and resources.

    Subscribe to PCORI Email Alerts

    Sign up for weekly emails to stay current on the latest results of our funded projects, and more.

  • Research & Results
    Close mega-menu

    Research & Results

    • Explore Our Portfolio
    • Research Fundamentals
    • Research Results Highlights
    • Putting Evidence to Work
    • Peer Review
    • Evidence Synthesis
    • About Our Research

    Evidence Updates from PCORI-Funded Studies

    These updates capture highlights of findings from systematic reviews and our funded research studies.

    Journal Articles About Our Funded Research

    Browse through a collection of journal publications that provides insights into PCORI-funded work.

    Explore Our Portfolio of Funded Projects

    Find out about projects based on the health conditions they focus on, the state they are in, and if they have results.

  • Topics
    Close mega-menu

    Topics

    • Addressing Disparities
    • Arthritis
    • Asthma
    • Cancer
    • Cardiovascular Disease
    • Children's Health
    • Community Health Workers
    • COVID-19
    • Dementia and Cognitive Impairment
    • Diabetes
    • Kidney Disease
    • Medicaid
    • Men's Health
    • Mental and Behavioral Health
    • Minority Mental Health
    • Multiple Chronic Conditions
    • Multiple Sclerosis
    • Obesity
    • Older Adults' Health
    • Pain Care and Opioids
    • Rare Diseases
    • Rural Health
    • Shared Decision Making
    • Telehealth
    • Transitional Care
    • Veterans Health
    • Women's Health

    Featured Topic: Women's Health

    Learn more about the projects we support on conditions that specifically or more often affect women.

  • Engagement
    Close mega-menu

    Engagement

    • The Value of Engagement
    • Engagement in Health Research Literature Explorer
    • Influencing the Culture of Research
    • Engagement Awards
    • Engagement Resources
    • Engage with Us

    Engagement Tools and Resources for Research

    This searchable peer-to-peer repository includes resources that can inform future work in patient-centered outcomes research.

    Explore Engagement in Health Literature

    This tool enables searching for published articles about engagement in health research.

    Research Fundamentals: A New On-Demand Training

    It enables those new to health research or patient-centered research to learn more about the research process.

  • Funding Opportunities
    Close mega-menu

    Funding Opportunities

    • What & Who We Fund
    • What You Need to Know to Apply
    • Applicant Training
    • Merit Review
    • Awardee Resources
    • Help Center

    PCORI Funding Opportunities

    View and learn about the newly opened funding announcements and the upcoming PFAs in 2021.

    Tips for Submitting a Responsive LOI

    Find out what PCORI looks for in a letter of intent (LOI) along with other helpful tips.

    PCORI Awardee Resources

    These resources can help awardees in complying with the terms and conditions of their contract.

  • Meetings & Events
    Close mega-menu

    Meetings & Events

    • Upcoming
    • Past Events

    PCORI 2021 and Beyond

    During this webinar, PCORI leaders shared ways to get involved in PCOR, improvements to our funding opportunities, and more.

    Confronting COVID-19: A Webinar Series

    Learn more about the series and access recordings and summary reports of all six sessions.

    2020 PCORI Annual Meeting

    Watch recordings of all sessions, and view titles and descriptions of the posters presented at the virtual meeting.

You are here

  • Research & Results
  • About Our Research
  • Research Methodology
  • The PCORI Methodology Report

The PCORI Methodology Report

The PCORI Methodology Report* provides minimal requirements to follow in the conduct of scientifically valid patient-centered outcomes research. The report addresses two legislative mandates: the development of methodology standards and development of a translation framework to guide the choice of study designs for specific research questions. It details the context and rationale for the PCORI Methodology Standards, published in late 2012, and most recently updated in February 2019. It includes stories and examples that illustrate different ways that good methodology makes a difference to patients and their care.

The PCORI Methodology Report includes an Executive Summary, an Introduction, and four sections:

  • Section I: Patient-Centered Outcomes Research reviews the need for methodological standards in patient-centered outcomes research. The standards guide researchers to adopt approaches most likely to produce the high-quality and relevant evidence needed to inform health decisions.

  • Section II: Identifying and Addressing Evidence Gaps in PCOR discusses the importance of a systematic process for prioritizing topics and determining which research designs can provide information that is both useful and timely. These activities align a program of patient-centered outcomes research with questions about what works best, for whom, and under what circumstances.

  • Section III: PCORI Methodology Standards explains how PCORI developed and updated its set of 54 methodology standards, discusses each group of standards, and summarizes the justifications for the standards. These standards can improve the way research questions are selected and formulated, how studies are designed and analyzed to address these questions, and how findings are reported.

  • Section IV: Advancing Understanding and Appropriate Use of Methods for PCOR emphasizes the role of the Methodology Standards in promoting transparency, which is a critical component of good research practices. Transparency enables other researchers to assess the reproducibility and validity of findings. This section also outlines the next steps for PCORI’s continued development of standards to support the design, conduct, analysis, and reporting of high-quality patient-centered outcomes research.

View the PCORI Methodology Report
  • View the 2017 version of the Methodology Report and Methodology Standards
  • View the 2013 version of the Methodology Report and Methodology Standards
  • Read what key leaders say about the report and standards

Draft report and background materials:

  • Draft Methodology Report (Posted July 23, 2012)
  • Public comments on the Draft Methodology Report (Received July 23-September 14, 2012)
  • Overview of the Methodology Committee’s Response to Public Comment
  • Proposed revisions to the Methodology Standards by the Methodology Committee (Published November 19, 2012)
  • PCORI Methodology Committee Research Recommendations (As presented to the Board November 19, 2012, and published December 14, 2012)

PCORI’s First Methodology Report

Reports to Support the Development of the First Report

All statements in these reports, including their findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors, or Methodology Committee. PCORI has not peer-reviewed or edited this content. The report is being made available free of charge for the information of the scientific community and general public as part of PCORI’s ongoing research programs. Questions or comments about this report may be sent to PCORI at [email protected] or by mail to 1828 L St., NW, Washington, DC 20036.

Review of Guidance Documents for Selected Methods in Patient-Centered Outcomes Research

  • Enhancing the Patient's Voice: Standards in the Design and Selection of Patient-Reported Outcomes Measures for Use in Patient-Centered Outcomes Research
    PCORI's Methodology Standards Chart
  • Minimal Standards in the Prevention and Handling of Missing Data in Observational and Experimental Patient-Centered Outcomes Research
  • Standards for the Design, Conduct, and Evaluation of Adaptive Randomized Clinical Trials
  • Standards for Causal Inference Methods in Analyses of Data from Observational and Experimental Studies in Patient-Centered Outcomes Research
  • Standards in Addressing Heterogeneity of Treatment Effectiveness in Observational and Experimental Patient Centered Outcomes Research
  • Standards in the Design, Conduct, and Evaluation of Diagnostic Testing for Use in Patient Centered Outcomes Research
  • Standards in the Conduct of Registry Studies for Patient-Centered Outcomes Research
  • Standards in the Use of Collaborative or Distributed Data Networks in Patient Centered Outcomes Research
  • The Design and Selection of Patient-Reported Outcomes Measures for Use in Patient-Centered Outcomes Research

Review and Synthesis of Evidence for Eliciting the Patient's Perspective in Patient-Centered Outcomes Research

  • Integrating Patients’ Voices in Study Design Elements with a Focus on Hard-to-Reach Populations

Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient’s Perspective in Patient-Centered Outcomes Research

  • Eliciting Patient Perspective in Patient-Centered Outcomes Research - A Meta-Narrative Systematic Review
  • Eliciting Patient Perspective in Patient-Centered Outcomes Research - Expert Interviews Part 1
  • Eliciting Patient Perspective in Patient-Centered Outcomes Research - Expert Interviews Part 2
  • Eliciting Patient Perspective in Patient-Centered Outcomes Research - Expert Interviews Part 3
  • Eliciting Patient Perspective in Patient-Centered Outcomes Research - Expert Interviews Part 4

Methods for Setting Priorities in Research

  • Methods for Involving Patients in Topic Generation for Patient-Centered Comparative Effectiveness Research – An International Perspective
  • Value of Information and Research Prioritization
  • Value-of-Information Analysis for Patient-Centered Outcomes Research Prioritization
  • Peer Review - A Research Priority
  • Prioritizing Future Research through Examination of Research Gaps in Systematic Reviews

*The PCORI Methodology Standards were updated February 26, 2019, and are available here.
An updated Methodology Report will be posted in later in 2019.


Posted: April 19, 2013; Updated: February 26, 2019

About Us

  • Our Programs
  • Governance
  • Financials and Reports
  • Procurement Opportunities
  • Our Staff
  • Our Vision & Mission
  • Contact Us

Research & Results

  • Explore Our Portfolio
  • Research Fundamentals
  • Research Results Highlights
  • Putting Evidence to Work
  • Peer Review
  • Evidence Synthesis
  • About Our Research

Engagement

  • The Value of Engagement
  • Engagement in Health Research Literature Explorer
  • Influencing the Culture of Research
  • Engagement Awards
  • Engagement Resources
  • Engage with Us

Funding Opportunities

  • What & Who We Fund
  • What You Need to Know to Apply
  • Applicant Training
  • Merit Review
  • Awardee Resources
  • Help Center

Meetings & Events

March 8
Engagement Awards 2021 Special Cycle -- Applicant Office Hours (One)
March 15
Priorities on the Health Horizon: Informing PCORI's Strategic Plan (Webinar)
March 15
PCORI Workshop on Methodologic Challenges in Intellectual and Developmental Disabilities Research

PCORI

Footer contact address

Patient-Centered Outcomes
Research Institute

1828 L Street, NW, Suite 900
Washington, DC 20036
Phone: (202) 827-7700 | Fax: (202) 355-9558
[email protected]

Subscribe to Newsletter

Twitter Facebook LinkedIn Vimeo

© 2011-2021 Patient-Centered Outcomes Research Institute. All Rights Reserved.

Privacy Policy | Terms of Use | Trademark Usage Guidelines | Credits | Help Center