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Patient-Centered Outcomes Research Institute

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    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.

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    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
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    Topics

    • Addressing Disparities
    • Arthritis
    • Asthma
    • Cancer
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    • Children's Health
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    • 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
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    • Telehealth
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    • 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.

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    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.

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    Funding Opportunities

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

    • Upcoming
    • Past Events

    PCORI Webinar: February 2, 2pm ET

    Hear from PCORI leaders about ways to get involved in PCOR, improvements to our funding opportunities, and more. Register

    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.

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  • Research & Results
  • Peer Review
  • The Draft Final Research Report

The Draft Final Research Report

The Draft Final Research Report (DFRR) is a detailed report of all work completed as part of the PCORI-funded contract. The report is organized like a journal article but longer (up to 15,000 words not including abstract, tables, figures, or references) and more detailed. The required sections of the report are summarized below. Authors should use the most recent version of the DFRR Instructions for Awardees for thorough information.

Major Sections of the DFRR

Abstract

The abstract is organized by Background, Objective, Methods, Results, Conclusions, and Limitations. It can be up to 750 words. Include statistical results from primary analyses.

Background

The Background should explain the evidence gap that led to this study. It should provide evidence through existing systematic reviews or the author’s review of existing research if no formal systematic reviews exist. At the end of the Background, authors should include the Aims and Hypotheses.

PCORI Peer Reviewer Jeffrey Oliver, MBA says that including patients in the peer-review process can benefit researchers by helping them focus on getting the end user of the research to see and understand their study’s findings.

Patient and Stakeholder Engagement

This section should describe how patient and stakeholder partners contributed to the design, implementation, and interpretation of the study. It should include the types of engagement and frequency of meetings, as well as some specific examples of how patient and stakeholder engagement affected the decisions made in the study.

Methods

The Methods should be described in detail, using the DFRR Instructions to Awardees and Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting study methods. At the end of the Methods, the authors include a section describing any changes made to the original study protocol.

Results

The Results also should be presented based on CONSORT guidelines. Most importantly, authors should present the preplanned analyses of the primary outcomes first, followed by secondary and exploratory analyses. Any post hoc or additional analyses should come last and be indicated as post hoc.

Key Resources
  • Draft Final Research Report Instructions for COVID-10 Enhancement Projects
    (Learn more about the projects)
  • Draft Final Research Report Instructions
    (Updated October 19, 2020)
  • FAQs: Preparing the DFRR
  • Webinar: How to Prepare for PCORI Review
    • with Eric Johnson, PhD; Associate Director/Associate Editor, Editorial Office (Dec. 9, 2019)
  • Currently Available Final Research Reports
  • Methodology Standards Checklist
  • Ancillary Information: Conflict of Interest Form
  • Ancillary Information: Return of Aggregate Research Results to Study Participants Reporting Form

Discussion

The Discussion section should start with a summary of the results and describe the relationship of the study’s results to existing research. By law, the DFRR is required to include sections in the Discussion on Study Limitations and Subgroup Considerations. Finally, the authors should consider potential for future research in their Discussion.

Conclusion

The Conclusion section is about a half-page high-level summary of the study, with a few sentences on the implications for clinical care, if appropriate.

What Else Is in the DFRR:

  • References
  • Publications from the study
  • Acknowledgments
  • Any appendices referenced in the text

The DFRR is submitted for peer review along with four separate required attachments:

  • Original study protocol
    • The protocol should include the original study plan, including plans for data safety, as well as any changes to the original plan that took place during the study.
    • The protocol will be posted publicly along with the Final Research Report.
  • Checklist of the study’s adherence to the current PCORI Methodology Standards
    • Report adherence even if the Standard was not in place when the study started.
    • Here is a link to the Checklist
  • Ancillary Information: Conflicts of Interest Disclosure Form signed by the awardee institution reporting any conflicts of interest for key personnel
    • Here is an example completed form
  • Ancillary Information: Return of Aggregate Research Results to Study Participants Reporting Form: This form collects information about the awardee’s completed and/or planned efforts to return aggregate study results to research participants.

Reminders to Avoid Common Pitfalls

Review the recommendations from one of PCORI’s associate editors in this webinar from 2019.

  • Start early! Peer review takes place after the study is complete and your research is working on other projects. Complete as much of the DFRR as possible while the study team is intact. Everything up to the Results section can be written in the year before the study closes.
  • Make sure that your report meets the current PCORI Methodology Standards.
  • Be sure to use CONSORT or other relevant accepted reporting guidelines to present your methods and findings.

Hanan Aboumatar, MD, MPH, shares some advice for researchers who are starting the PCORI Peer Review process.

  • Be sure to describe and report on all aims and outcomes that you prespecified. If you changed your analyses, be sure you described how and why. Include measures of precision, including the 95% Confidence Interval for mean effect size.
  • Structure the report so that it follows an understandable narrative flow. That may mean structuring the Methods and Results by study aim rather than having all methods first then all results.
  • Review your statistical plan to make sure you are reflecting PCORI Methodology Standards for data analysis, especially those related to accounting for missing data. Be prepared to explain your reasoning if your analytic strategy differs from the PCORI Standards.
  • Do not overstate the clinical significance of your results. If the primary outcome does not show a significant difference between study groups, acknowledge that any statistically significant secondary outcomes cannot be considered definitive.

Posted: March 8, 2019; Updated: January 15, 2021

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

February 2
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 9
Board of Governors Meeting: February 9, 2021
February 11
Advisory Panel on Patient Engagement Winter 2021 Meeting

PCORI

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Patient-Centered Outcomes
Research Institute

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

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