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.
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.
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