The Draft Final Research Report (DFRR) is a detailed report of all work completed as part of the PCORI-funded contract. The DFRR tells the story of the research project, including all of the protocol changes made during the study, all preplanned and follow-up analyses, and all of the lessons learned during the study. By law, the DFRR must include a section on study limitations and a section on subpopulations or subgroup differences tested in the study.
The audience for this report is the general scientific community and the report should be written so it can be easily understood by most clinical scientists.
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. Include notations in the text where you addressed methodology standards. Authors should download the most recent version of the DFRR Instructions for Awardees for comprehensive instructions. Where applicable, DFRRs should adhere to relevant reporting guidelines (e.g., CONSORT 2010, STROBE), which can be found on the EQUATOR Network website
Overview of DFRR Structure
The abstract should be organized by Background, Objective, Methods, Results, Conclusions, and Limitations. It can be up to 1,000 words and should adhere to relevant reporting guidelines. Include quantitative results from main analyses.
The Background section of the final report 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.
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 Methods should be described in detail, using the subheadings found in 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 should include a section describing any changes made to the original study protocol.
What Else Is in the DFRR:
- Publications supported by PCORI award
- Data-sharing plan
- Any appendices referenced in the text
The Results also should be presented following relevant reporting guidelines and should include a flow diagram, if applicable. Authors should present the preplanned analyses of the primary outcomes first, followed by secondary and exploratory analyses. The magnitude and precision of results should be reported in a manner that is likely to be meaningful to stakeholders such as patients and clinicians. Any post hoc or additional analyses should come last and be described explicitly as post hoc.
The Discussion section should start with a summary of the results and describe the relationship of the study’s results to existing research. Authors should include sections on Study Limitations and Subgroup Considerations here. Finally, the authors should consider potential for future research in their Discussion.
The Conclusion section should be about a half-page high-level summary of the study, with a few sentences on the implications for clinical care, if appropriate.
DFRR Required Attachments
The DFRR is submitted for peer review along with four required attachments:
- Final 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.
- Refer to the Checklist.
- Ancillary Information Conflicts of Interest Disclosure Form signed by the awardee institution reporting any conflicts of interest for key personnel
- Refer to example completed form.
- Ancillary information – Return of Aggregate Study Results Form: This form collects information about the awardee’s completed and/or planned efforts to return aggregate study results to research participants.
PCORnet® Distributed Data Network: Text for Draft Final Research Reports
Increasing numbers of PCORI DFRRs will be utilizing PCORnet®, the National Patient-Centered Clinical Research Network’s distributed data network as a component of their research. The amount of utilization of the PCORnet network will vary from project to project, depending on study design and methods. The use of data from participating sites and other infrastructure resources and tools can range from extensive engagement in many aspects of the work, such as a secondary data analysis of weight loss after bariatric surgery, to only modest involvement when the network is used, for example, to consistently identify potential participants for a trial but not with other aspects of the trial such as outcome data collection. Consistent description of the network is important so that readers know the provenance of the data, the ongoing quality checks, and the methods used.
The following text is approved for use in DFRRs and must be included in any DFRR in which the PCORnet distributed data network is used. Depending on how extensive the utilization of the PCORnet resources is, the description could be as short as a paragraph or as long as a page, with references to the appropriate publications. This text could also be in a short appendix and referred to in the text:
The research reported in this Final Research Report was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®).
PCORI funded the development of PCORnet® to address an urgent national need—capacity to conduct patient-centered outcomes research faster and more efficiently by leveraging the power of health data, reusable research infrastructure, and unique patient partnerships. PCORnet addresses several challenges of traditional clinical research, including the time and expense involved in developing a study, the lack of data on certain rare conditions or underserved populations, data quality concerns, and the recognition that many studies don’t answer the questions most important to patients.
Development of PCORnet began in 2014. The network is composed of a Coordinating Center, Clinical Research Networks (CRNs), and patient partners. Each CRN is made up of multiple healthcare delivery systems, including hospitals, primary care and specialty practices, and safety net clinics. CRNs participating in PCORnet work to capture complete, longitudinal healthcare data on their patient populations, including electronic health record data generated by patient care in the delivery system and claims information or other records representing care received outside the delivery system. This provides the ability to research care and outcomes in multiple diverse clinical settings over time. Patient partners are fully engaged in PCORnet governance, participate on committees, and provide valued input and leadership in all facets of the development and execution of research efforts. Standing and template data use agreements among the participating entities facilitate timely conduct of research.
PCORnet is a distributed research network utilizing harmonized data. In this distributed network, health information stays at the institution that generated the data through patient care. Information is transferred from the electronic health record system into the institution’s data warehouse where structured patient data are transformed into the PCORnet Common Data Model (CDM). In this way institution-specific information, such as vital signs, demographics, laboratory test results, or care utilization, is harmonized so that data have a common format to facilitate analysis. Through data harmonization, differences in data format related to the version or type of electronic health record are addressed. The distributed model is designed to keep patient data secure. The entire process is performed locally at the network site, and only aggregate deidentified results are returned to the Coordinating Center for PCORnet. The data remain at the network site behind institutional firewalls, maintaining security. The demographics of the individuals in the databases are broadly representative of the US population. All activities are conducted with the governance of data use agreements, HIPAA, and human subjects review boards (IRBs).
The Coordinating Center for PCORnet is responsible for maintaining and updating the PCORnet CDM, as well as for the development and enhancement of distributed data query tools. These tools facilitate extraction of information to conduct secondary data analyses as well as identify individuals who might be candidates for recruitment as participants in research studies such as cohort studies and clinical trials.
Assessment of the quality and completeness of the data used by PCORnet Network Partners is conducted on a regular basis. Data harmonization and transformation into the PCORnet CDM at the participating sites occurs every three months. The Coordinating Center for PCORnet conducts quarterly data quality assessments of the participating Network Partners. These detailed evaluations assess completeness and appropriate mapping to the PCORnet CDM or to standard reference terminologies such as LOINC for laboratory data or ICD10 for diagnoses, as well as other assessments. Additional information regarding the structure and process of the PCORnet distributed research model can be found at https://pcornet.org/ and in related publications.
Hanan Aboumatar, MD, MPH, shares some advice for researchers who are starting the PCORI Peer Review process.
Reminders to Avoid Common Pitfalls
- Start early! Peer review takes place after the study is complete and your research team 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 addresses the current applicable PCORI Methodology Standards.
- Draft Final Research Report Instructions
- FAQs: Preparing the DFRR
- Currently Available Final Research Reports
- Methodology Standards Checklist
- Ancillary Information Conflict of Interest Form
- Return of Aggregate Research Results to Study Participants Reporting Form
- PCORI Policy for Data Management and Data Sharing
- Be sure to adhere to relevant accepted reporting guidelines to present your methods and findings (e.g., CONSORT 2010, STROBE), which can be found on the EQUATOR website.
- 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.
- When reporting your results, include the magnitude of the effects and measures of precision, such as the 95% Confidence Interval for mean difference or risk ratio. Discuss the clinical importance of differences between groups.
- 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.
- Describe the totality of the evidence, focusing on the prespecified outcomes and analyses. For example, do not emphasize statistically significant secondary outcomes if there was no important difference for the primary outcome, or if the results for the primary outcome were very imprecise. Likewise, do not overinterpret secondary analysis, such as exploratory subgroup analyses that are not consistent with the primary analysis.
Posted: March 8, 2019; Updated: October 18, 2022
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