Understand the purpose. The Final Research Report:

a. Provides a narrative of the research project including how patient and stakeholder partners were involved and contributed to the project, describes all the study aims, methods, outcomes and results, and any protocol changes that the investigator needed to make.

b. Covers all activities that the investigator has completed as part of their PCORI project.

c. Is much longer and more detailed than a journal article. Comprehensive details include

i. description of patient and stakeholder engagement,

ii. all aspects of research methods, results, and discussions of the implications of the research.

iii. All results, positive and negative, and null findings are reported.

See our reviewer training videos for more information, including our instructional
video for subject matter experts.

General questions you should ask yourself when reviewing

a. Is the study presented clearly and are the methods and results reported completely?

b. Do the authors follow the PCORI Methodology Standards and existing reporting guidelines.
such as CONSORT, where applicable?

c. Is there sufficient detail that another investigator could deliver the intervention, replicate the study methods, and reproduce the analyses?

d. Are the report’s conclusions appropriate and presented without “spin”?

i. The conclusions should follow from the methods and results

ii. the importance of study
findings should not be overstated

iii. prespecified primary results should be emphasized

iv. secondary and exploratory outcomes should be identified as such.

e. Authors might not be able to change their methods or major statistical analyses in response to peer review. Authors should describe study limitations and lessons learned from implementing the study, and the implications of the project for future research. Do the authors explain the decisions they made along the way and why? Do the authors describe and document the
rationale for any modifications to their study protocol and procedures in the research report?

The above describe general questions are not meant to be exhaustive, exclusive, or prescriptive.
The editors want your honest, constructive, and courteous, feedback.

Examples of Useful Comments

a. “My understanding of the engagement process could be improved by providing examples of how
planned study methods were changed by the several meetings.”

b. “We are told that the engagement process was ‘extensive’, but how often did the group meet,
and how many people did the investigators talk with?’

c. “I understood that the intervention improved HgbA1c for diabetes, but how long did the intervention take, and how many patients dropped out?”

d. “Need more information about the types of clinics where this intervention takes place.
Are they urban or rural, how large?”

e. “We are told only that side effects were ‘rare’, Would like to know what the side effects were
and what ‘rare’ means?”

f. ” I could not tell what 2 points on the xxxx scale means in terms of how a child is functioning
in social environments.”

Examples of Less Useful Comments

a. “The authors clearly don’t understand what it’s like to have this disease.” May be true, but
“tell us more about the lived experience of the participants” might get a more positive response
from the authors.

b. The authors should have been in regular contact with patients and caregivers during the planning, conduct, and analysis of the study.” Fine to ask them to describe those activities in more detail.

c. If the authors did not have sufficient contact with patients and caregivers, that can be stated as a limitation of the study. All studies have limitations and the PCORI DFRR template has a specific section for that.

Additional Tips

a. It is fine to recommend changes to the Draft Final Research Report (DFRR).

i. The authors will respond to all comments, but they cannot change the research question, and they cannot be required to undertak e new studies or analyses. They can be discussed as a future research need of course.

b. All activities have been completed, and there is no more time or funding.

i. The authors cannot add new participants and they cannot have additional meetings with the advisory team.

c. Brief targeted comments are often most useful to authors.

d. Enter review comments directly in ReView, the online editorial system. Do not submit a
separate document (i.e. Word document with tracked changes).

e. Reviews often average 2-3 pages, but length may vary based on the (DFRR).