Final Research Report
This project's final research report is expected to be available by August 2022.
Results of This Project
Related Journal Citations
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers questioned how the researchers identified the number of study participants who were included in the planned analyses because it was not clear whether participants were excluded from analyses based on unforeseen factors such as rescinding their consent to participate in the study, participants not going through with the planned surgery, and changes to the study protocol which made some of the participants ineligible for the study. Over several revisions, the researchers clarified which participants were excluded from the analyses for the reasons stated above, and also clarified that participants who received incorrect feedback or missed other elements of the intervention were not excluded from analyses.
- The reviewers questioned the researchers’ assertions that their comparison analyses could not have been biased by the removal of participants from the analyses for the reasons stated above. The reviewers also noted that if participants were randomized to feedback group after the surgery these analysis problems could have been avoided. The researchers explained that the clinicians who determined whether to cancel a surgery or change the surgical procedures did not know to which feedback group participants were randomized, so their decisions could not have been biased based on group assignment. Further, the researchers explained that study participants had to be randomized before their surgeries because they needed to complete all study recruitment activities in order to complete baseline study questionnaires. The researchers did clarify the number of patients included in the analyses and added language to their limitations section regarding the potential for bias in the results, however small, due to removing some participants from the analyses.
- The reviewers asked for more detail about the patient and stakeholder engagement activities in this research project. They noted that the report did not describe how patients and other stakeholders contributed to study priorities, the research question or study design and therefore could not be considered “partners” to the investigators. The researchers assured the reviewers that community members were treated as study partners and this was reflected in the feedback these community members gave the investigators. The researchers expanded their description of patient partners’ participation in study planning and decision making.
Conflict of Interest Disclosures
- Has Results