Final Research Report
This project's final research report is expected to be available by November 2024.
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 asked for additional information about the composition and meeting frequency of the Patient Advisory Core. The researchers clarified the roles of the patients and stakeholders in the group, explaining for instance that three of the group members were patient representatives with lived experience of surgical complications and surgical site infections.
- The reviewers noted that subgroup analyses were not described consistently in the report. The researchers added language in the introduction explaining who would be considered part of a high-risk subgroup for closed fractures and for open fractures.
- The reviewers asked the researchers why upper-extremity fractures were excluded from the closed-fracture trial but included in the open-fracture trial. The researchers explained that upper-extremity closed fractures were much less likely to be associated with surgical site infections, so including patients with these fractures in the study would lower the baseline infection risk and potential study power. The researchers also noted that their decision was justified because the results for upper-extremity fractures were likely to be similar to the results from the study of lower-extremity fractures.
- The reviewers asked whether the predicted effect sizes (36% odds reduction for the closed-fracture study and 38% odds reduction for the open-fracture study) were based on previous data or experience. The researchers confirmed that their effect size estimates were based on a previous trial and added that citation to the report.
Conflict of Interest Disclosures
- Has Results