Final Research Report
This project's final research report is expected to be available by November 2023.
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 noted that the report did not include some of the statistical analyses proposed in the original study protocol, specifically non-inferiority tests of non-fatal pulmonary embolism or deep-vein thrombosis and superiority tests of rate of complications. The researchers explained that their statistical analysis plan evolved and recommended that the reviewers compare the final report to the final study protocol and statistical analysis plan found in the report’s appendix.
- The reviewers also noted that the report did not include the two planned interim analyses and asked for those to be added since the interim analyses could have led the data and safety monitoring board to end the study early. The researchers added a summary of the interim analyses, which were reviewed only by the data and safety monitoring board and resulted in no study protocol changes.
- Reviewers requested more rationale for comparing aspirin to low-molecular-weight heparin rather than other oral anticoagulants for thromboprophylaxis in orthopedic trauma patients. The researchers explained they wanted to focus on treatments currently in clinical use.
Patient / Caregiver Partners
- Peter W. Thomas
- Debra Marvel
- Larry Cutsail
- Dave Wells
- Jeremy Palmer
- Ian Weston, MBA, American Trauma Society/Trauma Survivors Network
- Randolf Fenninger, National Blood Clot Alliance
Other Stakeholder Partners
- Stephen Fisher, MD, PhD, Chesapeake Employers' Insurance Company
- Stephen Breazeale, CRNP, R Adams Cowley Shock Trauma Center
- Grace S. Rozycki, MD, MBA, American Association for the Surgery of Trauma
- Kevin J. Bozic, MD, MBA, American Association of Orthopaedic Surgeons
- Nicole Stassen, MD, FACS, FCCM, Eastern Association for the Surgery of Trauma
- Bryce Robinson, MD, MS, FACS, FCCM, Eastern Association for the Surgery of Trauma's Practice Management Guideline Section
- Theodore Miclau, MD, Orthopaedic Trauma Association
- William Obremskey, MD, MPH, MHHC, Chair of the Orthopaedic Trauma Association's Evidence-Based Medicine Resource List
- Thomas Scalea, MD, FACS, MCCM, Western Trauma Association
- Has Results