Final Research Report
View this project's final research report.
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 the study results showing higher incidence of venous thromboembolism (VTE) in patients with venous thromboembolic disease when receiving extended treatment with warfarin or direct oral anticoagulants (DOACs) compared to shorter three-month treatment. The higher incidence was particularly evident between three and six months of treatment but fell after that point. The researchers responded that the factors leading to this counterintuitive finding were likely to be unmeasured confounders, such as whether VTE events were provoked or unprovoked.
- The reviewers noted that the results could be confounded by differences between groups that were not considered in the analytic model. The researchers acknowledged that several factors predictive of a VTE event could not be measured in this study, such as medication adherence and changes in treatment regimen that are not reflected in prescription changes.
- The reviewers also asked the researchers for more information on how they calculated propensity scores for their analyses and noted that propensity scores would be more valid if the researchers included any measured confounders in the analyses. The researchers responded that the unmeasured confounders that could not be applied to propensity score calculation would still affect the validity of study results.
- The reviewers criticized the researchers’ subgroup analyses because the results were presented by subgroup, whereas heterogeneity of treatment effects by subgroup could only be determined by examining the interaction terms in their analytic model. The researchers revised their analyses to include the interaction terms, thereby providing a test of heterogeneity of treatment effects.
Conflict of Interest Disclosures
Patient / Caregiver Partners
- Mr. Randolph Fenninger
- The National Blood Clot Alliance
Other Stakeholder Partners
No information provided by awardee.
- Has Results