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 noted that the researchers used a composite outcome consisting of recurrent venous thromboembolism, major bleeding, and all-cause mortality for all of the data sets they reviewed even though the mortality component is only available in one of the data sets. The reviewers asked the researchers to explain how this was handled for the other two data sets. The researchers explained that mortality in the two other data sets was captured for in-patient deaths and for outpatient could be inferred from insurance disenrollment. The researchers noted in their study limitations section that the results for this composite outcome should be interpreted with caution given the limitations in capturing mortality.
- One reviewer questioned whether the study’s comparisons of treatment continuation versus treatment discontinuation both included only data for those patients who were still alive at each time point, noting lack of that data restriction could introduce bias to the results. The researchers responded by including additional information in their methods specifying that all patients were followed unless they disenrolled from insurance, there were no further data on them, or they died.
- The reviewers requested that the researchers expand their discussion to consider potential confounding, lack of focus on race and ethnicity, and lack of discussion regarding clinical implications of the study results. The researchers expanded their discussion section as suggested, including some reorganization with subheadings so that readers could follow these points more clearly.
Conflict of Interest Disclosures
- Has Results