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 confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not 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 how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.
In response to peer review, Dempsey made changes including
- Conducting an intent-to-treat analysis with imputed missing data so that the results included data for all randomized participants
- Including a participant flow diagram per CONSORT guidelines
- Expanding the description of engagement with patients and stakeholders throughout this study
- Revising the report conclusions to de-emphasize the significant changes within treatment groups, and acknowledge the lack of significant difference between the two treatment groups, which was the primary aim
- Clarifying that the age stratification presented in the report was prespecified, and also correcting information in ClinicalTrials.gov to reflect the changes made to the report after peer review
Conflict of Interest Disclosures
- Has Results