Results Summary and Professional Abstract
Final Research Report
View this project's final research report.
Related PCORI Dissemination and Implementation Project
Results of This Project
Peer-Review Summary
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.
The awardee made the following revisions in response to peer review:
- The awardee provided additional details on the use of complete case analysis to account for missing data on race and other variables for a substantial number of participants. The awardee also noted in the study limitations that because of the large amount of missing data, particularly for race, planned subgroup analyses on racial differences in uterine fibroid treatment could not occur.
- The awardee described the management of loss to follow-up. The study required all patients in the analytic data set to have had at least two years of follow-up data which the awardee used as the focus for its primary analyses. The awardee performed additional analyses using all follow-up data after first removing patients who were lost to follow-up.
- The awardee clarified the membership of the stakeholder advisory group, which included individuals who had experience with uterine fibroids and others who held roles with nonprofit advocacy groups for uterine fibroid awareness.
- The awardee revised its description of adherence to PCORI’s Methodology Standards. The awardee provided more detail in additional text that addresses handling of standards RQ-4 (Identify and assess participant subgroups); IR-1 (Specify plans for data analysis); IR-5 (Provide sufficient information in reports to allow for assessments of the study’s internal and external validity); and all standards for prevention and handling of missing data.
Conflict of Interest Disclosures
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Project Details
*Richard Gliklich, MD was the original principal investigator for this project.