Final Research Report
This project's final research report is expected to be available by October 2024.
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 study focus groups led to the researchers choosing three patient-reported outcomes measures (PROMs) to be used in the comparative clinical trial, but there was little information about these three measures in the final report. The researchers added more information, including the structure and the domains covered, about the chosen measures in the methods section of the report.
- The reviewers commented on the planned study analyses that were not conducted in the research. They understood that this was largely due to changes in the study design but asked the researchers to explain the changes in analyses more clearly. The researchers acknowledged that they did not carry through changes to the study protocol to make changes to the statistical plan. They did add language to the report explaining that two expected changes in implementation of the PROMs in a large-scale quality improvement program for metabolic and bariatric surgery (MBS) did not occur, reducing the scale of the program and therefore the sample size for analyses. The researchers explained that they changed their analytic plan due to this reduction.
- The reviewers asked for more information about how the researchers calculated power and effect size for their study. The researchers added an explanation about their sample size calculations needed to assume 90% power in detecting differences on the PROMs. They also added effect size estimates to a table listing the anticipated sample size requirements. They noted, however, that the changes to the improvement program meant that they did not have sufficient power to determine if any of their secondary outcomes were mediators of the main outcomes.
- The reviewers noted that there was a lack of diversity among the focus group participants, who were all recruited from the same region. Further, the reviewers were concerned that all of the MBS study participants had to be English-speaking. The researchers acknowledged these as limitations, explaining that these limitations were driven by limited resources.
- The reviewers asked the researchers to explain the difference between their measures of total weight and excess weight. The researchers explained that total weight indicates the amount of weight change between pre-operative and post-operative weights, whereas excess weight refers to the amount of weight participants carry above the goal weight equaling a BMI of 25.
- The reviewers were confused about the report’s use of Alpha and Beta pilots and their relationship to the focus groups. The researchers explained that participants in the pilots were not the same as participants in the focus groups. Rather, the third round of focus groups focused on the Alpha pilot, which was small, and the fourth round of focus groups focused on the Beta pilot, which was considerably larger.
Conflict of Interest Disclosures
- Has Results