Results Summary and Professional Abstract
|This project's final research report is expected to be available by January 2021.|
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 expressed concern that the minimally clinically important difference (MCID) the researchers chose was too high, and they suggested the researchers conduct additional analyses based on a smaller recommended MCID. The researchers responded that they used MCID for sample size calculation and not for statistical analysis, so they concluded that new analyses were beyond the scope of this project.
- The reviewers asked for a review of assumptions and calculations to make sure that the project’s high dropout rate did not compromise the validity of the study’s findings. The researchers agreed that loss to follow-up was higher than expected but said they used intention-to-treat analysis and complete case analysis to minimize potential bias. The researchers noted that the highest loss to follow-up occurred in the control group, reducing concern that the burden of intervention was the main reason people dropped out. Loss to follow-up rates were similar across the two intervention groups.
- The reviewers suggested they would like to have seen a broader set of outcomes assessed, especially clinical outcomes. The researchers explained that they focused on patient-reported outcomes in this report but that clinical outcomes such as fatigue and cognition would be important to consider in future studies.
Conflict of Interest Disclosures
View the COI disclosure form.