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 questioned the researchers’ approach to calculating their needed sample size, saying that sample size should be calculated based on the minimal effect of interest, or the minimal difference between groups that would be clinically important. The researchers clarified that there was no previous evidence of a reliable minimum clinical difference for the outcome measures that they could use to calculate the sample size.
- Reviewers were particularly concerned that some study participants were not included in the analyses because they had not submitted any data from their activity monitors, questioning whether the researchers conducted their analyses based on the intention-to-treat principle or on how the participants were randomized. The researchers pointed to a supplementary table where they had compared the demographic characteristics of the participants who provided some activity data to those who provided none. They also acknowledged that their analyses were completed with all available data, which is not intention-to-treat.
- Reviewers noted that the authors’ description of their methods to account for missing data was written in future tense. The researchers explained that there was no agreed-upon method for controlling for missing data when data from an activity monitor were not even available at the baseline assessment. The researchers said they used future tense in this section because at the time of writing they had not yet performed all of the sensitivity analyses they planned to account for the missing activity data.
Conflict of Interest Disclosures
- Has Results