Results Summary and Professional Abstract
|This project's final research report is expected to be available by July 2020.|
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 asked for greater clarity on when participants were randomly assigned to the intervention versus control groups because in some places the report indicated that group allocation occurred prior to the baseline home visit. The researchers explained that the study’s statistician randomized assignments upon confirming each patient’s eligibility, and study staff and participants found out patients’ study group assignments at the baseline home visit after the baseline measures had been collected.
- The reviewers then noted that out of the 186 individuals randomized to the intervention versus control groups before the baseline home visit, 120 completed the baseline visit. The reviewers recommended that the researchers conduct intent-to-treat analyses that included all 186 individuals, rather than only analyses on the 120 who completed baseline visits. The researchers added these analyses and presented a more in-depth series of tables and figures based on this reanalysis, which they said revealed no difference in treatment effect. At the reviewers’ recommendation, the researchers also added a comment about the large drop-out number in describing their study limitations.
- The reviewers questioned the approaches taken to address missing data and asked the researchers to clarify their strategies and to include their sensitivity analyses in the report. The researchers revised the report to explain that they came to a belief that the missing data in their study were missing at random because there were no external occurrences that could have affected which data were missing and when. In addition, their sensitivity analyses tested whether the results for skin and soft tissue recurrence changed if the missing values were all set to yes or all set to no. The researchers presented these results, which demonstrated no significant changes in the results based on these analyses.
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