Results Summary and Professional Abstract
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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.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers inquired about the lack of attention to missing data in the report and the use of complete case analysis to compare the two study arms, as this type of analysis tends to introduce potential bias into the results. The researchers responded by analyzing their data using mixed effects models, which accounted for missing data. These models also allowed them to include almost their entire sample rather than only complete cases, giving them a more robust result. In their limitations section, the researchers also discussed the issue of the amount of missing data.
- Reviewers suggested that the effects of the intervention might have been greater if the usual care control group did not already have relatively high engagement and receive some culturally sensitive services. The reviewers suggested using a term other than, usual care, for the control arm. The researchers agreed that the quality of service their community partners provided was high and has made finding an intervention effect more challenging. They retained the term, usual care, because they had used it in previous publications, and the term is widely used. However, they also added context in the report about what usual care represented in this study.
- Reviewers noted that because the decision to control for baseline scores is a complex one in randomized controlled trials, the researchers should provide additional discussion about their choices. The researchers argued that for randomized controlled trials statisticians widely agree on controlling for baseline scores as a way to increase precision and statistical power. They added information to their analysis description about their choices for the covariates to add to their analytic model.
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