Results Summary and Professional Abstract
|This project's final research report is expected to be available by May 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 a more detailed description of how the researchers concealed from the staff what participants’ assignments to study arms were. The researchers added some text to their paragraph on randomization and blinding. The researchers blinded the outcome assessors and the statistician performing data analysis. However, the researchers reiterated that the statistician who assigned participants to the two study arms was not blinded.
- The reviewers noted that the measure of mental health quality of life was not included in some of the analyses and results, despite the report’s assertion that the enhanced intervention would address some mental health and psychosocial stressors. The researchers added the results of this measure to the text and some figures, stating that the mental health measure did not change significantly at either follow-up time point in either treatment group.
- The reviewers asked that outcomes be reported as prespecified in the protocol, with body mass index (BMI) the primary outcome, instead of BMI and quality of life reported as dual primary outcomes. The researchers revised their manuscript throughout to report BMI as the primary outcome and quality of life as a secondary outcome, consistent with their protocol.
- The reviewers noted that the report indicated that discussion of generalizability should await future research with more positive results. The reviewers disagreed, noting that nonsignificant results are also important for generalizability and knowing what does and does not work in studies. The researchers revised this section in their discussion, noting that study results would likely generalize to other urban indigenous groups in the United States, especially California.
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