Results Summary and Professional Abstract
|This project's final research report is expected to be available by March 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 had many comments about how the researchers presented results . They noted that the researchers included so many outcomes that it was difficult to discern which were clinically meaningful. In addition, the researchers mostly reported standardized effect estimates rather than mean differences between groups, making the results more difficult to interpret. The researchers responded by emphasizing the primary outcomes in their narrative and by including estimated mean differences at 12 months in presenting their results. They noted that presenting estimated mean differences for the whole time period was not possible since the differences would vary by time point. However, the researchers primarily added this level of information for outcomes that were statistically significant rather than for all outcomes, as the reviewers asked. The researchers felt that it was important to provide the results for all of the outcome measures but stated that they limited the statistics reported for the nonsignificant measures to save space. In describing the strengths and limitations of the study, the researchers also acknowledged that testing multiple outcomes in multiple domains could open the door to spurious statistical findings. However, they felt that it was important to conduct so many statistical tests in order to better understand the complex impacts of behavioral interventions. The researchers cautioned the reader to be conservative in their interpretation of study results.
- The reviewers expressed concern about the way that the researchers interpreted the results; it seemed that the report emphasized some results that might not be clinically meaningful, and in other cases emphasized results that showed trends toward statistical significance without actually demonstrating statistical or clinical significance. The researchers revised their abstract, results, and discussion to provide a more balanced presentation of the results. They removed references to statistical trends and put more emphasis on key measures even if they showed no significant differences.
- The reviewers asked about the protocols used, how widespread their use is, and how easy they would be to implement in a typical clinic setting. The researchers emphasized that the two protocols were developed recently, one specifically for this study, and so neither is in widespread use. But the researchers said the protocols were designed for use in a typical clinic setting. This report is the first test of their effectiveness in such a setting.
Conflict of Interest Disclosures
The Conflict of Interest Disclosures for this project will be posted here soon.
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