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:
- Reviewers asked how the researchers recruited participants for the survey portion of the study and how that would affect interpretation of survey results. The researchers added more detail about their survey methods to the report. However, they also admitted that they were unable to provide an accurate survey response rate since the survey link was on a publicly available website to encourage multi-national responses.
- Reviewers said the report was unclear in its description of the handling of missing data, and they expressed concern that missing data were not handled as expected in the PCORI Methodology Standards. The researchers responded that they did not impute missing data for the primary outcomes and that by far the largest reason for missing primary outcomes data was being unable to contact families to assess six-month outcomes. There were few missing data for other study elements. The researchers indicated that they were not able to complete imputation analyses at this time.
- Reviewers stressed that this study was not a pilot or feasibility study but was a clinical trial that was not able to test its hypotheses because of underenrollment and significant loss to follow-up. Given the limited conclusions that could be drawn from an incomplete trial, the reviewers considered the comments on clinical implications and generalizability to be unwarranted. The researchers revised their discussion of the clinical trial, focusing more on lessons for future research and less on the clinical implications of this study’s results.
- Reviewers had difficulty understanding the rationale for the biomarker component of this study, and particularly the advantages of assessing a functional outcome by biomarker rather than by less invasive means. The researchers indicated that brain injury biomarkers have been used as diagnostic and prognostic tools, and trajectories of biomarkers could be informative in understanding changes in functioning after brain injury.
Conflict of Interest Disclosures
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