Results Summary and Professional Abstract
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 noted that in adaptive enrichment trial designs, researchers had many design decisions to make. Those decisions could have affected the validity of the study, such as when to include interim analyses and how many, and researchers could have provided in the report additional, useful guidance about how to approach such decisions. The researchers responded that they would prefer not to provide general guidance on these study-specific choices. Instead, the software the researchers created provides a range of options that clinical investigators can explore as part of designing an adaptive enrichment trial.
- Reviewers asked whether the results of the sensitivity analyses could be presented in a table with quantitative findings clearly provided. The researchers explained that this might require substantial space to explain the simulation step, and that a qualitative presentation through plots, would be more useful to the report overall.
Conflict of Interest Disclosures
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