Results Summary and Professional Abstract
Results of This Project
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 criticized the report for not reporting first on primary outcome results as they had been defined in the study protocol. The researchers revised the report to clearly state the results for the primary outcome. However, they explained that measuring both patient-reported and performance-based outcomes can be the best way to represent changes in physical function after total knee replacement surgery because of the complexity and challenges of measuring such function. They also noted recent literature recommending a move away from focusing on a single endpoint rather than the totality of evidence coming from a clinical trial.
- Reviewers asked for the use of statistical methods to address missing data. The researchers initially explained that based on their understanding, the use of linear mixed models meant that multiple imputation for missing data was unnecessary. However, the researchers ran sensitivity analyses using multiple imputation as well to test those assumptions. They added the information about the reasoning behind not using multiple imputation initially and the sensitivity analyses to their analytic methods section.
Conflict of Interest Disclosures
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