|This project's final research report is expected to be available by June 2019.|
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, noting that the exclusion of 7 percent of the sample, or 200 patients, from analyses because researchers had no post-baseline data, asked whether these patients differed in any way from the included patients. The investigators replied that the two groups differed on race and on one quality-of-life outcome at baseline. While the researchers added this limitation to the report, they said that they did not believe this difference changed their conclusions.
- The reviewers expressed concern that the analyses did not include a correction for multiple comparisons and that some apparently statistically significant differences might be due to chance. The researchers responded that they identified all of their hypotheses a priori and an adjustment for multiple comparisons was not appropriate when testing a pre-specified hypothesis.
- The reviewers requested additional information on how the researchers accounted for potential clustering by site in the analyses. Clustering by site can lead to unmeasured between-patient correlations that could bias the aggregate results. The researchers explained that they had accounted for site as a covariate in their statistical models but said that they did not test for a site by treatment interaction. The researchers added as a study limitation a comment about the potential for bias due to clustering by site.
Conflict of Interest Disclosures
View the COI disclosure form.
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