Results Summary and Professional Abstract
|This project's final research report is expected to be available by February 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. The comments and responses included the following:
- Reviewers asked for greater clarity about the requirements for inclusion in the study. Specifically, it seemed that researchers included only participants with complete baseline data in the sample, and the index procedure for subglottic stenosis may have occurred prior to the beginning of the study. The researchers confirmed both of these assumptions. They updated the abstract and the methods section to clarify that the study included both newly diagnosed and previously treated patients. The researchers also clarified that the final analysis only included patients who had completed baseline surveys and if researchers had documention of the patients’ initial procedures, some of which predated the study.
- Reviewers expressed concern that requiring complete baseline information may have biased the sample since many patients reportedly were not able to complete this information at their index visits. The researchers conducted a sensitivity analysis comparing participants with complete baseline information to those patients without complete information. The researchers found no differences between groups.
- Reviewers asked whether the study accounted for unmeasured effects of variables like surgeon, surgery center, or medication on the treatment outcomes. The researchers said they considered conducting analyses to disentangle these potential confounders but realized that the analyses would not be possible given the amount of potential missing data. Instead, the researchers discussed the limitations related to these potential confounders in the report’s discussion.
- Reviewers asked for more information on the possibility of competing interests in the study team, given that the study suggested that one procedure performed at one institution is superior to others. The researchers said that none of the investigators had financial relationships relevant to the analysis and that they performed the biostatistical analysis independently.
Conflict of Interest Disclosures
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