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:
- The reviewers asked that the researchers provide more clarity regarding some major limitations to the interpretability of the study results. Specifically, because this is an observational study, it can detect associations only, not cause and effect. Second, the reviewers noted that the study’s primary and secondary outcomes are highly correlated, given that three secondary outcomes are actually subdomains of one of the primary outcome measures. The researchers acknowledged the limitations in the text and added language related to these limitations in the discussion.
- The reviewers asked for an explanation for why the study focused on the 12-month final endpoint rather than incorporating data from all time points. The researchers explained that they only analyzed treatment effects at the final time point because the study had far fewer participants than originally anticipated, limiting the interpretability of analyses that would take each time point into consideration. The researchers added text explaining their decisions.
- The reviewers commented that the reported number of bladder management options evaluated was inconsistent, sometimes reporting three and sometimes four. The reviewers also commented that how the researchers compared the options was not always clear. The researchers said that the confusion reflected the differences between their original proposal and how they accomplished the study’s objectives. The original funding application discussed only three treatment groups, but the researchers included four groups in the analysis. The researchers changed language throughout the report to more accurately reflect what they did.
- The reviewers noted that the researchers stratified the analyses in the results section by whether participants were tetraplegic or paraplegic. However, they point out that the researchers did not state in advance any of their hypotheses or analysis plans relating to these subgroups. The researchers responded that they decided to stratify participants in this way only after their patient advisory group recommended it. They added text about the separation of participants into two groups including in the abstract.
Conflict of Interest Disclosures
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Individuals with Multiple Chronic/co-morbid Conditions