Final Research Report
View this project's final research report.
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Vallabh O. Shah, PhD, talks about the impact of including key community members in his project.
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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.
The awardee made the following revisions in response to peer review:
- The awardee revised the structure of the report to better tell the story of how the work in each aim led to the next aim. The awardee removed the parts of the aim 1 discussion that had confused reviewers. The awardee also revised the background section to focus on the evidence gap in disease burden and optimal care in chronic kidney disease.
- The awardee provided more information on stakeholder engagement by describing in detail the team’s long-standing collaboration with this American Indian community. The awardee explained that the study’s design and implementation involved close collaboration with this community.
- The awardee further explained its description of the study as both a randomized controlled trial, RCT, and a pilot study. The awardee clarified that the study uses a RCT design with pilot components, such as measuring the feasibility of testing the effect of the intervention on chronic kidney disease outcomes in future trials.
- The awardee defined the terms intent-to-treat analysis and per-protocol analysis. The awardee explained that in per-protocol analysis, it compared groups of patients who completed the study. The awardee further explained that in intent-to-treat analysis, it compared the intervention and control groups while including patients who had dropped out, with the assumption that those patients had no change in outcomes. The awardee treated this comparison as a sensitivity analysis.
- In the study limitations section, the awardee noted that this project was a pilot study but added that the awardee tried to account for baseline differences to make the findings as robust as possible. In all, the awardee described the results as tentative but promising.
Conflict of Interest Disclosures
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