Final Research Report
View this project's final research report.
Results of This Project
Related Journal Citations
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 noted that the usual care comparison condition in the study seemed to be quite comprehensive and asked the researchers to describe how it compared to standard practice. The researchers agreed that the enhanced usual care condition may have provided more attention to participants than they would normally receive, and that even the contacts with participants to collect survey data could encourage them to seek additional community resources. The researchers added language to their study limitations about how the enhanced usual care condition might have reduced the potential comparative effectiveness of their experimental intervention.
- The reviewers stated that patients appeared to not be very involved in this study. The researchers explained that patients were very involved in the pilot study on which the full trial was based, were important in the curriculum development for the new intervention, and helped determine how it should be delivered to study participants.
- The reviewers asked the researchers to add more discussion about why the study failed to find a significant difference in patient activation between the experimental condition and the enhanced usual care condition. The researchers disagreed about whether the study could be viewed as having failed to find an effect, instead describing their results as not being as robust as they had hypothesized. The researchers suggested some reasons for this lack of significant results, such as problems with the matching strategy, lack of sufficient power to find an effect, and inappropriate timing of survey collection. The researchers added discussion of these possibilities to the report.
- The reviewers wondered whether the burden of the intervention, which included multiple meetings and surveys, affected the outcomes and led to the lower-than-anticipated comparative benefit. The researchers acknowledged that some potential participants may have declined participation because of the anticipated burden, but that most of the participants who started the intervention sessions completed them and did not complain about the burden of the study, and some lamented the end of the study sessions.
Conflict of Interest Disclosures
Patient / Caregiver Partners
- The Trustees of the University of Pennsylvania
- City of Hope/Beckman Research Institute
- Yale University
Other Stakeholder Partners
- Ostomy Nurses:
- Nancy J. Tallman, RN, BSN, WOCN
- Lesley Hoffman, MSN, CNS, AOC
- Lucinda Pinchot, RN, BSN
- Peer Ostomates:
- Sue Reynolds
- Roger Iverson
- Frank Sova
- Marcie Felner
^Robert S. Krouse, MD, MS was affiliated with Arizona Board of Regents, University of Arizona when this study was initially funded.
- Has Results