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 expressed concern that the multiple outcomes, including several cut-points for glycated hemoglobin (also known as hemoglobin A1c or A1c), would lead to significant outcomes that could be attributed to chance. The reviewers noted that the study protocol focused on fewer comparisons and asked why the additional cut-points were added and whether these were predetermined or added post-hoc. The researchers clarified that their primary outcome was the measure of A1c under 7 percent, but that they had included post-hoc measurement at 9 percent or 8 percent, as well as several cut-points for the size of the difference in A1c from baseline to follow-up.
- The reviewers questioned one of the results of the study, indicating that there was a substantial increase in outpatient visits that were not focused on care management in the patients enrolled in the care management program, because this result did not seem to be consistent between electronic health records and claims data. The researchers acknowledged that this finding was not consistent across databases and this difference was probably attributable to how non-case management visits were documented.
- The reviewers also asked the researchers to clarify some of the methods that were used and how some of the analyses were performed, particularly with variable follow-up on the outcome measures. The researchers explained their methods further and particularly how they accounted for differences in the follow-up period, standardizing the number of months for follow-up if the outcome variable was sensitive to the time between baseline and follow-up.
- The reviewers commented on the application of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) to this research and especially that the researchers did not seem to apply this framework in the discussion of study results. The researchers added a table to the discussion that synthesized the results into each of the RE-AIM periods.
- The reviewers questioned the researchers’ conclusion that the modest decreases in mean A1c were clinically meaningful given that this was based on survey results in a paper that concluded the opposite. The researchers added text to the report indicating that the modest differences are probably not clinically meaningful, but it is encouraging that patients with higher A1c at baseline showed the greatest reduction by follow-up.
Conflict of Interest Disclosures
- Has Results