Final Research Report
View this project's final research report.
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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.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- Reviewers were concerned that the abstract overstated the inferences made from the study results, particularly because the highlighted results did not appear to come directly from the listed study objectives. The researchers responded that the analyses presented in the abstract were indeed all planned analyses, and that their results were robust enough to support the study conclusions. They did revise the abstract to include the primary aim results so that the Results section is better aligned with the study objectives.
- Reviewers particularly noted the strong inferences made about the moderating effects of gender on treatment outcomes over time and criticized the analytic approach to testing these moderating effects. The researchers rebutted that their approach to testing for the moderating effect of gender was appropriate because they first wanted to determine whether actual differences over time between the two treatments were present but masked by gender differences in outcomes.
- The reviewers were unclear about whether this cluster-randomized trial included 10 or 11 clinics, because both numbers were used. The researchers clarified the report to show that 11 clinics entered the trial, but that the two smallest clinics had similar enough characteristics that their data were combined.
- Reviewers were concerned that the study did not adequately account for multiple outcomes when determining the sample size for the study. In addition, reviewers felt it was unclear whether the study had enough power to test the heterogeneity of treatment effects. The researchers explained that they used the best available historical effect sizes for the primary outcomes to calculate sample size, and clarified that the heterogeneity of treatment effects analyses should be considered exploratory because the study was not adequately powered for those analyses.
- The reviewers commented on the significant loss-to-follow-up of participants between baseline and final outcome data collection, expressing concern because there were differences between completers and those who didn’t complete on some key measures. The researchers responded that they did not understand why completers differed from those who didn’t complete, but that they did account for it in their analyses.
The reviewers noted the significant and unexpected finding that patient-reported physical health status worsened over time and interpreted this as indication of the difficulty in improving health status within this population, even after improvement in mental health and patient activation. The researchers disagreed with this interpretation; they interpreted the worsening health status as a consequence of patients’ improved understanding and acknowledgement of their health brought about by their increased engagement in preventive and maintenance care. The researchers felt that longer periods of observation would demonstrate a gradual improvement in physical health as patient engagement translated into better health behavior.
Conflict of Interest Disclosures
- Has Results
- Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted
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