Final Research Report
View this project's final research report.
Results of This Project
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:
- This study hypothesized that mindfulness-based cognitive therapy would improve participant well-being more than a brief mindfulness intervention but found that the difference between the two treatments was statistically but not clinically significant. The reviewers asked whether the researchers’ threshold for clinical significance could be too large for such a diverse group of study participants. The researchers added a note in the report that their threshold for clinical significance was based on clinical studies where participants were likely to be much more similar to each other than they were in the present study.
- The reviewers questioned the use of linear models in the study analyses, stating that the seven assessment times over 20 weeks were more likely to show variable changes in the outcomes over time. The researchers acknowledged that this was likely to be the case and added later analyses to the report that allowed for variability in the outcome measures over time as a comparison to the pre-planned linear analyses.
- The reviewers pointed out also that the analyses the researchers conducted would only be valid if participant dropout was random, when in reality the participants who had dropped out of the study were those who were not benefitting from the treatment. The researchers acknowledged this possibility and added a limitation to the report that dropout was possibly not random, and the study results were skewed toward more positive results.
- The reviewers asked the researchers to provide more rationale for the moderator variables, and to adjust the results of moderator analyses for multiple comparisons. The researchers provided more information about the moderator variables they chose. However, they did not make statistical adjustments to their moderator analyses because these analyses were largely exploratory. Therefore, the researchers reported the unadjusted results for these analyses but also limited their interpretation of these results.
Conflict of Interest Disclosures
- Has Results