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 about the report’s recommendation to disseminate the pain coping skills training intervention when the results for the primary outcome did not show a benefit. The researchers said they included the recommendation because of promising findings from secondary outcomes but agreed that the conclusion should rely more on the primary outcome. As a result, the researchers removed the recommendation for dissemination from both the report’s abstract and conclusion.
- Some reviewers requested that the researchers include a per-protocol analysis based on sessions completed, rather than just the more robust intention-to-treat analysis, but the editor told the researchers that this was not necessary. The researchers added an analysis focusing on participants who attended at least seven sessions, the complier average causal effect, because they had already been asked to provide this analysis for their primary results journal publication.
- The reviewers questioned the inclusion of the 12-Item Short Form Survey, SF-12, as an outcome measure of quality of life, since this can be insensitive to change over a period as short as one year. The researchers acknowledged this limitation but stated that they included the measure not because they expected to see a difference in overall health but in response to stakeholders’ recommendations. They also noted that the SF-12, as a common measure, can be used as a metric to compare this study sample to other studies.
- The reviewers asked the researchers to provide more information about how they handled the higher loss to follow-up in the intervention group than the comparison group. The reviewers also suggested that this difference be noted as a limitation. The researchers explained that they accounted for this differential loss to follow-up by including the treatment arm into their analytic models as well as using multiple imputation for missing data. The result, they stated, was an unbiased treatment effect estimate. The researchers also noted that they separately addressed the issue of lower treatment engagement in the intervention group.
Conflict of Interest Disclosures
- Has Results