Final Research Report
View this project's final research report.
Results of This Project
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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. The comments and responses included the following:
- Reviewers had questions about the use of a patient activation measure as a primary outcome when other primary outcomes assessed health and quality of life, which seemed to be more direct measures of improvement. The researchers said patient activation is an important measure that helps providers tailor their care to the patient’s current activation level. They stated that the measure has become popular to assess in recent studies of disease management. Given the growing recognition that patients need to be active partners in their health care, the researchers felt that patient activation was an important primary outcome to include.
- Reviewers asked for more-detailed descriptions of the interventions, including usual care, so that others would be able to replicate them. In particular, the reviewers suggested using Consolidated Standards of Reporting Trials for Social and Psychological Interventions (CONSORT-SPI). The researchers expanded the description of their interventions but explained that they did not track the exact nature of the care delivered to patients in the control group. The researchers did emphasize that usual care was not at all similar to the two interventions in the study.
- Reviewers asked about the duration of follow-up, noting that most similar interventions have followed people for longer than 7 and 90 days as in this report. The researchers said that they based the 90-day follow-up on the well-recognized fact that most improvement in physical function after a stroke occurs in the first 90 days. They said many stroke trials measure outcomes at 3 months. The researchers agreed that longer-term outcomes would have been good to measure, but the three-year duration of the study prevented this.
- Reviewers questioned the interpretation of study results. In particular, they questioned how the combined treatments impacted global health but not mental health, given poor uptake of interventions by participants and the large number of measures and comparisons used, combined with potential bias in assessing outcomes. The researchers agreed that the results were challenging to understand and explain. They revised their discussion to address these concerns and to make sure the text did not overstate what the data showed. The researchers said more work will be required in the future to distinguish how much of the results were artifactual.
Conflict of Interest Disclosures
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