Final Research Report
View the 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 asked the researchers to elaborate on the methodological limitations of the study, since they found no difference in outcomes between the intervention and control groups. The researchers expanded their discussion of limitations, including a note that t the lack of baseline measurement of outcomes limited their comparisons for determining how much outcomes improved after the intervention. In addition, the post-intervention outcome measures were high in both groups, indicating a ceiling effect and not much room for improvement. Finally, in response to stakeholder input, the researchers compared the intervention group to best available standard care rather than usual care, reducing the differences in care delivery between groups.
- Reviewers asked why the researchers completed the study if an interim analysis could have shown that the patient activation tool seemed to have no measurable efficacy. The researchers said they decided to complete the project after an analysis halfway through the study in order to make sure that the patient activation tool had no negative effects. They also completed the project because they thought the patient activation tool might lead to fewer disability days, one of the outcomes being measured. The researchers noted that a PCORI team reviewed the interim results and agreed with the researchers that it would be useful to complete the trial.
- Reviewers asked the researchers to elaborate their rationale for the study and why they thought that a computational tool would lead to better results than talking with an experienced clinician alone. The researchers explained that the patient activation tool included additional features compared to the standardized consultation. The additional features included video explanations for the risks and benefits of different treatment options and interactive exercises to help patients prioritize the risks and benefits of each treatment. Ultimately, both groups took about 20 minutes for each intervention, a clinician consultation versus a consultation plus use of the patient activation tool.
Conflict of Interest Disclosures
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