Results Summary and Professional Abstract
|This project's final research report is expected to be available by March 2021.|
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:
- The reviewers indicated that the interpretability of this research was limited because the intervention was not compared to a control group. Instead, the investigators compared different iterations of the multi-part intervention. The researchers pointed out that they did not need to include a control or usual care group in a comparative effectiveness trial, since they were comparing different iterations of the intervention.
- The reviewers asked if the researchers had any concern about patients being well enough to participate in the study after several years. The researchers said many patients did decline and more partners than patient participants responded over time.
- The reviewers noted that this study’s broader outcomes like quality of life, the main outcome in this study, were problematic even though the reviewers applauded the researchers for identifying outcomes most important to patients. The reviewers explained that with this type of outcome, it would be difficult to find a way to alter the intervention in order to improve its effect on the outcome. The researchers countered that if a study focused on more mechanistic outcomes, such as brain atrophy in the case of cognitive impairment, and did not improve quality of life, the intervention would be of little value to patients. The researchers pointed out that intervention studies designed to understand the mechanisms of the intervention were different types of trials and did not represent what this study aimed to accomplish.
- The reviewers asked how the individual components of the Mayo Clinic intervention were chosen given that there are other components that have been successful in improving outcomes for this population. Specifically, they asked why aerobic physical activity was not considered. The researchers responded that yoga, a component of the intervention, is indeed an aerobic physical activity and was chosen over other activities such as walking and running because of its adaptability to the condition of participants. The researchers did not respond to the original question of how they decided to use the specific components that they included in the intervention.
- The reviewers said it was not clear to what extent participants remained engaged with the activities in the intervention. The researchers said they collected data on treatment adherence but noted that some activities required less commitment than others (e.g., attending a one-hour support group once a month versus. completing three and half hours of physical exercise each week). So, comparing adherence across treatment groups is challenging. The researchers said they are continuing to study how to compare adherence across study arms but that in this study analyzing adherence did not appreciably change their findings.
- The reviewers noted that the patient groups ranked outcomes in importance based on group input, whereas individuals presumably ranked outcomes differently, and differences in what patients regarded as important might have affected outcomes across individuals. The researchers strenuously agreed. They said that they included and analyzed a range of outcomes in this trial partly so it will be possible in the future to tailor interventions according to the priorities of individual patients.
Conflict of Interest Disclosures
The COI disclosure form for this project will be posted here soon.
Other Health Services Interventions
Training and Education Interventions
^Glenn E. Smith was affiliated with the Mayo Clinic when this project was funded.