Results Summary and Professional Abstract
|This project's final research report is expected to be available by February 2021.|
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 had questions about how the researchers measured adherence to the intervention and about the clinical meaning of the changes observed. The researchers agreed that using self-reported adherence was a limitation of this study. They added more information about baseline medication adherence levels for the intervention and control groups. The researchers noted that since this was a randomized trial, any bias in self-reported adherence should be similar between groups and therefore not account for any differences seen.
- The reviewers noted that change in medication adherence did not appear to lead to change in health outcomes. Given the existing literature on the adherence scale used in this study, the reviewers asked the researchers to report how much medication adherence change would be needed to change blood pressure outcomes. The researchers noted that past work has shown that self-reported adherence does correlate with disease control but said there is less information on whether self-reported measures effectively detect changes over time. The researchers said they had no data to assess how much self-reported change in medication adherence would be enough to affect a physiologic measure like blood pressure control.
- The reviewers suggested addressing whether such an intensive intervention, which required 11 phone calls per patient, was worth the effort in order to improve medication adherence when clinical outcomes did not improve. The researchers responded that even though the intervention did not improve clinical outcomes, it showed that lay members of the community could be trained as peer coaches to change patients’ beliefs about taking medication, which is a critical first step in improving medication adherence.
- The reviewers asked what the contribution was of the work in aim 1 of the project, since much that the researchers reported was already known in the literature. The researchers explained that the goal of the aim 1 qualitative work was to engage patient stakeholders in the development of the intervention using the recommended framework.
- The reviewers asked whether the intervention improved participants’ knowledge and health behaviors. The researchers replied that they saw a nonsignificant increase in knowledge. Diet also did not change significantly. The researchers said the intervention group did show a significant increase in the number of days walked for exercise.
- The reviewers suggested that the program might have led to greater changes in outcomes if the study had selected participants who were at greater risk of poor diabetes outcomes. The researchers agreed and said that they did focus on high-need communities for the intervention. However, in their discussions with community stakeholders, the stakeholders strongly advised against restrictive inclusion criteria, which could be seen negatively in a community with high levels of distrust for medical research.
Conflict of Interest Disclosures
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Other Clinical Interventions
Other Health Services Interventions
Training and Education Interventions
^Monika M. Safford, MD was affiliated with University of Alabama at Birmingham when this project was funded.