Results Summary and Professional Abstract
|This project's final research report is expected to be available by September 2021.|
|Article Highlight: When heart failure occurs or gets worse suddenly, it’s called acute heart failure, or AHF. In this PCORI-funded study, researchers tested whether a self-care program with a coach supported patients with AHF after they left the emergency room more than usual care supported them. After 30 days, patients in the self-care program had fewer AHF-related deaths and visits to the emergency room, hospital, or clinic, and had higher ratings of their health than those who received usual care. However, these improvements did not hold 90 days after hospitalization. These results are explored in a paper in JAMA Cardiology.|
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 raised concerns about the study design. In particular, they expressed concern that assigning individual patients within the same sites to different interventions could have caused cross-contamination in how the interventions were administered. The reviewers noted that the team of nurses, study coordinators, paramedics, and others who administered the interventions may have adopted elements of the intervention in their treatment of patients in the control arm because of their knowledge of the intervention and desire to provide the best care possible. The researchers acknowledged this was a limitation of the study. They said they randomized patients but stratified by site to ensure balanced randomization at each site because it would be difficult to use clinic randomization in this study design. The researchers added that they monitored the care that patients in the control arm, those receiving usual care, received to try to detect the possibility of cross-contamination and could confirm that they did not have home visits or coaching calls. However, the researchers acknowledged that being on a site with patients in the treatment arm could have affected usual care patients’ emergency department encounters.
- The reviewers said the researchers should address the lack of blinding as a potential limitation in the study design. In other words, patients and the coaches who administered the interventions were aware of who received the interventions, and the reviewers suggested that the awareness of being treated may have been sufficient to yield the statistically significant differences in patient-reported, subjective outcomes. The reviewers agreed this was an important limitation of their study design and said they tried to mitigate against it by ensuring that those who assessed outcomes had been blinded to the treatment that patients had received, and that the coaches would not know about patients’ follow-up cardiac events.
- The reviewers expressed concern that the researchers overstated the importance of the study results, given the lack of statistically significant or clinically significant findings. The researchers toned down the significance of their results, but also stated that the size of the difference that was identified (i.e., 4 percent absolute risk or 11 percent relative risk) was important and could be an impactful finding.
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