Results Summary and Professional Abstract
A Less-Invasive Way to Replace a Heart Valve: Is Newer Better? (right)
A nonsurgical method to replace the aortic valve turned out as safe as surgery and allowed more patients to go home from the hospital, rather than to a nursing home or rehabilitation facility.
Aortic Valve Disease Study Focuses on Patients’ Quality of Life
Asking patients about what health outcomes mattered most to them helped guide the focus of this PCORI-funded study comparing two treatment options for replacing the aortic valve, one surgical and one less invasive.
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 asked how blank clinical data fields might change results that users receive from the decision aid developed in this study. The researchers responded that generally there are three options in such cases: giving users an error message; generating an estimated value for the missing fields, in a way that requires a great deal of computing power; or assigning an average value for the missing data based on other data from the patient, which uses less computing power while allowing the user to personalize their risk estimate as much as possible. The researchers chose the third option but cautioned that their approach requires patients to use the tool’s results as only a starting point for discussions with their providers.
- The reviewers noted that because transcatheter aortic valve replacement (TAVR) is a more recent technology than surgical aortic valve replacement (SAVR), data from the cohort that underwent TAVR were more recent than the data from the cohort that underwent SAVR. The researchers agreed that the different time frames over which they collected data for the two groups was a limitation but said it was necessary. The researchers also said they did not expect the difference to have altered results substantially because outcomes for the SAVR procedure had been relatively stable.
- The reviewers asked why separate cohorts were not used to develop and test the decision model. The researchers agreed that this might lead to overestimating how well the models actually fit the data and added text to the limitations section explaining their reasoning. They explained that they did not have enough participants to allow for entirely independent cohorts when developing and testing the model.
Conflict of Interest Disclosures
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Training and Education Interventions