Although nearly 80 percent of patients prefer to receive cardiac device recall information directly from their cardiologist, more than half primarily receive information about device recalls from the media, according to results of a survey presented at the 2008 Heart Rhythm Society (HRS) meeting held last week in San Francisco.
The 18-question, quality-of-life questionnaire, which was given to 61 randomly selected patients at the University of Maryland School of Medicine in Baltimore and the Baltimore VA Medical Center, specifically examined recall information sources, actual patient awareness of recent recalls and psychological effects of the recall.
Specific findings include:
- Recall Information Sources: 24 percent of patients received recall information from their treating physicians and 51 percent received information from media sources. The survey also found that, despite extensive information campaigns, 18 percent of patients were not aware of recent recalls at all.
- Recall Information Source Preferences: 79 percent preferred to receive recall information from their cardiologist, while 14 percent cited the manufacturer as their preferred source. Only 2 percent preferred the media as the primary source.
- Psychological Effects: When asked about the effects of recalls on their quality of life, more than half indicated that they would be very worried if their device was recalled and 16 percent felt more nervous and anxious since the recent recalls have occurred.
Additionally, 44 percent of respondents said that they would worry if their cardiologist had a significant stock ownership in a device company, while 34 percent would find it irrelevant.
Timm-Michael Dickfeld, MD, PhD, director of electrophysiology at the Baltimore VA, and colleagues concluded that significant discrepancies exist between patients’ expectations and their actual education. However, overall confidence in device therapy is preserved (80 percent would recommend their device to others and 95 percent agreed that the device is still worth having).
A second patient study conducted by researchers at the University of Oklahoma in Oklahoma City found that the language used to describe performance issues can have a direct impact on a patient’s level of concern and overall state-of-mind.
As a result of recent device performance issues necessitating regulatory actions, some have suggested that the term “device recall” should be replaced by the term “safety advisory” or “safety alert.”
HRS has advocated for the change based on its broad-based task force report, but regulatory language has not been changed in the U.S. and objective data supporting this change is lacking, according to Christina M. Murray, MD, and colleagues at the University of Oklahoma.
The researchers conducted a first-of-its-kind study to explore patient understanding of and reaction to regulatory language used when a device recall occurs. The survey involved 165 randomly selected patients followed in the university clinics.
When the term “safety advisory” was used, 2.5 percent of respondents said they would want the device removed. When “device recall” was used, 5 percent said they would want the device removed. The difference is significant.
“Until now, there has been a lack of objective data to support changing recall terminology. However this study shows a direct link between the language used to address device performance and patient actions and perceptions,” said Murray, a cardiology fellow-in-training.
She added that because the magnitude of patients affected by regulatory terminology is considerable, a change from “device recall” to “device safety advisory” is warranted and “could reduce the number of patients insisting on device replacement by 50 percent.”