A recent Harvard study, published in Circulation, found a surprising level of inconsistency between what medical records say about whether people had a heart attack and what they report themselves in surveys.
About a quarter of Medicare patients who said in a survey that they previously had a heart attack have no record of having any heart-related hospital admission. Conversely, about one-third of patients who, according to Medicare, experienced a heart attack said they hadn’t.
This finding is consistent with an Emory study from cardiologists Neal Dickert and Habib Samady, in which participants in a clinical trial were interviewed just a couple days after the initial procedure. The trial was testing a “post-conditioning” modification of angioplasty+stenting performed during treatment for a heart attack. Just over half (55 percent) of the participants initially remembered being asked to participate when asked.
What this reflects is that the time when someone might be having a heart attack is difficult — the patient is probably in pain and may be confused. This touches on an ongoing debate on how informed consent should proceed in acute cardiology studies.
Some clinical trials in emergency medicine and traumatic brain injury take place under the framework of “exception from informed consent“, because informed consent is flat out impossible in those situations (the patient is unconscious and time is critical).
In contrast, patients may be able to sign a consent form in acute cardiology studies, but they are still not able to evaluate the potential risks and benefits in a relaxed, calm way. In 2014, an Emory team, led by Dickert, received a grant from PCORI to examine this issue.
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