Providing informed consent for any therapeutic intervention can be challenging. And, then there’s stroke. Acute stroke spans the gamut from mildly limiting to profoundly disabling – with a non-linear relationship between the NIHSS and disability. There are folks with NIHSS score of 4 who can walk into the Emergency Department, and there are folks with the same score or lower who are functionally incapacitated. All this means it’s a struggle to provide an individualized estimate of the benefits, risks and alternatives in consent for tPA.
This is a lovely, short, qualitative survey of a handful of (mostly) neurology consultants in the United Kingdom, asking a few questions regarding the diagnostic process, shared decision-making, and consent for thrombolysis. Not all consultants surveyed seemed to appreciate the challenges, but others recognized limitations in the data, as well as how difficult it made informed consent:
“I think there needs to be em, err a minimum standard, standardised information available based on what you believe is the right interpretation of the trial. We have to remember that this is based on em, err limited number of randomised trials ….. This is a particularly heterogeneous disease it cannot be applied to a single patient, I think the predictions em in model could be designed but again I don’t think it can be predicted for an individual group of pa-, individual patients so we believe these are the kind of risks and benefits but you know it cannot be predicted to the individual patient.”
Other physicians commented upon the challenges of making a rapid, certain diagnosis, and the inadequate demands made upon patients and families to choose in a time-compressed setting. Overall, it’s an interesting little read.
“Risk communication in the hyperacute setting of stroke thrombolysis: an interview study of clinicians”
http://emj.bmj.com/content/early/2014/05/16/emermed-2014-203717.short
"so we believe these are the kind of risks and benefits but you know it cannot be predicted to the individual patient.”
Funny neurologist !
Isn't that always the case, when implementing what RCTs tell us ? Even when our patients are comparable to the ones included ?
Ryan,
You should look again at the consent process the Germans performed in the "Drive by lysing" paper you recently reviewed. They assumed implied consent when patients were unable to communicate. This might be fine for a drug with a reasonably proven efficacy and safety profile… but for tPA is absolutely nuts.
In the end, informed consent for just about anything in the ED is an enormous challenge and the entire notion is probably a fallacy. I can barely understand when my mechanic explains what is wrong with my car… How should we expect the vast majority of patients (who likely have marginal health literacy) to understand something as complex as stroke thrombolysis. This is even made worse when dealing with the elderly, confused and under a time constraint. It's a wonder we haven't just abandoned the whole idea. Oh wait… I think the Germans already have? Now I'm confused…