Use of thrombolytic therapy in ischemic stroke is a perennial hot topic. Chances are that you will have as many people swearing AT the idea as you have swearing BY the idea of using thrombolytics for acute strokes. That fact alone should demonstrate that there is no “standard of care” for thrombolytic use in ischemic strokes.
If reasonable board certified doctors can’t agree that the risk of tPA outweighs the benefit of using tPA, how can there be a “standard” for using it?
I could go through the data and discuss the pros and cons of each trial studying thrombolytic use, but Dr. David Newman has done a far better job than I could ever hope to do and his analysis of thrombolytic therapy in acute ischemic stroke is published on TheNNT.com. In summary, of the available studies on thrombolytics up to March 2013, Dr. Newman found …
Two studies showed a marginal benefit in using thrombolytics
Four studies showed a demonstrable harm in using thrombolytics
Six studies showed no benefit from using thrombolytics
Back in 2011, EP Monthly asked for opinions on thrombolytic use for acute ischemic stroke in its now-defunct Standard of Care project, but those important data were never published or made available to the people who voted.
The debate over tPA use came to a head last year when ACEP representatives met with experts in the field of ischemic stroke, including representatives from ACEP and AAN and developed a policy which was then reviewed by representatives from the Society for Academic Emergency Medicine, the Emergency Nurses Association, the American College of Physicians, the Neurocritical Care Society, the American Academy of Family Physicians, the National Stroke Association, and the American Stroke Association.
The final “evidence based” policy advocated “offering” tPA to acute ischemic stroke when certain criteria were met (.pdf file). This recommendation was given a “Level A” status, meaning that it constituted
Generally accepted principles for patient management that reflect a high degree of clinical certainty (ie, based on strength of evidence Class I or overwhelming evidence from strength of evidence Class II studies that directly address all of the issues).
Needless to say, there was a lot of discussion after these “evidence based” “guidelines” were published.
Some people questioned whether this “evidence based” policy would create worse patient outcomes. Others were concerned that the guidelines, even though they contained a disclaimer, could create legal liability when not followed. Still others wondered whether this clinical policy was even helpful in determining a course of action since there was no “consensus” statement, only an “evidence based” policy.
Then the British Medical Journal advocated using a healthy “skepticism” in reviewing the data since almost all of the study authors had either direct or indirect ties to companies that manufactured thrombolytics:
for one of the guidelines recommending alteplase, seven of eight panel members had ties with industry: three had direct relationships with companies that market alteplase, while four had links with an educational foundation wholly funded by industry, whose president and founder was an outspoken advocate for alteplase on acute stroke. The remaining author had resigned from the panel six years earlier
Even more troubling is that several of those authors allegedly did not disclose their ties to the manufacturers in the publication of the clinical guidelines (which, if true, would constitute an ethical violation). See table below – taken from this article.
Whichever side of the expand/limit tPA in acute stroke debate you fall upon, the issues of sponsorship bias, one-sided panelists on a still-controversial practice, and lack of open peer review for the ACEP/AAN guidelines ought to be unacceptable.
Ten months later, ACEP just might be listening to some of the criticism. There is now a form on the ACEP web site where, for the next 60 days, ACEP members can comment on the thrombolytics in acute stroke policy and provide “supporting evidence” for their comments. These comments will then reportedly be presented to the ACEP Board.
I encourage interested parties to go to the site and add their comments.
Unfortunately, we don’t know whether the comments will also be available for public view. That’s the reason for this post.
I’m asking two favors from the readers who have an opinion on this topic.
First, vote in the poll below. It will provide data that will hopefully be available for web searches far into the future.
Second, if you have an opinion or additional “justification” that you plan to enter on the ACEP site, please also enter it into the comment section below. In that way, the comments – both pro and con – will be available for public review and discussion.
When answering the poll, keep in mind that the “standard of care” is what a reasonable physician would do under the same or similar circumstances. As noted on the defunct Standard of Care site, the standard of care is NOT “what the Best Practice would be, (arguably the top 5%); or what YOU would do (the top 25%); or or even what MOST physicians would do (the top 50%).”
The standard of care is the tipping point between “negligent” and “non-negligent” behavior. In essence, the question as asking whether a doctor has violated the standard of care and is therefore negligent and liable for damages if he or she does not administer tPA to an acute ischemic stroke victim.
Please don’t forget to add comments in the comment section!