In a somewhat bizarre turn of events, the American Heart Association (AHA)/American Stroke Association (ASA) has rescinded its recently released stroke guidelines, publishing a “correction” in which large parts of the document have been deleted.
A new paper, published online in Stroke on April 18, states: “Based on recent feedback received from the clinical stroke community…the American Heart Association/American Stroke Association has reviewed the guideline and is preparing clarifications, modifications, and/or updates to several sections in it. Currently, those sections, listed here, have been deleted from the guideline while this clarifying work is in process.”
The AHA/ASA adds: “After review, a revised guideline, with consideration given to the clarifications, modifications, and/or updates of the sections noted above, will be posted over the coming weeks.”
The sections that have been deleted are the following:
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Section 1.3: EMS Systems Recommendation 4
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Section 1.4: Hospital Stroke Capabilities Recommendation 1
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Section 1.6: Telemedicine Recommendation 3
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Section 2.2: Brain Imaging Recommendation 11
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Section 3.2: Blood Pressure Recommendation 3
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Section 4.3: Blood Pressure Recommendation 2
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Section 4.6: Dysphagia Recommendation 1
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Section 6.0: All subsections
The rescinding of the guidelines was done without the agreement of the Guideline Writing Committee.
Chair of the Guideline Writing Committee, William J Powers, MD, H Houston Merritt Distinguished Professor and Chair, Department of Neurology, University of North Carolina at Chapel Hill, told Medscape Medical News: “This action by the AHA was carried out against the strongly voiced opposition and without the agreement of the majority of the 2018 Acute Ischemic Stroke Writing Group.”
He added that he was “surprised and disappointed” by the way the AHA/ASA had handled the situation.
“A Challenging and Unfortunate Situation”
Commenting for Medscape Medical News, Mark Alberts, MD, chief of neurology, Hartford Hospital, Connecticut, said, “I don’t think this has ever happened before. This is a challenging and unfortunate situation. It’s not good for anyone — the AHA, the guidelines writing committee, or the patients.”
The guidelines were announced by the writing committee at the International Stroke Conference (ISC) in January and published at that time online in Stroke. They subsequently appeared in print in the March 2018 issue of the journal.
Alberts said there was some controversy at the ISC meeting about the guidelines. “Many in the medical community were unhappy about the process used to draw up the guidelines, saying they seem to have resulted in a very narrow perspective, and this has now led to formal complaints being made to the AHA.”
Alberts himself is not in agreement with the guidelines, but he says he has not made any complaint to the AHA. His concerns center on the guidelines appearing “to be focused totally on stroke outcomes rather than on the patient” and questioning or not giving strong enough recommendations for practices that he sees as fundamental in stroke care, such as resonance imaging (MRI and screening for dysphagia.
“Maybe screening for dysphagia has not been shown to have a major effect on stroke outcomes, but who in their right mind would think that risking your patient getting aspiration pneumonia is a good thing?” he asked.
“And who could possibly argue that doing an MRI scan to confirm the diagnosis of and pattern of the stroke is not important? That is nonsensical — it defies common sense,” he added.
“The guidelines appeared to question many of the things that we do in our routine treatment of stroke patients. They may not have been proven to improve stroke outcomes in a randomized trial, but it is not always possible to do randomized trials of everything we do. And we know they improve the process of care and the accuracy of diagnosis. It’s like asking whether a plane can fly without each individual piece of the aircraft — maybe, but many of these pieces are key to the comfort and safety of the passengers.”
“The writing committee are well respected, but they do seem to have approached these guidelines with a very narrow perspective,” he added. “Some of the recommendations that they have downgraded are for vitally important processes, and this may affect reimbursement, making them more difficult to do.”
Guidelines “Strictly Evidence Based”
Responding on these arguments, Powers said, “The writing committee was charged with putting together a comprehensive set of evidence-based guidelines, which is what we have done. We did evaluate evidence about how both diagnostic tests and treatments can affect patient health outcomes. Evaluating medical practice based on patient outcomes is the basis for how guidelines are formulated.”
He believes some of their recommendations have been misinterpreted.
Using the examples given by Alberts, he said, “In the case of MRI scans, we simply stated they don’t need to be routinely performed in all patients. There are certain patients in whom you have all the information you need to provide excellent evidence-based patient care without an MRI scan. We didn’t state that MRI scans should never be done in anyone, just each patient should be considered individually in deciding whether MRI would be of benefit.
“And in the case of screening for dysphagia, an AHA evidence review committee (which is completely separate from the guidelines writing group) recently reviewed this and they found three small studies which did not show consistently positive results, and in some cases, results were negative in improving patients’ health after stroke. So we didn’t think there was enough evidence to recommend that every patient must have this. We said it was reasonable, but not mandatory.”
Also commenting for Medscape Medical News was Amytis Towfighi, MD, associate professor of neurology, Keck School of Medicine, University of Southern California, Los Angeles.
“The writing group made recommendations based on available evidence,” Towfighi said. “There are strict protocols for this outlined by the Institute of Medicine. The gap has occurred because some things we do are not supported by randomized clinical trial data.
“Some people are saying that just because it doesn’t have randomized data doesn’t mean it’s not the right thing to do; lack of evidence is not necessarily equivalent to lack of efficacy.”
She added: “It is a matter of how the recommendations are framed. The problem has arisen because practice based strictly on evidence from randomized trials contrasts with what stroke neurologists actually do. In presenting clinical practice guidelines, the Institute of Medicine recommends inclusion of potential benefits and harms of recommendations, discussion of evidentiary gaps, quality (including applicability), quantity (including completeness), and consistency of the aggregate available evidence; an explanation of the part played by values, opinion, theory, and clinical experience in deriving the recommendation; and a description and explanation of any differences of opinion regarding the recommendations. I think any of these issues can probably be ironed out with appropriate language.”
Towfighi also points out that while the writing group disclosed any conflicts of interest they had, it isn’t known who has complained about the guidelines and what conflicts they may have.
Unprecedented Action by AHA
Maybe the most controversial aspect of the situation is the way the AHA/ASA has issued this “correction” and deleted sections of the guideline without consultation with the writing committee.
“To have major guidelines like this rescinded just a few months after publication without any discussion is unprecedented,” Alberts says. “And we’re not talking about one or two small typographical errors; these are major sections that have been deleted. It will affect patient care as many stroke doctors will have been changing their processes of care based on these guidelines.”
“You have to ask why these issues weren’t raised before the guidelines were released,” he added. “It does cause questions to be asked about the peer review process.”
Powers is also puzzled about the AHA’s actions.
“What normally happens when there is disagreement about aspects of new guidelines is a scientific debate in the journals,” he said. “There is normally a back and forth with responses from the guidelines writing group.”
He added: “We are very happy to discuss how we reached our recommendations and answer questions about it. Indeed, we spent two whole sessions at the ISC meeting doing this. If we have overlooked or misinterpreted any evidence, then we would like to know, since that would be cause for a correction to the guidelines.”
He believes that there is a way forward. “The writing committee is working closely with the AHA to address the issues that have been raised.”
Philip B. Gorelick, MD, Mercy Health Hauenstein Neurosciences
Grand Rapids, Michigan, defended the AHA’s actions.
“I have received a number of contacts from thoughtful community neurologists questioning some of the 2018 guidance recommendations,” Gorelick said. “One section in particular, the one on brain imaging, was an area of frequent concern for the practitioners. Such feedback has reached the level of AHA leadership, has been taken seriously, and after a thorough review, has led to the beginnings of deletions or re-workings of a number of the sections in the statement to provide clarity and modifications with the promise of this process being completed over the coming weeks. I view this as a positive step, as the AHA has responded to concerns over the guidance statement raised by its constituents. Also, this should allow AHA the opportunity to review its overall writing and review processes and strengthen them, if needed.”
The AHA sent the following statement to Medscape Medical News:
“A new guideline often generates healthy discussion and debate. Following questions from our volunteers and others in the stroke community regarding some of the recommendations in this guideline, there were several issues of clarity in wording that emerged after publication that we felt needed to be addressed.
“We believe that much of this occurred because we continually refine our system of categorizing evidence and the system used for the AIS guideline was the first time this Writing Group had used it,” the statement notes.
“We have reconvened the writing group to consider whether clarifications, modifications or updates would address the concerns about clarity. Their work to review and clarify select sections of the guideline is currently underway. We anticipate the updated guideline will be ready for publication this summer.”
The specific sections and recommendations that are being revisited are outlined in the correction notice posted, the AHA adds. “During this clarification period, these sections have been removed from the guideline now posted online. We continue to support this corrected version of the guideline and its use for clinical decision-making.”
The statement also adds that removal of these limited sections or subsections of the guideline is temporary. “During this process, we recommend clinicians continue to use good clinical decision making, leveraging this corrected version of the 2018 guideline (published online in this interim period without the sections of concern) and previously published recommendations on specialty topics, such as the 2014 Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack.”
Stroke. Published online April 18. Full text
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