Not all hospitals in the United States are following guidelines on determining brain death, a new study suggests.
Researchers found a wide variation in terms of incorporating the updated 2010 American Academy of Neurology practice parameters (AANPP) into hospital policy.
Although "policies appear to be more congruent this time around," compared with when the researchers studied this in past years, "they are not 100% compliant" with guidelines, said lead author David M. Greer, MD, professor and vice-chair, neurology, Yale University School of Medicine, New Haven, Connecticut.
"We still have work to do," Dr Greer told Medscape Medical News. "It's really important that policies be in line with national guidelines, which we created to make sure that there was no misdiagnosis. This is one of those diagnoses where we need to be correct 100% of the time."
The new study was published online December 28 in JAMA Neurology.
The updated 2010 guidelines provide clear step-by-step instructions, including a detailed checklist for accurate and consistent determination of brain death, specifically prerequisites, clinical testing, ancillary testing, and documentation.
"Our hope was that people would take this checklist, incorporate it into their policies and whammo, you would have a very good stringent policy that people could walk through very easily to make sure this is done correctly," said Dr Greer.
The new study included hospital policies from 492 hospitals or healthcare systems with adequate data for analysis, representing those from all 50 states (some analyses included 491 policies).
Of the total, about a third of policies (33.1%) required specialist expertise in neurology or neurosurgery, but 150 policies had no mention of who could perform the determination. Many policies still allow for more junior physicians to determine brain death, the authors noted.
For Dr Greer, it's not the type of specialist that's important but the training. "I'm a firm believer that the person or people who are doing this need to have expertise in this area. I've trained many intensivists, trauma surgeons, and pulmonary doctors to do this correctly, and I have seen many neurologists and neurosurgeons do it incorrectly."
In this analysis, the number of required examinations and the waiting period between each test varied. Most hospitals (65.9%) required two separate examinations to determine brain death, and 20.9% required more than two examinations; 13.0% required only one examination.
Dr Greer noted that some states require two examinations but one is acceptable, according to the guidelines.
Where more than one examination was required, 54.1% of policies specified a waiting period between examinations: 10.2%, less than 6 hours; 71.1%, at least 6 hours; 2.6%, at least 12 hours; and 1.1%, at least 24 hours.
Dr Greer pointed out that when there's a significant waiting period between examinations, organ donation rates may go down because people are less willing to consent and the viability of organs deteriorates.
"Our rule of thumb is, don't declare or even test the patient unless you are certain that there is no chance of reversibility. So if there's no chance of reversibility, a second test should not be necessary."
However, a "caveat" is in the case of cardiac arrest, where there is "clearly a chance for recovery of function after the patient initially looks brain dead," said Dr Greer. In the study, a specific waiting period for cardiac arrest was in 7.1% of policies that stipulated two tests, which was most commonly set at 24 hours or more.
Most policies (93.5%) stipulated prerequisites before clinical testing. Of these protocols, 82.9% required that the cause of brain dysfunction be established and 94.3% required the absence of effect of specific medications, including sedatives alone, paralytics alone, or both.
Specific drug levels (for example, of barbiturates) were mentioned in 25.1% of policies and absence of paralytic effect measured by peripheral nerve electrical stimulation in 11.2%. Absence of hypotension was required by 56.2% of protocols and patient temperature of at least 36°C by 79.4%. The new guidelines recommend a minimum body temperature of 36°C, Dr Greer noted.
With regard to required clinical examinations, Dr Greer noted that some policies didn't stipulate testing of lower brainstem function. "They are very good at making sure that pupillary reflexes and corneal reflexes are absent, and that there's coma — at 90% or 95%, that's pretty darn good — but when it comes to the cough reflex, which is a lower brainstem reflex, less than 80% of the policies stipulated that that needs to be absent, and we feel that is a core feature."
Why did some policies consider certain tests to be more important than others? "Perhaps people think, 'I have to check pupils and corneas and make sure they're in a coma,' but maybe they aren't thinking as much about checking for cough or gag or reaction to deep pain. These are all relatively easy to check, but may not all be at the tip of the tongue or front of mind for people doing the testing."
Most hospitals (97.4%) required apnea testing, with 66.4% specifically stipulating arterial blood gas measurements before initiation of testing for apnea and 59.1% delineated the appropriate baseline PCO2 level.
However, some policies didn't specify the requirement of the final PCO2 100% of the time. "This really needs to be specified," stressed Dr Greer.
A majority of policies (57.2%) recommend maintaining oxygenation by a cannula placed within the endotracheal tube. The specific number of liters per minute of oxygen supplied during the apnea test was overtly stated in 63.1% of policies.
According to the authors, hospital policies often lack the specifics of approved ancillary testing. And sometimes, policies include unapproved and/or nonvalidated ancillary tests.
"MRI and CT [computed tomographic] angiography are tests that are popular now but not proven, and there have been false positives with those tests," said Dr Greer. "We feel it's very important that those don't creep into the guidelines without having gone through a proper vetting process."
Although he knows of no documented report of patients regaining brain function after being declared brain dead, Dr Greer has heard anecdotally about proper protocols not being followed and patients being "mispronounced" and regaining some function.
Dr Greer said he hopes his paper will "light a fire" under hospitals to get them to ensure their brain death policies are "congruent" with updated guidelines. One way to get better compliance, he said, is to make it part of hospital accreditation.
A brain death "tool kit," including a sample checklist, is available on the Neurocritical Care Society website.
Reached for a comment, Gene Sung, MD, past-president, Neurocritical Care Society, and director, Division of Neurocritical Care and Stroke, Keck Medical School, University of Southern California, Los Angeles, said one of the most concerning "gaps" uncovered by the study was the number of policies that don't mention the qualifications needed for those determining brain death.
"It could be people who have no experience at all, and they're doing something important like saying if someone's alive or death," he told Medscape Medical News. "That's very concerning."
Those determining brain death may not even have heard of the new guidelines, even though they've been out for more than 5 years, said Dr Sung, who is working with the World Federation of Societies of Intensive and Critical Care Medicine to try to standardize brain death determination worldwide. Outside the United States, that is "an even bigger issue," he said.
Another of Dr Sung's concerns is that if there's such variation in what's written into a hospital brain death policy, how much more variation is there in what doctors are actually doing in practice.
"The concern is that the written policies don't even match the guidelines, and so then, are doctors actually even following them."
Dr Sung agreed that there have been no documented reports of regaining function after a declaration of brain death. "But still, we don't know for sure; maybe mistakes happened and they weren't reported," he said.
Although the study included information on fewer than 500 policies and there are over 5000 hospitals across the country, the institutions included in the study are probably the biggest and they deal with the issue of brain death the most, said Dr Sung.
Dr Greer and Dr Sung have disclosed no relevant financial relationships.
JAMA Neurol. Published online December 28, 2015. Abstract
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Cite this: Not All Hospital Brain Death Policies Comply With Guidelines - Medscape - Dec 30, 2015.