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Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Excited Delirium 2

Wed, 29 Sep 2010 16:56:48 -0400 by
I expect to be writing a lot about the EMS EduCast – Excited Delirium: Episode 72. It is very important essential for EMS providers.

The first comment in response to my post, Excited Delirium: Episode 72 EMS EduCast, is from Tom Bouthillet of Prehospital 12 Lead ECG.

This was an excellent episode and I applaud Mr. Johnson for sharing his experience so that we can all learn from it. Clearly he has paid a high price and he has my sympathy, but I can’t join you in saying that he “did nothing wrong.”

If my understanding is correct, it sounds like he used a police baton to restrain the patient. While this may not have been the proximal cause of the excited delirium, it was very poor judgment. A paramedic should never use a weapon to restrain a patient unless:

1.) The paramedic’s life or his partner’s life is in danger
2.) There is no opportunity for escape
3.) A weapon (or an improvised weapon) is needed to level the playing field to restore safety

I can hear it now. “Hindsight is 20/20″ and “you’re an arm chair quarterback.” No, I’m simply pointing out that it’s a mistake to say that Mr. Johnson did nothing wrong. Clearly at least one major mistake was made.

Tom,

I agree that using the baton was poor judgment. When faced with an unstable situation, we will make snap judgments. Marty Johnson’s explanation is that he felt it was the only way he could get a grip on the patient. He stated that the patient was sweaty and he had latex gloves on, so the patient kept slipping out of his grasp. I would take the gloves off. Even though the patient is bleeding, you have to assume that the gloves have already lost their much of ability to act as a barrier to transmission of germs, but the gloves are acting as a barrier to being able to manage the situation.

We occasionally have to make important decisions about the appropriate amount of force to use. We should have thought these out, as much as is practical, ahead of time. How many of us have thought these things through?

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This is a situation that may initially seem like it is not a big deal. the problem is that things do not get better. They get worse. Not just a little bit worse, but a lot worse. Not necessarily getting a lot worse right away, so that you just step back and re-evaluate or to retreat and call for help, but progressively worse, so that you may not be aware of the way things are spiraling out of control.

Turning and turning in the widening gyre
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;[1]

We expect to be in control.

During EMS education, we are even told the lie that we should be in control.

Because of this, we are frequently able to dismiss the evidence that we are not in control. Having developed this ability to ignore just how out of control things are, we react poorly when things do not go our way. We flail about and panic. Ironically, the patient may be doing exactly the same thing.

Would Marty Johnson do things differently, today. I think that he made that very clear. He is trying to get people to understand how badly things can turn out.

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Even more important than the baton is the perception of the baton. Is a baton a weapon, if it is not used to strike?

Is a baton a weapon, if the baton is used to protect the person the baton is being used on?

Is a sedative a weapon?

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Is a restraint a weapon?

A physical restraint?

A chemical restraint?

Consider the weaponized fentanyl variant used during the Moscow theater hostage rescue.

How much does the result affect the interpretation of the intent.

According to court testimony from Prof.A.Vorobiev, Director of Russian Academic Gemology Center, most if not all deaths were caused by suffocation when hostages collapsed on chairs with heads falling back or were transported and left lying by rescue workers on their backs; in such position, tongue prolapse causes blockage of breathing venues.[53]. Thus, part of casualties can be attributed to accident but at least some to unprofessional rescue efforts.[2]

Even if nobody had died in Moscow, the chemical would have been considered a weapon, but many of the deaths of the hostages would probably have been avoided with basic airway positioning. Some people vomited, aspirated, and asphyxiated. Others were suffocated by a lack of positioning, allowing the tongue to obstruct the airway. Had there been better organization of the evacuation, how many of these people would not have died that day? Had there been better organization of the evacuation, this might not have been a disaster.

How we act helps to show our intent.

When we are prepared, we can act more appropriately, even if the initial impression of onlookers (including medical command) is that we are being inappropriately aggressive.

When we are prepared, we can turn an unstable situation into a non-event, except for dealing with the protocols that discourage/prohibit appropriate care.

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We use our hands for many purposes. We can use them to deliver painful stimuli. When done appropriately, there should not be any permanent harm, and the pain should be stopped as soon as there is an adequate response to the stimulus and only repeated if stimulus is again appropriate. The entire point of painful stimulus is to produce a response, and we do this on a regular basis.

Most often, we are using verbal stimuli, but we move to more aggressive stimuli, when the less aggressive stimuli do not elicit a response.

If we omit painful stimuli from our assessment/treatment, then we are neglecting some of our patients.

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Was he charged with murder just because he used a baton to attempt to restrain a patient?

I don’t know.

Was Marty Johnson charged with murderous assault, even though he was driving the ambulance at the time the alleged crime occurred?

It does look that way.

If he had showed up and aggressively sedated this patient, would this have been anything other than a routine call?

Probably not.

The doctors may have made a big deal about aggressive sedation, even though it is probably the best thing for the patient.

Acting appropriately aggressively initially will often prevent a lot of bad outcomes. Our goal should be calls that are not memorable, because the patient was protected by aggressive intervention. Unfortunately, we have patients harmed by some protocols that discourage aggressive intervention, because What if . . . ?

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I am not cavalier about the aggressive use of sedatives, opioids, or other drugs. I think that aggressive treatments should be treated as sentinel events. RSI Intubation is an excellent example of a treatment that should not be treated as anything other than a sentinel event.

Everything that we do has the potential for harm.

Aggressive oversight means throwing out the medical command permission requirements, but requiring that medics be competent before allowing them to work on their own.

Aggressive oversight means throwing out the medical command permission requirements, but requiring that medics be accountable for all of their actions.

Medical command permission requirements are purely for the psychological benefit of the people who do not understand medical oversight.

Medical command permission requirements are dangerous.

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Footnotes:

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[1] The Second Coming
William Butler Yeats
Poem of the Week
Poem

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[2] Moscow theater hostage crisis – Chemical attack
Wikipedia
Article

According to court testimony from Prof.A.Vorobiev, Director of Russian Academic Gemology Center, . . . .

Gemology? – the science dealing with natural and artificial gems and gemstones?

Why is a gemologist, academic or otherwise, giving expert testimony on toxicology?

A better question may be – Why does the gemologist make more sense than everyone else quoted?

Or is it a translation error?

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Filed Under: Assessment, Critical Judgment, EMS EduCast, Excited Delirium, Heresy, Sedation Tagged With: , , ,

Excited Delirium: Episode 72 EMS EduCast

Wed, 29 Sep 2010 06:30:24 -0400 by
I have been trying to figure out a good way to address the risks/lack of risks of following protocols. The EMS EduCast has a podcast that really puts all of this in perspective.

The guest, Marty Johnson, NREMT-P of Medicology™, had a bit of a negative outcome from a patient care situation. He was charged with murder.

He didn’t do anything wrong.

Go listen to the podcast.

How would that work out for you?

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We may not take civil rights seriously, but this is what they are for. Every one of the rights in the Bill of Rights is there to make it difficult for the government to lock us up. Is that because the Bill of Rights was written by a bunch of criminals, or a bunch of bleeding heart liberals?

No.

It is because the people who wrote the Bill of Rights had just fought a war to rid themselves of a government that was comfortable searching people without warrants, spying on political groups they did not like, seizing property without due process, et cetera.

The Bill of Rights exists to protect us from the government. Governments will always do these things, because power corrupts.

Does anyone in the government have to worry about where their paycheck will come from while they are prosecuting us?

No.

They are getting paid to prosecute us. They might even get raises.

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So. Me against the government?

How will I do?

Will following protocols protect me?

That depends.

If I follow my protocols, will that prevent bad outcomes for my patients?

If I follow my protocols, will that prevent bad outcomes for me?

We all know that bad outcomes happen with even the best treatment.

If I follow my protocols, will that prevent bad outcomes?

No.

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What about being too aggressive with treatments?

Is that what led to the murder charge?

No. Quite the opposite.

If the patient had been aggressively sedated with doses large enough to remove every bit of medical director sphincter control, then this patient might still be alive.

But, No!

These doctors are more concerned about the possibility of respiratory depression occurring in hypermetabolic patients, than they are about the actual consequences of the patient’s metabolism being dangerously elevated.

Hypermetabolic = vital signs elevated enough to be dangerous.

Hypermetabolic = in need of respiratory depression.

So, what do these doctors want us to do?

Not sedate the patient and try to correct the dangerous vital signs, but wrestle with the patient and create a much more dangerous situation. Brilliant!

If I take a patient breathing at over 30 times a minute and cut his respiratory rate in half, is that dangerous respiratory depression? Is respiratory depression dangerous? How much midazolam/lorazepam/diazepam, haloperidol/droperidol, ketamine, et cetera would it take to cut his respiratory rate in half? What is considered normal respiratory rate for an adult?

Cutting his respiratory rate in half would probably require a lot more than a protocol permits.

Not to worry. I can always call medical command for more.

Picture riding a bull, while calling command, because however many people we have on scene – we don’t have enough – at least not enough to do this safely. The safest way to manage these patients is to heavily sedate them.

Safest for the people wrestling with the patient – police/fire/EMS.

Safest for the patient.

Safest.

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I can’t prove that with any data (no data that I know of), but hundreds of people die in custody every year.

These in-custody deaths are not from over-sedation.

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Some of these in-custody deaths may be from aspiration of vomit, but if I am going to sit there and allow a patient to choke to death on his vomit, then everything I do is dangerous. There is no safe way for me to treat patients if I sit back and watch them choke to death.

This is not a reason to avoid sedating patients.

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Should over-sedation be a problem for any competent EMS provider?

Only if you accept the National Registry definition of competent, or the absentee medical director definition of competent. For everyone else, this definition can be found everywhere else under the word incompetent.

If I cannot handle an overly sedated person, I should not be working in EMS.

Over-sedation (under-stimulation) is a little, easy to manage problem.

Under-sedation (over-stimulation) is a huge problem complicated by protocols written by doctors who fail to understand these relative risks.

Maybe this is the rhythm –

Maybe this is the rhythm –

Maybe it is some other rhythm.

We don’t know.

We can’t tell.

After sedating the patient, we can measure vital signs and hook them up to monitoring equipment, but the agitated patient in need of sedation will not tolerate assessment. His vital signs are a mystery. His vital signs are elevated, but we don’t know how elevated and we probably don’t have good information about his medical history and what drugs he may have taken. If any sedatives have been taken, the quantity can be described as not remotely enough.

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There is much more to write on this, but I am getting too worked up and need a sedative. More on this soon.

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Excited Delirium: Episode 72
EMS EduCast
Podcast

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Filed Under: Assessment, Critical Judgment, EMS EduCast, Excited Delirium, Heresy, Ketamine, Sedation

How to Study Epinephrine in Cardiac Arrest

Fri, 30 Apr 2010 02:35:47 -0400 by
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No. This is not a post about a study that did everything the right way. I don’t even think there is any such study in progress. This is my description of what is necessary for a future study to be valid.

I have written a lot about epinephrine in cardiac arrest. So far there is no research to support the use of epinephrine, unless we believe that the surrogate endpoint of ROSC (Return Of Spontaneous Circulation) is important. Surrogate endpoints have a long history of leading people to make bad mistakes. I have already written about surrogate endpoints several times.[1]

Here is one explanation of the way surrogate endpoints are used:

From this unhappy rhythm – the beginning point.

We add a drug that we know does a great job of improving the surrogate endpoint and then we have this happy rhythm. The improved rhythm is the surrogate endpoint. It is a surrogate (substitute) for showing improved survival, because this does not require as many study participants.

The surrogate endpoint also led us to the rhythm below. The surrogate endpoint misled us.

Survival with good neurological function is the only meaningful end point. Once we had enough participants in a well controlled trial, we were able to find out that making the rhythm look better did not make the patient better.

The study drugs did a great job of making the rhythm look better. It looked like a great drug – A lifesaver! – until there was a study large enough to show a difference in survival.

When a study large enough to show a significant difference in survival was done, we could see that more than 3 times as many patients receiving the study drugs were dropping dead.

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In looking at epinephrine for cardiac arrest, we need to forget about surrogate endpoints. We’ve studied that to death. We need to look at survival.

The study has to be large enough to show a difference in survival.

The study needs to control for confounding variables as much as possible.

The study needs to be randomized and double-blinded.

The study needs to track from before the first resuscitation drug is given to hospital admission, at the very minimum.

The study really should look at the difference in outcome between the study drug and the placebo after the first drug is given.

While the rate of patients resuscitated before medication should be equal in the placebo and study arms, we should probably recognize that these are not patients who will be affected by epinephrine. These may also be the patients least likely to present as needing aggressive post-resuscitation care. It is an assumption, but it does seem reasonable that, more responsive to initial interventions means less low-circulation/no-circulation time in cardiac arrest and, we might expect, less intensive post-resuscitation care.

–

What we want to know is the difference between the patients who do receive epinephrine and the patients who do not receive epinephrine, but would have received epinephrine if not in a study of epinephrine in cardiac arrest. These are the patients who do not receive epinephrine because of the study design, not because of responsiveness to earlier treatments. Nobody interacting with the medics should know which patient received which treatment.

We need some agreement on post-resuscitation care. I used to regularly present ACLS classes with this scenario of a patient just resuscitated. When someone would ask for vital signs, I would state that the blood pressure is 60 by palpation.

This presents them with an important treatment decision. This may be the most important treatment decision of this patient’s life.

How do we approach this patient?

1. A systolic pressure of less than 90. We must give fluids and dopamine.

2. We got a resuscitation. We’re going to Disney World. Maybe we’ll drop off the patient on the way.

3. The systolic pressure rose 60 points in the last minute. Maybe I should wait to see what happens in the next minute, and the minutes after the next minute, before making decisions about aggressive interventions that may discourage this patient from maintaining any pulse.

I think you will be able to guess what my approach is. I grew up with Disney movies on Sunday night. High Fives and high tail it to the park. 😉

We would need to have some sort of protocol to standardize post-resuscitation care, because I know a lot of people – doctors, nurses, and paramedics – who would already have dopamine running before the next blood pressure.

I think the research shows that therapeutic hypothermia works, so this would probably be a requirement for participation.

CPR should be standardized to whatever the next guidelines come up with before the beginning of the study. I hope that Dr. Ewy’s minimally interrupted, continuous compression CPR is what the AHA/ILCOR/ARC decide to adopt. (They did not. Ventilation is still viewed as important, even though there is not research to demonstrate that ventilations improve outcomes. We continue to mistakenly look at withholding an ineffective treatment as an intervention that needs to be supported by excellent evidence, rather than the actual treatment – ventilations, epinephrine, amiodarone, et cetera – as something that needs to be supported by excellent evidence.)

We need to look at subpopulations to see if epinephrine is effective in some groups, while not effective in other groups. This could explain why the overall effect is not impressive.

–

There needs to be a randomization of placebo and epinephrine syringes with many different identification markings, such as individual numbers with no pattern. The reason for the variety in the markings is to make it almost impossible for the medics to figure out which are active drugs and which are placebos. Those running the study should also be prevented from knowing which patients are receiving the active drug – epinephrine. Or some other method of randomization and blinding that can be shown to be effective at blinding EMS.

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If this is done the right way, there should not be much doubt about what to do with epinephrine after the conclusion of the study. Either epinephrine is significantly better than placebo and belongs in resuscitation guidelines, or we only use epinephrine when specifically indicated – potentially reversible causes of cardiac arrest and for any subpopulation identified as having better survival after epinephrine.

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I am sure there are things I have not included, but this is what is needed. Either we find out what is best for patients, or we continue to give a treatment that is based on tradition and the short-term ability to bring back a pulse.

Maybe I am wrong. Maybe this is already being done.

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Footnotes:

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[1] C A S T and Narrative Fallacy
Rogue Medic
Article

Some other surrogate endpoint posts:

New Series of Rants Second follow up

C A S T and Narrative Fallacy comment from Shaggy

EMS EdUCast – Journal Club 2: Episode 43

The association between emergency medical services staffing patterns and out-of-hospital cardiac arrest survival

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Updated 12-06-10 at 13:49 and some wording changed for clarity. In other words, parts that didn’t make as much sense as I thought they did, when I originally wrote them.

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Filed Under: Critical Judgment, EMS EduCast, Epinephrine, Heresy, Research Tagged With:

Journal Club 3: Episode 53

Sun, 28 Mar 2010 14:34:03 -0400 by

ResearchBlogging.org
Also posted over at Paramedicine 101 and at Research Blogging. Go check out the rest of the excellent material at both sites.

Of the two podcasts I had the opportunity to be on this week, this one is more to my liking, due to my desire to increase the use of research-based treatments. Having the lead author of one of the studies on the show was another positive. Greg Friese hosts Journal Club 3: Episode 53.

There is a much more thorough discussion of these papers on the podcast.

The papers covered are:

Resuscitation on television: realistic or ridiculous? A quantitative observational analysis of the portrayal of cardiopulmonary resuscitation in television medical drama.
Harris D, Willoughby H.
Resuscitation. 2009 Nov;80(11):1275-9. Epub 2009 Aug 20.
PMID: 19699021 [PubMed – indexed for MEDLINE].
Presented by Rob Theriault.

This study raises a lot of interesting questions about the way that people learn about making end of life decisions, what they anticipate the outcome of resuscitation will be, and even how medical professionals may respond to skills presented in TV medical dramas.[1]

Dismissing TV dramas as trivial ignores the effect that they may have on members of the audience, up to and including doctors.

The Canadian prehospital evidence-based protocols project: knowledge translation in emergency medical services care.
Jensen JL, Petrie DA, Travers AH; PEP Project Team.
Acad Emerg Med. 2009 Jul;16(7):668-73.
PMID: 19691810 [PubMed – indexed for MEDLINE].
Presented by Joe Clark.

This is a study that deserves several posts to cover, so I will not even start here. As with the other studies, this paper is discussed on the podcast.

My impression is that this resource is wonderful. If you know of a relevant paper that they do not cover on the site, send them a link to it. As with all of science, this will always be a work in progress, but that is certainly not a bad thing.

Canadian Prehospital Evidence Based Protocols.

Effectiveness of paramedic practitioners in attending 999 calls from elderly people in the community: cluster randomised controlled trial.
Mason S, Knowles E, Colwell B, Dixon S, Wardrope J, Gorringe R, Snooks H, Perrin J, Nicholl J.
BMJ. 2007 Nov 3;335(7626):919. Epub 2007 Oct 4.
PMID: 17916813 [PubMed – indexed for MEDLINE].
Presented by Bill Toon.

In the US, we have studies that show an inability of the medics (at least the medics in US studies) to be able to safely direct patients to alternative destinations, such as an appointment with a general practitioner. Is the basic EMS education difference, between the US and the UK, the reason?

This study does show that specially trained experienced paramedics can identify stable patients and safely direct these patients to more appropriate resources than the Emergency Department (Accident & Emergency in the UK).

This is an education program that appears to focus on critical judgment, rather than protocol adherence. If done the right way, this should be good for patients, and therefore good for EMS and hospitals.

The full text PDFs of the three papers discussed on the podcast are available for free (until the next EMS EduCast Journal Club) at the Journal Club page of the EMS Educast.

Special guests on the show are Joseph F. Clark, PhD of JosephFClark.com and Jan Jensen of the Canadian Prehospital Evidence Based Protocols.

Footnotes:

^ 1 Positioning prior to endotracheal intubation on a television medical drama: perhaps life mimics art.
Brindley PG, Needham C.
Resuscitation. 2009 May;80(5):604. Epub 2009 Mar 18. No abstract available.
PMID: 19297069 [PubMed – indexed for MEDLINE]

Inadequate positioning of the head and neck was especially prevalent prior to intubation attempts, and improving this was seen as a simple but important first step.

As part of ongoing nationwide efforts to ensure basic resuscitation skills5 we explored all potential causes for the inadequate positioning, and this included trainees’ prior experiences. Many trainees reported limited supervision or hands-on training. Remarkably, however, when asked how they had therefore learned, after “trial and error”, a surprising number answered that television medical dramas had been an important influence.

Of the remaining 22, none (0/22) achieved more than one, let alone all three, components of optimal airway positioning. In terms of individual components, the lower cervical-spine was flexed in 0/22, the atlanto-occipital joint extended in 1/22, and the ears level with the sternum in only 3/22 cases.

While few would suggest that medical dramas can be held responsible for physician performance, it has been previously suggested that they can significantly influence beliefs.6, 7

This does show that ignoring the effect of medical dramas has the potential to be harmful to patients.

Harris, D., & Willoughby, H. (2009). Resuscitation on television: Realistic or ridiculous? A quantitative observational analysis of the portrayal of cardiopulmonary resuscitation in television medical drama☆ Resuscitation, 80 (11), 1275-1279 DOI: 10.1016/j.resuscitation.2009.07.008

Jensen, J., Petrie, D., Travers, A., & , . (2009). The Canadian Prehospital Evidence-based Protocols Project: Knowledge Translation in Emergency Medical Services Care Academic Emergency Medicine, 16 (7), 668-673 DOI: 10.1111/j.1553-2712.2009.00440.x

Mason, S., Knowles, E., Colwell, B., Dixon, S., Wardrope, J., Gorringe, R., Snooks, H., Perrin, J., & Nicholl, J. (2007). Effectiveness of paramedic practitioners in attending 999 calls from elderly people in the community: cluster randomised controlled trial BMJ, 335 (7626), 919-919 DOI: 10.1136/bmj.39343.649097.55

Brindley, P., & Needham, C. (2009). Positioning prior to endotracheal intubation on a television medical drama: Perhaps life mimics art Resuscitation, 80 (5), 604-604 DOI: 10.1016/j.resuscitation.2009.02.007

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Filed Under: EMS EduCast, Heresy, Paramedicine 101, Research, Research Blogging Tagged With: , , ,

Fight for your Right: EMS Garage Episode 79

Sat, 27 Mar 2010 16:14:12 -0400 by

I had the opportunity to be on a couple of good podcasts this week.

Fight for your Right: EMS Garage Episode 79

Podcast master Chris Montera had invited Steve Wirth of Page, Wolfberg & Wirth, probably the best known EMS law firm, to explain. The topic was the ways that the case best described by Ambulance Driver was handled, could have been handled, and should have been handled.

A lot of good information covered here, especially for those who feel the need to use social media at work. I had wanted to bring up the way the administration in Pittsburgh is handling discipline, but there was so much else covered in this episode.

An interesting aspect of this segment is that Justin Schorr of Happy Medic and Chronicles of EMS was at work for the show. He is in the unusual situation of having a lot of support from his employer. Many employers may not have addressed any of these social media issues.

Also on the show were several people much more involved in social media than I am:

Kyle David Bates of KyleDavidBates.com and more importantly, of Mrs. Kyle David Bates.

Greg Friese of Everyday EMS Tips, EMSBootCamp.com, EMSEduCast.com, EPS411.com, and PIOSocialMediaTraining.com.

David Konig of DavidKonig.com and PIOSocialMediaTraining.com.

Natalie Quebodeaux of Ms Paramedic and the Gen Med Show.

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Filed Under: EMS EduCast, EMS Garage, Heresy Tagged With:

Education Problems, Autism, and Vaccines

Thu, 18 Mar 2010 00:01:35 -0400 by
Monday I wrote about the problems that can result from national standards. We do need to raise our education standards. An excellent example can be seen in the faulty logic used by those claiming that vaccines cause autism.

Hypothesis: Vaccines cause autism.

Experiment: Compare the rate of autism in groups with differences in vaccination methods. There are many ways this can be done, depending on the way the vaccine is hypothesized to cause autism.

However, the people claiming that vaccines cause autism do not accept the research that has been done. They claim that it is obvious that vaccines are dangerous and no amount of science will change their minds.

Vaccines contain thimerosal. Thimerosal is mercury. Mercury causes brain damage. The brain damage caused by mercury is exactly the same as autism. Mercury is one of the most toxic substances on the planet, so we have to stop poisoning children with it.

Clearly, this is a problem. We have a substance so dangerous that it must produce close to 100% brain damage. It is good that these public spirited people have raised this alarm.

Wait!

Using faulty logic, we can prove almost anything. Here is one example.

Zeno’s paradoxes provide several. Here is just one.

In a race, the quickest runner can never overtake the slowest, since the pursuer must first reach the point whence the pursued started, so that the slower must always hold a lead.[1]

Once the pursuer reaches the spot where the slower runner was, the process repeats infinitely. Since distances can be made ever smaller – there is no distance so infinitesimal, that is not made up of an infinite number of even smaller infinitesimal distances. Therefore, the faster runner can never catch up to a slower runner, who has just a tiny head start.

Using a different paradox, Zeno proves that the runner cannot even first reach the point whence the pursued started.

That which is in locomotion must arrive at the half-way stage before it arrives at the goal.[2]

The same endlessly repeating problem of infinitely divisible space is the explanation.

However, we know that these are not impossibilities. It is only by proposing an explanation that sounds reasonable, that these become confusing.

The way we find out the truth is simple. We test the claim.

Anyone capable of walking can walk across a room. There is no need to break the motion up into smaller and smaller parts. The motion is continuous.

Similarly, the problem of thimerosal only appears insurmountable. The only way to determine the accuracy of the claim is to test it.

The single study, that has supported any connection between thimerosal and autism, had such fatal flaws that it was retracted by the journal that published it. In 2004, most of the authors of the study had their names removed from the study, when they became aware of the fraud involved. The study was funded by lawyers hoping to win a big settlement from drug companies. All the lawyers needed was a study that showed this connection. About half a million dollars later, Andrew Wakefield was able to produce just such a study.

One problem with the explanation that thimerosal is such a toxic substance is that the occurrence of autism is supposed to happen so quickly after the vaccination, that the connection is inescapable. Some parents describe the onset of autism symptoms resembling somebody turning off a switch.

This study investigated if the discontinuation of thimerosal-containing vaccines paralleled a decrease in the occurrence of autism. The incidence of autism remained fairly constant during the period of use of thimerosal in Denmark, and the rise in incidence beginning in 1991 continued even in the group of children born after the discontinuation of thimerosal. The amount of thimerosal used in vaccines changed during the study period with less amount of thimerosal administered in the period 1970–1992. Moreover, the thimerosal-containing vaccine was gradually phased out meaning that the incidence rates should decline gradually if thimerosal has any impact on the development of autism. However, an increase (rather than a decrease) in the incidence rates of autism was observed.[3]

So much for throwing a switch.

Using the logic of the anti-vaccinationists, this must be evidence that thimerosal protects against autism.

There are many reasons for using this chart. The chart is from the same study as the paragraph that is above it, so it was handy. It is dramatic. It makes it easy to see that there is no connection between when thimerosal was in the vaccines (up until the vertical line) and autism (begins to increase just as the thimerosal is removed). There are other studies that show the same information. The evidence is clear.

There is no reason to believe that vaccines cause autism.

Then there is the comment that is supposed to silence disagreement. If you don’t have an autistic child, you cannot understand anything about autism. Unless you agree with the anti-vaccinationists. It doesn’t matter if you know what you are talking about, if you agree with them.

Therefore, if I want to know what is the best treatment for something, I should ignore doctors and ask a parent of a child with the condition. Using this logic, the most knowledgeable parent would be one with a child sick for the longest time with that disease. If being a parent of a sick child confers expertise, then the longer that illness continues, the greater the expertise conferred by this faulty logic.

If my child is sick, I am not going to look for parents with the same condition. These parents may have a lot of useful information about many things. However, the abilities to understand assessment, diagnosis, and treatment are not infections transmitted from the children to the parents.

The doctor to go to is also not the one treating children who do not get better. The anti-vaccinationists might conclude that the greatest expert is a parent who had at least one child die from the illness. They are persuaded by emotion, not reason.

There is a further problem with, I refuse to listen to anyone who does not have an autistic child. These parents even ostracize other parents of autistic children unless those parents agree with the emotional claims of the anti-vaccinationists about thimerosal. Catch-22 has nothing on them.

What about the mercury?

Thimerosal is C9H9HgNaO2S or sodium ethylmercurithiosalicylate. Mercury is Hg. Thimerosal is not mercury, but a compound that contains mercury. Being in a compound changes the characteristics and the effects of elements.

An example that people in EMS should understand is chlorine (Cl). This is so toxic, that it was used as a poison gas. Mix it with sodium (Na), which is also extremely toxic, and you have sodium chloride. Sodium chloride (NaCl) is known as common table salt. Sodium chloride is also the ingredient in normal saline, which we inject into the veins of just about every patient with a serious medical condition.

According to the anti-vaccinationists, No amount of mercury is safe. Based on what? Using the same criteria (Because I say so!), no amount of sodium or chlorine would be safe in the body. After all, they are toxic.*

The video below is less than 10 minutes long, but does a great job of explaining ways in which science keeps us from attributing too much to anecdotes, such as this. He was a normal little boy, until he received the vaccine. Autism is diagnosed at the time that children receive vaccinations. This is true, even for children who do not receive vaccinations. Since the vaccines do not cause autism, the only thing avoiding vaccination does is to endanger children.

The explanations that sound good, but are not supported by research are examples of narrative fallacy. I have written more than a little bit about narrative fallacy, because it is important. Using this devotion to reasonable sounding explanations, even though research demonstrates that these explanations are wrong, is a problem. Fortunately, in medicine there is more of an understanding of science. If that were not the case, we might be still bleeding patients to get rid of bad humors.

Narrative Fallacy –

Narrative Fallacy I

How did this happen? – Research

Narrative Fallacy II

CAST and Narrative Fallacy

C A S T and Narrative Fallacy comment from Shaggy

Some Research Podcasting Comments

Shaggy Comments on Some Research Podcasting Comments.

Spine Immobilization in Penetrating Trauma: More Harm Than Good?

EMS EdUCast – Journal Club 2: Episode 43

Education Problems, Autism, and Vaccines

Footnotes:

^ * This does ignore the obvious problem that both hyponatremia and hypocalcemia are fatal conditions, even though sodium and calcium are toxic. If only there were some kind of medical expert to explain cutting edge toxicology. Somebody like Paracelsus.

^ 1 Zeno’s paradoxes
Wikipedia
Achilles and the tortoise
Article

^ 2 Zeno’s paradoxes
Wikipedia
The dichotomy paradox
Article

^ 3 Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data.
Madsen KM, Lauritsen MB, Pedersen CB, Thorsen P, Plesner AM, Andersen PH, Mortensen PB.
Pediatrics. 2003 Sep;112(3 Pt 1):604-6.
PMID: 12949291 [PubMed – indexed for MEDLINE]

Pediatrics has the free full text and free PDF available at their site.
Free Full Text                 Free PDF

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Filed Under: Critical Judgment, EMS EduCast, Heresy, Narrative Fallacy, Science Tagged With: , , ,

EMS EdUCast – Journal Club 2: Episode 43

Thu, 28 Jan 2010 20:35:00 -0500 by

A week ago on the EMS EdUCast the topic was resuscitation. The big disagreement was about the IV vs No IV epinephrine study.[1]

One of the criticisms of the study is that Blair Bigham states that therapeutic hypothermia would lead to improved outcomes. However, the Oslo hospitals started routinely using therapeutic hypothermia only four months after the start of the study. So, almost all of the eligible patients did receive therapeutic hypothermia.[2] The therapeutic hypothermia study does show a doubling of survival to discharge with good neurological function at one year after discharge, so this does not appear to be any justification for doubting the effectiveness of treatment in Oslo.

Another concern is that PCI (Percutaneous Coronary Angiography or cardiac catheterization) might affect outcomes, but cardiac catheterization was also part of standard treatment in Oslo at the time.

Bill Toon mentions that some of the ambulances are staffed by physicians, but what difference is there between what a physician will do on scene and what a medic will do on scene? Physician staffed ambulances were present at 37% of no IV patients and 38% of IV patients, so this should not have affected either group more than the other.

A concern raised by Rob Theriault was the change in the CPR (CardioPulmonary Resuscitation) and ACLS (Advanced Cardiac Life Support) guidelines during the study period.

Until January 2006, ACLS was performed according to the International Guidelines 2000,14 with the modification that patients with ventricular fibrillation received 3 minutes of CPR before the first shock and between unsuccessful series of shocks.15 [1]

While they were not using the 2005 guidelines prior to January 2006 in Oslo, they were using a form of CPR that could be described as closer to the 2005 guidelines than the 2000 guidelines. According to the study –

Both groups had adequate and similar CPR quality with few chest compression pauses (median hands-off ratio, 0.15 for the intravenous group and 0.14 for the no intravenous group) and the compression and ventilation rates were within the guideline recommendations (Table 1).[1]

It appears that the compression interruptions are much less than what we would expect from a similar study done in the US, except where CCR (Continuous Compression Resuscitation or CardioCerebral Resuscitation) is being used correctly.

If you believe, as Blair appears to, that the improved outcomes in the US after the 2005 guidelines are at least partially due to epinephrine, likewise the improvements in the places using CCR, then you anticipate that when the first large enough randomized placebo-controlled study of drugs during cardiac arrest is published, it will show significantly better outcomes for those receiving epinephrine.

I doubt it. I expect something similar to the many studies of traditional treatments that could only be shown to improve surrogate end-points. Surrogate end-points are like alcohol. In moderation, the effects can be pleasant, while intemperate use distorts reality.

Some examples of being misled by surrogate end-points are the routine use of antiarrhythmic medication in post-MI (Myocardial Infarction) patients with PVCs (Premature Ventricular Contractions). The drugs did a great job of getting rid of the nasty looking PVCs, but making the rhythm look better did not improve outcomes. In spite of the wonderfully improved heart rhythms, the fatality rate more than tripled.[3]

We used to give furosemide (Lasix) to almost all patients presenting with symptoms of CHF (Congestive Heart Failure). Single-mindedly, we would try to remove as much water from CHF patients, because fluid in the lungs is a sign of fluid overload. Research, going back to the 1980s, shows that fluid in the lungs and fluid overload are not the same thing. Giving furosemide causes the body to dump water almost as dramatically as if we gave the patient an enema. Medical directors have responded to research showing harm from furosemide, and many have restricted the use of furosemide.

MAST/PASG (Medical Anti-Shock Trousers/Pneumatic Anti-Shock Garment) was the answer to blood loss. The same argument, that you have to have a pulse to leave the hospital alive, reared its head. Rather than focus on pulses in the ED, medical directors chose the meaningful outcome of more patients leaving the hospital able to care for themselves.

At one point, Buck Feris points out that post-resuscitation care is largely a matter of dealing with the side effects of epinephrine. Blair presents a paper that suggests that there are no post-resuscitation guidelines (not his conclusion). No post-resuscitation guidelines? There is an entire section of the ACLS guidelines on post-resuscitation care.[4] Just because there is no particular flow sheet to be memorized, does not mean that there are no guidelines. When I taught ACLS, post-resuscitation care was one of the essential parts I covered.

CPR/CCR, defibrillation, potentially reversible causes, and post resuscitation care are the things that make a difference in outcome. Why do we spend so much time on trying to resuscitate people, if we are not going to prepare them to actually deal with what happens after the return of a pulse?

Post-resuscitation care is not just about treating vital signs. Perhaps part of our problem is that we do not see this as part of resuscitation. If we understood this, maybe we would see that giving epinephrine is just about vital signs. Giving epinephrine is not about resuscitation. When we produce a pulse with epinephrine, we need to switch from resuscitation to trying to counter epinephrine toxicity.

Perhaps, if epinephrine were in any way considered good for the heart, I would be less cynical. There are not many drugs more toxic to the heart than epinephrine.

Narrative Fallacy –

Narrative Fallacy I

How did this happen? – Research

Narrative Fallacy II

CAST and Narrative Fallacy

C A S T and Narrative Fallacy comment from Shaggy

Some Research Podcasting Comments

Shaggy Comments on Some Research Podcasting Comments.

Spine Immobilization in Penetrating Trauma: More Harm Than Good?

EMS EdUCast – Journal Club 2: Episode 43

Education Problems, Autism, and Vaccines

Updated 9/14/2012 at 03:00 for formatting.

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Footnotes:

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[1] Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial.
Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, Wik L.
JAMA. 2009 Nov 25;302(20):2222-9.
PMID: 19934423 [PubMed – in process]

I wrote about this in Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial. If you want to read the full text of the study, it is available in PDF at the EMSEdUCast page for this episode.

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[2] Implementation of a standardised treatment protocol for post resuscitation care after out-of-hospital cardiac arrest.
Sunde K, Pytte M, Jacobsen D, Mangschau A, Jensen LP, Smedsrud C, Draegni T, Steen PA.
Resuscitation. 2007 Apr;73(1):29-39. Epub 2007 Jan 25.
PMID: 17258378 [PubMed – indexed for MEDLINE]

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[3] Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial.
Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al.
N Engl J Med. 1991 Mar 21;324(12):781-8.
PMID: 1900101 [PubMed – indexed for MEDLINE]

Free Full Text from NEJM.

CONCLUSIONS. There was an excess of deaths due to arrhythmia and deaths due to shock after acute recurrent myocardial infarction in patients treated with encainide or flecainide. Nonlethal events, however, were equally distributed between the active-drug and placebo groups. The mechanisms underlying the excess mortality during treatment with encainide or flecainide remain unknown.

I have written about this in C A S T and Narrative Fallacy and elsewhere.

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[4] 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Circulation. 2005;112:IV-84 – IV-88.
Part 7.5: Postresuscitation Support
Free Full Text       Free PDF

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Filed Under: EMS EduCast, Epinephrine, Heresy, Narrative Fallacy, Research Tagged With: , , ,

Spine Immobilization in Penetrating Trauma: More Harm Than Good?

Thu, 21 Jan 2010 21:11:04 -0500 by
ResearchBlogging.org

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Also posted over at Paramedicine 101. Go check out the rest of what is there.

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Correction posted 3/15/2011 in Correction to Spine Immobilization in Penetrating Trauma: More Harm Than Good.

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A recent study points out some of the problems with EMS (Emergency Medical Services) treatment in some places. Each medical director, or state medical director, is permitted to ignore the evidence that some treatments are harmful. They can use ignorance as an excuse for continuing harmful practices. Rather than ignorance, those familiar with the research will claim that somebody might benefit. Their battle cry is What if . . . ?

If we take that approach, there is no limit to how much we can do to a patient, and I do mean to a patient, not for a patient. This is not patient care. This is alternative medicine. Since alternative medicine is not medicine, but an alternative to medicine, this EMS treatment qualifies as alternative medicine. When our patients need care, they do not need an alternative to medicine that works, they need medicine that works.

Spine immobilization in penetrating trauma: more harm than good?[1] shows that What if . . . ? medicine can double or triple the death rate of our patients.

What if . . . ? we act as if our patients matter enough to be treated as human beings.

What if . . . ? we try to help our patients survive.

The reason for the continued use of What if . . . ? practices seems to be more of a fear of lawyers, than any kind of understanding of medicine. The medical directors appear to presume that they will never get in trouble for doing too much, as long as we are not using pain medicine. They seem to think that anything they recommend is good, or at worst, not harmful. We’ve got to do something! That is the theme in EMS these days.

We need to continue to harm our patients right up until there is inescapable proof that we are causing harm.

What does the study say?

This study seeks to measure the effect of prehospital spine immobilization on mortality in a large national sample of penetrating trauma patients drawn from the NTDB (National Trauma Data Bank). We hypothesized that penetrating trauma patients who underwent prehospital spine immobilization would have higher mortality than penetrating trauma patients who did not undergo spine immobilization. In addition, we expected that a very small proportion of penetrating trauma patients potentially benefited from prehospital spine immobilization.[2]

Patients were considered to have potentially benefited from prehospital spine immobilization if they had an incomplete spine injury and required an operative spine procedure (including vertebral spine repair, spine fusion, laminectomy, and/or halo placement).[2]

This seems as if it should be the way to determine which patients might have been best treated with immobilization, but there remains a big problem. There is no research to show that without prehospital spinal immobilization, outcomes would be any worse, even for patients with unstable spinal fractures. We presume that this is an effective treatment, but we are only hoping that we are doing the right thing.[3]

On subset analysis of specific patient populations, no group of penetrating trauma patients had any survival benefit with prehospital spine immobilization (Fig. 1) Even for patients with the least severe injuries (ISS <15), spine immobilization was independently associated with significantly decreased survival (OR of death 3.40, 95% CI 1.48–7.81). The OR of death was significantly elevated for GSW patients (OR 2.12; 95% CI 1.33–3.37) and for hypotensive patients (OR of death 2.42, 95% CI 1.37–4.27).[2]

The fatality rate appears to be multiplied, not just increased, by this treatment. Maybe it is time to stop killing so many of our patients. Fortunately, most places stopped this dangerous treatment long ago. This comes from Johns Hopkins. It appears to have been motivated by the continuing attempts by MIEMSS (Maryland Institute for Emergency Medical Services Systems) to stick to the What if . . . ? method of treatment, in spite of evidence of harm. MIEMSS protocols do not appear to differentiate between blunt and penetrating trauma, when determining if immobilization is necessary[4].

Of these 116 patients, 86 (74%) had complete spinal cord injury and would not have benefitted from spine immobilization. Only 30 (0.01%) of the 30,956 patients had incomplete spinal cord injury and underwent operative spine stabilization. The number needed to treat (NNT) with spine immobilization to potentially benefit one penetrating trauma patient was 1,032. The NNH (Number Needed to Harm) with spine immobilization to potentially contribute to one death was 66.[2]

The NNT is not at all clear. They are using a potential benefit of spinal immobilization that has only been presumed. That benefit has not been demonstrated. Where is the research to show that prehospital spinal immobilization in any way improves outcomes for patients with unstable spinal injuries even due to blunt trauma?

In this case, the NNH is not the Number Needed to Harm. What is reported is the Number Needed to Kill, because they are only looking at fatal harm in calculating NNH. When looking at benefit, if they were to look for lives saved by spinal immobilization for penetrating injuries, they would still be looking. If they had a unicorn to guide them, they might find something.

According to one study of the harm due to spinal immobilization, the NNH is less than 2.

Conclusion

In this population of alert and cooperative patients with no obvious distracting injuries or clinical signs of intoxication, 52% had no complaints of neck pain or back pain yet were transported to the ED using FSI (Full Spinal Immobilization), which increased both their level of discomfort and their EMS charges.[5]

The number needed to treat is 1,032 – assuming there is any benefit from prehospital spinal immobilization. Only 1 study has looked at this. It found no evidence of any benefit. Even those with unstable spinal fractures did worse with spinal immobilization. Unfortunately the study was too small to be statistically significant.[6]

The number needed to harm is less than 2.

The number needed to kill is 66.

The extremely optimistic number needed to treat is 1,032.

Although the intention behind conservative prehospital spine immobilization protocols is to protect the minority of patients who suffer spine injuries, this study demonstrates that spine immobilization is associated with higher mortality in penetrating trauma patients and may harm more penetrating trauma patients than it helps. Prehospital spine immobilization was associated with higher odds of death in all penetrating trauma patients, and this association was qualitatively robust across all subsets of penetrating trauma patients.[2]

The merits of IV fluid administration, endotracheal intubation, and now spine immobilization (in penetrating trauma patients) have been called into question, because their clinical benefit may not be worth the extra time on scene.[2]

This is an excellent example of narrative fallacy.

We know that spinal immobilization leads to worse outcomes for patients with penetrating injuries. That is the part that is important to know. Then there is an attempt at an explanation – because their clinical benefit may not be worth the extra time on scene. This explanation is where we make a mistake. I have written quite a bit about narrative fallacy. The posts are linked below, in chronological order, just above the footnotes.

In the limitations, they do acknowledge this to some extent.

Our conservative estimate of the benefit is possibly exaggerated as not all patients with an incomplete spinal cord injury who underwent surgery truly benefitted from spinal immobilization.[2]

Elsewhere in the limitations, they write this.

This retrospective study suffers some significant limitations, mainly because of the data available. The NTDB does not report prehospital scene or transport times or differentiate urban versus rural care. Thus, we could not demonstrate that the excess mortality in patients who underwent spine immobilization was associated with delays in transport to definitive care.[2]

There is not really a good reason to presume that extra time on scene is the reason for the dramatic increase in death among those immobilized. While it is possible that time does contribute to the result, it is a mistake to claim that a study that does not have the ability to examine prehospital times at all is capable of providing evidence that extra time on scene is the cause.

Another recent study showed that there is no reason to believe that prehospital times significantly affect outcomes even for the most unstable trauma patients.[7]

Where research is not being used, we need to find ways to get the medical directors to understand research. Then we need to get them to apply the research.

Narrative Fallacy –

Narrative Fallacy I

How did this happen? – Research

Narrative Fallacy II

CAST and Narrative Fallacy

C A S T and Narrative Fallacy comment from Shaggy

Some Research Podcasting Comments

Shaggy Comments on Some Research Podcasting Comments.

Spine Immobilization in Penetrating Trauma: More Harm Than Good?

EMS EdUCast – Journal Club 2: Episode 43

Education Problems, Autism, and Vaccines

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Footnotes:

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[1] Spine immobilization in penetrating trauma: more harm than good?
Haut ER, Kalish BT, Efron DT, Haider AH, Stevens KA, Kieninger AN, Cornwell EE 3rd, Chang DC.
J Trauma. 2010 Jan;68(1):115-20; discussion 120-1.
PMID: 20065766 [PubMed – in process]

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[2] Spine immobilization in penetrating trauma: more harm than good?
Haut ER, Kalish BT, Efron DT, Haider AH, Stevens KA, Kieninger AN, Cornwell EE 3rd, Chang DC.
J Trauma. 2010 Jan;68(1):115-20; discussion 120-1.
PMID: 20065766 [PubMed – in process]

This is the same as footnote [1]

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[3] Out-of-hospital spinal immobilization: its effect on neurologic injury.
Hauswald M, Ong G, Tandberg D, Omar Z.
Acad Emerg Med. 1998 Mar;5(3):214-9.
PMID: 9523928 [PubMed – indexed for MEDLINE]

I wrote about this study in Spinal Immobilization Harm.

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[4] MIEMSS Maryland Medical Protocols
Effective July 1, 2008
348 pages of trying to predict everything that might go wrong.
Free large PDF

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[5] Unnecessary out-of-hospital use of full spinal immobilization.
McHugh TP, Taylor JP.
Acad Emerg Med. 1998 Mar;5(3):278-80. No abstract available.
PMID: 9523943 [PubMed – indexed for MEDLINE]

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[6] Out-of-hospital spinal immobilization: its effect on neurologic injury.
Hauswald M, Ong G, Tandberg D, Omar Z.
Acad Emerg Med. 1998 Mar;5(3):214-9.
PMID: 9523928 [PubMed – indexed for MEDLINE]

This is the same study as footnote [3].

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[7] Emergency Medical Services Intervals and Survival in Trauma: Assessment of the “Golden Hour” in a North American Prospective Cohort.
Newgard CD, Schmicker RH, Hedges JR, Trickett JP, Davis DP, Bulger EM, Aufderheide TP, Minei JP, Hata JS, Gubler KD, Brown TB, Yelle JD, Bardarson B, Nichol G; Resuscitation Outcomes Consortium Investigators.
Ann Emerg Med. 2009 Sep 22. [Epub ahead of print]
PMID: 19783323 [PubMed – as supplied by publisher]

I wrote about this study in Emergency Medical Services Intervals and Survival in Trauma: Assessment of the “Golden Hour” in a North American Prospective Cohort.

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Haut, E., Kalish, B., Efron, D., Haider, A., Stevens, K., Kieninger, A., Cornwell, E., & Chang, D. (2010). Spine Immobilization in Penetrating Trauma: More Harm Than Good? The Journal of Trauma: Injury, Infection, and Critical Care, 68 (1), 115-121 DOI: 10.1097/TA.0b013e3181c9ee58

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Filed Under: 'Alternative' Medicine, Critical Judgment, EMS EduCast, Heresy, Paramedicine 101, Research, Research Blogging, Spinal Immobilization Tagged With: , , , ,
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