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

- Rogue Medic

What Treatments May Be De-Emphasized by EM/EMS in 2019? Part I

 

EM (Emergency Medicine) and EMS (Emergency Medical Services) have already started to eliminate/decrease use of a lot of our failed treatments, because people started to see through our excuses. Atropine for asystole stuck around for a long time, then just vanished.[1]. Calcium for cardiac arrest is also something that used to be standard of care, then we raised our standards.

We need to keep raising our standards, because our patients’ outcomes – their lives, their brains, their everything – depend on raising our standards.

We used to give antiarrhythmics to almost anyone with a cardiac complaint. Then there was CAST (The Cardiac Arrhythmia Suppression Trial[2]). While CAST did not study lidocaine, it did study longer term use of antiarrhythmics. Lidocaine is too dangerous for long term use, so the results of CAST may be much worse for lidocaine. We thought that the increased deaths among patients with frequent PVCs (Premature Ventricular Contractions) after having a heart attack was due to a problem with the conduction system. PVCs indicate a problem with conduction and antiarrhythmics cause the PVCs to go away.
 

Before receiving the antiarrhythmic (PVCs are circled in red).


 

After receiving the antiarrhythmic.


 

Problem solved.

Now the problem is, How do we get paid more? These drugs were the biggest selling drugs at the time. They making the drug companies a fortune. Whichever company made the drug that saved the most lives would make a lot more money then the others. Provide evidence that ______ saves more lives than all of the others.

The problem of the PVCs was solved, but the solution was killing many more patients than not giving drugs.

The result was not celebrated by the drug companies. The patients taking antiarrhythmics were dying at three times the rate of the patients taking placebos. A plausible physiological mechanism suggested the drugs would save lives, but that was based on an assumption that was not justified. This is the kind of reasoning that appeals to those who reject EBM (Evidence-Based Medicine). The evidence should convince these EBM opponents of the folly of relying on physiology and on a plausible explanation to justify not looking for the evidence that might expose their unreasonable assumptions. These otherwise reasonable people start making excuses for unreasonable assumptions, because they believe. They seem to need to convince others to join in and multiply their mistakes.[3]

The PVCs appear to have been just an indicator of an unhealthy heart.

Getting rid of the PVCs may have made the conduction in the heart less healthy.

Giving the drugs may have killed tens of thousands of patients.

Antiarrhythmic use decreased dramatically after the harm demonstrated in CAST, but some drug pushers are trying to get one of the worst antiarrhythmics (amiodarone, now in a new formula) to make a comeback, by creatively spinning research to claim results the research was never designed to evaluate.

Not having learned from the evidence, even though he has been the lead author on some of it, Dr. Peter Kudenchuk has been claiming that in EMS witnessed arrests, there was a significant improvement, even though his own published results contradict this claim. Here is what the results actually state:
 

Though prespecified, this subgroup analysis was performed in the context of an insignificant difference for the overall analysis, and the P value for heterogeneity in this subgroup analysis was not adjusted for the number of subgroup comparisons. Nonetheless, the suggestion that survival was improved by drug treatment in patients with witnessed out-of-hospital cardiac arrest, without evidence of harm in those with unwitnessed arrest, merits thoughtful consideration.[4]

 

Amiodarone has also been shown to be horrible for patients with ventricular tachycardia with a pulse. Amiodarone is so ineffective, that the rate of severe side effects is greater than the rate of improved outcomes. Amiodarone is more likely to make your patient’s medical condition much worse, but it is still considered to be the standard of care and amiodarone is still in EMS protocols.[5]

Maybe amiodarone can produce better results if it is used for execution by lethal injection.

I am expecting that there will be more failed treatments removed from our standards of care.

We need to raise our standards to improve outcomes, not lower our standards to make us look better than we are.

Continued in Part II. I will add Part III and others at some point and provide the links here.

Footnotes:

[1] Why Did We Remove Atropine From ACLS?
Rogue Medic

Part I
Sun, 13 Oct 2013

Part II
Wed, 16 Oct 2013

[2] 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.

[3] Why US EMS will never get to sit at the adult table – The Appeal to Authority
Sun, 04 May 2014
Rogue Medic
Article

Since Mike cites the original parachute study, as if it is not satire, it is amusing to point out that there is a new Parachute Study! Read Dr. Radecki’s description of this satirical poke at those who do not understand research in the satire issue of the BMJ, which they put out every Christmas as sort of a British IgNobel.

Don’t Bother With the Parachute!
Emergency Medicine Literature of Note
Dr. Ryan Radecki
December 21, 2018
Article
 

Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial.
Yeh RW, Valsdottir LR, Yeh MW, Shen C, Kramer DB, Strom JB, Secemsky EA, Healy JL, Domeier RM, Kazi DS, Nallamothu BK; PARACHUTE Investigators.
BMJ. 2018 Dec 13;363:k5094. doi: 10.1136/bmj.k5094. Erratum in: BMJ. 2018 Dec 18;363:k5343.
PMID: 30545967

Free Full Text from BMJ.

[4] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators.
N Engl J Med. 2016 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204. Epub 2016 Apr 4.
PMID: 27043165

Free Full Text from NEJM.

CONCLUSIONS Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.

 

Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’
Tue, 12 Apr 2016
Rogue Medic
Article
 

Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest
Mon, 04 Apr 2016
Rogue Medic
Article

[5] The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia
Rogue Medic
Wed, 17 Aug 2016
Article
 

Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study.
Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J; PROCAMIO Study Investigators.
Eur Heart J. 2016 Jun 28. pii: ehw230. [Epub ahead of print]
PMID: 27354046

Free Full Text from European Heart Journal.
 

Amiodarone or procainamide for the termination of sustained stable ventricular tachycardia: an historical multicenter comparison.
Marill KA, deSouza IS, Nishijima DK, Senecal EL, Setnik GS, Stair TO, Ruskin JN, Ellinor PT.
Acad Emerg Med. 2010 Mar;17(3):297-306.
PMID: 20370763 [PubMed – indexed for MEDLINE]

Free Full Text from Academic Emergency Medicine.
 

Amiodarone is poorly effective for the acute termination of ventricular tachycardia.
Marill KA, deSouza IS, Nishijima DK, Stair TO, Setnik GS, Ruskin JN.
Ann Emerg Med. 2006 Mar;47(3):217-24. Epub 2005 Nov 21.
PMID: 16492484 [PubMed – indexed for MEDLINE]
 

Intravenous amiodarone for the pharmacological termination of haemodynamically-tolerated sustained ventricular tachycardia: is bolus dose amiodarone an appropriate first-line treatment?
Tomlinson DR, Cherian P, Betts TR, Bashir Y.
Emerg Med J. 2008 Jan;25(1):15-8.
PMID: 18156531 [PubMed – indexed for MEDLINE]
 

Effects of intravenous amiodarone on ventricular refractoriness, intraventricular conduction, and ventricular tachycardia induction.
Kułakowski P, Karczmarewicz S, Karpiński G, Soszyńska M, Ceremuzyński L.
Europace. 2000 Jul;2(3):207-15.
PMID: 11227590 [PubMed – indexed for MEDLINE]

Free Full Text PDF + HTML from Europace
 

Adenosine for wide-complex tachycardia – diagnostic?
Thu, 23 Aug 2012
Rogue Medic
Article
 

Low doses of intravenous epinephrine for refractory sustained monomorphic ventricular tachycardia.
Bonny A, De Sisti A, Márquez MF, Megbemado R, Hidden-Lucet F, Fontaine G.
World J Cardiol. 2012 Oct 26;4(10):296-301. doi: 10.4330/wjc.v4.i10.296.
PMID: 23110246 [PubMed]

Free Full Text from PubMed Central.

.

The Grinch Who Stole Reality

 

And the Grinch, with his Grinch-feet ice cold in the snow, stood puzzling and puzzling, how could it be so?

It came without ribbons epi.

It came without tags amio.

It came without packages oxygen, boxes tubes or bags.

And he puzzled and puzzled ’till his puzzler was sore. Then the Grinch thought of something he hadn’t before.

Maybe Christmas living, he thought…doesn’t come from a store drug.

Maybe Christmas living, perhaps…means a little bit more!

 

With apologies to Dr. Seuss (Theodore Geisel) for the modification of his parable.

There are important differences between the minimal criteria for life and the criteria for a meaningful life. Many of us don’t like to think about that, because many of us don’t like thinking. Thinking can be hard. Making excuses for not thinking – priceless (at least, as long as you don’t think about it).

We have been focusing on the least honest way of reporting outcomes – a pulse – Oooh!, or maybe even 30 days of a pulse – Oood-Ahhh! After all, reality does not support continuing to do what we have been doing. If we admit that we have been causing harm, then we may have to take responsibility for our actions.

We do not want to take responsibility for our actions. We were only following orders.

Doctors, PAs (Physician Assistants), NPs (Nurse Practitioners), nurses, paramedics, EMTs, techs, . . . do not want to take responsibility for what we get paid for. Accountability is for people who think – not for us.

We have blamed science/evidence for requiring that we confront reality. As explained by Dr. Seuss, we want simple answers that do not require understanding. Give us algorithms to mindlessly follow. Give us mnemonics.

We have been giving epinephrine (adrenaline in Commonwealth countries) for over half a century with no evidence of safety or improvement in the outcome that matters most.

Why?

We haven’t wanted to know.

The first study to look at the effect of placebo vs. epinephrine on neurological survival was cut short – with only a tiny fraction of what would be needed to produce any kind of statistically useful information, except for some of the true believers, who made the same kinds of mistakes that have been made for other discarded treatments – treatments discarded due to failure to work, discarded due to harm, or discarded due to both.

Don’t study this. Just believe. Belief makes us feel good. Attack science for encouraging understanding.
 

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.[1]

 

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.[1]

 

What was the conclusion produced by the Jacobs study?
 

CONCLUSION: Patients receiving adrenaline during cardiac arrest had no statistically significant improvement in the primary outcome of survival to hospital discharge although there was a significantly improved likelihood of achieving ROSC.[1]

 

As the homeopaths put their spin on studies that do not really support their claims, people who do not understand science put similar spin on the results of this. For example, if you take a Bayesian approach[2], but distort it to mean that you give extra weight to everything that supports your belief and take away credit from everything else, you can claim that this is an example of science proving that epinephrine works.

Another way of doing this is to claim that you don’t give the 1 mg dose of epinephrine, therefore the study does not apply to your patients. After all, you are just engaging in a poorly documented, unapproved study, which allows you to think of the survivors as examples of the drug working and make excuses for the rest. Of course, if you don’t give the 1 mg dose of epinephrine, is there any evidence that your treatment is safe or effective? No.

Rather than insisting that this method of dosing patients be studied, in order to determine if it really is safe or if it really is effective at anything other than getting a pulse in a brain-dead body, claim to be ahead of the science.

Why find out what is really best for the patients, when there are so many ways of declaring victory and running away?

In 2018, we had the results of the next study of placebo vs. adrenaline (epinephrine in non-Commonwealth countries, but only Commonwealth countries have bothered to do the research). The conclusion was the same as the conclusion for the only previous study.
 

CONCLUSIONS: In adults with out-of-hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30-day survival than the use of placebo, but there was no significant between-group difference in the rate of a favorable neurologic outcome because more survivors had severe neurologic impairment in the epinephrine group.[3]

 

Has anyone else stated that the use of epinephrine should be limited to controlled trials?

Not that I know of.

Everyone else seems to be claiming that giving smaller boluses of epinephrine. or giving titrated infusions of epinephrine is different. Some claim that it is nihilism to refuse to believe in their slightly different treatment – at least until there is undeniable evidence of lack of benefit, or undeniable evidence of harm, or both.

Requiring evidence of benefit, before using a treatment on a patient is being reasonable.

Using inadequately studied treatments on people when they are at their most vulnerable is not good medicine.

A doctor’s oath to Apollo does not include a requirement to perpetuate dogma, but medicine is only slowly starting to focus on what is best for patients, rather than what is best for appearances.

Dr. Ryan Jacobsen addressed a similar dogma, when he got rid of the long spine board in the system where he was medical director. His description of the evidence applies to epinephrine (bolus, mini-bolus, infusion, patch, inhaler, down the tube, oral, whatever) –

Other than historical dogma and institutional EMS medical culture we can find no evidence-based reason to continue to use the Long Spine board epinephrine as it currently exists in practice today.[4]

I changed EMS to medical and the Long Spine board to epinephrine.

We have good evidence that if your loved one is a laboratory pig, rat, dog, . . . we can kill them and get them back neurologically intact with epinephrine – and with other treatments that have been discarded because they do not have the same effect on humans as on lab animals.

Let us treat your loved ones like the lab animals we think they are.

Don’t use EBM (Evidence-Based Medicine), because belief is more important than reality.

The world is a comedy to those that think; a tragedy to those that feel. – Horace Walpole.

Keep thinking. Keep demanding evidence. After the nonsense being preached by the believers is exposed, we can improve the outcomes for our patients, because medicine is about doing what is best for the patient, and not about protecting the dogma.

Footnotes:

[1] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial
Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL.
Resuscitation. 2011 Sep;82(9):1138-43. doi: 10.1016/j.resuscitation.2011.06.029. Epub 2011 Jul 2.
PMID: 21745533

Free Full Text PDF Download from semanticscholar.org

[2] Bayesian inference
Wikipedia
Article

[3] A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest.
Perkins GD, Ji C, Deakin CD, Quinn T, Nolan JP, Scomparin C, Regan S, Long J, Slowther A, Pocock H, Black JJM, Moore F, Fothergill RT, Rees N, O’Shea L, Docherty M, Gunson I, Han K, Charlton K, Finn J, Petrou S, Stallard N, Gates S, Lall R; PARAMEDIC2 Collaborators.
N Engl J Med. 2018 Aug 23;379(8):711-721. doi: 10.1056/NEJMoa1806842. Epub 2018 Jul 18.
PMID: 30021076

[4] Johnson County EMS System Spinal Restriction Protocol 2014
Ryan C. Jacobsen MD, EMT-P, Johnson County EMS System Medical Director
Jacob Ruthsrom MD, Deputy EMS Medical Director
Theodore Barnett MD, Chair, Johnson County Medical Society EMS Physicians Committee
Johnson County EMS System Spinal Restriction Protocol 2014 in PDF format.

.

Anti-Vaccine Means Pro-Corruption

 

Can you be opposed to vaccines and not be supporting corruption? What does it mean to oppose vaccines?

Vaccines are probably the safest and most effective medical intervention available. Anti-vaxers oppose that.

Vaccines save millions of lives every year. Anti-vaxers oppose that.

If you disagree, provide valid evidence that anything else is as safe as vaccines and provide valid evidence that anything else is as effective as vaccines. There is the small possibility that I am wrong and that vaccines are only second, or maybe even third, among the safest and most effective medical interventions available.

But aren’t the anti-vaxers trying to protect children from unnecessary risk?

That is one of many anti-vaccine claims, but it is just another anti-vax lie.

Look at these heroes of the anti-vaccine propaganda industry. Mark and David Geier.

David Geier pretends to be a doctor, even though he never has been a doctor, or even been enrolled in a medical school.
 

As explained above, the Board concludes that David Geier practiced medicine in Maryland without being licensed by the Board to practice in violation of section 14-601 of the Health Occupations Article.[1]

 

Mark Geier did become a doctor, but the corruption of the anti-vax propaganda and treatment business led him to violate his responsibility to protect his patients. If you see Mark Geier working as a doctor, call the police.
 

Since 2011, Geier’s medical license has been suspended or revoked in every state in which he was licensed over concerns about his autism treatments and his misrepresentation of his credentials to the Maryland Board of Health, where he falsely claimed to be a board-certified geneticist and epidemiologist.[4] [2]

 

What is so bad about the Geiers and why do anti-vaxers continue to worship the Geiers?

Mark and David Geier castrate children with a chemical that has been approved for some medical uses, but definitely not to treat autism. The chemical has never been shown to be safe or even slightly effective for that purpose. If you think that autism is the worst thing ever – worse than smallpox, measles, polio, pertussis, et cetera, you may think that it is morally acceptable to torture children and to have faith in these quacks.
 


 

The fake doctor (David) is on the left and the revoked license doctor (Mark) is on the right.

But isn’t it an exaggeration to call this chemical castration.
 

Speaking about one teen he put on the drug, Mark Geier said: “I wasn’t worried about whether he would have children when he is 25 years old. If you want to call it a nasty name, call it chemical castration. If you want to call it something nice, say you are lowering testosterone.”[3]

 

For those who claim that this would be a short-term treatment, and the side effects would be minimized, that’s not the way quacks work – especially with paying customers. These are not reasonable people. Quacks will be expected to keep giving the magic treatment, possibly increasing the dose several times, until that treatment works, because they think that they know believe that it works. Reasonable people would be expected to stop never start this unapproved and dangerous treatment to begin with. Since the treatment does not work, and is expected to make the patients’ conditions worse, these people would not be expected to stop. As with other alternative medicine, treatment failures are blamed on the patient, or on the family. Quacks do not take responsibility for the incompetence of using chemicals that are dangerous and ineffective.

But what if it really does work?

Almost every proposed treatment, regardless of what it is, will be found to be more harmful than beneficial. Most are discarded long before they get to the point of being tested on actual humans. Poisoning patients, based on What if it works? is dangerous, unethical, and irresponsible.

If you have an autistic child, do not let the Geiers chemically castrate your child for fun and profit.

How do the same anti-vaxers, who claim that they are protecting their children from what is probably the safest and most effective medical intervention available, support this dangerous, unethical, and irresponsible treatment?

That is the way anti-vaxers think. Anti-vccine claims are arrogant rejections of competence, science, and reality. Protect your children from anti-vaxers.

Footnotes:

[1] In the matter of David A. Geier before the Maryland State Board of Physicians
Case Nos. 2008-0022 & 2009-0318
Maryland Department of Health
Final Decision and Order in PDF format.

[2] Mark Geier
Wikipedia
Article

[3] ‘Miracle drug’ called junk science
Trine Tsouderos
Tribune reporter
May 21, 2009
Article

.

A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest – Part I

 
Also to be posted on ResearchBlogging.org when they relaunch the site.

The results are in from the only completed Adrenaline (Epinephrine in non-Commonwealth countries) vs. Placebo for Cardiac Arrest study.
 


 

Even I overestimated the possibility of benefit of epinephrine.

I had hoped that there would be some evidence to help identify patients who might benefit from epinephrine, but that is not the case.

PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest) compared adrenaline (epinephrine) with placebo in a “randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest”.

More people survived for at least 30 days with epinephrine, which is entirely expected. There has not been any controversy about whether giving epinephrine produces pulses more often than not giving epinephrine. As with amiodarone (Nexterone and Pacerone), the question has been whether we are just filling the ICUs and nursing home beds with comatose patients.
 

There was no statistical evidence of a modification in treatment effect by such factors as the patient’s age, whether the cardiac arrest was witnessed, whether CPR was performed by a bystander, initial cardiac rhythm, or response time or time to trial-agent administration (Fig. S7 in the Supplementary Appendix). [1]

 

The secondary outcome is what everyone has been much more interested in – what are the neurological outcomes with adrenaline vs. without adrenaline?

The best outcome was no detectable neurological impairment.
 

the benefits of epinephrine that were identified in our trial are small, since they would result in 1 extra survivor for every 112 patients treated. This number is less than the minimal clinically important difference that has been defined in previous studies.29,30 Among the survivors, almost twice the number in the epinephrine group as in the placebo group had severe neurologic impairment.

Our work with patients and the public before starting the trial (as summarized in the Supplementary Appendix) identified survival with a favorable neurologic outcome to be a higher priority than survival alone. [1]

 


Click on the image to make it larger.
 

Are there some patients who will do better with epinephrine than without?

Maybe (I would have written probably, before these results), but we still do not know how to identify those patients.

Is titrating tiny amounts of epinephrine, to observe for response, reasonable? What response would we be looking for? Wat do we do if we observe that response? We have been using epinephrine for over half a century and we still don’t know when to use it, how much to use, or how to identify the patients who might benefit.

I will write more about these results later

We now have evidence that, as with amiodarone, we should only be using epinephrine as part of well controlled trials.

Also see –

How Bad is Epinephrine (Adrenaline) for Cardiac Arrest, According to the PARAMEDIC2 Study?

Footnotes:

[1] A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest.
Perkins GD, Ji C, Deakin CD, Quinn T, Nolan JP, Scomparin C, Regan S, Long J, Slowther A, Pocock H, Black JJM, Moore F, Fothergill RT, Rees N, O’Shea L, Docherty M, Gunson I, Han K, Charlton K, Finn J, Petrou S, Stallard N, Gates S, Lall R; PARAMEDIC2 Collaborators.
N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMoa1806842. [Epub ahead of print]
PMID: 30021076

Free Full Text from NEJM

All supplementary material is also available at the end of the article at the NEJM site in PDF format –

Protocol

Supplementary Appendix

Disclosure Forms

There is also an editorial, which I have not yet read, by Clifton W. Callaway, M.D., Ph.D., and Michael W. Donnino, M.D. –

Testing Epinephrine for Out-of-Hospital Cardiac Arrest.
Callaway CW, Donnino MW.
N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMe1808255. [Epub ahead of print] No abstract available.
PMID: 30021078

Free Full Text from NEJM

.

Cardiac arrest victim Trudy Jones ‘given placebo’ – rather than experimental epinephrine

 

As part of a study to find out if epinephrine (adrenaline in Commonwealth countries) is safe to use in cardiac arrest, a patient was treated with a placebo, rather than the inadequately tested drug. Some people are upset that the patient did not receive the drug they know nothing about.[1]

The critics are trying to make sure that we never learn.

We need to find out how much harm epinephrine causes, rather than make assumptions based on prejudices.

When used in cardiac arrest, does epinephrine produce a pulse more often?

Yes.

When used in cardiac arrest, does epinephrine produce a good outcome more often?

We don’t know.

In over half a century of use in cardiac arrest, we have not bothered to find out.
 


 

We did try to find out one time, but the media and politicians stopped it.[2]

We would rather harm patients with unreasonable hope, than find out how much harm we are causing to patients.

We would rather continue to be part of a huge, uncontrolled, unapproved, undeclared, undocumented, unethical experiment, than find out what works.

Have we given informed consent to that kind of experimentation?

Ignorance is bliss.

The good news is that the enrollment of patients has finished, so the media and politicians will not be able to prevent us from learning the little that we will be able to learn from this research.[3]

Will the results tell us which patients are harmed by epinephrine?

Probably not – that will require a willingness to admit the limits of what we learn and more research.

What EMS treatments have been demonstrated to improve outcomes from cardiac arrest?

1. High quality chest compressions.
2. Defibrillation, when indicated.

Nothing else.

All other treatments, when tested, have failed to be better than nothing (placebo).

Footnotes:

[1] Cardiac arrest victim Trudy Jones ‘given placebo’
BBC News
23 March 2018
Article

[2] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial
Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL.
Resuscitation. 2011 Sep;82(9):1138-43. Epub 2011 Jul 2.
PMID: 21745533 [PubMed – in process]

Free Full Text PDF Download from semanticscholar.org
 

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

 

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

 

[3] Paramedic2 – The Adrenaline Trial
Warwick Medical School
Trial Updates
 

Trial Update – 19 February 2018:
PARAMEDIC2 has finished recruitment and we are therefore no longer issuing ‘No Study’ bracelets. The data collected from the trial is in the process of being analysed and we expect to publish the results in 2018. Once the results have been published, a summary will be provided on the trial website.

 

Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 2.

.

Does the parachute study prove that research doesn’t matter? Part II

 
I have finally written Part II. Part III will be next week.

In the comments to Does the parachute study prove that research doesn’t matter? Part I is the following from Kevin –
 

The parachute study is meant to address persons who regard only level 1 evidence as evidence. It does not mean to suggest that one should proceed with zero evidence. In fact, we have great evidence that parachutes do indeed work, just not level 1 evidence (that’s why we divide them into various levels–some are better than others, but the lower levels may still be good and adequate). That is why the authors wrote the tongue in cheek article.

 

The authors of the parachute paper were using an extreme position – a straw man – for the purpose of satire. There may be some people who insist on only randomized, placebo controlled, double-blinded, studies of every treatment, but even they should know that a meta-analysis of these would be higher level evidence than what your comment seems to suggest is level 1 evidence.
 

Evidence Pyramid

Evidence Pyramid


Image credit.
 

What does Evidence-Based Medicine (EBM) actually require?

If only there were a paper to clearly and concisely state what EBM actually is and what EBM is not. It might be called, Evidence based medicine: what it is and what it isn’t.

That paper does exist. The paper is over 20 years old. The full text of the paper is available for free from PubMed Central, so there is no valid reason for anyone examining EBM to be unfamiliar with the paper.
 

Evidence based medicine is not restricted to randomised trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.[1]

 

Why the confusion?

Is it because a lot of people just do not understand science?

Science requires humility and a lot of people are just not good at putting aside their assumptions in order to find out if those prejudices are true.

The truth is more important than our egos.

It is much more important to protect patients from harmful treatments, than to protect treatments that do not provide more benefit than harm. We have to learn from our mistakes.
 

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.[1]

 

What is the objection to EBM?

The use of evidence appears to hurt the feelings of some people.

We have been harming too many patients with treatments that should never have been used outside of well-controlled trials.

We need to stop trying to make treatments look better than they are.

We need to stop coming up with rationalizations for hurting patients.
 

Continued in Part III.
 
 

I have also written about EBM and the parachute paper in these posts –

Does the parachute study prove that research doesn’t matter? Part I – Wed, 22 Aug 2012

Common Sense vs. Evidence – Thu, 28 Mar 2013

The Parachute Study as an Objection to Studying Ventilations in Cardiac Arrest – Mon, 08 Apr 2013

Do we know that these treatments do not help? – Mon, 15 Apr 2013

Why Ignoring Evidence Based Medicine Kills Patients – Fri, 28 Jun 2013

JAMA Opinion Article in Support of Anecdote-Based Medicine – Thu, 28 Nov 2013

Why US EMS will never get to sit at the adult table – The Appeal to Authority – Sun, 04 May 2014

Natural Alternatives to the EpiPen, Because We Believe in Parachutes – Wed, 23 Dec 2015

Footnotes:

[1] Evidence based medicine: what it is and what it isn’t.
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS.
BMJ. 1996 Jan 13;312(7023):71-2.
PMID: 8555924 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central.

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Is placebo better than aggressive medical treatment for patients NOT having a heart attack?

Also to be posted on ResearchBlogging.org when they relaunch the site.
 

Is cardiac catheterization placebo better than aggressive medical treatment for patients not having a heart attack?

No.
 

The answer is not really different from before. This should not be surprising for anyone who pays attention to EBM (Evidence-Based Medicine). We should all pay attention to EBM, because it is the best way to find out what works.

Many routine treatments are not beneficial to patients, but are considered to be standards of care. We continue to give these treatments out of unreasonable optimism, a fear of litigation, or fear of criticism for not following orders. The difference between the banality of evil and the banality of incompetence does not appear to be significant in any way that matters.

PCI (Percutaneous Coronary Intervention) treatment does not add any benefit – unless you are having a heart attack.

The placebo group received sham PCI in addition to optimized medical treatment. this did not provide any benefit over actual PCI in addition to optimized medical treatment. The patients in the placebo group received all of the same medications that the patients in the PCI group received.

Why is this news today?

A recent article in The Lancet is encouraging snake oil salesmen and snake oil saleswomen to claim that it shows the miracle healing power of placebos, but this is not true.

Apparently, Big Placebo (the multi-billion dollar alternative medicine industry) is trying to use this to promote their scams (homeopathy, acupuncture, Reiki, naturopathy, prayer, . . . ).

Big Placebo seems to think that this study shows that placebo is better than medical treatment. A placebo is an inactive intervention that is undetectable when compared with the active treatment. The placebo group received the same aggressive medications that the treatment group received.
 

All patients were pretreated with dual antiplatelet therapy. In both groups, the duration of dual antiplatelet therapy was the same and continued until the fial (unblinding) visit. Coronary angiography was done via a radial or femoral arterial approach with auditory isolation achieved by placing over-the-ear headphones playing music on the patient throughout the procedure.[1]

 

What is new about this?

A much larger study a decade ago showed that aggressive medical therapy was as good as PCI and aggressive medical therapy. The difference is the use of sham PCI to create a placebo group for comparison, rather than using a No PCI group for comparison.
 

CONCLUSIONS:
As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.
[2]

 

Compare that with the conclusion (interpretation) of the new paper.
 

INTERPRETATION:
In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy.
[1]

 

The unfortunate outcome is that we will have fewer hospitals providing PCI, so patients with heart attacks (STEMI – ST segment Elevation Myocardial Infarctions) may have to wait longer for emergency PCI, which really does improve outcomes.
 

What other Standards Of Care are NOT supported by valid evidence?

Amiodarone is effective for cardiac arrest, whether unwitnessed, witnessed, or witnessed by EMS.

Kayexalate (Sodium Polystyrene) is a good treatment for hyperkalemia. Anything that causes diarrhea will lower your potassium level, but that does not make it a good treatment, unless you are in an austere environment (in other words – not in a real hospital).

Amiodarone is effective for VT (Ventricular Tachycardia).

Backboards are effective to protect against spinal injury while transporting patients.

Blood-letting is effective for anything except hemochromatosis (and some rare disorders).

More paramedics are better for the patient.

Prehospital intravenous lines save lives.

IV fluid saves lives in hemorrhagic shock.

Oxygen should be given to everyone having a heart attack.

The Golden Hour is important.

Driving fast saves lives. For only some rare conditions, it probably does – and that depends on traffic.

Flying people to the hospital saves lives. Again, for only some rare conditions, it probably does – and that depends on traffic and distance.

Tourniquets are dangerous. As with anything else, if used inappropriately, they are dangerous, but tourniquets save lives.

Prehospital intubation saves lives.

Ventilation in cardiac arrest improves outcomes (other than for respiratory causes of cardiac arrest, which are easy to identify).

Epinephrine improves outcomes in cardiac arrest. It does produce a pulse more often, but at what cost to the long-term survival of the patient and the patient’s brain? PARAMEDIC2 should help us to identify which patients benefit from epinephrine, since it is clear that many patients are harmed by epinephrine in cardiac arrest. If we limit treatment to patients reasonably expected to benefit from the treatment, we can improve long-term survival.

And there are many more.

Footnotes:

[1] Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial.
Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP; ORBITA investigators.
Lancet. 2017 Nov 1. pii: S0140-6736(17)32714-9. doi: 10.1016/S0140-6736(17)32714-9. [Epub ahead of print]
PMID: 29103656

[2] Optimal medical therapy with or without PCI for stable coronary disease.
Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group.
N Engl J Med. 2007 Apr 12;356(15):1503-16. Epub 2007 Mar 26.
PMID: 17387127

Free Full Text from N Engl J Med.

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Comment on Irresponsibility and Intubation – The EMS Standard Of Care

 

I wrote about the petition to protect paramedic incompetence in Irresponsibility and Intubation – The EMS Standard Of Care

Nathan Boone responded with the following comment
 

You’re forgetting about the rural medic out there.

 

No. I am not.

Are you suggesting that bad airway management for a longer period of time is less harmful than bad airway management for a shorter period of time?
 


 

Where we are with our patients for more then a hour, not 5 mintues.

 

The harm from incompetent airway management does not depend on distance from the hospital. Intubation even kills patients in the hospital.

You may believe that the efficacy of voodoo is directly related to the distance from the hospital, but it appears to be only your belief that increases.

Voodoo does not work, regardless of the distance from the hospital.

If the paramedic cannot manage an airway, the paramedic should not be permitted to intubate.
 

Sometimes air- craft isn’t available if its raining or on another call.. You want us to use a bvm and take chance of filling the patients stomic up for over a hour.. Yes we can be extremely careful and do everything in our power not to fill the stomic but there’s some patients out there who have difficult airways where bagging can be extremely difficult and or impossible.

 

Give incompetent paramedics dangerous tools to try to manage difficult airways because of distance? Wouldn’t it be better to try to make them competent – or to limit intubation to competent paramedics?

Intubation and BVM (Bag Valve Mask) are not the only forms of ventilation.
 

Rsi does save patients in rural areas, we need intubations..

 

Maybe. Maybe not. Maybe RSI kills more patients than it saves.

Actually, what I mean to write is, Maybe paramedics using RSI kill more patients than they save.

If you want to claim otherwise, prove it with high-quality research.

Unless you can provide high-quality research, your plastic airway religion is just another alt-med scam.

If your patients are important, then you need to demand that we find out what is best for the patients.
 

Do I believe that Rsi is risky and their is some medics out there who would rather make the patient more hypoxic then before until they give up and go to a secondary airway..absolutely.. But to take it away from Rural Medics when we can have anything to burn patients to anaphylactic reactions and to take our ONLY definitive airway;away from us..

 

You seem to think that RSI (Rapid Sequence Induction of anesthesia) becomes less risky the farther you are from the hospital.

Why?

Incompetence for a longer period will be expected to cause more harm.

Sometimes the incompetence of the paramedic doesn’t kill the patient.
 

Trauma patients were significantly more likely to have misplaced ETTs than medical patients (37% versus 14%, P<.01). With one exception, all the patients found to have esophageal tube placement exhibited the absence of ETCO2 on patient arrival. In the exception, the patient was found to be breathing spontaneously despite a nasotracheal tube placed in the esophagus.[1]

 

The patient clearly did not need intubation.

As with the crash of Trooper 2 in Maryland, the survival of the patient for hours in the woods, in the rain, following the helicopter crash that killed all of the other healthy people on board, was clear evidence that there was no reason to send this patient to the trauma center by air.

The same argument was provided by people, including Dr. Thomas Scalea, the head of Shock Trauma – If you don’t let us have our toys, people will die![2]

The rate of helicopter transport of trauma patients was dramatically cut.

That was almost a decade ago and we are still waiting for the dead bodies.

I expect that the same failure of prophesy will occur, when incompetent paramedics are prevented from intubating.

I expect that the fatality rate will decrease, when incompetent paramedics are prevented from intubating.
 

I think you’re out of your mind.

 

Many religious fanatics do.
 

In the city, I can maybe defend you. But the studies need to be done out in the sticks as well. I believe that we should have to go outpatient surgery every year or 2 or have number set of how many we need in that time period successfully to keep our skills sharp..

 

Every year or two?

WTF?

You don’t want to be taken seriously, do you?

This is something that requires a lot of skill and practice, so I get just a tiny bit, every other year. Trust me with your life.
 

After a Rsi and I have no one in the back but myself for over an hour.., I can place the patient on a vent and care for my patient. If RSI is taken away. I loose the capability to monitor my patient, and would be more focused on bagging my patient, or making sure the secondary away isn’t failing and I’m filling the stomic on the vent, because it can happen.

 

It is just a staffing issue.

That is different.

Competence isn’t needed when you are in the back by yourself.

Why are you opposed to competence?

Where is a single reasonable argument that intubation improves outcomes?

Where is a single reasonable argument that rural paramedics have an intubation success rate that is above 95%?

Even 95% means that some of your patients don’t end up with a properly placed endotracheal tube. What do you think happens to them?

Does your EMS agency have a better than 95% intubation success rate?

If you can’t manage at least 95%, why do you believe you can manage intubation?

Is each intubation on video, or do they just believe whatever you tell them?

If you want to be taken seriously, these are just some of the essential points to address.
 

This is not a new topic. You might also read the series below:

In Defense of Intubation Incompetence – Part I

In Defense of Intubation Incompetence – Part II

In Defense of Intubation Incompetence – Part III

How Accurate are We at Rapid Sequence Intubation for Pediatric Emergency Patients – Part I

How Accurate are We at Rapid Sequence Intubation for Pediatric Emergency Patients – Part II

Footnotes:

[1] Misplaced endotracheal tubes by paramedics in an urban emergency medical services system.
Katz SH, Falk JL.
Ann Emerg Med. 2001 Jan;37(1):32-7.
PMID: 11145768 [PubMed – indexed for MEDLINE]

Free Full Text PDF

[2] Helicopters and Bad Science
Thu, 09 Oct 2008
Rogue Medic
Article

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