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

- Rogue Medic

The Grinch Who Stole Reality

Fri, 28 Dec 2018 13:00:46 -0500 by
 

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.

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Footnotes:

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[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

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[2] Bayesian inference
Wikipedia
Article

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[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

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[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.

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Filed Under: 'Alternative' Medicine, ACLS, Cardiac Arrest, Critical Judgment, EBM, Epinephrine, Ethics, Evidence, Heresy, Pharmacology, Research, Science

Vaccines are probably the safest and most effective medical intervention available, so why do anti-vaxers lie about them

Sun, 16 Dec 2018 11:50:47 -0500 by
 

Why does anyone lie?

Anti-vaxers lie for the same reason as other people – for personal benefit.

Many anti-vaxers claim that there is an international conspiracy of doctors and researchers, as if all of the doctors and researchers, or even the pediatric doctors and researchers, in the world could agree on much of anything. When you realize how ridiculously large this conspiracy would be, how much a doctor or researcher would gain from providing valid information to expose such a conspiracy, and how aggressively law enforcement would punish those behind such a conspiracy, you understand the use of ridiculous is appropriate as a description of the conspiracy theory.

This is just another example of some people thinking they know more than everyone else, based on a lack of understanding. This feeds the over-inflated egos of anti-vaxers.

The smallpox vaccine has saved hundreds of millions of lives. Anti-vaxers opposed the smallpox vaccine and delayed the eradication of smallpox. Anti-vaxers helped smallpox kill people..

Our children are no longer vaccinated against smallpox, because smallpox has been wiped out by vaccines. Millions of children’s lives, and adult lives, are saved every year by the smallpox vaccine, without even giving it to children, because enough people rejected the lies of anti-vaxers.

Vaccines continue to save millions of lives every year, in spite of opposition by anti-vaxers.

There is plenty of research showing that vaccines are effective and safe, but to give the single clearest example of the benefit of vaccines, look at the following paper from JAMA. The Journal of the American Medical Association is one of the most respected medical publications in the world. Use any search engine to find a list of the most respected medical journals and you will find JAMA near the top.

Look at the decrease in the rates of illness and the rates of death for each vaccine-preventable illness after the introduction of the vaccine for that illness. Click on the image for a larger, easier to read version.
 


 

Table 1. Historical Comparison of Morbidity and Mortality for Vaccine-Preventable Diseases With Vaccines Licensed or Recommended Before 1980: Diphtheria, Measles, Mumps, Pertussis, Poliomyelitis, Rubella, Smallpox, Tetanusa [1]

 

This information has been simplified for those not comfortable with scientific research (I do not know the source of the image, it was not part of the paper in JAMA):
 


 

As you can see, these diseases are almost never a problem in America, where vaccination rates are still pretty high, although anti-vaxers are causing more and more outbreaks of diseases we had not seen in decades.

Some anti-vaxers will claim that the vaccines didn’t get rid of these diseases. These anti-vaxers claim that improved sanitation, improved hygiene, and improved diet got rid of these diseases. While these improvements are helpful, here is why that is just another anti-vax lie.

We have outbreaks of vaccine-preventable illnesses in America, when the rate of vaccination drops, even though sanitation, hygiene, and diet did not deteriorate. Yes, many of our diets are getting worse, but that is not what is causing outbreaks of whooping cough, measles, and other vaccine-preventable illnesses.

The rates of illness and death only have a dramatic change for each of the vaccine-preventable illnesses after the introduction of each vaccine. If sanitation, hygiene, and diet were the reasons, the illnesses would all start to go away at the same time, although not necessarily at the same rate. If that were the case, the decreases in these diseases could easily be shown to be due to improvements in sanitation, hygiene, and diet, but that is not the case.

Anti-vaxers cannot explain that, but anti-vaxers are not reasonable.
 

Why has the polio vaccine been so effective in India, when India has widespread problems with sanitation, hygiene, and diet?

Here is what the authors wrote:
 

India, a vastly diverse country with a 27 million birth cohort, undertook the largest vaccination drive against WPV (Wild Polio Virus) in the world. With high population density, poor civic infrastructure, poor sanitation, an almost nonexistent public health system, rampant malnutrition and diarrhea, difficult-to-reach locales, high population mobility, and extremely high force of WPV transmission in few states,3 the interruption of WPV transmission was extremely difficult and demanding. The interplay of these challenging factors provided a perfect milieu for the WPV to circulate, and the prospect of achieving zero-polio status seemed insurmountable.[2]

 

India completed a full 5 years as a “polio-free nation” on January 13, 2016.1 It was a remarkable feat considering the odds against achieving this status. [2]

Anti-vaxers will make excuses, but this clearly exposes the anti-vax lie that disease elimination being due to improved sanitation, hygiene, and diet, rather than due to vaccines.
 

The reason smallpox vaccine is no longer given to children, is the worldwide eradication of smallpox by vaccination.

Anti-vaers delayed the worldwide eradication of smallpox.

Anti-vaxers have prevented the worldwide eradication of polio.

Anti-vaxers continue to try to protect polio from eradication.

Children would no longer need polio vaccination, if it weren’t for anti-vaxers.

If you don’t like giving the polio vaccine to your child, blame the anti-vaxers.

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Footnotes:

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[1] Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States.
Roush SW, Murphy TV; Vaccine-Preventable Disease Table Working Group.
JAMA. 2007 Nov 14;298(18):2155-63.
PMID: 18000199

You can also read the full text of the article for free at JAMA at the link below, if you want to understand more of the details that the anti-vaxers don’t want you to understand.

Historical Comparisons of Morbidity and Mortality for Vaccine-Preventable Diseases in the United States

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[2] Polio Eradication in India: The Lessons Learned.
Thacker N, Vashishtha VM, Thacker D.
Pediatrics. 2016 Oct;138(4). pii: e20160461. Epub 2016 Sep 2. Review. No abstract available.
PMID: 27590898

You can also read the full text of the article for free at Pediatrics at the link below, if you want to understand more of the details that the anti-vaxers don’t want you to understand. Pediatrics is one of the most respected pediatric medical publications in the world. Use any search engine to find what pediatric medical journals are the most respected and you will find Pediatrics near the top.

Polio Eradication in India: The Lessons Learned

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Filed Under: Anti-Science, Critical Judgment, Ethics, Heresy, Research Blogging, Vaccines

Are We Killing Patients With Parochialism?

Tue, 02 Oct 2018 15:00:29 -0400 by
 
The variation in approaches to resuscitation in EMS is tremendous.

Many excuses center around the need for local people to be able to claim that they know something that the evidence does not show, although they consistently fail to provide valid evidence for these claims. This local knowledge appears to be intuitive – they just know it, but cannot provide anything to support their feelings.

The latest research can be interpreted in many different ways, but it definitely does not support the claims of the advocates of parochialism.
 

Results We identified 43 656 patients with OHCA treated by 112 EMS agencies. At EMS agency level, we observed large variations in survival to hospital discharge (range, 0%-28.9%; unadjusted MOR, 1.43 [95% CI, 1.34-1.54]), return of spontaneous circulation on emergency department arrival (range, 9.0%-57.1%; unadjusted MOR, 1.53 [95% CI, 1.43-1.65]), and favorable functional outcome (range, 0%-20.4%; unadjusted MOR, 1.54 [95% CI, 1.40-1.73]).[1]

 

MOR = Median Odds Ratio – how many times more likely is something to happen.

What is most commonly measured is what matters the least – ROSC (Return Of Spontaneous Circulation). Did we get a pulse back, for even the briefest period of time, regardless of outcomes that matter.

What matters? Does the person wake up and have the ability to function as they did before the cardiac arrest.

Those who justify focusing on ROSC claim that, If we don’t get a pulse back, nothing else matters, but that is the kind of excuse used by frauds. How we get a pulse back does matter. The evidence makes that conclusion irrefutable, but there will always be those who do not accept that they are causing harm. They will make excuses for the harm they are causing. Getting ROSC helps them to feel that they are not causing harm. ROSC encourages us to give drugs like epinephrine, which have been demonstrated to not improve any survival that matters.

The means of obtaining ROSC can be compared to the means of doing anything that requires finesse. Sure, it feels good to try to force something. Sure, you can claim that forcing something is the most direct way to accomplish the goal.

Can the advocates of focusing on ROSC produce any valid evidence that their approach leads to improvements in outcomes that matter? No. The evidence contradicts their claims. The evidence has caused us to eliminate many of their treatments – treatments they claimed had to work because of physiology. As it turns out, they were wrong. They were wrong about their treatments and wrong about their understanding of physiology.

If you want to win money, bet that any new treatment will not improve outcomes that matter.
 

This variation persisted despite adjustment for patient-level and EMS agency–level factors known to be associated with outcomes (adjusted MOR for survival 1.56 [95% CI 1.44-1.73]; adjusted MOR for return of spontaneous circulation at emergency department arrival, 1.50 [95% CI, 1.41-1.62]; adjusted MOR for functionally favorable survival, 1.53 [95% CI, 1.37-1.78]).[1]

 

Is presence of a pulse upon arrival at the emergency department an important outcome? Only for billing purposes. The presence of a pulse justifies providing more, and more expensive, treatments. Is the presence of a pulse upon arrival at the emergency department a goal worth trying for? As with ROSC, only if it does not cause us to harm patients to obtain this goal, which is just something that is documented, because it is a point of transfer of patient care.
 

After restricting analysis to those who survived more than 60 minutes after hospital arrival and including hospital treatment characteristics, the variation persisted (adjusted MOR for survival, 1.49 [95% CI, 1.36-1.69]; adjusted MOR for functionally favorable survival, 1.34 [95% CI, 1.20-1.59]).[1]

 

There is a lot of variability.

What did they find?
 


 

Most of the people in EMS, who claim to be doing what is best for their patients, are making things worse.
 

69% means that there are two EMS agencies producing bad outcomes for every EMS agency producing good outcomes.

Correction – The text crossed out is not accurate. I should have thought that through a bit better before I posted it. My caption for Table 1 is accurate. However, what I should have written afterward is –

The worse half of EMS agencies are only producing half as many good outcomes as the better half of EMS agencies.

We are bad at resuscitation and those doing the most resuscitating are doing the least good.

Why do so many of us refuse to improve our standards?

What is more important than the outcomes for our patients?
 

Why are we so overwhelmingly bad at resuscitation?
 

What are the authors’ conclusions?
 

This study has implications for improvement of OHCA management. First, the analysis indicates that the highest-performing EMS agencies had more layperson interventions and more EMS personnel on scene.[1]

 

They do not conclude that we need more doctors, more nurses, or more paramedics responding to cardiac arrest.
 

Second, our findings justify further efforts to identify potentially modifiable factors that may explain this residual variation in outcomes and could be targets of public health interventions.[1]

 

We need to figure out what we are doing, because the people telling us that they know that we need intubation are lying.

We need to figure out what we are doing, because the people telling us that they know that we need epinephrine are lying.

We need to figure out what we are doing, because the people telling us that they know that we need amiodarone are lying.

We need to figure out what we are doing, because the people telling us that they know that we need ________ are lying.

How dare I call them liars?

Let them produce valid evidence that the interventions they claim are necessary actually do improve outcomes that matter.

Have them stop making excuses and start producing results.

I dare them.

The only time we have made significant improvements in outcomes have been when we emphasized chest compressions, especially bystander chest compressions, and when we emphasized bystander defibrillation.

It is time to start requiring evidence of benefit for everything we do to patients.

Our patients are too important to be subjected to witchcraft, based on opinions and an absence of research.

There is plenty of valid evidence that using only chest compressions improves outcomes.
 

Cardiocerebral resuscitation improves survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Ewy GA.
Am J Med. 2006 Apr;119(4):335-40.
PMID: 16564776 [PubMed – indexed for MEDLINE]

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Cardiocerebral resuscitation improves neurologically intact survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Barney R, Keilhauer FA, Bellino M, Zuercher M, Ewy GA.
Ann Emerg Med. 2008 Sep;52(3):244-52. Epub 2008 Mar 28.
PMID: 18374452 [PubMed – indexed for MEDLINE]

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Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest.
Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB.
JAMA. 2008 Mar 12;299(10):1158-65.
PMID: 18334691 [PubMed – indexed for MEDLINE]

Free Full Text at JAMA

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Passive oxygen insufflation is superior to bag-valve-mask ventilation for witnessed ventricular fibrillation out-of-hospital cardiac arrest.
Bobrow BJ, Ewy GA, Clark L, Chikani V, Berg RA, Sanders AB, Vadeboncoeur TF, Hilwig RW, Kern KB.
Ann Emerg Med. 2009 Nov;54(5):656-662.e1. Epub 2009 Aug 6.
PMID: 19660833 [PubMed – indexed for MEDLINE]

And more.

 

It is not ethical to insist on giving treatments to patients in the absence of valid evidence of benefit to the patient. We need to begin to improve our ethics.
 

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

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Footnotes:

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[1] Variation in Survival After Out-of-Hospital Cardiac Arrest Between Emergency Medical Services Agencies.
Okubo M, Schmicker RH, Wallace DJ, Idris AH, Nichol G, Austin MA, Grunau B, Wittwer LK, Richmond N, Morrison LJ, Kurz MC, Cheskes S, Kudenchuk PJ, Zive DM, Aufderheide TP, Wang HE, Herren H, Vaillancourt C, Davis DP, Vilke GM, Scheuermeyer FX, Weisfeldt ML, Elmer J, Colella R, Callaway CW; Resuscitation Outcomes Consortium Investigators.
JAMA Cardiol. 2018 Sep 26. doi: 10.1001/jamacardio.2018.3037. [Epub ahead of print]
PMID: 30267053

Free Full Text from JAMA Cardiology

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Filed Under: ACLS, Correction, Critical Judgment, Ethics, Heresy, Mythology, Research Blogging

Why are we still intubating, when there is no evidence of benefit and we refuse to practice this “skill”?

Tue, 28 Aug 2018 16:05:09 -0400 by
 
Also to be posted on ResearchBlogging.org when they relaunch the site.

The results are in from two studies comparing intubation with laryngeal airways. There continues to be no good reason to intubate cardiac arrest patients. There is no apparent benefit and the focus on this rarely used, and almost never practiced, procedure seems to be more for the feelings of the people providing treatment, than for the patients.
 

Patients with a short duration of cardiac arrest and who receive bystander resuscitation, defibrillation, or both, are considerably more likely to survive and are also less likely to require advanced airway management.22 This problem of confounding by indication is an important limitation of many large observational studies that show an association between advanced airway management and poor outcome in out-of-hospital cardiac arrest.23 This study found that 21.1% (360/1704) of patients who did not receive advanced airway management achieved a good outcome compared with 3.3% (251/7576) of patients who received advanced airway management.[1]

 

In other words, we are the least skilled, are the least experienced, and we have the least amount of practice, but we are attempting to perform a difficult airway skill under the least favorable conditions. Ironically, we claim to be doing what is best for the patient. We are corrupt, incompetent, or both.

We also do not have good evidence that any kind of active ventilation is indicated for cardiac arrest, unless the cardiac arrest is due to respiratory conditions. Passive ventilation, which is the result of high quality chest compressions, appears to produce better outcomes (several studies are listed at the end).

We need to stop considering our harmful interventions to be the standard and withholding harmful treatments to be the intervention. We are using interventions that have well known and serious adverse effects. This attempt to defend the status quo, at the expense of honesty, has not been beneficial to patients.
 

The ETI success rate of 51% observed in this trial is lower than the 90% success rate reported in a meta-analysis.29 The reasons for this discordance are unclear. Prior reports of higher success rates may be susceptible to publication bias.[2]

 

Is that intubation success rate lower than you claim for your organization? Prove it.
 

Another possibility is that some medical directors encourage early rescue SGA use to avoid multiple unsuccessful intubation attempts and to minimize chest compression interruptions.5 Few of the study EMS agencies had protocols limiting the number of allowed intubation attempts, so the ETI success rate was not the result of practice constraints.[2]

 

Is there any reason to interrupt chest compressions, which do improve outcomes that matter, to make it easier to intubate, which does not improve any outcomes that matter? No.
 

While the ETI proficiency of study clinicians might be questioned, the trial included a diverse range of EMS agencies and likely reflects current practice.[2]

 

This is the state of the art of intubation in the real world of American EMS. Making excuses shows that we are corrupt, incompetent, or both.
 


I no longer have the link, but I think that this image came from Rescue Digest a decade ago.
 

These results contrast with prior studies of OHCA airway management. Observational studies have reported higher survival with ETI than SGA, but they were nonrandomized, included a range of SGA types, and did not adjust for the timing of the airway intervention.9,10,31-34 [2]

 

We should start doing what is best for our patients.

We should not continue to defend resuscitation theater – putting on a harmful show to make ourselves feel good.

What would a competent anesthesiologist use in the prehospital setting? Something that offers a benefit to the patient.

There is also an editorial analyzing these two studies.[3]

It is time to start requiring evidence of benefit for everything we do to patients.

Our patients are too important to be subjected to witchcraft, based on opinions and an absence of research.

There is plenty of valid evidence that using only chest compressions improves outcomes.
 

Cardiocerebral resuscitation improves survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Ewy GA.
Am J Med. 2006 Apr;119(4):335-40.
PMID: 16564776 [PubMed – indexed for MEDLINE]

–

Cardiocerebral resuscitation improves neurologically intact survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Barney R, Keilhauer FA, Bellino M, Zuercher M, Ewy GA.
Ann Emerg Med. 2008 Sep;52(3):244-52. Epub 2008 Mar 28.
PMID: 18374452 [PubMed – indexed for MEDLINE]

–

Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest.
Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB.
JAMA. 2008 Mar 12;299(10):1158-65.
PMID: 18334691 [PubMed – indexed for MEDLINE]

Free Full Text at JAMA

–

Passive oxygen insufflation is superior to bag-valve-mask ventilation for witnessed ventricular fibrillation out-of-hospital cardiac arrest.
Bobrow BJ, Ewy GA, Clark L, Chikani V, Berg RA, Sanders AB, Vadeboncoeur TF, Hilwig RW, Kern KB.
Ann Emerg Med. 2009 Nov;54(5):656-662.e1. Epub 2009 Aug 6.
PMID: 19660833 [PubMed – indexed for MEDLINE]

And more.

 

It is not ethical to insist on giving treatments to patients in the absence of valid evidence of benefit to the patient. We need to begin to improve our ethics.

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Also read/listen to these articles/podcasts released after I published this (I do not know the date of the Resus Room podcast) –

The Great Prehospital Airway Debate
August 31, 2018
Emergency Medicine Literature of Note
by Ryan Radecki
Article
 

EM Nerd-The Case of the Needless Imperative
August 31, 2018
EMNerd (EMCrit)
by Rory Spiegel
Article
 

Intubation or supraglottic airway in cardiac arrest; AIRWAYS-2
The Resus Room
Podcast with Simon Laing, Rob Fenwick, and James Yates with guest Professor Jonathan Benger, lead author of AIRWAYS-2.
Podcast, images, and notes
 

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Footnotes:

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[1] Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome: The AIRWAYS-2 Randomized Clinical Trial
Jonathan R. Benger, MD1; Kim Kirby, MRes1,2; Sarah Black, DClinRes2; et al Stephen J. Brett, MD3; Madeleine Clout, BSc4; Michelle J. Lazaroo, MSc4; Jerry P. Nolan, MBChB5,6; Barnaby C. Reeves, DPhil4; Maria Robinson, MOst2; Lauren J. Scott, MSc4,7; Helena Smartt, PhD4; Adrian South, BSc (Hons)2; Elizabeth A. Stokes, DPhil8; Jodi Taylor, PhD4,5; Matthew Thomas, MBChB9; Sarah Voss, PhD1; Sarah Wordsworth, PhD8; Chris A. Rogers, PhD4
August 28, 2018
JAMA. 2018;320(8):779-791.
doi:10.1001/jama.2018.11597

Abstract from JAMA.

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[2] Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial
Henry E. Wang, MD, MS1,2; Robert H. Schmicker, MS3; Mohamud R. Daya, MD, MS4; et al Shannon W. Stephens, EMT-P2; Ahamed H. Idris, MD5; Jestin N. Carlson, MD, MS6,7; M. Riccardo Colella, DO, MPH8; Heather Herren, MPH, RN3; Matthew Hansen, MD, MCR4; Neal J. Richmond, MD9,10; Juan Carlos J. Puyana, BA7; Tom P. Aufderheide, MD, MS8; Randal E. Gray, MEd, NREMT-P2; Pamela C. Gray, NREMT-P2; Mike Verkest, AAS, EMT-P11; Pamela C. Owens5; Ashley M. Brienza, BS7; Kenneth J. Sternig, MS-EHS, BSN, NRP12; Susanne J. May, PhD3; George R. Sopko, MD, MPH13; Myron L. Weisfeldt, MD14; Graham Nichol, MD, MPH15
August 28, 2018
JAMA. 2018;320(8):769-778.
doi:10.1001/jama.2018.7044

Free Full Text from JAMA.

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[3] Pragmatic Airway Management in Out-of-Hospital Cardiac Arrest
Lars W. Andersen, MD, MPH, PhD1; Asger Granfeldt, MD, PhD, DMSc2
August 28, 2018
JAMA. 2018;320(8):761-763. doi:10.1001/jama.2018.10824

Abstract from JAMA.

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Filed Under: ACLS, Airway Management, Cardiac Arrest, Common Sense, Critical Judgment, Ethics, Heresy, Intubation, Research Blogging, Resuscitation Theater

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

Thu, 19 Jul 2018 14:40:46 -0400 by
 
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

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Filed Under: 2018 ACLS Guidelines, ACLS, Common Sense, Critical Judgment, Drug Shortages, Epinephrine, Ethics, Evidence, Heresy, Intubation, Lasix, Mythology, Narrative Fallacy, Oxygen, Pharmacology, Placebo, Potentially Reversible Causes, Probability, Research, Research Blogging, Resuscitation Theater, tPA

Anti-Vax Doctors Lack Competence and Ethics

Sat, 30 Jun 2018 18:40:47 -0400 by
 
 

Effective July 27, 2018, the latest anti-vax doctor to have his license revoked will be Dr. Bob Sears. Yes, he promotes his image as Dr. Bob.

Who are the dangerous doctors Bob Sears will be joining?

Andrew Wakefield‘s fraudulent research, unnecessarily painful research on children, lack of ethical approval for research, and other corruption, convinced the British General Medical Council to revoke his license. Wakefield was also trying to sell a vaccine of his own, to compete with the MMR (polyvalent Measles, Mumps and Rubella) vaccine. Wakefield’s attempts to discredit the MMR vaccine would have helped him to sell his own competing vaccine.
 

the lawyers responsible for the MMR lawsuit had paid Wakefield personally more than £400,000, which he had not previously disclosed.[67] [1]

 

Andrew Wakefield claims that he is not a fraud and sues a lot of people.

All of the cases have been thrown out by the courts or have been withdrawn by Wakefield.[2]

Do those who claim to be trying to protect their children, by avoiding vaccines, based on a trust of this fraudulent doctor, know what Wakefield has done?

–

The kiddie castrators – David Geier and Mark Geier.

David Geier was never a doctor, but has been caught faking it.[3] In the make believe world of anti-vaxers, why let reality get in the way of pretending to have credibility?

Mark Geier was a doctor, but had his license revoked in every state where he had a license (Maryland, Washington, Virginia, California, Missouri, Illinois, and Hawaii). Why do the Geiers castrate children? Chemical castration is an approved treatment for some rare conditions. Mastectomy is an approved treatment for some breast cancers, but that does not mean that it is at all ethical, or competent, to recommend mastectomy as treatment for other medical conditions. The Geiers claim to believe that castration cures autism. There is no valid evidence to support their hunch.

Consider this. You have an autistic child and someone tells you there is a cure. The person says that they know their expensive chemicals work. The person may even say, I’ve seen it work.[4] All you have to do is give permission for this doctor (before his license was revoked), and his son the fake doctor, to use chemicals to castrate your child.

Do you ask for evidence?

Their is no valid evidence. You just have to trust the castrators and their excuses for the absence of evidence.

The “evidence” has been retracted, because the research is junk science. All human research has to be approved by an independent IRB (Institutional Review Board) to make sure that there are not any conflicts of interest or unnecessary risks to the children participating in the research. The members of the independent IRB were the Geiers, the Geier’s employees, and the Geier’s lawyer. That is not independent.

If chemical castration doesn’t work, the Geiers can sell you other expensive and dangerous treatments that do not work, such as chelation. Chelation is the use of chemicals to remove heavy metals from the body, based on the assumption that mercury causes autism. Chelation is harmful, so it is only indicated, when there is a good reason to believe the benefit will be greater than the harm. There is no valid evidence to support this hunch of the Geiers.

The motto of the company run by the Geiers is First do no harm. Are they completely unaware of the harm they cause, or so dishonest that they tell the boldest lies? Does it matter why they harm children?

–

What did Bob Sears do to get his license revoked? He claimed to assess patients, but did not keep records of what he claimed to do. His incompetence/negligence endangered patients.[5] ,[6]

For example, a mother frequently brought J.G., a 2 year old, to see Dr. Bob. One visit was for a head ache a couple of weeks after the child’s father hit the child on the head with a hammer. The only apparent concern of the mother and Dr. Bob was to prevent the child from receiving vaccines. There is no record of any neurological assessment, or referral to a competent doctor for a neurological assessment.

J.G. had visited Dr. Bob the previous month for constipation. Assessment and treatment plans were documented. Constipation can be very serious, but so can hitting a child on the head with a hammer. The reason for the difference in approaches was determined to be gross negligence. Another visit, following apparent resolution of otitis media following treatment with Omnicef (cefdinir), there was a diagnosis of a sudden onset of flu, with a prescription for Tamiflu (oseltamivir), so there is no apparent hesitation to use ineffective, or minimally effective, treatments. Is J.G.’s last name Munchausen, or is he just unlucky in his choice of parents?

Bob Sears does not appear to be hesitant to prescribe drugs based on hunches, but he does appear to recognize that being anti-vax can be very profitable. Sears has written 4 books, but still fails to document assessments.

Bob Sears will have to be monitored by another physician for 35 months, following this revocation, to be able to get his license reinstated. He must follow all laws, not be negligent, and not deviate from the standard of medical care. He cannot just take the 3 years off and write books, because he has to be monitored while working to get his license back.

It looks like Bob Sears will be vaccinating children, just as real doctors do.

–

Vaccines save millions of lives every year.

Vaccines are probably the safest and most effective medical intervention we have, and anti-vaxers hate that.

If some of us do not see the need for vaccines, it is because of the success of vaccines. Vaccines are an important part of the reason that the average life expectancy has doubled in a little over 100 years.

For a great review of the effect of vaccines on vaccine-preventable illnesses, there is a study in JAMA (Journal of the American Medical Association), which shows how the rate of each illness, and deaths from each illness, declined after the introduction of each vaccine. There are anti-vaxers who claim that it wasn’t the vaccines, but sanitation that stopped these illnesses. Don’t fall for that.[7]

Sanitation is important at preventing the spread of illnesses, but sanitation does not wait for each different vaccine to be introduced for each different vaccine-preventable illness to change the illness and fatality rates.

Look at the evidence.

Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States.
Roush SW, Murphy TV; Vaccine-Preventable Disease Table Working Group.
JAMA. 2007 Nov 14;298(18):2155-63.
PMID: 18000199

Free Full Text Article from JAMA.

–

Footnotes:

–

[1] Aftermath of initial controversy
Andrew Wakefield
Wikipedia
Article

The referenced article by Brian Deer is:

Huge sums paid to Andrew Wakefield
The Sunday Times
December 31 2006
Brian Deer
Article

Andrew Wakefield has repeatedly sued Brian Deer and lost or run away every time.

–

[2] Deer counter-response
Andrew Wakefield
Wikipedia
Article

–

[3] Medical licenses revoked
Mark Geier
Wikipedia
Article
 

In 2011, his son David Geier was charged by the Maryland State Board of Physicians with practicing as if a licensed physician when he only has a Bachelor of Arts degree in biology,[42] and was fined $10,000 in July 2012.[40]

 

Charges by the Maryland Medical Board
In the Matter of David A. Geier before the Maryland State Board of Physicians
Practicing without a license
PDF document of charges
 

The Respondent is not and never has been licensed to practice medicine or any other health profession in the State of Maryland or any other State.

 

–

[4] I’ve Seen It Work and Other Lies
Tue, 21 Jun 2011
Rogue Medic
Article

–

[5] Antivaccine pediatrician Dr. Bob Sears finally faces discipline from the Medical Board of California
Respectful Insolence
Orac
June 29, 2018
Article

–

[6] Stipulated Settlement and Disciplinary Order
Decision of the Medical Board of California
Department of Consumer Affairs
State of California
Case No. 800-2015-012268
OAH No. 2017100889
PDF of Decision

–

[7] “Vaccines didn’t save us” (a.k.a. “vaccines don’t work”): Intellectual dishonesty at its most naked
Science-Based Medicine
David Gorski
March 29, 2010
Article

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Filed Under: 'Alternative' Medicine, Anti-Science, Corruption, Critical Judgment, Denialism, Ethics, Fraud, Heresy, Malpractice, Vaccines

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

Mon, 26 Mar 2018 08:20:13 -0400 by
 

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.

 

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

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Filed Under: 'Alternative' Medicine, ACLS, Cardiac Arrest, Cardiology, Correction, CPR, Critical Judgment, Ethics, Evidence, Journalism, Pharmacology, Placebo, Research, Risk Management, Science

Happy Darwin Day 2018

Mon, 12 Feb 2018 20:05:40 -0500 by
 
Why do some people reject science? Evolution is just one aspect of science that some people claim, almost always without any scientific experience, is not real. The rest of the scientific community generally ignores these fringe dwellers, but politicians and the media love them.

The science deniers claim that scientists are arrogant, but science requires scientists to be transparent in their methods. Science requires scientists to invite criticism.

If you think that you can provide valid evidence to show that a scientific theory is wrong, you can expect to become rich and famous. Go ahead. Show the world that you know more than those arrogant scientists. I am sure that you will straighten those scientists out.
 


 

Science deniers are almost never open to criticism. Some even call for attacks on their critics. Mike Adams is one of the recent examples of these, but someone will probably do something more extreme before the decade is out.[1]

Flat Earthers, Creationists, anti-vaxers, climate change deniers, medicine deniers (alternative medicine quacks), anti-GMO activists, et cetera. They all lack credibility among scientists, because they all lack valid evidence. The same is true of Holocaust deniers, 9/11 Truthers, and others promoting revision of history without any valid evidence.

The most famous example of a victim of science deniers is probably Galileo, who was threatened with torture by the Inquisition (known as the Congregation for the Doctrine of the Faith since 1983), in order to coerce a recantation from Galileo for teaching the heretical idea of Nicolaus Copernicus that the Earth revolves around the Sun (helicentrism).
 

The proposition that the Sun is the center of the world and does not move from its place is absurd and false philosophically and formally heretical, because it is expressly contrary to Holy Scripture.[2]

 

In 1615, Galileo had been ordered to give up the said doctrine and not to teach it to others, not to defend it, nor even to discuss it;[2]

Don’t even discuss your ideas.

This time he was sentenced to house arrest for the rest of his life. His books, and other books on heliocentrism were prohibited by the Inquisition.

Ironically, many of the science deniers claim to be modern versions of Galileo, persecuted for their ideas. The reality is that they are ignored, because they do not produce valid evidence. Galileo was far from perfect, but he did produce valid evidence. Some of the evidence was misinterpreted by Galileo, but removing that evidence did not invalidate heliocentrism.

The scientific community does not prevent science deniers from publishing valid evidence.

The research presented by the science deniers has to meet the same standards as the rest of the research published in science journals.

The problem with the science deniers is that their research either does not meet the standards of publication in a science journal, does not contradict the existing research, or both.

What scientific evidence is there that Creationism is true?

Nothing.

The promotion of a claim as scientific, without any scientific evidence, is an excellent example of arrogance.

What scientific evidence is there that evolution is true?

Some people claim that evolution is anti-Christian, but this is not true. Most Christians accept that evolution is real. This is from BioLogos, a Christian science organization.

What does the fossil record show? [3]

The Smithsonian also has a lot of information specifically about human evolution.

Human Evolution Research [4]

DNA (DeoxyriboNucleic Acid) demonstrates how closely related any two living creatures are. You can see that we are related to other apes, as well as bananas and bacteria. Wikipedia’s primary rule for entries is that the information has to be supported by verifiable evidence. Here is the Wikipedia page on genetics, the science of examining DNA –

Genetics – Wikipedia [5]

Science is objective and has rules to eliminate, as much as possible, the role of prejudice.

As if that is not enough, science also takes all of its results and challenges people to find any flaws in the work.

Is there a problem with the way the evidence was obtained?

Is there a problem with the way the data were calculated?

Are there other valid interpretations that have not been considered (interpretations that are not ruled out by the evidence)?

DNA had not even been discovered at the time Darwin published On the Origin of Species.

DNA is probably most objective tool available for showing that all life on Earth has evolved from the same original species.

–

Footnotes:

–

[1] Mike Adams, Monsanto, Nazis, and a Very Disturbing Article
Discover Magazine
By Keith Kloor
July 22, 2014 5:05 pm
Article

–

[2] Papal Condemnation (Sentence) of Galileo
June 22, 1633
Trial of Galileo (1633)
Famous Trials
Professor Douglas O. Linder
Translation of Papal Condemnation

But whereas it was desired at that time to deal leniently with you, it was decreed at the Holy Congregation held before His Holiness on the twenty-fifth of February, 1616, that his Eminence the Lord Cardinal Bellarmine should order you to abandon altogether the said false doctrine and, in the event of your refusal, that an injunction should be imposed upon you by the Commissary of the Holy Office to give up the said doctrine and not to teach it to others, not to defend it, nor even to discuss it; and your failing your acquiescence in this injunction, that you should be imprisoned.

–

[3] What does the fossil record show?
BioLogos
Article

–

[4] Human Evolution Research
Smithsonian
Human Origins
Web page

–

[5] Genetics
Wikipedia
Web page

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Filed Under: Creationism, Critical Judgment, Ethics, Evidence, Heresy, Science
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