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

- Rogue Medic

Prehospital cooling to improve successful targeted temperature management after cardiac arrest: A randomized controlled trial

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

This is a nice study, which unfortunately ran into problems with enrollment and funding. There are some things that I think should have been done differently.

The doses of chilled IV (IntraVenous) fluid were not weight-based, while the fluid in the human body is weight-based. If midazolam (Versed) was given, the dose was just a single dose of 5 mg, or 2 doses of 5 mg each. The effects of midazolam are much less weight-based, than fluid, but the appropriate way to administer midazolam is to titrate to effect. Even if administering 10 mg of midazolam produces the desired effect in 80%, or 90%, of patients, that can still leave a significant portion inadequately sedated. The goal of TTM (Targeted Temperature Management) may be defeated by the movement of an even mildly agitated patient.

Would another drug, such as ketamine, be more appropriate? How much does use of midazolam affect the use of pressors to counter the vasodilatory effects of midazolam? Unlike other sedatives, ketamine does not seem to produce vasodilation and/or depress cardiac activity. The midazolam was only mentioned in the description of the study interventions and only described as being given to prevent shivering, so the dose may be adequate, but there is only the one mention in the entire paper.

The fluid administration was shown to be different with a p value of <0.0001. The difference is only 170 ml (5 3/4 oz), so it is a distinction described as significant by p value, but it does not appear to be a significant difference in any way that would affect patients. The SD (Standard Deviation - how much variability exists in about 2/3 of patients) is the same as the amount of fluid given to the control group and 2 3/4 times the amount of the difference. In other words, there was a lot of overlap in the volumes administered to the patients in the two groups. While the p value of <0.0001 suggests confidence in the results being due to change only one time in 10,000, that is misleading.  

Total fluid infused was not documented for 98 (35%) patients who received Prehospital Cooling and 121 (40%) control patients.[1]

 


 

The raw data on the volumes is not included, nor is the shape of the graph of distribution of the volumes, but it looks as if 20%, or 30%, of the control group may have received more fluid that the intervention group – and then there are the more than 35% of patients without documentation of fluid volumes.

Since the amount of difference is small, it does not seem to matter, but the intervention group was forcing the chilled fluid into the patients with pressure bags, so why so little difference between the groups?

How long does it take to administer 170 ml of chilled IV fluid by pressure infusion? Does it take longer than it takes to get from the ambulance to the hospital stretcher?

That is just a statistical oddity that is not going to affect outcomes.

The next may be the true the significant finding of the study.
 

Patients in the prehospital cooling group were more likely to (ever) receive TTM in hospital [190 (68%) vs 170 (56%); RR 1.21, p = 0.003] than patients in the control group.[1]

 


 

TTM (Targeted Temperature Management) is the new term for therapeutic hypothermia, which has been shown to be effective.

If not, why not?
 

Across all studies that used conventional cooling methods rather than no cooling (three studies; 383 participants), we found a 30% survival benefit (RR 1.32, 95% CI 1.10 to 1.65). The quality of the evidence was moderate.[2]

 

With no difference in the rhythms of the control group and the intervention group, why the difference in the rate of TTM in the hospital?

Will this be similar to the case of waveform capnography? EMS ended up pressuring many/some EDs to begin to use EtCO2 on all intubated patients. This was a change from the previous, much too common, ED practice of complaining about and pulling at the EtCO2 tubing, because it was an unknown item that was in the way.

EMS should not need to encourage the ED to provide better care, especially about treatments/assessments that originated as in-hospital treatments/assessments. It should be the reverse.

There is an excellent review of TTM research at Life In The Fast Lane.[3]

Footnotes:

[1] Prehospital cooling to improve successful targeted temperature management after cardiac arrest: A randomized controlled trial.
Scales DC, Cheskes S, Verbeek PR, Pinto R, Austin D, Brooks SC, Dainty KN, Goncharenko K, Mamdani M, Thorpe KE, Morrison LJ; Strategies for Post-Arrest Care SPARC Network.
Resuscitation. 2017 Dec;121:187-194. doi: 10.1016/j.resuscitation.2017.10.002. Epub 2017 Oct 5.
PMID: 28988962

Free Full text Article from Resuscitation.

[2] Hypothermia for neuroprotection in adults after cardiopulmonary resuscitation.
Arrich J, Holzer M, Havel C, Müllner M, Herkner H.
Cochrane Database Syst Rev. 2016 Feb 15;2:CD004128. doi: 10.1002/14651858.CD004128.pub4. Review.
PMID: 26878327

[3] Targeted temperature management (TTM) after cardiac arrest
Life In The Fast Lane
Chris Nickson
Reviewed and revised Aug 1, 2017 @ 7:07 pm
Article

Scales DC, Cheskes S, Verbeek PR, Pinto R, Austin D, Brooks SC, Dainty KN, Goncharenko K, Mamdani M, Thorpe KE, Morrison LJ, & Strategies for Post-Arrest Care SPARC Network (2017). Prehospital cooling to improve successful targeted temperature management after cardiac arrest: A randomized controlled trial Resuscitation, 121 (December), 187-194 : PMID: 28988962

Arrich J, Holzer M, Havel C, Müllner M, & Herkner H (2016). Hypothermia for neuroprotection in adults after cardiopulmonary resuscitation Cochrane Database Syst Rev : PMID: 26878327

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Baltimore Hospital Dumping Patients – Is it that simple?

 
You watch the video and wonder how could anyone be so callous and cold, to leave someone outside with only a hospital gown to wear – especially when it is so cold outside.

Is what we are seeing callous, or uncaring?

In the video farther down, there is a nice discussion of the problems, which are much more complicated than somebody being refused care for some bad reason.

I found a site that did mention her clothes being with her, but stated with her clothes and belongings scattered on the sidewalk. Here is the picture they posted. The clothes are in plastic patient belongs bags.
 


 

Psychotherapist Imamu Baraka was walking near the University of Maryland Medical Center’s midtown campus location when he saw a woman being dropped off by security at a bus stop with her clothes and belongings scattered on the sidewalk.[1]

 

Why didn’t she put her clothes on?

One of the first things discharged patients will do, if they can, is put their own clothes on.

There is no evidence that anyone was refused care. That would be an EMTALA (Emergency Medical Treatment and Labor Act) violation, resulting in a very big fine, which would be reported. Maybe I am wrong, but I do not expect that an investigation will end with any finding of any refusal to provide care.

But we saw it on the video!

No. I think that you saw someone being removed from private property for bad behavior in a hospital gown, and she refused to put on her own clothes on (the clothes in her bag) for reasons of her own.

Here is a video explaining this in more detail, but a couple of notes about people mentioned in the video.

Charlie Gard was an infant with irreversible MDDS (Mitochondrial DNA Depletion Syndrome). The doctors and nurses seem to have understood this, but parents, politicians, preachers, and the press thought that it would be a good idea to torture Charlie Gard with an experimental treatment with no expectation of a better outcome.

How would Solomon decide? To torture, on the ridiculously small chance of a better outcome, or to do not further harm?

Peter Gallogly is a doctor, who was selectively recorded on video to make it seem as if his unprofessional behavior was unprovoked. If you watch the video of Dr. Gallogly, realize that it is edited to distort reality. If you watch the ironically named Project Veritas videos of abortion clinics, they are similarly edited to distort reality, which is why they have been rejected as evidence in court. You might as well watch a Michael Moore film, if you want a highly edited distortion of reality.

The Delnor nurse protected staff from an escaped prisoner, when the corrections officer apparently fled. The nurse ended up being abducted for hours, grazed by a bullet, pistol whipped, and raped, but was reported as being unharmed after the inmate was killed.

 


 

We need to learn how to find out accurate information for ourselves, rather than blindly accept propaganda from far left or far right news sources. Even the mainstream news will often get information in specialized fields wrong and not realize it. When the story is from a specialized field, such as medicine, we should obtain our information from trustworthy people in that field.

More information on Charlie Gard.

More information on Peter Gallogly.

More information on the Delnor nurse.

All of the videos are from ZDoggMD.com

Footnotes:

[1] Video shows Baltimore hospital discharging half-naked woman into cold winter night
Ana Valens
Jan 11 at 7:27AM | Last updated Jan 12 at 3:36AM
The Daily Dot
Article

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

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

Continuing from Part II, which looked at the way the satirical parachute paper misrepresents EBM (Evidence-Based Medicine), but that is expected from satire. You could also provide a great defense of blood-letting as the best medicine using satire.

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

After claiming to know what he is writing about, Kevin finishes with this –
 

As a reminder, there is not level 1 evidence that oxygen works during an acute heart attack either. That is because we do not withhold it from anyone to study it in randomized fashion due to ethical concerns and assumptions made from non-level 1 evidence.

 

What does Kevin mean by level 1?

There have been some studies of oxygen. It is unethical to not study the drug oxygen.
 

3D Isolated Oxygen Tank


Image credit.
 

For example, there was a study of One hundred percent oxygen in the treatment of acute myocardial infarction and severe angina pectoris in JAMA (Journal of the American Medical Association) way back in 1950.

If oxygen is so much better than room air for heart attack patients, the patients receiving 100% oxygen should have dramatically better outcomes than patients receiving room air by mask in this double-blinded study. The results were not statistically significant, but patients receiving 100% oxygen did not do as well as the patients receiving room air by mask.[1]

Hypoxic patients were treated with oxygen, rather than enrolled in the study, because the study looked at treating heart attack, rather than treating hypoxia. Whether we should treat hypoxia without symptoms is also a different question.

Kevin’s comment was written in September, which is ironically when the paper Oxygen Therapy in Suspected Acute Myocardial Infarction was published. We have stopped using blood-letting to treat patients, even though withholding blood-letting used to be considered just as unethical.
 

CONCLUSIONS: Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality.[2]

 

The evil scientists did not uphold dogma? Burn the heretics.

The acronym for the study reflects the addiction to continuing questionable treatments, which must not be questioned. DETO2X.

Have competent people condemned this research as unethical?

I have not looked at any of the other medical research blogs, but you should go ahead and read them (listen to the podcasts, watch the videos) and see what they write. Tell me if anyone condemns the research. Don’t quote Gwyneth Paltrow or Dr. Oz, but competent science bloggers.

The actual dogma was to give oxygen to heart attack patients, so is routine oxygen for heart attack just another case of harming patients with tradition?

What does Cochrane tell us?
 

Authors’ conclusions There is no evidence from randomised controlled trials to support the routine use of inhaled oxygen in people with AMI, and we cannot rule out a harmful effect. Given the uncertainty surrounding the effect of oxygen therapy on all-cause mortality and on other outcomes critical for clinical decision, well-conducted, high quality randomised controlled trials are urgently required to inform guidelines in order to give definitive recommendations about the routine use of oxygen in AMI.[3]

 

well-conducted, high quality randomised controlled trials are urgently required

The purpose of research is to learn what is effective and what is safe. We should only be using treatments that are both effective and safe outside of well-controlled trials.

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.

We need higher standards.

 

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

Does the parachute study prove that research doesn’t matter? Part II – Thu, 30 Nov 2017

Footnotes:

[1] One hundred percent oxygen in the treatment of acute myocardial infarction and severe angina pectoris.
RUSSEK HI, REGAN FD, NAEGELE CF.
J Am Med Assoc. 1950 Sep 30;144(5):373-5. No abstract available.
PMID: 14774103 [PubMed – indexed for MEDLINE]

[2] Oxygen Therapy in Suspected Acute Myocardial Infarction.
Hofmann R, James SK, Jernberg T, Lindahl B, Erlinge D, Witt N, Arefalk G, Frick M, Alfredsson J, Nilsson L, Ravn-Fischer A, Omerovic E, Kellerth T, Sparv D, Ekelund U, Linder R, Ekström M, Lauermann J, Haaga U, Pernow J, Östlund O, Herlitz J, Svensson L; DETO2X–SWEDEHEART Investigators.
N Engl J Med. 2017 Sep 28;377(13):1240-1249. doi: 10.1056/NEJMoa1706222. Epub 2017 Aug 28.
PMID: 28844200

[3] Oxygen therapy for acute myocardial infarction.
Cabello JB, Burls A, Emparanza JI, Bayliss SE, Quinn T.
Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160. doi: 10.1002/14651858.CD007160.pub4. Review.
PMID: 27991651

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Honoring a Do Not Resuscitate tattoo in an unconscious patient

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

The DNR (Do Not Resuscitate) tattoo is the kind of problem that leads doctors, nurses, and EMS to pretend to be lawyers, lawyers to pretend to be ethical, and patients to be treated against their wishes.

EMS transports a patient to the emergency department. The patient has a chest tattoo of Do Not Resuscitate and what appears to be a signature.
 

Paramedics brought an unconscious 70-year-old man with a history of chronic obstructive pulmonary disease, diabetes mellitus, and atrial fibrillation to the emergency department, where he was found to have an elevated blood alcohol level.[1]

 

It appears that they have access to the patient’s history, but they do not have information about a DNR in the history.
 

Because he presented without identification or family, the social work department was called to assist in contacting next of kin. All efforts at treating reversible causes of his decreased level of consciousness failed to produce a mental status adequate for discussing goals of care.[1]

 


 

The patient does not currently appear to need an invasive airway, or anything else that would be prohibited by a DNR, so there is time to consult with others.
 

This decision left us conflicted owing to the patient’s extraordinary effort to make his presumed advance directive known; therefore, an ethics consultation was requested.[1]

 

Do we honor the stated, although perhaps not letter of the law until after a court decision, DNR?

If you want to be resuscitated, do not tattoo DNR, or Do Not Resuscitate, on your chest.

But what if he did it while drunk?

There was a case of a patient doing that.
 

When asked why his tattoo conflicted with his wishes to be resuscitated, he explained that he had lost a bet playing poker with fellow ancillary hospital staffers while inebriated in his younger years; the loser had to tattoo “D.N.R.” across his chest.[2]

 


 

They are called Darwin awards for a reason.

Hold my beer and watch this is not usually the start of a tale of wisdom, but of providing a learning opportunity for others.
 

It was suggested that he consider tattoo removal to circumvent future confusion about his code status. He stated he did not think anyone would take his tattoo seriously and declined tattoo removal.[2]

 

After driving to the bar, while sober, an individual decided to drive home, while drunk.

The person should clearly not be held accountable for a decision made while drunk.

A person puts a mask on and uses a cap gun to hold up a store where a friend works, because that kind of thing is funny. Someone calls 911, or . . ., and the humor loses something in translation to reality.

I can be very silly, but I take the wishes of the patient seriously.

If a DNR tattoo was a joke, well, that was may be a bad decision, because you don’t know who is going to be deciding how to treat you when you are not capable of expressing your wishes competently.

The EMS laws tell me that I should always start CPR (CardioPulmonary Resuscitation), while calling a doctor for permission to stop, because the wishes of the patient are less important than the wishes of the doctor on the other end of the phone.

I know too many immoral doctors, nurses, and EMS personnel.

For example, a patient who has a clear DNR, clearly states that intubation is not wanted, but is deteriorating. The doctor occasionally returns to ask the hypoxic patient, Do you want to breathe? The patient keeps indicating that intubation is not wanted. Finally, the patient, through surrender to the harassment or disorientation secondary to hypoxia, says, Yes.

The doctor gets to perform a procedure and satisfy himself that the right thing was done, because it is what the doctor wanted.

Is that an extreme example? It was not seen as extreme a couple of decades ago. Maybe today it is recognized as abuse, because we recognize that the purpose of patient care is to take care of the patient, not the doctor, not the nurse, not EMS, not the supervisors, and definitely not the lawyers.

But you have to obey orders. If the military did not obey orders, we would have chaos.

Even the military does not require that anyone obey any unlawful order.
 

Any person subject to this chapter who–

(1) violates or fails to obey any lawful general order or regulation;
(2) having knowledge of any other lawful order issued by any member of the armed forces, which it is his duty to obey, fails to obey the order; or
(3) is derelict in the performance of his duties;

shall be punished as a court-martial may dire(ct.)[3]

 

Refusing to follow unlawful orders is not easy.

People in EMS will often state that the reason they did something wrong (as in something bad for the patient) is that they did not want to get yelled at by the doctor and/or nurse.

Clearly, our integrity is not what it should be.

Should we only go out of our way for the patients we like? No. My objection to using the guy who obtained the tattoo while drunk, abd does not want to remove it is nothing to do with his drinking or his bad decision, but with his lack of concern for others. My concern is for people who do care what is done to them, regardless of the lack of concern of this uncaring patient.

Of course, the uncaring patient has had the opportunity to have this explained to him and he has decided to live with that risk. He may not have made the best decision, but it is his decision and it probably will not affect him.

But the person with just a tattoo does not have a legal tattoo!

Maybe it is not legal.

Maybe it is legal.

That is for a lawyer to decide.

As the article states, this patient has gone to extraordinary effort to make a statement with this tattoo.

In the absence of something to show that the tattoo does not express the patient’s informed decision, I accept it as expressing the patient’s wishes.

If I am there it is to take care of the patient, not the medical command physician, not the protocol, not the quality control department, not the legal department, not the supervisors, not the doctors, or nurses, in the emergency department, . . . .

When our medical and legal systems are so broken that we feel that we are forced to harm our patients to be able to do our jobs, we need to stop making excuses and start to change things.

Footnotes:

[1] An Unconscious Patient with a DNR Tattoo.
Holt GE, Sarmento B, Kett D, Goodman KW.
N Engl J Med. 2017 Nov 30;377(22):2192-2193. doi: 10.1056/NEJMc1713344. No abstract available.
PMID: 29171810

Free Full Text from NEJM.

[2] DNR tattoos: a cautionary tale.
Cooper L, Aronowitz P.
J Gen Intern Med. 2012 Oct;27(10):1383. Epub 2012 May 2. No abstract available.
PMID: 22549297

Free Full Text from J Gen Intern Med.

[3] UCMJ 892. Article 92—Failure to obey order or regulation.
Uniform Code of Military Justice
Subchapter 10
Punitive Article

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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.

.

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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If your Versed (midazolam) isn’t working, maybe it’s Zofran (ondansetron)

 
If you were giving a lot more midazolam (Versed) by intramuscular injection to stop a seizure and the seizure just would not stop, or got worse, maybe you were giving ondansetron (Zofran).

If you were giving a lot more midazolam by injection to sedate a patient and the sedation just wasn’t having its usual effect, maybe you were giving ondansetron. While rare, there can be very serious side effects from too much ondansetron.
 

Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions. Patients may also be at risk for serotonin syndrome. Serotonin syndrome is associated with increased serotonergic activity in the central nervous system. Most reports of serotonin syndrome have been associated with concomitant use of certain drugs, some commonly used during surgery, such as fentanyl. Some of the reported cases of serotonin syndrome were fatal.[1]

 

How do you recognize serotonin syndrome?
 

Serotonin syndrome (SS) is a group of symptoms that may occur following use of certain serotonergic medications or drugs. [1] The degree of symptoms can range from mild to severe.[2] Symptoms include high body temperature, agitation, increased reflexes, tremor, sweating, dilated pupils, and diarrhea.[1][2] Body temperature can increase to greater than 41.1 °C (106.0 °F).[2] Complications may include seizures and extensive muscle breakdown.[2] [2]

 

2 mg of midazolam is much too low a dose to try to stop a seizure, unless it is the only packaging you have and you are giving 5 intramuscular injections at a time. The best response to prehospital treatment of seizures was by giving 10 mg of intramuscular midazolam to adults (over 40 kg) and 5 mg of intramuscular midazolam to children (under 40 kg).

Maybe you think that is too much midazolam. The highest quality and largest pre-hospital study does not support using lower doses.
 

Our data are consistent with the finding that endotracheal intubation is more commonly a sequela of continued seizures than it is an adverse effect of sedation from benzodiazepines.11 [3]

 

There are other uses for midazolam, so you should be aware of the possibility that what you think is midazolam is really ondansetron.

Are the syringes labeled incorrectly for the contents?
 

Fresenius Kabi USA is voluntarily recalling Lot 6400048 of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection,
USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL.
[1]

 

Based on that, the syringes should be correctly labeled as ondansetron, but they are in blister packs labeled as containing midazolam or they are in boxes of blister packs listed as containing midazolam or both or something else.

If you use this packaging of midazolam, check the lot number, the syringe, and any other labels to make sure that they all agree.

What if you need some ondansetron pre-filled syringes?

Send them back anyway. Maybe only some of the syringes are labeled correctly.

What do the syringes look like?
 


 

What does the ondansetron syringe look like? This one is with a blister pack.
 


 

There are other possibilities for mislabeling that could be much more harmful, so read the syringe before you push anything by any manufacturer.
 


 

That probably would not be as harmful as it seems, because it would be pushed slowly, so it might be metabolized as quickly as it is pushed. The ones below would still be expected to produce a much greater respiratory depression than even an extreme midazolam respiratory depression.
 


 

Footnotes:

[1] Fresenius Kabi Issues Voluntary Nationwide Recall of Midazolam Injection, USP, 2 mg/2 mL Due to Reports of Blister Packages Containing Syringes of Ondansetron Injection, USP, 4 mg/2 mL
For Immediate Release
November 3, 2017
Voluntary Recall
Recall announcement

[2] Serotonin syndrome
Wikipedia
Article

[3] Intramuscular versus intravenous therapy for prehospital status epilepticus.
Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators.
N Engl J Med. 2012 Feb 16;366(7):591-600.
PMID: 22335736 [PubMed – in process]

Free Full Text from N Engl J Med.

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Have a Slow, Quiet Friday the Thirteenth

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

 

Superstitious appears to be common among medical people, so this may be seen as offensive. If you doubt me, comment that it is slow or quiet and see how many respond negatively, while they do not receive any criticism for their superstition-based complaints. Rather, people will make excuses for coddling the superstitions of those who are entrusted with the lives of patients.

The evidence does not support their superstitions.

One study did appear to show that women die in motor vehicle collisions more often on Friday the 13th, but that appears to be due to a lack of understanding of statistics by many who cite the article.
 

An additional factor is anxiolytic medication, used by significantly more women than men in Finland (7), which has been reported to reduce attention span and worsen driving performance (8). . . . Why this phenomenon exists in women but not in men remains unknown, but perhaps the twice-as-high prevalence of neurotic disorders and anxiety symptoms in women (7) makes them more susceptible to superstition and worsening of driving performance.[1]

 

The author suspects that those people with conditions that could be diagnosed as neuroses or anxiety disorders may be disproportionately affected by superstition.

In other words, superstition is not an external force affecting you. You are doing it to yourself.

The sample size was national, but still small, and was not able to adjust for many possible confounding variables, so the study would need to be replicated using a much larger data base to be useful.

In other superstition news – the next apocalypse, in a long line of predicted apocalypses, is going to be this Sunday – the 15 of October, 2017, according to David Meade. Meade twice previously predicted that a magical planet would hit the Earth and kill us all. This time he claims that his calculations are accurate, because that was the problem with his previous calculations – inaccuracy, not that they were a superstition deserving of derision.

If you are superstitious, and feel that your neuroses/anxieties will cause you to harm others, or yourself, you may want to stay home today and Sunday – perhaps even until you are capable of grasping reality.

Of course, we would never base treatment on superstition in medicine.

Amiodarone is the go to antiarrhythmic drug for cardiac arrest and ventricular tachycardia, but there are much safer much more effective drugs available. We have our own prophets misrepresenting research results to make it seem that using amiodarone for these is a good idea. The research says these preachers are wrong. The next guidelines will probably promote the superstition and reject the science.[2],[3]

Ventilation during cardiac arrest has been shown to be a good idea only for patients who arrested for respiratory reasons. We do a great job of identifying these patients. We have our own prophets misrepresenting research results to make it seem that providing ventilations for these is a good idea. The research says these preachers are wrong. The next guidelines will probably promote the superstition and reject the science.[4]

Medicine is full of superstition and superstitious people.

Why?

Too many of us believe the lie that, I’ve seen it work.

I have also written about the superstition of Friday the 13th here –

Acute coronary syndrome on Friday the 13th: a case for re-organising services? – Fri, 13 Jan 2017

The Magical Nonsense of Friday the 13th – Fri, 13 May 2016

Happy Friday the 13th – New and Improved with Space Debris – Fri, 13 Nov 2015

Friday the 13th and full-moon – the ‘worst case scenario’ or only superstition? – Fri, 13 Jun 2014

Blue Moon 2012 – Except parts of Oceanea – Fri, 31 Aug 2012

2009’s Top Threat To Science In Medicine – Fri, 01 Jan 2010

T G I Friday the 13th – Fri, 13 Nov 2009

Happy Equinox! – Thu, 20 Mar 2008

Footnotes:

[1] Traffic deaths and superstition on Friday the 13th.
Näyhä S.
Am J Psychiatry. 2002 Dec;159(12):2110-1.
PMID: 12450968

Free Full Text from Am J Psychiatry.

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

There are a dozen links to the research in the footnotes to that article. There are also links to other articles on the failure of amiodarone to live up to its hype.

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

[4] Cardiac Arrest Management is an EMT-Basic Skill – The Hands Only Evidence
Fri, 09 Dec 2011
Rogue Medic
Article

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