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

- Rogue Medic

How Effective Is Epinephrine for Improving Survival Among Patients in Cardiac Arrest?

Sun, 30 Jun 2019 22:20:08 -0400 by
   

There have been two studies comparing epinephrine with placebo to treat out of hospital cardiac arrest. The Jacobs study was stopped early, because of interference by those who do not want to know if their medicine actually works.[1] The purpose of research is to determine, as objectively as possible, if a treatment is better than placebo nothing.  

Click on the image to make it larger.  

Even the small sample size shows a impressive p values of <0.001 for both ROSC (Return Of Spontaneous Circulation) and being admitted to the hospital. Unfortunately, that does not lead to outcomes that are better than placebo.

The Perkins study (PARAMEDIC2) did not find a significant difference between adrenaline (epinephrine in non-Commonwealth countries) and placebo.[2] The Jacobs study also did not find a difference, but the numbers were small, due to the interference by the less than knowledgeable. Following the Jacobs study, some intervention proponents have suggested that the problem is not a lack of evidence of benefit, but need to look at the evidence from the right perspective. The inadequate evidence is not “inadequate”, but really just misunderstood. All we need to do is use a method of analysis that compensates for the tiny sample size. A Bayesian approach will produce the positive outcome that is not justified by so few patients.[3]

What happens when the numbers are combined, so that the sample size is large enough to eliminate the need for statistical chicanery to come up with something positive?

The outcomes do not improve.  

Neither standard dose adrenaline, high-dose adrenaline,vasopressin nor a combination of adrenaline and vasopressin improved survival with a favourable neurological outcome.[4]
 

If the Bayesian approach were appropriate, then the much larger sample size would have provided more than enough patients to confirm the optimism of the epinephrine advocates. The result is still not statistically significant. Maybe a much, much larger study will show a statistically significant, but tiny, improvement in outcomes with epinephrine, but don’t hold your breath for that. It took half a century to produce the first study, then seven more years for the second. With the cost of research and the problems coordinating such a large study, it is more likely that the guidelines will continue to recommend spending a lot of time and money giving a drug that diverts attention from the interventions that do improve outcomes.

There is still no evidence that adrenaline provides better outcomes than placebo in human cardiac arrest patients.

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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  

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.

  –  

[2] 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

Free Full Text from N Engl J Med.

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[3] Regarding “Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial”. Youngquist ST, Niemann JT. Resuscitation. 2012 Apr;83(4):e105; author reply e107. doi: 10.1016/j.resuscitation.2011.09.035. Epub 2012 Jan 18. No abstract available. PMID: 22266068

Free Full Text from Resuscitation.

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[4] Adrenaline and vasopressin for cardiac arrest. Finn J, Jacobs I, Williams TA, Gates S, Perkins GD. Cochrane Database Syst Rev. 2019 Jan 17;1:CD003179. doi: 10.1002/14651858.CD003179.pub2. PMID: 30653257    

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Filed Under: ACLS, ALS, Anti-Science, Cardiac Arrest, CPR, Critical Judgment, EBM, Epinephrine, Ethics, Evidence, Pharmacology, Research, Risk Management

Closed chest compressions reduce survival in an animal model of haemorrhage-induced traumatic cardiac arrest

Fri, 31 May 2019 19:00:44 -0400 by
   

This is an animal study, rather than a human study, but it has fewer disadvantages than the usual animal studies of medical cardiac arrest. Animals do not develop the comorbidities that humans do, but have artificially created heart attacks, rather than by the development of actual heart disease. In studying trauma, this is less of a problem, since trauma is artificially created. This study is much more representative of penetrating injuries with a low velocity objects, than blunt force trauma, or penetrating injury with a high velocity object.

Are we really killing trauma patients with our chest compressions?

Maybe. This is one small study (39 pigs), but it does raise questions about the ways we can minimize the harm we cause.

 

 
CCC were associated with increased mortality and compromised haemodynamics compared to intravenous fluid resuscitation. Whole blood resuscitation was better than saline.[1]

 
A soft tissue injury was created, with 3 shots to the right thigh using a captive bolt (Cash Special, Accles and Shelvoke, Sutton Coldfield, UK). Two minutes later animals underwent a controlled haemorrhage (30% blood volume) at an exponentially reducing rate as previously described12 until the mean arterial blood pressure (MAP) was 45 mmHg. Blood was collected into CPD (citrate phosphate dextrose) and stored at room temperature until required for later transfusion.[1]
 

Image source

 

This study, conducted in an animal model of haemorrhage-induced traumatic cardiac arrest, has demonstrated that chest compressions confer no benefit over fluid resuscitation alone, and blood should be the fluid therapy of choice.[1]

  That seems to be concluding too much, since this is just one study, but it does reinforce the results of other, similar studies. We should study the outcomes in humans, since there does appear to be equipoise. There never was a physiological justification for chest compressions in traumatic cardiac arrest which appears to be due to hemorrhage. Now there is more evidence that chest compressions produce more harm than benefit in traumatic cardiac arrest which appears to be due to hemorrhage.

 
One study using a baboon traumatic cardiac arrest model found that the improvements in haemodynamics seen with chest compressions for normovolaemic cardiac arrest were not reproduced in hypovolaemic arrest.14 The authors suggested that CCC should not delay correction of the underlying deficit causing TCA, but the study was undertaken in only three animals, perhaps limiting its clinical relevance. A more recent study using a canine model of pulseless electrical activity in TCA found no benefit of chest compressions over fluid therapy alone or fluid combined with chest compressions; in fact the chest compression only group had worse survival, base deficit and ejection fraction.15 The authors concluded that further research was required to determine whether CPR has a role for the patient in haemorrhagic shock.[1]

  Most important is that the outcome is ROSC (Return Of Spontaneous Circulation), not return to normal neurological function. Since these are pigs, even the appearance of normal neurological function may not mean anything in humans. Still, the treatment is not evidence-based, so there does not appear to be a good reason to prefer to continue using compressions for traumatic cardiac arrest which appears to be due to hemorrhage.

Here in America, we are unlikely to do the research, because we are more concerned with appearances than with improving outcomes for patients. Maybe somebody in Britain or Australia will have to demonstrate some responsibility, so we can stop using chest compressions to kill trauma patients.

  Footnotes:

  [1] Closed chest compressions reduce survival in an animal model of haemorrhage-induced traumatic cardiac arrest. Watts S, Smith JE, Gwyther R, Kirkman E. Resuscitation. 2019 May 9;140:37-42. doi: 10.1016/j.resuscitation.2019.04.048. [Epub ahead of print]

PMID: 31077754

Free Full Text from Resuscitation

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Filed Under: ACLS, CPR, Heresy, Potentially Reversible Causes, Research, Trauma

The Big Government, Big Religion, Immoral Opposition to Physician Assisted Suicide

Fri, 19 Apr 2019 05:50:12 -0400 by
 
 

The government should not force people to die painful deaths, in order to please the people who can only think of the ways something can go wrong and/or the Bible thumpers. These patients are not harming anyone else and we should stop condemning them as if they are the ones rejecting morality.

There are ways to protect vulnerable patients from being taken advantage of by family, or by others, without forcing everyone to die painfully. Physician assisted suicide is a way to protect vulnerable patients from being taken advantage of by those who claim to know what is best for everyone and want to force it on everyone, for their own good.

The alternative to physician assisted suicide is to require moral physicians break the law in order to provide the care the patient needs – relief of suffering that cannot otherwise be relieved. Physician assisted suicide should not be opposed by any ethical medical organization.

The older I get, the more I see patients abused by this hypocritical legal prohibition on ethical behavior.

Providing the care that the patient requests, with fully informed consent by the patient, is far more ethical than claiming that other people should control patients’ lives for the patients.

This does not affect me much, as a patient, because I can acquire whatever I need to end my life, whenever I feel it is the best option. I also have the ability to administer whatever medications I might choose to use, but I would probably have to do this sooner than I would like, in order to avoid having to rely on others to do what is right.

I will not ask anyone else to put themselves at legal risk, in order to allow me more time.

I will do whatever I need to do before I lose the ability to do everything on my own. Obviously, this will not apply to many medical conditions that have catastrophic sudden onset. I am not currently experiencing any symptoms and I do not have any diagnosis of any condition that would encourage me to end my life, but I may need to move to a state that does not require patients to be tortured to death, if that changes. If the SCOTUS literalists/originalists imposes a big government sharia decision to prohibit ethical end of life decisions by patients, then I might need to move to another country in order to have a longer life.

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Filed Under: Corruption, Ethics, Heresy, Legal Medicine, Mythology

ILCOR wants the appearance of public comments with less than half the substance

Mon, 01 Apr 2019 14:45:53 -0400 by
 

The International Liaison Committee on Resuscitation (ILCOR) shows its priorities in the way it handles its problem with public comments.
 

Last week ILCOR posted the two new draft CoSTRs listed below for public comment. It became apparent that the commenting link was broken and those who visited the site could not comment. We apologize for the inconvenience. The commenting link is now fixed and we invite you to comment at ilcor.org/costr.

  • Advanced Airway Management During Adult Cardiac Arrest
  • Vasopressors in Adult Cardiac Arrest

    • As a reminder, the public comment period will close on 4 April 2019.[1]

     

    ILCOR made a mistake that prevented public comments from being submitted for most of the public comment period.

    ILCOR is so interested in your public comments that they have decided to send out an email to let people know that they have the same drop dead date for the comments as before, but this time they might actually be able to get the comments to work. Maybe.

    The lack of evidence of benefit of epinephrine (adrenaline in Commonwealth countries) has lasted over half a century, so what is the rush to get these new guidelines out?

    There is only one outcome that matters – survival without severe brain damage.
     


     

    ILCOR evaluates 23 outcomes.

    ILCOR considers 15 of these outcomes critical, but they are really just 5 outcomes, with some of them repeated over different rhythms. These are (in increasing order of importance to the only one that matters):

    1. For the critical outcome of survival to hospital discharge, 2. For the critical outcome of survival at 3 months, 3. For the critical outcome of favorable neurologic outcome at hospital discharge, 4. For the critical outcome of survival with unfavorable neurologic outcome at 3 months, 5. For the critical outcome of favorable neurologic outcome at 3 months,

    Many of them are repeated for each cardiac arrest rhythm or for each vasopressor, or vasopressor cocktail:

    1. Epinephrine plus vasopressin compared to epinephrine only – Any rhythm 2. Initial vasopressin compared to initial epinephrine – Any rhythm 3. Epinephrine compared to placebo – Non-shockable rhythms 4. Epinephrine compared to placebo – Shockable rhythms 5. Epinephrine compared to placebo – Any initial rhythm

    There is only one outcome that matters – survival without severe brain damage.

    There is only one study that was large enough to answer this:
     

    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.[2]

     

    If the people at ILCOR really think that epinephrine is beneficial in cardiac arrest, they should encourage a much larger study.

    There were 4,000 patients in each group – 4,000 placebo and 4,000 epinephrine.

    Maybe with 8,000 patients in each group, the ever decreasing “trend toward better outcome” will reach significance. Maybe it will be shown to be just another insignificant appearance of a “trend” that is the result of having so few survivors to compare.

    There were only 161 survivors without severe brain damage out of 8,000 cardiac arrest patients – 74 placebo and 87 epinephrine.

    Those resuscitated before receiving epinephrine/placebo were excluded from the study, so this is not a case of EMS that only has a 2% resuscitation rate. The focus on epinephrine is a focus on the patients least likely to be resuscitated and a focus on counterproductive outcomes.

    Almost all of our good outcomes (without severe brain damage) will be without epinephrine, because these resuscitations happen before epinephrine can be give by even the most aggressive epi enthusiast.

    What we are doing is making excuses for memorizing ineffective interventions and requiring their application is a specific way, in order to determine the quality of care. We are promoting fantasy.

    We learned that distracting from the quality of chest compressions is the most deadly thing we can do in resuscitation.

    CPR = only chest compressions – the exception is when the arrest is believed to be due to a respiratory event, such as when the Smurf sign or a respiratory/choking history is present. Chest compressions provide all of the pulmonary resuscitation that a human needs for a non-respiratory event and the respiratory events are not easily missed.

    Why require a whole bunch of skills be applied for such a tiny portion of good outcomes among cardiac arrest patients?

    Why not give up on requiring these skills when the evidence makes it clear that there is no benefit?

    All we are doing is adding cognitive load to make us feel like we are doing something special.

    We could learn something that actually benefits patients, such as how to assess patients when giving high-dose NTG (NiTroGlycerin or GTN GlycerylTriNitrate in Commonwealth countries) for even hypotensive CHF/ADHF (Congestive Heart Failure/Acute Decompensated Heart Failure), where we can make much more of a difference and prevent cardiac arrest, but we don’t.[3],[4],[5]
     


     

    Cognitive load is not just a problem for paramedics and nurses, or med/surg doctors, but also for emergency physicians:

    Cognitive Load and the Emergency Physician
    April 12, 2016
    James O’Shea
    emDocs
    Article

    Why are we distracting everyone from things that do improve the only outcome that matters, in order to promote things that do not improve any outcome that matters?

    Here is what I wrote –
     

    The primary source for the recommendation to keep things the same is a brand new study – PARAMEDIC2.

    This showed no statistically significant improvement in the only outcome that matter – survival without severe brain damage.

    A larger study might show that there is a real improvement – or it may put the epi hypothesis out of its misery.

    I will eventually have a cardiac arrest. If I am resuscitated, whom will ILCOR send to change my diaper, and attend to the other things I can no longer attend to?

    We need evidence of a significant benefit in order to justify distracting everyone from interventions that actually do improve survival without severe brain damage.

    .

     

    The commenting link is now fixed and we invite you to comment at ilcor.org/costr

    Maybe they will pay attention. Dr. Rory Spiegel of EM Nerd has a detailed comment that is also critical of ILCOR’s proposed “strong recommendation” of epinephrine.

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    Footnotes:

    –

    [1] Vasopressors in Adult Cardiac Arrest
    Time left for commenting: 11 days 15:49:49
    ILCOR staff
    Created: March 21, 2019 · Updated: March 21, 2019
    Draft for public comment
    Consensus on Science with Treatment Recommendations (CoSTR)
    Vasopressors in Adult Cardiac Arrest page for comments until April 04, 2019 at 06:00 Eastern Time

    –

    [2] 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

    Free Full Text from N Engl J Med.
     

    In a Bayesian analysis that used an assumption of no benefit from adrenaline, the posterior probability that the absolute rate of survival was at least 1 percentage point higher in the epinephrine group than in the placebo group was 37% (Fig. S3 in the Supplementary Appendix). The probability that the absolute survival rate was at least 2 percentage points higher was 0.2%. With respect to the rate of survival with a favorable neurologic outcome at hospital discharge, the probabilities that the rate was at least 1 or 2 percentage points higher with epinephrine were 1.9% and 0%, respectively (Fig. S4 in the Supplementary Appendix).

     

    The probability of a good outcome (no severe brain damage) is not improved with epinephrine.

    If we want to improve outcomes, we need to look elsewhere, because there is nothing to be gained with epi.

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    [3] Intravenous nitrates in the prehospital management of acute pulmonary edema.
    Bertini G, Giglioli C, Biggeri A, Margheri M, Simonetti I, Sica ML, Russo L, Gensini G.
    Ann Emerg Med. 1997 Oct;30(4):493-9.
    PMID: 9326864 [PubMed – indexed for MEDLINE]

    –

    [4] Unreasonable Fear of Hypotension and High-Dose NTG – Part I
    Thu, 29 Aug 2013
    Rogue Medic
    Article

    –

    [5] Unreasonable Fear of Hypotension and High-Dose NTG – Part II
    Wed, 04 Sep 2013
    Rogue Medic
    Article

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    Filed Under: ACLS, Airway Management, Cardiac Arrest, Cardiology, CPR, Critical Judgment, Epinephrine, Heresy, NTG, Pharmacology, Research

    ACLS Excuses for Causing Harm with Epinephrine

    Sat, 23 Mar 2019 15:06:14 -0400 by
     

    The next ACLS guidelines are available for review and comment, before they are finalized. The Consensus on Science with Treatment Recommendations (CoSTR) from the International Liaison Committee on Resuscitation (ILCOR) are available for two guidelines:

    Vasopressors in Adult Cardiac Arrest

    Advanced Airway Management During Adult Cardiac Arrest

    We have been using these interventions for so long, that there should be great evidence to show that benefits and harms of both interventions, but there is no good evidence to support either intervention.

    For epinephrine (adrenaline in Commonwealth countries), the most commonly used vasopressor and the only one rally being considered, there is no evidence of actual benefit – increased survival without severe brain damage.

    Nothing else matters.

    There is no valid evidence that increasing any surrogate endpoint improves survival without severe brain damage. The evidence cited by ILCOR shows that epinephrine increases the rate of severe brain damage.
     

    Intervention: Vasopressor or a combination of vasopressors provided intravenously or intraosseously during cardiopulmonary resuscitation.[1]

     

    Here are the outcomes that are supposed to indicate that the patient is better.
     

    Outcomes: Short-term survival (return of spontaneous circulation (ROSC) and survival to hospital admission), mid-term survival (survival to hospital discharge, 28 days, 30 days, or 1 month), mid-term favorable neurological outcomes (Cerebral Performance Category score of 1-2 or modified Rankin Scale 0-3 at hospital discharge, 28 days, 30 days, or 1 month) and long-term favorable and poor (modified Rankin Score 4-5) neurological outcomes (after 1 month).[1]

     

    Is ROSC an improvement?

    We aren’t supposed to ask that question. These are faulty assumption that the guidelines are based on.

    1. Doing something more is better than only doing things supported by valid evidence of improved survival without severe brain damage.

    No.

    How much harm is being caused in this rush to get a pulse back?

    We are supposed to ignore our understanding of research, look at a statistically insignificant “trend”, and extrapolate that statistically insignificant “trend” to support the prejudice that our intervention has not been harmful.

    That is not good science.

    That is not good medicine.
     

    Why aren’t there any studies large enough to show improved survival without severe brain damage for anything other than rapid defibrillation (when indicated VF/pulseless VT) and chest compressions?

    The research has only produced excuses and surrogate endpoint. Surrogate endpoints are for hypothesis generation and sales pitches to the least knowledgeable, but not for treatment guidelines.

    ILCOR has told us this before, but that was because the choice was between large doses of epinephrine and small doses of epinephrine, not between epinephrine and no epinephrine.

    The choice is the same.

    Is the more aggressive intervention helping?

    The answer is the same. No. That is not the conclusion of the evidence.
     

    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.[2]

     

    If the goal is a pulse with more severe brain damage, then epinephrine is the way to go.

    If the goal is increased survival without severe brain damage, we have to keep looking.

    We should limit the use of epinephrine to well controlled research until there is evidence of improvement in outcomes that matter.

    If this evidence is never found, our patients will not have been harmed by epinephrine.

    If this evidence is eventually found, it is something that should have been insisted on decades ago. We should not use wishful thinking and surrogate endpoints to justify interventions that harm patients.

    We used to stop compressions to let the medic/nurse/doctor intubate, or start an IV (IntraVenous) line.

    We knew that the tube was more important.

    We knew that the drugs given through the IV line were more important.

    The 2005 guidelines told us to continue compressions during intubation and during IV attempts and to improve the quality of the compressions.

    That focus on high quality compressions is the only time we have improved outcomes that matter.
     

    CONCLUSIONS: Compared with controls, patients with out-of-hospital cardiac arrest treated with a renewed emphasis on improved circulation during CPR had significantly higher neurologically intact hospital discharge rates.[3]

     

    33 1/3% vs 60% increased survival without severe brain damage.
     

    In 2004, we began a statewide program to advocate chest compression-only CPR for bystanders of witnessed primary OHCA. Over the next five years, we found that survival of patients with a shockable rhythm was 17.7% in those treated with standard bystander CPR (mouth-to-mouth ventilations plus chest compression) compared to 33.7% for those who received bystander chest-compression-only CPR.[4]

     

    18% vs 34% increased survival only – not increased survival without severe brain damage.
     

    In the analysis of MICR [Minimally Interrupted Cardiac Resuscitation] protocol compliance involving 2460 patients with cardiac arrest, survival was significantly better among patients who received MICR than those who did not (9.1% [60/661] vs 3.8% [69/1799]; OR, 2.7; 95% CI, 1.9-4.1), as well as patients with witnessed ventricular fibrillation (28.4% [40/141] vs 11.9% [46/387]; OR, 3.4; 95% CI, 2.0-5.8).[5]

     

    9% vs 4% increased survival only – not increased survival without severe brain damage.
     

    Neurologic outcomes were also better in the patients who received CCR (OR=6.64, 95% CI=1.31 to 32.8).[6]

     

    6 2/3 more likely to have increased survival without severe brain damage. The range is 1 1/3 to almost 33 times, because of the small numbers, but unlike epinephrine, this is statistically significant and supported by other research.

    We are still making excuses for using a drug that causes harm and does not appear to provide a benefit that is greater than the harm. If there is more benefit, it is too small to be measured, even in a study with over 9,000 patients. We do not know which patients benefit and which patients are harmed, so we do not know how to minimize the harm that we cause.

    Our patients deserve better.

    –

    Footnotes:

    –

    [1] Vasopressors in Adult Cardiac Arrest
    Time left for commenting: 11 days 15:49:49
    ILCOR staff
    Created: March 21, 2019 · Updated: March 21, 2019
    Draft for public comment
    Consensus on Science with Treatment Recommendations (CoSTR)
    Vasopressors in Adult Cardiac Arrest page for comments until April 04, 2019 at 06:00 Eastern Time

    –

    [2] 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

    Free Full Text from N Engl J Med.

    –

    [3] Implementing the 2005 American Heart Association Guidelines improves outcomes after out-of-hospital cardiac arrest.
    Aufderheide TP, Yannopoulos D, Lick CJ, Myers B, Romig LA, Stothert JC, Barnard J, Vartanian L, Pilgrim AJ, Benditt DG.
    Heart Rhythm. 2010 Oct;7(10):1357-62. doi: 10.1016/j.hrthm.2010.04.022. Epub 2010 Apr 24.
    PMID: 20420938

    Free Full Text from Heart Rhythm.

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    [4] The cardiocerebral resuscitation protocol for treatment of out-of-hospital primary cardiac arrest.
    Ewy GA.
    Scand J Trauma Resusc Emerg Med. 2012 Sep 15;20:65. doi: 10.1186/1757-7241-20-65. Review.
    PMID: 22980487

    Free Full Text from PubMed Central.

    –

    [5] 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. doi: 10.1001/jama.299.10.1158.
    PMID: 18334691

    Free Full Text from JAMA.

    –

    [6] Cardiocerebral resuscitation is associated with improved survival and neurologic outcome from out-of-hospital cardiac arrest in elders.
    Mosier J, Itty A, Sanders A, Mohler J, Wendel C, Poulsen J, Shellenberger J, Clark L, Bobrow B.
    Acad Emerg Med. 2010 Mar;17(3):269-75. doi: 10.1111/j.1553-2712.2010.00689.x.
    PMID: 20370759

    Free Full Text from Acad Emerg Med.

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    Filed Under: ACLS, Cardiac Arrest, Critical Judgment, EBM, Epinephrine, Ethics, Evidence, Pharmacology, Research Blogging

    Protecting Systemic Incompetence – Part I

    Thu, 28 Feb 2019 15:01:12 -0500 by

    We demand the lowest standards, because we are willfully ignorant and we do not want to understand. The surprise is that so many of us survive our devotion to incompetence. The loudest voices tend to dominate the discussions and the loudest voices demand that their excuses for incompetence be accepted. The rest of us don’t oppose incompetence enough.

    A nurse was told to give 2 mg Versed (the most common brand of midazolam in the US) for sedation for a scan, intended to give 1 mg Versed, but actually gave an unknown quantity of vecuronium (Norcuron is the most common brand in the US). The patient was observed to be unresponsive and pulseless by the techs in the scan. A code was called. The family learned the details from a newspaper article, not from the hospital.

    A Tennessee nurse charged with reckless homicide after a medication error killed a patient pleaded not guilty on Wednesday in a Nashville courtroom packed with other nurses who came in scrubs to show their support.[1]

    The nurse intended to give a medication that should be limited to patients who are monitored (ECG and waveform capnography), because different patients will respond in different ways. This is basic drug administration and deviation from that basic competence may even have been common in this Neuro ICU (Neurological Intensive Care Unit). We demand low standards, because we do not want to understand.

    We don’t need to monitor for that, because that almost never happens.

    Except these easily preventable errors do happen. And we lie about it. We help to cover it up, because we demand low standards, regardless of how many patients have to suffer for the benefit of our incompetence.

    This is a common argument used by doctors, nurses, paramedics, . . . . It makes no sense, but we keep demonstrating that we don’t care.

    The people in charge should act responsibly, but they delegate responsibility and we reward them.

    Back to the hospital, Vanderbilt University Medical Center (VUMC) is a university medical center, so the standards should be high. VUMC was founded in 1874 and is ranked as one of the best hospitals in America.

    There is a drug dispensing machine, from which less-than-skilled nurses can obtain almost anything and administer almost anything, without understanding enough to recognize the problem. This is an administrative problem. This was designed by someone with no understanding of risk management.

    The over-ride of the selection is not the problem, because emergencies happen and it is sometimes necessary to bypass normal procedures during an emergency. Ambulances are equipped with lights, sirens, and permission to violate certain traffic rules for this reason.

    Some of the many blatant problems are:

    * The failure of the nurse to have any understanding of the medication supposed to be given

    * The failure of the nurse to recognize that the drug being given was not the drug ordered.

    * The failure of the nurse to monitor the patient being given a drug for sedation.

    * Most of all, the failure of the hospital – the nurses, the doctors, the administrators, to try to make sure that at least these minimum standards are in place.

    * How often do nurses in the Neuro ICU give midazolam?

    * Why is a nurse, who is clearly not familiar with midazolam, giving midazolam to any patient?

    * How is a nurse, working unsupervised in a Neuro ICU not familiar with midazolam?

    * What kind of qualifications are required for a nurse to give sedation without supervision?

    * Since this nurse was orienting another nurse, what qualifies this nurse to orient anyone?

    * Given the side effects of midazolam, why was midazolam ordered without monitoring?

    * Given the side effects of midazolam, was it the most appropriate sedative for use in a setting where monitoring is going to be difficult?

    * Was it the more rapid onset of sedation, in order to free up the PET scan more quickly and/or avoid having to reschedule the scan, that led to the choice of midazolam?

    * How well do any of the doctors understand the pharmacology of midazolam if they are giving orders for a nurse to grab a dose, take it down to the scan, give the drug, and return to the unit, abandoning the monitoring of the patient to the techs in the PET scan?

    * This is not a criticism of the techs in PET scan, but are techs authorized to manage sedated patients?

    * Even though they will often scan sedated patients, are the techs required to demonstrate any competence at managing sedated patients?
    The nurses being oriented apparently thought that it is customary to give sedation:

    1. without even looking at the name of the medication

    2. without confirming by looking at the name again, it before administration

    3. without double checking with a nurse, or tech, that the label matches the name of the drug to be given
    How many of the doctors, responsible for the care of ICU patients, would agree to be sedated, without being monitored, and to have their care handed off to PET scan technicians?

    Why didn’t the doctors and nurses see this as a problem before it made the news?

    If the problems were reported, nothing appears to have been done to address the problems beyond the usual – Nothing to see here. Move along. or That’s above your pay grade.

    That is the primary point I am trying to make.

    The problem is well above the pay grade of the nurse.
    Here is the part that experienced nurses have jumped on immediately:

    Why did the nurse think that midazolam needs to be reconstituted?

    Vecuronium (most common brand name is Norcuron) is a non-depolarizing neuromuscular-blocker, which comes as a powder, that needs to be reconstituted.

    Image source
    1. Read label instructions?

    This nurse has repeatedly demonstrated a need to be supervised, but those responsible for that supervision have apparently ignored their responsibilities in a way that far exceeds any failures by this nurse.

    Is it possible that this is a one time event and that the nurse has behaved in an exemplary manner at all times while around doctors and other nurses before this day? It is possible, but the number and severity of the failures on the part of the nurse strongly suggest a pattern of not understanding, not caring, or both. I suspect that any lack of caring is due to a lack of understanding, because I have not yet lost all hope in humanity.

    –

    Footnotes:

    –

    [1] Nurse charged in fatal drug-swap error pleads not guilty
    By Travis Loller
    February 20, 2019
    Associated Press
    Article

    .

    Edited 3/24/2022 at 00:34 to correct spelling from less-than-killed to less-than-skilled and poweder top powder.

    Filed Under: Appearances, Assessment, Ethics, Experience, Heresy, Legal Medicine, Malpractice, Midazolam, Mythology, Pharmacology, Risk Management, Rules of safe drug administration, Sedation, Waveform Capnography

    Happy Darwin and Lincoln Day 2019

    Tue, 12 Feb 2019 14:30:47 -0500 by
     

    Today we celebrate two 210th birthdays. Both stood up to right wing religious fanatics and were attacked for it. One was assassinated.

    The first birthday boy is Abraham Lincoln, who might have been the most famous aggressively pro-civil rights, do gooder, Social Justice Warrior president – except that secession began before Lincoln even took office. The slave states were so afraid of what Lincoln might do that they didn’t even wait to find out. They didn’t use any valid legal means to try to win their case, but essentially stated, We’re leaving and we’re taking these parts of America, because we believe they belong to us and secession is 9/10ths of the law. We double dog dare you to enforce the law – and just to comply with the wording of the Constitution of the United States, we are going to open fire on the United States Army. The hurt themselves and the rest of America by promoting secessionists’ devotion to enslaving those not white and the secessionists’ adamant opposition to states’ rights. Yes, the secessionists’ claimed to be fighting for states’ rights, but liars lie.
     

    Treason against the United States, shall consist only in levying war against them, or in adhering to their enemies, giving them aid and comfort. No person shall be convicted of treason unless on the testimony of two witnesses to the same overt act, or on confession in open court.

    The Congress shall have power to declare the punishment of treason, but no attainder of treason shall work corruption of blood, or forfeiture except during the life of the person attainted.[1]

     

    Ironically, those who seceded were Democrats, but the parties have flipped and the Republicans are now the anti-civil rights party.

    The following statement is from Sen. Barry Goldwater, who was the 1964 Republican and Conservative candidate for president, but now would be rejected by the Conservatives and the Republicans.
     

    Mark my word, if and when these preachers get control of the [Republican] party, and they’re sure trying to do so, it’s going to be a terrible damn problem. Frankly, these people frighten me. Politics and governing demand compromise. But these Christians believe they are acting in the name of God, so they can’t and won’t compromise. I know, I’ve tried to deal with them.[2]

     

    Modern America has moved so far to the right, that Goldwater would probably be accused of being a socialist and a communist by various members of the right wing media. Sen. Goldwater also opposed government intrusion into the personal lives of LGBT people, because he was opposed to the big government that much of the right wing wants to use to force their lifestyle on everyone.

    At that time, the right wing media being condemned by Sen. Goldwater was just beginning a resurgence. The ironically named Moral Majority was preaching its Christian sharia law to gather a lot of followers. Jerry Falwell, Sr. was their leader and Barry Goldwater condemned that earlier, less powerful, Falwell. His son, Jerry Falwell, Jr. seems to be able to tell our current president what to do, but a lot of people manipulate the president.
     

    I think every good Christian ought to kick Falwell right in the ass.[3]

     

    Since the Civil War, the propaganda machine of the secessionists has been more successful. They have been able to place statues of the traitors throughout the states they led in treason to show everyone that the secessionists still maintain power in spite of being defeated on the battlefield. Why don’t we have statues of Benedict Arnold?

    We could celebrate Robert E. Lee for his opposition to secessionists after the war and for Lee’s unintentional(?) destruction of his cavalry at Gettysburg. Pickett’s Charge may have been the final straw for the Army Promoting Expansion of Slavery.

    –

    The second 210th birthday boy is Charles Darwin, who is remembered for explaining the diversity of life on Earth. Evolution explains the evidence showing the progression from the simplest life form to the current diversity of life – a diversity which appears to be decreasing due to our failure to value our children above our politics. Extinction is a part of that explanation. Extinction was once thought to be an argument against evolution, because it would violate God’s perfect plan, but eventually, extinction became undeniable, too. Oddly, people still deny biology. Evolution is so essential to biology, that Theodosius Dobzhansky wrote a paper titled, Nothing in Biology Makes Sense Except in the Light of Evolution.[4]

    It is interesting that the science denial that affects biology, Creationism, is promoted most aggressively in the same slave states Bible Belt that fought against the United States of America in favor of treating diversity as a justification for violence.

    It was science that helped the liberal Christians to convince the rest of America that slavery is wrong – something that much of the often less Christian rest of world already understood.
     

    Book that Changed America - cover 1
     

    As I wrote in 2017:

    Darwin provided scientific evidence for a common origin, which gave a scientific argument to those criticizing slavery. How is it moral to enslave other humans? Well, the Bible repeatedly endorses slavery and Jesus never criticized slavery. Jesus actually used slavery as an analogy for belief in God, with believers as slaves and the slave owners as God.

    Contrariwise, those who focused on the good parts of the Bible and avoided the bad parts, used Darwin’s book as the basis for advocating for a more moral approach to our fellow humans. Those who read the Bible differently from the advocates of slavery saw that they were not along. Science also opposed the moral abyss of slavery.

    Not to spoil the ending, but the abolitionists were not successful at reasoning with those in the Bible Belt to end slavery in America. We ended up with over 600,000 Americans dead over different interpretations of the Bible on how to treat humans.[5]

    The anti-science of Young Earth Creationism, the most basic form of Creationism, is the belief that the particular version of the God of that sect of believers literally just poofed itself into existence, then created life in its current diversity and that mutation can never produce a beneficial outcome.

    For some bizarre reason, this God has organs of evolution. A true only one of its kind creature would not be male, nor would it be female, but the plot holes are numerous and demonstrate the impossibility of the story, when promoted as accurate. What other creature(s) God need sexual organs for? How did this God evolve them? Most Christians seem to view the two contradictory Creation stories in Genesis (Genesis 1 vs. Genesis 2) as metaphorical. How else do you defend something that dramatically changes when you turn to the next page? Hallucinogens? Hypoxia? Dementia? Metaphor – it is poetic, rather than literal. At least, that is the only reasonable approach.

    Some Creationists take a shot at creating a middle approach. These not-so-literalists claim that microevolution is real, but macroevolution is impossible. These are real terms, but not the way the not-so-literalist Creationists use them.

    These Creationists see that microevolution is undeniable, so they try to move the goalposts to try to protect their belief in Separate Creation.

    Here is a further irony. These not-so-literalist Creationists claim that while they cannot deny that evolution happens on a small scale, they absolutely refuse to accept that it continues. Evolution is required to stop. Although they cannot provide any kind of evidence to support their claim and scientists provide plenty of evidence that evolution is not stopped, they continue to make this claim.

    The irony gets even greater, because when you are dealing with apologists, the excuses will differ, thus the increasing disagreements among the dozens/hundreds/thousands of flavors of Creationism. Some of these micro yes, macro no Creationists claim that the restriction on evolution prevents the development of any new species, because they just can’t seem to understand that a lot of change can produce a dramatic difference. Other micro yes, macro no Creationists claim that this restriction prevents the evolution of any new genus. They claim that the story of the Ark saving 8 people from the murderous God of the Bible is the reason. This story is borrowed from the Babylonians, who taught the Israelites to write during the Babylonian captivity.[6]

    Anyway, the story of the Ark mentions 19 Every beast, every creeping thing, and every fowl, and whatsoever creepeth upon the earth, after their kinds, went forth out of the ark.[7] This is a justification for being able to put billions of creatures on one supposedly seaworthy vessel. Not everything had evolved at the time, some evolved after their kinds after they disembarked. Two contradictions attacked with one excuse. Brilliant!

    Some of the not-so-literalist Creationists accept that evolution is possible, as long as it does not produce a new species, because that would be too much. They insist that there must be an artificial limit on evolution.

    Other not-so-literalist Creationists accept that evolution is possible, as long as it does not produce a new genus, because that would be too much. They insist that there must be an artificial limit on evolution.

    Still other not-so-literalist Creationists accept that evolution is possible, as long as it does not produce a new family, because that would be too much. They insist that there must be an artificial limit on evolution.
     


    Taxonomic Rank, from Wikipedia page
     

    No matter what they have to invoke, all flavors of Creationist insist that there is some sort of artificial limit on evolution. Some Creationists insist that all evolution is prevented, while others accept varying amounts of evolution, rather than try to reject the overwhelming evidence.

    We flawed humans must be explained, but their ambiguous creator must just be believed in all of its million different interpretations, and with all of its impossible contradictions – and all of the other Gods are just made up by people.

    –

    Footnotes:

    –

    [1] Constitution
    Article III, Section 3
    The Legal Information Institute
    Article III

    –

    [2] Barry Goldwater
    Wikiquote
     

    Said in November 1994, as quoted in John Dean, Conservatives Without Conscience (2006).

     

    –

    [3] Barry Goldwater
    Wikiquote
     

    Said in July 1981 in response to Moral Majority founder Jerry Falwell’s opposition to the nomination of Sandra Day O’Connor to the Supreme Court, of which Falwell had said, “Every good Christian should be concerned.” as quoted in Ed Magnuson, “The Brethren’s First Sister,” Time Magazine, (July 20, 1981).
    According to John Dean, Goldwater actually suggested that good Christians ought to kick Falwell in the “nuts”, but the news media “changed the anatomical reference.”
    Dean, John (2008). Broken Government: How Republican Rule Destroyed the Legislative, Executive, and Judicial Branches. Penguin Group. “I know because I was there when he said it.”(2006).

     

    A further irony is that there is nothing in the Bible that is even slightly critical of abortion, but the Bible thumpers lie about this. If you claim that Thou shalt not kill applies to abortion, you have to find someplace – any place where the Bible refers to abortion as killing. The Bible does not make that claim. The Christian sharia promoters make far more judgmental claims (judge not, lest ye be judged), because irony knows no bounds among fundamentalists.

    The Bible states that life begins with the first breath. Genesis 2:7 and Job 33:4 and that a fetus is not a person Exodus 21:22. The Biblical literalists need to reinterpret the words to massage the meaning to be able to come up with something that allows them to claim their interpretation of their God agrees with them.

    There is condemnation of divorce, by Jesus, but the religious right has chosen to vote for divorced leaders in order to get the political power that they want. Almost everything Jesus says in the Sermon on the Mount (Matthew 5-7) is a condemnation of the goals of the religious right in America today, but that is not the only place where Jesus condemns the religious right in America today.

    Why do so many right wing Christians hate Jesus so much that they blaspheme Jesus?

    If you want more information than provided above, read these:

    The ‘biblical view’ that’s younger than the Happy Meal
    February 18, 2012
    Fred Clark
    Article
     

    In 1979, McDonald’s introduced the Happy Meal.

    Sometime after that, it was decided that the Bible teaches that human life begins at conception.

     

    and

    The Not-So-Lofty Origins of the Evangelical Pro-Life Movement
    February 5, 2013
    Jonathan Dudley
    Religion Dispatches
    Article
     

    Although evangelicals were mostly silent on abortion after Roe v. Wade, they were not silent on other political issues. Paul Weyrich, one of the evangelical right’s most influential founders, recalls that the movement initially emerged to defend racially segregated Christian schools from government intrusion:

     

    Abortion was chosen as the rallying cry, because the religious right were losing ground defending segregation. Now abortion is the headline, while the religious right still work for segregation by more politically correct means.

    –

    [4] Nothing in Biology Makes Sense Except in the Light of Evolution
    Theodosius Dobzhansky
    The American Biology Teacher, Vol. 35, No. 3 (Mar., 1973)
    Article in PDF format
     

    I am a creationist and an evolutionist. Evolution is God’s, or Nature’s method of creation. Creation is not an event that happened in 4004 BC; it is a process that began some 10 billion years ago and is still under way.

     

    Does the evolutionary doctrine clash with religious faith? It does not. It is a blunder to mistake the Holy Scriptures for elementary textbooks of astronomy, geology, biology, and anthropology. Only if symbols are construed to mean what they are not intended to mean can there arise imaginary, insoluble conflicts. As pointed out above, the blunder leads to blasphemy: the Creator is accused of systematic deceitfulness.

     

    –

    [5] The Book That Changed America: How Darwin’s Theory of Evolution Ignited a Nation
    Randall Fuller

    Read ‘The Book That Changed America’ for Darwin Day 2017
    Sun, 12 Feb 2017
    Rogue Medic
    Article

    and

    Kirkus Review

    and

    January 24, 2017
    Randy Dotinga
    Christian Science Monitor
    Review

    –

    [6] The Ark Before Noah: Decoding the Story of the Flood
    Irving Finkel

    Kirkus Review

    and

    How the ark changed shape
    13 February, 2014
    Will Gore
    Catholic Herald
    Article/Interview

    Here is part of that interview with Irving Finkel from Catholic Herald:
     

    We also discuss the negative reaction that his theories might provoke in some Christian quarters. He admits that those who tend towards a literalist reading of the Bible will never be persuaded of its links to the Babylonian era.

    He hopes, though, that he is handling the topic sensitively. He is at pains to point out, for example, that, despite what some headlines have suggested, he is not claiming the Bible story to be wrong and that Noah’s Ark should be round. He has, he says, simply traced the origins of the story found in Genesis.

    Finkel has resolved to make sure he maintains a sense of humour when dealing with critics. He’s obviously very content with the conclusions he has drawn. Behind that big beard it’s not hard to detect a smile as he says: “I can’t imagine somebody will find something that proves my ideas wrong, so if people reject them it doesn’t matter. People often reject things they don’t like and not necessarily on logical grounds. If I give a lecture and people throw vegetables, then so be it.”

     

    Here is a video of a presentation by Irving Finkel.
     


     

    –

    [7] Genesis 8:19
    King James Version
    Verse at BibleHub in all versions

    .

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

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

    Wed, 09 Jan 2019 15:00:19 -0500 by
     

    I showed the problems with amiodarone for both live patients and dead patients in Part I. The higher the quality of the evidence, the less the evidence supports the use of amiodarone on humans.

    Amiodarone is all sales pitch and no medical benefit, but Dr. Kudenchuk keeps trying to spin the results like an acupuncturist, when the evidence clearly does not support Dr. Kudenchuk’s claims.[1]
     

    What else should be de-emphasized?

    Obviously, adrenaline (epinephrine in non-Commonwealth countries) for cardiac arrest. As the quality of the epinephrine research has improved, the claims of supposed benefits have disappeared.[2], [3]

    Now, the goalposts have shifted, again, and the claims are that some other dosing is safe and effective, even though the evidence to support these claims does not exist. This is alternative medicine. This is dishonest. This is experimenting on patients without any kind of ethical approval, or collection of data, or anything else that would accompany a true experiment. We are learning that we are very good at lying to ourselves, but we knew that.

    Eventually, we may be claiming that we have not studied what happens when we stand on one leg while giving epinephrine.

    How can we possibly stop using adrenaline if we have not proven that it doesn’t work when standing on one leg? How can we refuse to provide this one legged hope to patients?

    We are sorry for what we did to your _______, but we consider justifying doing something harmful, based on low quality evidence and even lower quality excuses, to be more important than the outcomes of our patients. If we don’t throw in the kitchen sink, how can we claim that we did everything we could for to your _______?
     


    Click on the image to make it larger.
    I modified the original to add the outcomes reported by PARAMEDIC2. Severe neurological impairment is the wording from the conclusion, but that would not fit. If you think that harm is not an accurate synonym for impairment, you may be dangerous to patients.
    Source of original – R.E.B.E.L. EM – Beyond ACLS: Cognitively Offloading During a Cardiac Arrest
     

    If the next revision of ACLS/ILCOR (Advanced Cardiac Life Support/International Liaison Committee on Resuscitation) does not state that epinephrine/adrenaline should be limited to use in high quality research, it will be encouraging abuse of patients.

    This is alternative medicine. This is not medicine.

    The difference is that real medicine relies on valid evidence that it works, while alternative medicine relies on marketing strategies and misinformation.

    Do you want to be treated by someone who can tell the difference between these approaches?

    Medicine requires doing what is best for the patient.

    Alternative medicine requires doing what makes the guru look best, so that the guru can keep making sales.

    The doctors promoting this unethical approach do not appear to be ashamed of what they are doing, but they keep making excuses. We need to make it clear that their excuses are not ethical.

    To all of the doctors claiming that a drip works. Demonstrate that you are ethical and competent. Show that what you are doing improves outcomes that matter to patients, in a high quality study, or stop.

    If doctors won’t do that, maybe we should add DNA (Do Not Amio) and DNE (Do Not Epi) to our list of advance directives, for those who do not think that resuscitation to a come, where sepsis and aspiration pneumonia are what we aspire to.

    –

    Footnotes:

    –

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

    Free Full Text from NEJM.

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

     

    Here are some comments from Dr. Kudenchuk, which contradict the conclusion of Dr. Kudenchuk’s study:
     

    This trial shows that amiodarone and lidocaine offer hope for bringing patients back to life and into the hospital after cardiac arrest,” said principal study author Peter Kudenchuk, M.D.

     

    This trial shows that amiodarone and lidocaine offer no hope for outcomes that matter to patients.
     

    Importantly, there was a significant improvement in survival to hospital discharge with either drug when the cardiac arrest was bystander-witnessed.”

     

    There is no truth to Dr. Kudenchuk’s claim. This is what the authors of the study actually wrote:
     

    We observed an interaction of treatment with the witnessed status of out-of-hospital cardiac arrest, which is often taken as a surrogate for early recognition of cardiac arrest, a short interval between the patient’s collapse from cardiac arrest and the initiation of treatment, and a greater likelihood of therapeutic responsiveness. Though prespecified, this subgroup analysis was performed in the context of an insignificant difference for the overall analysis, and the P value for heterogeneity in this subgroup analysis was not adjusted for the number of subgroup comparisons. Nonetheless, the suggestion that survival was improved by drug treatment in patients with witnessed out-of-hospital cardiac arrest, without evidence of harm in those with unwitnessed arrest, merits thoughtful consideration.

     

    The best that can be stated about these drugs is that if the researchers used a large enough study, they might be able to find a statistically significant result – or the researchers may demonstrate that this was just another example of a statistically insignificant run of luck, which means nothing and is just as likely to have gone the other way.

    A run of heads in a row, while flipping a coin is a reason to examine the coin for bias, but if no bias is found, it is expected to be just what is expected to happen in a large number of coin flips. A lack of understanding of coincidence leads to faulty conclusions.

    The difference in outcomes, that Dr. Kudenchuk claims is significant, not statistically significant.

    Does Dr. Kudenchuk not understand the way research works or does Dr. Kudenchuk have some unstated motive for distorting the results? It appears that the New England Journal of Medicine refused to publish the conclusion that Dr. Kudenchuk wanted, so Dr. Kudenchuk is using more gullible people to spread his misinformation.

    Go ahead and read the full paper, which is available from NEJM here.

    Also read Dr. Kudenchuk’s press release, which misrepresents the results of Dr. Kudenchuk’s study. You would think that Dr. Kudenchuk would know better.
     

    Antiarrhythmic drugs found beneficial when used by EMS treating cardiac arrest
    NHLBI NEWS|News Release
    April 4, 2016, 9:00 AM EDT
    Press Release
     

    I have nothing to hide. I want you to look all of the evidence.
     

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

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

    –

    [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.

     

    The results do not show an improvement in the any outcome that matters to patients.
     

    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.

     

    –

    [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 Jul 18. doi: 10.1056/NEJMoa1806842. [Epub ahead of print]
    PMID: 30021076

    Free Full Text from NEJM

    It appears that the full text of PARAMEDIC2 is no longer available for free from NEJM, but there is the option of registering for 3 free papers a month (Register for 3 FREE subscriber-only articles each month.) in a red pop-up banner at the bottom of the page.

    Once again, the results do not show an improvement in the any outcome that matters to patients.
     

    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.

     

    .

    Filed Under: ACLS, Cardiac Arrest, Critical Judgment, Ethics, Evidence, Heresy, Research
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