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

- Rogue Medic

Are We Killing Patients With Parochialism?

Tue, 02 Oct 2018 15:00:29 +0000 by 2 Comments
 
The variation in approaches to resuscitation in EMS is tremendous.

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

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

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

 

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

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

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

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

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

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

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

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

 

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

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

 

There is a lot of variability.

What did they find?
 


 

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

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

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

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

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

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

What is more important than the outcomes for our patients?
 

Why are we so overwhelmingly bad at resuscitation?
 

What are the authors’ conclusions?
 

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

 

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

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

 

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

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

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

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

How dare I call them liars?

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

Have them stop making excuses and start producing results.

I dare them.

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

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

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

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

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

–

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

–

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

Free Full Text at JAMA

–

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

And more.

 

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

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

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Footnotes:

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

Free Full Text from JAMA Cardiology

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

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

Tue, 28 Aug 2018 16:05:09 +0000 by 1 Comment
 
Also to be posted on ResearchBlogging.org when they relaunch the site.

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

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

 

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

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

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

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

 

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

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

 

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

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

 

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


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

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

 

We should start doing what is best for our patients.

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

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

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

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

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

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

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

–

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

–

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

Free Full Text at JAMA

–

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

And more.

 

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

–

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

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

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

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

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Footnotes:

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

Abstract from JAMA.

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

Free Full Text from JAMA.

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

Abstract from JAMA.

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

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

Sat, 21 Jul 2018 19:15:59 +0000 by Leave a Comment
 
Also to be posted on ResearchBlogging.org when they relaunch the site.

Do we have to stop using epinephrine (adrenaline in Commonwealth countries) for cardiac arrest?
 


 

PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest) compared adrenaline (epinephrine) with placebo in a “randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest”.[1]

The results showed that 1 mg of epinephrine every 3 – 5 minutes is even worse than I expected, but a lot of the more literate doctors have not been using epinephrine that way. What does this research tell us about their various methods? The podcast REBEL Cast (Rational Evidence Based Evaluation of Literature in Emergency Medicine) has a discussion of this question in REBEL Cast Ep56 – PARAMEDIC-2: Time to Abandon Epinephrine in OHCA?.[2]

The current ACLS/ILCOR (Advanced Cardiac Life Support/International Liaison Committee on Resuscitation) advice on epinephrine does not state that epinephrine is a good idea, or even require that you give epinephrine to follow their protocol –
 

The major changes in the 2015 ACLS guidelines include recommendations about prognostication during CPR based on exhaled CO2 measurements, timing of epinephrine administration stratified by shockable or nonshockable rhythms, and the possibility of bundling treatment of steroids, vasopressin, and epinephrine for treatment of in-hospital arrests. In addition, the administration of vasopressin as the sole vasoactive drug during CPR has been removed from the algorithm.[3]

 

What was the ACLS/ILCOR advice in the 2010 guidelines?
 

The 2010 Guidelines stated that it is reasonable to consider administering a 1-mg dose of IV/IO epinephrine every 3 to 5 minutes during adult cardiac arrest.[4]

 

This is in a paragraph that links to the PICO (Population-Intervention-Comparator-Outcomes) question that has been an open question for over half a century – In cardiac arrest, is giving epinephrine better than not giving epinephrine?[5]

They only considered it reasonable, based on low quality evidence.

What was the ACLS/ILCOR advice in the 2015 guidelines?
 

Standard-dose epinephrine (1 mg every 3 to 5 minutes) may be reasonable for patients in cardiac arrest (Class IIb, LOE B-R).[6]

 

Again, ACLS/ILCOR only considered a dose of epinephrine to be reasonable. Again, this was based on low quality evidence. I am not criticizing the efforts of those who worked on the Jacobs study of adrenaline vs. placebo, because they were stopped by the willfully ignorant opponents of science.[7]

What about the method of attempting to titrate an infusion to the hemodynamic response, which Dr. Swaminathan and Dr. Rezaie alluded to?

There is a lot of anecdotal enthusiasm from doctors who use this method, but I do not know of any research that has been published comparing outcomes using this method with anything else. How do we know that the positive reports from doctors are anything other than confirmation bias? We don’t.

This year is the 200th anniversary of the publication of the very first horror novel – Frankenstein; or, The Modern Prometheus. The doctor in the novel used electricity to raise the dead (and the subjects were very dead). There were no chest compressions in the novel, but it is interesting that we have barely made progress from the fiction imagined by an 18 year old with no medical training, although she did have the opportunity to listen to many of the smartest people in England discuss science. Mary Godwin (later Mary Wollstonecraft Shelley by marriage) was 16 when she started writing the novel.[8]

We have barely made more progress at resuscitation than a teenager did 200 years ago in a novel. Most of our progress has been in finally admitting that the treatments we have been using have been producing more harm than benefit. Many of us are not even that honest about the harm we continue to cause.

We dramatically improved resuscitation in one giant leap – when we focused on high quality chest compressions and ignoring the medical theater of advanced life support.

There are two treatments that work during cardiac arrest – high quality chest compressions and rapid defibrillation.

Why haven’t we made more progress?

We have been too busty making excuses for remaining ignorant.

We need to stop being so proud of our ignorance.

We now know that amiodarone doesn’t work for cardiac arrest (and is more dangerous than beneficial for ventricular tachycardia – even adenosine appears to be better for VTach), atropine doesn’t work for cardiac arrest, calcium chloride doesn’t work for cardiac arrest (unless it is due to hyperkalemia/rhabdomyolysis), vasopressin doesn’t work for cardiac arrest, high dose epinephrine doesn’t work for cardiac arrest, standard dose epinephrine doesn’t work for cardiac arrest – in other words, we have tried all sorts of drugs, based on hunches and the weakest of evidence, but we still haven’t learned that there isn’t a magic resuscitation drug.

Should anyone be using any epinephrine to treat cardiac arrest outside of a well controlled study?

No.

–

Also –

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

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Footnotes:

–

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

Free Full Text from NEJM

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

Protocol

Supplementary Appendix

Disclosure Forms

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

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

Free Full Text from NEJM

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[2] REBEL Cast Ep56 – PARAMEDIC-2: Time to Abandon Epinephrine in OHCA?
Anand Swaminathan, MD and Salim Rezaie, MD, FACEP
July 20, 2018
Episode 56 and show notes

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[3] Introduction
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Mark S. Link, Lauren C. Berkow, Peter J. Kudenchuk, Henry R. Halperin, Erik P. Hess, Vivek K. Moitra, Robert W. Neumar, Brian J. O’Neil, James H. Paxton, Scott M. Silvers, Roger D. White, Demetris Yannopoulos, Michael W. Donnino
Circulation. 2015;132:S444-S464, originally published October 14, 2015
https://doi.org/10.1161/CIR.0000000000000261
Introduction – scroll down to the last paragraph

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[4] Vasopressors in Cardiac Arrest: Standard-Dose Epinephrine
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Mark S. Link, Lauren C. Berkow, Peter J. Kudenchuk, Henry R. Halperin, Erik P. Hess, Vivek K. Moitra, Robert W. Neumar, Brian J. O’Neil, James H. Paxton, Scott M. Silvers, Roger D. White, Demetris Yannopoulos, Michael W. Donnino
Circulation. 2015;132:S444-S464, originally published October 14, 2015
https://doi.org/10.1161/CIR.0000000000000261
2010 epinephrine advice

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[5] Epinephrine Versus Placebo
ILCOR Scientific Evidence Evaluation and Review
Epinephrine Versus Placebo

 

Among adults who are in cardiac arrest in any setting (P), does does the use of epinephrine (I), compared with compared with placebo or not using epinephrine (C), change Survival with Favorable neurological/functional outcome at discharge, 30 days, 60 days, 180 days AND/OR 1 year, Survival only at discharge, 30 days, 60 days, 180 days AND/OR 1 year, ROSC (O)?

 

–

[6] 2015 Recommendation—Updated
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Mark S. Link, Lauren C. Berkow, Peter J. Kudenchuk, Henry R. Halperin, Erik P. Hess, Vivek K. Moitra, Robert W. Neumar, Brian J. O’Neil, James H. Paxton, Scott M. Silvers, Roger D. White, Demetris Yannopoulos, Michael W. Donnino
Circulation. 2015;132:S444-S464, originally published October 14, 2015
https://doi.org/10.1161/CIR.0000000000000261
2015 Recommendation—Updated

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[7] 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.

 

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[8] Frankenstein
Wikipedia
Article

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Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 7.

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Filed Under: ACLS, Correction, Critical Judgment, Epinephrine, Research Blogging

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

Thu, 19 Jul 2018 14:40:46 +0000 by 3 Comments
 
Also to be posted on ResearchBlogging.org when they relaunch the site.

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


 

Even I overestimated the possibility of benefit of epinephrine.

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

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

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

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

 

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

The best outcome was no detectable neurological impairment.
 

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

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

 


Click on the image to make it larger.
 

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

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

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

I will write more about these results later

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

–

Also see –

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

–

Footnotes:

–

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

Free Full Text from NEJM

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

Protocol

Supplementary Appendix

Disclosure Forms

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

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

Free Full Text from NEJM

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

Anti-Vax Doctors Lack Competence and Ethics

Sat, 30 Jun 2018 18:40:47 +0000 by Leave a Comment
 
 

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

Who are the dangerous doctors Bob Sears will be joining?

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

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

 

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

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

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

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The kiddie castrators – David Geier and Mark Geier.

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

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

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

Do you ask for evidence?

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

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

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

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

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

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

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

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

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

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

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Vaccines save millions of lives every year.

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

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

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

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

Look at the evidence.

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

Free Full Text Article from JAMA.

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Footnotes:

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[1] Aftermath of initial controversy
Andrew Wakefield
Wikipedia
Article

The referenced article by Brian Deer is:

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

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

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[2] Deer counter-response
Andrew Wakefield
Wikipedia
Article

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[3] Medical licenses revoked
Mark Geier
Wikipedia
Article
 

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

 

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

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

 

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

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

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

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

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

Why do people deny they are having heart attacks? NSFW language in video

Thu, 31 May 2018 23:30:43 +0000 by 2 Comments
 

Why is this NSFW (Not Safe For Work)? Because some of the language in the video is not appropriate for some workplaces.

Why have Keven Smith talk about a heart attack?

Because we generally do not get an opportunity to have the patient explain what they were thinking while they were having the heart attack. We have to negotiate with the patient to be able to assess the medical condition properly, but we don’t usually have the time to have an extended discussion about why the patient is not feeling cooperative.
 


 

When did he realize that his significant family history of heart disease was causing his problems? Apparently, not until after the words heart attack were used by EMS.

How can people try to deny that the chest pressure, difficulty breathing, diaphoresis, nausea, et cetera are not a heart attack? Because it is natural for our species to assume either of two extremes – that bad things happen to other people or that bad things always happen to me. We are not good at being reasonable.

I had a cardiologist as a patient. He had the same presentation.

I was able to show him 9 of the 12 leads (not the augmented leads, because we did not have a 12 lead capable monitor). He admitted that the ST segment elevation was consistent with an acute myocardial infarction. He refused to leave.

As a cardiologist, he could easily explain that he understood cardiology better than I do, and therefore did understand the gravity of the situation.

He was answering all questions appropriately.

He felt that he would ruin the event he was attending if he left in an ambulance. His shirt was covered with what had been the contents of his stomach an little earlier. Nobody suggested that he should stay at the event.

Some men you just can’t reach.

How do you get someone to accept reality, when he adamantly insist that his opinion is real and that the evidence is wrong?

We did not end up back at that location the rest of the night and nobody else was dispatched to that location, so it appears that he did not drop dead right away. Beyond that, I don’t know. Maybe he was smart enough to see a fellow cardiologist soon after. Maybe it was something other than a heart attack. If it was a heart attack, maybe it was minor.

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Filed Under: Cardiology, Critical Judgment, Heresy

Happy Friday the 13th – Only Ten Days to the Next End of the World

Fri, 13 Apr 2018 17:53:53 +0000 by Leave a Comment
 
I hope that you have been out enjoying the day as much as I have. You have two extra days to procrastinate, before taxes are due this year on the 17th.

The End of the World isn’t coming until after taxes are due, so don’t let that discourage you.

What will we do when the brimstone hits the fan, this time?[1]
 


 

The same thing we did last time, and the time before that, and the time before that, and . . . .

We will listen to more excuses.

There have been many Ends of the World, but nobody seems to have noticed.

We need to demand better Ends of the World.

Why do prophets get away with such low standards?

We should notice something.

Maybe I should sell End of the World protection amulets.
 

This survived the last End of the world, and the one before that, and the one before that, and . . .

Clearly, this is extremely effective and reusable.

Act now.

Your supply of gullibility may be limited.

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Footnotes:

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[1] End of the world 2018: Will the Rapture occur on April 23? SHOCK prediction says YES
THE end of the world could be arriving sooner than we thought, as a new theory suggests we are now in the ‘end times’. Could this shock prophecy be true? Will the Rapture occur on April 23?
By Owen Gough
Published: 07:09, Fri, Apr 13, 2018 | Updated: 11:36, Fri, Apr 13, 2018
Article

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Filed Under: Heresy, Mythology, Superstition

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

Mon, 26 Mar 2018 08:20:13 +0000 by 1 Comment
 

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

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

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

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

Yes.

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

We don’t know.

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


 

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

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

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

Have we given informed consent to that kind of experimentation?

Ignorance is bliss.

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

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

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

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

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

Nothing else.

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

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Footnotes:

–

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

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[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.

 

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

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

 

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

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