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

- Rogue Medic

What Will Be the Next Standard Of Care We Eliminate

We have too many harmful Standards Of Care. Which will be the next to go?

Will it be Spinal Immobilization using a long spine board, straps, head blocks, and a cervical collar?

Will it be epinephrine in cardiac arrest?

Will it be amiodarone or lidocaine in cardiac arrest?

Will it be ventilations by EMS in cardiac arrest?

Will it be the idea that any treatment can become the Standard Of Care without any evidence of improvement in patient outcomes?

None of these have any evidence that they improve outcomes.

We have put ourselves in a difficult situation, where people claim that it would be unethical to find out if these treatments work. If medicine is about providing the best care to patients, then how can we use fashion to determine what is required patient care, even when all of the research shows that the Standard Of Care is harmful?

From the very beginning of the use of amiodarone in cardiac arrest, the idea of making amiodarone a Standard Of Care was rejected by emergency physicians.

AAEM Position Statement: Use of Amiodarone in Refractory Pulseless VT/VF
“It is the position of the American Academy of Emergency Medicine that the use of amiodarone in refractory pulseless ventricular tachycardia or ventricular fibrillation (VT/VF) should not be considered the current ‘standard of care’ for this condition. The Academy does not condemn non-research use of amiodarone given the absence of any proven beneficial alternatives, however, there is currently no reason to conclude that its use is mandatory or represents a ‘standard of care.’ Until ongoing or future research clarifies this issue, emergency physicians should use their own discretion regarding antiarrhythmic therapy in patients with cardiac arrest.”[1]

Has anything changed?

Where is the survival research that was supposed to convince us that amiodarone did not just result in more people dying in the hospital?

They state this about High-Dose Epinephrine (HDE) –

Although it was assumed by some that a medication that is associated with improved ROSC and survival to hospital admission would also be associated with improved survival to hospital discharge and neurologic recovery, this was never the case with HDE. Subsequent studies confirmed that HDE in adult victims of cardiac arrest is not associated with an improvement in patient survival to hospital discharge or neurologic recovery (14-20). As a result, the use of high dosages of epinephrine is no longer recommended in the most recent Guidelines (5). =[1]

Does the AAEM consider the ACLS Guidelines to set the Standards Of Care?

Conclusion: This Working Group finds that the use of amiodarone in refractory pulseless VT/VF should not be considered “standard of care” for this condition. Indeed, it could be argued that amiodarone should only be used in cardiac arrest (if at all) in the context of further study protocols. Nevertheless, the Working Group believes it would be inappropriate to condemn non-research use of amiodarone, given the absence of any proven beneficial alternatives. On the other hand, there is certainly no reason to conclude that its use is mandatory, or represents a “standard of care.” Ongoing and future studies may clarify this issue, but until such time, emergency physicians should use their own discretion regarding antiarrhythmic therapy in patients with cardiac arrest.=[1]

Apparently not.

How long did it take to even start a study looking at survival from cardiac arrest with groups randomized to amiodarone, and placebo (with lidocaine thrown in as a crowd favorite in some areas)?

Why are we going to have results from this study?

Drug: amiodarone

300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists.
Other Name: PM 101, Nexterone[2]

It is interesting that there is no mention of epinephrine. Based on the attitude of the investigators toward epinephrine, I don’t think they will be omitting that drug, but there is no mention of epinephrine, or any other pressor, in the study description.

Detailed Description:
The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (PM101) compared to placebo.

The corresponding null hypothesis is that survival to hospital discharge is identically distributed when out-of-hospital VF/VT arrest is treated with PM101 or placebo.

The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of:

  1. Lidocaine compared to placebo
  2. PM101 compared to lidocaine The corresponding null hypotheses are that survival to hospital admission is identically distributed when out-of-hospital VF/VT arrest is treated with lidocaine as compared with placebo, and with PM101 as compared with lidocaine.[2]

This study is expected to last 3 years and enroll 3,000 patients in three arms in an attempt to refute what people have been saying since the 1990s – Amiodarone just changes the location of death.

September 2015 is the estimated completion date, so this is unlikely to affect the next revision of ACLS (Advanced Cardiac Life Support) Guidelines.

Footnotes:

[1] Position Statement on the Use of Amiodarone in Refractory Pulseless VT/VF
The AAEM Amiodarone for Refractory VT/VF Working Group is comprised of Amal Mattu, MD FAAEM, Carey Chisholm, MD FAAEM, and Jerome R. Hoffman, MA MD FAAEM.
American Academy of Emergency Medicine
Position Statements
May 5, 2001
Position Statement

[2] Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (ALPS)
ClinicalTrials.Gov
Last Updated on September 21, 2011
ClinicalTrials.gov Identifier: NCT01401647
Trial data

.

Comments

  1. I say the next standard of care will be to get rid of EMS providers such as you and myself. That is to say, those that think, question, and are not little automatons/good little soldiers will be winnowed out of the industry to make place for the non thinking, the protocol says this and doesn’t piss off anyone so that the managers/medical directors/chiefs don’t have to deal with complaints about EMS that didn’t give the patient what they “need(want)”. Just my two cynical cents.

    • You may very well be right, Clowns Will Eat Me (is that a Native-American name?) I’m retired now, after being in EMS from 1972 to 2007. Even in the pioneer days, nobody was particularly pleased with having input from independent free-thinking individuals who were actually the ones doing the job. There were always “experts and authorities” far better equipped to figure that stuff out. The fact that many of them didn’t know which end of the ambulance to put the gurney in was beside the point. I was always considered a loose cannon and a cowboy for trying to be my patients’ primary advocate for beneficial care with proven positive outcomes.

  2. Those of us that think are a dying breed. We are not only being replaced by “automatons/good little soldiers”, we are being replaced by those that can’t wait to dive into the drug box hoping to actually sava a life. No one ever teaches paramedic students that sometimes the best treatment for the patient is a bolus of diesel fuel. Its unfortunate that the new paramedics don’t want to listen to anyone who actually has a clue.

    • I’m the paramedic student that is looking to learn from those with experience.
      I will ask several current medic the same question, not for a definitive answer, but to understand different approaches to a difficult answer.
      When I’m ready, ill gladly take the torch!

  3. I disagree @preach on. I’m a new paramedic and I know that even though I have the classroom
    Knowledge I dont have the many years of experience that an older medic has. I find myself asking another medic or even an EMT partner on some calls what they think. After all what we do is for the good of the patient. First do no harm, right?

  4. New Medic from my experience you are not the norm. When I was a new medic I constantly asked questions. I listened to what those around me said. If I had not listened then I would have been put in my place. When you are riding with a very seasoned medic, remember you have two ears and one mouth, use them accordingly.

  5. I have to agree with “medicboymatt”, I’m glad I’m retired too. The “cookbook” medic is becoming the norm. Nothing personal, it is the nature of the beast now. Nothing proactive anymore. And alot of it has to do with the fear by medical directors of being sued by unscrupulous lawyers.
    The ones I feel the most sorry for are the military field medics coming out of service to civilian EMS. These are people saving lives in combat and now have to ask permission to do simple, common-sense things. I was fortunate (for the most part) to work under medical directors who let us work in the field without them having to “look over our shoulder” every minute. We were allowed to treat protocols as guidelines, not the absolute.
    Good luck to all people in and getting into EMS.

  6. I think some of those who have commented above are a bit overly cynical. I see a lot of good thinking medics both in ems now and currently being trained. There are about the same percentages as I saw in the old guard if not even more in the new medics I see. It could be a regional thing. Drugs in cardiac arrest will always be changing because of research, because of business models, and because of a million different reasons. What should be the next to go in my opinion is universal immobilization. Despite the flak I get from the powers that be and the powers that want to be, the evidence shows it is rarely if at all helpful, and often harmful.
    I’d like to weigh in on amiodarone as well. I agree that it does often only change the location of death. However I have seen it work well and folks go home too. Even if that were not the case “Merely changing the location of the death” is a big deal and a great service to the families who continue on. We live in a scattered society. If letting a patient hang on a few days more for the family to gather is all that a few hundred milligrams of pacerone buys us, isn’t that worth it? Have you never wished you had one more day to get where you needed to be to say goodbye to a loved one? I damn sure have.
    What I fear coming down the pipe is not the research driven changes that guide us toward better and more effective care, but the changes driven by the bottomline. Changes born of the sham that has been labeled healthcare reform. Changes that help the budget but not the individual patient. EMS under “Obamacare” is a creature we have not yet known or faced in the trenches, but I have seen it’s shape and smelled it’s breath. It is a new creature and I see little real good in it.

  7. The problem is that “Standard of Care” is a legal term, not a medical term. As long as medicine is dictated by the legal system (via lawsuits and micro-managing legislators), the “old tried and true” remedies will remain in place. TOTWTYTR has another explanation why studies that are medically necessary will not be done for non-medical reasons: http://tooldtowork.com/2012/03/detective-work/

    Preach On,

    I was hoping this wouldn’t get sidetracked into a “damn kids”/”damn old-timers” back and forth. Maybe it’s the fact that I’m relatively new to EMS but in my 40’s that affects my perspective; but I’ve seen the problem isn’t the age or experience of the medic, it’s the attitude. In fact the attitude of listening but not speaking out (i.e. two ears, one mouth) is exactly what Can’t Say is trying to avoid. Be respectful, certainly; but never blindly believe the older medic’s statements just because he’s an older medic.

  8. I’m afraid with all this new ALS protocols, are out weighing the fact that we have forgotten our BLS “standard if care”. We as medics just jump at the chance to use all the new equipment and meds out there and forget about what really works.
    I have been a medic for 23 years, there’s not much I haven’t seen. I have traveled to gorrific disasters and the one thing our superiors kept drilling in us is don’t forget the basics. You can’t do any ALS without your basic assessment. I have taught several basic, I’s and medic classes, and I don’t ever let them forget what they learned as basics. Maybe medics save lives I think it’s cuz they don’t forget their roots.

  9. @Roguemedic. After reading a number of your blogs I have come to the following conclusion. Your purpose in writing is not to make, those reading, better medics. Rather it is to create controversy, and try to make statements that you are not qualified to make. You have based your whole position on this epi debate on an OPINION paper. Before you start beating your drum, wait for the FACTS. Before you say it, I know that reading a blog is a choice. I choose to stop reading yours. Thank you for you time.

    • SARmission, please stop reading here, and thank you. I for one like the controversy, the one thing always reminding one here is do your BLS, with out it there is no ALS or incorrect ALS. Sometimes less is better, advocate for your patients best interest, controversy leads to discussion, which is ment to not be gossipal as they say but to think for yourself and cause one to think, one of the first things I was taught other than a few of the above was not to judge a patient or someone in our field. After 30 years it still holds true, what will be the next thing we let go, who really knows, but my top would be the ever present C-collar head boards ect, for everthing. I recently learned there is a huge diffrence in the way one feels in this respect from a diffrent point of view, of being in the stretcher instead of beside it.

  10. Sometimes, you have to stop and take a breath. Before everyone starts beating their breasts and wresting your garments, stop and breath. These discussions are a great sounding board to explore almost every conceivable angle regarding the “Standards of Care”. What’s right in every situation? What’s right in your situation? Whats wrong to do in any situation is probably more easily definable. I learn some new things every time I read any blog, but the fact remains, knowledge is akin to grocery shopping, you don’t buy everything just the things you need. Policy dictates what we should do in the ideal situation/scenario. But, as you all know, Murphy is the third rider on most shifts. But I digress, until policy changes in my organization and comes down the pike, I will continue to work within the parameters of our protocols and do what’s in the best interest of the patient.

    • WitchDr,

      But I digress, until policy changes in my organization and comes down the pike, I will continue to work within the parameters of our protocols and do what’s in the best interest of the patient.

      You do need to work within your protocols, but there is no evidence that doing so is in the best interest of the patient.

      You do not have to remain silent about the problems with the protocols, because we can get the doctors to change the protocols.

      .

  11. I have to agree with “medicboymatt”, I’m glad I’m retired too. The “cookbook” medic is becoming the norm. Nothing personal, it is the nature of the beast now. Nothing proactive anymore. And alot of it has to do with the fear by medical directors of being sued by unscrupulous lawyers.

    Definitely this is becoming more and more common. Unfortunately, the other thing that seems to be happening at the same time is that those “cookbook medics” not only seem to have no ability to think critically, but they also seem to have no respect for those who do. And it is frustrating.

    The remedy for this involves patience, but I do believe that some of these type of medics can still be taught to think critically. Many newer medics that do have this skill have decent experience as BLS providers, and as it was so eloquently put in a previous reply, they haven’t forgotten where they came from. It seems to be the ones who either have very little or no BLS experience that are struck with the “cookbook medic” syndrome. But we continue to work on those folks as well in the hope that they will come around.

    You do not have to remain silent about the problems with the protocols, because we can get the doctors to change the protocols.

    This is certainly true, at least in principle. And in some places, the docs do listen. In others, they simply don’t, and that seems to vary from state to state. Right now I work in two states (at one point I was licensed in four, all with varying degrees of active on-line participation by medical control) and the differences I see as to how EMS providers of any level are dealt with are as different as night and day. It’s both puzzling and frustrating at the same time.

  12. I think the whole problem with the Standard of Care driven Protocol is that it’s being conceived by anonymous bureaucrats and attorneys deep within the System I remember some years back – I was on my county’s Medical Control Authority, and wound up being appointed to A committee charged with updating our state’s Master Protocols. Admittedly, I had two strikes against me going into it: I was a field provider, and I was still a Basic EMT, so naturally I was treated like a retarded cousin that is best left locked up in the attic.

    We had thought that we were actually going to rewrite the Master Protocol, but this was not the case. We were presented with the proposed revision, and were expected to rubber-stamp it. Nobody seemed to know exactly who originated the revision. Many of us were disappointed, as it did not address what we felt were emerging scenarios – for example, Mass Casualty Incidents, Bio-terrorism, and emerging virulent infectious diseases (Ebola, etc). we dutifully made our annotations and recommendations, and turned it in. It was ultimately published as originally written by the anonymous bureaucrats. I realized then that the situation was indeed truly hopeless.

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