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

- Rogue Medic

Misrepresenting Current Topics in EMS Research from EMS Expo – IMMEDIATE

 

At EMS Expo, I was told that Dr. Paul Pepe also did not mention covering Intramuscular versus intravenous therapy for prehospital status epilepticus[1] without mentioning the doses of midazolam (Versed) and lorazepam (Ativan) used in his presentation on the Eagles conference. So John Studnek, PhD has some company in his omission of important information. I don’t know if Dr. Pepe covered the IMMEDIATE trial, too.[2]

If your protocol doses are to start with 4 mg of IV lorazepam or with 10 mg of IM midazolam, then the doses are not important. These large doses of benzodiazepines appear to decrease the need for intubation.[3]

I suspect that 4 mg lorazepam IV (IntraVenous) or 10 mg midazolam (IntraMuscular) will scare a lot of medical directors. They will worry about the need for intubation with large doses of benzodiazepines and switch to IM midazolam, but at a low dose that is less effective and more likely to result in intubation.
 

The second study – IMMEDIATE.

The GIK (Glucose, Insulin, and Kalium [Latin for potassium]) study was undeservedly hyped when it came out and Dr. Studnek continues that misrepresentation.

Should we ignore that the study was originally supposed to be large enough to produce statistically significant results – 15,450 people?[4]

Dr. Studnek points out that there were 911 people in the study. That is the emergency number in the US, so it can help us remember how many patients there were, but that number is before exclusions. There were fewer than 900 patients included in the study. After eliminating almost all of the 15,000 patients who were supposed to be in the study, even 911 patients is a significant disappointment.

Dr. Studnek points out that this was published in JAMA, which is a prestigious journal, so that means that it is of high quality. The week before JAMA hyped this study, they hyped a paper on helicopters in EMS that is garbage.[5]

Being published in JAMA does not mean a study is of high quality.

Should we ignore that the resulting number of patients is only 6.7% of the original and that the error bars on the results are frequently much larger than the possible benefit of treatment?

So what that there is a statistically significant improvement in one, and only one, of the secondary endpoints of the study? This is to be expected when there are that many targets. It is unlikely that everything will come up negative, especially in a study with a small number of patients.

The statistically significant improvement disappears when reassessed one month later.

Is this the epinephrine effect all over again?

Epinephrine increases the return of pulses, but fewer people treated with epinephrine survive to leave the hospital alive. This is less harmful.

The benefit disappears before discharge from the hospital.

Is that what we call success?

We can provide a statistically significant benefit that disappears when you leave the hospital!

Yawn. Let us know about treatments that make a difference in outcomes that matter.
 


Click on the image to make it larger.
 

Even the authors do not make exaggerated claims.
 

Among patients with suspected ACS, out-of-hospital administration of intravenous GIK, compared with glucose placebo, did not reduce progression to MI.[6]

 

Further studies are needed to assess the out-of-hospital use of GIK as therapy for patients with ACS.[6]

 

Maybe we should listen to the authors encouragement to not read too much into this study. Studies of 20,000 earlier patients did not show benefit.

Further study is needed, not further hype.

This is an interesting treatment idea, but it should only be used as a part of a controlled study.
 

Go read the comments of some astute emergency physicians on this study –

The IMMEDIATE trial: Should EMS give Glucose-Insulin-Potassium? by Dr. Brooks Walsh in Mill Hill Ave Command.

and

Glucose-Insulin-Potassium For MI? By Dr. Ryan Radecki in EM Literature of Note.

Footnotes:

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

Free Full Text from N Engl J Med.

[2] A View From the Eagle’s Nest: A Recap of the 2012 EMS State of the Sciences Conference
Nov 2 2012 9:30AM
Room: 210
Category: General
Paul E. Pepe
Conference schedule for Friday

Current Topics in EMS Research
Nov 1 2012 4:30PM
Room: 219
Category: Educator
Jonathan R. Studnek, Ph.D
Conference schedule for Thursday

[3] Misrepresenting Current Topics in EMS Research from EMS Expo – RAMPART
Rogue Medic
Fri, 02 Nov 2012
Article

[4] Should We Start Using a Glucose-Insulin-Potassium Cocktail
Rogue Medic
Wed, 04 Apr 2012
Article

[5] Flawed Helicopter EMS vs Ground EMS Research – Part I
Rogue Medic
Wed, 18 Apr 2012
Article

Part II

[6] Out-of-Hospital Administration of Intravenous Glucose-Insulin-Potassium in Patients With Suspected Acute Coronary Syndromes: The IMMEDIATE Randomized Controlled Trial.
Selker HP, Beshansky JR, Sheehan PR, Massaro JM, Griffith JL, D’Agostino RB, Ruthazer R, Atkins JM, Sayah AJ, Levy MK, Richards ME, Aufderheide TP, Braude DA, Pirrallo RG, Doyle DD, Frascone RJ, Kosiak DJ, Leaming JM, Van Gelder CM, Walter GP, Wayne MA, Woolard RH, Opie LH, Rackley CE, Apstein CS, Udelson JE.
JAMA. 2012 Mar 27. [Epub ahead of print]
PMID: 22452807 [PubMed – as supplied by publisher]

Free Full Text From JAMA

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