Open Letter to the European Resuscitation Council.
Dear Ladies and Gentlemen,
Since the PARAMEDIC2 Trial was published, the medical community has been actively debating the different aspects of resuscitation in OHCA. Through free online access medical education (FOAM) different authors have been interpreting the results, and commenting on ethical issues.
The German Resuscitation Council (GRC – Deutscher Rat für Wiederbelebung) posted a comment on their Facebook page on the 13th of August 2018. This is the link.
I will translate the comment for your benefit, which was written by Professor Bernd Böttiger, currently the chairman of the GRC, and member of your board, director of science and research.
“Last week Wednesday the PARAMEDIC2-Trial, a randomised, controlled trial with adrenaline compared to placebo with 8016 patients with OHCA in Great Britain was posted here. Since there have been many comments, Professor Böttiger has written up some more important facts:
– Adrenaline versus a placebo was trialled in a “paramedic” only system
– Emergency doctors were not on scene in Great Britain
– The thirty day survival rate was very very low, at 2,4% and 3,2% – in Germany this rate is 3-4 times higher
– In 2003 Professor Fischer proved in an EU-funded trial in a direct comparison of the cities Bonn and Birmingham that our physician-based system has a 4x higher survival rate than the “paramedic”-system in England https://www.ncbi.nlm.nih.gov/m/pubmed/14508702/?i=6&from=fischer%20and%20birmingham%20and%20resuscitation
– We, ourselves, could prove that the survival rate doubles through the use of emergency physicians during prehospital resuscitation in a world-wide Meta-Analysis https://www.ncbi.nlm.nih.gov/m/pubmed/26747085/?i=1&from=b%C3%B6ttiger%20and%20knapp%20and%20resuscitation
– The trial drug (adrenaline or placebo) was given 21 minutes after the emergency call, although the ambulance service was on scene very very quickly, in just under 7 minutes (median 6.5 min). The vasopressor was only used very very late, and we know very well – again from trials: the sooner adrenaline is administered, the better it works. In physician-based systems this happens much faster. One might say: 21 min after the call the patients were were so dead – as displayed by the very bad survival rates – that their heart could be restarted, but the brain couldn’t be.
– and another thing: only about 70% of the patients of this adrenaline-trial received an i.v. line, the other 33% received an intraosseous line – and that is usually done only if you cannot establish an i.v. line in a certain time…
– It’s a similar story with the airway management in the adrenaline trial: 71% received an extraglottic airway, and only 30% were intubated (ETI)…
– A high percentage of patients was taken to hospital during CPR…
– SO IN CONCLUSION the most impressive thing in the negative sense was the very very low survival rate – both with and without adrenaline – despite a bystander CPR rate of 60%! How can or should one explain that, other than because of a system, that perhaps can or must be improved greatly?
– So therefore my clear statement: Our OHCA survival is luckily 3-4 times better and if this is the case then we don’t know if adrenaline might help or not in our quite obviously much better outcome-associated system….
– SORRY, I believe if one is really sick, and one’s life is in danger, then a well trained doctor is helpful. That goes for situations in prehospital and hospital settings, and in hospitals doctors are probably helpful…. That’s what I think….
– I therefore plead in favour of our nation wide cooperative ambulance and emergency doctor system which should be in high regard and maintained.
Thank You”
There are a number of things I find irritating about this commentary.
I kindly ask if you could elaborate on some points, for example, is the 30 day survival in Germany and the UK comparable, or are there aspects which must be taken into consideration when comparing these numbers?
For instance the low survival rate of the trial could be explained by some 600 patients having ROSC early, and therefore not being included in the trial and subsequently not being included in the trial results?
Are you aware of reasons which could contribute to the long time from arrival of EMS until administration of adrenaline? Does the UK use single responder paramedics and could the challenges faced by such a single responder help explain these times?
Professor Böttiger states that an emergency physician on scene will improve OHCA survival rates by 50 to over 200%, can you elaborate on this point?
Professor Böttiger’s statement has caused confusion and uncertainty inside the German paramedic and emergency medicine community, is this comment an accurate depiction of the current data regarding OHCA and ALS-CPR? If so, will you be recommending introducing doctor-based EMS in all European countries?
Thank you to everyone involved in the ERC and national RCs for your valuable work, in giving providers guidance on the best possible course of action based on evidence. Please help us understand this statement better.
Respectfully,
Michael Stanley
Dass sind ein paar gute Punkte die du da anrürst. Allererst, bitte ich um Vergebung für die sicherlich reichlichen Schreiebefehler in meinem Deutsch. Est ist nicht meine Muttersprache und geschrieben fallen ein par Sachen immer viel mehr auf als im Gespräch.
Wass mir noch fehlt, in einer Zeit wo wir ‚Evidence Based‘ (mit recht!) als Norm verheben haben, ist die grosse Schierigkeit die wir zu scheinen haben mit der Interpretation von der Statistik.
Auch im Paramedic-2 trial sehe ich meine Befunden aus der Praxis korrekt zurück, lese aber die ganze Zeit einen völlig umgedrehten Fazit von jedem der die Studie anholt!
Dies ist Statistik, kein ‚Glass halb voll oder halb leer‘-punkt! Offenbar brauchen wir jede menge Besserung in dieser Fähigkeit. Wie letztlich in einer Amerikanischer Studie den Fazit gezogen wurde, nach einem statistischen Verband zwischen light-Getränke und Obesitas, dass Light-Getränke wohl zu Obesitas führen könnten(??), so klaut die Paramedic-2 Studie den Teufel über 20 Wanabe-Toten von der Karre mit ein bischen Adrenalin und konkludiert dann, dass in der viel grösseren Gruppe vond ROSC-patienten, den neurologischem Outcome PROZENTUAL niedriger war! Dass ist ja wie der Doktor der eine 100% Überlebensrate und 0% Komplikationsrate hatt, aber nur Patienten mit unkomplizierter Blasenentzündung behandelt!
In der Placebo-gruppe sind diese über 20 Patienten ja braf verstorben! Da wiegt man deren neurologischem Outcome ja nicht mehr mit! Damit macht die Studie sich meiner Meinung nach dann auch am klassischem ‚Selection-Bias‘ schuldig. Adrenalin wird in dieser Studie gar nicht geprüft auf neurologischem Outcome, sondern auf Überlebensrate. Wenn mann die neurologischen favourable Outcome hätte testen möchten, muss das geschehen gegen ein anderes Medikament oder Placebo mit gleicher Überlebensrate. Oder man soll die viel grössere Gruppe korrigieren und die extra-überlebenden Patienten mit schwerster Betroffenheit aus der Gruppe weg-korrigieren.
Ich würde daher gerne aufrufen zur Abschliesung aller Studien IMMER mit einen deutlichem Fazit zu kommen und explizit alle andere möchliche Fazitte aus dieser Datensatz aus zu schliessen.
Denn von den 24 oder 28 Patienten die mit dem Adrenalin das Leben gerettet wurden, haben nicht alle einen schlechtem neurologischem Outcome. Wenn dies deine Oma oder Vater betreffen würde, wass hättest du den gerne welchen Protokoll gefolgt würde?
FvH – ElMecky