I write a lot about research. EMS research, medical research, and non-medical research. The reason is simple. If we want to know how the world works, research is the way to find out. The scientific method is the formula to tell us what works. What worked yesterday, what works today, and what will work tomorrow.
Some people become confused when there are changes in the science. They see this as science being unreliable. Just the opposite. This is science responding to new information. Science is correcting itself.
An analogy is driving a car down a road. If you do not turn, when there is a bend in the road, you will crash. The car is not defective, just because it has a steering wheel, because occasionally the wheel is used to change direction. The car is effective because it has a steering wheel.
In science, the research is the way we learn what works. We then create hypotheses about the ways that new information (the latest research) may be used to learn more about things we want to know about. Science does not progress in a straight line. Science needs to respond to new information.
Science is about making mistakes. A lot of mistakes. A few will not be mistakes. these non-mistakes, or not complete mistakes, will lead to more opportunities to make mistakes. This is what we need to encourage. It is by making mistakes that we learn.
Expert opinion is a hunch that is used by someone with experience, but it isn't specific research. Expert opinion should include all of the relevant research, but in many areas, the research is vague, or non-existent. In EMS we have had all sorts of expert opinions inflicted on our patients. Spinal immobilization. Epinephrine for cardiac arrest. Antiarrhythmics for cardiac arrest. Antiarrhythmics for chest pain patients. Furosemide for CHF. 50% dextrose for hypoglycemia. High flow oxygen for everything. Helicopter transport for almost everything. Lights and sirens. CISM/CISD. Et cetera.
We have learned that many of these treatments are not just ineffective, but harmful. Some claim that this is evidence that science does not work. No. When an expert makes a guess, and later that guess turns out to be wrong, the guess can be a part of the scientific process. The correction of the incorrect idea is the science.
Learning from our mistakes is science. Ignoring our mistakes is something that defines itself. Ignoring our mistakes is ignorant.
Some of the things I mentioned have been removed from our protocols (almost everywhere), and some are still in the protocols (almost everywhere).
These were, some still are, based on expert opinion.
All of them.
Every single one.
Expert opinion. There may have been some research that suggested that there might be some benefit from using these treatments. As those initial studies, vaguely related to the specific treatments, have been followed up with specific studies; We have learned that the expected benefit; The hoped for benefit; The wouldn't it be great idea that led to the treatment; Was not what we had hoped for. Maybe the treatment had side effects that cancelled out any benefit. Maybe the side effects were much worse than the benefits. Maybe there were no benefits.
Unfortunately, in spite of abundant evidence of lack of benefit, some of these treatments are still used. Epinephrine, antiarrhythmics, and other ALS (Advanced Life Support) treatments for cardiac arrest. In stead, we have learned that the percentage of patients we have been resuscitating is a just small fraction of those we should be resuscitating. If only we would ignore the ALS and focus on compressions and defibrillation. In many places, the resuscitation rates have tripled with the focus on continuous compressions.
There is not any research to support the use of these ALS treatments in cardiac arrest, but we insist that we must use them. Why? Because we do not understand science. We have more faith in old discredited hunches, that have not worked out, than we have understanding of the current science.
The evidence for it? What if? What about the lawyers? But we were taught . . . .
Given that solid basis, somebody must be doing research to determine if there actually is a benefit to the patient. Or to find out what the rate of side effects is.
Not a chance.
Everybody is afraid of the harm of depriving patients of this essential treatment - this Gold Standard. The IRBs (Institutional Research Boards/Institutional Review Boards) consider it unethical to deprive patients of the standard of care. In their eyes, it is much better to force an untested treatment based on expert opinion on patients. The lack of ability to provide accurate information to the patient, so that actual informed consent would be possible - this ignorant consent is essential (according to the behavior of the IRBs). This is unethical behavior.
We are required to provide information to the patient, so that the patient may make an informed decision, when possible. The IRBs are against informed consent.
The IRBs prevent us from having accurate information to provide to patients. The EMS Yahoo screaming, Do you want to be a quad?! is not really providing less information than is available from the best research in these areas. We make King Lear look like a man with vision.
However, the IRBs say that the research is unethical, and the IRBs are the ones who are there to protect patients from unethical treatment.
So, if we learn later on, from studies carried out in other countries, that the treatment itself is more harmful than beneficial, and therefore unethical to use; When you learn this remember that the IRBs are there requiring these harmful treatments, because they are protecting the patients from progress.
It is not the job of the IRB to protect the patient from progress. It is not the job of the IRB to force harmful treatments on patients. But that is what IRBs do. Rather than know more about the safety of treatments, we are forcing experimental treatments on the patients, because the IRBs will not allow the research to find out if the treatments are effective, or even safe. If there is not research to show that a treatment is effective or safe, then the treatment is by definition experimental.
Part of the role of the IRB is to protect patients from unauthorized research, but here they are forcing everyone treated to be part of a huge, uncontrolled, unapproved, undeclared, undocumented, unethical experiment. The IRBs have abandoned the patients they are supposed to be protecting.
The IRBs seem less concerned with making mistakes, than with appearing to make mistakes. If we are afraid of making mistakes, then we are afraid of learning. If we are afraid of appearing to make mistakes, then we take that ignorance to a much more dangerous level.
I was on the EMS Garage episode that is the title of this post. You didn't forget about the title already? So, now it is time to get to the point of the title. The topic of the show is research. There were many important research points brought up in the show. There was a lot of frustration among the participants - frustration with the obstacles to research in EMS. This was the topic I ranted about for a little bit.
We need to educate the IRBs about ethics. Their superficial understanding of what is good for patients is harmful and unethical. They turn down far too many studies. There needs to be more coordination among IRBs, rather than having IRB approval be a scavenger hunt for the researchers to participate in.
We need to oppose ignorant consent.
Well, that is an expanded version of my little rant from the broadcast. I will write more about this episode, but I needed to cover this rant, first.
Listen to the whole episode. It is longer than average, but the material is very important.
Science alone of all the subjects contains within itself the lesson of the danger of belief in the infallibility of the greatest teachers in the preceding generation ... Learn from science that you must doubt the experts. As a matter of fact, I can also define science another way:
Science is the belief in the ignorance of experts. Richard Feynman.
Science works differently from the way most people think. Science shows that hypotheses are valid when we cannot prove them wrong, no matter how hard we try. Most people approach hypotheses with the goal of protecting them. This hypothesis is my pet idea. I must protect it. That is the wrong approach. If we never test hypotheses to the point of failure, we never learn if the hypotheses are failures. Then we end up protecting these failures. In medicine, and EMS is a part of medicine, untested hypotheses (probable failures) kill patients.
Or we could go back to bleeding patients. If it makes you feel that bad, and even kills some patients, it has to be strong medicine. We could do that. But even the IRBs are not that unethical.
Research and EMS What are We Missing: EMS Garage Episode 53
Links to broadcast and downloads.