I've heard people say you can't randomize extremely ill patients. A trial presented at ESC proves this idea false
“Treating people is not like fixing machines. We are complicated. Treatments often lead to unintended consequences.” Great quote. This applies to public health too.
Thanks John. SCIENCE is how our species can move beyond "common sense" and "conventional wisdom" which are often ... what's the word ... WRONG! But there are many forces (cognitive, financial, reputational) opposing that methodology of progress. Sad.
Great article that should be required reading in every medical school class and post graduate medical training program. I took my cardiology fellowship during the 1970s when coronary artery surgery was being increasingly recommended for practically anyone who demonstrable disease. There were a few people who questioned whether there should be some randomized trials that showed some real benefits before widespread acceptance of the procedure. Of course they were ridiculed because the procedure "obviously made sense." Although I accepted the consensus the scientist in me still had some lingering doubts. Now long retired I still don't know if any study was ever done to answer this question.
Hopefully we will soon see an RCT of impella in CS as well. So far the biological plausibility-rubber has hit the evidence based-road in the form of a faceplant, and yet this still is used regularly. One wonders why…🤔
ECLS-SHOCK wasn't actually done on the most dire of patients (from the point of view of intensivists like me), rather it was done on patients in cardiogenic shock who could be stabilized by best medical therapy. Those who could not (in the control group) were put on ECMO. Thus this was actually a trial of ECMO before reaching dire straits versus waiting until the patient is in dire straits and then putting him on. This has been done in multiple ECMO trials and they consistently come back negative. The trial does not inform us whether or not to use ECMO on patients who have failed best medical therapy and I doubt such a trial will ever be run - though it probably should be
"Does not work"? "No difference in outcomes" ? Since when does p > 0.05 allow these interpretations? What were the most favorable confidence limits?
One would hope the study actually changes practices. The financial incentives are a strong counterforce. And the "more is better " cultural bias. I'll believe it when it happens.
I am compelled to ask the question: how did medicine get here, such that we are dependent on the "curiosity and courage" of Thiele, et al?
Is the history of ECMO observational studies in 70s (I guess 🤷♂️) what lead medicine astray in this instance?
Did ECMO RCTs Zapol, et al (1979), Morris, et al (1994), CESAR (2009), EOLIA (2014) contribute to "bio-plausibility" claims?
What exactly is the scientific threshold for "bio-plausibility"?
I do not know the history, but were there actual RCTs in animals that actually supported so-called "human bio-plausibility"?
The same curiosity and courage that fueled Thiele, et al arguable fueled the use in the first place!
So maybe curiosity and courage are being rewarded in the wrong ways too. Maybe the virtue we see here is really the preexisting vice. Curiosity and courage may in the big picture be the problem?
I concur that professional courage was required to perform the study and publish it. I'm not optimistic that such courage is contagious to the field of drug interventions. While I respect Dr Mandorla and would like to be under his care (actually), it's no longer close to uniformly true that something must be proven as true to continue its application or use.
Having read your substack, I am not confident things will change. "In medicine, you have to show something works to reduce an important outcome in real patients.
If Professor Thiele and his colleagues had not been curious and brave, we would be doing this invasive costly procedure for years. And. We would be harming patients and not knowing it."
If it makes money for the hospital, will they stop based on this new data? Maybe once insurance says they will no longer pay?