If you are doing almost anything related to health care today, being
“evidence based” is de rigueur. Even when it is not obligatory to do so, claiming
to be “evidence based” conveys a measure of credibility nowadays that is valuable
to have.

So state Earl Steinberg and Bryan Luce in “Evidence Based? Caveat Emptor!” (Health Affairs 2005;24(1):81-92. If you Google for “evidence based medicine”, 1.3 million hits pop. Something is afoot, and patients and providers need to understand it.

The term “evidence based medicine” is relatively new. Beginning in the 1990’s, investigation into medical variation, both because of differences in quality and differences in cost, began in earnest. Perhaps the most famous product of this investigation is “To Err is Human”, the Institute of Medicine’s publication that rang the alarm bell concerning the large number of deaths due to improper medical care. The book can be read online here: http://www.nap.edu/openbook.php?isbn=0309068371

David has an interesting slide of Charles Handy sigmoid curves that explains the relationship of utility to management paradigm over the last century, and now is a good time to introduce it. (Sorry, but my attempt to embed the photo here has been unsuccessful–it can be found on virtually all of his recent presentations under “Resources”) The curves are instructive as they trace the utility from Scientific Management though Systems Thinking and into Sense-Making. Evidence Based Medicine grew out of the application of systems thinking to health care.

But I am perhaps getting ahead of myself. The non-physician must understand that the “scientific method” has been hammered into medical education every since the Flexner Report of 100 years ago placed medical education under the university system with grounding in “hard” science of anatomy, physiology, pharmacology, pathology, etc.. At the time, it was necessary, as so much of medicine was based upon bogus opinion. It is interesting that I was taught that, almost without exception, the “scientific method” involved what has been termed “OFAT” investigation. To understand a problem, it is reduced to its smallest component parts by varying “one factor at a time” and testing the results. One of the tests I used to evaluate the significance between categorical data was the “Fisher’s Exact Test”.

It is fascinating to read the history of Sir Ronald Aylmer Fisher http://en.wikipedia.org/wiki/Ronald_Fisher While at the Rothamsted Experimental Station in Hertfordshire, he was faced with the need to evaluate soil and seed samples. The outcome was his famous “design of experiment” that allowed for the investigation of multiple factors with minimal experimentation and the added benefit of analysis of interaction of factors. FISHER WAS A FARMER!! If only I had been exposed to that side of his work, and not just the side that dovetailed with the reductionism that so pervaded medical education, and persists to this day.

Once again, I find it so helpful to return to the Cynefin Framework in understanding how evidence based medicine fits into the overall picture of health care. The whole thrust of EBM is that there is ONE (or at most, a couple) of best answers for the given problem. In some areas of medicine, that is indeed the case. It is fundamentally a reductionist view, however. That mindset is, in other areas of health care, deluded and at worst, out and out dangerous. EBM works for complicated problems. Even then, it is imperative that the evidence is understood for what it is and that its application is free from patient or physician bias, either overt or unnoticed. In other words, the PROCESS (the evidence based medicine) must be matched to the STRUCTURE (starting point). Is this sounding familiar? After all, it’s not rocket science!

The picture starts to get a bit more fuzzy (this is the dangerous part) when the desired “outcome” is described differently by the stakeholders in the equation. For the patient, the desired outcome may be “cure” or “improvement”. Up until recently, that outcome was by and large shared by the other entities involved in the care. However, that is no longer the assumed case. Cost and resource utilization are of concern to society as a whole. “Fairness” is raised as something that must be considered. And recently, political realities have dictated which classes of people may be exempt from constraints imposed upon others. Terms such as “quality adjusted life years” (QALY) have sprung up in an attempt to plug a number into an equation to give a “simple” answer to what is at its essence a “complex” question. Political entities such as the National Institute for Health and Clinical Excellence (NICE) in the UK and Comparative Effectiveness Panel in the US have been instituted to balance the public good with the private interest. The definition of “Excellence” and “Effectiveness” will prove to be exceedingly complex, I am sure. The danger is when those concepts are made simple or complicated.

Whereas in the past, the primary duty of the physician has been guided by best interest of the individual patient and codified in instruments such as the Hippocratic Oath, things are changing. There are those who believe the primary allegiance of a physician should be to the population, not to the individual:

The current prevailing view is that participation in biomedical research is
above and beyond the call of duty. While some commentators have offered
reasons against this, we propose a novel public goods argument for an obligation
to participate in biomedical research. Biomedical knowledge is a public
good, available to any individual even if that individual does not contribute
to it. Participation in research is a critical way to support an important
public good. Consequently, all have a duty to participate. The current social
norm is that individuals participate only if they have a good reason to do so.
The public goods argument implies that individuals should participate unless
they have a good reason not to. Such a shift would be of great aid to the
progress of biomedical research, eventually making society significantly
healthier and longer lived.

GO Schaefer, EJ Emanuel, A Wertheimer, “The Obligation to Participate in Biomedical Research” JAMA 2009;302(1)67-72

In case it was not obvious, the authors are talking about the obligation of patients, not physicians, to be research subjects. Contrast this with the Nuremberg Code extracted from the Trials of War Criminals before the Nuermberg Military Control Council: http://ohsr.od.nih.gov/guidelines/nuremberg.html

I am emphatically NOT stating that EBM is a Nazi plot! I use it every day in my clinical care of patients, and employ it when I act as a peer reviewer for medical literature. What I am saying, however, is that we all must be extremely careful in not attributing “complicated” or “simple” characteristics to what are undeniably the “complex” parts of health care. Are the terms “effective” and “excellent” absolutes in themselves, or do they both beg the question, “For whom?” In the well-known Stacey diagram of Agreement/Certainty, we need to know where we are, and apply the proper tools for the situation. We are at the Edge of Chaos, but that is also where creativity reigns….

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