Toward a Rainbow Coalition of Evidence in EBM

There are known knowns. There are things we know that we know. There are known unknowns. That is to say, there are things we know we don't know. But there are also unknown unknowns. There are things we don't know we don't know.

This tortuous bit of phraseology came to us some years ago from Secretary of Defense Donald Rumsfeld, clarifying the U.S. policy on the war on terror at a Pentagon briefing. As it turns out, his epistemology may not seem so absurd after all when we try to come to grips with the state of evidence-based medicine.

The question comes down to reaching the tipping point in implementing what we like to believe are "best practices." The point is, as long as we slavishly follow one set of rules or guidelines, the danger exists that all manner of questioning or critical appraisal will be left behind. There is no doubt that reproducibility and standardization occupy a true and important place in both scientific research and best practices. But at the same time, as I have argued in so many previous places,research designs which are customarily placed at the top of the pecking order in terms of validity and acceptance (such as randomized controlled trials, meta-analyses, and systematic reviews) can be misused or, at worst, corrupted.^1-3 If results from these flawed reports are then accepted without question, we are gunning for a train wreck.

Maybe I'm just admitting my susceptibility to the parallel narratives that are typical of postmodernism. This line of thinking hasn't left my cranium ever since I was quizzed on the subject quite by surprise after a seminar I'd given at the now-defunct Colorado College of Chiropractic. I remember fumbling somewhat, trying to define the terms in terms of architecture, the postmodern style tapping into all the forms of materials, methods, forms and colors available to architects. Turns out I wasn't far from the truth. Philosophically, I was joining the company of Kierkegaard and Nietzsche, who emphasized skepticism regarding social norms, the likes of the Dadaists and Surrealists, who blurred the distinctions between high and low culture, and such literary figures as Samuel Beckett, who emphasized the inability of humanity to overcome limitations in language.⁴

Add to this postmodernism's primary tool - deconstruction - and now you're talking about going behind the text. Begin with Jacques Derrida, who argued that multiple meanings can be derived from a passage after close textual analysis. The result of such an approach would be to yield not just written words, but also a broad spectrum of symbols and phenomena within Western thought.⁴

So, you must be thinking: How does this all relate to EBM, anyway? Quite simply and quite shockingly, after you consult a recent paper by Holmes which appeared in the International Journal of Evidence-Based Healthcare.⁵ The very title of the article, "Deconstructing the Evidence-Based Discourse in Health Sciences," does give the answer to this riddle away. Holmes argues that EBM could become a "regime of truth" or as Michel Foucault would say, "A regimented and institutionalized version of truth." In this scenario, pluralism of speech is extinguished. In a nutshell: It is deeply questionable whether many current models of EBM promote the multiple ways of knowing (italics mine) considered to be important within most health disciplines. Within such regimes, one may become desensitized to query and fall under a spell which Foucault has referred to as a "clinical gaze."⁶

Holmes proceeds with his heralded deconstruction of EBM, arguing that a variety of assumptions, such as mind versus body, limit the true ability of EBM to capture the full breadth of clinical knowledge. This is the point at which we can refer to the ascendancy of observational studies, comorbidities, patient expectations and patient values into a more accurate construct of EBM, as I have discussed at length previously.^1-3

But it gets nastier - a whole lot nastier. Holmes then ratchets his argument to another level by suggesting that subjugated knowledge and hegemonic norms such as those seen in EBM models give rise to the increased prominence of administrative power. If this ideology should fill a political vacuum, this begins to smack of totalitarianism or even fascism.⁷ At its extreme, this ossifying means of discourse becomes reminiscent of the "Newspeak" which appeared in George Orwell's 1984.⁸

Probably the best example of drawing the conventional wisdom of RCTs out to absurd lengths comes from a recent publication by Smith and Pell,⁹ who conducted a brilliant tongue-in-cheek systematic review of randomized controlled trials involving the use of parachutes. Following the footsteps of those who blindly argue in favor of RCTs, Smith and Pell point out that observational studies demonstrate that lower rates of ischemic heart disease occur among women using hormone replacement therapy,¹⁰ whereas RCTs demonstrate precisely the opposite.11 Medical interventions based solely on observational data must be carefully scrutinized, argue Smith and Pell, and the parachute is no exception. Further study such as by RCTs is warranted by these facts:

1. Adverse outcomes after free fall is by no means inevitable.¹²
2. Use of parachutes has been associated with iatrogenic complications such as harness burn.¹³
3. Industry-sponsored trials such as those offered by the parachute manufacturers are more likely to conclude in favor of their commercial product.¹⁴

Smith and Pell therefore suggest that the world would benefit if the most radical supporters of EBM organized and participated in a double-blind, randomized, placebo-controlled crossover trial of the parachute. Being unable to identify any RCTs of parachute intervention, the authors then suggest: "Individuals who insist that all interventions need to be validated by a randomized controlled trial need to come down to earth with a bump."⁹

All this is to simply cast out a warning against falling into a trance by accepting one line of clinical inquiry at the risk of subjugating other means for obtaining significant information. I am even sensing that there is a movement afoot to soft-pedal the term evidence-based medicine into one which suggests that good medicine is guided by evidence rather than being shackled by it. What all this is telling us is that sound clinical judgment and the condition and needs of the patient, in addition to multiple forms of experimental evidence, can never be ignored in what we would hope to truly refer to as "best practices."

References

1. Rosner A. The shifting sands of EBM. Dynamic Chiropractic Feb. 26, 2008;26(5).
2. Rosner A. Thinking outside of the pyramid. Dynamic Chiropractic May 6, 2008;26(10).
3. Rosner A. Fables of foibles: Inherent problems with RCTs. JMPT 2003;26(7):460-7.
4. http://en.wikipedia.org/wiki/Postmodernism.
5. Holmes D, Murray SJ, Perron A, Rail G. Deconstructing the evidence-based discourse in health sciences: truth, power and fascism. Int J Evid Based Healthcare 2006;4:180-6.
6. Foucault M. The Birth of the Clinic: AnArchaeology of Medical Perception. New York: Random House, 1973.
7. Arendt H. The Origins of Totalitarianism, First Edition. New York: Harcourt, 1976.
8. Orwell G. 1984. New York: Signet Classic, 1950.
9. Smith GCS, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: Systematic review of randomized controlled trials. BMJ 2003;327:1459-61.
10. Smith DG, Elbrahim S. Data dredging bias, or confounding. BMJ 2002;325:1437-8.
11. Pines A, Mijatovic V, van der Mooren MJ, Kenemans P. Hormone replacement therapy and cardioprotection: Basic concepts and clinical considerations. Eur J Obset Gynecol Reprod Biol 1997;71:193-7.
12. Highest fall survived without a parachute.In: Cunningham A. Guiness World Record 2002. London: Guiness World Records, 2002.
13. Lasczkowski G, Hasenfuss S, Verhoff M, Weiler G. An unusual airplane crash: deadly life saver. Unintentional activation of an automated reserve opening device causing airplane accident. For Sci Int 2002;125:250-3.
14. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ 2003;326:1167-70.