rct, ebm, and archie cochrane…

Posted on Tuesday 11 October 2016

I’ve run out of ways to say how far away from mainstream medicine I drifted for the last 20 years of my medical career, or how much coming back to it felt like waking up 25 years later in a strange land. Every time I say that, it sounds melodramatic and exaggerated – but that’s not at all how it feels. For example, I had never directly heard the term evidence-based medicine used to describe a discipline or a movement.  As a matter of fact, one of my earlier blogs was about encountering a particularly concrete example of EBM [Evidence-Based Medicine] and being dumbfounded by the article [Barriers to implementation of a computerized decision support system for depression: an observational report on lessons learned in "real world" clinical settings]. I ended up writing a little series of blogs trying to figure it out [evidence-based medicine I… 28 Jan 2011]. Ironically, it was in that same article that I encountered the first example of a multi-paragraph declaration of conflicts of interest [which was even more dumbfounding!].

Back then, I drew a little diagram to illustrate what I was reading. A structured interview [SCID] lead to a diagnosis [DSM-IV]. Enter that into Dr. Madhukar Trivedi‘s computer program and it spit out an evidence-based treatment informed by the latest RTCs [Randomized Clinical Trials]. The evidence-based treatments for depression provided were either the second generation antidepressants or CBT [Cognitive Behavior Therapy]. And then you went round and round the process hopefully iterating towards success. The actual article I was reading had Dr. Trivedi‘s reflections about why the clinicians ignored his system unless he was actively looking over their shoulder. I had no difficulty at all understanding that myself [but I’ll fight the temptation to say why yet again]. But that was then, and this is now.

Something else I encountered for the first time on awakening – the Cochrane Collaboration and their Systematic Reviews. Founded in 1993, it’s a virtual army of thousands of volunteer scientists who publish comprehensive meta-analyses of RCTs including an evaluation of the scientific rigor of each trial. It’s an invaluable resource that counteracted some of my horror on discovering so many jury-rigged RCTs corrupting the medical literature, particularly in my specialty of psychiatry.

It was named after Archie Cochrane, an early advocate of RCTs  and something of a grandfather to the general idea of Evidence-Based Medicine later introduced by Guyatt G, Cairns J. Churchill D, et al. in Evidence-based medicine. A new approach to teaching the practice of medicine [JAMA 1992 268:2420-5.]:
Archibald Leman Cochrane [12 January 1909 – 18 June 1988] was a Scottish doctor noted for his book Effectiveness and Efficiency: Random Reflections on Health Services. His advocacy of randomized controlled trials eventually led to the development of the Cochrane Library database of systematic reviews, the establishment of the UK Cochrane Centre in Oxford and the international Cochrane Collaboration.
One final introductory remark. In the course of the life of a scientific paradigm, there comes a point where something that was a good idea at its inception has been turned into dogma, and then it runs out of gas as the exceptions and shortcomings become so prominent that people begin to question if it was ever a good idea in the first place – a phenomenon known as paradigm exhaustion [I would argue until I’m blue in the face that Dr. Trivedi’s scheme for treating something as complicated as human depression using a simple computerized algorithm is as fine an example as you’ll ever find of pushing such a paradigm beyond its limits]. In the period of paradigm exhaustion, one often finds a flurry of articles that go back to the concept’s roots to show that the failed end-stage elaborations were never part of what the originator had in mind. In an area familiar to me, there’s a surprisingly robust literature returning to Freud’s writing to illustrate how far afield some of the latter day saints had wandered. It’s beginning to happen with Robert Spitzer’s thoughts about his DSM-III, what he really said. Such reflections are often called a Renaissance, after the period when europe rediscovered its history.

Who would want to argue with  the idea of looking for a scientific way to answer questions in medicine? Or asking "what is the evidence?" when someone suggests some course of action. What’s the alternative? But who could’ve imagined that simple ideas like Randomized Clinical Trials [RCTs] or Evidence-Based Medicine [EBM] could’ve become vehicles for so much corruption in some segments of medicine? creating a virtual superhighway for the commercial contamination if our literature. This article from the University of Oslo Medicine/Humanities faculty filled in a piece of that story that I didn’t really know much of anything about. And it’s an important history. I don’t know that this piece will usher in a Renaissance, as it’s hidden away in a think journal behind a pay wall, but it is certainly clarifying and worth putting some effort into getting hold of [I’m going to write the authors to see is there’s a free full-text version available for general consumption]. The abstract only paints some broad strokes…

by Clemet Askheim, Tony Sandset, and Eivind Engebretsen
Medical Humanities Online First, 6 October 2016

Abstract: Over the last 20 years, the evidence-based medicine [EBM] movement has sought to develop standardised approaches to patient treatment by drawing on research results from randomised controlled trials [RCTs]. The Cochrane Collaboration and its eponym, Archie Cochrane, have become symbols of this development, and Cochrane’s book Effectiveness and Efficiency from 1972 is often referred to as the first sketch of what was to become EBM. In this article, we claim that this construction of EBM’s historical roots is based on a selective reading of Cochrane’s text. Through a close reading of this text, we show that the principal aim of modern EBM, namely to warrant clinical decisions based on evidence drawn from RCTs, is not part of Cochrane’s original project. He had more modest ambitions for what RCTs can accomplish, and, more importantly, he was more concerned with care and equality than are his followers in the EBM movement. We try to reconstruct some of Cochrane’s lost legacy and to articulate some of the important silences in Effectiveness and Efficiency. From these clues it might be possible, we argue, to remodel EBM in a broader, more pluralistic, more democratic and less authoritarian manner.

UPDATE: I wrote author Eivind Engebretsen who replied:
  1.  
    October 13, 2016 | 1:27 AM
     

    Wanted to reference George Dawson’s post from a couple of days ago on how numbers are used as a means of legitimizing nonsense. It seems relevant to what is going on in “Evidence Biased Medicine” (mis-spelling intended).
    http://real-psychiatry.blogspot.com/2016/10/big-data-what-is-it-good-for.html

    He references the book Weapons of Math Destruction which apparently goes into the more general misuses of “evidence”. I ordered the book as it looked quite interesting.

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