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Just a paradigm: evidence-based medicine in epistemological context

  • Original paper in Philosophy of Medicine
  • Published:
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Abstract

Evidence-Based Medicine (EBM) developed from the work of clinical epidemiologists at McMaster University and Oxford University in the 1970s and 1980s and self-consciously presented itself as a "new paradigm" called "evidence-based medicine" in the early 1990s. The techniques of the randomized controlled trial, systematic review and meta-analysis have produced an extensive and powerful body of research. They have also generated a critical literature that raises general concerns about its methods. This paper is a systematic review of the critical literature. It finds the description of EBM as a Kuhnian paradigm helpful and worth taking further. Three kinds of criticism are evaluated in detail: criticisms of procedural aspects of EBM (especially from Cartwright, Worrall and Howick), data showing the greater than expected fallibility of EBM (Ioaanidis and others), and concerns that EBM is incomplete as a philosophy of science (Ashcroft and others). The paper recommends a more instrumental or pragmatic approach to EBM, in which any ranking of evidence is done by reference to the actual, rather than the theoretically expected, reliability of results. Emphasis on EBM has eclipsed other necessary research methods in medicine. With the recent emphasis on translational medicine, we are seeing a restoration of the recognition that clinical research requires an engagement with basic theory (e.g. physiological, genetic, biochemical) and a range of empirical techniques such as bedside observation, laboratory and animal studies. EBM works best when used in this context.

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Notes

  1. The term “evidence-based practice” may be replacing EBM, acknowledging the fact that the practice of medicine requires not only physicians but other health care professionals.

  2. Some canonical definitions are unhelpful for a general understanding of EBM, for example, that given in (Sackett et al. 1996): “Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” This particular definition is probably used widely because it is brief, and because it has a rhetorical purpose—to address the frequent criticism of EBM that it applies to populations, not individuals.

  3. “Double-masked” has largely replaced “double-blinded,” in order to avoid inappropriate use of terms relating to disability.

  4. A useful essay discussing the differences and interactions between EBM and MDM is (Elstein 2004)

  5. They were not, however, claiming along with many Kuhnians that there is subjectivity or relativity involved in what gets to count as evidence.

  6. There are many such hierarchies in use, but all put double-masked RCTs at the top, or right after meta-analyses of RCTs, and clinical experience, expert consensus and physiological rationale at the bottom.

  7. Interestingly, Sehon and Stanley (2003) argue that EBM should not be thought of as a Kuhnian paradigm, but, instead, as part of a Quinean holistic network of beliefs. My focus here is on the historic, rather than the popular meaning of “paradigm” and on what EBM is, not on what it should be.

  8. There are many other characteristics of Kuhnian paradigms, such as the narrative of paradigm change, the emphasis on high-level theory, and the idea that paradigms replace one another, that do not apply to this case. I am not trying to apply Kuhn exhaustively, just to use some of his concepts where they may be explanatorily useful.

  9. Double-masking is the standard for high quality RCTs.

  10. Critics of EBM have occasionally presented EBM as a political and rhetorical movement, e.g. (Charlton and Miles 1998), emphasizing the ways in which it appears to lack rationality.

  11. Cartwright’s (2010) four conditions are knowledge of “Roman laws“(laws that are general enough), “the right support team” (all necessary conditions), “straight sturdy ladders” (for climbing up and down levels of abstraction) and “unbroken bridges” (no interfering conditions).

  12. Worrall might respond that he is only criticizing those methodologists who make abstract and general claims about freedom from “all possible” biases. This is fine, so long as no conclusions are drawn for RCTs in practice.

  13. Michael Rawlins is the head of NICE (National Institute of Health and Clinical Excellence) in the UK, which bases its policies and guidelines on the results of EBM.

  14. In this context, a positive trial is one in which the experimental arm of the trial is more effective, a null result is one in which both arms are equally effective, and a negative trial is one in which the control arm is more effective.

  15. I recommend that in the meantime we correct for funding bias by asking for a higher level of significance from the results of trials funded by pharmaceutical companies.

  16. An editorial in the same issue of NEJM (Pocock and Elbourne 2000) strongly protests these conclusions, partly in the name of EBM orthodoxy, but partly also on the basis of some well known RCTs which contradicted the results of observational trials

  17. In fact, EBM is the successor to ancient “empiric” approaches to medicine.

  18. Cartwright is, of course, a realist about underlying causal processes.

  19. Technically, “translational research” includes both the bench-to-bedside-and-back (T1) and the clinical research to everyday practice (T2) “translational blocks.” See (Woolf 2008). But most of the resources and rhetoric favor the former.

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  1. Department of Philosophy, Temple University, Philadelphia, PA, 19122, USA

    Miriam Solomon

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  1. Miriam Solomon
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Correspondence to Miriam Solomon.

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I am grateful to two anonymous reviewers for the European Journal for Philosophy of Science for helpful corrections and comments on this paper.

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Solomon, M. Just a paradigm: evidence-based medicine in epistemological context. Euro Jnl Phil Sci 1, 451 (2011). https://doi.org/10.1007/s13194-011-0034-6

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