THE EVIDENCE HOUSE: HOW TO BUILD AN INCLUSIVE BASE FOR COMPLEMENTARY MEDICINE
 
   

The Evidence House: How to Build an
Inclusive Base for Complementary Medicine

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:
   Frankp@chiro.org
 
   

FROM: West J Med 2001 (Aug);   175 (2):   79–80

Wayne B Jonas

Department of Family Medicine Uniformed Services
University of the Health Sciences
Bethesda, MD 20814


See also: Commentary by by Anthony L. Rosner, Ph.D.


We all want good evidence available when making medical decisions. Evidence, however, comes in a variety of forms and purposes, and what may be good for one purpose may not be good for another. The term “evidence-based medicine” (EBM) has become almost a cliché in recent years, being used as a synonym for “good” or “scientific,” both to support and refute the value of complementary medicine practices. [1] But EBM takes a narrow view of what constitutes “good” evidence, and it excludes important qualitative and observational information about the use and benefits of complementary medicine.

The key idea of EBM is a “hierarchy of evidence” (figure 1). In this hierarchy, information from systematic reviews of randomized controlled trials is the “best” evidence, followed by individual randomized controlled trials, then by nonrandomized trials, observational studies, and finally case-series. [2] When the evidence of what type of medicine works and what type does not is synthesized, the type of emphasis is at the top of the pyramid, and the evidence that is considered inferior is at the lower levels. Clinical experiments that isolate a causal and additive link between a specific intervention and a specific clinical outcome are seen as the “gold standard” in this evidence model.


Figure 1:   The traditional hierarchy of evidence is narrow




As most clinicians know, the reasons that patients recover from illness are complex and synergistic, and many cannot simply be isolated in controlled environments. The best evidence under these circumstances may be observational data from clinical practice that can estimate the likelihood of a patient's recovery in a realistic context. [3] In addition, patient's illnesses are complex physical, psychological, and social experiences that cannot be reduced to single, objective measures. [4] In some cases, the most valuable information for a clinical decision is a highly subjective judgment about life quality. This personal experience of illness might be captured only through qualitative research, not using questionnaires or results of blood tests. [5] The “best” evidence under these circumstances may be the meaning that patients give to their illness and recovery.

At other times, the “best” evidence comes from laboratory studies. The discovery that St John's wort can reduce blood levels of immunosuppressive drugs, for example, is the most crucial evidence when making decisions about its use in patients taking immunosuppressive medications. [6] Findings of controlled trials often do not reveal such drug interactions. Arranging types of evidence in a “hierarchy” obscures the fact that sometimes the best evidence is not objective, not additive, and not clinical. [7]

In the place of an evidence hierarchy, I suggest we build an “evidence house” with “rooms” for different types of information and purposes (figure 2). The rooms on the left side of the house contain types of information that seek out causal attributions and mechanisms of action. One such room is for laboratory research, which forms a foundation of understanding of mechanisms and causal links on which controlled clinical research can build. In the case of homeopathy or prayer, for example, randomized controlled trial data seem to point us in an illogical direction, eg, that pills with no active ingredients have specific effects. [8] Other rooms on the left side of the house are for randomized controlled trials and systematic reviews, which attempt to verify the suspected links between specific interventions and specific outcomes.


Figure 2:   The evidence house affords greater accessibility to important information





If confined to the left side of the evidence house, however, physicians will never obtain information about the relevance of medicine for patients, what happens in the actual world of clinical practice, or the generalizability of an intervention in our health care delivery system. Information about relevance and utility of practice, both proven and unproven, is available in rooms on the right side of the house.

The evidence house has something for everyone. Regulatory agencies and those interested in the approval of new treatments are most interested in the rooms on the left side. They want data from randomized controlled trials and systematic reviews rather than findings from observational research, yet the need for alternative approaches to treatment is evident. [9] Other stakeholders in the health care system are more interested in information from the right side of the house. Health care practitioners often want to know the anticipated effects of an intervention in the clinical practice setting. Those paying for care are generally more interested in health services research. Patients are intensely interested in stories and detailed descriptions of cases similar to their own. [10]

If resources are disproportionately invested in certain rooms of the house to the neglect of others, it is not possible to obtain the evidence needed for full public participation in clinical decisions. A livable house should not have an elaborate kitchen and no bathroom. Each has different functions and all need to be high quality.

Complementary and alternative medicine helps us think about who will live in the evidence house and how it should be constructed. The public is the architect, driving the interest in complementary medicine. They seek holistic and preventive care, safer treatments for chronic illness, and more participation in health care decisions. [11] As patient advocates, physicians must help them find a seat at the research table, so it is possible to build an evidence house where everyone can live.


Competing interests: None declared


References:

  1. Fontanarosa PB, Lundberg GD.
    Alternative medicine meets science.
    JAMA 1998;280: 1618-1619

  2. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't [editorial]. BMJ 1996;312: 71-72

  3. Pincus T.
    Analyzing long-term outcomes of clinical care without randomized controlled clinical trials: the consecutive patient questionnaire database.
    Adv Mind Body Med 1997;13: 3-31

  4. Cassel EJ.
    The nature of suffering and the goals of medicine.
    N Engl J Med 1982;306: 639-645

  5. Feinstein AR.
    Clinical judgment revisited: the distraction of quantitative models.
    Ann Intern Med 1994;120: 799-805

  6. Yue Q, Bergquist C, Gerden B.
    Safety of St. John's wort.
    Lancet 2000;355: 576-577

  7. Linde K, Jonas WB.
    Evaluating complementary and alternative medicine: the balance of rigor and relevance.
    In: Jonas WB, Levin JS, eds. Essentials of Complementary and Alternative Medicine.
    Philadelphia: Lippincott Williams & Wilkins; 1999: 57-71

  8. Linde K, Clausius N, Ramirez G, et al.
    Are the clinical effects of homeopathy all placebo effects? A meta-analysis of randomized, placebo controlled trials.
    Lancet 1997;350: 834-843

  9. Norquist G, Lebowitz B, Hyman S.
    Expanding the frontier of treatment research. Prevention & Treatment 1999;
    Available at: www.journals.apa.org/prevention.

  10. Kelner M, Wellman B.
    Complementary and Alternative Medicine: Challenge and Change.
    London: Gordon & Breach; 2000




Commentary by Anthony L. Rosner, Ph.D., from his article:

Comprehensive Review of Chiropractic Research
www.chiro.org/LINKS/FULL/Rosner_2010.shtml


Limitations of EBM and Transformation to "Evidence-Informed" Best Practices:

Figure 1: The Hierarchy of Clinical Evidence   [15]



Cracks in the foundation of one of the strongest pillars of conventional definitions of EBM based upon the pyramid shown in FIGURE 1 began to appear in the 1980s, when the quality of observational [cohort, case series] studies was found to improve, such that their predictive value in clinical situations could now be compared to that seen in the more rigorous RCTs. [17, 18]

At the same time, RCTs began to be seriously challenged due to their limited applicability in clinical situations. [19, 20] Among other problems, RCTs were found to lack insight into lifestyles, nutritional interventions, and long-latency deficiency diseases. [21] Quirks have likewise surfaced which demonstrate how even the exalted meta-analysis is subject to human error and bias. [22]

In addition to factoring in the judgment of the clinician to EBM, effective patient care requires, in the final analysis, the attributes of the actual patient. Such patient-based outcome measures as the Health Related Quality of Life Index and cost-effectiveness will continue to grow as elements which cannot be ignored in EBM. Indeed, it has been argued that “the most compelling and growing” component of EBM is the empowerment of the patient in the decision-making process. [23] With patients being the best judge of values, clinical decisions are becoming recognized as necessarily shared between the patient and clinician. [24]

Figure 1.5: The Evidence House Affords Greater Accessibility To Important Information   [25]



This shifting of the EBM sands echoes what a few years ago appeared to be a revolutionary upheaval suggested by Wayne Jonas, who presented what appeared to be for all intents and purposes a virtual inversion of the classical evidence pyramid.

In Jonas' presentation of the “Evidence House”, such entities as use testing, public health, and audience preferences gained ascendancy. [25]

Despite all these revisions, these upgrades of EBM have not been able to outrun all of the most severe critics of EBM. When EBM is applied in a unilateral, heavy-handed manner, it has run the risk of becoming a “regime of truth” in such a manner as to discourage free inquiry.

Put in other terms, it is questionable whether many current models of EBM promote the multiple ways of knowing considered to be important in most health disciplines, [26] falling under a spell which Foucault has referred to as a “clinical gaze.” [27]

For these reasons, proponents of EBM have fallen back to a position in which the best evidence is now considered to guide or inform rather than mandating a clinical decision. [28, 29]


References:

  1. http://phpartners.org/tutorial/04-ebph/2-keyConcepts/images/4.2.7.1.jpg
    Downloaded 02/18/08

  2. Sackett DL.
    Evidence-based medicine.
    Seminars in Perinatology 1997; 21: 3-5

  3. Benson K, Hartz AJ.
    A comparison of observational studies and randomized, controlled trials.
    New England Journal of Medicine 2000; 342(25): 1878-1886

  4. Concato J, Nirav-Shah, Horwitz RI.
    Randomized, controlled trials, observational studies and the hierarchy of research designs.
    New England Journal of Medicine 2000; 342(25): 1887-1892

  5. Wallach H, Jonas WB, Lewith GT.
    The role of outcomes research in evaluating complementary and alternative medicine.
    Alternative Therapies in Health and Medicine 2002; 8(3): 88-95

  6. Tonelli MR.
    The philosophical limits of evidence-based medicine.
    Academic Medicine 1998; 73(12): 1234-1240

  7. Heany R.
    Long-latency deficiency disease: Insights from calcium and vitamin D.
    American Journal of Clinical Nutrition 2003; 78: 912-919

  8. Rosner A.
    Fables or Foibles: Inherent Problems with RCTs
    Journal of Manipulative and Physiological Therapeutics 2003 (Sep);   26 (7):   460–467

  9. Fisher CG, Wood KB.
    Introduction to and techniques of evidence-based medicine.
    Spine 2007; 32(19S): S66-S72

  10. O'Connor A.
    Using patient decision aids to promote evidence-based decision making.
    EMB Notebook 2001; 6: 100-102

  11. Jonas W.
    The Evidence House: How to Build an Inclusive Base for Complementary Medicine
    Western Journal of Medicine 2001 (Aug); 175 (2); 79-80 ~ FULL TEXT

  12. Holmes D, Murray SJ, Perron A, Rail G.
    Deconstructing the evidence-based discourse in health sciences: Truth, power and fascism.
    International Journal of Evidence Based Healthcare 2006; 4: 180-186

  13. Foucault M.
    The Birth of the Clinic: An Archaeology of Medical Perception.
    New York, NY: Random House, 1973

  14. Glasziou P.
    Evidence based medicine: Does it make a difference? Make it evidence informed practice with a little wisdom.
    British Medical Journal 2005; 330(7482): 92; discussion 94

  15. Rycroft-Malone J.
    Evidence-informed practice: From individual to context.
    Journal of Nursing Management 2008; 16(4): 404-408


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