Evidence-Based Medicine:
Changing with the TidesThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
From the ChiroACCESS ArchiveAnthony L. Rosner, Ph.D., LL.D.[Hon.], LLC
Published March 5, 2009
Evidence-based medicine, to which all clinical researchers strive and all third party payors genuflect, is anything but the immutable Gold Standard of medical decision-making in recent years. Rather than being viewed as a Rock of Gibraltar, EBM almost appears more like a sand castle subject to the shifting sands of changing public sentiment as well as the updated scientific findings themselves.
One can go back to the 1980s when the quality of observational (cohort, case series) studies was found to rival that of randomized clinical trials (RCTs) in their abilities to predict clinical effects. [1, 2] This occurred during the same period in which RCTs began to be seriously challenged because of their limited applicability in clinical situations. [3, 4]
Included in the list of deficiencies of RCTs were such problems as their lack of insight into lifestyles, nutritional interventions, and long-latency deficiency diseases. [6] The problems were found even to extend to meta-analyses, which were found to be susceptible to human error and bias. [6]
No longer was it sufficient to simply paint by the numbers. One had to face such realities as patient subgroups and comorbidities as playing a major role in therapeutic decisions, such that clinical judgment now became recognized as a key component in patient care. This sentiment could not have been more clearly laid out by the noted epidemiologist David Sackett, who wrote: [7]“[EBM] means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that we individual clinicians acquire through clinical experience and clinical practice. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centered clinical research into the accuracy and precision of diagnostic tests [including clinical examination], the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough [emphasis added]. Without clinical expertise, practice risks becoming tyrannized by external evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best external evidence, practice risks becoming rapidly out of date, to the detriment of patients.”
As if these considerations from the clinician were not sufficient to add to EBM's plate, one now had to think of the patient as well. In their recent introduction to what they hold to be the tools of evidence-based medicine, Fisher and Wood make it clear that the use of such patient-based outcome measures as the Health Related Quality of Life Index and cost-effectiveness will continue to emerge as integral parts of EBM. They argue that "the most compelling and growing" component of EBM is the empowerment of the patient in the decision-making process. [8] It reminds you of how quickly and extensively the patient factor must be considered a part of the EBM edifice, just as such electronic media terms as Facebook and Twitter have become part of our daily language in just a few months.
Given that patients hold the key to being the best judge of values, clinical decisions now necessarily have to be shared between patient and clinician. [9] This phenomenon can easily be showed by the proliferation of such personal preference-based outcome measures as the EQ-5D, [10] the Health Utilities Index, [11] and the SF-36D. [12] This upwelling of personal outcomes criteria simply echoes what a few years earlier 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 concepts as use testing, public health, and audience preferences gained rapid ascendancy, partially displacing systematic reviews, meta-analyses, and RCTs as the original penthouse dwellers of the pyramid. [13]
Such is not to discredit EBM per se, but to be mindful that it must never be divorced from human values or used indiscriminately. In a thought-provoking essay, Erich Loewy argues that EBM actually becomes an anti-intellectual tool when it is applied in the interest of efficiency for profit. Using EBM to simply hold down costs, a tempting and often-used strategy by third-party payors, represents the most egregious abuse of EBM. For here there could be instances in which patients — sometimes with few alternatives — are discouraged from following certain highly promising leads in experimentation, such as stem cell therapy. Pigeonholing patients into groups that were not actually tested and excluding alternative choices which have been shown to be safe and inexpensive and supported by some data could be argued to be at odds with the tenets of truly informed consent in experimental science. These principles of ethical conduct in clinical experimentation have all been painstakingly laid down over the years by the Nuremburg Code, the Helsinki Declaration, and the Belmont Report. To disregard all of these puts the decision-maker on moral thin ice. [14]
Put in other terms, if our concepts of EBM become ossified, they risk becoming more of an algorithm, a paint-by-numbers exercise that excludes intelligence and intuitions which might in certain instances actually be of benefit to a particular patient in a given situation. What are these intuitions? Some might call them hunches which in more cases than not draw from a network of information which Stewart Hampshire has termed a compost heap, [15] no longer capable of being separated into component parts. Our collective informational storehouse must also include the outstanding case studies such as those which formed our basic understanding and acceptance of everything from heart transplants to Paget's disease to Freudian psychology, yet never went on to become RCTs in their own right. Not to be ignored are several outstanding examples in the chiropractic literature as well, to which further additions must continue to be made by the field practitioner.
For these reasons, it is a sorry day indeed when the physician is reduced to therapeutic choices simply because it is what a managed care organization might have mandated — often using EBM as a justification without seriously asking whether it is truly in the patient's best interest. This warning needs to be especially heeded when we realize that the current model of medical diagnosis and treatment fails to adequately address the chronic disease burden affecting over 1/3 of the American population. [16]
Indeed, the retreat from Olympus of classical concepts of EBM could not have been more apparent by the emergence of a new terminology, evidence-informed medicine as a progressive, kinder and gentler means to meet the current needs of the patient. [17, 18] Perhaps with this added seasoning the traditional concepts of EBM will have cut the physician, patient, and third party payor enough slack to be better equipped to meet the current demands of an already overburdened healthcare system.
References:
Benson K, Hartz AJ.
A comparison of observational studies and randomized, controlled trials.
New England Journal of Medicine 2000; 342(25): 1878-1886.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.Walach 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.Tonelli MR.
The philosophical limits of evidence-based medicine.
Academic Medicine 1998; 73(12): 1234-1240.Heany R.
Long-latency deficiency disease: Insights from calcium and vitamin D.
American Journal of Clinical Nutrition 2003; 78: 912-919.Rosner A.
Fables or Foibles: Inherent Problems with RCTs
J Manipulative Physiol Ther 2003 (Sep); 26 (7): 460–467Sackett DL.
Evidence-based medicine.
Seminars in Perinatology 1997; 21: 3-5.Fisher CG, Wood KB.
Introduction to and Techniques of Evidence-based Medicine
Spine (Phila Pa 1976) 2007 (Sep 1); 32 (19 Suppl): S66–72O'Connor A.
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EMB Notebook 2001; 6: 100-102.Brooks R.
EuroQuol: The current state of play.
Health Policy 1996; 37: 53-72.Torrance GW, Furlong W, Feeny D, Boyle M.
Multi-attribute preference functions: Health Utilities Index.
Pharmacoeconomics 1995; 7(6): 503-520.Brazier J, Roberts J, Deverill M.
The estimation of a preference-based measure of health from the SF-36.
Journal of Health Economics 2002; 21: 271-292.Jonas W
The Evidence House:
How to Build an Inclusive Base for Complementary Medicine
Western Journal of Medicine 2001 2001 (Aug); 175 (2): 79–80Loewy EH.
Ethics and evidence-based medicine. Is there a conflict?
www.medscape.com/viewarticle/559977_1. Posted 08/07/07.Hampshire S.
Innocence and Experience.
Cambridge, MA: Harvard University Press, 1989, p. 121.theintegratorblog.com/sites/index/php?option=com_content&task;=view&id;=94&itemid;=144
Downloaded 08/16/06.Dagenais S, Mayer J, Wooley JR, Haldeman S.
Evidence-informed management of chronic low-back pain
with medicine-assisted manipulation.
Spine Journal 2008; 8(1): 142-149.Glasziou P.
Evidence-based medicine: Does it make a difference?
Make it evidence-informed practice with a little wisdom.
British Medical Journal 2005; 330(7882): 92; discussion 94.
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