"People need to be logical. If you find a person that you've never seen before getting into a crop duster that doesn't belong to you, report it." Did you get that, campers? I'm still banging my head against the wall over this quotation from none other than our president, George W.
How do you approach clinical evidence? You have to begin with the fact that an abundance of writings have pointed out that from a historical perspective, painting by the numbers and abiding by current medical standards at face value must be tempered by the following realities:
- The history of medicine is replete with examples of resistance to change and discarded therapies that now appear ludicrous, even at the risk of the patient's health.2
- Medicine is rooted in beliefs, not necessarily objective reality.2
- The current model of medical diagnosis and treatment fails to adequately address the chronic- disease burden that affects morethan 1/3 of the American population.3
- The "gold standard" research tool (the randomized clinical trial) lacks insight into lifestyle, nutritional interventions and long-latency deficiency diseases.4
- Heavy marketing of off-label uses of medication abounds.5
- A positive bias exists in the medical literature, due to the lack of publication of negative medical trials.6
- Funding of research by private industry leads to a financial conflict of interest, resulting in the suppression of results and/or incomplete or biased conclusions.7
The solution to this dilemma has evolved over the past decade such that the entire "house of evidence" supporting interventions has been re-evaluated,8 much like the nutritional food pyramid.9 In more recent times, observational studies have gained traction. They have been found to predict treatment effects as accurately as randomized clinical trials,10,11 which have been seriously challenged due to their limited applicability to clinical situations.12,13
So, how do we move toward a more responsive, and arguably hu-mane, way to evaluate evidence? One recently published approach, which I discussed at length in October,14 had to do with whole-systems research - he problem being that several top-rated clinical trials were found to possess egregious flaws that had slipped under the radar of the quality/evaluation "yardsticks."15 From a practical standpoint, third-party payers may have thought that they had a solution by shutting down patient challenges after eliminating the tort system and professing to save a bundle through simply closing the books on whiplash episodes, with insufficient review of actual patient outcomes.16 Way, way wrong answer. It flies directly in the face of patient-centered paradigms, laid out in some detail a dozen years ago by Dr. Meridel Gatterman.17
The premature settlement of claims by insurers also ignores a sizeable body of literature which indicates that chronic back pain is recurrent, likely to reappear after weeks in which symptoms are subdued or absent altogether.18-20 Closing the books on a patient in haste is actually self-defeating, since it threatens to classify reappearing symptoms as an entirely new episode, rather than a recurring one. Under such an arbitrary and myopic scenario, such patients would normally be admitted with a new evaluation, workup and cluster of more intensive interventions at greater expense than if the patient were retained for a somewhat longer period with fewer, more widely spaced visits. Exacerbation of symptoms, therefore, would have to be considered to be the result of an insufficient period of treatment with premature dismissal rather than failed or ineffective treatment - provided there is an initial period of improvement that can be documented. Episodes of both the condition and treatment therefore may need to be revisited.
So, perhaps epidemiologist David Sackett is responsible for one of the major counterrevolutionary steps after expressing the fact that:21 "[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.
"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."
That brings the clinician into the picture, but what about the actual patient? That third and critical ingredient seems to have been brought to the table by a recent paper published in Spine, which predicted that the use of such patient-based outcome measures as the Health Related Quality of Life (HRQOL) Index and cost-effectiveness indices will continue to grow as integral parts of evidence-based medicine.22 Indeed, it has been suggested that "the most compelling and growing component" of EBM is the empowerment of the patient in the decision-making process. A patient is considered the best judge of values; thus, these decisions are to be shared between the patient and clinician.23 Preference-based measures such as the EuroQuol,24 the Health Utilities Index,25 and SF-36D26 are therefore becoming more prevalent.
As patients become recognized as playing a more valuable role in even the most orthodox circles of EBM, it behooves both the research and clinical communities of chiropractors to thoroughly educate the public. With the national health care system close to overload and substantially behind that of most other industrialized countries,27,28 this directive becomes even more urgent. Add to this the fact that the U.S. is entering an election year with health care becoming a leading topic of discussion. The current lack of understanding of the masses as to what are the accomplishments and potential of chiropractic research and practice is eclipsed by the national debt - and this needs to be addressed promptly.
- President George W. Bush, as quoted by R. Blount, Jr. Long Time Leaving: Dispatches From up South. New York: Alfred A. Knopf, p. 4.
- Hyman M. Paradigm shift: the end of "normal science" in medicine. Understanding function in nutrition, health, and disease. Alternative Therapies in Health and Medicine, 2004;10(5):10-15, 90-94.
- Available at www.theintegratorblog.com/sites/index/php ?option=com_content&task=view&id=94&itemid=144. Accessed Aug. 16, 2006.
- Heany R. Long-latency deficiency disease: insights from calcium and vitamin D. American Journal of Clinical Nutrition, 2003;78:912-9.
- Fonda D. Curbing the Drug Marketers. Time, July 5, 2004:40-2.
- Wolfe SM. Direct-to-consumer advertising: education or emotion promotion? New England Journal of Medicine, 2002; 346(7):524-6.
- Kassirer JP. Financial conflicts of interest in biomedical research. New England Journal of Medicine, 1993;329(8):570-1.
- Henry RG, Zaner RM, Dittus RS. View-point: moving beyond evidence-based medicine. Academic Medicine, 2007; 82(3):292-7.
- Jonas WB. The evidence house: how to build an inclusive base for complementary medicine. Western Journal of Medicine, 2001;175:79-80.
- Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. New England Journal of Medicine, 2000;342(25):1878-86.
- 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):1887-92.
- 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):1234-40.
- Rosner A. Under the radar, or is that "boardwalk"? Dynamic Chiropractic, Oct. 22, 2007;25(22). www.chiroweb.com/archives/25/22/17.html.
- Hawk C, Khorsan R, Lisi AJ, et al. Chiropractic care for nonmusculoskeletal conditions: a systematic review with implications for whole systems research. Journal of Alternative and Complementary Medicine, 2007;13(5):491-512.
- Cassidy JD, Caroll LJ, Cote P, et al. Effect of eliminating compensation for pain and suffering on the outcome of insurance claims for whiplash injury. New England Journal of Medicine, 2000;342(16):1179-86.
- Gatterman M. A patient-centered paradigm: A model for chiropractic education and research. Journal of Alternative and Complementary Medicine, 1995;1(4):371-86.
- Croft PR, Macfarlane GJ, Papageorgiou AC, et al. Outcome of low back pain in general practice: A prospective study. British Medical Journal, 1998;316:1356-9.
- McGorry RW, Webster BS, Snook SH, Hsiang SM. The relation between pain intensity, disability, and the episodic nature of chronic and recurrent low back pain. Spine, 2000;25(7):834-41.
- Hestbaek L, Leboeuf-Yde C, Engberg M, et al. The course of low back pain in a general population: results from a 5-year prospective study. Journal of Manipulative and Physiological Therapeutics, 2003;26(4):213-9.
- Sackett DL. Evidence-based medicine. Seminars in Perinatology, 1997;21:3-5.
- Fisher CG, Wood KB. Introduction to and techniques of evidence-based medicine. Spine, 2007;32(19S):S66-72.
- O'Connor A. Using patient decision aids to promote evidence-based decision making. EMB Notebook, 2001;6:100-2.
- 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):503-20.
- Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. Journal of Health Economics, 2002;21:271-92.
- Starfield B. Primary Care: Balancing Health Needs, Services, and Technology. New York: Oxford University Press, 1998.
- Feachem RG. Health systems: more evidence, more debate [editorial]. Bulletin of the World Health Organization, 2000;78(6):715.
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