Posted on | August 24, 2009 | No Comments
As the debate over health reform continues to create a storm of opinion and a range of emotions across the nation, a group of experts struggle quietly to steer our nation’s health system toward an endpoint that would simultaneously increase quality while better managing cost. Getting there is not made easier by bogus and biased claims that those supporting a strategic national approach will unleash “death panels” to dispense of our frail elderly citizens.1 The leaders of such nonsense use fear as currency to disrupt and confuse. They deserve our contempt.
In contrast, a range of constructive health care leaders are working diligently to design a system that would advantage what we know for certain – commonly termed “evidence” – and apply it to health care practice nationwide consistently and without wide variability from one location to another. Evidence-based medicine, as it is called, is a powerful tool that holds great promise if used properly. It has been defined as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.2 It has the potential to enhance the patient-physician relationship and improve patient care. Looking at a brief history of evidence-based medicine helps to clarify its potential.
The search for truth and physicians’ desire to base their treatments and therapies on sound knowledge is as old as the medical profession itself. But medicine’s first systematic randomized trials, which tested the use of streptomycin for tuberculosis, didn’t occur until the 1940s.3 Some 20 years later, in the wake of the thalidomide tragedy that caused birth defects in thousands of babies, the focus on “process” in medical research was greatly expanded. Beginning in 1962, New Food and Drug Administration regulations required “controlled trials” to demonstrate safety and effectiveness of new drugs as a condition of FDA approval.4
The focus remained on drugs, in relative exclusion of interventional treatment and diagnostics, until 1971 when Archie Cochrane, an epidemiologist, suggested that much of what modern medicine did lacked evidence and might indeed be harmful.5 Further complicating the issue, critical research in 1974 documented that what we did know to be true about medicine was not systematically incorporated into textbooks or teaching materials in real time, creating a translational gap.6 The 1980s and early 1990s focused on defining rules for systematic review of data and acquiring research funding to develop clinical practice guidelines.7 The various guidelines from various sources typically took several years to develop, were often outdated by the time they were published, and often didn’t represent real-world practice. Thus, adherence to guidelines was not optimal.4
It was within this context that David Sackett penned a classic article titled “Evidence Based Medicine: What it is and what it isn’t” in 1996.2 In the article, he clearly described that when used correctly, evidence-based medicine incorporates evidence, physician expertise, and patient values. In his words, “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 evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best evidence, practice risks becoming rapidly out of date, to the detriment of patients.”
Over the past decade, a critical examination of evidence-based medicine has begun to flesh out the complexity that Sackett highlighted. In caring for a patient, the physician ideally attempts a precise identification of the problem; accesses information necessary to solve the problem, searching the literature; selects relevant studies; applies the rules of evidence to determine validity; applies this knowledge to the individual patient and clinical setting; and continually updates the knowledge, discarding what’s old and out of date and adding what is new.8 The need to constantly evolve and update knowledge in a reliable and systematic manner and also to deliver knowledge to patients and their physicians simultaneously is complex and requires coordination, planning and reliable systems.
Adding to the complexity of evidence-based medicine and resistance to adopting new approaches to care is the fear that it will inappropriately be used as a cost-containment device.9 Thus the “death panelists” claims this summer that health reform would enforce euthanasia on elderly frail citizens. Sackett defined the issue when he said, “Some fear that evidence-based medicine will be hijacked by purchasers and managers to cut the costs of health care. This would not only be a misuse of evidence-based medicine but suggests a fundamental misunderstanding of its financial consequences. Doctors practicing evidence-based medicine will identify and apply the most efficacious interventions to maximize the quality and quantity of life for individual patients. This may raise, rather than lower, the cost of care.”2
Standards for evidence-based medicine must be consistent, transparent and applied to all parties. This means applying them equally to all health care interventions – diagnostic and therapeutic. It means standardizing evidence-based medicine use by all health care participants. It means having a process that is open not only to standard stakeholders but to the public as well. It means considering the clinical merits of recommendations that impact access, and independently considering cost. And it means up-to-date, on-going evaluation by those with the greatest clinical expertise and real-world testing to advance doable applications.
Evidence-based medicine makes all the sense in the world if applied in a principled fashion. What are those principles? First, evidence-based medicine should support, not supplant the decision-making function of the patient-physician relationship. Second, evidence-based medicine should enable the delivery of the best available patient care and consider the patient’s individual condition and priorities. Third, financial impact studies should include the costs of the entire system of care and the entire treatment horizon. Fourth, evidence-based medicine must be reviewed regularly in light of evolving evidence, be shared with doctors and patients simultaneously, and evolve in a manner that preserves personalized, prospective and predictive medicine.
For Health Commentarty, I’m Mike Magee.
1.Rutenberg J and Calmes J, False Death Panel Rumors Have Some Familiar Roots. NYT. August 13, 2009
2.Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312:71-72.
3.Colston J. Descending the Magic Mountain: how early clinical trials transformed the treatment of tuberculosis. National Institute for Medical Research. Available at: http://www.nimr.mrc.ac.uk/MillHillEssays/1998/clintrial.htm?setFont=LargeText. Accessed March 15, 2005.
4.U.S. Food and Drug Administration. The Evolution of U.S. Drug Law. Available at: http://www.fda.gov/fdac/special/newdrug/benlaw.html. Accessed March 15, 2005.
5.Cochrane AL. Random reflections on health services: Effectiveness and efficiency. 1971 (reprinted by RSM Press 1999).
6.Chalmers TC. The impact of controlled trials on the practice of medicine. Mt Sinai J Med. 1974;41:753-759.
7.Perfetto EM, Morris LS. Agency for Health Care Policy and Research clinical practice guidelines. Ann Pharmacother. 1996;30:1181.
8.Evidence-Based Medicine. A new approach to teaching the practice of medicine. Evidence-based Medicine Working Group. JAMA. 1992;268:2420-2425.
9.Soumerai SB. Benefits and risks of increasing restrictions on access to costly drugs in Medicaid. Health Affairs. 2004;23:141