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Evidence-based medicine (EBM) aims to apply evidence gained from the scientific method to certain parts of medical practice. It seeks to assess the quality of evidenceElstein AS (2004). "On the origins and development of evidence-based medicine and medical decision making". Inflamm. Res. 53 Suppl 2: S184-9. doi:10.1007/s00011-004-0357-2. PMID 15338074. relevant to the risks and benefits of treatments (including lack of treatment). According to the Centre for Evidence-Based Medicine, "Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients."Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996). "Evidence based medicine: what it is and what it isn\'t". BMJ 312 (7023): 71-2. PMID 8555924.
EBM recognizes that many aspects of medical care depend on individual factors such as quality and value-of-life judgments, which are only partially subject to scientific methods. EBM, however, seeks to clarify those parts of medical practice that are in principle subject to scientific methods and to apply these methods to ensure the best prediction of outcomes in medical treatment, even as debate about which outcomes are desirable continues.
Practicing evidence-based medicine requires clinical expertise, but also expertise in retrieving, interpreting, and applying the results of scientific studies and in communicating the risks and benefits of different courses of action to patients.
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Using techniques from science, engineering, and statistics, such as meta-analysis of medical literature, risk-benefit analysis, and randomized controlled trials, EBM aims for the ideal that healthcare professionals should make "conscientious, explicit, and judicious use of current best evidence" in their everyday practice.
Generally, there are three distinct, but interdependent, areas of EBM. The first is to treat individual patients with acute or chronic pathologies by treatments supported in the most scientifically valid medical literature. Thus, medical practitioners would select treatment options for specific cases based on the best research for each patient they treat. The second area is the systematic review of medical literature to evaluate the best studies on specific topics. This process can be very human-centered, as in a journal club, or highly technical, using computer programs and information techniques such as data mining. Increased use of information technology turns large volumes of information into practical guides. Finally, evidence-based medicine can be understood as a medical "movement" in which advocates work to popularize the method and usefulness of the practice in the public, patient communities, educational institutions, and continuing education of practicing professionals.
Evidence-based medicine has demoted ex cathedra statements of the "medical expert" to the least valid form of evidence. All "experts" are now expected to reference their pronouncements to scientific studies.
Two types of evidence-based medicine have been proposed.Eddy DM (2005). "Evidence-based medicine: a unified approach". Health affairs (Project Hope) 24 (1): 9-17. doi:10.1377/hlthaff.24.1.9. PMID 15647211.
Evidence-based guidelines (EBG) is the practice of evidence-based medicine at the organizational or institutional level. This includes the production of guidelines, policy, and regulations.
Evidence-based individual decision (EBID) making is evidence-based medicine as practiced by the individual health care provider. There is concern that current evidence-based medicine focuses excessively on EBID.
Although testing medical interventions for efficacy has existed since the time of Avicenna\'s The Canon of Medicine in the 11th century,D. Craig Brater and Walter J. Daly (2000), "Clinical pharmacology in the Middle Ages: Principles that presage the 21st century", Clinical Pharmacology & Therapeutics 67 (5), p. 447-450 [449].Walter J. Daly and D. Craig Brater (2000), "Medieval contributions to the search for truth in clinical medicine", Perspectives in Biology and Medicine 43 (4), p. 530–540 [536], Johns Hopkins University Press. it was only in the 20th century did this effort evolve to impact almost all fields of health care and policy. Professor Archie Cochrane, a Scottish epidemiologist, through his book Effectiveness and Efficiency: Random Reflections on Health Services (1972) and subsequent advocacy, caused increasing acceptance of the concepts behind evidence-based practice. Cochrane\'s work was honoured through the naming of centres of evidence-based medical research — Cochrane Centres — and an international organization, the Cochrane Collaboration. The explicit methodologies used to determine "best evidence" were largely established by the McMaster University research group led by David Sackett and Gordon Guyatt. The term "evidence based" was first used in 1990 by David Eddy.Eddy DM (1990). "Practice policies: where do they come from?". JAMA 263 (9): 1265, 1269, 1272 passim. PMID 2304243. Eddy DM (2005). "Evidence-based medicine: a unified approach". Health affairs (Project Hope) 24 (1): 9-17. doi:10.1377/hlthaff.24.1.9. PMID 15647211. The term "evidence-based medicine" first appeared in the medical literature in 1992 in a paper by Guyatt et al. Guyatt G, Cairns J, Churchill D, et al. [‘Evidence-Based Medicine Working Group’] "Evidence-based medicine. A new approach to teaching the practice of medicine." JAMA 1992;268:2420-5. PMID 1404801
Evidence-based medicine categorizes different types of clinical evidence and ranks them according to the strength of their freedom from the various biases that beset medical research. For example, the strongest evidence for therapeutic interventions is provided by systematic review of randomized, double-blind, placebo-controlled trials involving a homogeneous patient population and medical condition. In contrast, patient testimonials, case reports, and even expert opinion have little value as proof because of the placebo effect, the biases inherent in observation and reporting of cases, difficulties in ascertaining who is an expert, and more.
Systems to stratify evidence by quality have been developed, such as this one by the U.S. Preventive Services Task Force for ranking evidence about the effectiveness of treatments or screening:
The UK National Health Service uses a similar system with categories labeled A, B, C, and D. The above Levels are only appropriate for treatment or interventions; different types of research are required for assessing diagnostic accuracy or natural history and prognosis, and hence different "levels" are required. For example, the Oxford Centre for Evidence-based Medicine suggests levels of evidence (LOE) according to the study designs and critical appraisal of prevention, diagnosis, prognosis, therapy, and harm studies: Oxford Centre for Evidence-based Medicine Levels of Evidence and Grades of Recommendation
A newer system is by the Grade Working Group and takes in account more dimensions that just the quality of medical evidence.GRADE working group. Retrieved on 2007-09-24. "Extrapolations" are where data is used in a situation which has potentially clinically important differences than the original study situation. Thus, the quality of evidence to support a clinical decision is a combination of the quality of research data and the clinical \'directness\' of the data.Atkins D, Best D, Briss PA, et al (2004). "Grading quality of evidence and strength of recommendations". BMJ 328 (7454): 1490. doi:10.1136/bmj.328.7454.1490. PMID 15205295.
Despite the differences between systems, the purposes are the same: to guide users of clinical research information about which studies are likely to be most valid. However, the individual studies still require careful critical appraisal.
In guidelines and other publications, recommendation for a clinical service is classified by the balance of risk versus benefit of the service and the level of evidence on which this information is based. The U.S. Preventive Services Task Force uses:Task Force Ratings. Retrieved on 2007-09-24.
This is a distinct and conscious improvement on older fashions in recommendation and the interpretation of recommendations where it was less clear which parts of a guideline were most firmly established.
Evidence-based medicine attempts to express clinical benefits of tests and treatments using mathematical methods. Tools used by practitioners of evidence-based medicine include:
An NNT of 1 is the most effective and means each patient treated responds, e.g., in comparing antibiotics with placebo in the eradication of Helicobacter pylori. An NNT of 2 or 3 indicates that a treatment is quite effective (with one patient in 2 or 3 responding to the treatment). An NNT of 20 to 40 can still be considered clinically effective.McQuay, Henry J.; Moore, R. Andrew (1997-05-01). Numbers Needed to Treat. Bandolier. Retrieved on 2006-06-27.
Evidence-based medicine attempts to objectively evaluate the quality of clinical research by critically assessing techniques reported by researchers in their publications.
It is recognised that not all evidence is made accessible, that this can limit the effectiveness of any approach, and that effort to reduce various publication and retrieval biases is required.
Failure to publish negative trials is the most obvious gap, and moves to register all trials at the outset, and then to pursue their results, are underway. Changes in publication methods, particularly related to the Web, should reduce the difficulty of obtaining publication for a paper on a trial that concludes it did not prove anything new, including its starting hypothesis.
Treatment effectiveness reported from clinical studies may be higher than that achieved in later routine clinical practice due to the closer patient monitoring during trials that leads to much higher compliance rates. "Patient Compliance with statins" Bandolier Review 2004
There are mixed reports about whether evidence-based medicine is effective. Using the classification scheme above --dividing evidence-based medicine into evidence-based guidelines (EBG) and evidence-based individual decision (EBID)-- may explain the conflict. It is difficult to find evidence that EBID improves health care,Coomarasamy A, Khan KS (2004). "What is the evidence that postgraduate teaching in evidence based medicine changes anything? A systematic review". BMJ 329 (7473): 1017. doi:10.1136/bmj.329.7473.1017. PMID 15514348. whereas there is growing evidence of improvements in the efficacy of health care when evidence-based medicine is practiced at the organizational level.Yealy DM, Auble TE, Stone RA, et al (2005). "Effect of increasing the intensity of implementing pneumonia guidelines: a randomized, controlled trial". Ann. Intern. Med. 143 (12): 881-94. PMID 16365469. One of the virtues of healthcare accreditation is that it offers an opportunity to assess the overall functioning of a hospital or healthcare organisation against the best of the currently-available evidence and to assist the hospital or healthcare organisation to move towards a more effective application of evidence-based medical.
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The neutrality of this section is disputed. Please see the discussion on the talk page. This section has been tagged since December 2007. |
Critics of EBM say lack of evidence and lack of benefit are not the same, and that the more data are pooled and aggregated, the more difficult it is to compare the patients in the studies with the patient in front of the doctor — that is, EBM applies to populations, not necessarily to individuals. In The limits of evidence-based medicine,Tonelli, MR (2001). "The limits of evidence-based medicine". Respiratory Care 46 (12): 1435–1440. Tonelli argues that "the knowledge gained from clinical research does not directly answer the primary clinical question of what is best for the patient at hand." Tonelli suggests that proponents of evidence-based medicine discount the value of clinical experience.
Although evidence-based medicine is becoming regarded as the "gold standard" for clinical practice and treatment guidelines,[citation needed] there are a number of reasons why most current medical and surgical practices do not have a strong literature base supporting them.
An additional problem is that large randomized controlled trials are useful for examining discrete interventions for carefully defined medical conditions. The more complex the patient population (e.g. severity of condition, co-morbid conditions, etc) in the study, the more difficult it is to assess the treatment effect (i.e., treatment mean - control group mean), relative to the random variation (within group variation of both the treatment and control groups). Because of this, a number of studies obtain non-significant results, either because there is insufficient power to show a difference, or because the groups are not well-enough "controlled". Ironically, the fewer restrictions there are on who can participate in a study (i.e., the greater the generalizability of the results to the type of patient being seen in a real world setting) the less able the study to detect real differences between groups for a given sample size.
Furthermore, evidence-based guidelines do not remove the problem of extrapolation to different populations or longer timeframes. Even if several top-quality studies are available, questions always remain about how far, and to which populations, their results are "generalizable". Furthermore, skepticism about results may always be extended to areas not explicitly covered: for example a drug may influence a "secondary endpoint" such as test result (blood pressure, glucose, or cholesterol levels) without having the power to show that it decreases overall mortality or morbidity in a population.
In managed healthcare systems, evidence-based guidelines have been used as a basis for denying insurance coverage for some treatments which are held by the physicians involved to be effective, but of which randomized controlled trials have not yet been published. In some cases, these denials were based upon questions of induction and efficacy as discussed above. For example, if an older generic statin drug has been shown to reduce mortality, is this enough evidence for use of a much more expensive newer statin drug which lowers cholesterol more effectively, but for which mortality reductions have not had time enough to be shown? [1] If a new, costly therapy that works on tumor blood vessels causes two kinds of cancer to go into remission, is it justified as an expense in a third kind of cancer, before this has specifically been proven? [2]. Kaiser Permanente did not change its methods of evaluating whether or not new therapies were too "experimental" to be covered, until it was successfully sued twice: once for delaying IVF treatments for two years after the courts determined that scientific evidence of efficacy and safety had reached the "reasonable" stage, and in another case where Kaiser refused to pay for liver transplantation in infants when it had already been shown to be effective in adults, on the basis that use in infants was still "experimental." [3] Here again the problem of induction plays a key role in arguments.
In his 1996 inaugural speechSmith, A.F.M. (1996). "Mad cows and ecstasy: chance and choice in an evidence-based society". Journal of the Royal Statistical Association, Series A 159: 367-83. as President of the Royal Statistical Society, Adrian Smith held out evidence-based medicine as an exemplar for all public policy. He proposed that Evidence-Based Practice should be established for education, prisons and policing policy and all areas of government.
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