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Evidence-based medicine

Evidence-based medicine (EBM) applies the scientific method to medical practice. 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.".

Systems to stratify evidence by quality have been developed, such as this one by the U.S. Preventive Services Task Force:
*Level I: Evidence obtained from at least one properly designed randomized controlled trial.
*Level II-1: Evidence obtained from well-designed controlled trials without randomization.
*Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
*Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
*Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

The UK National Health Service uses a similar system with categories labelled A, B, C, and D.

Categories of recommendations

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 Service Task Force uses:
*Level A: Good scientific evidence suggests that the benefits of the clinical service substantially outweighs the potential risks. Clinicians should discuss the service with eligible patients.
*Level B: At least fair scientific evidence suggests that the benefits of the clinical service outweights the potential risks. Clinicians should discuss the service with eligible patients.
*Level C: At least fair scientific evidence suggests that there are benefits provided by the clinical service, but the balance between benefits and risks are too close for making general recommendations. Clinicians need not offer it unless there are individual considerations.
*Level D: At least fair scientific evidence suggests that the risks of the clinical service outweighs potential benefits. Clinicans should not routinely offer the service to asymptomatic patients.
*Level I: Scientific evidence is lacking, of poor quality, or conflicting, such that the risk versus benefit balance cannot be assessed. Clinicians should help patients understand the uncertainty surrounding the clinical service.

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.

The Oxford Centre for Evidence-based Medicine uses these levels of evidence (LOE) and "grades of recommendations" 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
*Level A: consistent Randomised Controlled Clinical Trial, Cohort Study, All or None, Clinical Decision Rule validated in different populations.
*Level B: consistent Retrospective Cohort, Exploratory Cohort, Ecological Study, Outcomes Research, Case-Control Study; or extrapolations from level A studies.
*Level C: Case-series Study or extrapolations from level B studies
*Level D: Expert opinion without explicit critical appraisal, or based on physiology, bench research or first principles

"Extrapolations" are where data is used in a situation which has potentially clinically important differences than the original study situation.

Limitations of available evidence

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

Criticism of evidence-based medicine

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 â€" that is, EBM applies to populations, not necessarily to individuals. In The limits of evidence-based medicine{{cite web
url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11728302&dopt=Abstracttitle=The limits of evidence-based medicinelast=Tonellifirst=MRpublisher=NCBI PubMedyear=2001accessdate=2006-06-27, 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 quickly becoming the "gold standard" for clinical practice and treatment guidelines, there are a number of reasons why most current medical and surgical practices do not have a strong literature base supporting them. First, in some cases, such as in open-heart surgery, conducting randomized controlled trials would be unethical, although observational studies are designed to address these problems to some degree. Second, certain groups have been historically under-researched (women, racial minorities, people with many co-morbid diseases), and thus the literature is sparse in areas that do not allow for generalizability. Third, the types of trials considered "gold standard" (i.e. randomized double-blind placebo-controlled trials) may be expensive, so that funding sources play a role in what gets investigated. For example, public authorities may tend to fund preventive medicine studies to improve public health as a whole, while pharmaceutical companies fund studies intended to demonstrate the efficacy and safety of particular drugs. Fourth, the studies that are published in medical journals may not be representative of all the studies that are completed on a given topic (published and unpublished) or may be misleading due to conflicts of interest (i.e. publication bias){{cite web
url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14748860&itool=iconabstrtitle=Relationship between conflicts of interest and research resultslast=Friedmanfirst=LScoauthors=Richter, EDpublisher=NCBI PubMedyear=2004accessdate=2006-06-27. Thus the array of evidence available on particular therapies may not be well-represented in the literature. Since the 2004 statement by the International Committee of Medical Journal Editors that they will refuse to publish clinical trial results if the trial was not recorded publicly at its outset, this may become less of a problem. Fifth, the quality of studies performed varies, making it difficult to generalize about the results, although well conducted meta-analyses remove poor quality studies from influencing data.

Large randomized controlled trials are useful for examining discrete interventions for carefully defined medical conditions. The more complex the patient population, the conditions, and the intervention, the more difficult it is to separate the treatment effect from random variation. 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".

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.

See also

* Adverse drug reaction
* Adverse effect (medicine)
* Clinical trials with surprising outcomes
* Consensus (medical)
* Epidemiology
* Guideline (medical)
* History of medicine
* Medical algorithm
* Medical research
* Nocebo
* Placebo (origins of technical term)
* Systematic Reviews
* Evidence-based management

References

External links

* ACC.org - 'What Is Evidence-Based Medicine?' American College of Cardiology
* AHRQ.gov - 'U.S. Preventive Services Task Force (USPSTF)', Agency for Health Care Research and Quality
* BEEMCourse.com - 'The Best Evidence In Emergency Medicine (BEEM) Team' Group based out of McMaster University (Hamilton, Ontario, Canada) that actively reviews the best emerging evidence based research in emergency medicine.
* BMJ.com - 'Evidence based medicine: what it is and what it isn't: It's about integrating individual clinical expertise and the best external evidence', (editorial) British Medical Journal, vol 312, p 71-72 (January 13, 1996):* BMJ.com - 'Evidence based medicine: Socratic dissent', (Education and debate) British Medical Journal, vol 310, p 1126-1127 (April 29, 1995)
* CEBM.net - Oxford Centre for Evidence-Based Medicine (UK)
* CMAJ.ca - 'Evidence-based medicine: a commentary on common criticisms', Dr. Sharon E. Straus, Dr. Finlay A. McAlister, Canadian Medical Association Journal, Vol 163, No 7, pp 837 - 841 (October 3, 2000)
* Cochrane.org - 'The Cochrane Collaboration: The reliable source for evidence in healthcare' (systematic reviews of the effects of health care interventions), Cochrane Library
* EBOnCall.org - 'Evidence compendia' (evidence-based summaries of 38 on-call medical conditions), Evidence-Based On-Call (EBOC)
* GPNoteBook.co.uk - 'Evidence-based medicine (EBM)', General Practice Notebook
* HERTS.ac.uk - Evidence-Based Medicine', University of Hertfordshire
* JournalReview.org - 'An unbiased forum for review of the medical literature', An On-Line journal club
* JR2.ox.ac.uk - 'Bandolier: Evidence-based thinking about health care', Bandolier (journal)
* MJA.com.au - 'Evidence-based medicine: useful tools for decision making', Jonathan C. Craig, Les M. Irwig, Martin R. Stockler, Medical Journal of Australia, vol 174, p 248-253 (2001)
* SHEF.ac.uk - 'Netting the Evidence: A ScHARR Introduction to Evidence Based Practice on the Internet' (resource directory), University of Sheffield
* TRIPDatabase.com - 'TRIP Database - EBM search engine' (resource directory), TRIP Knowledge Service



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