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What is Evidence Based Medicine?

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The Best Available Evidence Does Not Dictate How Medicine is Practiced. In other words, the average patient does not dictate a rule, a protocol or a practice standard.

Clinicians are hyper-individualistic to a fault, only sometimes following peer-reviewed, published guidelines. Guideline developers need to be sensitive to that and to achieve buy-in, they should rethink their goals and objectives. "In addition to summarizing the evidence, developers, perhaps in partnership with implementation scientists, should consider barriers, explore theories of change, and suggest ways to implement guidelines at the bedside."  In my opinion (over 30 years as a physician executive and the developer of a computerized pateiet record in the mid '80's, guidance needs to be available at the point of contact with the patient.  It may take the form of heuristicsrule-based logic–'If I do that, this may happen,' feedback about past decisions (processes of care) and results (outcomes of case mix-adjusted episodes of care).
Five strategies could help promulgate guidelines. Consequently, guideline developers should:
  1. "include a prioritized checklist of important interventions with the greatest evidence for benefit to patients at the lowest risks and costs." 
  2. "with implementation scientists, [they] could help clinicians identify and mitigate barriers to guideline use and share successful implementation strategies."
  3. "collaborate to integrate guidelines for conditions that commonly coexist. ...However, these checklists have not been collated and integrated into a care plan or daily workflow to reliably ensure delivery of the practices."
  4. "rely on systems, rather than the actions of individual clinicians, to ensure patients receive recommended therapies.....the ecosystem will be [enhanced by] software applications, written on an interface platform, linking the EMR to multiple devices, creating an information ecosystem."
  5. "create transdisciplinary teams and pool expertise from clinical epidemiology (evidence synthesis), implementation science, and systems engineering to develop scholarly guidelines with practice strategies."

Peter J. Pronovost, MD, PhD.."Enhancing Physicians’ Use of Clinical Guidelines." JAMA. Published online December 05, 2013. doi:10.1001/jama.2013.281334

So what is a well-intentioned, conscientious practitioner to do when the history and physical examination(s), referrals and clinical data are inconclusive?

One solution or tool is non-prescriptive guidelines in the form of a systematic review, wherein "researchers gather and re-read the many clinical trials published on a given topic. For some subjects, such as the use of antibiotics for routine ear infections, the completed studies can number in the hundreds, even thousands. Each article is evaluated for methodological rigor, risk of bias and other important variables. Those that prove worthy are fed into a fresh re-analysis that provides a bigger statistical punch and a more durable conclusion."

Many governmental resources, specialty societies and academicians perform systematic reviews, but the gold standard in the field is, clearly, the Cochrane Collaboration."

“Cochrane divides human disease among 53 independent ‘review groups’ of volunteer experts who oversee each analysis. They turn out more than 400 systematic reviews annually. In recent years, the reviewers have provided definitive guidance for adult influenza vaccination (fairly useful), exercise to treat depression (no clear evidence but suggestive), and when to cut the umbilical cord postpartum (wait awhile). They also examine less critical but still important topics such as whether an electric toothbrush is superior to manual brushing (it is) or if flossing prevents cavities (who knows?).”

The  Collaboration regularly finds itself defending its findings (or the lack, thereof). 

For example, consider what it said about Oseltamivir (Tamiflu), a drug that had been considered to be an ‘essential medicine’ by the World Health Organization—well it actually offers “little benefit to normal adults with influenza….the drug decreases symptoms by less than a day and had no impact on survival or complications.”

Sepkowitz Kent  "Looking for the Final Word on Treatment." NY Times, pub online May 14, 2014

The Best Available Information
"The proposed practice of "evidence-based medicine," which calls for careful clinical judgment in evaluating the "best available evidence," should be differentiated from the special collection of data regarded as suitable evidence. Although the proposed practice does not seem new, the new collection of "best available" information has major constraints for the care of individual patients. Derived almost exclusively from randomized trials and meta-analyses, the data do not include many types of treatments or patients seen in clinical practice; and the results show comparative efficacy of treatment for an "average" randomized patient, not for pertinent subgroups formed by such cogent clinical features as severity of symptoms, illness, co-morbidity, and other clinical nuances.
The intention-to-treat analyses do not reflect important post-randomization events leading to altered treatment; and the results seldom provide suitable background data when therapy is given prophylactically rather than remedially, or when therapeutic advantages are equivocal. Randomized trial information is also seldom available for issues in etiology, diagnosis, and prognosis, and for clinical decisions that depend on pathophysiologic changes, psychosocial factors and support, personal preferences of patients, and strategies for giving comfort and reassurance. The laudable goal of making clinical decisions based on evidence can be impaired by the restricted quality and scope of what is collected as "best available evidence." The authoritative aura given to the collection, however, may lead to major abuses that produce inappropriate guidelines or doctrinaire dogmas for clinical practice."


  • "Evidence based medicine: what it is and what it isn't" BMJ. Jan. 13, 1996;312:71-72 
  • Feinstein AR, Horwitz RI. "Problems in the 'evidence' of Evidence based medicine." Am J Med. 1997 Dec; 103(6):529-35.  [Department of Medicine, Yale U. School of Medicine, New Haven, CT 06510].
  • Comment in:  Am J Med. 1998 Oct;105(4):361-2. 
  • See also, Vence L. Bonham., Shawneequa L. Callier, and Charmaine D. Royal. "Will Precision Medicine Move Us beyond Race?" New Eng J Med5/26/16 where it says:
    • "Precision medicine is premised on the idea of improving health outcomes by generating and using many sources of personal data to more accurately group and treat patients. If the major challenges can be overcome, precision medicine could lead the way in reducing and ultimately eliminating the use of crude racial and ethnic census categories in drug prescribing.... 

[But] There are many hurdles to overcome if a precision medicine approach to health care is to replace the use of race in treatment decisions. First, greater inclusion of patients of diverse ancestry in genomic and other biomedical research can improve understanding of intrapopulation and interpopulation diversity....

Rising costs present a second major challenge to precise drug prescribing....prospective cohort studies will help establish an evidence base regarding the effectiveness of drugs for individual patients — and thereby advance equitable distribution.....

Third, moving the drug-selection process beyond race to more accurate indicators of drug response will depend on the ease and usefulness of implementing a precision medicine approach."

With "available and emerging tools, risk for disease can be quantified and prevention measures initiated before pathology develops — and that when it does, its mechanisms can be identified so that disease is treated with precision....

The 1910 Flexner Report shocked the medical establishment into incorporating scientific advances to transform how disease is defined, diagnosed, and treated. More than a century later and a decade since the genomic revolution, it’s again time to redesign clinical care to also enhance health and prevent disease.

Fundamental change is not easy, however. As President and CEO of the Duke University Health System from 1998 to 2004, I (Ralph Snyderman) witnessed firsthand the financial obstacles created by perverse reimbursement incentives that inhibit implementation of innovative clinical delivery models."

"To Adopt Precision Medicine, Redesign Clinical Care," a Dec. 28, 2016 N Eng J Med, Catalyst (Care Redesign) article featuring Ralph Snyderman, MD, Caroline Meade, BS and Connor Drake, MPA from Duke's Center for Research on Personalized Health Care