On Evidence-Based Clinical Medical Guidelines

About the Institute for Clinical Systems Integration [ICSI] 

By Brent A. Metfessel MD, CMP™


The Institute for Clinical Systems Integration (ICSI) is a strong proponent of the value of evidence-based clinical guidelines, and cites the following objections that make their implementation and acceptance more difficult.


The Issues

These issues generally apply to technology assessments as well:

  • Guidelines are a legal hazard:  There is a fear that following a guideline that turns out to be wrong increases the risk of litigation.  Good guidelines, however, are evidence-based and not opinion-based drivers of care.  Furthermore, once a review of the literature takes place and is synthesized into a preliminary guideline, multi-specialty physician focus groups review the guidelines prior to finalization.  The strength of evidence supporting each conclusion is usually stated, highlighting areas of remaining scientific uncertainty.  “Evidence hierarchies” are often used as aids to grading recommendations, with meta-analysis, systematic reviews, and randomized controlled trials being at or near the top of the hierarchy in strength, with narrative reviews, case reports, and medical opinion pieces being considered the weakest forms of evidence.  This provides additional checks and balances to guideline development.
  • Guidelines are cookbook medicine:  Guidelines are just that – guidelines.  Each patient should be provided treatment according to his/her individual needs.  Evidence-based clinical guidelines are based on extensive reviews of the literature and are applicable to the vast majority of cases for a particular clinical condition but not necessarily all cases.  In the case of practice pattern evaluation or profiling, comparisons of such patterns to medical guidelines can help identify overall systematic variations from the norm rather than variations due to particular patients with special needs.
  • Guidelines do not work:  When used as the sole basis for practice improvement, this statement contains some truth. However, when incorporated into a systematic continuous quality improvement approach, they have been shown to improve practice patterns and reduce variation.
  • Physicians will not use guidelines:  Once physicians know that the guidelines are based on a sound review of the medical literature, practitioner buy-in greatly increases.  In addition, clinicians need to realize that clinical guidelines are only one part of the total treatment picture since a team approach to patient care is becoming the norm.
  • Guidelines need validation through actual outcomes data:  This is correct when based on a continuous quality improvement approach, but is incorrect if outcomes are based on individual events.  Local implementation of guidelines can be compared to outcomes data one or two years after implementation.  Depending on the actual level of practice pattern improvement, minor alterations can be made to the guidelines to reflect local needs.

Guideline Adaptation

National guidelines in some cases may need adaptation to local patient needs and concerns.  For example, a practice in a major metropolitan area where specialty care is readily available differs in major ways from a rural practice which is based more on primary care.  Practices where many patients are poor or on public assistance also differs from practices in affluent areas.  When used as basic guides to appropriate practice, however, clinical guidelines can significantly decrease practice variation.

Evidence Based Medicine

With the recent emphasis on evidence-based medicine and on decreasing the time lag between evidence publication and its effect on actual patient care, a number of agencies have added clinical guideline and technology assessment development to their task lists.  Such agencies include specialty societies such as the American College of Cardiology (ACC), private companies and non-profit organizations, governmental bodies such as the Agency for Health Care Research and Quality (AHRQ), and MCOs that review the scientific evidence for the purpose of determining coverage policy.


MCOs may post medical coverage policies on the Web for physicians to access, and these generally contain narrative justifications (often with evidence grading) in terms of why a particular procedure or diagnostic test may or may not be covered based on level of efficacy shown in scientific studies.  It is important to note that for many high-tech or new procedures, different MCOs may have somewhat different coverage policies based on variation in terms of interpreting the evidence, especially in areas where the science is less certain.


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8 Responses

  1. On EBM

    “The Cochrane Collaboration is an enterprise that rivals the Human
    Genome Project in its potential implications for modern medicine.”


    – The Lancet


  2. Does EBM Reduce Physician Autonomy?

    What does Evidence-Based-Medicine really mean? Just think about it for a second. Does it mean that MDs should now actually practice medicine based on bona fide evidence?

    Well, according to this “angry” orthopedic surgeon, what the hell have doctors been doing for the past decades? Making it all up?




  3. The Cochrane Collaboration and Reviews

    How do you know if one healthcare intervention works better than another, or if it will do more harm than good?”

    Cochrane Reviews are systematic reviews of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care. They investigate the effects of interventions for prevention, treatment and rehabilitation. They also assess the accuracy of a diagnostic test for a given condition in a specific patient group and setting. They are published online in The Cochrane Library.


    Ann Miller RN MHA


  4. Why I am Pleased with EBM – Today

    In 1977, as a young medical student at Temple University in Philadelphia, I had few thoughts on domestic health care or the US health system. Passing my courses, working to pay tuition, long distance running – and chasing the occasional pretty woman occupied most of my time.

    If you had asked me back then what proportion of health care delivered was grounded in evidence, I am sure I’d have said “most” or “nearly all” or possibly even “all”. And, I would bet the vast majority of Americans think that today. If so, they’re wrong, just as I would have been in 1977.

    Yet, a new paradigm for medical practice is emerging. Evidence-based medicine de-emphasizes intuition, unsystematic clinical experience, and patho-physiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research.

    We call the new paradigm “evidence-based medicine.”

    Thirty-Five years on, according to economist Austin Frakt PhD, it’s astonishing how little progress we’ve made. Could we have done better? Should we have? Even our relative successes at improving the efficiency and effectiveness of US medical practice through research leaves a lot of room for improvement.

    Still today, green shoots … finally!

    Dr. David Edward Marcinko MBA


  5. Study Finds Docs with Links to Drug Companies Influence Treatment Guidelines

    Doctors with financial ties to drug companies have heavily influenced treatment guidelines recommending the most lucrative drugs in American medicine, an analysis by the Milwaukee Journal Sentinel and MedPage Today has found.


    The guidelines affect how doctors across the country treat patients for everything from diabetes to asthma, chronic pain, depression and high cholesterol … surprised?



  6. On cookbook medicine


    Brent – Do eHRs, templates, guidelines and checklists etc, make doctors clinically lazy?

    Dr. Altman


  7. Evidence-based medicine goes mobile

    As EBM enters its prime, the mobile app marketplace has made strides to accommodate it, supplementing physicians’ judgment and professional expertise.




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