Editorial| Volume 43, ISSUE 6, P339-340, November 2004

Enigmas and evidence

      There are many enigmatic questions in our discipline. Here are a few that interest me:
      Are orthotics better than arch supports for plantar fasciitis?
      Is Lapidus an improvement to first metatarsal osteotomy bunionectomy?
      Is first metatarsophalangeal joint fusion better than metallic hemi implant in patients with diabetes?
      Are injected steroids better than local anesthesia alone for plantar fasciitis?
      Do prescription shoes actually reduce the rate of diabetic foot ulceration?
      Does triceps lengthening for neuropathic forefoot ulceration have late morbidity?
      Does nerve decompression for diabetic peripheral neuropathy work?
      Do injected hyaluronic acids reduce osteoarthritic pain in the ankle?
      Are diabetic patients less compliant than nondiabetic patients?
      I am certain that you, like me, would like answers to these and many other enigmas in foot and ankle surgery.
      The medical community is increasingly being asked to substantiate claims and treatment methodologies by both payers and receivers of care. This pressure has driven changes in medical and surgical practice. An example of such change includes high-profile medical advances such as the immediate use of thrombolytic drugs after myocardial infarction. Evidence has driven changes in acute myocardial infarction protocols, most notable is the fact that intravenous lidocaine is no longer used in acute myocardial infarction protocols. Careful studies showed that although it improved the appearance of the electrocardiogram, the patient cohort receiving it had higher morbidity. These changes in medical treatment were driven by carefully controlled studies (randomized controlled trials) that were able to withstand rigorous critical appraisal. These studies are designed and managed to eliminate introduction of bias and to deal with multiple variables by careful study design and statistical evaluation.
      Foot and ankle surgeons are increasingly being asked to provide this kind of evidence for developing technologies. The recent introduction of extra corporeal shock wave treatment for plantar fasciitis is an example of technology being available without strong evidence to support both the development of the technology and the payment of extra corporeal shock wave treatment. There is a respectable international list of papers on this methodology; why are they not acceptable? The answer lies in the fact that the literature that exists, when systematically reviewed, is plagued with bias and questionable research methodology.
      Treatment of plantar fasciitis has a response to placebo that may be 40% to 50%! Assuming that there is a 40% placebo effect in both the sham and the treatment arm of the study, how do you deal with a 65% cure rate in the treatment group? Does this mean that only 25% responded to the extra corporeal shock wave treatment? How do you differentiate placebo? How many of these patients spontaneously resolved in the middle of the study? What were the confounding variables? Did a certain patient type (age, body mass index, sex, activity) perform differently than the whole set? How many patients had reoccurrence within 2 years? Suddenly there are more questions than we ever expected, further clouding a promising new treatment method.
      The answers are out there; they can be found in good evidence. This kind of evidence is not easy to acquire. It demands careful and rigorous randomization, control of variables and bias, and then careful statistical evaluation. Well-designed, well-performed trials lead to truthful answers. The application of evidence to the art of medicine is evidence-based medicine (EBM). EBM has been best described by David Sackett: “Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.”
      • Sackett D.L.
      • Rosenberg W.M.
      • Gray J.A.
      • Haynes R.B.
      • Richardson W.S.
      Evidence based medicine what it is and what it isn’t.
      What does this mean to the frontline clinician? It means that one must always be questioning the assumptions of community standard. It also means that clinicians are tasked with critically appraising the literature and honestly answering questions that their patients ask regarding their care. Patients are increasingly aware of the confusing array of treatment choices and challenge us with increasing frequency for the “right” answer to their problems.
      What are we to do? Here are some recommendations:
      • 1)
        Become familiar with the terminology of EBM hierarchy of study designs:
        • Level 1 consists of randomized control trials (called the gold standard for evidence) and systematic reviews of all randomized control trial data, including metaanalyses.
        • Level 2 consists of cohort studies and their systematic reviews.
        • Level 3 consists of case control studies and their systematic reviews.
        • Level 4 consists of case series.
        • Level 5 consists of expert opinion without explicit critical appraisal, or based on physiology, bench research, or first principles.
      • 2)
        In an effort to increase EBM awareness and promote EBM culture the ACFAS will be making efforts to grow EBM in our discipline. The Journal of Foot and Ankle Surgery will soon be categorizing submissions as to their place in this hierarchy of evidence. Research presentations at the Annual Meeting of the American College of Foot and Ankle Surgeons will also be categorized in this hierarchy.
      • 3)
        Read the EBM literature. You can start with Google or go to the American College of Foot and Ankle Surgeons web site for links and online instruction.
      • 4)
        Read medical and surgical literature critically, using EBM methodology.
      • 5)
        Ask your residents and medical students to find evidence on the clinical questions you face in daily practice.
      • 6)
        Take an EBM course and begin using the tools for improving patient care in your practice.
      • 7)
        Participate in research.
      Foot and ankle surgeons also need to be become practitioners of EBM. The benefits include making you aware of new innovations that may be of value when treating patients and helping you to critically appraise and evaluate interventions that you are already using. Lastly, in the long view, EBM will save time. The EBM process inherently leads to the generation of evidence-based medical summaries and clinical practice guidelines, which may then be applicable to our individual patients.
      EBM is a paradigm shift in medicine. It is a necessary tool that will improve patient care and care efficiency. Welcome to the new world.


        • Sackett D.L.
        • Rosenberg W.M.
        • Gray J.A.
        • Haynes R.B.
        • Richardson W.S.
        Evidence based medicine.
        BMJ. 1996; 312: 71-72