Javad Parvizi,Thorsten Gehrke
The medical and surgical community understands and supports evidence-based medicine, which involves the judicious and explicit use of current best evidence when making decisions about the care of our patients. The community also recognizes that some aspects of medicine may not lend themselves to creating high-level evidence, nor should one attempt to do so in such cases. One will fail to discover any Level-I studies endorsing the importance of hand washing or the use of surgical gloves during surgery. The shrewd observations of intellectuals and scholars who came before us serve as the basis of some of the most critical practices in medicine today. Sir John Charnley, through extensive studies, was perhaps one of the first scholars who outlined the importance of perioperative antibiotics for the prevention of periprosthetic joint infection. There is another barrier that may stand in the way of generating high-level evidence. As eloquently described by Benjamin Freedman, equipoise, or “a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial,” needs to exist for one to contemplate starting a randomized study. What if an orthopaedic surgeon truly believes that the addition of antibiotics to cement spacers provides a more effective treatment for patients with chronic periprosthetic joint infection? Would randomizing patients to receive spacers that do not contain antibiotics and, in essence, are an inferior mode of treatment, not present an ethical issue? The interest in generating high-level evidence may, at times, meet logistic issues that could prevent the execution of such studies. One can, for example, foresee the logistic issues that may exist for a study that attempts to examine the role of personal protection systems in the prevention of periprosthetic joint infection. Evidence-based medicine has been criticized on another front as well. The “artificial” circumstances under which randomized studies are executed often undervalue the importance of surgical expertise in decision making and the complexity of clinical circumstances that require individualization. Randomized trials also often overlook patient preferences and cultural differences that may exist. As stated by Sackett et al., a true model of evidence-based medicine should include the “integration of best research evidence with clinical expertise and patient values.”