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Is high-level evidence always warranted or possible?

Issue: July 2013

ByThorsten Gehrke, MD

ByJavad Parvizi, MD, FRCS

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A recent publication in Clinical Infectious Diseases seized our attention. The publication, based on the systematic review of the available literature, concluded that there was no level 1 study substantiating the role of antibiotics added to cement spacers. The authors, who were members of the FDA, urged the orthopedic community to consider generating evidence supporting this common practice. They suggested that patients who undergo two-stage exchange arthroplasty be randomized to receiving spacers with or without antibiotics.

While we, the medical community, should applaud any attention to an evidence gap in medicine, need to also realize that generating level 1 evidence is neither possible nor is it warranted in every aspect of practice of medicine. It is inspiring to witness that the young generation has abandoned the eminence-based medicine in search of evidence for most practices in medicine. It is also equally important to realize that some of the common wisdom in medicine is as a result of many years of trial and errors that trump level 1 evidence. The “art” of medicine is generated as a result of collective wisdom of many, who have sacrificed their professional lives for the advancement of the field and improvement of care for patients. We doubt any surgeon would be willing to question the observations of Louis Pasteur, John Hunter, Joseph Lister, Robert Koch or Christian Barnard. Should we question the wisdom of wearing surgical gloves during surgery or administering antibiotics to patients with pneumonia? There are numerous practices in medicine that have not been subjected to level 1 study and will, or should, never be questioned.

 

Javad Parvizi

The medical community needs to comprehend the importance of high-level evidence and engage in generation of such evidence whenever possible. The community also needs to recognize that some aspects of medicine will never lend itself to generation of high-level evidence nor should one attempt to do so.

Management of periprosthetic infection is one such arena in medicine where physicians from different disciplines, in their best intentions, commit to practices that have not all been scrutinized by level 1 studies. How much and which antibiotic should one add to cement spacers, should one always take samples for culture during revision arthroplasty, what metric should one use to decide on the optimal timing of re-implantation, what are the indications and contraindications for irrigation and debridement, when is it a safe time to perform elective arthroplasty in a patient with history of septic arthritis, and many other questions pose challenges to orthopedic surgeons on a daily basis. While some of these questions are in dire need of level 1 evidence, others can hardly be subjected to scrutiny of a randomized study.

Thorsten Gehrke

It is with the recognition of the latter, that we have decided to bring together more than 350 experts from around the world to partake in a meeting in Philadelphia in August to reach consensus on many of these issues that pose challenge to us as practicing orthopedic surgeons and, most importantly, to our patients who suffer from the dreaded complication of joint replacement, namely periprosthetic joint infection (PJI). The delegates for the meeting will turn every stone in search of evidence for common practices in management of PJI. In cases where the evidence is lacking, such as the role of antibiotics in cement spacers, the delegates will reach a consensus on what practice, at this juncture, is in the best interest of our patients. It is hoped that the consensus reached will bring accord to our community and will serve those unfortunate patients who have fallen victim to PJI. The results of the consensus meeting will be disseminated to orthopedic surgeons around the world in the hope of implementing practices that aim to diminish the suffering of our patients.