Evidence-based Medicine in Orthopaedics: Are We There Yet?

James G. Wright, M.D., FRCSC
Toronto, ON

The goal of clinical practice is that treatment for individual patients must do more good than harm and result in the greatest improvement in health compared to no treatment or alternative treatments. Major advancements in orthopaedics over the past 30 years include total joint replacement, internal fixation of fractures, instrumentation for the spine and the Ponseti treatment for club foot. Based on uncontrolled case series, these treatments were obviously superior to existing options and quickly adopted. However, since that time, there have been relatively few comparable leaps in improvements in patient outcomes. Evidence-based medicine has the potential to improve patient care. Evidence-based medicine was defined in 1996 by David Sackett as "the use of current best evidence, integrated with individual expertise to make the best decisions about the care of individual patients". In order for this to be effective, surgeons must recognize the need for evidence, evidence must exist, surgeons must be able to find the evidence, and surgeons need to use the evidence in their clinical practice.

 

A striking example of the power of evidence-based medicine comes from paediatric oncology. Approximately 30 years ago, paediatric oncologists had the same variability in treatment as orthopaedic surgeons do now. At that time paediatric oncologists began to enroll their patients in randomized clinical trials. Over the past 30 years, improvement in survival for childhood cancer has jumped from 10% to 70%. Upwards of 70% of children with malignancy are currently entered into clinical trials in North America. This is a powerful example of how randomized clinical trials can improve quality of care.

Over the past ten years, there have been significant advances in the use of evidence by journals, the promotion of evidence by professional societies, the development of specialty-based randomized trials, increased capacity in designing and understanding trials, and providing evidence in an accessible form. In 2000, the American Journal of Bone and Joint Surgery (JBJS) introduced an Evidence-based Orthopaedics section. Approximately 40 journals are reviewed to identify all Level I evidence relevant to orthopaedic surgeons. On a quarterly basis, we construct three structured abstracts with solicited commentaries so that orthopaedic surgeons can identify the latest evidence-based treatments. Shortly thereafter, JBJS introduced Levels of Evidence ratings for all clinical papers. Studies are divided into four types; therapeutic, prognostic, diagnostic, and economic/decision analysis. Studies are graded from Level I through Level V with a Level of Evidence grade attached to the bottom of the abstract. Orthopaedic surgeons should look very seriously at Level I and Level II studies as they are likely to have a significant impact on their practice. More recently the JBJS has introduced the concept called Grades of Recommendation for review articles. While each individual study has a Level of Evidence in making a treatment recommendation, Grades of Recommendation provide a summary of the totality of the literature. Grade A evidence is consistent Level I studies, Grade B evidence is consistent Level II and Level III evidence, Grade C is consistent Level IV and Level V studies, and Grade I is either insufficient or conflicting evidence, not allowing recommendation for or against intervention. A Grade is attached to treatment recommendations in review articles, thereby assisting readers in judging the importance and strength of recommendations arising from review articles.

Professional societies have also dramatically progressed in their use of evidence. For example, the Paediatric Orthopaedic Society of North America (POSNA) requires Levels of Evidence ratings for all abstracts submitted to their annual meeting. Even more powerful have been society-wide clinical trials. For example, a POSNA-wide clinical trial published in JBJS in 2008 evaluated healing, function and pain comparing intralesional methylprednisolone with autologous bone marrow for simple bone cysts. This multi-centre trial of 28 centres involving 90 patients demonstrated that the more recent and popular treatment of injection of bone marrow had lower incidence of healing than the standard treatment of methylprednisolone for simple bone cysts.

The AOA has embarked on a process to improve the capability for designing clinical trials. Because many surgeons do not have the time to devote to a full clinical trials course (such as a Masters degree), the AOA has developed a 22-module (with ten core modules) designed to teach the essentials of randomized clinical trials. The course, with an instructor guide, is specifically designed to be taught by non-experts. A recent JBJS publication demonstrated this course can result in significant improvement in knowledge.

A recent study by Hanzlik has shown that randomized clinical trials Level I evidence now comprises almost 25% of articles published in JBJS and in the year 2005 the number of case series published in JBJS dropped below 50%. This finding demonstrates that the amount of evidence in orthopaedics is accumulating. For surgeons looking to find evidence, there are several sources including Medline (using Clinical Queries), the Cochrane database, or the Up-to-Date web site. In addition there are recent textbooks such as Evidence-based Orthopaedics, that addresses clinical questions based on systematic literature searches of controlled Level I to Level III studies with Grades of Recommendations. The day is not far off when we will be able to search for evidence-based answers at the bedside using our smart phones.

In conclusion, high quality evidence in orthopaedics is increasing. The culture of orthopaedics is becoming evidence-based. High quality evidence is available in several forms. The next challenge will be the final step of having surgeons adopt and adhere to evidence-based treatments.

References

  1. Diamond, I. R., C. Murray, et al. (2009). The American Orthopaedic Association Clinical Trials Curriculum. J Bone Joint Surg Am 91(4): 1007-1011.
  2. Hanzlik, S., R. C. Mahabir, et al. (2009). Levels of evidence in research published in The Journal of Bone and Joint Surgery (American Volume) over the last thirty years. J Bone Joint Surg Am 91(2): 425-428.
  3. Sackett, D. L., W. M. Rosenberg, et al. (1996). Evidence based medicine:  What it is and what it isn't. BMJ 312(7023): 71-72.
  4. Wright, J. G. (2000). Introducing a new journal section: Evidence-based orthopaedics. J Bone Joint Surg 82: 759.
  5. Wright, J. G. (2006). Revised grades of recommendation for summaries or reviews of orthopaedic surgical studies. J Bone Joint Surg Am 88-A(5): 1161-1162.
  6. Wright, J. G. (2009). Evidence-Based Orthopaedics: The Best Answers to Clinical Questions, Elsevier.
  7. Wright, J. G., M. Swiontkowski, et al. (2006). Levels of evidence. J Bone Joint Surg Br 88-B(9): 1264-.
  8. Wright, J. G., M. F. Swiontkowski, et al. (2003). Introducing levels of evidence to the journal. J Bone Joint Surg Am 85-A(1): 1-3.
  9. Wright, J. G., S. Yandow, et al. (2008). A Randomized Clinical Trial Comparing Intralesional Bone Marrow and Steroid Injections for Simple Bone Cysts. J Bone Joint Surg Am 90(4): 722-730.

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