The American Orthopaedic Association Clinical Trials Curriculum By Ivan R. Diamond, MD, Camille Murray, MHS, Michael J. Bosse, MD, James D. Heckman, MD, Sohail K. Mirza, MD, Terrance D. Peabody, MD, Khaled J. Saleh, MD, Marc F. Swiontkowski, MD, and James G. Wright, MD In clinical care, high-quality, random- ized controlled trials are generally ac- knowledged to provide the best evidence in evaluating treatment effi- cacy 1 . However, the proportion of or- thopaedic publications that are clinical trials is relatively low. Although the frequency is increasing 2 , many surgical trials are of low quality 3,4 . The reasons for the low number and poor quality of surgical trials are multifactorial 5-7 . The design and conduct of surgical ran- domized trials pose unique challenges, including small numbers of patients, the heterogeneity of surgical patients, ac- ceptability of randomization for surgical procedures, difficulty in standardizing surgical procedures, and issues of sur- gical proficiency such as the learning curve. Although blinded trials afford the best opportunity for unbiased assess- ment of outcomes, such trials are not always feasible in the surgical setting where the comparator group may be a less invasive procedure or a nonopera- tive approach. Despite these challenges, many questions in orthopaedics are amenable to clinical trials. In order to increase the number of trials, ortho- paedic surgeons need an appreciation of a well-designed clinical trial. The ob- jective of this article is to describe the rationale, objectives, design, and pre- liminary evaluation of a curriculum developed by the American Ortho- paedic Association (AOA) to facilitate the conduct of clinical trials in orthopaedics. Rationale for a Clinical Trials Curriculum Given the many challenges posed in performing clinical trials in surgery, particular expertise is needed. Few sur- geons, however, are sufficiently trained to design and conduct such trials. While surgeons or surgical groups could hire clinical research organizations or con- sultants to design and run clinical trials, collaborate with local experts in schools of public health or departments of clinical epidemiology, or recruit non- clinical faculty with advanced training in clinical trials methodology as would be obtained in a masters program in public health or a doctoral program in clinical epidemiology, an alternative or perhaps even a preferred option would be to educate and promote surgeons to develop the necessary skills. One approach to increase capacity in clinical trial design would be to inte- grate training in this methodology into the curriculum for residents and fel- lows. To this end, the AOA, as described below, has developed a series of learning modules for orthopaedic surgery trainees. Exposure during residency or early after staff appointment has several advantages. First, many current resi- dents would have been exposed to evidence-based medicine during medi- cal school and therefore would be more amenable than previous generations to training in clinical trials. Second, resi- dents may be able to use this training for research projects during the resi- dency and therefore provide practical application of skills. Finally, investing in residents through education and learn- ing has the potential to influence an entire career. Curriculum Development The AOA established a task force, under the leadership of the senior author of this paper (J.G.W.), for the purpose of Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from The Journal of Bone and Joint Surgery and the Orthopaedic Research and Education Foundation. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. 1007 COPYRIGHT Ó 2009 BY THE J OURNAL OF BONE AND J OINT SURGERY,INCORPORATED J Bone Joint Surg Am. 2009;91:1007-11 d doi:10.2106/JBJS.H.01864