The American Orthopaedic Association Clinical Trials Curriculum

Abstract

In clinical care, high-quality, randomized controlled trials are generally acknowledged to provide the best evidence in evaluating treatment efficacy1. However, the proportion of orthopaedic publications that are clinical trials is relatively low. Although the frequency is increasing2, many surgical trials are of low quality3,4. The reasons for the low number and poor quality of surgical trials are multifactorial5-7. The design and conduct of surgical randomized trials pose unique challenges, including small numbers of patients, the heterogeneity of surgical patients, acceptability of randomization for surgical procedures, difficulty in standardizing surgical procedures, and issues of surgical proficiency such as the learning curve. Although blinded trials afford the best opportunity for unbiased assessment of outcomes, such trials are not always feasible in the surgical setting where the comparator group may be a less invasive procedure or a nonoperative approach. Despite these challenges, many questions in orthopaedics are amenable to clinical trials. In order to increase the number of trials, orthopaedic surgeons need an appreciation of a well-designed clinical trial. The objective of this article is to describe the rationale, objectives, design, and preliminary evaluation of a curriculum developed by the American Orthopaedic Association (AOA) to facilitate the conduct of clinical trials in orthopaedics. Given the many challenges posed in performing clinical trials in surgery, particular expertise is needed. Few surgeons, however, are sufficiently trained to design and conduct such trials. While surgeons or surgical groups could hire clinical research organizations or consultants to design and run clinical trials, collaborate with local experts in schools of public health or departments of clinical epidemiology, or recruit nonclinical 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, …