An Endpoint Adjudication Committee for the Assessment of Computed Tomography Scans in Fracture Healing

Abstract

AbstractThe use of endpoint adjudication committees (EACs) has the potential to reduce subjectivity and potential bias in clinical research trials and contribute to a higher quality of research. In a recent randomized control trial (RCT), we used serial computed tomography (CT) imaging to visualize fracture healing of the scaphoid as a primary outcome. The scaphoid bone poses a challenge in the diagnosing of fractures and non-unions due to its complicated shape. An EAC was created to increase the quality of the data and the validity of our findings. While an adjudication process has long been proposed and described for X-rays, this study outlines a rational approach to CT scan adjudication for bone fracture healing. A total of 364 scans were acquired in the RCT and of these, 101 were adjudicated for a binary endpoint of union vs. non-union. The application of EACs such as described in this paper is a useful tool in orthopaedic research requiring the adjudication of fracture healing as a study outcome.