Adjudicating outcomes: fundamentals.

The adjudication of outcomes has rarely been reported in the orthopaedic literature, although this process is commonly used and reported in clinical trials of other medical disciplines. Adjudication of outcomes provides more reliable and valid outcome assessment, especially when the outcome is subjective as in the case of fracture-healing. The successful implementation of adjudication in a clinical trial is an important and complex process. The process requires a substantial infrastructure of research personnel to oversee data collection at the clinical sites. The development of an adjudication charter specific to the study is a critical aspect of adjudication as it outlines the adjudication committee membership as well as their roles and responsibilities and defines the adjudication process and the decision rules. Web-based adjudication has facilitated the process as it allows rapid, efficient, and timely adjudication. This article provides an overview of the adjudication process, along with details on the common pearls and pitfalls associated with this method of outcomes assessment.