Abstract
Purpose: Radiographic healing is a common outcome measure in orthopaedic trials and adjudication by outcome assessors is often conducted using only plain radiographs. We explored the effect of adding clinical notes to radiographs in the adjudication process of a pilot trial of tibial shaft fractures.
Method: Radiographic and clinical data from a multicenter clinical trial of 51 patients with operatively treated tibial fractures formed the basis of the study data. An independent adjudication committee of three blinded orthopaedic trauma surgeons evaluated radiographs for time to fracture healing. This committee then evaluated clinical notes associated with each radiographic follow up visit and were asked to either revise or maintain their initial impression. We calculated the proportion of time to healing consensus decisions that changed after evaluation of clinical notes. We further examined the contents of the clinical notes and its relative influence on the committee’s decisions.
Results: Forty-seven of 51 patients were determined to have radiographic evidence of healing during the trial follow-up period, and consideration of the clinical notes resulted in a change of 40% (19 of 47) of time to healing consensus decisions; however, revised decisions were equally likely to support an earlier or a later time to healing.
Conclusion: Addition of clinical notes changed the adjudication committee’s decision of radiographic fracture healing in a substantial number of cases. Our findings suggest that orthopedic trialists should consider the addition of clinical notes to adjudication material in studies of fracture healing.
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