Subjective vs. objective evaluation of gallbladder opacification during oral cholecystography in comparative clinical trials: implications for studies involving visual assessment.

Radiographs and CT images taken during oral cholecystography in dogs were interpreted in an independent, blind fashion by three radiologists on two occasions and visual assessment of gallbladder density compared to the actual CT values. While there was significant intra- and inter-observer variation, the mean scores for the observers' interpretations of both radiographs and prints correlated well with the actual CT values (p less than 0.05). In five out of six comparisons between first and second readings, the observers gave a lower score on the second reading. The considerable variation reflects the problems inherent in subjective evaluation of agents that produce small but measurable differences in radiographic density. Studies involving such subjective data have to be carefully designed in order to obtain meaningful results.