TABLE 1

Summary of Analytic Studies to Evaluate Performance Characteristics of Automated BSI as a Consistent Imaging Biomarker to Standardize Quantitative Analysis of Bone Scans

Analytic studyObjectiveDesignEndpoint
Simulation studyAccuracy and precisionSimulation of bone scans with known phantom BSI as analytic standardMeasuring automated BSI against phantom BSI
Repeat bone scan studyReproducibilityMetastatic patients with repeat bone scansMeasuring difference between 2 automated BSI interpretations
Follow-up bone scan studyInterobserver variabilityMetastatic patients with 2 routine follow-up clinical bone scansMeasuring observer agreement in assessing automated BSI change