Summary of Analytic Studies to Evaluate Performance Characteristics of Automated BSI as a Consistent Imaging Biomarker to Standardize Quantitative Analysis of Bone Scans
Analytic study | Objective | Design | Endpoint |
Simulation study | Accuracy and precision | Simulation of bone scans with known phantom BSI as analytic standard | Measuring automated BSI against phantom BSI |
Repeat bone scan study | Reproducibility | Metastatic patients with repeat bone scans | Measuring difference between 2 automated BSI interpretations |
Follow-up bone scan study | Interobserver variability | Metastatic patients with 2 routine follow-up clinical bone scans | Measuring observer agreement in assessing automated BSI change |