Level 1 Technical efficacy
Resolution of line pairs
Modulation transfer function change
Gray-scale range
Amounts of mottle
Sharpness
Computerized imaging parameters
Level 2 Diagnostic accuracy efficacy
Yield of abnormal or normal diagnoses in a case series
Diagnostic accuracy (percentage of correct diagnoses in case series)
Sensitivity, specificity, and positive/negative predictive value in a defined
clinical problem setting
Measures of area under the receiver operating characteristic (ROC) curve
Level 3 Diagnostic thinking efficacy
Number (percentage) of cases in a series in which image was judged
"helpful" to making the diagnosis
Entropy change in differential diagnosis probability distribution
Difference in clinicians’ subjectively estimated diagnosis probabilities
before and after test information
Level 4 Therapeutic efficacy
Number (percentage) of times image was judged "helpful" in planning
patient care in a case series
Percentage of times medical or surgical procedure avoided due to image
information
Number or percentage of times planned therapy pretest changed after the
image information was obtained (retrospectively inferred from clinical
records)
Number or percentage of times clinicians’ prospectively stated therapeutic
choices changed after test information
? Patient utility assessment
Level 5 Patient outcome efficacy
Percentage of patients improved with test vs without test
Morbidity (or procedures) avoided after having image information
Change in quality-adjusted life expectancy
Expected value of test information in quality-adjusted life years (QALYs)
Cost per QALY saved with image information
Patient utility assessment (eg. Markov modeling, time trade-off)
Level 6 Societal efficacy
Benefit-cost analysis from societal viewpoint
Cost-effectiveness analysis from societal viewpoint
References
1. Intermediate Outcomes: Diagnostic and Therapeutic Impact. Thornbury JR. 1999 Academic Radiology; 6 (Suppl. 1): S58-65
2. The Efficacy of Diagnostic Imaging. Fryback DG, Thornbury JR. 1991 Med Decis Making;11:88-94