Diagnostic Outcomes | N = 264 | |||
% (95% CI) | ||||
Diagnostic yield at index, using first definition | 85.2% (80.9%, 89.5%) | |||
Diagnostic yield at 12 months, using first definition | ||||
Base case | 79.4% (74.4%, 84.3%) | |||
Worst case | 77.3% (72.2%, 82.3%) | |||
Best case | 79.9% (75.1%, 84.8%) | |||
Sensitivity for malignancy at 12 months | ||||
Base case scenario | 79.3% (72.7%, 85.9%) | |||
Worst case scenario | 74.2% (67.3%, 81.1%) | |||
Comparison of Diagnostic Yield Definitions | ||||
Index Diagnostic yield | 12-month Diagnostic yield | |||
Index Diagnosis Status | First Definition | Second Definitiona | First Definition | Second Definition |
Malignant | TP (N = 115) | TP (N = 115) | TP (N = 115) | TP (N = 115) |
Benign specific | TN (N = 32) | TN (N = 40) | TN (N = 32) | TN (N = 32) |
Benign non-specific | TN (N = 78) | FN (N = 70) | TN (N = 57), FN (N = 14), or inconclusive (N = 7) | TN (N = 57), FN (N = 14), or inconclusive (N = 7) |
Non-diagnostic | FN (N = 39) | FN (N = 39) | FN (N = 39) | TN (N = 22), FN (N = 14), or inconclusive (N = 3) |
Diagnostic Yield | ||||
Numerator | 225 | 155 | 204 | 226 |
Denominator | 264 | 264 | 257 | 254 |
Estimate, % (95% CI) | 85.2% (80.9%, 89.5%) | 58.7% (52.8%, 64.7%) | 79.4% (74.4%, 84.3%) | 89.0% (85.1%, 92.8%) |