Noninferiority and Equivalence Evaluation of Clinical Performance among Computed Radiography, Film, and Digitized Film for Telemammography Services
Table 8
Evaluation of dense breasts. Mean values, pairwise comparisons, and observed delta for equivalence for TP, TN, FP, sensitivity, specificity, accuracy, VPP, VPN, and AUC.
TP
TN
FP
FN
SEN
SPE
ACC
VPP
VPN
AUC
Device (resolution)
CR (3,560 × 4,640)
0.46
0.33
0.05
0.16
0.74
0.86
0.78
0.77
0.53
0.86
ICR (2,436 × 3,636)
0.46
0.30
0.08
0.16
0.74
0.79
0.76
0.76
0.53
0.90
LUMIX (2,538 × 3,463)
0.45
0.29
0.10
0.17
0.73
0.75
0.73
0.73
0.53
0.88
FILM
0.51
0.33
0.05
0.11
0.82
0.88
0.84
0.86
0.53
0.90
Tests of model effects
Chi-square
26.01
7.25
7.25
9.26
12.70
16.52
24.84
10.23
10.02
4.82
Degree of freedom
3
3
3
3
3
3
3
3
3
3
value
0.026
0.064
0.064
0.026
0.005
0.001
0.000
0.017
0.018
0.186
Pairwise comparisons
CR versus ICR
Bonferroni’s significance
1.000
1.000
1.000
1.000
1.000
0.944
1.000
0.568
1.000
0.304
Delta for equivalence
0.022
0.061
0.061
0.022
0.036
0.0155
0.068
0.018
0.0
0.073
CR versus LUMIX
Bonferroni’s significance
1.000
0.223
0.223
1.000
1.000
0.063
0.518
0.011
0.424
1.000
Delta for equivalence
0.040
0.073
0.073
0.040
0.065
0.0176
0.093
0.075
0.001
0.049
FILM-CR
Bonferroni’s significance
0.094
1.000
1.000
0.094
0.048
1.000
0.078
0.009
0.380
0.532
Delta for equivalence
0.091
0.026
0.026
0.091
0.0144
0.068
0.0102
0.0134
0.0
0.068
FILM-ICR
Bonferroni’s significance
0.045
0.662
0.662
0.045
0.016
0.449
0.005
0.009
1.000
1.000
Delta for equivalence
0.083
0.069
0.069
0.083
0.0138
0.0172
0.0133
0.0139
0.0
0.038
FILM-LUMIX
Bonferroni’s significance
0.042
0.193
0.193
0.042
0.014
0.046
0.000
0.010
0.147
1.000
Delta for equivalence
0.097
0.084
0.084
0.097
0.0154
0.0197
0.0154
0.0199
0.001
0.052
Each mean was calculated from 147 observations (21 cases and seven radiologists). TP: true positive proportion, TN: true negative proportion, FN: false negative proportion, FP: false positive proportion, PPV: positive predictive value, SEN: sensibility; SPE: specificity; ACC: accuracy, ROC: receiver operating characteristic, AUC: area under ROC curve, δ: difference of the means allowed to achieve equivalence (i.e., to claim equivalence with a significant value).
