Noninferiority and Equivalence Evaluation of Clinical Performance among Computed Radiography, Film, and Digitized Film for Telemammography Services
Table 5
Equivalence tests (δ = 0.05) for TN, TP, FN, and FP by paired devices.
Variable
Compared devices
(1-2α)% confidence interval for equivalence testing
() device
() device
Lower
Upper
TN
LUMIX
ICR
−0.023
0.011
−4.31
<0.001
Ha
0.023
LUMIX
CR
−0.020
0.008
−5.23
<0.001
Ha
0.020
LUMIX
FILM
−0.032
0.000
−3.43
<0.001
Ha
0.032
ICR
CR
−0.015
0.015
−5.48
<0.001
Ha
0.015
ICR
FILM
−0.026
0.006
−4.10
<0.001
Ha
0.026
FILM
CR
−0.001
0.021
−5.98
<0.001
Ha
0.021
TP
LUMIX
ICR
0.000
0.032
−3.43
<0.001
Ha
0.032
LUMIX
CR
−0.025
0.009
−4.04
<0.001
Ha
0.025
LUMIX
FILM
−0.051
−0.011
−1.59
0.06
Ho
0.051
ICR
CR
−0.042
−0.007
−2.45
0.007
Ha
0.042
ICR
FILM
−0.069
−0.025
−0.23
0.41
Ho
0.069
FILM
CR
−0.003
0.047
−1.82
0.03
Ha
0.047
FN
LUMIX
ICR
−0.032
0.000
−3.43
<0.001
Ha
0.032
LUMIX
CR
−0.009
0.025
−4.04
<0.001
Ha
0.025
LUMIX
FILM
0.011
0.051
−1.59
0.06
Ho
0.051
ICR
CR
0.007
0.042
−2.45
<0.001
Ha
0.042
ICR
FILM
0.025
0.069
−0.23
0.41
Ho
0.069
FILM
CR
−0.047
0.003
−1.82
0.03
Ha
0.047
FP
LUMIX
ICR
−0.011
0.023
−4.31
<0.001
Ha
0.023
LUMIX
CR
−0.008
0.020
−5.23
<0.001
Ha
0.020
LUMIX
FILM
0.000
0.032
−3.43
<0.001
Ha
0.032
ICR
CR
−0.015
0.015
−5.48
<0.001
Ha
0.015
ICR
FILM
−0.006
0.026
−4.10
<0.001
Ha
0.026
FILM
CR
−0.021
0.001
−5.98
<0.001
Ha
0.021
Each comparison was calculated from 980 observations (70 cases, seven radiologists, and two devices). TN: true negative proportion, TP: true positive proportion, FN: false negative proportion, FP: false positive proportion, SE: standard error of the mean, Ho: null hypothesis, Ha: alternative hypothesis for testing equivalence, α: significance of the test (0.05), δ: difference of the means allowed to achieve equivalence, : test for difference of compared devices, that is, = (Difference () − δ)/SE, : retained hypothesis equivalence at δ level (“Ha” indicates equivalence achieved and “Ho” indicates failing to reject the null hypothes). Ho: difference () − δ = 0. Ha: difference () − δ < 0.