Noninferiority and Equivalence Evaluation of Clinical Performance among Computed Radiography, Film, and Digitized Film for Telemammography Services

Table 7

Equivalence tests for accuracy, PPV, sensitivity, specificity, and AUC by paired devices (δ = 0.05).

Variable	Compared devices		⁢(1-2α)% confidence interval ⁢for equivalence testing
	() device	() device	Lower	Upper
Accuracy	LUMIX	ICR	−0.013	0.034	−2.80	0.003	Ha	0.034
	LUMIX	CR	−0.036	0.008	−2.69	0.004	Ha	0.036
	LUMIX	FILM	−0.072	−0.022	−0.20	0.42	Ho	0.072
	ICR	CR	−0.047	−0.002	−1.84	0.03	Ha	0.047
	ICR	FILM	−0.084	−0.031	0.44	0.67	Ho	0.084
	FILM	CR	0.006	0.060	−1.06	0.14	Ho	0.060
PPV	LUMIX	ICR	−0.011	0.006	−9.10	<0.001	Ha	0.011
	LUMIX	CR	−0.015	0.001	−8.68	<0.001	Ha	0.015
	LUMIX	FILM	−0.017	−0.001	−8.20	<0.001	Ha	0.017
	ICR	CR	−0.012	0.003	−9.68	<0.001	Ha	0.012
	ICR	FILM	−0.013	0.000	−1.71	<0.001	Ha	0.013
	FILM	CR	−0.002	0.007	−17.47	<0.001	Ha	0.007
Sensitivity	LUMIX	ICR	0.001	0.068	−0.76	0.22	Ho	0.068
	LUMIX	CR	−0.053	0.019	−1.49	0.07	Ho	0.053
	LUMIX	FILM	−0.105	−0.025	0.61	0.73	Ho	0.105
	ICR	CR	−0.087	−0.017	0.09	0.54	Ho	0.087
	ICR	FILM	−0.142	−0.057	1.94	0.97	Ho	0.142
	FILM	CR	−0.004	0.100	−0.08	0.47	Ho	0.100
Specificity	LUMIX	ICR	−0.043	0.020	−2.00	0.023	Ha	0.043
	LUMIX	CR	−0.038	0.014	−2.43	0.008	Ha	0.038
	LUMIX	FILM	−0.061	−0.001	−1.05	0.15	Ho	0.061
	ICR	CR	−0.028	0.028	−2.90	0.002	Ha	0.028
	ICR	FILM	−0.049	0.011	−1.68	0.05	Ha	0.049
	FILM	CR	−0.001	0.040	−2.47	0.007	Ha	0.040
AUC	LUMIX	ICR	−0.098	0.115	−0.638	0.26	Ho	0.115
	LUMIX	CR	−0.073	0.042	−0.980	0.16	Ho	0.073
	LUMIX	FILM	−0.093	0.042	−0.592	0.28	Ho	0.093
	ICR	CR	−0.133	0.084	−0.387	0.35	Ho	0.133
	ICR	FILM	−0.118	0.049	−0.308	0.38	Ho	0.118
	FILM	CR	−0.066	0.086	−0.865	0.19	Ho	0.086

Each comparison was calculated from 980 observations (70 cases, seven radiologists, and two devices). PPV: positive predictive value, ROC: receiver operating characteristic, AUC: area under ROC curve, 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.